For other versions of this document, see http://wikileaks.org/wiki/CRS-RL33175 ------------------------------------------------------------------------------ Order Code RL33175 CRS Report for Congress Received through the CRS Web Importation of Prescription Drugs: A Side-by-Side Comparison of Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700 December 6, 2005 Susan Thaul and Donna U. Vogt Specialists in Social Legislation Domestic Social Policy Division Congressional Research Service ~ The Library of Congress Importation of Prescription Drugs: A Side-by-Side Comparison of Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700 Summary As prices of prescription drugs have risen, many in Congress have sponsored legislation to permit the importation of FDA-approved drugs from less expensive foreign sources. In the 109th Congress, three pairs of bills have been introduced to repeal the existing import restrictions and provide for limited forms of importation of prescription drugs. Current law and the bills all seek to balance the availability of imported prescription drugs -- both for commercial and personal use -- and the assurance that those imports would be safe and effective. An underlying goal is to reduce or restrain the growth of the financial burden that prescription drugs place on U.S. consumers. The drug importation provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA, P.L. 108-173) effectively do not allow the commercial or personal-use importation of prescription drugs. Congress, with the MMA, continued the major legal obstacle to importation: the requirement that the Secretary of Health and Human Services first certify that imports are safe and offer cost savings to U.S. consumers -- something no Secretary has been willing to do. This report, which will be updated, briefly discusses major differences among current law and the introduced bills, and presents a side-by-side comparison of their provisions. The bills are the Pharmaceutical Market Access Act of 2005 (S. 109, H.R. 328), the Safe Importation of Medical Products and Other Rx Therapies Act of 2005 (the Safe IMPORT Act of 2005; S. 184, H.R. 753), and the Pharmaceutical Market Access and Drug Safety Act of 2005 (S. 334, H.R. 700). Although all three pairs of bills seek to make lower-priced prescription drugs available to U.S. consumers by allowing importation while also ensuring that the drugs are safe and effective, they take different approaches. The proposed bills use extensive registration, licensing, facility inspection, and records requirements to document an imported shipment's chain-of-custody requirements, rather than the MMA's use of mandated laboratory testing of imported drugs to verify their content, potency, and labeling. Current law and the bills each have different lists of countries from which imports could be imported, and they provide the Secretary with different time frames and criteria for determining whether to permit commercial or personal- use importation. Secretarial reporting requirements vary as do mechanisms to fund the import activities: current law relies on appropriations alone, while the proposed bills each create specific user-fee provisions. The proposed bills also address the regulation of Internet pharmacies. S. 109/H.R. 328 and S. 334/H.R. 700 propose links to patent law to influence industry behavior. While current law does not specify when importation could begin, S. 109/H.R. 328 requires regulations to allow personal-use and commercial imports 180 days after enactment. S. 184/H.R. 753 provides for personal-use imports at enactment and commercial imports one year later. S. 334/H.R. 7000 begins imports from registered exporters 90 days after enactment and by registered importers one year after enactment. Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Safe and Effective Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Relationship to FDA Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Permitted Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Ensuring Drug Identity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Monitoring, Inspecting, and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Packaging and Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Internet Pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Cost Savings to U.S. Consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Discrimination and Unfair Acts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Drug Differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Patent Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Administration of Importation Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Effective Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Side-by-Side Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Direction to regulate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Commencem ent of program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 Permitted countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Qualifying drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Relationship to FDA approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Manufacturer requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Monitoring and inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Records of chain of custody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Registration of exporters and importers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Secretary's approval or disapproval of registration . . . . . . . . . . . . . . . . . . . 51 Licensing as pharmacist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Importer and exporter fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Packaging and anti-counterfeiting programs . . . . . . . . . . . . . . . . . . . . . . . . 65 Suspension and termination of importation of a product or by an importer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Prior notice of shipments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Warning notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Unfair and discriminatory acts and practices . . . . . . . . . . . . . . . . . . . . . . . . 84 Drugs refused admission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Drugs recalled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Personal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Rulemaking deadlines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Effective dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Internet pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 Prohibition of port shopping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 Charitable contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Controlled substances exemption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 List of Tables Table 1. Comparison of Prescription Drug Importation Provisions in Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Importation of Prescription Drugs: A Side-by-Side Comparison of Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700 Introduction In recent years, as prices of prescription drugs have risen, many in Congress have sponsored legislation to permit the importation of Food and Drug Administration (FDA) approved drugs from less expensive foreign sources. In the 109th Congress, three pairs of bills have been introduced to repeal the existing import restrictions and provide for limited forms of importation of prescription drugs. Current law and the bills all seek to balance the availability of imported prescription drugs -- both for commercial and personal use -- and the assurance that those imports would be safe and effective. An underlying goal is to reduce or restrain the growth of the financial burden that prescription drugs place on U.S. consumers. Current law bars importation unless the Secretary of Health and Human Services (HHS) certifies that imports are safe and offers cost savings to U.S. consumers. Congress reaffirmed this requirement, first established by the Medicine Equity and Drug Safety (MEDS) Act of 2000, most recently in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA, P.L. 108-173) in December 2003. The three bill pairs each would eliminate this requirement and, instead, include other potential safeguards regarding drug safety and effectiveness. They all would act primarily by replacing or amending Section 804 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which had been initially added to the FFDCA by the Medicine Equity and Drug Safety (MEDS) Act of 2000; individual bills would amend other laws. This report compares the provisions of three approaches to prescription drug importation (represented by three Senate and three House bills) with provisions on the subject in current law.1 The three bill pairs are: 1 For a detailed comparison of changes in Section 804 made by the MMA to the preexisting law (as established by the 2000 MEDS Act), see CRS Report RL32271, Importation of Prescription Drugs Provisions in P.L. 108-173, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, by Susan Thaul and Donna U. Vogt. For an analysis of the issues involved in drug importation, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt. CRS-2 ! The Pharmaceutical Market Access Act of 2005: S. 109, introduced by Senator Vitter on January 24, 2005, and H.R. 328, introduced by Representative Gutknecht on January 25, 2005; referred to in this report as the Vitter-Gutknecht bills. No action has been taken. ! The Safe Importation of Medical Products and Other Rx Therapies Act of 2005, or the Safe IMPORT Act of 2005: S. 184, introduced by Senator Gregg on January 26, 2005, and H.R. 753, introduced by Representative Bradley on February 10, 2005; referred to in this report as the Gregg-Bradley bills. No action has been taken. ! The Pharmaceutical Market Access and Drug Safety Act of 2005: S. 334, introduced by Senator Dorgan on February 9, 2005, and H.R. 700, introduced the same day by Representative Emerson; referred to in this report as the Dorgan-Emerson bills. In July 2005, Senator Dorgan successfully offered the drug importation provisions as an amendment to the Federal Trade Commission reauthorization bill (S. 1392) ordered to be reported by the Senate Commerce, Science and Transportation Committee.2 The differences in approach across the bills fall into three areas: attempts to ensure that imported drugs are safe and effective; attempts to influence industry behavior so drugs are available for import by U.S. consumers at cost savings to current domestic prices; and administrative arrangements. Safe and Effective Drugs Relationship to FDA Approval Current law and language proposed by the Vitter-Gutknecht and Gregg-Bradley bills explicitly require that an imported drug be approved for U.S. sale by the FDA. The Dorgan-Emerson bills would allow different administrative requirements for importation while maintaining the substantive elements of FDA approval. The Dorgan-Emerson bills require that a manufacturer notify the HHS Secretary when a drug that could be imported differs from the version FDA had approved for sale in the United States (the "U.S. label drug"). The bills require extensive information about whether the difference, if it were to be made to a U.S. label drug, would require a supplemental application to FDA and whether FDA would require that the application be processed before the drug could be marketed. 2 Elaine S. Povich, "Drug Importation Tacked to FTC Bill," July 21, 2005, at [http://nationaljournal.com]. CRS-3 Permitted Countries The three bills and current law vary in the countries from which they would permit drug importation. The most inclusive are the Vitter-Gutknecht bills,3 which include Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, members of the European Union, Iceland, Liechtenstein, and Norway. These bills also would allow the Secretary to designate additional countries that have equivalent regulatory requirements regarding safety and effectiveness, or to remove a country that does not. The Dorgan-Emerson bills differ from the Vitter-Gutknecht bills by excluding Israel, South Africa, and members of the European Economic Area that are not also members of the European Union (excluded are Iceland, Liechtenstein, and Norway), and, for European Union countries, by adding a reference to their Annex to the Treaty of Accession that essentially disqualifies the 10 countries admitted to membership in May 2004 (excluded are Cyprus, the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic). The Gregg- Bradley bills would include Canada and allow the Secretary, three years after enactment, to designate as eligible any members of the European Union as of December 2003. Current law includes only Canada, although it allows the Secretary to grant waivers permitting personal-use importation from other countries. Ensuring Drug Identity Sponsors of all three pairs of bills are concerned about the potential for entry of adulterated or counterfeit drugs into the U.S. market. Consequently, they call for a variety of procedures covering the registration of exporters or importers; chain-of-custody documentation; inspections of manufacturing, storage, and shipping facilities; laboratory testing of drug samples; packaging; and labeling of shipping containers and consumer products. Registration. Current law requires that a Canadian establishment involved in importing prescription drugs to the United States register its name and place of business and the name of its U.S. agent with the Secretary. All three bills have extensive registration requirements. The specifics vary and cover extensive recordkeeping, monitoring, inspections, and fees. The Vitter-Gutknecht bills would require all exporters to register; the Gregg-Bradley and Dorgan-Emerson bills require all exporters and all commercial importers to register. Monitoring, Inspecting, and Testing. While current law relies on laboratory testing of samples of every shipment of imported drugs to verify their content, potency, and labeling, the three proposed bills focus on documentation of a monitored, uninterrupted chain of custody from manufacturing facility to importer. The requirements related to registration involve ongoing and onsite physical monitoring of the facilities of a drug's manufacturer, exporter, or importer. If the Secretary determines it necessary, these would include the inspection of any facility (and its records) that handles the product along the chain of custody. 3 In one of the very few differences between S. 109 and H.R. 328, the Gutknecht bill restricts European Union members to those included as of Dec. 31, 2003. CRS-4 Packaging and Labeling. In addressing counterfeiting and product tampering, all three bills promote measures intended to ensure that the drug dispensed to the individual consumer is the same product that was tested, monitored, or inspected at the manufacturing, shipping, or storage facility. The Vitter-Gutknecht bills would require that the packaging of all prescription drugs (not just those being imported) incorporate overt optically variable counterfeit-resistant technologies that provide visible identification of the product, and be similar to those used to secure U.S. currency. In addition, manufacturers must incorporate the technologies into multiple elements of the packaging (including blister packs, shrink wrap, package labels, package seals, bottles, and boxes). Also, shipping containers of prescription drugs must have labels that incorporate technologies that enable inspectors to verify the authenticity of the shipment. The Gregg-Bradley bills would direct the Secretary to require the use of electronic track-and-trace technology at the case and pallet level that would identify each sale, purchase, or trade of each case or pallet. The Dorgan-Emerson bills require that the exporter and importer agree to mark each shipping container to identify its compliance with all registration conditions. The markings must include anti-counterfeiting or track-and-trace technology, taking into account their economic and technical feasibility, and must be designed to prevent unauthorized affixation. Internet Pharmacies. Current law does not address use of the Internet to sell or purchase imported prescription drugs. The Vitter-Gutknecht bills have no provisions specifically related to Internet pharmacy procedures, but include qualified Internet pharmacies among other registered exporters and the extensive associated requirements. The Gregg-Bradley and Dorgan-Emerson bills do address Internet sales. Their provisions address registration, posted information, prescriptions, and relationship to medical care. The Gregg-Bradley bills present an extensive statutory and regulatory structure for Internet pharmacies, placing it in the FFDCA but set apart from the importation sections. In addition to registration, the bills would require that Internet pharmacies provide specific professional services, including confidential patient medication profiles, "interactive and meaningful consultation by a licensed pharmacist," and verification of prescription validity. They require advance notice of commercial shipments of prescription drugs and include a licensing fee. Providers of interactive computer services would be liable if they accept advertising for a prescription drug from an unlicensed Internet pharmacy or accept advertising stating that a physician's prescription is not needed to obtain a prescription drug. The Gregg-Bradley bills also require policies and procedures to prevent payments for unlawful Internet pharmacy requests. The Dorgan-Emerson bills would require that detailed information be accessible on the Internet site, covering pharmacist credentials, address and telephone contacts, and the name and professional licensure information of the person, if any, who provides for medical consultations through the site for purposes of providing prescriptions. No one could dispense or sell a drug if the purchaser or patient who communicated through the Internet did not have a valid U.S. prescription. The dispenser of the prescription drug must have a "qualifying medical relationship with the patient." CRS-5 Cost Savings to U.S. Consumers Impetus to amend current law goes beyond the concern with drug safety. Even were the Secretary to issue the certification necessary to begin the drug importation section in the FFDCA, many analysts and Members of Congress anticipate manufacturer resistance. The Vitter-Gutknecht and Dorgan-Emerson bills contain specific provisions designed to influence industry behavior; the Gregg-Bradley bills do not. Discrimination and Unfair Acts The Vitter-Gutknecht bills and the Dorgan-Emerson bills would make it "unlawful for a manufacturer, directly or indirectly (including being a party to a licensing or other agreement)," to discriminate or act unfairly against an exporter, importer, or person who distributes, sells, or uses an imported prescription drug by charging a higher price; denying, restricting, or delaying supplies; or refusing to do business. Drug Differences The Vitter-Gutknecht and Dorgan-Emerson bills would make it unlawful for a manufacturer to make a drug for distribution in a permitted country so that it differs from the drug made for U.S. distribution "for the purpose of restricting importation of the drug.... " Provisions describe involvement of the Federal Trade Commission and the state attorneys general. The extensive notification requirements in the Dorgan-Emerson bills regarding differences between a drug a manufacturer produces for sale in a permitted country and the drug it produces for U.S. distribution could serve, in addition to addressing safety, to influence industry decisions. Patent Law The Vitter-Gutknecht and Dorgan-Emerson bills would insert a new subsection in the Patent and Trademark Act that would reverse judicial precedent holding that sales of patented goods outside the United States do not exhaust the U.S. patent. Under this provision, goods that were the subject of authorized foreign sales by the U.S. patent holder may be imported into the United States without regard to the U.S. patent. Administration of Importation Provisions The timing and funding of