S 242 ISCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes.CommentsClose CommentsPermalink

January 10, 2007

Mr. DORGAN (for himself, Ms. SNOWE, Mr. GRASSLEY, Mr. KENNEDY, Mr. MCCAIN, Ms. STABENOW, Mr. SPECTER, Mr. BINGAMAN, Ms. COLLINS, Mrs. FEINSTEIN, Mr. DURBIN, Mr. NELSON of Florida, Mr. PRYOR, Mr. KOHL, Mr. LEVIN, Mr. SCHUMER, Mr. LEAHY, Mr. OBAMA, Mr. WYDEN, Mr. SANDERS, Mr. KERRY, Mr. BROWN, Mr. FEINGOLD, Mr. INOUYE, Mrs. LINCOLN, Mr. SALAZAR, Mrs. CLINTON, Mrs. BOXER, and Mr. TESTER) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the `Pharmaceutical Market Access and Drug Safety Act of 2007'.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

Congress finds that--CommentsClose CommentsPermalink





(1) Americans unjustly pay up to 5 times more to fill their prescriptions than consumers in other countries;CommentsClose CommentsPermalink





(2) the United States is the largest market for pharmaceuticals in the world, yet American consumers pay the highest prices for brand pharmaceuticals in the world;CommentsClose CommentsPermalink





(3) a prescription drug is neither safe nor effective to an individual who cannot afford it;CommentsClose CommentsPermalink





(4) allowing and structuring the importation of prescription drugs to ensure access to safe and affordable drugs approved by the Food and Drug Administration will provide a level of safety to American consumers that they do not currently enjoy;CommentsClose CommentsPermalink





(5) American spend more than $200,000,000,000 on prescription drugs every year;CommentsClose CommentsPermalink





(6) the Congressional Budget Office has found that the cost of prescription drugs are between 35 to 55 percent less in other highly-developed countries than in the United States; andCommentsClose CommentsPermalink





(7) promoting competitive market pricing would both contribute to health care savings and allow greater access to therapy, improving health and saving lives.CommentsClose CommentsPermalink

SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF PRESCRIPTION DRUGS.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804.CommentsClose CommentsPermalink

SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT RESTRICTIONS.

(a) In General- Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 3, is further amended by inserting after section 803 the following:CommentsClose CommentsPermalink

`SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.

`(a) Importation of Prescription Drugs-CommentsClose CommentsPermalink





`(1) IN GENERAL- In the case of qualifying drugs imported or offered for import into the United States from registered exporters or by registered importers--CommentsClose CommentsPermalink





`(A) the limitation on importation that is established in section 801(d)(1) is waived; andCommentsClose CommentsPermalink





`(B) the standards referred to in section 801(a) regarding admission of the drugs are subject to subsection (g) of this section (including with respect to qualifying drugs to which section 801(d)(1) does not apply).CommentsClose CommentsPermalink





`(2) IMPORTERS- A qualifying drug may not be imported under paragraph (1) unless--CommentsClose CommentsPermalink





`(A) the drug is imported by a pharmacy, group of pharmacies, or a wholesaler that is a registered importer; orCommentsClose CommentsPermalink





`(B) the drug is imported by an individual for personal use or for the use of a family member of the individual (not for resale) from a registered exporter.CommentsClose CommentsPermalink





`(3) RULE OF CONSTRUCTION- This section shall apply only with respect to a drug that is imported or offered for import into the United States--CommentsClose CommentsPermalink





`(A) by a registered importer; orCommentsClose CommentsPermalink





`(B) from a registered exporter to an individual.CommentsClose CommentsPermalink





`(4) DEFINITIONS-CommentsClose CommentsPermalink





`(A) REGISTERED EXPORTER; REGISTERED IMPORTER- For purposes of this section:CommentsClose CommentsPermalink





`(i) The term `registered exporter' means an exporter for which a registration under subsection (b) has been approved and is in effect.CommentsClose CommentsPermalink





`(ii) The term `registered importer' means a pharmacy, group of pharmacies, or a wholesaler for which a registration under subsection (b) has been approved and is in effect.CommentsClose CommentsPermalink





`(iii) The term `registration condition' means a condition that must exist for a registration under subsection (b) to be approved.CommentsClose CommentsPermalink





`(B) QUALIFYING DRUG- For purposes of this section, the term `qualifying drug' means a drug for which there is a corresponding U.S. label drug.CommentsClose CommentsPermalink





`(C) U.S. LABEL DRUG- For purposes of this section, the term `U.S. label drug' means a prescription drug that--CommentsClose CommentsPermalink





`(i) with respect to a qualifying drug, has the same active ingredient or ingredients, route of administration, dosage form, and strength as the qualifying drug;CommentsClose CommentsPermalink





`(ii) with respect to the qualifying drug, is manufactured by or for the person that manufactures the qualifying drug;CommentsClose CommentsPermalink





`(iii) is approved under section 505(c); andCommentsClose CommentsPermalink





`(iv) is not--CommentsClose CommentsPermalink





`(I) a controlled substance, as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802);CommentsClose CommentsPermalink





`(II) a biological product, as defined in section 351 of the Public Health Service Act (42 U.S.C. 262), including--CommentsClose CommentsPermalink

`(aa) a therapeutic DNA plasmid product;CommentsClose CommentsPermalink

`(bb) a therapeutic synthetic peptide product;CommentsClose CommentsPermalink

`(cc) a monoclonal antibody product for in vivo use; andCommentsClose CommentsPermalink

`(dd) a therapeutic recombinant DNA-derived product;CommentsClose CommentsPermalink

`(III) an infused drug, including a peritoneal dialysis solution;CommentsClose CommentsPermalink





`(IV) an injected drug;CommentsClose CommentsPermalink





`(V) a drug that is inhaled during surgery;CommentsClose CommentsPermalink





`(VI) a drug that is the listed drug referred to in 2 or more abbreviated new drug applications under which the drug is commercially marketed; orCommentsClose CommentsPermalink





`(VII) a sterile opthlamic drug intended for topical use on or in the eye.CommentsClose CommentsPermalink





`(D) OTHER DEFINITIONS- For purposes of this section:CommentsClose CommentsPermalink





`(i)(I) The term `exporter' means a person that is in the business of exporting a drug to individuals in the United States from Canada or from a permitted country designated by the Secretary under subclause (II), or that, pursuant to submitting a registration under subsection (b), seeks to be in such business.CommentsClose CommentsPermalink





`(II) The Secretary shall designate a permitted country under subparagraph (E) (other than Canada) as a country from which an exporter may export a drug to individuals in the United States if the Secretary determines that--CommentsClose CommentsPermalink





`(aa) the country has statutory or regulatory standards that are equivalent to the standards in the United States and Canada with respect to--CommentsClose CommentsPermalink

`(AA) the training of pharmacists;CommentsClose CommentsPermalink

`(BB) the practice of pharmacy; andCommentsClose CommentsPermalink

`(CC) the protection of the privacy of personal medical information; andCommentsClose CommentsPermalink

`(bb) the importation of drugs to individuals in the United States from the country will not adversely affect public health.CommentsClose CommentsPermalink





`(ii) The term `importer' means a pharmacy, a group of pharmacies, or a wholesaler that is in the business of importing a drug into the United States or that, pursuant to submitting a registration under subsection (b), seeks to be in such business.CommentsClose CommentsPermalink





`(iii) The term `pharmacist' means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.CommentsClose CommentsPermalink





`(iv) The term `pharmacy' means a person that--CommentsClose CommentsPermalink





`(I) is licensed by a State to engage in the business of selling prescription drugs at retail; andCommentsClose CommentsPermalink





`(II) employs 1 or more pharmacists.CommentsClose CommentsPermalink





`(v) The term `prescription drug' means a drug that is described in section 503(b)(1).CommentsClose CommentsPermalink





`(vi) The term `wholesaler'--CommentsClose CommentsPermalink





`(I) means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 503(e)(2)(A); andCommentsClose CommentsPermalink





`(II) does not include a person authorized to import drugs under section 801(d)(1).CommentsClose CommentsPermalink





`(E) PERMITTED COUNTRY- The term `permitted country' means--CommentsClose CommentsPermalink





`(i) Australia;CommentsClose CommentsPermalink





`(ii) Canada;CommentsClose CommentsPermalink





`(iii) a member country of the European Union, but does not include a member country with respect to which--CommentsClose CommentsPermalink





`(I) the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired; orCommentsClose CommentsPermalink





`(II) the Secretary determines that the requirements described in subclauses (I) and (II) of clause (vii) will not be met by the date on which such transitional measure for the regulation of human pharmaceutical products expires;CommentsClose CommentsPermalink





`(iv) Japan;CommentsClose CommentsPermalink





`(v) New Zealand;CommentsClose CommentsPermalink





`(vi) Switzerland; andCommentsClose CommentsPermalink





`(vii) a country in which the Secretary determines the following requirements are met:CommentsClose CommentsPermalink





`(I) The country has statutory or regulatory requirements--CommentsClose CommentsPermalink

`(aa) that require the review of drugs for safety and effectiveness by an entity of the government of the country;CommentsClose CommentsPermalink

`(bb) that authorize the approval of only those drugs that have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs;CommentsClose CommentsPermalink

`(cc) that require the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country to be adequate to preserve their identity, quality, purity, and strength;CommentsClose CommentsPermalink

`(dd) for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective; andCommentsClose CommentsPermalink

`(ee) that require the labeling and promotion of drugs to be in accordance with the approval of the drug.CommentsClose CommentsPermalink

`(II) The valid marketing authorization system in the country is equivalent to the systems in the countries described in clauses (i) through (vi).CommentsClose CommentsPermalink





`(III) The importation of drugs to the United States from the country will not adversely affect public health.CommentsClose CommentsPermalink





`(b) Registration of Importers and Exporters-CommentsClose CommentsPermalink





`(1) REGISTRATION OF IMPORTERS AND EXPORTERS- A registration condition is that the importer or exporter involved (referred to in this subsection as a `registrant') submits to the Secretary a registration containing the following:CommentsClose CommentsPermalink





`(A)(i) In the case of an exporter, the name of the exporter and an identification of all places of business of the exporter that relate to qualifying drugs, including each warehouse or other facility owned or controlled by, or operated for, the exporter.CommentsClose CommentsPermalink





`(ii) In the case of an importer, the name of the importer and an identification of the places of business of the importer at which the importer initially receives a qualifying drug after importation (which shall not exceed 3 places of business except by permission of the Secretary).CommentsClose CommentsPermalink





`(B) Such information as the Secretary determines to be necessary to demonstrate that the registrant is in compliance with registration conditions under--CommentsClose CommentsPermalink





`(i) in the case of an importer, subsections (c), (d), (e), (g), and (j) (relating to the sources of imported qualifying drugs; the inspection of facilities of the importer; the payment of fees; compliance with the standards referred to in section 801(a); and maintenance of records and samples); orCommentsClose CommentsPermalink





`(ii) in the case of an exporter, subsections (c), (d), (f), (g), (h), (i), and (j) (relating to the sources of exported qualifying drugs; the inspection of facilities of the exporter and the marking of compliant shipments; the payment of fees; and compliance with the standards referred to in section 801(a); being licensed as a pharmacist; conditions for individual importation; and maintenance of records and samples).CommentsClose CommentsPermalink





`(C) An agreement by the registrant that the registrant will not under subsection (a) import or export any drug that is not a qualifying drug.CommentsClose CommentsPermalink





`(D) An agreement by the registrant to--CommentsClose CommentsPermalink





`(i) notify the Secretary of a recall or withdrawal of a qualifying drug distributed in a permitted country that the registrant has exported or imported, or intends to export or import, to the United States under subsection (a);CommentsClose CommentsPermalink





`(ii) provide for the return to the registrant of such drug; andCommentsClose CommentsPermalink





`(iii) cease, or not begin, the exportation or importation of such drug unless the Secretary has notified the registrant that exportation or importation of such drug may proceed.CommentsClose CommentsPermalink





`(E) An agreement by the registrant to ensure and monitor compliance with each registration condition, to promptly correct any noncompliance with such a condition, and to promptly report to the Secretary any such noncompliance.CommentsClose CommentsPermalink





`(F) A plan describing the manner in which the registrant will comply with the agreement under subparagraph (E).CommentsClose CommentsPermalink





`(G) An agreement by the registrant to enforce a contract under subsection (c)(3)(B) against a party in the chain of custody of a qualifying drug with respect to the authority of the Secretary under clauses (ii) and (iii) of that subsection.CommentsClose CommentsPermalink





`(H) An agreement by the registrant to notify the Secretary not more than 30 days before the registrant intends to make the change, of--CommentsClose CommentsPermalink





`(i) any change that the registrant intends to make regarding information provided under subparagraph (A) or (B); andCommentsClose CommentsPermalink





`(ii) any change that the registrant intends to make in the compliance plan under subparagraph (F).CommentsClose CommentsPermalink





`(I) In the case of an exporter--CommentsClose CommentsPermalink





`(i) An agreement by the exporter that a qualifying drug will not under subsection (a) be exported to any individual not authorized pursuant to subsection (a)(2)(B) to be an importer of such drug.CommentsClose CommentsPermalink





`(ii) An agreement to post a bond, payable to the Treasury of the United States that is equal in value to the lesser of--CommentsClose CommentsPermalink





`(I) the value of drugs exported by the exporter to the United States in a typical 4-week period over the course of a year under this section; orCommentsClose CommentsPermalink





`(II) $1,000,000;CommentsClose CommentsPermalink





`(iii) An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B).CommentsClose CommentsPermalink





`(iv) An agreement by the exporter to report to the Secretary--CommentsClose CommentsPermalink





`(I) not later than August 1 of each fiscal year, the total price and the total volume of drugs exported to the United States by the exporter during the 6-month period from January 1 through June 30 of that year; andCommentsClose CommentsPermalink





`(II) not later than January 1 of each fiscal year, the total price and the total volume of drugs exported to the United States by the exporter during the previous fiscal year.CommentsClose CommentsPermalink





`(J) In the case of an importer, an agreement by the importer to report to the Secretary--CommentsClose CommentsPermalink





`(i) not later than August 1 of each fiscal year, the total price and the total volume of drugs imported to the United States by the importer during the 6-month period from January 1 through June 30 of that fiscal year; andCommentsClose CommentsPermalink





`(ii) not later than January 1 of each fiscal year, the total price and the total volume of drugs imported to the United States by the importer during the previous fiscal year.CommentsClose CommentsPermalink





`(K) Such other provisions as the Secretary may require by regulation to protect the public health while permitting--CommentsClose CommentsPermalink





