I 

111TH CONGRESS 

1ST SESSION H. R. 1298 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

importation of prescription drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 4, 2009 

Mr. BERRY (for himself and Mrs. EMERSON) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the importation of prescription drugs, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pharmaceutical Mar5 ket Access and Drug Safety Act of 2009’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 

8 (1) Americans unjustly pay up to 5 times more 

9 to fill their prescriptions than consumers in other 

10 countries; 


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1 (2) the United States is the largest market for 

2 pharmaceuticals in the world, yet American con3 sumers pay the highest prices for brand pharma4 ceuticals in the world; 

5 (3) a prescription drug is neither safe nor effec6 tive to an individual who cannot afford it; 

7 (4) allowing and structuring the importation of 

8 prescription drugs to ensure access to safe and af9 fordable drugs approved by the Food and Drug Ad10 ministration will provide a level of safety to Amer11 ican consumers that they do not currently enjoy; 

12 (5) Americans spend more than 

13 $200,000,000,000 on prescription drugs every year; 

14 (6) the Congressional Budget Office has found 

15 that the cost of prescription drugs are between 35 

16 to 55 percent less in other highly-developed coun17 tries than in the United States; and 

18 (7) promoting competitive market pricing would 

19 both contribute to health care savings and allow 

20 greater access to therapy, improving health and sav21 ing lives. 


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1 SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPOR2 TATION OF PRESCRIPTION DRUGS. 

3 Chapter VIII of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 381 et seq.) is amended by striking 

5 section 804. 

6 SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 

7 OF CERTAIN IMPORT RESTRICTIONS. 

8 (a) IN GENERAL.—Chapter VIII of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 

10 as amended by section 3, is further amended by inserting 

11 after section 803 the following: 

12 ‘‘SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF 

13 PRESCRIPTION DRUGS. 

14 ‘‘(a) IMPORTATION OF PRESCRIPTION DRUGS.— 

15 ‘‘(1) IN GENERAL.—In the case of qualifying 

16 drugs imported or offered for import into the United 

17 States from registered exporters or by registered im18 porters— 

19 ‘‘(A) the limitation on importation that is 

20 established in section 801(d)(1) is waived; and 

21 ‘‘(B) the standards referred to in section 

22 801(a) regarding admission of the drugs are 

23 subject to subsection (g) of this section (includ24 ing with respect to qualifying drugs to which 

25 section 801(d)(1) does not apply). 


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1 ‘‘(2) IMPORTERS.—A qualifying drug may not 

2 be imported under paragraph (1) unless— 

3 ‘‘(A) the drug is imported by a pharmacy, 

4 group of pharmacies, or a wholesaler that is a 

5 registered importer; or 

6 ‘‘(B) the drug is imported by an individual 

7 for personal use or for the use of a family mem8 ber of the individual (not for resale) from a reg9 istered exporter. 

10 ‘‘(3) RULE OF CONSTRUCTION.—This section 

11 shall apply only with respect to a drug that is im12 ported or offered for import into the United 

13 States— 

14 ‘‘(A) by a registered importer; or 

15 ‘‘(B) from a registered exporter to an indi16 vidual. 

17 ‘‘(4) DEFINITIONS.— 

18 ‘‘(A) REGISTERED EXPORTER; REG19 ISTERED IMPORTER.—For purposes of this sec20 tion: 

21 ‘‘(i) The term ‘registered exporter’ 

22 means an exporter for which a registration 

23 under subsection (b) has been approved 

24 and is in effect. 


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1 ‘‘(ii) The term ‘registered importer’ 

2 means a pharmacy, group of pharmacies, 

3 or a wholesaler for which a registration 

4 under subsection (b) has been approved 

5 and is in effect. 

6 ‘‘(iii) The term ‘registration condition’ 

7 means a condition that must exist for a 

8 registration under subsection (b) to be ap9 proved. 

10 ‘‘(B) QUALIFYING DRUG.—For purposes of 

11 this section, the term ‘qualifying drug’ means a 

12 drug for which there is a corresponding U.S. 

13 label drug. 

14 ‘‘(C) U.S. LABEL DRUG.—For purposes of 

15 this section, the term ‘U.S. label drug’ means 

16 a prescription drug that— 

17 ‘‘(i) with respect to a qualifying drug, 

18 has the same active ingredient or ingredi19 ents, route of administration, dosage form, 

20 and strength as the qualifying drug; 

21 ‘‘(ii) with respect to the qualifying 

22 drug, is manufactured by or for the person 

23 that manufactures the qualifying drug; 

24 ‘‘(iii) is approved under section 

25 505(c); and 


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1 ‘‘(iv) is not— 

2 ‘‘(I) a controlled substance, as 

3 defined in section 102 of the Con4 trolled Substances Act (21 U.S.C. 