importation activities vary across current law and the proposed bills. Funding Current law includes no explicit funding mechanism other than authorizing appropriations of such sums as necessary to implement the prescription drug CRS-6 importation provisions. The Vitter-Gutknecht bills would not only authorize appropriations but also provide for exporter fees to cover the cost of administering the import provisions. The Gregg-Bradley and Dorgan-Emerson bills provide for both exporter and commercial importer fees designed to cover all costs of the program. All three bills link the aggregate total of all fees to the estimated costs of the importation program, setting a limit of 1% of the total price of drugs imported. The Secretary would collect from each exporter (and importer, except in the Vitter- Gutknecht bills) both a flat registration fee and a proportional registration fee. Each individual importer or exporter would pay the latter fee based on the extent of its own activity and calculated to estimate its proportion of the aggregate amount. The bills would require that these fees be used only for the administration of the importation provisions that the bills would add. Effective Dates Current law does not specify when importation could begin, other than linking it to the required safety and cost certification by the Secretary. It directs the Secretary to exercise discretion to permit importation by an individual for personal use, if it does not appear to present an unreasonable risk to the individual. The three proposed bills stipulate various time frames for commercial and personal-use importation, with varying times for different countries. The Vitter-Gutknecht bills would require that the HHS Secretary, in consultation with the United States Trade Representative and the Commissioner of Customs, issue regulations not later than 180 days after enactment, permitting pharmacists, pharmacies, wholesalers, and individuals to import qualifying drugs from permitted countries. The Gregg-Bradley bills' section on personal importation would take effect on the date of enactment, and their section on commercial importation would take effect one year after enactment, both "without regard to whether the Secretary ... has promulgated regulations.... " The Dorgan-Emerson bills would require that the Secretary promulgate a final rule for implementing the importation provisions not later than one year after promulgating an interim rule. It also states that the importation provisions shall "permit the importation of qualifying drugs ... without regard to the status of the issuance of implementing regulations" from registered exporters 90 days after enactment and from permitted countries by registered importers one year after enactment. Side-by-Side Comparison The following table arrays the prescription drug importation provisions of current law and the three pairs of proposed bills, with the columns ordered chronologically based on the date of enactment or introduction. Organized by topic, the rows do not directly follow the order of provisions in any of the compared documents. CRS-7 Table 1. Comparison of Prescription Drug Importation Provisions in Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Legislation Section 804 of the Federal [Section 4]a Amends Section [Section 2] Adds a new [Sections 3 and 4] Amends Food, Drug, and Cosmetic Act 804 of the FFDCA [21 USC Subchapter B -- "Importation Chapter VIII of the FFDCA by (FFDCA) was first established 384]. of Prescription Drugs" -- to replacing Section 804. under the Medicine Equity and Chapter VIII of the FFDCA, Drug Safety Act of 2000 (P.L. Also amends or adds provisions adding Sections 811-817. Also amends, deletes, or adds 106-387) as Importation of in other sections of the FFDCA, provisions in other sections of Covered Products. Section a n d i n 3 5 US C 2 7 1 [Section 16] Repeals Section the FFDCA, and in the 1121(a) of the Medicare [Infringement of Patent]. 804 of the FFDCA. Controlled Substances Import Prescription Drug, and Export Act [21 USC Improvement, and Also amends, deletes, or adds 956(a)(2)], and in 35 USC 271 Modernization Act of 2003 provisions in other sections of [Infringement of Patent]. (P.L. 108-173) replaced the FFDCA, and in the Section 804 entirely, renaming Controlled Substances Import it Importation of Prescription and Export Act [21 USC 956]. Drugs [21 USC 384]. a To distinguish between the section numbers of the bills pending in the 109th Congress and the section numbers they would change in the law, this table notes the former in brackets. Direction to 804(b). Regulations. Section 804(b). Regulations. Similar [Section 2(b)] Regulations. 804(a)(1-3). Importation of regulate 801(d)(1) of the FFDCA to current law, but (1) adds Authorizes the HHS Secretary prescription drugs. Waives allows only a drug's requirement to publish to promulgate regulations to Section 801(d)(1), which manufacturer to import that regulations within 180 days of carry out Section 812 [personal prohibits a drug's importation by drug. Section 804(b) requires enactment, (2) would allow importation] and directs the any entity other than its CRS-8 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 the Secretary of HHS, after pharmacies and individuals to Secretary to promulgate interim manufacturer, as long as the consultation with the United import in addi t i on to final regulations to carry out drug complies with the standards States Trade Representative pharmacists and wholesalers, Section 813 [pharmacy and of Section 801(a), which allow and the Commissioner of and (3) would allow imports wholesaler importation of only certain drugs to be Customs, to promulgate from other permitted countries, prescription drugs] of the imported. A qualifying drug regulations permitting not just Canada. FFDCA (as added by this may not be imported unless the pharmacists and wholesalers to section). Even if the Secretary drug is imported by a pharmacy, import prescription drugs from has not promulgated a group of pharmacies, or a Canada into the United States. regulations, Section 812 shall wholesaler that is a registered take effect on the date of importer, or by an individual for 804(j)(2). Waiver authority. enactment of this act, and personal or family member use The Secretary is authorized to Section 813 shall take effect (and not for resale) from a grant waivers, either through one year after enactment. registered exporter. rule-making or on a case-by- case basis, of the law that 813. Pharmacy and wholesaler allows only manufacturers to importation of prescription import FDA-approved drugs, drugs. A drug importation to allow individuals to bring in facility, pharmacy, Internet pharmaceuticals under pharmacy, or wholesaler may conditions the Secretary import a prescription drug from determines appropriate. The Canada or a permitted country Secretary must publish into the United States. guidance describing the consistent circumstances in which waivers would be granted to individuals. Commencem 804(l)(1). Commencement of No provision. No provision. No provision. CRS-9 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 ent of program. The drug import program program can begin only if the Secretary first certifies to Congress that its implementation would pose no additional risk to public health and safety, and would result in a significant reduction in the cost of covered products to American consumers. Termination 804(l)(2). Termination of No provision. No provision. No provision. of program program. The authority of the Secretary to terminate the program is restricted to the procedure in this section. Between 12 and 18 months after the regulations are implemented, if the Secretary certifies to Congress that, based on substantial evidence, in the opinion of the Secretary, the benefits of the implementation of the import program do not outweigh any detriment, drug imports under the section would cease 30 days after the certification is CRS-10 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 submitted. However, the certification may not be submitted unless, after a public hearing, the Secretary finds it is more likely than not that implementation will result in an increased risk to the public health; identifies, in qualitative and quantitative terms, the nature and causes of the increased risk; considers whether measures can be taken to avoid, reduce, or mitigate the increased risk and, if those measures would require additional statutory authority, to report to Congress describing needed legislation; identifies, in qualitative and quantitative terms, the benefits that would result from the program, including reductions in the cost of drugs to U.S. consumers, which would allow them to obtain needed medications without foregoing other necessities of life; and, in specific terms, compares the CRS-11 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 detriment with those benefits and determines the benefits do not outweigh the detriment. Permitted Stipulates that the Secretary's 804(a)(2). The term "permitted 811*(4)(A). [Note: Section 811 804(a)(4)(E). A "permitted countries regulations would include only country" means a country listed does not have a letter country" means Australia, Canada for imports by in FFDCA Section designating the beginning of Canada, Japan, New Zealand, pharmacists and wholesalers; 802(b)(1)(A); these are this subsection, which an Switzerland, or a member does not specify country for Australia, Canada, Israel, Japan, asterisk notes here.] Defines country of the European Union.b individual imports. New Zealand, Switzerland, "permitted country" as a Does not include a country South Africa, and a member member of the European Union whose Annex to the Treaty of country of the European Unionb as of December 31, 2003,b that Accession to the EU 2003 or a country in the European is designated by the Secretary i ncl udes a n o n - e x p i red Economic Area if the drug is based on a report due to the transitional measure for the marketed in that country or Senate HELP Committee and regulation of pharmaceuticals, or authoriz ed for general the House Energy and a country that does not meet the marketing in the European Commerce Committee three criteria the Secretary may use to Economic Area. The Secretary years after enactment (see add a country not listed here. may add a country, union, or under "Study and report," Those criteria relate to the economic area to the list if it below). country's having statutory or has a pharmaceutical regulatory requirements that infrastructure equivalent or 811*(4)(B). Report. Requires require the governmental review superior to that in the United that the Secretary, three years of the drug's safety and States; or remove from the list after enactment, submit to the effectiveness; authorize approval if it does not. In this decision, Senate HELP Committee and of only those drugs that have the Secretary should consider the House Committee on been determined to be safe and pharmacist qualifications, Energy and Commerce a report effective by experts qualified to pharmacy storage procedures, that includes a list of permitted j u d g e t h e s a f e t y a n d CRS-12 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 drug distribution and countries and why the Secretary effectiveness of the drugs based dispensing systems, and market determined that drug imports on adequate and well-controlled regulation. from such countries would not investigations, including clinical increase risk to the public investigations conducted by health. experts qualified by scientific training to evaluate the drug; Requires the Secretary to list require the methods used in and those countries from which the facilities and controls used prescription drug imports are for manufacturing, processing, not permitted and why, and and packing of drugs be what possible actions those adequate to preserve their countries might take to avoid, identity, quality, purity, and reduce, or mitigate increased strength; require reporting of risk. Authorizes the Secretary adverse reactions to drugs and to determine whether to procedures to withdraw or designate as permitted other remove unsafe or ineffective countries at any time after drugs; and require the labeling submission of the report. and promotion of drugs to be in accordance with the drug's 813(d). Prohibits the approval. The marketing importation of a prescription authorization system must be drug that had entered any equivalent to systems in the country other than Canada or countries that have qualified, and another the import of drugs into the permitted country after leaving United States from the country the control of the manufacturer. will not adversely affect U.S. Even when a drug comes from public health. a permitted country, if it had CRS-13 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 been outside the manufacturer's control, the Secretary may prohibit its import if the Secretary determines that allowing it would present a risk to the public health. b The European Union (EU), as of January 1, 2003, consisted of the following 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. On May 1, 2004, 10 countries joined the EU: Cyprus, the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic. [Note: S. 109 refers to EU; H.R. 328 specifies EU as of 12/31/03.] The European Economic Area consists of the European Union plus Iceland, Liechtenstein, and Norway. (The European Free Trade Association consists of Iceland, Liechtenstein, Norway, Switzerland, and the member states of the European Union.) CRS-14 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Definitions 804(a). Definitions. Defines 804(a). "Pharmacist," 811. Definitions. Defines 804(a)(4). Definitions. "importer" to mean a "wholesaler," and "qualifying "drug importation facility" as a "Pharmacist" and "wholesaler" pharmacist or a wholesaler; laboratory" are defined as in person, other than an individual are defined as in current law. "pharmacist" to mean a person current law. Defines importing a prescription drug Defines "registered exporter" to licensed by a state to practice "importer" to include not only under Section 812, located mean an exporter with an pharmacy, including the a pharmacist and wholesaler but outside the United States (other approved registration in effect; dispensing and selling of also a pharmacy, and group of than a transporter) that engages "registered importer" to mean a prescription drugs; and pharmacies. The term in the distribution or dispensing p h a r m acy, a gr o u p o f "wholesaler" to mean a person "pharmacy" means a person of a prescription drug that is pharmacies, or a wholesaler with licensed as a wholesaler or licensed by a state to sell imported or offered for an approved and in effect distributor of prescription prescription drugs at retail who importation into the United registration; and a "registration drugs in the United States, but employs 1 or more pharmacists. States. Defines "Internet condition" to mean a condition does not incl u d e the pharmacy" as a person that that must exist for a registration manufacturer of the drug being A "quali f yi ng Int er net offers to dispense a prescription to be approved. imported. "Qualifying pharmacy" means a registered drug through an Internet laboratory" is defined as a exporter that dispenses website in interstate commerce, Defines "exporter" to mean a laboratory in the United States qualifying drugs to individuals regardless of whether its person who is in the business of that has been approved by the over the Internet. physical location is in the exporting a drug to individuals Secretary for the purposes of United States. Defines in the United States from this section. Defines "registered exporter" "pharmacy" as a person Canada or from a permitted to mean an exporter that is licensed by a state to dispense country designated by the exporting or seeking to export a prescription drugs or to provide Secretary, or that seeks to be in drug to individuals in the pharmaceutical care. Defines such a business pursuant to United States with an approved "treating provider" as a submitting a registration. The registration in effect. licensed health care provider Secretary shall designate that (A) performs a documented countries (other than Canada) patient evaluation (including a that have statutory or regulatory patient history and physical standards equivalent to U.S. and CRS-15 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 examination) of an individual to Canadian standards for establish the diagnosis for pharmacist training and practice, which a prescription drug is protection of personal medical prescribed; discusses with the information privacy, and whose individual the treatment options imports will not adversely affect of the individual and the risks public health. The term and benefits of treatment; and "importer" to mean a pharmacy, maintains contemporaneous a group of pharmacies, or a medical records concerning the wholesaler that is in the drug individual; or (B) provides care importing business or that seeks to an individual as part of an an approved registration to do on-call or cross-coverage so; "pharmacy" means a person arrangement with a health care licensed by a state to engage in provider. Defines "wholesaler" the business of selling as a person licensed as a prescription drugs at retail and wholesaler or distributor of e m p l o ys o n e o r m o r e prescription drugs in the United pharmacists. States, but does not include the manufacturer of the drug being imported or an individual importing for personal use. Qualifying 804(a). Defines "prescription 804(a)(5). Same as current law. 811*(5). Defines "prescription 804(a)(4)(B,C). Defines drug drug" as a drug subject to drug" similarly to current law "prescription drug" as a drug Section 503(b) [a drug 804(a)(6). A "qualifying drug" [i.e., an FDA-approved drug], described in current law intended for use by man that is is a drug approved under with additional exceptions: a (FFDCA Section 503(b)(1)). not safe for use except under Section 505(b)(1) and is not a drug manufactured through any the supervision of a licensed drug manufactured through 1 or b i o t e c h n o l o g y p r o c e s s , A "qualifying drug" means a CRS-16 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 practitioner (as approved under more biotechnology processes, including a therapeutic DNA drug for which there is a U.S. Section 505)] other than a not required to be refrigerated, plasmid product, a therapeutic label drug. controlled substance, a and not a photoreactive drug. synthetic peptide product of not biological product, an infused more than 40 amino acids, a A "U.S. label drug" means a drug, an intravenously injected [Section 4(c)] Amends 804(c) monoclonal antibody product drug that has the same active drug, a drug that is inhaled by replacing "prescription for in vivo use, and a ingredient(s), route of during surgery, or a parenteral drug" with "qualifying drug" therapeutic recombinant DNA- administration, dosage form, and drug that the Secretary throughout. derived product; a drug strength as the qualifying drug; determines poses a threat to requiring refrigeration at any is manufactured by or for the the public health. time; or a photoreactive drug. person manufacturing the qualifying drug; is approved under Section 505(c) of the FFDCA; and is not a controlled substance, a biological product (including a therapeutic DNA plasmid product, a therapeutic synthetic peptide product, a monoclonal antibody product for in vivo use, and a therapeutic recombinant DNA-derived product), an infused drug, an injected drug, a drug inhaled during surgery, or a drug that is the listed drug referred to in two or more abbreviated new drug applications (ANDAs) under which the drug is commercially marketed. CRS-17 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 804(c). Sources of qualifying drugs. An exporter or importer may export or import a drug only if there is compliance with the following: the drug must have been manufactured in an FDA-registered establishment [registered under Sections 510(h) or 510(i)], and the establishment has been inspected either by the Secretary or by a permitted country whose regulatory system is recognized as equivalent under a mutual recognition agreement as provided in Section 510(i)(3) [ cooperative agree m e n t s between Secretary and foreign countries regarding means to determine whether a drug shall be refused admission into the United States], Section 803 [agreements between the Secretary and foreign countries regarding mutual recognition of good manufacturing practice regulations], or 21 CFR 26 [ m u t u a l re c o g n i t i o n o f CRS-18 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 pharmaceutical good manufacturing practice reports, medical device quality system audit reports, and certain medical device product evaluation reports: United States and the European Community] or a successor rule or regulation. The establishment, located in any country, manufactured the drug for distribution in the United States or a permitted country. In addition, the exporter or importer must obtain the drug directly from the manufacturing establishment or directly from an entity that, by contract with the exporter or importer, provides a chain of custody statement from the manufacturing establishment, identifying each prior sale, purchase, or trade with dates and names and CRS-19 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 addresses of all parties to the transaction; agrees to permit the Secretary to inspect the statements and related records to determine accuracy; and agrees to allow the Secretary to inspect warehouses and other facilities and records involved, including those of all contracting chain of custody parties, through contracts as necessary, to determine whether facilities are in compliance with any FFDCA standards that are applicable to facilities of that type in the United States. The foreign country from which the exporter will export the drug is the permitted country in which the exporter is located, or the foreign country from which the importer will import the drug is a permitted country. The exporter or importer ensures that during any period in which the drug was not in the drug manufacturer's control, the drug CRS-20 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 did not enter a non-permitted country. The exporter or importer must retain a sample of each lot of the drug, sufficient for testing by the Secretary. Relationship 804(c). L i m i t a t i o n . 