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:

804.

Commercial and personal importation of prescription drugs

(a)

Importation of prescription drugs

(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— (A)the limitation on importation that is established in section 801(d)(1) is waived; and (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). (2)

Importers

A qualifying drug may not be imported under paragraph (1) unless— (A)the drug is imported by a pharmacy, group of pharmacies, or a wholesaler that is a registered importer; or (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. (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— (A)by a registered importer; or (B)from a registered exporter to an individual. (4)

Definitions

(A)

Registered exporter; registered importer

For purposes of this section: (i)The term registered exporter means an exporter for which a registration under subsection (b) has been approved and is in effect. (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. (iii)The term registration condition means a condition that must exist for a registration under subsection (b) to be approved. (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. (C)

U.S. label drug

For purposes of this section, the term U.S. label drug means a prescription drug that— (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; (ii)with respect to the qualifying drug, is manufactured by or for the person that manufactures the qualifying drug; (iii)is approved under section 505(c); and (iv)is not— (I)a controlled substance, as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802); (II)a biological product, as defined in section 351 of the Public Health Service Act (42 U.S.C. 262), including— (aa)a therapeutic DNA plasmid product; (bb)a therapeutic synthetic peptide product; (cc)a monoclonal antibody product for in vivo use; and (dd)a therapeutic recombinant DNA-derived product; (III)an infused drug, including a peritoneal dialysis solution; (IV)an injected drug; (V)a drug that is inhaled during surgery; (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; or (VII)a sterile opthlamic drug intended for topical use on or in the eye. (D)

Other definitions

For purposes of this section: (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. (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— (aa)the country has statutory or regulatory standards that are equivalent to the standards in the United States and Canada with respect to— (AA)the training of pharmacists; (BB)the practice of pharmacy; and (CC)the protection of the privacy of personal medical information; and (bb)the importation of drugs to individuals in the United States from the country will not adversely affect public health. (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. (iii)The term pharmacist means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. (iv)The term pharmacy means a person that— (I)is licensed by a State to engage in the business of selling prescription drugs at retail; and (II)employs 1 or more pharmacists. (v)The term prescription drug means a drug that is described in section 503(b)(1). (vi)The term wholesaler— (I)means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 503(e)(2)(A); and (II)does not include a person authorized to import drugs under section 801(d)(1). (E)

Permitted country

The term permitted country means— (i)Australia; (ii)Canada; (iii)a member country of the European Union, but does not include a member country with respect to which— (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; or (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; (iv)Japan; (v)New Zealand; (vi)Switzerland; and (vii)a country in which the Secretary determines the following requirements are met: (I)The country has statutory or regulatory requirements— (aa)that require the review of drugs for safety and effectiveness by an entity of the government of the country; (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; (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; (dd)for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective; and (ee)that require the labeling and promotion of drugs to be in accordance with the approval of the drug. (II)The valid marketing authorization system in the country is equivalent to the systems in the countries described in clauses (i) through (vi). (III)The importation of drugs to the United States from the country will not adversely affect public health. (b)

Registration of importers and exporters

(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: (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. (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). (B)Such information as the Secretary determines to be necessary to demonstrate that the registrant is in compliance with registration conditions under— (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); or (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). (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. (D)An agreement by the registrant to— (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); (ii)provide for the return to the registrant of such drug; and (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. (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. (F)A plan describing the manner in which the registrant will comply with the agreement under subparagraph (E). (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. (H)An agreement by the registrant to notify the Secretary not more than 30 days before the registrant intends to make the change, of— (i)any change that the registrant intends to make regarding information provided under subparagraph (A) or (B); and (ii)any change that the registrant intends to make in the compliance plan under subparagraph (F). (I)In the case of an exporter— (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. (ii)An agreement to post a bond, payable to the Treasury of the United States that is equal in value to the lesser of— (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; or (II)$1,000,000; (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). (iv)An agreement by the exporter to report to the Secretary— (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; and (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. (J)In the case of an importer, an agreement by the importer to report to the Secretary— (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; and (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. (K)Such other provisions as the Secretary may require by regulation to protect the public health while permitting— (i)the importation by pharmacies, groups of pharmacies, and wholesalers as registered importers of qualifying drugs under subsection (a); and (ii)importation by individuals of qualifying drugs under subsection (a). (2)