5 802); 

6 ‘‘(II) a biological product, as de7 fined in section 351 of the Public 

8 Health Service Act (42 U.S.C. 262), 

9 including— 

10 ‘‘(aa) a therapeutic DNA 

11 plasmid product; 

12 ‘‘(bb) a therapeutic synthetic 

13 peptide product; 

14 ‘‘(cc) a monoclonal antibody 

15 product for in vivo use; and 

16 ‘‘(dd) a therapeutic recom17 binant DNA-derived product; 

18 ‘‘(III) an infused drug, including 

19 a peritoneal dialysis solution; 

20 ‘‘(IV) an injected drug; 

21 ‘‘(V) a drug that is inhaled dur22 ing surgery; 

23 ‘‘(VI) a drug that is the listed 

24 drug referred to in 2 or more abbre25 viated new drug applications under 


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1 which the drug is commercially mar2 keted; or 

3 ‘‘(VII) a sterile opthlamic drug 

4 intended for topical use on or in the 

5 eye. 

6 ‘‘(D) OTHER DEFINITIONS.—For purposes 

7 of this section: 

8 ‘‘(i)(I) The term ‘exporter’ means a 

9 person that is in the business of exporting 

10 a drug to individuals in the United States 

11 from Canada or from a permitted country 

12 designated by the Secretary under sub13 clause (II), or that, pursuant to submitting 

14 a registration under subsection (b), seeks 

15 to be in such business. 

16 ‘‘(II) The Secretary shall designate a 

17 permitted country under subparagraph (E) 

18 (other than Canada) as a country from 

19 which an exporter may export a drug to in20 dividuals in the United States if the Sec21 retary determines that— 

22 ‘‘(aa) the country has statutory 

23 or regulatory standards that are 

24 equivalent to the standards in the 


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1 United States and Canada with re2 spect to— 

3 ‘‘(AA) the training of phar4 macists; 

5 ‘‘(BB) the practice of phar6 macy; and 

7 ‘‘(CC) the protection of the 

8 privacy of personal medical infor9 mation; and 

10 ‘‘(bb) the importation of drugs to 

11 individuals in the United States from 

12 the country will not adversely affect 

13 public health. 

14 ‘‘(ii) The term ‘importer’ means a 

15 pharmacy, a group of pharmacies, or a 

16 wholesaler that is in the business of im17 porting a drug into the United States or 

18 that, pursuant to submitting a registration 

19 under subsection (b), seeks to be in such 

20 business. 

21 ‘‘(iii) The term ‘pharmacist’ means a 

22 person licensed by a State to practice 

23 pharmacy, including the dispensing and 

24 selling of prescription drugs. 


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1 ‘‘(iv) The term ‘pharmacy’ means a 

2 person that— 

3 ‘‘(I) is licensed by a State to en4 gage in the business of selling pre5 scription drugs at retail; and 

6 ‘‘(II) employs 1 or more phar7 macists. 

8 ‘‘(v) The term ‘prescription drug’ 

9 means a drug that is described in section 

10 503(b)(1). 

11 ‘‘(vi) The term ‘wholesaler’— 

12 ‘‘(I) means a person licensed as a 

13 wholesaler or distributor of prescrip14 tion drugs in the United States under 

15 section 503(e)(2)(A); and 

16 ‘‘(II) does not include a person 

17 authorized to import drugs under sec18 tion 801(d)(1). 

19 ‘‘(E) PERMITTED COUNTRY.—The term 

20 ‘permitted country’ means— 

21 ‘‘(i) Australia; 

22 ‘‘(ii) Canada; 

23 ‘‘(iii) a member country of the Euro24 pean Union, but does not include a mem25 ber country with respect to which— 


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1 ‘‘(I) the country’s Annex to the 

2 Treaty of Accession to the European 

3 Union 2003 includes a transitional 

4 measure for the regulation of human 

5 pharmaceutical products that has not 

6 expired; or 

7 ‘‘(II) the Secretary determines 

8 that the requirements described in 

9 subclauses (I) and (II) of clause (vii) 

10 will not be met by the date on which 

11 such transitional measure for the reg12 ulation of human pharmaceutical 

13 products expires; 

14 ‘‘(iv) Japan; 

15 ‘‘(v) New Zealand; 

16 ‘‘(vi) Switzerland; and 

17 ‘‘(vii) a country in which the Sec18 retary determines the following require19 ments are met: 

20 ‘‘(I) The country has statutory or 

21 regulatory requirements— 

22 ‘‘(aa) that require the review 

23 of drugs for safety and effective24 ness by an entity of the govern25 ment of the country; 


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1 ‘‘(bb) that authorize the ap2 proval of only those drugs that 

3 have been determined to be safe 

4 and effective by experts employed 

5 by or acting on behalf of such en6 tity and qualified by scientific 

7 training and experience to evalu8 ate the safety and effectiveness of 

9 drugs on the basis of adequate 

10 and well-controlled investigations, 

11 including clinical investigations, 

12 conducted by experts qualified by 

13 scientific training and experience 

14 to evaluate the safety and effec15 tiveness of drugs; 

16 ‘‘(cc) that require the meth17 ods used in, and the facilities and 

18 controls used for the manufac19 ture, processing, and packing of 

20 drugs in the country to be ade21 quate to preserve their identity, 

22 quality, purity, and strength; 

23 ‘‘(dd) for the reporting of 

24 adverse reactions to drugs and 

25 procedures to withdraw approval 


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1 and remove drugs found not to 

2 be safe or effective; and 

3 ‘‘(ee) that require the label4 ing and promotion of drugs to be 

5 in accordance with the approval 

6 of the drug. 