804(a)(6). A qualifying drug 813(b)(1,2). Requirements. 804(g)(1). Compliance with to FDA Regulations must ensure that must be FDA-approved under Requires that each imported section 801(a) [Imports and approval all imported prescription drugs Section 505(b)(1). prescription drug be FDA- Exports]. For each exported or meet the same safety and approved [Section 505] and imported qualifying drug, the efficacy standards as drugs comply with FDA requirements exporter or importer must approved in the United States regarding adulteration [Section comply with FFDCA Section and that the importer comply 501] and misbranding [Section 801(a) standards subject to with all information, reporting, 502]. FFDCA Sections 505 [approval and testing requirements. The status], 502 [labeling], and 501 Secretary is permitted to adopt [adulteration]. such rules as necessary to safeguard public health or as a 804(g)(2)(A). Approval status. means to facilitate the A qualifying drug imported or importation of prescription offered for import must comply drugs. with conditions of the approved FDA new drug application under FFDCA Section 505(b) for the U.S. label drug. 804(g)(2)(B)(i). Approval CRS-21 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 status; Notice by manufacturer; General provisions. The manufacturer of the drug for commercial distribution in a permitted country shall submit notice to the Secretary that includes either (a) each di ffer e n c e b e t w e en t he qualifying drug and the U.S. label drug beyond variations provided for in the application and any difference in labeling (other than ingredient labeling), or (b) a statement of no such difference. 804(g)(2)(B)(ii). The notice must include information that the Secretary may require under FFDCA Section 506A [manufacturing changes]; any additional information (which may include data on bioequivalence if not otherwise required under 506A); the date that the qualifying drug with CRS-22 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 such a difference will be (or was) introduced for commercial distribution in the permitted country; demonstration that the manufacturer also notified the permitted country in writing that it is submitting this notice to the Secretary; and copies, with certified English translation, of all materials the manufacturer submitted to the permitted country for marketing approval in the permitted country. 804(g)(2)(B)(iii). The chief executive officer and the chief medical officer of the manufacturer must certify that the information in the notice is complete and true and has been provided also to the FTC and the state attorneys general. [Section 4(e)(4-5)] For the 100 prescription drugs with the highest dollar volume of sales in CRS-23 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 the United States in the preceding year (as defined), sets varying time limits for providing notice based on whether drug is for import from Canada (30 days) or from other countries (180 days). [Section 4(e)(6)] Notice for other drugs for import. Requires the Secretary to establish a series of notice submission dates for drugs not among the top 100 (see subparagraphs 4-5) in a manner allowing the consistent and efficient use of available resources and staff but to be completed not later than five years after enactment. The Secretary must establish these dates to allow review of notices regarding qualifying drugs with higher dollar volume of sales in the United States before review of notices regarding drugs with lower U.S. sales. CRS-24 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 [Section 4(e)(7)] Notices for drugs approved after effective date. Subparagraphs 4(e)(4-6) do not apply to a qualifying drug first introduced for commercial distribution in a permitted country after enactment of this act. [Section 4(e)(8)] Report. The Secretary must submit a report to Congress within 90 days of the end of each fiscal year, beginning with FY2006, concerning the FDA's progress in reviewing notices referred to in paragraphs (4-6) of Section 4(e). 804(g)(4). Section 501; Adulteration. A qualified drug imported or offered for import shall be considered in compliance with Section 501 [adulterated drugs] if the drug complies with subsection (c) CRS-25 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 [sources of qualifying drugs]. Manufacturer No provision. 804(l)(8). Amends section so No provision. 804(g)(2)(B)(iv). Fee. If a requirements that the term "manufacturer" in notice submitted shows that the this subsection means any difference would require the entity, including any affiliate or submission of a supplemental licensee of that entity, that is application if made as a change engaged in: (A) the production, to the U.S. label drug, the preparation, propagation, manufacturer submitting the compounding, conversion, or notice must pay to the Secretary processing of a prescription a fee in the same amount as drug, either directly or would apply if the person were indirectly, by extraction from paying a Prescription Drug User substances of natural origin, or Fee Act (PDUFA) fee for a independently by means of supplemental application. chemical synthesis, or by a Subject to Appropriations Acts, combination of extraction and such fees collected by the chemical synthesis; or (B) the Secretary are available only to packaging, repackaging, the Secretary and are for the sole labeling, relabeling, or purpose of paying the costs of distribution of a prescription reviewing notices. drug. 804(g)(2)(B)(v). Timing of submission of notices. For a notice regarding drug differences that would require approval CRS-26 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 before being marketed, the notice must be submitted to the Secretary at least 120 days before the changed drug is introduced for commercial distribution in a permitted country, unless the country requires earlier distribution. For a drug difference that would not require prior approval under Section 506A, the manufacturer must submit notice no later than the day its commercial distribution begins in the permitted country. 804(g)(2)(B)(vi). Review by the Secretary: The Secretary must review the difference between the qualifying drug and the U.S. label drug as if it were a manufacturing change to the U.S. label drug under Section 506A, using the same safe and effective standard for approving CRS-27 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 or disapproving a change. If the Secretary would approve the difference under 506A and the qualifying drug is not bioequivalent to the U.S. label drug, the Secretary may either: (1) include in the labeling a prominent advisory stating that the qualifying drug is safe and effective but is not bioequivalent to the U.S. label drug, if the Secretary decides an advisory is necessary for health care practitioners and patients to use the qualifying drug safely and effectively; or (2) decline to approve the difference if the Secretary decides that the availability of both the qualifying drug and the U.S. label drug would pose a threat to the public health. The Secretary must review and approve or disapprove the notice CRS-28 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 of a difference in the qualifying drug that would require prior approval under 506A within 120 days of its submission. If the review would require an inspection by the Secretary of the manufacturing establishment, such inspection shall be authorized. The Secretary may rely on a satisfactory report from a permitted country of a good manufacturing practice (GMP) inspection of the establishment if the Secretary recognizes such inspections as equivalent under a mutual recognition agreement as p ro v ided under Sect i o n 510(i)(3), Section 803, or 21 CFR 26. 804(g)(2)(B)(vii). Through FDA's Internet website and a toll-free telephone number, the Secretary shall readily make available to the public a list of notices submitted, dates of CRS-29 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 submissions, and the status of the Secretary's review, including determinations of whether the import was allowed in. The Secretary shall promptly update the Internet website with any changes to the list. 804(g)(2)(C). Notice; Drug difference requiring prior approval. If the notice regarding an imported drug shows that the difference, if made to a U.S. label drug, would require the approval of a supplemental application to FDA, the Secretary must notify registered exporters, registered importers, the Federal Trade Commission (FTC), and the state attorneys general that the notice has been submitted. If, by the date on which the drug involved is to be introduced for commercial distribution in a CRS-30 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 permitted country, the Secretary has not made a determination whether such a supplemental application would be approved, the Secretary must order that the importation of the involved drug not begin until the Secretary completes review of the notice. The Secretary must also promptly notify registered exporters, registered importers, the FTC, and the state attorneys general. If the Secretary decides that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall stop its importation or continue the earlier order, if any, to hold until the review had been completed; notify the permitted country that approved the drug for commercial distribution of the determination; and promptly CRS-31 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 notify registered exporters, registered importers, the FTC, and the state attorneys general of the determination. If the Secretary determines that the supplemental application regarding the U.S. label drug would be approved, the Secretary must vacate the hold order, if any, that had been placed on the import pending completion of the review; consider the difference to be a variation provided for in the approved application for the U.S. label drug; permit importation of the drug; and promptly notify registered exporters, registered importers, the FTC, and the state attorneys general of the determination. 804(g)(2)(D). Notice; Drug difference not requiring prior approval. If, under Section CRS-32 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 506(A)(3)(B), the difference described in the notice would not require prior approval before it could be made to the U.S. label drug, the following shall occur: During the period in which the notice is being reviewed by the Secretary, the authority under this subsection to import the drug involved continues in effect. If the Secretary determines that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall order that the importation of the drug involved from the permitted country cease; notify the permitted country that approved the drug for commercial distribution of the determination; and promptly notify registered exporters, registered importers, the FTC, and the state attorneys general of CRS-33 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 the determination. If the Secretary decides that a supplemental application concerning the U.S. label drug would be approved, the difference shall be considered a variation provided for in the approved application for the U.S. label drug. 804(g)(2)(E). Notice; Drug difference not requiring approval; No difference. If the difference between the U.S. label drug and the drug to be commercially distributed in a permitted country would not requi re a s u p p l e m e nt al application for the U.S. label drug under Section 506(A)(d)(1)(A), or if the notice states that there is no difference, the Secretary shall consider such difference to be a variation provided for in the approved CRS-34 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 application for the U.S. label drug, may not stop the importation, and must promptly notify registered exporters and importers. 804(g)(2)(F). Differences in active ingredient, route of administration, dosage form, or strength. A manufacturer of a drug approved under Section 505(b) [new drug approval] must submit an application under that section of the FFDCA for approval of a drug that it manufactures for distribution in a permitted country if: "there is n o q u a l i f yi n g d ru g i n commercial distribution in permitted countries whose combined population represents at least 50 percent of the total population of all permitted countries with the same active ingredient or ingredients, route of administration, dosage form, CRS-35 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and strength as the drug approved under Section 505(b)"; and "each active ingredient of the other drug is related to an active ingredient of the drug approved under section 505(b)...." [For purposes of this paragraph, active ingredients are related if they are "the same; or different salts, esters, or complexes of the same moiety."] The application under Section 505(b) must request approval of the drug for the indication(s) for which the U.S. label drug is approved and include the information [with a verified English translation, if necessary] that the manufacturer submitted to the government of the permitted country for purposes of obtaining approval for that drug's commercial distribution; include a right of reference to the application under Section 505(b) for the U.S. label drug; CRS-36 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and include such additional information as the Secretary may require. This application shall be submitted to the Secretary not later than the day on which the previous information is submitted to the government of the permitted country. The Secretary shall promptly notify registered exporters and importers, the FTC, and the state at t orneys general of a determination to approve or to disapprove an application. Testing 804(e). Testing. The importer 804(e). Testing. The importer No provision. No provision. or the manufacturer must (not the manufacturer) must conduct the required conduct the testing of authenticity testing at a qualifying drugs unless the drug qualified laboratory. If the is subject to the counterfeit- importer conducts these tests, resistant technologies the manufacturer must give the requirement. (Mention is not importing pharmacist or made to a qualified laboratory. wholesaler the information Nor is mention made here to needed to authenticate the manufacturer's labeling or product and confirm its protecting trade secrets and labeling. Also, testing information.) CRS-37 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 information must be kept in confidence and used only for testing or to otherwise comply with this act. The Secretary may adopt rules to protect trade secrets and commercial or financial information that is privileged or confidential. Monitoring No provision. 