Approval or disapproval of registration

(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. (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. (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. (4)

Suspension and termination

(A)

Suspension

With respect to the effectiveness of a registration submitted under paragraph (1): (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. (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. (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. (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. (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— (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); or (B)failed to permit the Secretary to conduct an inspection described under subsection (d). (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: (1)The drug was manufactured in an establishment— (A)required to register under subsection (h) or (i) of section 510; and (B) (i)inspected by the Secretary; or (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). (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). (3)The exporter or importer obtained the drug— (A)directly from the establishment; or (B)directly from an entity that, by contract with the exporter or importer— (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); (ii)agrees to permit the Secretary to inspect such statements and related records to determine their accuracy; (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; and (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. (4) (A)The foreign country from which the importer will import the drug is a permitted country; or (B)The foreign country from which the exporter will export the drug is the permitted country in which the exporter is located. (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. (6)The exporter or importer retains a sample of each lot of the drug for testing by the Secretary. (d)

Inspection of facilities; marking of shipments

(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— (A)the exporter agrees to permit the Secretary— (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; (ii)to have access, including on a day-to-day basis, to— (I)records of the exporter that relate to the export of such drugs, including financial records; and (II)samples of such drugs; (iii)to carry out the duties described in paragraph (3); and (iv)to carry out any other functions determined by the Secretary to be necessary regarding the compliance of the exporter; and (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. (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— (A)be designed to prevent affixation of the markings to any shipping container that is not authorized to bear the markings; and (B)include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies. (3)

Certain duties relating to exporters

Duties of the Secretary with respect to an exporter include the following: (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. (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. (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. (D)Monitoring the affixing of markings under paragraph (2). (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. (F)Determining whether the exporter is in compliance with all other registration conditions. (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— (A)the name and complete contact information of the person submitting the notice; (B)the name and complete contact information of the importer involved; (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; (D)the identity of the manufacturer of the drug, including the identity of the establishment at which the drug was manufactured; (E)the country from which the drug is shipped; (F)the name and complete contact information for the shipper of the drug; (G)anticipated arrival information, including the port of arrival and crossing location within that port, and the date and time; (H)a summary of the chain of custody of the drug from the establishment in which the drug was manufactured to the importer; (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); and (J)such other information as the Secretary may require by regulation. (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— (A)be designed to prevent affixation of the markings or other technology to any container that is not authorized to bear the markings; and (B)shall include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of such technologies. (6)

Certain duties relating to importers

Duties of the Secretary with respect to an importer include the following: (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. (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. (C)Reviewing notices under paragraph (4). (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. (E)Determining whether the importer is in compliance with all other registration conditions. (e)

Importer fees

(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). (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). (3)

Amount of inspection fee

(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— (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); (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; and (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). (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). (C)

Total price of drugs

(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). (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). (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. (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). (4)

Use of fees

(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). (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). (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. (f)

Exporter fees

(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). (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). (3)

Amount of inspection fee

(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— (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); (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; and (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). (B)

Limitation

Total price of drugs

(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). (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). (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. (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). (4)

Use of fees

(A)

In general

Sole purpose

Collection of fees

Compliance with Section 801(a)

(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). (2)

Section 505; approval status

(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. (B)

Notice by manufacturer; general provisions

(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— (I)includes each difference in the qualifying drug from a condition established in the approved application for the U.S. label drug beyond— (aa)the variations provided for in the application; and (bb)any difference in labeling (except ingredient labeling); or (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— (aa)the variations provided for in the application; and (bb)any difference in labeling (except ingredient labeling). (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: (I)The date on which the qualifying drug with such difference was, or will be, introduced for commercial distribution in the permitted country. (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. (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. (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— (I)the information provided in the notice is complete and true; and (II)a copy of the notice has been provided to the Federal Trade Commission and to the State attorneys general. (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). (v)