7 ‘‘(II) The valid marketing au8 thorization system in the country is 

9 equivalent to the systems in the coun10 tries described in clauses (i) through 

11 (vi). 

12 ‘‘(III) The importation of drugs 

13 to the United States from the country 

14 will not adversely affect public health. 

15 ‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT16 ERS.— 

17 ‘‘(1) REGISTRATION OF IMPORTERS AND EX18 PORTERS.—A registration condition is that the im19 porter or exporter involved (referred to in this sub20 section as a ‘registrant’) submits to the Secretary a 

21 registration containing the following: 

22 ‘‘(A)(i) In the case of an exporter, the 

23 name of the exporter and an identification of all 

24 places of business of the exporter that relate to 

25 qualifying drugs, including each warehouse or 


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1 other facility owned or controlled by, or oper2 ated for, the exporter. 

3 ‘‘(ii) In the case of an importer, the name 

4 of the importer and an identification of the 

5 places of business of the importer at which the 

6 importer initially receives a qualifying drug 

7 after importation (which shall not exceed 3 

8 places of business except by permission of the 

9 Secretary). 

10 ‘‘(B) Such information as the Secretary 

11 determines to be necessary to demonstrate that 

12 the registrant is in compliance with registration 

13 conditions under— 

14 ‘‘(i) in the case of an importer, sub15 sections (c), (d), (e), (g), and (j) (relating 

16 to the sources of imported qualifying 

17 drugs; the inspection of facilities of the im18 porter; the payment of fees; compliance 

19 with the standards referred to in section 

20 801(a); and maintenance of records and 

21 samples); or 

22 ‘‘(ii) in the case of an exporter, sub23 sections (c), (d), (f), (g), (h), (i), and (j) 

24 (relating to the sources of exported quali25 fying drugs; the inspection of facilities of 


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1 the exporter and the marking of compliant 

2 shipments; the payment of fees; and com3 pliance with the standards referred to in 

4 section 801(a); being licensed as a phar5 macist; conditions for individual importa6 tion; and maintenance of records and sam7 ples). 

8 ‘‘(C) An agreement by the registrant that 

9 the registrant will not under subsection (a) im10 port or export any drug that is not a qualifying 

11 drug. 

12 ‘‘(D) An agreement by the registrant to— 

13 ‘‘(i) notify the Secretary of a recall or 

14 withdrawal of a qualifying drug distributed 

15 in a permitted country that the registrant 

16 has exported or imported, or intends to ex17 port or import, to the United States under 

18 subsection (a); 

19 ‘‘(ii) provide for the return to the reg20 istrant of such drug; and 

21 ‘‘(iii) cease, or not begin, the expor22 tation or importation of such drug unless 

23 the Secretary has notified the registrant 

24 that exportation or importation of such 

25 drug may proceed. 


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1 ‘‘(E) An agreement by the registrant to 

2 ensure and monitor compliance with each reg3 istration condition, to promptly correct any 

4 noncompliance with such a condition, and to 

5 promptly report to the Secretary any such non6 compliance. 

7 ‘‘(F) A plan describing the manner in 

8 which the registrant will comply with the agree9 ment under subparagraph (E). 

10 ‘‘(G) An agreement by the registrant to 

11 enforce a contract under subsection (c)(3)(B) 

12 against a party in the chain of custody of a 

13 qualifying drug with respect to the authority of 

14 the Secretary under clauses (ii) and (iii) of that 

15 subsection. 

16 ‘‘(H) An agreement by the registrant to 

17 notify the Secretary not more than 30 days be18 fore the registrant intends to make the change, 

19 of— 

20 ‘‘(i) any change that the registrant in21 tends to make regarding information pro22 vided under subparagraph (A) or (B); and 

23 ‘‘(ii) any change that the registrant 

24 intends to make in the compliance plan 

25 under subparagraph (F). 


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1 ‘‘(I) In the case of an exporter: 

2 ‘‘(i) An agreement by the exporter 

3 that a qualifying drug will not under sub4 section (a) be exported to any individual 

5 not authorized pursuant to subsection 

6 (a)(2)(B) to be an importer of such drug. 

7 ‘‘(ii) An agreement to post a bond, 

8 payable to the Treasury of the United 

9 States that is equal in value to the lesser 

10 of— 

11 ‘‘(I) the value of drugs exported 

12 by the exporter to the United States 

13 in a typical 4-week period over the 

14 course of a year under this section; or 

15 ‘‘(II) $1,000,000. 