804(f)(5). Registration of [Section 13] Authority to 804(d)(1). Inspection of and exporters; Inspection of commission other federal and facilities. To assist the Secretary inspections importers and registered state officials to conduct to determine exporter exporters. The Secretary shall inspections. Amends the compliance with all required inspect warehouses, other FFDCA to permit the Secretary conditions, the exporter must facilities, and records of to sign a memorandum of agree to permit the Secretary: to importers and registered understanding with another conduct on-site inspections exporters as often as the federal agency or a state for its (including monitoring on a day- Secretary determines necessary e m p l o ye e s t o c o n d u c t to-day basis) of facilities that are to ensure compliance. examinations and investigations exporter owned, controlled or for the purposes of enforcing operated that relate to qualifying compliance with this act. The drugs; to have day-to-day access memorandum is to include to records, including financial provisions for ensuring records, and drug samples; to adequate training and verify the chain of custody of a reimbursement. Reporting to statistically significant sample of the Senate HELP Committee qualifying drugs, monitor and the House Committee on markings, and sample the CRS-38 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Energy and Commerce is exported drugs to assure required on the joint activities. compliance; and to carry out The Secretary may contract other functions that the Secretary with a state to use State Board determines necessary regarding of Pharmacy personnel to compliance. The Secretary is to conduct examinations and assign (on a continuous basis) inspections required by this act. one or more employees to Agreements with a state are perform these functions effective only in that state and randomly, but at least 12 times a for facilities located in that year at the exporter's places of state, and agreements are business. effective only at facilities that are jointly regulated by the Secretary and the other agency. Records of 804(d)(1). Information and 804(d)(1). Information and [ S ection 15(a ) ] 804(d)(3). Certain duties chain of records. Drug importers must records. Eliminates section of Anticounterfeiting provisions; relating to exporters. The custody provide information that the law referring to a drug Required records. Amends Secretary shall: randomly includes the name and amount being imported directly from Section 503(e) of the FFDCA inspect at least 12 times annually of the active ingredient of the the first foreign recipient; by requiring the wholesale an exporter's places of business drug; the dosage form of the correspondingly renames the distributor of record, for each where qualifying drugs are drug; the date the drug is list items; and deletes distribution, to provide to the stored and from where they are shipped; the quantity shipped; requirement that importer recipient the identity of the shipped; and verify the chain of information about its origin provide the Secretary with its immediately previous custody of a statistically and destination; the price paid professional license number. distributor of record from significant sample of qualifying by the importer; the original which the prescription drug was drugs from the manufacturing source of the drug; the amount purchased; and, for each establishment, which may be CRS-39 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 of each lot received from that wholesale distribution of an accomplished or supplemented source; the manufacturer's lot imported drug, to provide the by the use of anti-counterfeiting or control number; and the purchaser with identifying or track-and-trace technologies, importer's name, address, and information, such as dates and taking into account the economic license number. the names and addresses of all and technical feasibility of these parties to each transaction. technologies, except that no drug For a prescription drug Requires the distributor to keep shall be excluded if it lacks the imported directly from the first the records available for two technologies. foreign recipient from the years for Secretarial inspection, manufacturer, there must be including the immediately If exports are made to documentation indicating that previous and subsequent individuals for personal use, the the drug came directly from distributors of all distributions, Secretary is directed to randomly the manufacturer and was and, for imports, each previous review records of those exports subsequently shipped by that and subsequent distributor, to to determine whether the recipient to the importer; that the extent feasible. conditions required for the amount being imported is individual imports are being not greater than the quantity [Section 9] Adds to the met. That review process must that was originally received; FFDCA a new Section 815, allow a statistically significant and verification that each Maintenance and Inspection of determination of compliance. batch of the drug has been Records for Prescription The Secretary is directed to statistically sampled and tested Drugs. Authorizes the monitor the required markings of for authenticity and Secretary to establish, by exports. The inspectors shall degradation prior to regulation, requirements inspect, as the Secretary importation. Samples of relating to the establishment determines is necessary, the subsequent shipments of these and maintenance, for not longer warehouses and other facilities drugs must also be tested for than two years, of records by: a of other parties in the chain of authenticity and degradation. drug importation facility, custody of qualifying drugs, and CRS-40 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 For a prescription drug not pharmacy, Internet pharmacy, determine whether the exporter imported directly from the first or wholesaler engaged in the is in compliance with all other recipient in the foreign importation of prescription registration conditions. country, there must be drugs into the United States, or documentation demonstrating in the dispensing of such drugs; that each batch in each and any person that processes, shipment of the drug has been packages, distributes, receives, statistically sampled and tested holds, or transports a for authenticity and prescription drug imported degradation prior to under this subchapter. If the importation. Secretary has reason to believe that an imported prescription Also, the importer or drug presents a risk to the manufacturer must certify that public health, requires that the the drug is FDA-approved, drug importation facility, properly labeled, not pharmacy, Internet pharmacy, adulterated, and not or wholesaler that imports the misbranded; and provide prescription drug, and each laboratory records of person that processes, packages, authenticity testing, including distributes, receives, holds, or data, and evidence that testing transports the prescription drug was conducted in an approved permit the Secretary's officer or U.S. laboratory. The importer employee, with appropriate is required to provide any credentials and a written notice, other information that the at reasonable times, within Secretary determines is reasonable limits and in a necessary to ensure the public reasonable manner, to have CRS-41 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 health. access to and copy all records, in any format, at any location, needed to determine whether the prescription drug presents a risk to the public health. Requires the Secretary to prevent the unauthorized disclosure of any trade secret, confidential, or privileged information. The Secretary's requirements do not apply to personal-use imports. 804(d)(6). Certain duties relating to importers. The Secretary shall randomly inspect at least 12 times annually an importer's places of business where the qualifying drugs are i n i t i a l l y r e c e i v e d a f t er importation. During these inspections, the Secretary shall: (1) verify the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the CRS-42 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 importer, which shall be accomplished by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except a drug that lacks these technologies from the point of manufacture shall n o t b e e x cl u d ed f r o m importation by an importer; (2) review prior notices of shipments and inspect, if necessary, the warehouses and other facilities, including records, of other parties in the chain of custody of qualifying drugs; and (3) determine whether the importer is in compliance with all other registration conditions. 503(e)(1)(A) requires that [Section 7(a)] Wholesale anyone engaged in the distribution of drugs: Statements wholesale distribution of a regarding prior sale, purchase, drug and who is not the or trade; Striking of exemptions; manufacturer or an authorized Applicability to registered CRS-43 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 distributor of record of such exporters. Amends FFDCA drug must, before each Section 503(e) to include an wholesale distribution of such authorized distributor of record drug, provide to the person along with all wholesale who receives the drug a distributors to retail pharmacies statement identifying each to provide to the person who prior sale, purchase, or trade of receives the drug a statement such drug (including the date identifying each prior sale, of the transaction and the purchase, or trade of such drugs. names and addresses of all Also, requires the Secretary by parties to the transaction). r e gu l a t i o n t o e s t a b l i s h alternative requirements to identify the chain of custody through all transactions, which could include standardized anticounterfeiting or track-and- trace technologies that would identify chain-of-custody or the identity of the discrete package of the drug at least as well as the statements required by current law, and be economically and technically feasible. [Section 7(b)] Amends FFDCA Section 503(c) to require that each manufacturer of a CRS-44 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 prescription drug maintain a list of authorized distributors of record, defining "authorized distributors of record" to mean those with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products. [Section 7(c)] Provides effective dates, including a distinction for drugs at high risk of being counterfeited. Maintenance 804(d)(2). Maintenance by the Importers of drugs are to 804(j). Maintenance of records of Records Secretary. Records regarding maintain records for two years. and samples. Both importers an imported prescription drug and exporters must maintain must be provided to the records and samples of each lot Secretary, and then kept for of a drug required under this such time as the Secretary section for not less than two determines to be appropriate. years. The importer shall keep the records at the place of business at which the importer initially received the drug after importation. The exporter shall keep the records at the facility from which the exporter ships CRS-45 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 the qualifying drug to the United States. Registration 804(f). Registration of foreign 804(f). Registration of [Section 8] Registration of 804(b)(1). Registration of of exporters sellers. Requires any exporters; Inspections. To prescription drug importation importers and exporters. To and importers Canadian establishment register, an exporter must facilities. Adds to the FFDCA register, the importer or the engaged in the distribution of a submit to the Secretary the a new Section 814, Registration exporter (referred to as the prescription drug imported or name and addresses of every of certain importers, to require registrant) must submit to the offered for importation into the place of business of the a drug importation facility, Secretary: United States to register its exporter that relates to pharmacy, Internet pharmacy, name and place of business qualifying drugs, including or wholesaler engaged in the for exporters, the name and with the Secretary. Also each warehouse or other facility importation or offering for identification of all places of requires that the Canadian owned or controlled by, or importation of prescription business of the registrant, establishment register the operated for, the registrant. drugs into the United States, or including each warehouse or name of its U.S. agent. in the dispensing of such drugs, other facility owned or to register with the Secretary. controlled by, or operated for, the exporter; and To register, the person must submit: for importers, the name and identification of up to three [814(b)(1)(A)] the name and places of business (more with addr e s s of each drug permission of the Secretary) at importation facility, pharmacy, which the importer initially In t e r n e t p h a r m a c y, o r receives the qualifying drug after wholesaler at which, and all importation. trade names under which, the registrant conducts business; CRS-46 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 [814(b)(1)(B)] the name of each prescription drug to be imported into the United States; [814(b)(1)(C)] the name and address of an agent for service of process in the United States; and [814(b)(2)] timely notification of any change in the information. The registrant agrees: to Such information as is necessary make its places of business to demonstrate that the importer and records available to the is i n com p l i an ce w ith Secretary for onsite registration conditions relating inspections, without prior to the sources of exported drugs; notice, for the purpose of the inspection of facilities of the determining whether the importer; the payment of fees; registrant is in compliance compliance with the standards with this act's requirements; referred to in Section 801(a); and maintenance of records and samples. Such information is necessary to demonstrate that the exporter is in compliance with registration conditions relating CRS-47 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 to the sources of exported drugs; the inspection of facilities of the exporter and the marking of compliant shipments; the payment of fees; compliance with Section 801(a) standards; being licensed as a pharmacist; conditions for individual importation from Canada; and maintenance of records and samples. to export only qualifying The importer or the exporter drugs; must agree not to import or export any nonqualifying drug. to export only to persons The exporter must agree not to authorized to import the export a qualifying drug to drugs; anyone who is not a registered importer or an individual importing the drug for personal use or the use of a family member. to notify the Secretary of a The registrant must agree: to recall or withdrawal of a notify the Secretary of a recall or qualifying drug in a permitted withdrawal of a drug distributed country to or from which the in a permitted country that the CRS-48 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 drug will be imported or registrant has or intends to exported; export or import; provide for the return to the registrant of such a drug; and cease or not begin the exportation or importation of such a drug unless the Secretary has notified the registrant that imports may proceed. to monitor compliance with The registrant agrees to ensure conditions of registration and and monitor compliance with report any noncompliance each registration condition, to promptly; promptly correct any noncompliance, to promptly report to the Secretary any such noncompliance; to submit a compliance plan and to submit a plan as to how showing how the registrant the registrant will comply with will correct violations, if any; this compliance agreement. and to notify the Secretary The registrant must agree to promptly of any changes in update any information provided the registration information. in the registration or in the compliance plan; to notify the Secretary not more than 30 days before the registrant acts to make a change; CRS-49 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and to post a bond payable to the Treasury of the United States if, after opportunity for an informal hearing, the Secretary decides that the exporter has exported a drug to the United States that is not a qualifying drug or that is not in compliance with subsection (g). The bond amount is the lesser of the value of drugs exported by the exporter to the United States in a typical four-week period over the course of a year under this section, or $1,000,000. The Secretary may require other conditions for registration that would protect the public health while permitting imports of qualifying drugs by pharmacies, groups of pharmacies, wholesalers as registered importers, and individuals. The registrant must agree to enforce a contract under CRS-50 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 subsection (c)(3)(B) (records of chain of custody of a drug) against a party in the chain of custody of a qualifying drug and under the authority of the Secretary to permit the Secretary to inspect chain-of-custody statements to determine their accuracy and agree to facility and record inspections. The exporter agrees to comply with applicable provisions of Canadian law or the laws of the permitted countries that protect the privacy of personal information of each person importing from that exporter. 804(b)(1)(I) and (J). The exporter and importer agree to report to the Secretary not later than August 1 of each fiscal year, the total price and volume of drugs exported/imported by the exporter/importer during January through June of that CRS-51 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 year; and not later than January 1 of each fiscal year the total price and volume of drugs exported/imported the previous fiscal year. Secretary's No provision. 804(f)(2). Notice of approval 814(b)(3). Requires the 804(b)(2). Approval or approval or or disapproval. Within 90 Secretary, not later than 60 daysdisapproval of registration. The disapproval of days after receiving a after receipt of a completed Secretary must approve or registration complete registration, the registration, to assign a disapprove a registration within Secretary must notify the registration number to each 90 days of its submission and registrant of the receipt of the registered drug importation notify the registrant. If the regi s t rat ion, as s i gn a facility, pharmacy, Internet registration is disapproved, the registration number to the pharmacy, and wholesaler, and Secretary must notify the registrant, and approve or notify the registrant of the registrant as to why. After a disapprove the application. receipt of the registration. registration has been denied, if The Secretary can disapprove and when the registrant is in a registration if the registrant 814(c). Requires that the compliance, the Secretary must is not in compliance with a Secretary provide for and notify the registrant. Within 30 registration condition, and require electronic filing of days of receiving a registrant's may reverse the decision if he registrations, with adequate compliance plan, described or she later finds that the authentication protocols to above, the Secretary must decide registrant does comply. allow identification of the if the change affects the registrant and validation of the registrant's registration approval 804(f)(3). List. The Secretary data. and inform the registrant. shall maintain and update promptly a list of registered Requires that the Secretary 804(b)(3). Publication of CRS-52 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 exporters, including keep an up-to-date list of contact information for qualifying Internet registrants and make it registered exporters. The pharmacies, and make the list available to the public on an Secretary shall post publicly on available to the public on the Internet website and through a the FDA website and via a toll- FDA's website and via a toll- toll-free telephone number. free telephone number a list of free telephone number. registered exporters, including the exporters' contact 804(f)(4). Education of information, and update this consumers. The Secretary information promptly. shall carry out activities (through the website and toll- [Section 4(g)] Consumer free telephone number) that education. The Secretary must educate consumers about the act to educate consumers availability of qualifying regarding the availability of drugs for import for personal qualifying drugs for import for use, including how to verify personal use from a registered whether an exporter is exporter, including information registered. on how to verify whether an exporter is registered and approved by use of the FDA website and toll-free telephone number. The Secretary must educate consumers that the United States Customs Service (and Border Protection) may seize and destroy drugs CRS-53 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 otherwise imported, and that drugs from unregistered exporters may be counterfeit, unapproved, un s a f e, or ineffective. The Secretary must also educate consumers about the availability of qualifying drugs at registered domestic retail pharmacies. [Section 4(e)(2)] Review of registration by certain exporters. In the review of registration submissions, the Secretary must set as a priority within the first 90 days after enactment Canadian entities that are significant ex porters of prescription drugs to individuals in the United States as of the date of enactment, allowing a 30-day (rather than a 90-day) review period to approve or disapprove a registration. Whether the Canadian entity exported drugs to U.S. CRS-54 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 individuals on or before 90-days post enactment shall not serve as a basis for disapproving a registration. During the first year after enactment, the Secretary may limit the number of registered exporters to not less than 50, if the Secretary gives priority to those exporters with demonstrated ability to process a high volume of shipments of drugs to individuals in the United States. During the second year, the allowed limit is not less than 100. After two years, the Secretary may ask Congress for authority to limit the number of registered exporters if the limitation is necessary for the effective and efficient enforcement of requirements and the limitation will not restrict the ability of individuals to import CRS-55 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 prescription drugs for personal use from registered exporters. [Section 4(e)(3)] Limits on number of importers. During the first year after enactment, the Secretary may limit the number of registered importers to not less than 100 (of which at least a significant number shall be groups of pharmacies, as feasible), giving priority to those importers with demonstrated ability to process a high volume of shipments of drugs imported into the United States. The allowed limit for the second year is not less than 200, giving priority to importers with demonstrated ability to process a high volume of shipments of drugs to individuals in the United States. After three years, the Secretary may ask Congress for authority to limit the number of registered importers if the CRS-56 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 limitation is necessary for the effective and efficient enforcement of requirements, and the limitation will not restrict the ability of individuals to purchase qualifying imported drugs or restrict the savings available to individuals from those purchases. 