`(i) the importation by pharmacies, groups of pharmacies, and wholesalers as registered importers of qualifying drugs under subsection (a); andCommentsClose CommentsPermalink





`(ii) importation by individuals of qualifying drugs under subsection (a).CommentsClose CommentsPermalink





`(2) APPROVAL OR DISAPPROVAL OF REGISTRATION-CommentsClose CommentsPermalink





`(A) IN GENERAL- Not later than 90 days after the date on which a registrant submits to the Secretary a registration under paragraph (1), the Secretary shall notify the registrant whether the registration is approved or is disapproved. The Secretary shall disapprove a registration if there is reason to believe that the registrant is not in compliance with one or more registration conditions, and shall notify the registrant of such reason. In the case of a disapproved registration, the Secretary shall subsequently notify the registrant that the registration is approved if the Secretary determines that the registrant is in compliance with such conditions.CommentsClose CommentsPermalink





`(B) CHANGES IN REGISTRATION INFORMATION- Not later than 30 days after receiving a notice under paragraph (1)(H) from a registrant, the Secretary shall determine whether the change involved affects the approval of the registration of the registrant under paragraph (1), and shall inform the registrant of the determination.CommentsClose CommentsPermalink





`(3) PUBLICATION OF CONTACT INFORMATION FOR REGISTERED EXPORTERS- Through the Internet website of the Food and Drug Administration and a toll-free telephone number, the Secretary shall make readily available to the public a list of registered exporters, including contact information for the exporters. Promptly after the approval of a registration submitted under paragraph (1), the Secretary shall update the Internet website and the information provided through the toll-free telephone number accordingly.CommentsClose CommentsPermalink





`(4) SUSPENSION AND TERMINATION-CommentsClose CommentsPermalink





`(A) SUSPENSION- With respect to the effectiveness of a registration submitted under paragraph (1):CommentsClose CommentsPermalink





`(i) Subject to clause (ii), the Secretary may suspend the registration if the Secretary determines, after notice and opportunity for a hearing, that the registrant has failed to maintain substantial compliance with a registration condition.CommentsClose CommentsPermalink





`(ii) If the Secretary determines that, under color of the registration, the exporter has exported a drug or the importer has imported a drug that is not a qualifying drug, or a drug that does not comply with subsection (g)(2)(A) or (g)(4), or has exported a qualifying drug to an individual in violation of subsection (i)(2)(F), the Secretary shall immediately suspend the registration. A suspension under the preceding sentence is not subject to the provision by the Secretary of prior notice, and the Secretary shall provide to the registrant an opportunity for a hearing not later than 10 days after the date on which the registration is suspended.CommentsClose CommentsPermalink





`(iii) The Secretary may reinstate the registration, whether suspended under clause (i) or (ii), if the Secretary determines that the registrant has demonstrated that further violations of registration conditions will not occur.CommentsClose CommentsPermalink





`(B) TERMINATION- The Secretary, after notice and opportunity for a hearing, may terminate the registration under paragraph (1) of a registrant if the Secretary determines that the registrant has engaged in a pattern or practice of violating 1 or more registration conditions, or if on 1 or more occasions the Secretary has under subparagraph (A)(ii) suspended the registration of the registrant. The Secretary may make the termination permanent, or for a fixed period of not less than 1 year. During the period in which the registration is terminated, any registration submitted under paragraph (1) by the registrant, or a person that is a partner in the export or import enterprise, or a principal officer in such enterprise, and any registration prepared with the assistance of the registrant or such a person, has no legal effect under this section.CommentsClose CommentsPermalink





`(5) DEFAULT OF BOND- A bond required to be posted by an exporter under paragraph (1)(I)(ii) shall be defaulted and paid to the Treasury of the United States if, after opportunity for an informal hearing, the Secretary determines that the exporter has--CommentsClose CommentsPermalink





`(A) exported a drug to the United States that is not a qualifying drug or that is not in compliance with subsection (g)(2)(A), (g)(4), or (i); orCommentsClose CommentsPermalink





`(B) failed to permit the Secretary to conduct an inspection described under subsection (d).CommentsClose CommentsPermalink





`(c) Sources of Qualifying Drugs- A registration condition is that the exporter or importer involved agrees that a qualifying drug will under subsection (a) be exported or imported into the United States only if there is compliance with the following:CommentsClose CommentsPermalink





`(1) The drug was manufactured in an establishment--CommentsClose CommentsPermalink





`(A) required to register under subsection (h) or (i) of section 510; andCommentsClose CommentsPermalink





`(B)(i) inspected by the Secretary; orCommentsClose CommentsPermalink





`(ii) for which the Secretary has elected to rely on a satisfactory report of a good manufacturing practice inspection of the establishment from a permitted country whose regulatory system the Secretary recognizes as equivalent under a mutual recognition agreement, as provided for under section 510(i)(3), section 803, or part 26 of title 21, Code of Federal Regulations (or any corresponding successor rule or regulation).CommentsClose CommentsPermalink





`(2) The establishment is located in any country, and the establishment manufactured the drug for distribution in the United States or for distribution in 1 or more of the permitted countries (without regard to whether in addition the drug is manufactured for distribution in a foreign country that is not a permitted country).CommentsClose CommentsPermalink





`(3) The exporter or importer obtained the drug--CommentsClose CommentsPermalink





`(A) directly from the establishment; orCommentsClose CommentsPermalink





`(B) directly from an entity that, by contract with the exporter or importer--CommentsClose CommentsPermalink





`(i) provides to the exporter or importer a statement (in such form and containing such information as the Secretary may require) that, for the chain of custody from the establishment, identifies each prior sale, purchase, or trade of the drug (including the date of the transaction and the names and addresses of all parties to the transaction);CommentsClose CommentsPermalink





`(ii) agrees to permit the Secretary to inspect such statements and related records to determine their accuracy;CommentsClose CommentsPermalink





`(iii) agrees, with respect to the qualifying drugs involved, to permit the Secretary to inspect warehouses and other facilities, including records, of the entity for purposes of determining whether the facilities are in compliance with any standards under this Act that are applicable to facilities of that type in the United States; andCommentsClose CommentsPermalink





`(iv) has ensured, through such contractual relationships as may be necessary, that the Secretary has the same authority regarding other parties in the chain of custody from the establishment that the Secretary has under clauses (ii) and (iii) regarding such entity.CommentsClose CommentsPermalink





`(4)(A) The foreign country from which the importer will import the drug is a permitted country; orCommentsClose CommentsPermalink





`(B) The foreign country from which the exporter will export the drug is the permitted country in which the exporter is located.CommentsClose CommentsPermalink





`(5) During any period in which the drug was not in the control of the manufacturer of the drug, the drug did not enter any country that is not a permitted country.CommentsClose CommentsPermalink





`(6) The exporter or importer retains a sample of each lot of the drug for testing by the Secretary.CommentsClose CommentsPermalink





`(d) Inspection of Facilities; Marking of Shipments-CommentsClose CommentsPermalink





`(1) INSPECTION OF FACILITIES- A registration condition is that, for the purpose of assisting the Secretary in determining whether the exporter involved is in compliance with all other registration conditions--CommentsClose CommentsPermalink





`(A) the exporter agrees to permit the Secretary--CommentsClose CommentsPermalink





`(i) to conduct onsite inspections, including monitoring on a day-to-day basis, of places of business of the exporter that relate to qualifying drugs, including each warehouse or other facility owned or controlled by, or operated for, the exporter;CommentsClose CommentsPermalink





`(ii) to have access, including on a day-to-day basis, to--CommentsClose CommentsPermalink





`(I) records of the exporter that relate to the export of such drugs, including financial records; andCommentsClose CommentsPermalink





`(II) samples of such drugs;CommentsClose CommentsPermalink





`(iii) to carry out the duties described in paragraph (3); andCommentsClose CommentsPermalink





`(iv) to carry out any other functions determined by the Secretary to be necessary regarding the compliance of the exporter; andCommentsClose CommentsPermalink





`(B) the Secretary has assigned 1 or more employees of the Secretary to carry out the functions described in this subsection for the Secretary randomly, but not less than 12 times annually, on the premises of places of businesses referred to in subparagraph (A)(i), and such an assignment remains in effect on a continuous basis.CommentsClose CommentsPermalink





`(2) MARKING OF COMPLIANT SHIPMENTS- A registration condition is that the exporter involved agrees to affix to each shipping container of qualifying drugs exported under subsection (a) such markings as the Secretary determines to be necessary to identify the shipment as being in compliance with all registration conditions. Markings under the preceding sentence shall--CommentsClose CommentsPermalink





`(A) be designed to prevent affixation of the markings to any shipping container that is not authorized to bear the markings; andCommentsClose CommentsPermalink





`(B) include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies.CommentsClose CommentsPermalink





`(3) CERTAIN DUTIES RELATING TO EXPORTERS- Duties of the Secretary with respect to an exporter include the following:CommentsClose CommentsPermalink





`(A) Inspecting, randomly, but not less than 12 times annually, the places of business of the exporter at which qualifying drugs are stored and from which qualifying drugs are shipped.CommentsClose CommentsPermalink





`(B) During the inspections under subparagraph (A), verifying the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the exporter, which shall be accomplished or supplemented by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except that a drug that lacks such technologies from the point of manufacture shall not for that reason be excluded from importation by an exporter.CommentsClose CommentsPermalink





`(C) Randomly reviewing records of exports to individuals for the purpose of determining whether the drugs are being imported by the individuals in accordance with the conditions under subsection (i). Such reviews shall be conducted in a manner that will result in a statistically significant determination of compliance with all such conditions.CommentsClose CommentsPermalink





`(D) Monitoring the affixing of markings under paragraph (2).CommentsClose CommentsPermalink





`(E) Inspecting as the Secretary determines is necessary the warehouses and other facilities, including records, of other parties in the chain of custody of qualifying drugs.CommentsClose CommentsPermalink





`(F) Determining whether the exporter is in compliance with all other registration conditions.CommentsClose CommentsPermalink





`(4) PRIOR NOTICE OF SHIPMENTS- A registration condition is that, not less than 8 hours and not more than 5 days in advance of the time of the importation of a shipment of qualifying drugs, the importer involved agrees to submit to the Secretary a notice with respect to the shipment of drugs to be imported or offered for import into the United States under subsection (a). A notice under the preceding sentence shall include--CommentsClose CommentsPermalink





`(A) the name and complete contact information of the person submitting the notice;CommentsClose CommentsPermalink





`(B) the name and complete contact information of the importer involved;CommentsClose CommentsPermalink





`(C) the identity of the drug, including the established name of the drug, the quantity of the drug, and the lot number assigned by the manufacturer;CommentsClose CommentsPermalink





`(D) the identity of the manufacturer of the drug, including the identity of the establishment at which the drug was manufactured;CommentsClose CommentsPermalink





`(E) the country from which the drug is shipped;CommentsClose CommentsPermalink





`(F) the name and complete contact information for the shipper of the drug;CommentsClose CommentsPermalink





`(G) anticipated arrival information, including the port of arrival and crossing location within that port, and the date and time;CommentsClose CommentsPermalink





`(H) a summary of the chain of custody of the drug from the establishment in which the drug was manufactured to the importer;CommentsClose CommentsPermalink





`(I) a declaration as to whether the Secretary has ordered that importation of the drug from the permitted country cease under subsection (g)(2)(C) or (D); andCommentsClose CommentsPermalink





`(J) such other information as the Secretary may require by regulation.CommentsClose CommentsPermalink





`(5) MARKING OF COMPLIANT SHIPMENTS- A registration condition is that the importer involved agrees, before wholesale distribution (as defined in section 503(e)) of a qualifying drug that has been imported under subsection (a), to affix to each container of such drug such markings or other technology as the Secretary determines necessary to identify the shipment as being in compliance with all registration conditions, except that the markings or other technology shall not be required on a drug that bears comparable, compatible markings or technology from the manufacturer of the drug. Markings or other technology under the preceding sentence shall--CommentsClose CommentsPermalink





`(A) be designed to prevent affixation of the markings or other technology to any container that is not authorized to bear the markings; andCommentsClose CommentsPermalink





`(B) shall include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of such technologies.CommentsClose CommentsPermalink





`(6) CERTAIN DUTIES RELATING TO IMPORTERS- Duties of the Secretary with respect to an importer include the following:CommentsClose CommentsPermalink





`(A) Inspecting, randomly, but not less than 12 times annually, the places of business of the importer at which a qualifying drug is initially received after importation.CommentsClose CommentsPermalink





`(B) During the inspections under subparagraph (A), verifying the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the importer, which shall be accomplished or supplemented by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except that a drug that lacks such technologies from the point of manufacture shall not for that reason be excluded from importation by an importer.CommentsClose CommentsPermalink





`(C) Reviewing notices under paragraph (4).CommentsClose CommentsPermalink





`(D) Inspecting as the Secretary determines is necessary the warehouses and other facilities, including records of other parties in the chain of custody of qualifying drugs.CommentsClose CommentsPermalink





`(E) Determining whether the importer is in compliance with all other registration conditions.CommentsClose CommentsPermalink





`(e) Importer Fees-CommentsClose CommentsPermalink





`(1) REGISTRATION FEE- A registration condition is that the importer involved pays to the Secretary a fee of $10,000 due on the date on which the importer first submits the registration to the Secretary under subsection (b).CommentsClose CommentsPermalink





`(2) INSPECTION FEE- A registration condition is that the importer involved pays a fee to the Secretary in accordance with this subsection. Such fee shall be paid not later than October 1 and April 1 of each fiscal year in the amount provided for under paragraph (3).CommentsClose CommentsPermalink





`(3) AMOUNT OF INSPECTION FEE-CommentsClose CommentsPermalink





`(A) AGGREGATE TOTAL OF FEES- Not later than 30 days before the start of each fiscal year, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of the Treasury, shall establish an aggregate total of fees to be collected under paragraph (2) for importers for that fiscal year that is sufficient, and not more than necessary, to pay the costs for that fiscal year of administering this section with respect to registered importers, including the costs associated with--CommentsClose CommentsPermalink





`(i) inspecting the facilities of registered importers, and of other entities in the chain of custody of a qualifying drug as necessary, under subsection (d)(6);CommentsClose CommentsPermalink





`(ii) developing, implementing, and operating under such subsection an electronic system for submission and review of the notices required under subsection (d)(4) with respect to shipments of qualifying drugs under subsection (a) to assess compliance with all registration conditions when such shipments are offered for import into the United States; andCommentsClose CommentsPermalink





`(iii) inspecting such shipments as necessary, when offered for import into the United States to determine if such a shipment should be refused admission under subsection (g)(5).CommentsClose CommentsPermalink