16 ‘‘(iii) An agreement by the exporter to 

17 comply with applicable provisions of Cana18 dian law, or the law of the permitted coun19 try designated under subsection 

20 (a)(4)(D)(i)(II) in which the exporter is lo21 cated, that protect the privacy of personal 

22 information with respect to each individual 

23 importing a prescription drug from the ex24 porter under subsection (a)(2)(B). 


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1 ‘‘(iv) An agreement by the exporter to 

2 report to the Secretary— 

3 ‘‘(I) not later than August 1 of 

4 each fiscal year, the total price and 

5 the total volume of drugs exported to 

6 the United States by the exporter dur7 ing the 6-month period from January 

8 1 through June 30 of that year; and 

9 ‘‘(II) not later than January 1 of 

10 each fiscal year, the total price and 

11 the total volume of drugs exported to 

12 the United States by the exporter dur13 ing the previous fiscal year. 

14 ‘‘(J) In the case of an importer, an agree15 ment by the importer to report to the Sec16 retary— 

17 ‘‘(i) not later than August 1 of each 

18 fiscal year, the total price and the total 

19 volume of drugs imported to the United 

20 States by the importer during the 6-month 

21 period from January 1 through June 30 of 

22 that fiscal year; and 

23 ‘‘(ii) not later than January 1 of each 

24 fiscal year, the total price and the total 

25 volume of drugs imported to the United 


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1 States by the importer during the previous 

2 fiscal year. 

3 ‘‘(K) Such other provisions as the Sec4 retary may require by regulation to protect the 

5 public health while permitting— 

6 ‘‘(i) the importation by pharmacies, 

7 groups of pharmacies, and wholesalers as 

8 registered importers of qualifying drugs 

9 under subsection (a); and 

10 ‘‘(ii) importation by individuals of 

11 qualifying drugs under subsection (a). 

12 ‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA13 TION.— 

14 ‘‘(A) IN GENERAL.—Not later than 90 

15 days after the date on which a registrant sub16 mits to the Secretary a registration under para17 graph (1), the Secretary shall notify the reg18 istrant whether the registration is approved or 

19 is disapproved. The Secretary shall disapprove 

20 a registration if there is reason to believe that 

21 the registrant is not in compliance with one or 

22 more registration conditions, and shall notify 

23 the registrant of such reason. In the case of a 

24 disapproved registration, the Secretary shall 

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1 istration is approved if the Secretary deter2 mines that the registrant is in compliance with 

3 such conditions. 

4 ‘‘(B) CHANGES IN REGISTRATION INFOR5 MATION.—Not later than 30 days after receiv6 ing a notice under paragraph (1)(H) from a 

7 registrant, the Secretary shall determine wheth8 er the change involved affects the approval of 

9 the registration of the registrant under para10 graph (1), and shall inform the registrant of 

11 the determination. 

12 ‘‘(3) PUBLICATION OF CONTACT INFORMATION

13 FOR REGISTERED EXPORTERS.—Through the Inter14 net website of the Food and Drug Administration 

15 and a toll-free telephone number, the Secretary shall 

16 make readily available to the public a list of reg17 istered exporters, including contact information for 

18 the exporters. Promptly after the approval of a reg19 istration submitted under paragraph (1), the Sec20 retary shall update the Internet website and the in21 formation provided through the toll-free telephone 

22 number accordingly. 

23 ‘‘(4) SUSPENSION AND TERMINATION.— 


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1 ‘‘(A) SUSPENSION.—With respect to the 

2 effectiveness of a registration submitted under 

3 paragraph (1): 

4 ‘‘(i) Subject to clause (ii), the Sec5 retary may suspend the registration if the 

6 Secretary determines, after notice and op7 portunity for a hearing, that the registrant 

8 has failed to maintain substantial compli9 ance with a registration condition. 

10 ‘‘(ii) If the Secretary determines that, 

11 under color of the registration, the ex12 porter has exported a drug or the importer 

13 has imported a drug that is not a quali14 fying drug, or a drug that does not comply 

15 with subsection (g)(2)(A) or (g)(4), or has 

16 exported a qualifying drug to an individual 

17 in violation of subsection (i)(2)(F), the 

18 Secretary shall immediately suspend the 

19 registration. A suspension under the pre20 ceding sentence is not subject to the provi21 sion by the Secretary of prior notice, and 

22 the Secretary shall provide to the reg23 istrant an opportunity for a hearing not 

24 later than 10 days after the date on which 

25 the registration is suspended. 


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1 ‘‘(iii) The Secretary may reinstate the 

2 registration, whether suspended under 

3 clause (i) or (ii), if the Secretary deter4 mines that the registrant has demonstrated 

5 that further violations of registration con6 ditions will not occur. 