814(d)(1). Authority. Nothing in this section authorizes the Secretary to require an application, review, or licensing process for a drug importation f a c i l i t y, p h a r m a c y, o r wholesaler. 814(d)(2). Importation by individuals. This section does not apply to a prescription drug imported by an individual for personal use or to a commercial transaction conducted between an Internet pharmacy and an individual. CRS-57 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 813(h). Jurisdiction. The district courts of the United States shall have jurisdiction in an action brought by the United States against a person importing or offering for importation a prescription drug in violation of the requirements of this section. [Section 8(c)] Amends Section 801 by adding 801(t), Failure to register. Prohibits delivery of a prescription drug until the drug importation facility, pharmacy, Internet pharmacy, or wholesaler is registered. Requires that the drug be held in a secure facility and not be transferred; does not authorize the delivery of the prescription drug pursuant to the execution of a bond while the prescription drug is held under this subsection. CRS-58 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Licensing as No provision. No provision. No provision. 804(h). Licensing as pharmacist pharmacist. A condition of registration is that the exporter agrees that a qualifying drug will be exported to an individual only if the Secretary has verified that the exporter is authorized under the law of the permitted country in which the exporter is located to dispense prescription drugs; and the exporter employs enough persons licensed under the law of the permitted country in which the exporter is located to dispense safely prescription drugs to individuals, and the exporter assigns to those persons responsibility for dispensing such qualifying drugs to individuals. Appropriation 804(m). Authorization of Same as current law. No provision. No provision. s appropriations. Authorizes to be appropriated such sums as are necessary to carry out this section. CRS-59 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Importer and No provision. [No importer fee provision.] [Section 14] Adds to the 804(e). Importer fees. exporter fees FFDCA a new Section 740A, [Section 5] Adds a new Section Fees relating to prescription 804(e)(1-2). Registration fee 740A to the FFDCA, Fees drug importation. Requires and inspection fee. With its relating to prescription drug the Secretary to establish a user registration submission, an importation. fee program under which a drug importer must pay the Secretary importation facility, pharmacy, a $10,000 fee. In addition, the 740A(a-c). Requires the In t e r n e t p h a r m a c y, o r importer must pay the Secretary Secretary to establish a wholesaler registering with the a semiannual inspection fee not registration fee program. For Secretary under Section 814 later than October 1 and April 1 the fiscal year in which the shall be required to pay the of each fiscal year. registered exporter first submits Secretary a fee beginning for a registration under Section 804 FY2005. Directs the Secretary 804(e)(3)(A). Aggregate total of (or resubmits a registration), the to determine the amount fees. The Secretary, in registered exporter will pay a annually based on anticipated consultation with the Secretaries fee of $10,000, payable when costs of enforcing this act, of Homeland Security and the the exporter submits the publish the fee 60 days in Treasury and not later than 30 registration. In subsequent advance of each fiscal year, days before the start of each years, the fee shall be payable hold a public meeting, and fiscal year, shall establish an on or before October 1 each provide time for public aggregate total of fees to be year and shall be paid only once comment. Directs the Secretary collected for a fiscal year from for each registered exporter. to use the collected fees, all importers that is sufficient, The Secretary will determine without further appropriation, and no more than necessary, to annually the amount of the fee to enforce the act. The fee shall pay the costs of administering based on the anticipated costs be payable annually and only this section with respect to of enforcement of the import once for each facility. From 30 registered importers for a fiscal CRS-60 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 program. The total aggregate days after the due date, a year. These are costs for fee collected shall not exceed registered facility may not inspecting the facilities of 1% of the total price of the import a prescription drug until importers and others in the chain drugs exported annually to the all fees are paid. Requires the of custody of the drug; U.S. by registered exporters. Secretary, 60 days after the end developing, implementing, and An exporter's fee shall be based of FY2006 and annually operating an electronic system on the Secretary's reasonable thereafter, to submit a report to for the submission and review of estimate of the exporter's the Senate HELP Committee prior notices of drug shipments; annual share of the volume of and the House Committee on and inspecting shipments, as drugs exported. Energy and Co m m erce necessary, to determine whether describing implementation of a shipment should be refused 740A(d). Requires fees be used the user fee authority during the admission. only for: administering this fiscal year and the use of the section, including the costs fees by the Secretary. 804(e)(3)(B). Amount of associated with inspecting the inspection fee; Limitation. The registered exporter facilities and aggregate total of fees collected other entities in the chain of for a fiscal year shall not exceed custody of a qualifying drug; 1% of the total price of drugs and developing, implementing, imported that year by registered and maintaining a system to importers under this section. decide if the registered exporters are complying with 804(e)(3)(C). Total price of the registration conditions and drugs. To estimate the total when shipments of qualifying price of qualifying drugs drugs are offered for import. imported in the United States by The fees shall also pay for registered importers, the CRS-61 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 inspecting shipments, when Secretary shall add the total necessary, to determine if any price of qualifying drugs should be refused admission. imported by each registered importer from January 1 to June 740A(e). The Secretary, 60 30 of the previous fiscal year. days prior to each fiscal year By March 1 of the following (beginning after Sept. 30, fiscal year, the Secretary shall 2005), must establish calculate the total by adding the registration fees. totals as reported to the Secretary. If the total price as 740A(f). If a fee is not paid calculated is less than the within 30 days after it is due, aggregate total of fees collected the Secretary will not permit for that fiscal year, the Secretary the registered exporter to export must, on April 1, provide a pro- to the United States or offer rata adjustment to each drugs for exportation until all registered importer of the fees are paid. subsequent fiscal year. 740A(g). Reports. Within 60 804(e)(3)(D). Individual days of the start of the fiscal importer fee. The fee to be paid year, the Secretary must publish on October 1 and April 1 by an the registration fees, hold a individual importer must be meeting where the public can proportional to a reasonable comment on the estimate by the Secretary of the recommendation, and provide a semiannual share of the importer 30-day period for written of the volume of drugs imported CRS-62 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 comments. Within 60 days by all U.S. importers. after the end of the fiscal year when fees are collected, the 804(e)(4). Use of fees. Subject Secretary shall submit to the to appropriations acts, the fees Senate HELP Committee and collected by the Secretary must the House Energy and be credited to the appropriations Commerce Committee a report account for FDA's salaries and that describes how the expenses until expended without registration fee authority was fiscal year limitation. The implemented and how the fees Secretary may, in consultation were used. with the Secretaries of Homeland Security and the Treasury, transfer some portion of the fees to the appropriation account for salaries and expenses of the Bureau of Customs and Border Protection until expended. Fees collected by the Secretary are available only to the Secretary (and, if transferred, to the Secretary of Homeland Security) and are for the sole purpose of paying the costs of activities outlined in 804(e)(3)(A). CRS-63 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 804(e)(5). Collection of fees. If the fees are not paid within 30 days after they are due, the fee shall be a claim of the U.S. Government (subject to subchapter II of Chapter 37, Title 31 USC). 804(f). Exporter fees. Requirements for exporters are similar to the requirements for importers, as above, except that the aggregate total of exporter fees must cover the costs of inspecting facilities of registered exporters and others in the chain of custody, as necessary; developing, implementing, and operating a system to screen marked shipments offered for import into the United States to indicate compliance with all registration conditions; and screening the markings and inspecting, as necessary, to determine if shipment should be CRS-64 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 refused admission. [Section 4(e)(9)] User fees. To establish the aggregate total of fees from exporters for FY2006, directs the Secretary to estimate the total price of drugs imported by registered exporters that year as $1 billion. To establish the aggregate total of fees from importers, directs the Secretary to estimate the total price of drugs imported by registered importers as $1 billion for FY2006 and $10 billion for FY2007. Directs the Secretary to allow for reestimates and adjustments for FY2007; and to prepare and submit an annual report on the implementation of the fee authority and the use, by FDA, of those fees. Also directs the Secretary of CRS-65 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 H o m e l a n d S e c u r i t y, i n consultation with the Secretary of the Treasury, beginning in FY2006, to prepare and submit a report to Congress on the use of the fees transferred to the Bureau of Customs and Border Protection. Packaging Requires that all imported [Section 6(a)] Counterfeit- [Section 3] Protection against 804(d)(2). Marking of and anti- drugs be FDA-approved and resistant technology. Amends adulterated prescription drugs. compliant shipments. The counterfeiting carry the FDA-approved the FFDCA by adding a new Amends Section 801(h) of the exporter must agree to mark programs labeling. subsection 502(v), stating that FFDCA [as added by P.L. 107- each shipping container of drugs if a drug is subject to section 188] to include prescription identifying that the shipment is 503(b), it shall be deemed to bedrugs along with food, as in compliance with all misbranded unless the drug's follows. Directs the Secretary registration conditions. The packaging complies with to give high priority to markings shall be designed to requirements of section 505C improving FDA information prevent unauthorized affixation, for counterfei t -res i s t ant management systems to allow and shall include anti- technologies. the Secretary to better allocate counterfeiting or track-and-trace resources, detect the intentional technologies, taking into account [Section 6(b)] Amends the adulteration, and facilitate the the economic and technical FFDCA by establishing a new importation of prescription feasibility of those technologies. Section 505C, Counterfeit- drugs. Also requires the Resistant Technologies. The Secretary to improve linkages 804(d)(5). The importer must Secretary must require that the with other federal regulatory comply with similar marking CRS-66 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 packaging of all prescription agencies, states, and Indian requirements, before wholesale drugs (not just those being tribes to ensure the safety of distribution, except the markings imported) incorporate overt imported prescription drugs. or other technology shall not be optically variable counterfeit- required on a drug that bears resistant technologies (as [ S ection 1 5 ( b ) ] comparable, compatible described in (b) according to Anticounterfeiting provisions; markings or technology from the standards in (c)) or technologies Electronic track and trace manufacturer of the drug. that the Secretary determines to technology. Directs the have an equivalent function of Secretary to require, no later security. than December 31, 2007, the adoption and use of electronic The technologies employed track-and-trace technology for a must provide visible prescription drug at the case identification of the product and pallet level that will (without the need for readers, identify each sale, purchase, or microscopes, lighting devices, trade of that case or pallet or scanners); be similar to those (including the date of used by the Bureau of transmission and the names and Engraving and Printing to addresses of all parties to the secure U.S. currency; be made transaction). and distributed in a secure environment; and should [ S ect i o n 1 5 (c)] integrate non-visible security Anticounterfeiting provisions; f e a t u r e s w i t h f orens i c Distributors of record. capability. Amends Section 503(e) of the FFDCA as follows. Defines CRS-67 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Manufacturers must incorporate "distributor of record" as a the technologies into multiple person that takes title to or elements of the packaging for possession of a drug from prescription drugs (including manufacture; this includes a blister packs, shrink wrap, person that manufactures, package labels, package seals, processes, packs, distributes, bottles, and boxes). Also, receives, holds, imports, or shipping containers for drugs offers for importation, and this must have labels that does not include a transporter. incorporate technologies that Defines "transporter" as the enable inspectors to verify the United States Postal Service, authenticity of the shipment. foreign government postal The labels must have: chain-of- service, or a private carrier in custody procedures according the business of transporting to contractual agreements for packages. Defines "wholesale the use and distribution of distribution" as the distribution labels; audit methods; and of a drug to other than the access to databases for consumer or patient but not government agencies to audit or including an intracompany sale verify the use of the labels. or distribution by a transporter. This section shall take effect 180 days after this act's [ S ection 15(d)] enactment. Anticounterfeiting programs. Requires the Secretary to establish a Counterfeit Alert Network to notify health CRS-68 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 professionals and the public of counterfeit drugs; and to develop, publish, and keep up- to-date (quarterly) an Internet- accessible reference document to identify prescription drugs marketed in the United States, Canada, and other countries as the Secretary permits. Directs the Secretary to develop and publish a range of materials, including those to help the identification and reporting of counterfeit drugs, practice guidelines (in cooperation with drug supply chain members) for the sale and distribution of drugs, and revised model rules (in cooperation with the National Association of Boards of Pharmacy) for state licensure of wholesalers. Labeling 804(h). Approved labeling. 813(b)(3,4). Requires that the 804(g)(3)(A). Labeling; Requires a drug manufacturer container have a prominent and Importation by registered to give the importer written conspicuous label with the importer. To be considered as CRS-69 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 authorization to use, at no cost, following items: the lot complying with FFDCA Section the approved labeling for the number; the name, address, and 502 and the labeling prescription drug. phone number of the drug requirements under the U.S. importation facility; a statement label drug's approved that the drug was imported, application, a qualifying drug naming the country from which that an importer imports or it came; and a unique identifier, offers for import must bear: the indicating that the drug has labeling approved for the U.S. been imported, based on the label drug by FDA according to national drug code of the FFDCA Section 505, without prescription drug. Requires regard to whether the copy bears that the drug comply with any the trademark; the name and other FFDCA requirements. location of the manufacturer; the lot number assigned by the 813(c). Approved labeling. manufacturer; the name, Requires that a drug location, and registration number importation facility demonstrate of the importer; and the National to the Secretary that the Drug Code number that the labeling of the prescription drug Secretary assigned to the to be imported into the United qualifying drug. States complies with the requirements of Sections 502 The Secretary shall provide a [ ad u l t eration] a n d 5 0 3 copy of the label to the [misbranding]. Requires that registered importer involved, the Secretary approve or deny upon request of the importer. the application within 60 days This labeling shall: (1) include CRS-70 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 of receipt and notify the the established name (as defined applicant of the decision and, if in Section 502(e)(3)) of each the application is denied, active ingredient; (2) not include provide the reason for the the brand or proprietary name of denial. Requires the Secretary the U.S. label drug or its active to maintain an up-to-date list of ingredient(s); (3) if required, application status. include a prominent advisory notice that the qualifying drug is 813(e). Prohibition of safe and effective but not commingling. Prohibits a drug bioequivalent to the U.S. label importation facility, pharmacy, drug; and (4) if the inactive In t e r n e t p h a r m a c y, o r ingredients are different from wholesaler from commingling those in the U.S. label drug, imported and not imported include a prominent notice that prescription drugs. Requires the ingredients differ. A that a pharmacy or Internet qualifying drug with different pharmacy that dispenses a inactive ingredients must be prescription drug imported dispensed with an advisory to from Canada or a permitted people with allergies about this country affix on each dispensed difference and with a list of the container of the drug the label ingredients of the qualifying required by FDA, unless such a drug as would be required under label is already affixed to the Section 502(e). container. 