`(B) LIMITATION- Subject to subparagraph (C), the aggregate total of fees collected under paragraph (2) for a fiscal year shall not exceed 2.5 percent of the total price of qualifying drugs imported during that fiscal year into the United States by registered importers under subsection (a).CommentsClose CommentsPermalink





`(C) TOTAL PRICE OF DRUGS-CommentsClose CommentsPermalink





`(i) ESTIMATE- For the purposes of complying with the limitation described in subparagraph (B) when establishing under subparagraph (A) the aggregate total of fees to be collected under paragraph (2) for a fiscal year, the Secretary shall estimate the total price of qualifying drugs imported into the United States by registered importers during that fiscal year by adding the total price of qualifying drugs imported by each registered importer during the 6-month period from January 1 through June 30 of the previous fiscal year, as reported to the Secretary by each registered importer under subsection (b)(1)(J).CommentsClose CommentsPermalink





`(ii) CALCULATION- Not later than March 1 of the fiscal year that follows the fiscal year for which the estimate under clause (i) is made, the Secretary shall calculate the total price of qualifying drugs imported into the United States by registered importers during that fiscal year by adding the total price of qualifying drugs imported by each registered importer during that fiscal year, as reported to the Secretary by each registered importer under subsection (b)(1)(J).CommentsClose CommentsPermalink





`(iii) ADJUSTMENT- If the total price of qualifying drugs imported into the United States by registered importers during a fiscal year as calculated under clause (ii) is less than the aggregate total of fees collected under paragraph (2) for that fiscal year, the Secretary shall provide for a pro-rata reduction in the fee due from each registered importer on April 1 of the subsequent fiscal year so that the limitation described in subparagraph (B) is observed.CommentsClose CommentsPermalink





`(D) INDIVIDUAL IMPORTER FEE- Subject to the limitation described in subparagraph (B), the fee under paragraph (2) to be paid on October 1 and April 1 by an importer shall be an amount that is proportional to a reasonable estimate by the Secretary of the semiannual share of the importer of the volume of qualifying drugs imported by importers under subsection (a).CommentsClose CommentsPermalink





`(4) USE OF FEES-CommentsClose CommentsPermalink





`(A) IN GENERAL- Subject to appropriations Acts, fees collected by the Secretary under paragraphs (1) and (2) shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration until expended (without fiscal year limitation), and the Secretary may, in consultation with the Secretary of Homeland Security and the Secretary of the Treasury, transfer some proportion of such fees to the appropriation account for salaries and expenses of the Bureau of Customs and Border Protection until expended (without fiscal year limitation).CommentsClose CommentsPermalink





`(B) SOLE PURPOSE- Fees collected by the Secretary under paragraphs (1) and (2) are only available to the Secretary and, if transferred, to the Secretary of Homeland Security, and are for the sole purpose of paying the costs referred to in paragraph (3)(A).CommentsClose CommentsPermalink





`(5) COLLECTION OF FEES- In any case where the Secretary does not receive payment of a fee assessed under paragraph (1) or (2) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink





`(f) Exporter Fees-CommentsClose CommentsPermalink





`(1) REGISTRATION FEE- A registration condition is that the exporter involved pays to the Secretary a fee of $10,000 due on the date on which the exporter first submits that registration to the Secretary under subsection (b).CommentsClose CommentsPermalink





`(2) INSPECTION FEE- A registration condition is that the exporter involved pays a fee to the Secretary in accordance with this subsection. Such fee shall be paid not later than October 1 and April 1 of each fiscal year in the amount provided for under paragraph (3).CommentsClose CommentsPermalink





`(3) AMOUNT OF INSPECTION FEE-CommentsClose CommentsPermalink





`(A) AGGREGATE TOTAL OF FEES- Not later than 30 days before the start of each fiscal year, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of the Treasury, shall establish an aggregate total of fees to be collected under paragraph (2) for exporters for that fiscal year that is sufficient, and not more than necessary, to pay the costs for that fiscal year of administering this section with respect to registered exporters, including the costs associated with--CommentsClose CommentsPermalink





`(i) inspecting the facilities of registered exporters, and of other entities in the chain of custody of a qualifying drug as necessary, under subsection (d)(3);CommentsClose CommentsPermalink





`(ii) developing, implementing, and operating under such subsection a system to screen marks on shipments of qualifying drugs under subsection (a) that indicate compliance with all registration conditions, when such shipments are offered for import into the United States; andCommentsClose CommentsPermalink





`(iii) screening such markings, and inspecting such shipments as necessary, when offered for import into the United States to determine if such a shipment should be refused admission under subsection (g)(5).CommentsClose CommentsPermalink





`(B) LIMITATION- Subject to subparagraph (C), the aggregate total of fees collected under paragraph (2) for a fiscal year shall not exceed 2.5 percent of the total price of qualifying drugs imported during that fiscal year into the United States by registered exporters under subsection (a).CommentsClose CommentsPermalink





`(C) TOTAL PRICE OF DRUGS-CommentsClose CommentsPermalink





`(i) ESTIMATE- For the purposes of complying with the limitation described in subparagraph (B) when establishing under subparagraph (A) the aggregate total of fees to be collected under paragraph (2) for a fiscal year, the Secretary shall estimate the total price of qualifying drugs imported into the United States by registered exporters during that fiscal year by adding the total price of qualifying drugs exported by each registered exporter during the 6-month period from January 1 through June 30 of the previous fiscal year, as reported to the Secretary by each registered exporter under subsection (b)(1)(I)(iv).CommentsClose CommentsPermalink





`(ii) CALCULATION- Not later than March 1 of the fiscal year that follows the fiscal year for which the estimate under clause (i) is made, the Secretary shall calculate the total price of qualifying drugs imported into the United States by registered exporters during that fiscal year by adding the total price of qualifying drugs exported by each registered exporter during that fiscal year, as reported to the Secretary by each registered exporter under subsection (b)(1)(I)(iv).CommentsClose CommentsPermalink





`(iii) ADJUSTMENT- If the total price of qualifying drugs imported into the United States by registered exporters during a fiscal year as calculated under clause (ii) is less than the aggregate total of fees collected under paragraph (2) for that fiscal year, the Secretary shall provide for a pro-rata reduction in the fee due from each registered exporter on April 1 of the subsequent fiscal year so that the limitation described in subparagraph (B) is observed.CommentsClose CommentsPermalink





`(D) INDIVIDUAL EXPORTER FEE- Subject to the limitation described in subparagraph (B), the fee under paragraph (2) to be paid on October 1 and April 1 by an exporter shall be an amount that is proportional to a reasonable estimate by the Secretary of the semiannual share of the exporter of the volume of qualifying drugs exported by exporters under subsection (a).CommentsClose CommentsPermalink





`(4) USE OF FEES-CommentsClose CommentsPermalink





`(A) IN GENERAL- Subject to appropriations Acts, fees collected by the Secretary under paragraphs (1) and (2) shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration until expended (without fiscal year limitation), and the Secretary may, in consultation with the Secretary of Homeland Security and the Secretary of the Treasury, transfer some proportion of such fees to the appropriation account for salaries and expenses of the Bureau of Customs and Border Protection until expended (without fiscal year limitation).CommentsClose CommentsPermalink





`(B) SOLE PURPOSE- Fees collected by the Secretary under paragraphs (1) and (2) are only available to the Secretary and, if transferred, to the Secretary of Homeland Security, and are for the sole purpose of paying the costs referred to in paragraph (3)(A).CommentsClose CommentsPermalink





`(5) COLLECTION OF FEES- In any case where the Secretary does not receive payment of a fee assessed under paragraph (1) or (2) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink





`(g) Compliance With Section 801(a)-CommentsClose CommentsPermalink





`(1) IN GENERAL- A registration condition is that each qualifying drug exported under subsection (a) by the registered exporter involved or imported under subsection (a) by the registered importer involved is in compliance with the standards referred to in section 801(a) regarding admission of the drug into the United States, subject to paragraphs (2), (3), and (4).CommentsClose CommentsPermalink





`(2) SECTION 505; APPROVAL STATUS-CommentsClose CommentsPermalink





`(A) IN GENERAL- A qualifying drug that is imported or offered for import under subsection (a) shall comply with the conditions established in the approved application under section 505(b) for the U.S. label drug as described under this subsection.CommentsClose CommentsPermalink





`(B) NOTICE BY MANUFACTURER; GENERAL PROVISIONS-CommentsClose CommentsPermalink





`(i) IN GENERAL- The person that manufactures a qualifying drug that is, or will be, introduced for commercial distribution in a permitted country shall in accordance with this paragraph submit to the Secretary a notice that--CommentsClose CommentsPermalink





`(I) includes each difference in the qualifying drug from a condition established in the approved application for the U.S. label drug beyond--CommentsClose CommentsPermalink

`(aa) the variations provided for in the application; andCommentsClose CommentsPermalink

`(bb) any difference in labeling (except ingredient labeling); orCommentsClose CommentsPermalink

`(II) states that there is no difference in the qualifying drug from a condition established in the approved application for the U.S. label drug beyond--CommentsClose CommentsPermalink

`(aa) the variations provided for in the application; andCommentsClose CommentsPermalink

`(bb) any difference in labeling (except ingredient labeling).CommentsClose CommentsPermalink

`(ii) INFORMATION IN NOTICE- A notice under clause (i)(I) shall include the information that the Secretary may require under section 506A, any additional information the Secretary may require (which may include data on bioequivalence if such data are not required under section 506A), and, with respect to the permitted country that approved the qualifying drug for commercial distribution, or with respect to which such approval is sought, include the following:CommentsClose CommentsPermalink





`(I) The date on which the qualifying drug with such difference was, or will be, introduced for commercial distribution in the permitted country.CommentsClose CommentsPermalink





`(II) Information demonstrating that the person submitting the notice has also notified the government of the permitted country in writing that the person is submitting to the Secretary a notice under clause (i)(I), which notice describes the difference in the qualifying drug from a condition established in the approved application for the U.S. label drug.CommentsClose CommentsPermalink





`(III) The information that the person submitted or will submit to the government of the permitted country for purposes of obtaining approval for commercial distribution of the drug in the country which, if in a language other than English, shall be accompanied by an English translation verified to be complete and accurate, with the name, address, and a brief statement of the qualifications of the person that made the translation.CommentsClose CommentsPermalink





`(iii) CERTIFICATIONS- The chief executive officer and the chief medical officer of the manufacturer involved shall each certify in the notice under clause (i) that--CommentsClose CommentsPermalink





`(I) the information provided in the notice is complete and true; andCommentsClose CommentsPermalink





`(II) a copy of the notice has been provided to the Federal Trade Commission and to the State attorneys general.CommentsClose CommentsPermalink





`(iv) FEE- If a notice submitted under clause (i) includes a difference that would, under section 506A, require the submission of a supplemental application if made as a change to the U.S. label drug, the person that submits the notice shall pay to the Secretary a fee in the same amount as would apply if the person were paying a fee pursuant to section 736(a)(1)(A)(ii). Subject to appropriations Acts, fees collected by the Secretary under the preceding sentence are available only to the Secretary and are for the sole purpose of paying the costs of reviewing notices submitted under clause (i).CommentsClose CommentsPermalink





`(v) TIMING OF SUBMISSION OF NOTICES-CommentsClose CommentsPermalink





`(I) PRIOR APPROVAL NOTICES- A notice under clause (i) to which subparagraph (C) applies shall be submitted to the Secretary not later than 120 days before the qualifying drug with the difference is introduced for commercial distribution in a permitted country, unless the country requires that distribution of the qualifying drug with the difference begin less than 120 days after the country requires the difference.CommentsClose CommentsPermalink





`(II) OTHER APPROVAL NOTICES- A notice under clause (i) to which subparagraph (D) applies shall be submitted to the Secretary not later than the day on which the qualifying drug with the difference is introduced for commercial distribution in a permitted country.CommentsClose CommentsPermalink





`(III) OTHER NOTICES- A notice under clause (i) to which subparagraph (E) applies shall be submitted to the Secretary on the date that the qualifying drug is first introduced for commercial distribution in a permitted country and annually thereafter.CommentsClose CommentsPermalink





`(vi) REVIEW BY SECRETARY-CommentsClose CommentsPermalink





`(I) IN GENERAL- In this paragraph, the difference in a qualifying drug that is submitted in a notice under clause (i) from the U.S. label drug shall be treated by the Secretary as if it were a manufacturing change to the U.S. label drug under section 506A.CommentsClose CommentsPermalink





`(II) STANDARD OF REVIEW- Except as provided in subclause (III), the Secretary shall review and approve or disapprove the difference in a notice submitted under clause (i), if required under section 506A, using the safe and effective standard for approving or disapproving a manufacturing change under section 506A.CommentsClose CommentsPermalink





`(III) BIOEQUIVALENCE- If the Secretary would approve the difference in a notice submitted under clause (i) using the safe and effective standard under section 506A and if the Secretary determines that the qualifying drug is not bioequivalent to the U.S. label drug, the Secretary shall--CommentsClose CommentsPermalink

`(aa) include in the labeling provided under paragraph (3) a prominent advisory that the qualifying drug is safe and effective but is not bioequivalent to the U.S. label drug if the Secretary determines that such an advisory is necessary for health care practitioners and patients to use the qualifying drug safely and effectively; orCommentsClose CommentsPermalink

`(bb) decline to approve the difference if the Secretary determines that the availability of both the qualifying drug and the U.S. label drug would pose a threat to the public health.CommentsClose CommentsPermalink

`(IV) REVIEW BY THE SECRETARY- The Secretary shall review and approve or disapprove the difference in a notice submitted under clause (i), if required under section 506A, not later than 120 days after the date on which the notice is submitted.CommentsClose CommentsPermalink





`(V) ESTABLISHMENT INSPECTION- If review of such difference would require an inspection of the establishment in which the qualifying drug is manufactured--CommentsClose CommentsPermalink

`(aa) such inspection by the Secretary shall be authorized; andCommentsClose CommentsPermalink

`(bb) the Secretary may rely on a satisfactory report of a good manufacturing practice inspection of the establishment from a permitted country whose regulatory system the Secretary recognizes as equivalent under a mutual recognition agreement, as provided under section 510(i)(3), section 803, or part 26 of title 21, Code of Federal Regulations (or any corresponding successor rule or regulation).CommentsClose CommentsPermalink

`(vii) PUBLICATION OF INFORMATION ON NOTICES-CommentsClose CommentsPermalink





`(I) IN GENERAL- Through the Internet website of the Food and Drug Administration and a toll-free telephone number, the Secretary shall readily make available to the public a list of notices submitted under clause (i).CommentsClose CommentsPermalink