7 ‘‘(B) TERMINATION.—The Secretary, after 

8 notice and opportunity for a hearing, may ter9 minate the registration under paragraph (1) of 

10 a registrant if the Secretary determines that 

11 the registrant has engaged in a pattern or prac12 tice of violating 1 or more registration condi13 tions, or if on 1 or more occasions the Secretary 

14 has under subparagraph (A)(ii) suspended the 

15 registration of the registrant. The Secretary 

16 may make the termination permanent, or for a 

17 fixed period of not less than 1 year. During the 

18 period in which the registration is terminated, 

19 any registration submitted under paragraph (1) 

20 by the registrant, or a person that is a partner 

21 in the export or import enterprise, or a prin22 cipal officer in such enterprise, and any reg23 istration prepared with the assistance of the 

24 registrant or such a person, has no legal effect 

25 under this section. 


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1 ‘‘(5) DEFAULT OF BOND.—A bond required to 

2 be posted by an exporter under paragraph (1)(I)(ii) 

3 shall be defaulted and paid to the Treasury of the 

4 United States if, after opportunity for an informal 

5 hearing, the Secretary determines that the exporter 

6 has— 

7 ‘‘(A) exported a drug to the United States 

8 that is not a qualifying drug or that is not in 

9 compliance with subsection (g)(2)(A), (g)(4), or 

10 (i); or 

11 ‘‘(B) failed to permit the Secretary to con12 duct an inspection described under subsection 

13 (d). 

14 ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra15 tion condition is that the exporter or importer involved 

16 agrees that a qualifying drug will under subsection (a) be 

17 exported or imported into the United States only if there 

18 is compliance with the following: 

19 ‘‘(1) The drug was manufactured in an estab20 lishment— 

21 ‘‘(A) required to register under subsection 

22 (h) or (i) of section 510; and 

23 ‘‘(B)(i) inspected by the Secretary; or 

24 ‘‘(ii) for which the Secretary has elected to 

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1 turing practice inspection of the establishment 

2 from a permitted country whose regulatory sys3 tem the Secretary recognizes as equivalent 

4 under a mutual recognition agreement, as pro5 vided for under section 510(i)(3), section 803, 

6 or part 26 of title 21, Code of Federal Regula7 tions (or any corresponding successor rule or 

8 regulation). 

9 ‘‘(2) The establishment is located in any coun10 try, and the establishment manufactured the drug 

11 for distribution in the United States or for distribu12 tion in 1 or more of the permitted countries (without 

13 regard to whether in addition the drug is manufac14 tured for distribution in a foreign country that is 

15 not a permitted country). 

16 ‘‘(3) The exporter or importer obtained the 

17 drug— 

18 ‘‘(A) directly from the establishment; or 

19 ‘‘(B) directly from an entity that, by con20 tract with the exporter or importer— 

21 ‘‘(i) provides to the exporter or im22 porter a statement (in such form and con23 taining such information as the Secretary 

24 may require) that, for the chain of custody 

25 from the establishment, identifies each 


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1 prior sale, purchase, or trade of the drug 

2 (including the date of the transaction and 

3 the names and addresses of all parties to 

4 the transaction); 

5 ‘‘(ii) agrees to permit the Secretary to 

6 inspect such statements and related 

7 records to determine their accuracy; 

8 ‘‘(iii) agrees, with respect to the quali9 fying drugs involved, to permit the Sec10 retary to inspect warehouses and other fa11 cilities, including records, of the entity for 

12 purposes of determining whether the facili13 ties are in compliance with any standards 

14 under this Act that are applicable to facili15 ties of that type in the United States; and 

16 ‘‘(iv) has ensured, through such con17 tractual relationships as may be necessary, 

18 that the Secretary has the same authority 

19 regarding other parties in the chain of cus20 tody from the establishment that the Sec21 retary has under clauses (ii) and (iii) re22 garding such entity. 

23 ‘‘(4)(A) The foreign country from which the im24 porter will import the drug is a permitted country; 

25 or 


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1 ‘‘(B) The foreign country from which the ex2 porter will export the drug is the permitted country 

3 in which the exporter is located. 

4 ‘‘(5) During any period in which the drug was 

5 not in the control of the manufacturer of the drug, 

6 the drug did not enter any country that is not a per7 mitted country. 

8 ‘‘(6) The exporter or importer retains a sample 

9 of each lot of the drug for testing by the Secretary. 