804(g)(3)(B). Labeling; CRS-71 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Importation by individual. A drug imported or offered for import by a registered exporter to an individual shall be considered to be in compliance with Section 502 and labeling requirements under the U.S. label drug's approved application if the packaging and labeling comply with the regulations promulgated under Sections 3 and 4 of the Poison Prevention Packaging Act of 1970 and the labeling includes directions for use by the consumer; the lot number assigned by the manufacturer; the name and registration number of the exporter; if required, a prominent advisory that the drug is safe and effective but not bioequivalent to the U.S. label drug; a prominent advisory for persons with allergies if the inactive ingredients differ from those of the U.S. label drug, and CRS-72 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 a list of the drug's ingredients as would be required under Section 502(e); and bear a copy of any special labeling that would be required by the Secretary had the drug been dispensed by a pharmacist in the United States, without regard to whether the special labeling bears any trademark involved. The Secretary shall provide to the registered exporter involved a copy of the special labeling, the advisory, and the ingredient list of the drug, upon request of the exporter. The requested labeling and ingredient list shall include the established name for each active ingredient and not include the proprietary name of the U.S. drug or any of its active ingredients. 804(l). Drug labeling. When an imported drug is dispensed by a CRS-73 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 pharmacist to an individual, the pharmacist must provide packaging and labeling that comply with all applicable regulations promulgated under Sections 3 and 4 of the Poison Prevention Packaging Act of 1970 and include with any other labeling to the individual the lot number assigned by the manufacturer, and the name and registration number of the importer. If the inactive ingredients differ from those of the U.S. label drug, the pharmacist must provide a prominent advisory that persons with allergies should check the ingredients, and also provide a list of the ingredients as would be required under FFDCA Section 502(e). If the Secretary had determined that the difference(s) in the qualifying drug would have been treated as a manufacturing change to the CRS-74 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 U.S. label drug under FFDCA Section 506A, the pharmacist must provide a prominent advisory that the drug is safe and effective but not bioequivalent to the U.S. label drug. CRS-75 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Suspension 804(g). Suspension of 804(g)(A). Suspension of [Section 6] Adds new Section 804(b)(4). Suspension and and importations. At the time of importation. Authorizes the 817, Suspension of importation. termination. termination of discovering a pattern of Secretary to suspend an Allows the Secretary to importation of counterfeit or violative exporter's registration, after i m m e d i a t e l y o rder t he 804(b)(4)(A). Suspension. The a product or products, the Secretary must notice and opportunity for a suspension of the importation Secretary may suspend a by an suspend importation of that hearing, for failing to maintain of a particular prescription drug registration if, after notice and importer specific prescription drug or compliance with registration or a particular dosage form by a opportunity for a hearing, the by that specific importer. The conditions. No prior notice is drug importation facility, exporter or importer fails to suspension must stay in effect required if the Secretary pharmacy, Internet pharmacy, maintain substantial compliance determines the exporter has until the Secretary investigates or wholesaler, or a country (but with registration conditions. In and determines whether the exported a non-qualifying drug not an individual importing for addition, the Secretary shall public is being adequately or exported a qualifying drug to personal use or an individual suspend immediately, without protected from counterfeit and an individual in violation of this engaged in an Internet prior notice, the registrant's violative drug products under section. Allows the Secretary pharmacy transaction) if the registration if the existing importation to reinstate a suspended Secretary determines it presents exporter/importer has regulations. registration if the Secretary a risk to the public health. exported/imported a non- determines that the registered Allows this action to be qualifying drug, not met the 804(k). Construction. exporter has demonstrated that appealed; requires that the requirements relating to a U.S. Nothing in this section limits further violations of registration Secretary, after providing label drug, or exported a drug to the Secretary's authority conditions will not occur. opportunity for an informal an individual who did not meet relating to the importation of hearing, confirm or terminate the conditions under law. prescription drugs, other than 804(g)(2)(B). Termination. the order within 30 days. An with respect to Section After notice and the opportunity order under this section shall The Secretary must give the 801(d)(1), which allows only for a hearing, the Secretary may not be subject to judicial exporter a hearing within 10 the manufacturer to import a terminate a registration if the review. days of the suspension. If the prescription drug. exporter has a pattern or Secretary determines that there CRS-76 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 practice of violating one or If the Secretary determines that would be no further violations, more registration conditions, or a drug importation facility, the Secretary may reinstate the if the exporter has had its pharmacy, Internet pharmacy, suspended registration. registration suspended on one or wholesaler, or a country (but or more occasions. During the not an individual importing for 804(b)(4)(B). Termination. period in which a registration is personal use or an individual Same as S. 109. terminated, any registration will engaged in an Internet have no legal effect if the pharmacy transaction) is 804(b)(5). Default of bond. exporter or a partner or engaged in a pattern of After opportunity for an principal officer of the importation that violates the informal hearing, the exporter's enterprise assisted in the act's requirements, the bond shall be defaulted and paid preparation of the registration. Secretary may immediately to the U.S. Treasury if the order suspension of importation exporter: shipped a non- of prescription drugs from that qualifying drug or a drug not in 804(g). Suspension of person or country. compliance with FFDCA importation. Rather than Section 505(b) for the U.S. label basing reinstatement on the drug [new drug applications], or Secretary's determination that Allows that this action be Section 501 [adulteration]; the public is adequately appealed; and requires the required conditions for shipment protected, the decision would Secretary, after providing to an individual; or failed to be based on the Secretary's opportunity for an informal permit an inspection. determination that the violation hearing, to confirm or terminate has been corrected and that the the order within 30 days. An importer has demonstrated that order under this section shall further violations will not not be subject to judicial occur. It also specifies that this review. CRS-77 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 subsection does not apply to a 813(i). Effect of section. drug imported by an individual Similar to current law. Nothing or shipped to an individual by a in this section [Pharmacy and qualifying Internet pharmacy. wholesaler importation of prescription drugs] limits the authority of the Secretary relating to the importation of prescription drugs (including the interdiction of prescription drugs that are unapproved, adulterated, or misbranded), other than with respect to the banning of anyone other than the m anufact urer from importing a prescription drug that had been supplied as a charitable contribution. Prior notice No provision. No provision. [Section 10] Advance notice of 804(d)(4). Prior notice of of shipments imported prescription drug shipments. A condition of shipments. Amends FFDCA registration is that the importer Section 801 to allow the of the prescription drug must Secretary to inspect drug give the Secretary advance imports at ports of entry. The (between 8 hours and five days) person importing or offering for notice of the name and contact importation the prescription person submitting the notice and CRS-78 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 drug must give the Secretary the importer; the established advance (between 24 hours and name of the drug, its quantity, five days) notice of: the manufacturer lot number, name established name, dosage form, of manufacturer and production and quantity of the prescription facility; country from which drug; the name of the shipper; drug will be shipped and the name of the country from shipper's contact information; which the prescription drug anticipated arrival information originates; the country from including port of arrival, which it is shipped; the name of crossing location, and the date the port of entry; and time; a summary of the documentation of the original chain of custody of the drug source of the prescription drug; from the establishment where the quantity of each lot of the manufactured to the importer; prescription drug originally and declaration whether the received by the facility from Secretary has ordered that that source; the lot or control imports cease from the permitted number assigned to the country as a result of review or prescription drug by the pending review of differences manufacturer of the prescription from the U.S. label drug; and drug; the name, address, other information that the telephone number, and Secretary may require by professional license number of regulation. the drug importation facility located in Canada or a permitted country; and CRS-79 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 certification from the drug importation facility located in a foreign country or from the manufacturer of the prescription drug that the prescription drug is approved for marketing in the United States and is not adulterated or misbranded and meets all labeling requirements under this act. Failure to provide notice results in holding of the drug at the point of entry. Enforcement FFDCA Section 301(aa) [Section 7] Prohibited acts. [Section 2(c)] Prohibited act. [Section 4(b)] Prohibited acts. prohibits the importation of a Amends the FFDCA to insert Amends Section 301 of the Amends FFDCA by replacing prescription drug in violation new subsection 301(l), adding FFDCA by prohibiting the Section 301(aa) to prohibit the of Section 804, the failure to register in accordance dispensing or offering to sale or trade by a pharmacist, or falsification of any record with Section 804(f) or to import dispense a prescription drug by a business organization of required to be maintained or or offer to import a drug in imported into the United States which the pharmacist is a part, of provided to the Secretary violation of a suspension order in violation of the requirements a qualifying drug that the under such section, or any under Section 804(g) (relating of the new Section 813 (relating pharmacist imported unless the other violation of regulations to being suspended from to pharmacy and wholesaler drug sold at retail is dispensed to under such section. importation). importation). a customer of the pharmacist or organization or is sold or traded to a pharmacy or wholesaler CRS-80 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 registered to import drugs; prohibit an individual who imports a drug for personal use from selling or trading that drug; prohibit the making of false, fictitious, or fraudulent statements in filing a notice or application regarding differences between the qualifying and the U.S. label drug, or to fail to submit such notice; and prohibit the falsification of any record required by the Secretary or any registration conditions. Amends FFDCA Section 303(a), by requiring violators of 301(i)(2-3) or 301(aa)(4) to be imprisoned not more than 10 years, fined, or both. [Section 7] Debarment for repeated or serious drug importation violations. Amends Section 306(b) of the FFDCA to allow the Secretary CRS-81 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 to debar a person (other than an individual importing for personal use or an individual engaged in an Internet pharmacy transaction) from importing a prescription drug for up to five years if the person has been convicted of a felony for conduct relating to the importation into the United States of any prescription drug; or has engaged in a pattern of importing or offering for import a prescription drug that presents a risk to the public health. Allows the Secretary to withdraw the debarment if the conviction on which it was based is reversed or if it serves the interests of justice and adequately protects the integrity of the prescription drug importation process. Amends FFDCA by adding Section 801(s), Importation of CRS-82 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 prescription drugs by debarred persons. Requires that a prescription drug imported by a debarred person be held at its port of entry or moved to a secure facility, if appropriate, and not otherwise be transferred. While the prescription drug is held under a bond, it may not be delivered. While the drug is being held, prohibits its transfer by any person from the port of entry or the secure facility where it is held. Allows for the delivery of a prescription drug to a non- debarred person if that person shows, at their own expense, that the drug complies with FFDCA requirements. Warning 801(g). Prohibits the [Section 4(c)] Amendment of notices Secretary from sending a certain provisions. Replaces warning notice (i.e., a FFDCA Section 801(g). communication from the Requires that, if a drug is Secretary notifying or clearly imported or offered for import CRS-83 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 suggesting to a person that by an individual not in the importing the drug for business of such importation, not personal use is or appears to be shipped by a registered exporter, a violation of this act) to an and refused admission, the individual not in the business Secretary notify the individual of importation with respect to that the drug was refused a drug being imported or admission because it was not a offered for import into the lawful import and is not United States unless the otherwise subject to a waiver; import is or appears to be: in and that the individual may violation of Section 801(a) lawfully import from a [Imports and Exports] if the registered exporter and can find drug is or appears to be information, including a list of adulterated, misbranded, or in registered exporters, on the violation of FFDCA Section FDA's website or toll-free 505 [New Drugs]; forbidden or telephone number. restricted in sale in the country in which it was produced and from which it was exported; in violation of Section 801(d)(1) [regarding insulin]; or otherwise in violation of federal law. The notice must state the reasons underlying the determination made by the Secretary, including a brief CRS-84 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 application of the principal facts involved in the provision of law that is the basis of the determination. Unfair and [Section 9(a)] Adds subsection 804(n)(1). Unfair and discriminator 804(l), Unfair or discriminatory acts and y acts and discriminatory acts and practices. Makes it unlawful for practices practices, to make it unlawful a manufacturer, directly or for a manufacturer, directly or indirectly (including by being a indirectly (including being a party to a licensing or other party to a licensing or other agreement) to: agreement) to discriminate or act unfairly against an exporter, discriminate against a registered importer, or person who exporter or other person in a distributes, sells, or uses permitted country that exports a prescription drugs imported to qualifying drug to the United the United States under Section States, a registered importer or 804 by: charging a higher price; other person that distributes, denying, restricting, or delaying sells, or uses a qualifying drug supplies; or refusing to do imported into the United States business. It is also unlawful to by charging a higher price; cause there to be a difference denying, restricting, or delaying (including a difference in active supplies; publicly, privately, or ingredient, route of otherwise refusing to do administration, dosage form, business with a registered CRS-85 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 strength, formulation, exporter, registered importer, or manufacturing establishment, other person that distributes, manufacturing process, or sells, or uses a qualifying person that manufactures the imported drug; drug) between the drug for distribution in the United States to knowingly fail to submit and the prescription drug for notices required by this act distribution in a permitted regarding differences between country for the purpose of the qualifying drug and the U.S. restricting importation of the label drug; to fail to submit them drug into the United States; to by required dates; or to refuse to allow a required k n owingly submit fal s e inspection or fail to conform to statements to fail to provide good manufacturing practice; or promptly information the to become a party to a licensing Secretary requests to review the or other agreement that fails to notice; provide for compliance with all requirements of this section, or to cause there to be a difference that would have the effect of (including a difference in active prohi bi t i n g t h e drug's ingredient, route of importation; or to engage in any administration, dosage form, other action that the FTC strength, formulation, determines to discriminate manufacturing establishment or against a person that engages process, or person that in, or to impede, delay, or block manufactures the drug) between the process for, the importation a drug for distribution in the US CRS-86 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 of the drug under this section. and in the permitted country; to refuse to allow authorized inspection of an establishment that manufactures the drug for commercial distribution in a permitted country; to fail to conform to good manufacturing practice of methods or facilities used for manufacturing, processing, packing, or holding a drug to be commercially distributed in a permitted country; to be a party to a licensing or other agreement related to a qualifying drug that fails to provide for compliance with all requirements of this section; to enter into a contract that restricts, prohibits, or delays the importation of a qualifying drug; to engage in any other action to restrict, prohibit, or delay the CRS-87 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 importation of a qualifying drug; or to engage in any other action that the FTC determines to discriminate against a person that engages or attempts to engage in the importation of a qualifying drug under this section. [Section 9(a)] The new 804(n)(2) addresses Affirmative subsection 804(l)(2,3) defense; Discrimination and addresses Affirmative defense, drug differences. Similar to S. and Presumption and 109 in that the presumption of affirmative defense. An entity affirmative defense is based on charged with any of the unfair the same language. But in or discriminatory acts and addition, the drug differences practices listed in this section can also be used as an has a defense to these charges if affirmative defense if the person its actions are based at least in manufacturing the drug for U.S. part on any reason other than a distribution has notified the reason relating to the person Secretary that the drug for U.S. exporting, importing, distribution is not different from distributing, selling, or using an a drug for distribution in imported drug. An affirmative permitted countries whose defense can also be based on combined population represents the presumption that the at least 50% of the total CRS-88 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 difference in active ingredient, population of all permitted route of administration, dosage countries; or if the difference form, strength, formulation, was not caused, in whole or in manufacturing establishment, part, for the purpose of manufacturing process, is restricting importation of the required by the country in drug into the United States. which the drug is distributed; or the Secretary has determined that the difference was necessary to improve the safety or effectiveness of the drug. 804(l)(4)(A). Sales in other 804(n)(3)(A). Sales in other countries. Specifies that the countries. Same as S. 109. subsection applies only to the sale or distribution of a prescription drug in a country if the manufacturer of the drug chooses to sell or distribute the drug in the country. Does not compel the manufacturer of a drug to distribute or sell the drug in a country. 