`(II) CONTENTS- The list under subclause (I) shall include the date on which a notice is submitted and whether--CommentsClose CommentsPermalink

`(aa) a notice is under review;CommentsClose CommentsPermalink

`(bb) the Secretary has ordered that importation of the qualifying drug from a permitted country cease; orCommentsClose CommentsPermalink

`(cc) the importation of the drug is permitted under subsection (a).CommentsClose CommentsPermalink

`(III) UPDATE- The Secretary shall promptly update the Internet website with any changes to the list.CommentsClose CommentsPermalink





`(C) NOTICE; DRUG DIFFERENCE REQUIRING PRIOR APPROVAL- In the case of a notice under subparagraph (B)(i) that includes a difference that would, under section 506A(c) or (d)(3)(B)(i), require the approval of a supplemental application before the difference could be made to the U.S. label drug the following shall occur:CommentsClose CommentsPermalink





`(i) Promptly after the notice is submitted, the Secretary shall notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general that the notice has been submitted with respect to the qualifying drug involved.CommentsClose CommentsPermalink





`(ii) If the Secretary has not made a determination whether such a supplemental application regarding the U.S. label drug would be approved or disapproved by the date on which the qualifying drug involved is to be introduced for commercial distribution in a permitted country, the Secretary shall--CommentsClose CommentsPermalink





`(I) order that the importation of the qualifying drug involved from the permitted country not begin until the Secretary completes review of the notice; andCommentsClose CommentsPermalink





`(II) promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the order.CommentsClose CommentsPermalink





`(iii) If the Secretary determines that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall--CommentsClose CommentsPermalink





`(I) order that the importation of the qualifying drug involved from the permitted country cease, or provide that an order under clause (ii), if any, remains in effect;CommentsClose CommentsPermalink





`(II) notify the permitted country that approved the qualifying drug for commercial distribution of the determination; andCommentsClose CommentsPermalink





`(III) promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination.CommentsClose CommentsPermalink





`(iv) If the Secretary determines that such a supplemental application regarding the U.S. label drug would be approved, the Secretary shall--CommentsClose CommentsPermalink





`(I) vacate the order under clause (ii), if any;CommentsClose CommentsPermalink





`(II) consider the difference to be a variation provided for in the approved application for the U.S. label drug;CommentsClose CommentsPermalink





`(III) permit importation of the qualifying drug under subsection (a); andCommentsClose CommentsPermalink





`(IV) promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination.CommentsClose CommentsPermalink





`(D) NOTICE; DRUG DIFFERENCE NOT REQUIRING PRIOR APPROVAL- In the case of a notice under subparagraph (B)(i) that includes a difference that would, under section 506A(d)(3)(B)(ii), not require the approval of a supplemental application before the difference could be made to the U.S. label drug the following shall occur:CommentsClose CommentsPermalink





`(i) During the period in which the notice is being reviewed by the Secretary, the authority under this subsection to import the qualifying drug involved continues in effect.CommentsClose CommentsPermalink





`(ii) If the Secretary determines that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall--CommentsClose CommentsPermalink





`(I) order that the importation of the qualifying drug involved from the permitted country cease;CommentsClose CommentsPermalink





`(II) notify the permitted country that approved the qualifying drug for commercial distribution of the determination; andCommentsClose CommentsPermalink





`(III) promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination.CommentsClose CommentsPermalink





`(iii) If the Secretary determines that such a supplemental application regarding the U.S. label drug would be approved, the difference shall be considered to be a variation provided for in the approved application for the U.S. label drug.CommentsClose CommentsPermalink





`(E) NOTICE; DRUG DIFFERENCE NOT REQUIRING APPROVAL; NO DIFFERENCE- In the case of a notice under subparagraph (B)(i) that includes a difference for which, under section 506A(d)(1)(A), a supplemental application would not be required for the difference to be made to the U.S. label drug, or that states that there is no difference, the Secretary--CommentsClose CommentsPermalink





`(i) shall consider such difference to be a variation provided for in the approved application for the U.S. label drug;CommentsClose CommentsPermalink





`(ii) may not order that the importation of the qualifying drug involved cease; andCommentsClose CommentsPermalink





`(iii) shall promptly notify registered exporters and registered importers.CommentsClose CommentsPermalink





`(F) DIFFERENCES IN ACTIVE INGREDIENT, ROUTE OF ADMINISTRATION, DOSAGE FORM, OR STRENGTH-CommentsClose CommentsPermalink





`(i) IN GENERAL- A person who manufactures a drug approved under section 505(b) shall submit an application under section 505(b) for approval of another drug that is manufactured for distribution in a permitted country by or for the person that manufactures the drug approved under section 505(b) if--CommentsClose CommentsPermalink





`(I) there is no qualifying drug in 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, and strength as the drug approved under section 505(b); andCommentsClose CommentsPermalink





`(II) each active ingredient of the other drug is related to an active ingredient of the drug approved under section 505(b), as defined in clause (v).CommentsClose CommentsPermalink





`(ii) APPLICATION UNDER SECTION 505(b)- The application under section 505(b) required under clause (i) shall--CommentsClose CommentsPermalink





`(I) request approval of the other drug for the indication or indications for which the drug approved under section 505(b) is labeled;CommentsClose CommentsPermalink





`(II) include the information that the person submitted to the government of the permitted country for purposes of obtaining approval for commercial distribution of the other drug in that country, which if in a language other than English, shall be accompanied by an English translation verified to be complete and accurate, with the name, address, and a brief statement of the qualifications of the person that made the translation;CommentsClose CommentsPermalink





`(III) include a right of reference to the application for the drug approved under section 505(b); andCommentsClose CommentsPermalink





`(IV) include such additional information as the Secretary may require.CommentsClose CommentsPermalink





`(iii) TIMING OF SUBMISSION OF APPLICATION- An application under section 505(b) required under clause (i) shall be submitted to the Secretary not later than the day on which the information referred to in clause (ii)(II) is submitted to the government of the permitted country.CommentsClose CommentsPermalink





`(iv) NOTICE OF DECISION ON APPLICATION- The Secretary shall promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of a determination to approve or to disapprove an application under section 505(b) required under clause (i).CommentsClose CommentsPermalink





`(v) RELATED ACTIVE INGREDIENTS- For purposes of clause (i)(II), 2 active ingredients are related if they are--CommentsClose CommentsPermalink





`(I) the same; orCommentsClose CommentsPermalink





`(II) different salts, esters, or complexes of the same moiety.CommentsClose CommentsPermalink





`(3) SECTION 502; LABELING-CommentsClose CommentsPermalink





`(A) IMPORTATION BY REGISTERED IMPORTER-CommentsClose CommentsPermalink





`(i) IN GENERAL- In the case of a qualifying drug that is imported or offered for import by a registered importer, such drug shall be considered to be in compliance with section 502 and the labeling requirements under the approved application for the U.S. label drug if the qualifying drug bears--CommentsClose CommentsPermalink





`(I) a copy of the labeling approved for the U.S. label drug under section 505, without regard to whether the copy bears any trademark involved;CommentsClose CommentsPermalink





`(II) the name of the manufacturer and location of the manufacturer;CommentsClose CommentsPermalink





`(III) the lot number assigned by the manufacturer;CommentsClose CommentsPermalink





`(IV) the name, location, and registration number of the importer; andCommentsClose CommentsPermalink





`(V) the National Drug Code number assigned to the qualifying drug by the Secretary.CommentsClose CommentsPermalink





`(ii) REQUEST FOR COPY OF THE LABELING- The Secretary shall provide such copy to the registered importer involved, upon request of the importer.CommentsClose CommentsPermalink





`(iii) REQUESTED LABELING- The labeling provided by the Secretary under clause (ii) shall--CommentsClose CommentsPermalink





`(I) include the established name, as defined in section 502(e)(3), for each active ingredient in the qualifying drug;CommentsClose CommentsPermalink





`(II) not include the proprietary name of the U.S. label drug or any active ingredient thereof;CommentsClose CommentsPermalink





`(III) if required under paragraph (2)(B)(vi)(III), a prominent advisory that the qualifying drug is safe and effective but not bioequivalent to the U.S. label drug; andCommentsClose CommentsPermalink





`(IV) if the inactive ingredients of the qualifying drug are different from the inactive ingredients for the U.S. label drug, include--CommentsClose CommentsPermalink

`(aa) a prominent notice that the ingredients of the qualifying drug differ from the ingredients of the U.S. label drug and that the qualifying drug must be dispensed with an advisory to people with allergies about this difference and a list of ingredients; andCommentsClose CommentsPermalink

`(bb) a list of the ingredients of the qualifying drug as would be required under section 502(e).CommentsClose CommentsPermalink

`(B) IMPORTATION BY INDIVIDUAL-CommentsClose CommentsPermalink





`(i) IN GENERAL- In the case of a qualifying drug that is imported or offered for import by a registered exporter to an individual, such drug shall be considered to be in compliance with section 502 and the labeling requirements under the approved application for the U.S. label drug if the packaging and labeling of the qualifying drug complies with all applicable regulations promulgated under sections 3 and 4 of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.) and the labeling of the qualifying drug includes--CommentsClose CommentsPermalink





`(I) directions for use by the consumer;CommentsClose CommentsPermalink





`(II) the lot number assigned by the manufacturer;CommentsClose CommentsPermalink





`(III) the name and registration number of the exporter;CommentsClose CommentsPermalink





`(IV) if required under paragraph (2)(B)(vi)(III), a prominent advisory that the drug is safe and effective but not bioequivalent to the U.S. label drug;CommentsClose CommentsPermalink





`(V) if the inactive ingredients of the drug are different from the inactive ingredients for the U.S. label drug--CommentsClose CommentsPermalink

`(aa) a prominent advisory that persons with an allergy should check the ingredient list of the drug because the ingredients of the drug differ from the ingredients of the U.S. label drug; andCommentsClose CommentsPermalink

`(bb) a list of the ingredients of the drug as would be required under section 502(e); andCommentsClose CommentsPermalink

`(VI) a copy of any special labeling that would be required by the Secretary had the U.S. label drug been dispensed by a pharmacist in the United States, without regard to whether the special labeling bears any trademark involved.CommentsClose CommentsPermalink





`(ii) PACKAGING- A qualifying drug offered for import to an individual by an exporter under this section that is packaged in a unit-of-use container (as those items are defined in the United States Pharmacopeia and National Formulary) shall not be repackaged, provided that--CommentsClose CommentsPermalink





`(I) the packaging complies with all applicable regulations under sections 3 and 4 of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.); orCommentsClose CommentsPermalink





`(II) the consumer consents to waive the requirements of such Act, after being informed that the packaging does not comply with such Act and that the exporter will provide the drug in packaging that is compliant at no additional cost.CommentsClose CommentsPermalink





`(iii) REQUEST FOR COPY OF SPECIAL LABELING AND INGREDIENT LIST- The Secretary shall provide to the registered exporter involved a copy of the special labeling, the advisory, and the ingredient list described under clause (i), upon request of the exporter.CommentsClose CommentsPermalink





`(iv) REQUESTED LABELING AND INGREDIENT LIST- The labeling and ingredient list provided by the Secretary under clause (iii) shall--CommentsClose CommentsPermalink





`(I) include the established name, as defined in section 502(e)(3), for each active ingredient in the drug; andCommentsClose CommentsPermalink





`(II) not include the proprietary name of the U.S. label drug or any active ingredient thereof.CommentsClose CommentsPermalink





`(4) SECTION 501; ADULTERATION- A qualifying drug that is imported or offered for import under subsection (a) shall be considered to be in compliance with section 501 if the drug is in compliance with subsection (c).CommentsClose CommentsPermalink





`(5) STANDARDS FOR REFUSING ADMISSION- A drug exported under subsection (a) from a registered exporter or imported by a registered importer may be refused admission into the United States if 1 or more of the following applies:CommentsClose CommentsPermalink





`(A) The drug is not a qualifying drug.CommentsClose CommentsPermalink





`(B) A notice for the drug required under paragraph (2)(B) has not been submitted to the Secretary.CommentsClose CommentsPermalink





`(C) The Secretary has ordered that importation of the drug from the permitted country cease under paragraph (2) (C) or (D).CommentsClose CommentsPermalink





`(D) The drug does not comply with paragraph (3) or (4).CommentsClose CommentsPermalink





`(E) The shipping container appears damaged in a way that may affect the strength, quality, or purity of the drug.CommentsClose CommentsPermalink





`(F) The Secretary becomes aware that--CommentsClose CommentsPermalink





`(i) the drug may be counterfeit;CommentsClose CommentsPermalink





`(ii) the drug may have been prepared, packed, or held under insanitary conditions; orCommentsClose CommentsPermalink





`(iii) the methods used in, or the facilities or controls used for, the manufacturing, processing, packing, or holding of the drug do not conform to good manufacturing practice.CommentsClose CommentsPermalink





`(G) The Secretary has obtained an injunction under section 302 that prohibits the distribution of the drug in interstate commerce.CommentsClose CommentsPermalink





`(H) The Secretary has under section 505(e) withdrawn approval of the drug.CommentsClose CommentsPermalink





`(I) The manufacturer of the drug has instituted a recall of the drug.CommentsClose CommentsPermalink





`(J) If the drug is imported or offered for import by a registered importer without submission of a notice in accordance with subsection (d)(4).CommentsClose CommentsPermalink





`(K) If the drug is imported or offered for import from a registered exporter to an individual and 1 or more of the following applies:CommentsClose CommentsPermalink





`(i) The shipping container for such drug does not bear the markings required under subsection (d)(2).CommentsClose CommentsPermalink





`(ii) The markings on the shipping container appear to be counterfeit.CommentsClose CommentsPermalink





`(iii) The shipping container or markings appear to have been tampered with.CommentsClose CommentsPermalink





`(h) Exporter Licensure in Permitted Country- A registration condition is that the exporter involved agrees that a qualifying drug will be exported to an individual only if the Secretary has verified that--CommentsClose CommentsPermalink





`(1) the exporter is authorized under the law of the permitted country in which the exporter is located to dispense prescription drugs; andCommentsClose CommentsPermalink





`(2) the exporter employs persons that are licensed under the law of the permitted country in which the exporter is located to dispense prescription drugs in sufficient number to dispense safely the drugs exported by the exporter to individuals, and the exporter assigns to those persons responsibility for dispensing such drugs to individuals.CommentsClose CommentsPermalink





`(i) Individuals; Conditions for Importation-CommentsClose CommentsPermalink





`(1) IN GENERAL- For purposes of subsection (a)(2)(B), the importation of a qualifying drug by an individual is in accordance with this subsection if the following conditions are met:CommentsClose CommentsPermalink