10 ‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP11 MENTS.— 

12 ‘‘(1) INSPECTION OF FACILITIES.—A registra13 tion condition is that, for the purpose of assisting 

14 the Secretary in determining whether the exporter 

15 involved is in compliance with all other registration 

16 conditions— 

17 ‘‘(A) the exporter agrees to permit the Sec18 retary— 

19 ‘‘(i) to conduct onsite inspections, in20 cluding monitoring on a day-to-day basis, 

21 of places of business of the exporter that 

22 relate to qualifying drugs, including each 

23 warehouse or other facility owned or con24 trolled by, or operated for, the exporter; 


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1 ‘‘(ii) to have access, including on a 

2 day-to-day basis, to— 

3 ‘‘(I) records of the exporter that 

4 relate to the export of such drugs, in5 cluding financial records; and 

6 ‘‘(II) samples of such drugs; 

7 ‘‘(iii) to carry out the duties described 

8 in paragraph (3); and 

9 ‘‘(iv) to carry out any other functions 

10 determined by the Secretary to be nec11 essary regarding the compliance of the ex12 porter; and 

13 ‘‘(B) the Secretary has assigned 1 or more 

14 employees of the Secretary to carry out the 

15 functions described in this subsection for the 

16 Secretary randomly, but not less than 12 times 

17 annually, on the premises of places of busi18 nesses referred to in subparagraph (A)(i), and 

19 such an assignment remains in effect on a con20 tinuous basis. 

21 ‘‘(2) MARKING OF COMPLIANT SHIPMENTS.—A 

22 registration condition is that the exporter involved 

23 agrees to affix to each shipping container of quali24 fying drugs exported under subsection (a) such 

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1 essary to identify the shipment as being in compli2 ance with all registration conditions. Markings under 

3 the preceding sentence shall— 

4 ‘‘(A) be designed to prevent affixation of 

5 the markings to any shipping container that is 

6 not authorized to bear the markings; and 

7 ‘‘(B) include anticounterfeiting or track8 and-trace technologies, taking into account the 

9 economic and technical feasibility of those tech10 nologies. 

11 ‘‘(3) CERTAIN DUTIES RELATING TO EXPORT12 ERS.—Duties of the Secretary with respect to an ex13 porter include the following: 

14 ‘‘(A) Inspecting, randomly, but not less 

15 than 12 times annually, the places of business 

16 of the exporter at which qualifying drugs are 

17 stored and from which qualifying drugs are 

18 shipped. 

19 ‘‘(B) During the inspections under sub20 paragraph (A), verifying the chain of custody of 

21 a statistically significant sample of qualifying 

22 drugs from the establishment in which the drug 

23 was manufactured to the exporter, which shall 

24 be accomplished or supplemented by the use of 

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1 nologies, taking into account the economic and 

2 technical feasibility of those technologies, except 

3 that a drug that lacks such technologies from 

4 the point of manufacture shall not for that rea5 son be excluded from importation by an ex6 porter. 

7 ‘‘(C) Randomly reviewing records of ex8 ports to individuals for the purpose of deter9 mining whether the drugs are being imported 

10 by the individuals in accordance with the condi11 tions under subsection (i). Such reviews shall be 

12 conducted in a manner that will result in a sta13 tistically significant determination of compli14 ance with all such conditions. 

15 ‘‘(D) Monitoring the affixing of markings 

16 under paragraph (2). 

17 ‘‘(E) Inspecting as the Secretary deter18 mines is necessary the warehouses and other fa19 cilities, including records, of other parties in the 

20 chain of custody of qualifying drugs. 

21 ‘‘(F) Determining whether the exporter is 

22 in compliance with all other registration condi23 tions. 

24 ‘‘(4) PRIOR NOTICE OF SHIPMENTS.—A reg25 istration condition is that, not less than 8 hours and 


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1 not more than 5 days in advance of the time of the 

2 importation of a shipment of qualifying drugs, the 

3 importer involved agrees to submit to the Secretary 

4 a notice with respect to the shipment of drugs to be 

5 imported or offered for import into the United 

6 States under subsection (a). A notice under the pre7 ceding sentence shall include— 

8 ‘‘(A) the name and complete contact infor9 mation of the person submitting the notice; 

10 ‘‘(B) the name and complete contact infor11 mation of the importer involved; 

12 ‘‘(C) the identity of the drug, including the 

13 established name of the drug, the quantity of 

14 the drug, and the lot number assigned by the 

15 manufacturer; 

16 ‘‘(D) the identity of the manufacturer of 

17 the drug, including the identity of the establish18 ment at which the drug was manufactured; 

19 ‘‘(E) the country from which the drug is 

20 shipped; 

21 ‘‘(F) the name and complete contact infor22 mation for the shipper of the drug; 

23 ‘‘(G) anticipated arrival information, in24 cluding the port of arrival and crossing location 

25 within that port, and the date and time; 


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1 ‘‘(H) a summary of the chain of custody of 

2 the drug from the establishment in which the 

3 drug was manufactured to the importer; 

4 ‘‘(I) a declaration as to whether the Sec5 retary has ordered that importation of the drug 

6 from the permitted country cease under sub7 section (g)(2)(C) or (D); and 

8 ‘‘(J) such other information as the Sec9 retary may require by regulation. 