Timing of submission of notices

(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. (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. (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. (vi)

Review by Secretary

(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. (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. (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— (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; or (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. (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. (V)

Establishment inspection

If review of such difference would require an inspection of the establishment in which the qualifying drug is manufactured— (aa)such inspection by the Secretary shall be authorized; and (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). (vii)

Publication of information on notices

(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). (II)

Contents

The list under subclause (I) shall include the date on which a notice is submitted and whether— (aa)a notice is under review; (bb)the Secretary has ordered that importation of the qualifying drug from a permitted country cease; or (cc)the importation of the drug is permitted under subsection (a). (III)

Update

The Secretary shall promptly update the Internet website with any changes to the list. (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: (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. (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— (I)order that the importation of the qualifying drug involved from the permitted country not begin until the Secretary completes review of the notice; and (II)promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the order. (iii)If the Secretary determines that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall— (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; (II)notify the permitted country that approved the qualifying drug for commercial distribution of the determination; and (III)promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination. (iv)If the Secretary determines that such a supplemental application regarding the U.S. label drug would be approved, the Secretary shall— (I)vacate the order under clause (ii), if any; (II)consider the difference to be a variation provided for in the approved application for the U.S. label drug; (III)permit importation of the qualifying drug under subsection (a); and (IV)promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination. (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: (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. (ii)If the Secretary determines that such a supplemental application regarding the U.S. label drug would not be approved, the Secretary shall— (I)order that the importation of the qualifying drug involved from the permitted country cease; (II)notify the permitted country that approved the qualifying drug for commercial distribution of the determination; and (III)promptly notify registered exporters, registered importers, the Federal Trade Commission, and the State attorneys general of the determination. (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. (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— (i)shall consider such difference to be a variation provided for in the approved application for the U.S. label drug; (ii)may not order that the importation of the qualifying drug involved cease; and (iii)shall promptly notify registered exporters and registered importers. (F)

Differences in active ingredient, route of administration, dosage form, or strength

(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— (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); and (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). (ii)

Application under Section 505(b)

The application under section 505(b) required under clause (i) shall— (I)request approval of the other drug for the indication or indications for which the drug approved under section 505(b) is labeled; (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; (III)include a right of reference to the application for the drug approved under section 505(b); and (IV)include such additional information as the Secretary may require. (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. (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). (v)

Related active ingredients

For purposes of clause (i)(II), 2 active ingredients are related if they are— (I)the same; or (II)different salts, esters, or complexes of the same moiety. (3)

Section 502; labeling

(A)

Importation by registered importer

(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— (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; (II)the name of the manufacturer and location of the manufacturer; (III)the lot number assigned by the manufacturer; (IV)the name, location, and registration number of the importer; and (V)the National Drug Code number assigned to the qualifying drug by the Secretary. (ii)

Request for copy of the labeling

The Secretary shall provide such copy to the registered importer involved, upon request of the importer. (iii)

Requested labeling

The labeling provided by the Secretary under clause (ii) shall— (I)include the established name, as defined in section 502(e)(3), for each active ingredient in the qualifying drug; (II)not include the proprietary name of the U.S. label drug or any active ingredient thereof; (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; and (IV)if the inactive ingredients of the qualifying drug are different from the inactive ingredients for the U.S. label drug, include— (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; and (bb)a list of the ingredients of the qualifying drug as would be required under section 502(e). (B)

Importation by individual

(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— (I)directions for use by the consumer; (II)the lot number assigned by the manufacturer; (III)the name and registration number of the exporter; (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; (V)if the inactive ingredients of the drug are different from the inactive ingredients for the U.S. label drug— (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; and (bb)a list of the ingredients of the drug as would be required under section 502(e); and (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. (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— (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.); or (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. (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. (iv)