`(A) The drug is accompanied by a copy of a prescription for the drug, which prescription--CommentsClose CommentsPermalink





`(i) is valid under applicable Federal and State laws; andCommentsClose CommentsPermalink





`(ii) was issued by a practitioner who, under the law of a State of which the individual is a resident, or in which the individual receives care from the practitioner who issues the prescription, is authorized to administer prescription drugs.CommentsClose CommentsPermalink





`(B) The drug is accompanied by a copy of the documentation that was required under the law or regulations of the permitted country in which the exporter is located, as a condition of dispensing the drug to the individual.CommentsClose CommentsPermalink





`(C) The copies referred to in subparagraphs (A)(i) and (B) are marked in a manner sufficient--CommentsClose CommentsPermalink





`(i) to indicate that the prescription, and the equivalent document in the permitted country in which the exporter is located, have been filled; andCommentsClose CommentsPermalink





`(ii) to prevent a duplicative filling by another pharmacist.CommentsClose CommentsPermalink





`(D) The individual has provided to the registered exporter a complete list of all drugs used by the individual for review by the individuals who dispense the drug.CommentsClose CommentsPermalink





`(E) The quantity of the drug does not exceed a 90-day supply.CommentsClose CommentsPermalink





`(F) The drug is not an ineligible subpart H drug. For purposes of this section, a prescription drug is an `ineligible subpart H drug' if the drug was approved by the Secretary under subpart H of part 314 of title 21, Code of Federal Regulations (relating to accelerated approval), with restrictions under section 520 of such part to assure safe use, and the Secretary has published in the Federal Register a notice that the Secretary has determined that good cause exists to prohibit the drug from being imported pursuant to this subsection.CommentsClose CommentsPermalink





`(2) NOTICE REGARDING DRUG REFUSED ADMISSION- If a registered exporter ships a drug to an individual pursuant to subsection (a)(2)(B) 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 the individual and the exporter of such refusal and the reason for the refusal.CommentsClose CommentsPermalink





`(j) Maintenance of Records and Samples-CommentsClose CommentsPermalink





`(1) IN GENERAL- A registration condition is that the importer or exporter involved shall--CommentsClose CommentsPermalink





`(A) maintain records required under this section for not less than 2 years; andCommentsClose CommentsPermalink





`(B) maintain samples of each lot of a qualifying drug required under this section for not more than 2 years.CommentsClose CommentsPermalink





`(2) PLACE OF RECORD MAINTENANCE- The records described under paragraph (1) shall be maintained--CommentsClose CommentsPermalink





`(A) in the case of an importer, at the place of business of the importer at which the importer initially receives the qualifying drug after importation; orCommentsClose CommentsPermalink





`(B) in the case of an exporter, at the facility from which the exporter ships the qualifying drug to the United States.CommentsClose CommentsPermalink





`(k) Drug Recalls-CommentsClose CommentsPermalink





`(1) MANUFACTURERS- A person that manufactures a qualifying drug imported from a permitted country under this section shall promptly inform the Secretary--CommentsClose CommentsPermalink





`(A) if the drug is recalled or withdrawn from the market in a permitted country;CommentsClose CommentsPermalink





`(B) how the drug may be identified, including lot number; andCommentsClose CommentsPermalink





`(C) the reason for the recall or withdrawal.CommentsClose CommentsPermalink





`(2) SECRETARY- With respect to each permitted country, the Secretary shall--CommentsClose CommentsPermalink





`(A) enter into an agreement with the government of the country to receive information about recalls and withdrawals of qualifying drugs in the country; orCommentsClose CommentsPermalink





`(B) monitor recalls and withdrawals of qualifying drugs in the country using any information that is available to the public in any media.CommentsClose CommentsPermalink





`(3) NOTICE- The Secretary may notify, as appropriate, registered exporters, registered importers, wholesalers, pharmacies, or the public of a recall or withdrawal of a qualifying drug in a permitted country.CommentsClose CommentsPermalink





`(l) Drug Labeling and Packaging-CommentsClose CommentsPermalink





`(1) IN GENERAL- When a qualifying drug that is imported into the United States by an importer under subsection (a) is dispensed by a pharmacist to an individual, the pharmacist shall provide that the packaging and labeling of the drug complies with all applicable regulations promulgated under sections 3 and 4 of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.) and shall include with any other labeling provided to the individual the following:CommentsClose CommentsPermalink





`(A) The lot number assigned by the manufacturer.CommentsClose CommentsPermalink





`(B) The name and registration number of the importer.CommentsClose CommentsPermalink





`(C) If required under paragraph (2)(B)(vi)(III) of subsection (g), a prominent advisory that the drug is safe and effective but not bioequivalent to the U.S. label drug.CommentsClose CommentsPermalink





`(D) If the inactive ingredients of the drug are different from the inactive ingredients for the U.S. label drug--CommentsClose CommentsPermalink





`(i) a prominent advisory that persons with allergies should check the ingredient list of the drug because the ingredients of the drug differ from the ingredients of the U.S. label drug; andCommentsClose CommentsPermalink





`(ii) a list of the ingredients of the drug as would be required under section 502(e).CommentsClose CommentsPermalink





`(2) PACKAGING- A qualifying drug that is packaged in a unit-of-use container (as those terms are defined in the United States Pharmacopeia and National Formulary) shall not be repackaged, provided that--CommentsClose CommentsPermalink





`(A) the packaging complies with all applicable regulations under sections 3 and 4 of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.); orCommentsClose CommentsPermalink





`(B) the consumer consents to waive the requirements of such Act, after being informed that the packaging does not comply with such Act and that the pharmacist will provide the drug in packaging that is compliant at no additional cost.CommentsClose CommentsPermalink





`(m) Charitable Contributions- Notwithstanding any other provision of this section, this section does not authorize the importation into the United States of a qualifying drug donated or otherwise supplied for free or at nominal cost by the manufacturer of the drug to a charitable or humanitarian organization, including the United Nations and affiliates, or to a government of a foreign country.CommentsClose CommentsPermalink





`(n) Unfair and Discriminatory Acts and Practices-CommentsClose CommentsPermalink





`(1) IN GENERAL- It is unlawful for a manufacturer, directly or indirectly (including by being a party to a licensing agreement or other agreement), to--CommentsClose CommentsPermalink





`(A) discriminate by charging a higher price for a prescription drug sold to a registered exporter or other person in a permitted country that exports a qualifying drug to the United States under this section than the price that is charged, inclusive of rebates or other incentives to the permitted country or other person, to another person that is in the same country and that does not export a qualifying drug into the United States under this section;CommentsClose CommentsPermalink





`(B) discriminate by charging a higher price for a prescription drug sold to a registered importer or other person that distributes, sells, or uses a qualifying drug imported into the United States under this section than the price that is charged to another person in the United States that does not import a qualifying drug under this section, or that does not distribute, sell, or use such a drug;CommentsClose CommentsPermalink





`(C) discriminate by denying, restricting, or delaying supplies of a prescription drug to a registered exporter or other person in a permitted country that exports a qualifying drug to the United States under this section or to a registered importer or other person that distributes, sells, or uses a qualifying drug imported into the United States under this section;CommentsClose CommentsPermalink





`(D) discriminate by publicly, privately, or otherwise refusing to do business with a registered exporter or other person in a permitted country that exports a qualifying drug to the United States under this section or with a registered importer or other person that distributes, sells, or uses a qualifying drug imported into the United States under this section;CommentsClose CommentsPermalink





`(E) knowingly fail to submit a notice under subsection (g)(2)(B)(i), knowingly fail to submit such a notice on or before the date specified in subsection (g)(2)(B)(v) or as otherwise required under subsection (e) (3), (4), and (5) of section 4 of the Pharmaceutical Market Access and Drug Safety Act of 2007, knowingly submit such a notice that makes a materially false, fictitious, or fraudulent statement, or knowingly fail to provide promptly any information requested by the Secretary to review such a notice;CommentsClose CommentsPermalink





`(F) knowingly fail to submit an application required under subsection (g)(2)(F), knowingly fail to submit such an application on or before the date specified in subsection (g)(2)(F)(ii), knowingly submit such an application that makes a materially false, fictitious, or fraudulent statement, or knowingly fail to provide promptly any information requested by the Secretary to review such an application;CommentsClose CommentsPermalink





`(G) cause there to be a difference (including a difference in active ingredient, route of administration, dosage form, strength, formulation, manufacturing establishment, manufacturing process, or person that manufactures the drug) between a prescription drug for distribution in the United States and the drug for distribution in a permitted country;CommentsClose CommentsPermalink





`(H) refuse to allow an inspection authorized under this section of an establishment that manufactures a qualifying drug that is, or will be, introduced for commercial distribution in a permitted country;CommentsClose CommentsPermalink





`(I) fail to conform to the methods used in, or the facilities used for, the manufacturing, processing, packing, or holding of a qualifying drug that is, or will be, introduced for commercial distribution in a permitted country to good manufacturing practice under this Act;CommentsClose CommentsPermalink





`(J) become a party to a licensing agreement or other agreement related to a qualifying drug that fails to provide for compliance with all requirements of this section with respect to such drug;CommentsClose CommentsPermalink





`(K) enter into a contract that restricts, prohibits, or delays the importation of a qualifying drug under this section;CommentsClose CommentsPermalink





`(L) engage in any other action to restrict, prohibit, or delay the importation of a qualifying drug under this section; orCommentsClose CommentsPermalink





`(M) engage in any other action that the Federal Trade Commission determines to discriminate against a person that engages or attempts to engage in the importation of a qualifying drug under this section.CommentsClose CommentsPermalink





`(2) REFERRAL OF POTENTIAL VIOLATIONS- The Secretary shall promptly refer to the Federal Trade Commission each potential violation of subparagraph (E), (F), (G), (H), or (I) of paragraph (1) that becomes known to the Secretary.CommentsClose CommentsPermalink





`(3) AFFIRMATIVE DEFENSE-CommentsClose CommentsPermalink





`(A) DISCRIMINATION- It shall be an affirmative defense to a charge that a manufacturer has discriminated under subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that the higher price charged for a prescription drug sold to a person, the denial, restriction, or delay of supplies of a prescription drug to a person, the refusal to do business with a person, or other discriminatory activity against a person, is not based, in whole or in part, on--CommentsClose CommentsPermalink





`(i) the person exporting or importing a qualifying drug into the United States under this section; orCommentsClose CommentsPermalink





`(ii) the person distributing, selling, or using a qualifying drug imported into the United States under this section.CommentsClose CommentsPermalink





`(B) DRUG DIFFERENCES- It shall be an affirmative defense to a charge that a manufacturer has caused there to be a difference described in subparagraph (G) of paragraph (1) that--CommentsClose CommentsPermalink





`(i) the difference was required by the country in which the drug is distributed;CommentsClose CommentsPermalink





`(ii) the Secretary has determined that the difference was necessary to improve the safety or effectiveness of the drug;CommentsClose CommentsPermalink





`(iii) the person manufacturing the drug for distribution in the United States has given notice to the Secretary under subsection (g)(2)(B)(i) that the drug for distribution in the United States is not different from a drug for distribution in permitted countries whose combined population represents at least 50 percent of the total population of all permitted countries; orCommentsClose CommentsPermalink





`(iv) the difference was not caused, in whole or in part, for the purpose of restricting importation of the drug into the United States under this section.CommentsClose CommentsPermalink





`(4) EFFECT OF SUBSECTION-CommentsClose CommentsPermalink





`(A) SALES IN OTHER COUNTRIES- This 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. Nothing in this subsection shall be construed to compel the manufacturer of a drug to distribute or sell the drug in a country.CommentsClose CommentsPermalink





`(B) DISCOUNTS TO INSURERS, HEALTH PLANS, PHARMACY BENEFIT MANAGERS, AND COVERED ENTITIES- Nothing in this subsection shall be construed to--CommentsClose CommentsPermalink





`(i) prevent or restrict a manufacturer of a prescription drug from providing discounts to an insurer, health plan, pharmacy benefit manager in the United States, or covered entity in the drug discount program under section 340B of the Public Health Service Act (42 U.S.C. 256b) in return for inclusion of the drug on a formulary;CommentsClose CommentsPermalink





`(ii) require that such discounts be made available to other purchasers of the prescription drug; orCommentsClose CommentsPermalink





`(iii) prevent or restrict any other measures taken by an insurer, health plan, or pharmacy benefit manager to encourage consumption of such prescription drug.CommentsClose CommentsPermalink





`(C) CHARITABLE CONTRIBUTIONS- Nothing in this subsection shall be construed to--CommentsClose CommentsPermalink





`(i) prevent a manufacturer from donating a prescription drug, or supplying a prescription drug at nominal cost, to a charitable or humanitarian organization, including the United Nations and affiliates, or to a government of a foreign country; orCommentsClose CommentsPermalink





`(ii) apply to such donations or supplying of a prescription drug.CommentsClose CommentsPermalink





`(5) ENFORCEMENT-CommentsClose CommentsPermalink





`(A) UNFAIR OR DECEPTIVE ACT OR PRACTICE- A violation of this subsection shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section 18(a)(1)(B) of the Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).CommentsClose CommentsPermalink





`(B) ACTIONS BY THE COMMISSION- The Federal Trade Commission--CommentsClose CommentsPermalink





`(i) shall enforce this subsection in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (15 U.S.C. 41 et seq.) were incorporated into and made a part of this section; andCommentsClose CommentsPermalink





`(ii) may seek monetary relief threefold the damages sustained, in addition to any other remedy available to the Federal Trade Commission under the Federal Trade Commission Act (15 U.S.C. 41 et seq.).CommentsClose CommentsPermalink





`(6) ACTIONS BY STATES-CommentsClose CommentsPermalink





`(A) IN GENERAL-CommentsClose CommentsPermalink





`(i) CIVIL ACTIONS- In any case in which the attorney general of a State has reason to believe that an interest of the residents of that State have been adversely affected by any manufacturer that violates paragraph (1), the attorney general of a State may bring a civil action on behalf of the residents of the State, and persons doing business in the State, in a district court of the United States of appropriate jurisdiction to--CommentsClose CommentsPermalink





`(I) enjoin that practice;CommentsClose CommentsPermalink





`(II) enforce compliance with this subsection;CommentsClose CommentsPermalink





`(III) obtain damages, restitution, or other compensation on behalf of residents of the State and persons doing business in the State, including threefold the damages; orCommentsClose CommentsPermalink





`(IV) obtain such other relief as the court may consider to be appropriate.CommentsClose CommentsPermalink