10 ‘‘(5) MARKING OF COMPLIANT SHIPMENTS.—A 

11 registration condition is that the importer involved 

12 agrees, before wholesale distribution (as defined in 

13 section 503(e)) of a qualifying drug that has been 

14 imported under subsection (a), to affix to each con15 tainer of such drug such markings or other tech16 nology as the Secretary determines necessary to 

17 identify the shipment as being in compliance with all 

18 registration conditions, except that the markings or 

19 other technology shall not be required on a drug 

20 that bears comparable, compatible markings or tech21 nology from the manufacturer of the drug. Markings 

22 or other technology under the preceding sentence 

23 shall— 

24 ‘‘(A) be designed to prevent affixation of 

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1 tainer that is not authorized to bear the mark2 ings; and 

3 ‘‘(B) shall include anticounterfeiting or 

4 track-and-trace technologies, taking into ac5 count the economic and technical feasibility of 

6 such technologies. 

7 ‘‘(6) CERTAIN DUTIES RELATING TO IMPORT8 ERS.—Duties of the Secretary with respect to an im9 porter include the following: 

10 ‘‘(A) Inspecting, randomly, but not less 

11 than 12 times annually, the places of business 

12 of the importer at which a qualifying drug is 

13 initially received after importation. 

14 ‘‘(B) During the inspections under sub15 paragraph (A), verifying the chain of custody of 

16 a statistically significant sample of qualifying 

17 drugs from the establishment in which the drug 

18 was manufactured to the importer, which shall 

19 be accomplished or supplemented by the use of 

20 anticounterfeiting or track-and-trace tech21 nologies, taking into account the economic and 

22 technical feasibility of those technologies, except 

23 that a drug that lacks such technologies from 

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1 son be excluded from importation by an im2 porter. 

3 ‘‘(C) Reviewing notices under paragraph 

4 (4). 

5 ‘‘(D) Inspecting as the Secretary deter6 mines is necessary the warehouses and other fa7 cilities, including records of other parties in the 

8 chain of custody of qualifying drugs. 

9 ‘‘(E) Determining whether the importer is 

10 in compliance with all other registration condi11 tions. 

12 ‘‘(e) IMPORTER FEES.— 

13 ‘‘(1) REGISTRATION FEE.—A registration con14 dition is that the importer involved pays to the Sec15 retary a fee of $10,000 due on the date on which 

16 the importer first submits the registration to the 

17 Secretary under subsection (b). 

18 ‘‘(2) INSPECTION FEE.—A registration condi19 tion is that the importer involved pays a fee to the 

20 Secretary in accordance with this subsection. Such 

21 fee shall be paid not later than October 1 and April 

22 1 of each fiscal year in the amount provided for 

23 under paragraph (3). 

24 ‘‘(3) AMOUNT OF INSPECTION FEE.— 


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1 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

2 later than 30 days before the start of each fis3 cal year, the Secretary, in consultation with the 

4 Secretary of Homeland Security and the Sec5 retary of the Treasury, shall establish an aggre6 gate total of fees to be collected under para7 graph (2) for importers for that fiscal year that 

8 is sufficient, and not more than necessary, to 

9 pay the costs for that fiscal year of admin10 istering this section with respect to registered 

11 importers, including the costs associated with— 

12 ‘‘(i) inspecting the facilities of reg13 istered importers, and of other entities in 

14 the chain of custody of a qualifying drug 

15 as necessary, under subsection (d)(6); 

16 ‘‘(ii) developing, implementing, and 

17 operating under such subsection an elec18 tronic system for submission and review of 

19 the notices required under subsection 

20 (d)(4) with respect to shipments of quali21 fying drugs under subsection (a) to assess 

22 compliance with all registration conditions 

23 when such shipments are offered for im24 port into the United States; and 


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1 ‘‘(iii) inspecting such shipments as 

2 necessary, when offered for import into the 

3 United States to determine if such a ship4 ment should be refused admission under 

5 subsection (g)(5). 

6 ‘‘(B) LIMITATION.—Subject to subpara7 graph (C), the aggregate total of fees collected 

8 under paragraph (2) for a fiscal year shall not 

9 exceed 2.5 percent of the total price of quali10 fying drugs imported during that fiscal year 

11 into the United States by registered importers 

12 under subsection (a). 

13 ‘‘(C) TOTAL PRICE OF DRUGS.— 

14 ‘‘(i) ESTIMATE.—For the purposes of 

15 complying with the limitation described in 

16 subparagraph (B) when establishing under 

17 subparagraph (A) the aggregate total of 

18 fees to be collected under paragraph (2) 

19 for a fiscal year, the Secretary shall esti20 mate the total price of qualifying drugs im21 ported into the United States by registered 

22 importers during that fiscal year by adding 

23 the total price of qualifying drugs imported 

24 by each registered importer during the 6- 

25 month period from January 1 through 


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1 June 30 of the previous fiscal year, as re2 ported to the Secretary by each registered 

3 importer under subsection (b)(1)(J). 

4 ‘‘(ii) CALCULATION.—Not later than 

5 March 1 of the fiscal year that follows the 

6 fiscal year for which the estimate under 

7 clause (i) is made, the Secretary shall cal8 culate the total price of qualifying drugs 

9 imported into the United States by reg10 istered importers during that fiscal year by 

11 adding the total price of qualifying drugs 

12 imported by each registered importer dur13 ing that fiscal year, as reported to the Sec14 retary by each registered importer under 

15 subsection (b)(1)(J). 