Requested labeling and ingredient list

The labeling and ingredient list provided by the Secretary under clause (iii) shall— (I)include the established name, as defined in section 502(e)(3), for each active ingredient in the drug; and (II)not include the proprietary name of the U.S. label drug or any active ingredient thereof. (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). (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: (A)The drug is not a qualifying drug. (B)A notice for the drug required under paragraph (2)(B) has not been submitted to the Secretary. (C)The Secretary has ordered that importation of the drug from the permitted country cease under paragraph (2) (C) or (D). (D)The drug does not comply with paragraph (3) or (4). (E)The shipping container appears damaged in a way that may affect the strength, quality, or purity of the drug. (F)The Secretary becomes aware that— (i)the drug may be counterfeit; (ii)the drug may have been prepared, packed, or held under insanitary conditions; or (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. (G)The Secretary has obtained an injunction under section 302 that prohibits the distribution of the drug in interstate commerce. (H)The Secretary has under section 505(e) withdrawn approval of the drug. (I)The manufacturer of the drug has instituted a recall of the drug. (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). (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: (i)The shipping container for such drug does not bear the markings required under subsection (d)(2). (ii)The markings on the shipping container appear to be counterfeit. (iii)The shipping container or markings appear to have been tampered with. (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— (1)the exporter is authorized under the law of the permitted country in which the exporter is located to dispense prescription drugs; and (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. (i)

Individuals; conditions for importation

(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: (A)The drug is accompanied by a copy of a prescription for the drug, which prescription— (i)is valid under applicable Federal and State laws; and (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. (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. (C)The copies referred to in subparagraphs (A)(i) and (B) are marked in a manner sufficient— (i)to indicate that the prescription, and the equivalent document in the permitted country in which the exporter is located, have been filled; and (ii)to prevent a duplicative filling by another pharmacist. (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. (E)The quantity of the drug does not exceed a 90-day supply. (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. (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. (j)

Maintenance of records and samples

(1)

In general

A registration condition is that the importer or exporter involved shall— (A)maintain records required under this section for not less than 2 years; and (B)maintain samples of each lot of a qualifying drug required under this section for not more than 2 years. (2)

Place of record maintenance

The records described under paragraph (1) shall be maintained— (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; or (B)in the case of an exporter, at the facility from which the exporter ships the qualifying drug to the United States. (k)

Drug recalls

(1)

Manufacturers

A person that manufactures a qualifying drug imported from a permitted country under this section shall promptly inform the Secretary— (A)if the drug is recalled or withdrawn from the market in a permitted country; (B)how the drug may be identified, including lot number; and (C)the reason for the recall or withdrawal. (2)

Secretary

With respect to each permitted country, the Secretary shall— (A)enter into an agreement with the government of the country to receive information about recalls and withdrawals of qualifying drugs in the country; or (B)monitor recalls and withdrawals of qualifying drugs in the country using any information that is available to the public in any media. (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. (l)

Drug labeling and packaging

(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: (A)The lot number assigned by the manufacturer. (B)The name and registration number of the importer. (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. (D)If the inactive ingredients of the drug are different from the inactive ingredients for the U.S. label drug— (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; and (ii)a list of the ingredients of the drug as would be required under section 502(e). (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— (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.); or (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. (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. (n)

Unfair and discriminatory Acts and practices

(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— (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; (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; (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; (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; (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; (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; (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; (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; (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; (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; (K)enter into a contract that restricts, prohibits, or delays the importation of a qualifying drug under this section; (L)engage in any other action to restrict, prohibit, or delay the importation of a qualifying drug under this section; or (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. (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. (3)

Affirmative defense

(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— (i)the person exporting or importing a qualifying drug into the United States under this section; or (ii)the person distributing, selling, or using a qualifying drug imported into the United States under this section. (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— (i)the difference was required by the country in which the drug is distributed; (ii)the Secretary has determined that the difference was necessary to improve the safety or effectiveness of the drug; (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; or (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. (4)

Effect of subsection

(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. (B)

Discounts to insurers, health plans, pharmacy benefit managers, and covered entities

Nothing in this subsection shall be construed to— (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; (ii)require that such discounts be made available to other purchasers of the prescription drug; or (iii)prevent or restrict any other measures taken by an insurer, health plan, or pharmacy benefit manager to encourage consumption of such prescription drug. (C)