804(l)(4)(B). Discounts to 804(n)(3)(B). Discounts to insurers, health plans, insurers, health plans, pharmacy pharmacy benefit managers, benefit managers, and covered CRS-89 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and covered entities. This act entities. Same as S. 109. does not: (i) prevent or restrict a drug manufacturer from providing discounts to an insurer, health plan, pharmacy benefit manager in the U.S., or a covered entity in the drug discount program under drug pricing agreements authorized in the Public Health Service Act in return for inclusion of the drug on a formulary; (ii) require that such discounts be made available to other prescription drug purchasers; or (iii) prevent or restrict any other measures taken by an insurer, health plan, or pharmacy benefit manager to encourage consumption of a prescription drug. 804(l)(5). Enforcement; Unfair 804(n)(4). Same as S. 109. In or discriminatory act or addition to allowing the FTC to practice; and Actions by the seek monetary relief threefold commission. A violation of this the damages sustained, allows CRS-90 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 new subsection shall be treated any other remedy available to as a violation of a rule defining the FTC under the FTC Act. an unfair or deceptive act or practice prescribed under Section 18(a)(1)(B) of the Federal Trade Commission (FTC) Act. The FTC must enforce this section as if the same terms and jurisdiction, powers and duties of the FTC under Section 18(a)(1)(B) were incorporated into this section. The FTC may seek threefold damages as monetary relief. 804(l)(6). Unfair or 804(n)(5-7). Actions by States. discriminatory acts and Similar to S. 109. practices; Actions by states. A state attorney general may bring a civil action in an appropriate U.S. district court to enjoin an unfair or discriminatory act or practice; enforce compliance; obtain damages, restitution, or other compensation on behalf of residents and persons doing CRS-91 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 business in the state, including three-fold damages; or obtain further relief as the court may deem appropriate. The state must provide a written prior notice to the FTC of the civil action and provide the FTC with a copy of the complaint except if it is not feasible to provide prior notice, then the state can serve the notice immediately upon instituting such an action and provide a notice and complaint copy to the FTC at the same time as the attorney general files the action. Once it receives the notice, the FTC has the right to intervene, to be heard on all matters, and to file petitions for appeal. Nothing in this chapter shall prevent a state attorney general from exercising the powers conferred on the attorney general by the CRS-92 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 laws of the state to conduct investigations or administer oaths or affirmations or to compel witnesses to attend or to produce documentary or other evidence. A state may not institute an action against the same defendant named in a complaint instituted by or on behalf of the FTC for a violation during the pendency. However, a state attorney general may intervene on behalf of the state's residents in an FTC action and, if so, the attorney general must be heard with respect to any matter that arises in that action and to file a petition for appeal. All civil actions brought before a U.S. district court may be brought where venue is proper under 28 USC §1391. The process may be served in any CRS-93 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 district in which the defendant lives or may be found. Any enforcement action taken by the FTC or a state attorney general will be forever barred unless it begins within five years after the FTC or the state attorney general knew that the cause of action accrued. No barred action under the existing law on the effective date of this act shall be revived by this act. If a defendant has been found to have violated a provision, damages may be assessed in the aggregate by statistical or sampling methods, by computing illegal overcharges, or by other systems of estimating aggregate damages as the court may deem appropriate without separately proving the individual claim of or amount of damage to persons on whose behalf the suit was CRS-94 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 brought. The district court must exclude from the monetary award any monetary relief that duplicates the amounts already awarded for the same injury. 804(l)(6)(G). Limitation of actions. 804(l)(7). Effect of antitrust laws. Nothing in this new subsection shall be construed to modify, impair, or supercede the operation of federal antitrust laws. [Section 9(b)] Regulations. The FTC shall promulgate regulations to carry out the enforcement program under new Section 804(1) of the FFDCA. [Section 6] Civil actions regarding property. Amends FFDCA Section 303 by adding CRS-95 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Section 303(g) that allows the Attorney General to commence civil action in any federal court to stop a person from alienating or disposing of property relating to a drug imported in violation of Section 801(a or d), with proceedings in a manner as applies under 18 USC 1345 and to take effect 90 days after enactment. Drugs refused FFDCA Section 801 prohibits 740A(d). In listing the allowed [Section 11] Authority to mark 804(g)(5). Standards for admission the importati on of a uses of collected fees, includes prescription drugs refused refusing admission. A drug prescription drug by anyone inspections necessary to admission into the United from a registered exporter may other than its manufacturer. determine whether a shipment States. Further amends Section be refused entry into the United The Secretary works with the should be refused admission. 801 of the FFDCA (as amended States if one or more of the Secretary of the Treasury to by Section 10(a) of this act) to following applies: the drug is refuse admission of all other allow the Secretary to require not a qualifying drug; a notice drugs. [Note: The U.S. the owner or consignee of the for the drug has not been Customs Service had been part drug to label any prescription submitted to the Secretary; the of the Dept. of the Treasury drug refused admission Secretary has ordered that until Congress created the "UNITED STATES: imports of the drug from the Dept. of Homeland Security, REFUSED ADMISSION" until permitted country cease because which includes customs the Secretary determines that differences from the U.S. label functions in its U.S. Customs the prescription drug has been drug would not have been CRS-96 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and Border Protection brought into compliance with approved in a supplemental component.] this act. The owner or application; the drug does not consignee shall be responsible comply with the labeling for all labeling expenses. requirements; the shipping Amends Section 502 of the container appears damaged in a FFDCA so that if the way that could affect the prescription drug does not carry strength, quality, or purity of the the label after the Secretary has drug; the Secretary becomes informed the owner, it shall be aware that the drug may be considered misbranded. This counterfeit, may have been does not apply to a personal-use prepared, packed, or held under import or a commercial insanitary conditions, or the transaction between an Internet methods used in or the facilities pharmacy and an individual. or controls used for the This section does not limit the manufacturing processing, authority of the HHS Secretary packing, or holding do not or the Secretary of the Treasury conform to good manufacturing to require the marking of processes; the Secretary has prescription drugs refused obtained an injunction under admission under any other Section 302 prohibiting the provision of law. drug's distribution in interstate commerce or has withdrawn the approval of the drug under Section 505(e); the manufacturer has instituted a recall of the drug; the drug is imported or CRS-97 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 offered for import by a registered importer without submission of a prior notice of shipment; or the drug is imported or offered for import from a registered exporter to an individual and the shipping container does not bear the r e q u i red m a r k i n gs , t h e container's markings appear to be counterfeit, or the shipping container or markings appear to have been tampered with. 804(i)(2). Notice regarding drug refused admission. If a registered exporter ships a drug to an individual and the drug is refused admission to the United States, a written notice shall be sent to the individual and to the exporter that informs them of the refusal and the reason for the refusal. [Section 5(a)] Creates in the [Section 5] Disposition of CRS-98 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 FFDCA a new Section 816, certain drugs denied admission Administrative detention. An into United States. Adds a new officer or qualified employee of FFDCA Section 805. the FDA may order the detention of any prescription 805(a-c). The Secretary of drug that it believes to present a Homeland Security shall deliver risk to the public health. If the to the HHS Secretary a drug Secretary approves, requires shipment (1) that has a declared that the drug be detained for upvalue less than $10,000 and to 30 days, labeled as detained whose shipping container does and placed in a secure facility.not bear required markings [of Until the Secretary releases thecompliance], or (2) of which the drug or the detention period HHS Secretary has requested expires, prohibits the transfer of delivery. The new section does the drug from detention, not authorize delivery pursuant including delivery pursuant to to a bond, nor may the drugs be the execution of a bond. exported. The HHS Secretary Allows the claimant to appeal must destroy these shipments if the detention and the Secretary the drugs violate any standard must confirm within five days described in Sections 804(g)(5) or the order will be terminated.[ s t an d ard s f o r r efu s i n g admission], 801(a) [imports and [Section 5(b)] Amends Section e x p o r t s ] , o r 8 0 1 ( d ) ( 1 ) 801 of the FFDCA by adding a [prohibition of importation of an paragraph (r), Temporary hold insulin product by other than its at port of entry. With approval manufacturer]. CRS-99 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 by the Secretary or a designated 805(d-f). Sets out procedures to official (director of the district identify and destroy a substantial in which the drug is located, or majority of violative shipments, a senior official of the director), allowing for preservation of directs an FDA officer or potential evidence, while qualified employee who efficiently using federal believes there is a risk to public resources. health and was unable to inspect to request the Secretary [Section 5(b-c)] Requires that of the Treasury to detain the procedures to carry out Section prescription drug for 24 hours 805 be established not later than to allow inspection. [Note: 90 days after enactment at which The U.S. Customs Service had time they would take effect. been part of the Dept. of the Treasury until Congress created the Dept. of Homeland Security, which includes customs functions in its U.S. Customs and Border Protection component.] Directs FDA, when detaining a drug, to notify the state of the port of entry. Prohibits the transfer of a detained drug or its removal or alteration of the detention label. Prohibits delivery of the CRS-100 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 prescription drug being held pursuant to the execution of a bond. This subsection does not apply to a drug imported by an individual for personal use or to a commercial transaction between an Internet pharmacy and an individual. Drugs No provision. No provision. 813(f). Drug recalls. Requires 804(k). Drug recalls. A recalled that a drug importation facility manufacturer of a drug imported promptly provide the Secretary from a permitted country shall and any person to whom the promptly inform the Secretary if prescription drug was the drug is recalled or withdrawn distributed a notice that the from the market in a permitted drug has been recalled or country; how the drug may be withdrawn from the market. identified, including lot number; Requires that the notification and the reason for the recall or include identifying information withdrawal. (including the lot number) and the reason for the recall or The Secretary shall enter into an withdrawal. agreement with the government of each permitted country to receive information about recalls and withdrawals of qualifying prescription drugs in the CRS-101 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 country; or monitor recalls and withdrawals of prescription drugs in permitted countries using any information that is available to the public. The Secretary may notify registered exporters, registered importers, wholesalers, pharmacies, or the public of a recall or withdrawal of a qualified drug in a permitted country. Personal use 804(j). Waiver authority for [Section 4(h)] Amends FFDCA 812. Personal importation. 804(i)(1). Individuals; importation by individuals. Section 804(j), Waiver Allows an individual to import Conditions for importation. An 804(j)(1). Declaration. authority for individuals. a prescription drug from individual may import a Congress declares that the Within 180 days of enactment, Canada or a permitted country qualifying drug if: the drug is Secretary should use discretion the Secretary shall by into the United States for accompanied by a copy of a when enforcing the current regulation permit an individual personal use (not for resale) if: prescription that is valid under legal prohibition against to import a drug from a the prescription drug is federal and state laws and was persons importing drugs or permitted country if it is a purchased from a licensed issued by a practitioner who, devices. The Secretary should qualifying drug; imported from pharmacy in Canada or a under the state law of which the focus enforcement on cases a licensed pharmacy or p e r m i t t ed co u n t r y a n d individual resides or receives where the importing may pose qualifying Internet pharmacy; dispensed in compliance with care from the practitioner, is a significant threat to public for personal use by an that country's applicable laws; authorized to administer CRS-102 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 health. When the importation individual or family member it is imported for personal use prescription drugs; the drug is is clearly for personal use and and not for resale; does not (not for resale) by the accompanied by documentation the prescription drug or device exceed a 90-day supply during individual; it is imported required by the permitted does not appear to present an any 90-day period; and has with physically by the individual; it country in which the exporter is unreasonable risk to the it a copy of a prescription, valid does not exceed a 90-day located to dispense the drug to individual, the Secretary under state and federal laws, supply during any 90-day the individual; copies of the U.S. should exercise discretion to that was issued by a practitioner period; and the prescription prescription and the permitted permit the importation by the authorized to administer drug is accompanied by a copy country's documentation must individual. prescription drugs. of a prescription valid in a state be marked to indicate the and cosigned by a prescribing prescription has been filled and 804(j)(3). The Secretary is An individual may import a physician in Canada or the to prevent duplicative filling by required to grant waivers, by drug from a non-permitted permitted country or, if the another pharmacist; the regulation, so persons can country if the individual while prescription drug is available in individual must have given the import for personal use up to a traveling in the country Canada or the permitted registered exporter a complete 90-day supply of an FDA- received the drug with a valid country without a prescription, list of all drugs used by the approved prescription drug prescription under that a copy of the valid prescription individual for review by those from a licensed pharmacy in country's laws and regulations, signed by a pharmacist licensed who dispense the drug; and the Canada, so long as the drug's enters the United States with in that country. quantity of the drug does not final dosage form was made in the drug, and the drug is exceed a 90-day supply. an FDA-registered facility, approved for commercial Compassionate use. Authorizes Ineligible for importation is a came from a registered distribution in the country the Secretary to permit an drug approved under accelerated Canadian seller, was where it was obtained, does not individual to import up to a procedures for serious or life- accompanied by a valid appear to be adulterated, and 90-day supply of a drug that is threatening illness with prescription, and was imported does not exceed a 14-day not approved by the Secretary restrictions to assure safe use (21 under conditions the Secretary supply. under FFDCA Section 505 if CFR 314 subpart H) and for determines were necessary to the importation is for which the Secretary has CRS-103 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 ensure public safety. continuation of personal use by published a Federal Register the individual for treatment, notice stating there is good cause begun in a foreign country, of a to refuse the import of this drug. serious medical condition. Rulemaking No provision. No provision. [Section 8(b)] Requires that the [Section 4(e)(f)] The Secretary deadlines Secretary, not later than one may promulgate an interim rule ye a r a f t e r e n a c t m e n t , for implementing Section 804 promulgate regulations to carry and may do so without providing out Section 814 [to register general notice of proposed prescription drug importation rulemaking. The Secretary must facilities]. promulgate a final rule not later than one year after promulgation date of interim rule. Effective No provision. 804(b). Directs the Secretary to [Section 2(b)(1)(B)] Directs [Section 4(e)(1)] Section 804 dates promulgate regulations that personal-use importation shall permit the importation of permitting commercial be allowed from enactment of qualifying drugs without regard importation of qualifying drugs this act, even if the Secretaryto the issuance of implementing from permitted countries not has not issued regulations. regulations (1) from registered later than 180 days after exporters 90 days after the act's enactment. [Section 2(b)(2)(B)] Directs enactment, and (2) from that pharmacy and wholesaler permitted countries by registered 804(j). Directs the Secretary to importation be allowed one importers one year after the date permit, by regulation, personal- year after enactment of this act of enactment. use importation not later than even if the Secretary has not 180 days after enactment. issued regulations. CRS-104 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 [Section 8(b)] Directs that registration of prescription drug importation facilities requirements take effect on the effective date of the final regulations or, if the final regulations have not been made effective, one year after enactment. Internet No provision. [Section 4] Includes various [Section 4] Adds to the [Section 8] Internet sales of pharmacies r e f e r e n c e s t o In t e r n e t FFDCA a new Section 511, prescription drugs. Adds to the pharmacies. Internet pharmacies. FFDCA a new Section 503B. 804(a)(7). Defines "qualifying 511(a). Definitions. Defines 503B(e). Defines "practitioner" Internet pharmacy" as a the terms "advertising service and "prescription drug" as in registered exporter that provider," "designated payment S ec t i o n 5 0 3 ( b ) ( 1 ) , an d dispenses qualifying drugs to system," "federal functional "qualifying medical individuals over an Internet regulator," "restricted relationship" as in new Section website. transaction," "unlawful Internet 503B(b). pharmacy request," "credit," "creditor," "credit card," 503B(f). Defines "Internet," "electronic fund transfer," "link," "page," "site" and "financial institution," "money "address," "domain name," and transmitting business," and "Internet Protocol numbers" and "money transmitting service." allows the Secretary to modify CRS-105 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 any definition to account for changes in technology. 