`(ii) NOTICE-CommentsClose CommentsPermalink





`(I) IN GENERAL- Before filing an action under clause (i), the attorney general of the State involved shall provide to the Federal Trade Commission--CommentsClose CommentsPermalink

`(aa) written notice of that action; andCommentsClose CommentsPermalink

`(bb) a copy of the complaint for that action.CommentsClose CommentsPermalink

`(II) EXEMPTION- Subclause (I) shall not apply with respect to the filing of an action by an attorney general of a State under this paragraph, if the attorney general determines that it is not feasible to provide the notice described in that subclause before filing of the action. In such case, the attorney general of a State shall provide notice and a copy of the complaint to the Federal Trade Commission at the same time as the attorney general files the action.CommentsClose CommentsPermalink





`(B) INTERVENTION-CommentsClose CommentsPermalink





`(i) IN GENERAL- On receiving notice under subparagraph (A)(ii), the Federal Trade Commission shall have the right to intervene in the action that is the subject of the notice.CommentsClose CommentsPermalink





`(ii) EFFECT OF INTERVENTION- If the Federal Trade Commission intervenes in an action under subparagraph (A), it shall have the right--CommentsClose CommentsPermalink





`(I) to be heard with respect to any matter that arises in that action; andCommentsClose CommentsPermalink





`(II) to file a petition for appeal.CommentsClose CommentsPermalink





`(C) CONSTRUCTION- For purposes of bringing any civil action under subparagraph (A), nothing in this subsection shall be construed to prevent an attorney general of a State from exercising the powers conferred on the attorney general by the laws of that State to--CommentsClose CommentsPermalink





`(i) conduct investigations;CommentsClose CommentsPermalink





`(ii) administer oaths or affirmations; orCommentsClose CommentsPermalink





`(iii) compel the attendance of witnesses or the production of documentary and other evidence.CommentsClose CommentsPermalink





`(D) ACTIONS BY THE COMMISSION- In any case in which an action is instituted by or on behalf of the Federal Trade Commission for a violation of paragraph (1), a State may not, during the pendency of that action, institute an action under subparagraph (A) for the same violation against any defendant named in the complaint in that action.CommentsClose CommentsPermalink





`(E) VENUE- Any action brought under subparagraph (A) may be brought in the district court of the United States that meets applicable requirements relating to venue under section 1391 of title 28, United States Code.CommentsClose CommentsPermalink





`(F) SERVICE OF PROCESS- In an action brought under subparagraph (A), process may be served in any district in which the defendant--CommentsClose CommentsPermalink





`(i) is an inhabitant; orCommentsClose CommentsPermalink





`(ii) may be found.CommentsClose CommentsPermalink





`(G) MEASUREMENT OF DAMAGES- In any action under this paragraph to enforce a cause of action under this subsection in which there has been a determination that a defendant has violated a provision of this subsection, damages may be proved and assessed in the aggregate by statistical or sampling methods, by the computation of illegal overcharges or by such other reasonable system of estimating aggregate damages as the court in its discretion may permit without the necessity of separately proving the individual claim of, or amount of damage to, persons on whose behalf the suit was brought.CommentsClose CommentsPermalink





`(H) EXCLUSION ON DUPLICATIVE RELIEF- The district court shall exclude from the amount of monetary relief awarded in an action under this paragraph brought by the attorney general of a State any amount of monetary relief which duplicates amounts which have been awarded for the same injury.CommentsClose CommentsPermalink





`(7) EFFECT ON ANTITRUST LAWS- Nothing in this subsection shall be construed to modify, impair, or supersede the operation of the antitrust laws. For the purpose of this subsection, the term `antitrust laws' has the meaning given it in the first section of the Clayton Act, except that it includes section 5 of the Federal Trade Commission Act to the extent that such section 5 applies to unfair methods of competition.CommentsClose CommentsPermalink





`(8) MANUFACTURER- In this subsection, the term `manufacturer' means any entity, including any affiliate or licensee of that entity, that is engaged in--CommentsClose CommentsPermalink





`(A) the production, preparation, propagation, compounding, conversion, or processing of a prescription drug, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; orCommentsClose CommentsPermalink





`(B) the packaging, repackaging, labeling, relabeling, or distribution of a prescription drug.'.CommentsClose CommentsPermalink





(b) Prohibited Acts- The Federal Food, Drug, and Cosmetic Act is amended--CommentsClose CommentsPermalink





(1) in section 301 (21 U.S.C. 331), by striking paragraph (aa) and inserting the following:CommentsClose CommentsPermalink





`(aa)(1) The sale or trade by a pharmacist, or by a business organization of which the pharmacist is a part, of a qualifying drug that under section 804(a)(2)(A) was imported by the pharmacist, other than--CommentsClose CommentsPermalink





`(A) a sale at retail made pursuant to dispensing the drug to a customer of the pharmacist or organization; orCommentsClose CommentsPermalink





`(B) a sale or trade of the drug to a pharmacy or a wholesaler registered to import drugs under section 804.CommentsClose CommentsPermalink





`(2) The sale or trade by an individual of a qualifying drug that under section 804(a)(2)(B) was imported by the individual.CommentsClose CommentsPermalink





`(3) The making of a materially false, fictitious, or fraudulent statement or representation, or a material omission, in a notice under clause (i) of section 804(g)(2)(B) or in an application required under section 804(g)(2)(F), or the failure to submit such a notice or application.CommentsClose CommentsPermalink





`(4) The importation of a drug in violation of a registration condition or other requirement under section 804, the falsification of any record required to be maintained, or provided to the Secretary, under such section, or the violation of any registration condition or other requirement under such section.'; andCommentsClose CommentsPermalink





(2) in section 303(a) (21 U.S.C. 333(a)), by striking paragraph (6) and inserting the following:CommentsClose CommentsPermalink





`(6) Notwithstanding subsection (a), any person that knowingly violates section 301(i) (2) or (3) or section 301(aa)(4) shall be imprisoned not more than 10 years, or fined in accordance with title 18, United States Code, or both.'.CommentsClose CommentsPermalink





(c) Amendment of Certain Provisions-CommentsClose CommentsPermalink





(1) IN GENERAL- Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by striking subsection (g) and inserting the following:CommentsClose CommentsPermalink





`(g) With respect to a prescription drug that is imported or offered for import into the United States by an individual who is not in the business of such importation, that is not shipped by a registered exporter under section 804, and that is refused admission under subsection (a), the Secretary shall notify the individual that--CommentsClose CommentsPermalink





`(1) the drug has been refused admission because the drug was not a lawful import under section 804;CommentsClose CommentsPermalink





`(2) the drug is not otherwise subject to a waiver of the requirements of subsection (a);CommentsClose CommentsPermalink





`(3) the individual may under section 804 lawfully import certain prescription drugs from exporters registered with the Secretary under section 804; andCommentsClose CommentsPermalink





`(4) the individual can find information about such importation, including a list of registered exporters, on the Internet website of the Food and Drug Administration or through a toll-free telephone number required under section 804.'.CommentsClose CommentsPermalink





(2) ESTABLISHMENT REGISTRATION- Section 510(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is amended in paragraph (1) by inserting after `import into the United States' the following: `, including a drug that is, or may be, imported or offered for import into the United States under section 804,'.CommentsClose CommentsPermalink





(3) EFFECTIVE DATE- The amendments made by this subsection shall take effect on the date that is 90 days after the date of enactment of this Act.CommentsClose CommentsPermalink





(d) Exhaustion-CommentsClose CommentsPermalink





(1) IN GENERAL- Section 271 of title 35, United States Code, is amended--CommentsClose CommentsPermalink





(A) by redesignating subsections (h) and (i) as (i) and (j), respectively; andCommentsClose CommentsPermalink





(B) by inserting after subsection (g) the following:CommentsClose CommentsPermalink





`(h) It shall not be an act of infringement to use, offer to sell, or sell within the United States or to import into the United States any patented invention under section 804 of the Federal Food, Drug, and Cosmetic Act that was first sold abroad by or under authority of the owner or licensee of such patent.'.CommentsClose CommentsPermalink





(2) RULE OF CONSTRUCTION- Nothing in the amendment made by paragraph (1) shall be construed to affect the ability of a patent owner or licensee to enforce their patent, subject to such amendment.CommentsClose CommentsPermalink





(e) Effect of Section 804-CommentsClose CommentsPermalink





(1) IN GENERAL- Section 804 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall permit the importation of qualifying drugs (as defined in such section 804) into the United States without regard to the status of the issuance of implementing regulations--CommentsClose CommentsPermalink





(A) from exporters registered under such section 804 on the date that is 90 days after the date of enactment of this Act; andCommentsClose CommentsPermalink





(B) from permitted countries, as defined in such section 804, by importers registered under such section 804 on the date that is 1 year after the date of enactment of this Act.CommentsClose CommentsPermalink





(2) REVIEW OF REGISTRATION BY CERTAIN EXPORTERS-CommentsClose CommentsPermalink





(A) REVIEW PRIORITY- In the review of registrations submitted under subsection (b) of such section 804, registrations submitted by entities in Canada that are significant exporters of prescription drugs to individuals in the United States as of the date of enactment of this Act will have priority during the 90 day period that begins on such date of enactment.CommentsClose CommentsPermalink





(B) PERIOD FOR REVIEW- During such 90-day period, the reference in subsection (b)(2)(A) of such section 804 to 90 days (relating to approval or disapproval of registrations) is, as applied to such entities, deemed to be 30 days.CommentsClose CommentsPermalink





(C) LIMITATION- That an exporter in Canada exports, or has exported, prescription drugs to individuals in the United States on or before the date that is 90 days after the date of enactment of this Act shall not serve as a basis, in whole or in part, for disapproving a registration under such section 804 from the exporter.CommentsClose CommentsPermalink





(D) FIRST YEAR LIMIT ON NUMBER OF EXPORTERS- During the 1-year period beginning on the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the `Secretary') may limit the number of registered exporters under such section 804 to not less than 50, so long as 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.CommentsClose CommentsPermalink





(E) SECOND YEAR LIMIT ON NUMBER OF EXPORTERS- During the 1-year period beginning on the date that is 1 year after the date of enactment of this Act, the Secretary may limit the number of registered exporters under such section 804 to not less than 100, so long as 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.CommentsClose CommentsPermalink





(F) FURTHER LIMIT ON NUMBER OF EXPORTERS- During any 1-year period beginning on a date that is 2 or more years after the date of enactment of this Act, the Secretary may limit the number of registered exporters under such section 804 to not less than 25 more than the number of such exporters during the previous 1-year period, so long as 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.CommentsClose CommentsPermalink





(3) LIMITS ON NUMBER OF IMPORTERS-CommentsClose CommentsPermalink





(A) FIRST YEAR LIMIT ON NUMBER OF IMPORTERS- During the 1-year period beginning on the date that is 1 year after the date of enactment of this Act, the Secretary may limit the number of registered importers under such section 804 to not less than 100 (of which at least a significant number shall be groups of pharmacies, to the extent feasible given the applications submitted by such groups), so long as the Secretary gives priority to those importers with demonstrated ability to process a high volume of shipments of drugs imported into the United States.CommentsClose CommentsPermalink





(B) SECOND YEAR LIMIT ON NUMBER OF IMPORTERS- During the 1-year period beginning on the date that is 2 years after the date of enactment of this Act, the Secretary may limit the number of registered importers under such section 804 to not less than 200 (of which at least a significant number shall be groups of pharmacies, to the extent feasible given the applications submitted by such groups), so long as the Secretary gives priority to those importers with demonstrated ability to process a high volume of shipments of drugs into the United States.CommentsClose CommentsPermalink





(C) FURTHER LIMIT ON NUMBER OF IMPORTERS- During any 1-year period beginning on a date that is 3 or more years after the date of enactment of this Act, the Secretary may limit the number of registered importers under such section 804 to not less than 50 more (of which at least a significant number shall be groups of pharmacies, to the extent feasible given the applications submitted by such groups) than the number of such importers during the previous 1-year period, so long as the Secretary gives priority to those importers with demonstrated ability to process a high volume of shipments of drugs to the United States.CommentsClose CommentsPermalink





(4) NOTICES FOR DRUGS FOR IMPORT FROM CANADA- The notice with respect to a qualifying drug introduced for commercial distribution in Canada as of the date of enactment of this Act that is required under subsection (g)(2)(B)(i) of such section 804 shall be submitted to the Secretary not later than 30 days after the date of enactment of this Act if--CommentsClose CommentsPermalink





(A) the U.S. label drug (as defined in such section 804) for the qualifying drug is 1 of the 100 prescription drugs with the highest dollar volume of sales in the United States based on the 12 calendar month period most recently completed before the date of enactment of this Act; orCommentsClose CommentsPermalink





(B) the notice is a notice under subsection (g)(2)(B)(i)(II) of such section 804.CommentsClose CommentsPermalink





(5) NOTICE FOR DRUGS FOR IMPORT FROM OTHER COUNTRIES- The notice with respect to a qualifying drug introduced for commercial distribution in a permitted country other than Canada as of the date of enactment of this Act that is required under subsection (g)(2)(B)(i) of such section 804 shall be submitted to the Secretary not later than 180 days after the date of enactment of this Act if--CommentsClose CommentsPermalink





(A) the U.S. label drug for the qualifying drug is 1 of the 100 prescription drugs with the highest dollar volume of sales in the United States based on the 12 calendar month period that is first completed on the date that is 120 days after the date of enactment of this Act; orCommentsClose CommentsPermalink





(B) the notice is a notice under subsection (g)(2)(B)(i)(II) of such section 804.CommentsClose CommentsPermalink





(6) NOTICE FOR OTHER DRUGS FOR IMPORT-CommentsClose CommentsPermalink





(A) GUIDANCE ON SUBMISSION DATES- The Secretary shall by guidance establish a series of submission dates for the notices under subsection (g)(2)(B)(i) of such section 804 with respect to qualifying drugs introduced for commercial distribution as of the date of enactment of this Act and that are not required to be submitted under paragraph (4) or (5).CommentsClose CommentsPermalink





(B) CONSISTENT AND EFFICIENT USE OF RESOURCES- The Secretary shall establish the dates described under subparagraph (A) so that such notices described under subparagraph (A) are submitted and reviewed at a rate that allows consistent and efficient use of the resources and staff available to the Secretary for such reviews. The Secretary may condition the requirement to submit such a notice, and the review of such a notice, on the submission by a registered exporter or a registered importer to the Secretary of a notice that such exporter or importer intends to import such qualifying drug to the United States under such section 804.CommentsClose CommentsPermalink