Charitable contributions

Nothing in this subsection shall be construed to— (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; or (ii)apply to such donations or supplying of a prescription drug. (5)

Enforcement

(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)). (B)

Actions by the commission

The Federal Trade Commission— (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; and (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.). (6)

Actions by States

(A)

In general

(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— (I)enjoin that practice; (II)enforce compliance with this subsection; (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; or (IV)obtain such other relief as the court may consider to be appropriate. (ii)

Notice

(I)

In general

Before filing an action under clause (i), the attorney general of the State involved shall provide to the Federal Trade Commission— (aa)written notice of that action; and (bb)a copy of the complaint for that action. (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. (B)

Intervention

(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. (ii)

Effect of intervention

If the Federal Trade Commission intervenes in an action under subparagraph (A), it shall have the right— (I)to be heard with respect to any matter that arises in that action; and (II)to file a petition for appeal. (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— (i)conduct investigations; (ii)administer oaths or affirmations; or (iii)compel the attendance of witnesses or the production of documentary and other evidence. (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. (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. (F)

Service of process

In an action brought under subparagraph (A), process may be served in any district in which the defendant— (i)is an inhabitant; or (ii)may be found. (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. (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. (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. (8)

Manufacturer

In this subsection, the term manufacturer means any entity, including any affiliate or licensee of that entity, that is engaged in— (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; or (B)the packaging, repackaging, labeling, relabeling, or distribution of a prescription drug.

(b)

Prohibited Acts

The Federal Food, Drug, and Cosmetic Act is amended— (1)in section 301 (21 U.S.C. 331), by striking paragraph (aa) and inserting the following:

(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— (A)a sale at retail made pursuant to dispensing the drug to a customer of the pharmacist or organization; or (B)a sale or trade of the drug to a pharmacy or a wholesaler registered to import drugs under section 804. (2)The sale or trade by an individual of a qualifying drug that under section 804(a)(2)(B) was imported by the individual. (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. (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.

; and

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

(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.

(c)

Amendment of certain provisions

(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:

(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— (1)the drug has been refused admission because the drug was not a lawful import under section 804; (2)the drug is not otherwise subject to a waiver of the requirements of subsection (a); (3)the individual may under section 804 lawfully import certain prescription drugs from exporters registered with the Secretary under section 804; and (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.

(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,. (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. (d)

Exhaustion

(1)

In general

Section 271 of title 35, United States Code, is amended— (A)by redesignating subsections (h) and (i) as (i) and (j), respectively; and (B)by inserting after subsection (g) the following:

(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.

(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. (e)

Effect of Section 804

(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— (A)from exporters registered under such section 804 on the date that is 90 days after the date of enactment of this Act; and (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. (2)

Review of registration by certain exporters

(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. (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. (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. (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. (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. (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. (3)

Limits on number of importers

(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. (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. (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. (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— (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; or (B)the notice is a notice under subsection (g)(2)(B)(i)(II) of such section 804. (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— (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; or (B)the notice is a notice under subsection (g)(2)(B)(i)(II) of such section 804. (6)

Notice for other drugs for import

(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). (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. (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. (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). (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). (9)

User fees

(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. (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— (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; and (ii)the second fiscal year in which this Act is in effect to be $3,000,000,000. (C)

Second year adjustment

(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. (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— (I)the total price of qualifying drugs imported by each importer as reported under clause (i); multiplied by (II)3. (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). (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. (E)

Annual report

(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. (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. (10)

Special rule regarding importation by individuals

(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. (B)

Timing and criteria

The Secretary shall designate such additional countries under subparagraph (A)— (i)not later than 6 months after the date of the action by the Government of Canada described under such subparagraph; and (ii)using the criteria described under subsection (a)(4)(D)(i)(II) of such section 804. (f)

Implementation of Section 804

(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. (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. (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. (g)

Consumer education

The Secretary shall carry out activities that educate consumers— (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; (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; (3)with regard to the suspension and termination of any registration of a registered importer or exporter under such section 804; and (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. (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. (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.