804(f)(3). Includes qualifying In particular, defines "Internet 503B(a). Requirements Internet pharmacies among pharmacy" as a person that regarding information on registered exporters that the dispenses or offers to dispense Internet site. Makes it illegal, in Secretary must list. a prescription drug through an general, for anyone to "dispense Internet website in interstate a prescription drug pursuant to a 804(g)(2). Excludes a commerce in the United States sale of the drug by such person" prescription drug shipped to an regardless of whether the unless the person provides individual by a qualifying physical location of the certain required information on Internet pharmacy from certain principal place of business of each page of the site or a link to importation suspension the Internet pharmacy is in the a page with that information. authority of the Secretary. United States or in another These items are: the name of the country. Defines "unlawful dispensing person; each state in 804(j)(1)(B). Includes Internet pharmacy request" as which that person is authorized qualifying Internet pharmacies the request, or transmittal of a by law to dispense drugs; the in directing the Secretary to request for a prescription drug address and telephone number of permit by regulation an made to an unlicensed Internet each place of business of the individual to import a drug pharmacy by mail (including a person that sells drugs through from a permitted country. private carrier), facsimile, the Internet; the name of each phone, or electronic mail, or by person who serves as a a means that involves the use, pharmacist for drugs mailed or in whole or in part, of the shipped from that site's business Internet. and each state in which that person is authorized by law to CRS-106 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 511(b,c). Licensing of Internet dispense drugs; and, if the pharmacies. To dispense a person provides for medical prescription drug to a person in consultations through the site for the United States, requires that purposes of providing an Internet pharmacy be prescriptions, then the name of licensed with the Secretary and the person doing the have its principal place of consultations, each state in business in the United States, which that person is authorized Canada, or a permitted country. by law to do so or practice medicine, and the types of health In each state in which an professions for which the person Internet pharmacy seeks to holds a license or other dispense prescription drugs, authorization. The site shall also requires that the license have the words "licensing and application include verification contact information" with a link of compliance with all federal displayed in a clear and and state laws regarding the prominent place and manner. practice of pharmacy and the manufacturing and distribution 503B(d). Excludes a registered of controlled substances and, exporter from this section. for an Internet pharmacy in Canada or a permitted country, requires verification regarding compliance with applicable laws of that country. Also requires the application to CRS-107 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 include verification that the Secretary has not terminated a previous Internet pharmacy license of the owner, that the owner will permit inspections by the Secretary, and that any agreement between the Internet pharmacy and a patient releasing liability for negligence is null and void. Identification requirements. Requires that the Internet pharmacy website include the street address and telephone number of each place of business; the names of the supervising and Internet-service pharmacists; the names of all states or countries where the pharmacy and pharmacists are licensed or otherwise authorized to d i s p en s e prescription drugs; the name, address, telephone number, and state of licensure of any health CRS-108 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 care practitioner to whom the Internet pharmacy makes referrals; and a statement that it will dispense prescription drugs only after receipt of a valid prescription. Licensure procedure. Requires that the Secretary assign an ID number, notify the applicant of license application receipt, and issue a license within 60 days, if pharmacy complies with all required conditions. Directs the Secretary to require electronic submission of application and to ensure adequate authentication protocols. Requires that the Secretary keep an up-to-date list of licensees and make the list available to the public by an Internet website and a toll-free telephone number. CRS-109 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 511(c)(5). Licensing fee. The licensing fee for the year in which an Internet pharmacy first submits an application is $5,000. Requires that the Secretary publish, at least 60 days before the start of each fiscal year, and allow 30 days for comment, the licensing fee based on anticipated costs of enforcing requirements of this section in the subsequent year. Requires that the Secretary use, without further appropriation, the fees to carry out this section. The fee is due October 1 of each year and payable only once for each Internet pharmacy. If the Internet pharmacy has not paid the fee 30 days after the due date, prohibits it from dispensing drugs until it pays. Requires the Secretary, in 2005 and each subsequent year, to submit a report to Congress describing CRS-110 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 the implementation of the licensing fee authority and the use of the collected fees. Allows the Secretary to terminate a license if the Internet pharmacy has a pattern of noncompliance, made an untrue statement in the license application, or is in violation of an applicable federal or state law. Requires that, before renewing a license, the Secretary conduct an evaluation of compliance that may include testing of the website and other systems and a physical inspection of the records and premises. Authorizes the Secretary to award a renewable five-year contract to operate the licensing program, with annual performance reviews. P r o f e s s i o n a l s e r v i c e s 503B(b). Internet sales without requirements. Requires an a p p r o p r i a t e m e d i c a l Internet pharmacy to maintain relationships. No one can CRS-111 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 patient medication profiles, dispense or sell a drug if: the conduct prospective drug use purchaser or patient reviews, ensure patient communicated through the confidentiality in accordance Internet and did not, when with the Health Insurance communications began, have a Portability and Accountability valid U.S. prescription; the Act of 1996, offer interactive dispensing person provided for a and meaningful consultation by practitioner's involvement, or a licensed pharmacist, establish for someone the person a mechanism to report errors represented as a practitioner and and suspected adverse reactions that person issued a prescription and to document responses, for the drug that was purchased; develop a system to inform and the dispenser knew or had about drug recalls, educate reason to know that the about disposal of medications, individual referred to as the assure the sale is in accordance practitioner did not have a with a prescription from the qualifying medical relationship treating provider of the with the patient and the individual, and verify dispenser received payment for prescription validity by mail or dispensing the drug. electronic mail receipt from the treating provider. If the Such conditions do not apply to prescription is for a controlled dispensing or selling a drug substance, the Internet pursuant to telemedicine pharmacy must confirm with practices sponsored by a hospital the treating provider that the or certain group practices of at CRS-112 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 prescription is accurate and least 100 physicians with must provide the individual's provider agreements under name and address, identity and Medicare, or if the Secretary quantity of the drug, date determines the practice promotes prescription was presented to the public health. the Internet pharmacy, date and time of the verification request, To have a "qualifying medical and the name, telephone, fax, relationship with the patient," and e-mail contacts of the the practitioner must have Internet pharmacy contact conducted at least one in-person person. If the treating provider medical evaluation of the does not respond within 72 patient, or the practitioner hours or informs the pharmacy conducts an evaluation as a that the prescription is covering practitioner. An "in- inaccurate or expired, the person medical examination" Internet pharmacy may not fill requires the physical presence of the prescription. The Internet the patient as part of the pharmacy must maintain evaluation, without regard to records of direct whether other health communications with treating professionals conduct other providers. portions of the evaluation. Covering practitioners are practitioners who conduct a medical evaluation of the patient at the request of a practitioner who previously has conducted CRS-113 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 an in-person medical evaluation but is temporarily unavailable to conduct the evaluation of the patient. Someone who is not a practitioner lacks the legal capacity to have a qualifying medical relationship with any patient. This section does not prohibit conduct that is a standard practice of pharmacy. The qual i fying medical relationship requirement applies only to this section and does not affect interpretation of state law concerning the practice of medicine. 511(d). Providers of 503B(g). Interactive computer interactive computer services service; Advertising. If the or advertising services. provider of an interactive Establishes that these providers computer service (as defined in are liable if they accept Communications Act of 1934 advertising for a prescription [47 USC 230(f)(2)]) or of drug from an unlicensed advertising services does not CRS-114 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Internet pharmacy, or accept own or exercise corporate advertising stating a physician's control over a person selling or prescription is not needed to dispensing drugs in violation of obtain a prescription drug. this section, the provider shall not be held liable for that selling or dispensing. 511(e). Policies and [Section 8] Lists dispensing or procedures required to prevent selling a drug in violation of payments for unlawful Internet Section 503B as a prohibited act. pharmacy requests. Requires It also directs the Secretary to regulations within a year of consider practices and enactment regarding design procedures of public and private (using, for example, entities that certify as legitimate authorization codes) of the businesses selling prescription payment system (with system drugs through Internet sites, participant participation, if includi ng practices and feasible) to prevent or block procedures regarding disclosure restricted transactions. formats and verification Establishes that there be no programs. liability for blocking or refusing t o h o n o r a res t r i c t e d Authorizing appropriations of transaction. Requires that the $100,000 for each of FY2005- FTC and other federal FY2007, directs the Secretary to functional regulators (as make an award or contract to the defined in the Gramm-Leach- National Clearinghouse on CRS-115 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Bliley Act, 15 USC 6809) Internet Prescribing (operated by enforce this section taking into the Federation of State Medical consideration the person's Boards) to identify (and report to hi s t ory and ex t ent of state licensing boards, the compliance, the extent to which Attorney General, and the the person knew the transaction Secretary) Internet sites that was related to an unlawful appear to violate laws Internet pharmacy request, and concerning drug dispensing, and the feasibility of any specific to report annually to the remedy. Secretary describing investigations. 511(f). Reports regarding Internet-related violations of federal and state laws on dispensing of drugs. Directs the Secretary to award a grant or contract to develop and maintain a system of: identifying unlicensed Internet pharmacy websites or those in violation of federal or state laws; reporting these to state m edi cal and pharm acy licensing boards, the Attorney General, and the Secretary; and submitting reports each fiscal CRS-116 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 year to the Secretary. [Section 4(b)] Prohibited acts. Amends FFDCA Section 301, adding violations of Section 511 including drug sale or Internet pharmacy ownership, representing that a prescription drug may be obtained without a prescription, or accepting advertising from an Internet pharmacy without having a copy of the pharmacy's license on file. [Section 4(c)] Links to illegal Internet pharmacies. Amends FFDCA Section 302, stating that U.S. district courts and courts of the territories shall have jurisdiction to order an interactive computer service to remove or disable access to a website that violates this section. States that relief shall be available after notice and CRS-117 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 opportunity to appear; shall not oblige the provider to actively or passively monitory activity for violations; and shall specify the provider to which the relief applies. [Section 4(d)] Requires that the Secretary, within one year of enactment, promulgate interim final regulations consistent with the Verified Internet Pharmacy Sites certification program developed by the National Association of Boards of Pharmacy. States that the licensure requirement will take effect no later than 90 days after the publication of interim regulations. [Section 4(e)] Return to sender. Requires that a shipment of a prescription drug from an unlicensed Internet pharmacy be refused admission CRS-118 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 and that the Secretary return it at the pharmacy's expense. Directs the Secretary to return to the pharmacy at the pharmacy's expense a refused shipment from a licensed Internet pharmacy and to notify the individual and the Internet pharmacy of the reason. Prohibits the return of a prescription drug that is required to be destroyed. 503B(c). Actions by states. State attorney general can bring a civil action on if he or she believes that the state's residents have been or were threatened or adversely affected by someone engaging in a pattern or practice that violates Section 301(l), and may obtain reasonable attorneys fees and costs if the state prevails in the civil action or obtain further relief as the court may deem appropriate. The CRS-119 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 state must serve prior written notice upon the Secretary and provide a copy of the complaint. The Secretary then shall have the right to intervene. Does not prohibit an authorized state official from proceeding in state court. Prohibition of No provision. No provision. 813(a)(2). Limitation to certain No provision. port shopping ports. Allows the Secretary to limit to a reasonable number the ports of entry in the United States through which a prescription drug may be imported under this section. 813(c)(3)(B). Lists; Ports. Requires the Secretary to maintain an updated list of ports through which a prescription drug may be imported under this section and to make the list available to the public on an Internet website. CRS-120 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 [Section 12] Prohibition of port shopping. Prohibits entry of the prescription drug if it has previously been refused admission under Section 801(a), unless the person reoffering the prescription drug affirmatively establishes, at the expense of the owner or consignee of the prescription drug, that the prescription drug complies with the applicable requirements of this act, as determined by the Secretary. This section does not apply to a personal-use import or to a commercial transaction between an Internet pharmacy and an individual. Patents No provision. [Section 8] Patents. Amends No provision. [Section 4(d)] Exhaustion. the Patent and Trademark Act, Same as S. 109 Section 8. Patents and Protection of Patent Patents. [Amends Section 271 of Rights [35 U.S.C. Section 271], Title 35 USC by inserting a new which defines the protection of subsection (h) that would reverse patent rights and infringement judicial precedent holding that CRS-121 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 of a patent, by inserting sales of patented goods outside subsection 271(h), stating that it the United States do not exhaust would not be an act of the U.S. patent. Under this infringement to use, sell, or provision, goods that were the offer to sell a patented subject of authorized foreign prescription drug under Section sales by the U.S. patent holder 804 of the FFDCA if the drug may be imported into the United were first sold abroad by or States without regard to the U.S. under the authority of the patent.] owner or licensee of such patent. Charitable 804(i). Charitable [Section 9(a)] Adds Section 8 1 3 ( g ) . C h a r i t a b l e 804(m) and 804(n)(3)(C). contributions contributions. Section 804(l)(4)(C), Charitable contributions. Same as current Charitable contributions. Same 801(d)(1) of the act, which contributions. Amends current law. as S. 109. allows only the U.S. law to include a drug supplied manufacturer of a drug to at nominal cost by a import it into the United manufacturer. Also specifies States, will continue to apply that this subsection should not to a prescription drug donated prevent a manufacturer from or otherwise supplied at no making these transactions. charge by the manufacturer to a charitable or humanitarian organization or foreign government. CRS-122 S. 184 (Gregg 1/26/2005) and H.R. 753 (Bradley Current law: 2/10/2005) S. 334 (Dorgan 2/9/2005) Medicare Prescription S. 109 (Vitter 1/24/2005) and Safe Importation of and H.R. 700 (Emerson Drug, Improvement, and H.R. 328 (Gutknecht Medical Products and 2/9/2005) Modernization Act of 2003, 1/25/2005) Other Rx Therapies Act of Pharmaceutical Market enacted 12/8/2003 as P.L. Pharmaceutical Market 2005 or the Safe IMPORT Access and Drug Safety Act Topic 108-173 [117 Stat. 2464] Access Act of 2005 Act of 2005 of 2005 Controlled No provision. No provision. [Section 16(a)] Conforming [Section 9] Importation substances amendments. Repeals Section exemption under Controlled exemption 1006 of the Controlled Substances Import and Export Substances Import and Export Act. Amends Section 1006(a)(2) Act. of the Controlled Substances Import and Export Act by substituting a 10 dosage unit limit for the current 50 dosage unit limit for importation. ------------------------------------------------------------------------------ For other versions of this document, see http://wikileaks.org/wiki/CRS-RL33175