(C) PRIORITY FOR DRUGS WITH HIGHER SALES- The Secretary shall establish the dates described under subparagraph (A) so that the Secretary reviews the notices described under such subparagraph with respect to qualifying drugs with higher dollar volume of sales in the United States before the notices with respect to drugs with lower sales in the United States.CommentsClose CommentsPermalink





(7) NOTICES FOR DRUGS APPROVED AFTER EFFECTIVE DATE- The notice required under subsection (g)(2)(B)(i) of such section 804 for a qualifying drug first introduced for commercial distribution in a permitted country (as defined in such section 804) after the date of enactment of this Act shall be submitted to and reviewed by the Secretary as provided under subsection (g)(2)(B) of such section 804, without regard to paragraph (4), (5), or (6).CommentsClose CommentsPermalink





(8) REPORT- Beginning with the first full fiscal year after the date of enactment of this Act, not later than 90 days after the end of each fiscal year during which the Secretary reviews a notice referred to in paragraph (4), (5), or (6), the Secretary shall submit a report to Congress concerning the progress of the Food and Drug Administration in reviewing the notices referred to in paragraphs (4), (5), and (6).CommentsClose CommentsPermalink





(9) USER FEES-CommentsClose CommentsPermalink





(A) EXPORTERS- When establishing an aggregate total of fees to be collected from exporters under subsection (f)(2) of such section 804, the Secretary shall, under subsection (f)(3)(C)(i) of such section 804, estimate the total price of drugs imported under subsection (a) of such section 804 into the United States by registered exporters during the first fiscal year in which this Act takes effect to be an amount equal to the amount which bears the same ratio to $1,000,000,000 as the number of days in such fiscal year during which this Act is effective bears to 365.CommentsClose CommentsPermalink





(B) IMPORTERS- When establishing an aggregate total of fees to be collected from importers under subsection (e)(2) of such section 804, the Secretary shall, under subsection (e)(3)(C)(i) of such section 804, estimate the total price of drugs imported under subsection (a) of such section 804 into the United States by registered importers during--CommentsClose CommentsPermalink





(i) the first fiscal year in which this Act takes effect to be an amount equal to the amount which bears the same ratio to $1,000,000,000 as the number of days in such fiscal year during which this Act is effective bears to 365; andCommentsClose CommentsPermalink





(ii) the second fiscal year in which this Act is in effect to be $3,000,000,000.CommentsClose CommentsPermalink





(C) SECOND YEAR ADJUSTMENT-CommentsClose CommentsPermalink





(i) REPORTS- Not later than February 20 of the second fiscal year in which this Act is in effect, registered importers shall report to the Secretary the total price and the total volume of drugs imported to the United States by the importer during the 4-month period from October 1 through January 31 of such fiscal year.CommentsClose CommentsPermalink





(ii) REESTIMATE- Notwithstanding subsection (e)(3)(C)(ii) of such section 804 or subparagraph (B), the Secretary shall reestimate the total price of qualifying drugs imported under subsection (a) of such section 804 into the United States by registered importers during the second fiscal year in which this Act is in effect. Such reestimate shall be equal to--CommentsClose CommentsPermalink





(I) the total price of qualifying drugs imported by each importer as reported under clause (i); multiplied byCommentsClose CommentsPermalink





(II) 3.CommentsClose CommentsPermalink





(iii) ADJUSTMENT- The Secretary shall adjust the fee due on April 1 of the second fiscal year in which this Act is in effect, from each importer so that the aggregate total of fees collected under subsection (e)(2) for such fiscal year does not exceed the total price of qualifying drugs imported under subsection (a) of such section 804 into the United States by registered importers during such fiscal year as reestimated under clause (ii).CommentsClose CommentsPermalink





(D) FAILURE TO PAY FEES- Notwithstanding any other provision of this section, the Secretary may prohibit a registered importer or exporter that is required to pay user fees under subsection (e) or (f) of such section 804 and that fails to pay such fees within 30 days after the date on which it is due, from importing or offering for importation a qualifying drug under such section 804 until such fee is paid.CommentsClose CommentsPermalink





(E) ANNUAL REPORT-CommentsClose CommentsPermalink





(i) FOOD AND DRUG ADMINISTRATION- Not later than 180 days after the end of each fiscal year during which fees are collected under subsection (e), (f), or (g)(2)(B)(iv) of such section 804, the Secretary shall prepare and submit to the House of Representatives and the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for the fiscal year for which the report is made and credited to the Food and Drug Administration.CommentsClose CommentsPermalink





(ii) CUSTOMS AND BORDER CONTROL- Not later than 180 days after the end of each fiscal year during which fees are collected under subsection (e) or (f) of such section 804, the Secretary of Homeland Security, in consultation with the Secretary of the Treasury, shall prepare and submit to the House of Representatives and the Senate a report on the use, by the Bureau of Customs and Border Protection, of the fees, if any, transferred by the Secretary to the Bureau of Customs and Border Protection for the fiscal year for which the report is made.CommentsClose CommentsPermalink





(10) SPECIAL RULE REGARDING IMPORTATION BY INDIVIDUALS-CommentsClose CommentsPermalink





(A) IN GENERAL- Notwithstanding any provision of this Act (or an amendment made by this Act), the Secretary shall expedite the designation of any additional countries from which an individual may import a qualifying drug into the United States under such section 804 if any action implemented by the Government of Canada has the effect of limiting or prohibiting the importation of qualifying drugs into the United States from Canada.CommentsClose CommentsPermalink





(B) TIMING AND CRITERIA- The Secretary shall designate such additional countries under subparagraph (A)--CommentsClose CommentsPermalink





(i) not later than 6 months after the date of the action by the Government of Canada described under such subparagraph; andCommentsClose CommentsPermalink





(ii) using the criteria described under subsection (a)(4)(D)(i)(II) of such section 804.CommentsClose CommentsPermalink





(f) Implementation of Section 804-CommentsClose CommentsPermalink





(1) INTERIM RULE- The Secretary may promulgate an interim rule for implementing section 804 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section.CommentsClose CommentsPermalink





(2) NO NOTICE OF PROPOSED RULEMAKING- The interim rule described under paragraph (1) may be developed and promulgated by the Secretary without providing general notice of proposed rulemaking.CommentsClose CommentsPermalink





(3) FINAL RULE- Not later than 1 year after the date on which the Secretary promulgates an interim rule under paragraph (1), the Secretary shall, in accordance with procedures under section 553 of title 5, United States Code, promulgate a final rule for implementing such section 804, which may incorporate by reference provisions of the interim rule provided for under paragraph (1), to the extent that such provisions are not modified.CommentsClose CommentsPermalink





(g) Consumer Education- The Secretary shall carry out activities that educate consumers--CommentsClose CommentsPermalink





(1) with regard to the availability of qualifying drugs for import for personal use from an exporter registered with and approved by the Food and Drug Administration under section 804 of the Federal Food, Drug, and Cosmetic Act, as added by this section, including information on how to verify whether an exporter is registered and approved by use of the Internet website of the Food and Drug Administration and the toll-free telephone number required by this Act;CommentsClose CommentsPermalink





(2) that drugs that consumers attempt to import from an exporter that is not registered with and approved by the Food and Drug Administration can be seized by the United States Customs Service and destroyed, and that such drugs may be counterfeit, unapproved, unsafe, or ineffective;CommentsClose CommentsPermalink





(3) with regard to the suspension and termination of any registration of a registered importer or exporter under such section 804; andCommentsClose CommentsPermalink





(4) with regard to the availability at domestic retail pharmacies of qualifying drugs imported under such section 804 by domestic wholesalers and pharmacies registered with and approved by the Food and Drug Administration.CommentsClose CommentsPermalink





(h) Effect on Administration Practices- Notwithstanding any provision of this Act (and the amendments made by this Act), the practices and policies of the Food and Drug Administration and Bureau of Customs and Border Protection, in effect on January 1, 2004, with respect to the importation of prescription drugs into the United States by an individual, on the person of such individual, for personal use, shall remain in effect.CommentsClose CommentsPermalink





(i) Report to Congress- The Federal Trade Commission shall, on an annual basis, submit to Congress a report that describes any action taken during the period for which the report is being prepared to enforce the provisions of section 804(n) of the Federal Food, Drug, and Cosmetic Act (as added by this Act), including any pending investigations or civil actions under such section.CommentsClose CommentsPermalink

SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED STATES.

(a) In General- Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 4, is further amended by adding at the end the following section:CommentsClose CommentsPermalink

`SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

`(a) In General- The Secretary of Homeland Security shall deliver to the Secretary a shipment of drugs that is imported or offered for import into the United States if--CommentsClose CommentsPermalink





`(1) the shipment has a declared value of less than $10,000; andCommentsClose CommentsPermalink





`(2)(A) the shipping container for such drugs does not bear the markings required under section 804(d)(2); orCommentsClose CommentsPermalink





`(B) the Secretary has requested delivery of such shipment of drugs.CommentsClose CommentsPermalink





`(b) No Bond or Export- Section 801(b) does not authorize the delivery to the owner or consignee of drugs delivered to the Secretary under subsection (a) pursuant to the execution of a bond, and such drugs may not be exported.CommentsClose CommentsPermalink





`(c) Destruction of Violative Shipment- The Secretary shall destroy a shipment of drugs delivered by the Secretary of Homeland Security to the Secretary under subsection (a) if--CommentsClose CommentsPermalink





`(1) in the case of drugs that are imported or offered for import from a registered exporter under section 804, the drugs are in violation of any standard described in section 804(g)(5); orCommentsClose CommentsPermalink





`(2) in the case of drugs that are not imported or offered for import from a registered exporter under section 804, the drugs are in violation of a standard referred to in section 801(a) or 801(d)(1).CommentsClose CommentsPermalink





`(d) Certain Procedures-CommentsClose CommentsPermalink





`(1) IN GENERAL- The delivery and destruction of drugs under this section may be carried out without notice to the importer, owner, or consignee of the drugs except as required by section 801(g) or section 804(i)(2). The issuance of receipts for the drugs, and recordkeeping activities regarding the drugs, may be carried out on a summary basis.CommentsClose CommentsPermalink





`(2) OBJECTIVE OF PROCEDURES- Procedures promulgated under paragraph (1) shall be designed toward the objective of ensuring that, with respect to efficiently utilizing Federal resources available for carrying out this section, a substantial majority of shipments of drugs subject to described in subsection (c) are identified and destroyed.CommentsClose CommentsPermalink





`(e) Evidence Exception- Drugs may not be destroyed under subsection (c) to the extent that the Attorney General of the United States determines that the drugs should be preserved as evidence or potential evidence with respect to an offense against the United States.CommentsClose CommentsPermalink





`(f) Rule of Construction- This section may not be construed as having any legal effect on applicable law with respect to a shipment of drugs that is imported or offered for import into the United States and has a declared value equal to or greater than $10,000.'.CommentsClose CommentsPermalink





(b) Procedures- Procedures for carrying out section 805 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall be established not later than 90 days after the date of the enactment of this Act.CommentsClose CommentsPermalink





(c) Effective Date- The amendments made by this section shall take effect on the date that is 90 days after the date of enactment of this Act.CommentsClose CommentsPermalink

SEC. 6. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS REGARDING PRIOR SALE, PURCHASE, OR TRADE.

(a) Striking of Exemptions; Applicability to Registered Exporters- Section 503(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1)--CommentsClose CommentsPermalink





(A) by striking `and who is not the manufacturer or an authorized distributor of record of such drug';CommentsClose CommentsPermalink





(B) by striking `to an authorized distributor of record or'; andCommentsClose CommentsPermalink





(C) by striking subparagraph (B) and inserting the following:CommentsClose CommentsPermalink





`(B) The fact that a drug subject to subsection (b) is exported from the United States does not with respect to such drug exempt any person that is engaged in the business of the wholesale distribution of the drug from providing the statement described in subparagraph (A) to the person that receives the drug pursuant to the export of the drug.CommentsClose CommentsPermalink





`(C)(i) The Secretary shall by regulation establish requirements that supersede subparagraph (A) (referred to in this subparagraph as `alternative requirements') to identify the chain of custody of a drug subject to subsection (b) from the manufacturer of the drug throughout the wholesale distribution of the drug to a pharmacist who intends to sell the drug at retail if the Secretary determines that the alternative requirements, which may include standardized anti-counterfeiting or track-and-trace technologies, will identify such chain of custody or the identity of the discrete package of the drug from which the drug is dispensed with equal or greater certainty to the requirements of subparagraph (A), and that the alternative requirements are economically and technically feasible.CommentsClose CommentsPermalink





`(ii) When the Secretary promulgates a final rule to establish such alternative requirements, the final rule in addition shall, with respect to the registration condition established in clause (i) of section 804(c)(3)(B), establish a condition equivalent to the alternative requirements, and such equivalent condition may be met in lieu of the registration condition established in such clause (i).';CommentsClose CommentsPermalink





(2) in paragraph (2)(A), by adding at the end the following: `The preceding sentence may not be construed as having any applicability with respect to a registered exporter under section 804.'; andCommentsClose CommentsPermalink





(3) in paragraph (3), by striking `and subsection (d)--' in the matter preceding subparagraph (A) and all that follows through `the term `wholesale distribution' means' in subparagraph (B) and inserting the following: `and subsection (d), the term `wholesale distribution' means'.CommentsClose CommentsPermalink





(b) Conforming Amendment- Section 503(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(4) Each manufacturer of a drug subject to subsection (b) shall maintain at its corporate offices a current list of the authorized distributors of record of such drug.CommentsClose CommentsPermalink





`(5) For purposes of this subsection, the term `authorized distributors of record' means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products.'.CommentsClose CommentsPermalink





(c) Effective Date-CommentsClose CommentsPermalink





(1) IN GENERAL- The amendments made by paragraphs (1) and (3) of subsection (a) and by subsection (b) shall take effect on January 1, 2010.CommentsClose CommentsPermalink





(2) DRUGS IMPORTED BY REGISTERED IMPORTERS UNDER SECTION 804- Notwithstanding paragraph (1), the amendments made by paragraphs (1) and (3) of subsection (a) and by subsection (b) shall take effect on the date that is 90 days after the date of enactment of this Act with respect to qualifying drugs imported under section 804 of the Federal Food, Drug, and Cosmetic Act, as added by section 4.CommentsClose CommentsPermalink





(3) EFFECT WITH RESPECT TO REGISTERED EXPORTERS- The amendment made by subsection (a)(2) shall take effect on the date that is 90 days after the date of enactment of this Act.CommentsClose CommentsPermalink





(4) ALTERNATIVE REQUIREMENTS- The Secretary shall issue regulations to establish the alternative requirements, referred to in the amendment made by subsection (a)(1), that take effect not later than January 1, 2010.CommentsClose CommentsPermalink





(5) INTERMEDIATE REQUIREMENTS- The Secretary shall by regulation require the use of standardized anti-counterfeiting or track-and-trace technologies on prescription drugs at the case and pallet level effective not later than 1 year after the date of enactment of this Act.CommentsClose CommentsPermalink





(6) ADDITIONAL REQUIREMENTS-CommentsClose CommentsPermalink





(A) IN GENERAL- Notwithstanding any other provision of this section, the Secretary shall, not later than 18 months after the date of enactment of this Act, require that the packaging of any prescription drug incorporates--CommentsClose CommentsPermalink





(i) a standardized numerical identifier unique to each package of such drug, applied at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing); andCommentsClose CommentsPermalink





(ii)(I) overt optically variable counterfeit-resistant technologies that--CommentsClose CommentsPermalink





(aa) are visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;CommentsClose CommentsPermalink





(bb) are similar to that used by the Bureau of Engraving and Printing to secure United States currency;CommentsClose CommentsPermalink





(cc) are manufactured and distributed in a highly secure, tightly controlled environment; andCommentsClose CommentsPermalink





(dd) incorporate additional layers of nonvisible convert security features up to and including forensic capability, as described in subparagraph (B); orCommentsClose CommentsPermalink





(II) technologies that have a function of security comparable to that described in subclause (I), as determined by the Secretary.CommentsClose CommentsPermalink





(B) STANDARDS FOR PACKAGING- For the purpose of making it more difficult to counterfeit the packaging of drugs subject to this paragraph, the manufacturers of such drugs shall incorporate the technologies described in subparagraph (A) into at least 1 additional element of the physical packaging of the drugs, including blister packs, shrink wrap, package labels, package seals, bottles, and boxes.CommentsClose CommentsPermalink

SEC. 7. INTERNET SALES OF PRESCRIPTION DRUGS.

(a) In General- Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A the following:CommentsClose CommentsPermalink

`SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

`(a) Requirements Regarding Information on Internet Site-CommentsClose CommentsPermalink





`(1) IN GENERAL- A person may not dispense a prescription drug pursuant to a sale of the drug by such person if--CommentsClose CommentsPermalink





`(A) the purchaser of the drug submitted the purchase order for the drug, or conducted any other part of the sales transaction for the drug, through an Internet site;CommentsClose CommentsPermalink





`(B) the person dispenses the drug to the purchaser by mailing or shipping the drug to the purchaser; andCommentsClose CommentsPermalink





`(C) such site, or any other Internet site used by such person for purposes of sales of a prescription drug, fails to meet each of the requirements specified in paragraph (2), other than a site or pages on a site that--CommentsClose CommentsPermalink





`(i) are not intended to be accessed by purchasers or prospective purchasers; orCommentsClose CommentsPermalink





`(ii) provide an Internet information location tool within the meaning of section 231(e)(5) of the Communications Act of 1934 (47 U.S.C. 231(e)(5)).CommentsClose CommentsPermalink





`(2) REQUIREMENTS- With respect to an Internet site, the requirements referred to in subparagraph (C) of paragraph (1) for a person to whom such paragraph applies are as follows:CommentsClose CommentsPermalink





`(A) Each page of the site shall include either the following information or a link to a page that provides the following information:CommentsClose CommentsPermalink





`(i) The name of such person.CommentsClose CommentsPermalink





`(ii) Each State in which the person is authorized by law to dispense prescription drugs.CommentsClose CommentsPermalink





`(iii) The address and telephone number of each place of business of the person with respect to sales of prescription drugs through the Internet, other than a place of business that does not mail or ship prescription drugs to purchasers.CommentsClose CommentsPermalink





`(iv) The name of each individual who serves as a pharmacist for prescription drugs that are mailed or shipped pursuant to the site, and each State in which the individual is authorized by law to dispense prescription drugs.CommentsClose CommentsPermalink





`(v) If the person provides for medical consultations through the site for purposes of providing prescriptions, the name of each individual who provides such consultations; each State in which the individual is licensed or otherwise authorized by law to provide such consultations or practice medicine; and the type or types of health professions for which the individual holds such licenses or other authorizations.CommentsClose CommentsPermalink





`(B) A link to which paragraph (1) applies shall be displayed in a clear and prominent place and manner, and shall include in the caption for the link the words `licensing and contact information'.CommentsClose CommentsPermalink





`(b) Internet Sales Without Appropriate Medical Relationships-CommentsClose CommentsPermalink





`(1) IN GENERAL- Except as provided in paragraph (2), a person may not dispense a prescription drug, or sell such a drug, if--CommentsClose CommentsPermalink





`(A) for purposes of such dispensing or sale, the purchaser communicated with the person through the Internet;CommentsClose CommentsPermalink





`(B) the patient for whom the drug was dispensed or purchased did not, when such communications began, have a prescription for the drug that is valid in the United States;CommentsClose CommentsPermalink





`(C) pursuant to such communications, the person provided for the involvement of a practitioner, or an individual represented by the person as a practitioner, and the practitioner or such individual issued a prescription for the drug that was purchased;CommentsClose CommentsPermalink





`(D) the person knew, or had reason to know, that the practitioner or the individual referred to in subparagraph (C) did not, when issuing the prescription, have a qualifying medical relationship with the patient; andCommentsClose CommentsPermalink





`(E) the person received payment for the dispensing or sale of the drug.CommentsClose CommentsPermalink





For purposes of subparagraph (E), payment is received if money or other valuable consideration is received.CommentsClose CommentsPermalink





`(2) EXCEPTIONS- Paragraph (1) does not apply to--CommentsClose CommentsPermalink





`(A) the dispensing or selling of a prescription drug pursuant to telemedicine practices sponsored by--CommentsClose CommentsPermalink





`(i) a hospital that has in effect a provider agreement under title XVIII of the Social Security Act (relating to the Medicare program); orCommentsClose CommentsPermalink





`(ii) a group practice that has not fewer than 100 physicians who have in effect provider agreements under such title; orCommentsClose CommentsPermalink





`(B) the dispensing or selling of a prescription drug pursuant to practices that promote the public health, as determined by the Secretary by regulation.CommentsClose CommentsPermalink





`(3) QUALIFYING MEDICAL RELATIONSHIP-CommentsClose CommentsPermalink





`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--CommentsClose CommentsPermalink





`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; orCommentsClose CommentsPermalink





`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.CommentsClose CommentsPermalink





`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.CommentsClose CommentsPermalink





`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.CommentsClose CommentsPermalink





`(4) RULES OF CONSTRUCTION-CommentsClose CommentsPermalink





`(A) INDIVIDUALS REPRESENTED AS PRACTITIONERS- A person who is not a practitioner (as defined in subsection (e)(1)) lacks legal capacity under this section to have a qualifying medical relationship with any patient.CommentsClose CommentsPermalink





`(B) STANDARD PRACTICE OF PHARMACY- Paragraph (1) may not be construed as prohibiting any conduct that is a standard practice in the practice of pharmacy.CommentsClose CommentsPermalink





`(C) APPLICABILITY OF REQUIREMENTS- Paragraph (3) may not be construed as having any applicability beyond this section, and does not affect any State law, or interpretation of State law, concerning the practice of medicine.CommentsClose CommentsPermalink





`(c) Actions by States-CommentsClose CommentsPermalink





`(1) IN GENERAL- Whenever an attorney general of any State has reason to believe that the interests of the residents of that State have been or are being threatened or adversely affected because any person has engaged or is engaging in a pattern or practice that violates section 301(l), the State may bring a civil action on behalf of its residents in an appropriate district court of the United States to enjoin such practice, to enforce compliance with such section (including a nationwide injunction), to obtain damages, restitution, or other compensation on behalf of residents of such State, to obtain reasonable attorneys fees and costs if the State prevails in the civil action, or to obtain such further and other relief as the court may deem appropriate.CommentsClose CommentsPermalink





`(2) NOTICE- The State shall serve prior written notice of any civil action under paragraph (1) or (5)(B) upon the Secretary and provide the Secretary with a copy of its complaint, except that if it is not feasible for the State to provide such prior notice, the State shall serve such notice immediately upon instituting such action. Upon receiving a notice respecting a civil action, the Secretary shall have the right--CommentsClose CommentsPermalink





`(A) to intervene in such action;CommentsClose CommentsPermalink





`(B) upon so intervening, to be heard on all matters arising therein; andCommentsClose CommentsPermalink





`(C) to file petitions for appeal.CommentsClose CommentsPermalink





`(3) CONSTRUCTION- For purposes of bringing any civil action under paragraph (1), nothing in this chapter shall prevent an attorney general of a State from exercising the powers conferred on the attorney general by the laws of such State to conduct investigations or to administer oaths or affirmations or to compel the attendance of witnesses or the production of documentary and other evidence.CommentsClose CommentsPermalink





`(4) VENUE; SERVICE OF PROCESS- Any civil action brought under paragraph (1) in a district court of the United States may be brought in the district in which the defendant is found, is an inhabitant, or transacts business or wherever venue is proper under section 1391 of title 28, United States Code. Process in such an action may be served in any district in which the defendant is an inhabitant or in which the defendant may be found.CommentsClose CommentsPermalink





`(5) ACTIONS BY OTHER STATE OFFICIALS-CommentsClose CommentsPermalink





`(A) Nothing contained in this section shall prohibit an authorized State official from proceeding in State court on the basis of an alleged violation of any civil or criminal statute of such State.CommentsClose CommentsPermalink





`(B) In addition to actions brought by an attorney general of a State under paragraph (1), such an action may be brought by officers of such State who are authorized by the State to bring actions in such State on behalf of its residents.CommentsClose CommentsPermalink





`(d) Effect of Section- This section shall not apply to a person that is a registered exporter under section 804.CommentsClose CommentsPermalink





`(e) General Definitions- For purposes of this section:CommentsClose CommentsPermalink





`(1) The term `practitioner' means a practitioner referred to in section 503(b)(1) with respect to issuing a written or oral prescription.CommentsClose CommentsPermalink





`(2) The term `prescription drug' means a drug that is described in section 503(b)(1).CommentsClose CommentsPermalink





`(3) The term `qualifying medical relationship', with respect to a practitioner and a patient, has the meaning indicated for such term in subsection (b).CommentsClose CommentsPermalink





`(f) Internet-Related Definitions-CommentsClose CommentsPermalink





`(1) IN GENERAL- For purposes of this section:CommentsClose CommentsPermalink





`(A) The term `Internet' means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected world-wide network of networks that employ the transmission control protocol/internet protocol, or any predecessor or successor protocols to such protocol, to communicate information of all kinds by wire or radio.CommentsClose CommentsPermalink





`(B) The term `link', with respect to the Internet, means one or more letters, words, numbers, symbols, or graphic items that appear on a page of an Internet site for the purpose of serving, when activated, as a method for executing an electronic command--CommentsClose CommentsPermalink





`(i) to move from viewing one portion of a page on such site to another portion of the page;CommentsClose CommentsPermalink





`(ii) to move from viewing one page on such site to another page on such site; orCommentsClose CommentsPermalink





`(iii) to move from viewing a page on one Internet site to a page on another Internet site.CommentsClose CommentsPermalink





`(C) The term `page', with respect to the Internet, means a document or other file accessed at an Internet site.CommentsClose CommentsPermalink





`(D)(i) The terms `site' and `address', with respect to the Internet, mean a specific location on the Internet that is determined by Internet Protocol numbers. Such term includes the domain name, if any.CommentsClose CommentsPermalink





`(ii) The term `domain name' means a method of representing an Internet address without direct reference to the Internet Protocol numbers for the address, including methods that use designations such as `.com', `.edu', `.gov', `.net', or `.org'.CommentsClose CommentsPermalink





`(iii) The term `Internet Protocol numbers' includes any successor protocol for determining a specific location on the Internet.CommentsClose CommentsPermalink





`(2) AUTHORITY OF SECRETARY- The Secretary may by regulation modify any definition under paragraph (1) to take into account changes in technology.CommentsClose CommentsPermalink





`(g) Interactive Computer Service; Advertising- No provider of an interactive computer service, as defined in section 230(f)(2) of the Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising services shall be liable under this section for dispensing or selling prescription drugs in violation of this section on account of another person's selling or dispensing such drugs, provided that the provider of the interactive computer service or of advertising services does not own or exercise corporate control over such person.'.CommentsClose CommentsPermalink





(b) Inclusion as Prohibited Act- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after paragraph (k) the following:CommentsClose CommentsPermalink





`(l) The dispensing or selling of a prescription drug in violation of section 503B.'.CommentsClose CommentsPermalink





(c) Internet Sales of Prescription Drugs; Consideration by Secretary of Practices and Procedures for Certification of Legitimate Businesses- In carrying out section 503B of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section), the Secretary of Health and Human Services shall take into consideration the practices and procedures of public or private entities that certify that businesses selling prescription drugs through Internet sites are legitimate businesses, including practices and procedures regarding disclosure formats and verification programs.CommentsClose CommentsPermalink





(d) Reports Regarding Internet-Related Violations of Federal and State Laws on Dispensing of Drugs-CommentsClose CommentsPermalink





(1) IN GENERAL- The Secretary of Health and Human Services (referred to in this subsection as the `Secretary') shall, pursuant to the submission of an application meeting the criteria of the Secretary, make an award of a grant or contract to the National Clearinghouse on Internet Prescribing (operated by the Federation of State Medical Boards) for the purpose of--CommentsClose CommentsPermalink





(A) identifying Internet sites that appear to be in violation of Federal or State laws concerning the dispensing of drugs;CommentsClose CommentsPermalink





(B) reporting such sites to State medical licensing boards and State pharmacy licensing boards, and to the Attorney General and the Secretary, for further investigation; andCommentsClose CommentsPermalink





(C) submitting, for each fiscal year for which the award under this subsection is made, a report to the Secretary describing investigations undertaken with respect to violations described in subparagraph (A).CommentsClose CommentsPermalink





(2) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out paragraph (1), there is authorized to be appropriated $100,000 for each of the first 3 fiscal years in which this section is in effect.CommentsClose CommentsPermalink





(e) Effective Date- The amendments made by subsections (a) and (b) take effect 90 days after the date of enactment of this Act, without regard to whether a final rule to implement such amendments has been promulgated by the Secretary of Health and Human Services under section 701(a) of the Federal Food, Drug, and Cosmetic Act. The preceding sentence may not be construed as affecting the authority of such Secretary to promulgate such a final rule.CommentsClose CommentsPermalink