16 ‘‘(iii) ADJUSTMENT.—If the total 

17 price of qualifying drugs imported into the 

18 United States by registered importers dur19 ing a fiscal year as calculated under clause 

20 (ii) is less than the aggregate total of fees 

21 collected under paragraph (2) for that fis22 cal year, the Secretary shall provide for a 

23 pro-rata reduction in the fee due from each 

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1 sequent fiscal year so that the limitation 

2 described in subparagraph (B) is observed. 

3 ‘‘(D) INDIVIDUAL IMPORTER FEE.—Sub4 ject to the limitation described in subparagraph 

5 (B), the fee under paragraph (2) to be paid on 

6 October 1 and April 1 by an importer shall be 

7 an amount that is proportional to a reasonable 

8 estimate by the Secretary of the semiannual 

9 share of the importer of the volume of quali10 fying drugs imported by importers under sub11 section (a). 

12 ‘‘(4) USE OF FEES.— 

13 ‘‘(A) IN GENERAL.—Subject to appropria14 tions Acts, fees collected by the Secretary under 

15 paragraphs (1) and (2) shall be credited to the 

16 appropriation account for salaries and expenses 

17 of the Food and Drug Administration until ex18 pended (without fiscal year limitation), and the 

19 Secretary may, in consultation with the Sec20 retary of Homeland Security and the Secretary 

21 of the Treasury, transfer some proportion of 

22 such fees to the appropriation account for sala23 ries and expenses of the Bureau of Customs 

24 and Border Protection until expended (without 

25 fiscal year limitation). 


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1 ‘‘(B) SOLE PURPOSE.—Fees collected by 

2 the Secretary under paragraphs (1) and (2) are 

3 only available to the Secretary and, if trans4 ferred, to the Secretary of Homeland Security, 

5 and are for the sole purpose of paying the costs 

6 referred to in paragraph (3)(A). 

7 ‘‘(5) COLLECTION OF FEES.—In any case where 

8 the Secretary does not receive payment of a fee as9 sessed under paragraph (1) or (2) within 30 days 

10 after it is due, such fee shall be treated as a claim 

11 of the United States Government subject to sub12 chapter II of chapter 37 of title 31, United States 

13 Code. 

14 ‘‘(f) EXPORTER FEES.— 

15 ‘‘(1) REGISTRATION FEE.—A registration con16 dition is that the exporter involved pays to the Sec17 retary a fee of $10,000 due on the date on which 

18 the exporter first submits that registration to the 

19 Secretary under subsection (b). 

20 ‘‘(2) INSPECTION FEE.—A registration condi21 tion is that the exporter involved pays a fee to the 

22 Secretary in accordance with this subsection. Such 

23 fee shall be paid not later than October 1 and April 

24 1 of each fiscal year in the amount provided for 

25 under paragraph (3). 


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1 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

2 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

3 later than 30 days before the start of each fis4 cal year, the Secretary, in consultation with the 

5 Secretary of Homeland Security and the Sec6 retary of the Treasury, shall establish an aggre7 gate total of fees to be collected under para8 graph (2) for exporters for that fiscal year that 

9 is sufficient, and not more than necessary, to 

10 pay the costs for that fiscal year of admin11 istering this section with respect to registered 

12 exporters, including the costs associated with— 

13 ‘‘(i) inspecting the facilities of reg14 istered exporters, and of other entities in 

15 the chain of custody of a qualifying drug 

16 as necessary, under subsection (d)(3); 

17 ‘‘(ii) developing, implementing, and 

18 operating under such subsection a system 

19 to screen marks on shipments of qualifying 

20 drugs under subsection (a) that indicate 

21 compliance with all registration conditions, 

22 when such shipments are offered for im23 port into the United States; and 

24 ‘‘(iii) screening such markings, and 

25 inspecting such shipments as necessary, 


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1 when offered for import into the United 

2 States to determine if such a shipment 

3 should be refused admission under sub4 section (g)(5). 

5 ‘‘(B) LIMITATION.—Subject to subpara6 graph (C), the aggregate total of fees collected 

7 under paragraph (2) for a fiscal year shall not 

8 exceed 2.5 percent of the total price of quali9 fying drugs imported during that fiscal year 

10 into the United States by registered exporters 

11 under subsection (a). 

12 ‘‘(C) TOTAL PRICE OF DRUGS.— 

13 ‘‘(i) ESTIMATE.—For the purposes of 

14 complying with the limitation described in 

15 subparagraph (B) when establishing under 

16 subparagraph (A) the aggregate total of 

17 fees to be collected under paragraph (2) 

18 for a fiscal year, the Secretary shall esti19 mate the total price of qualifying drugs im20 ported into the United States by registered 

21 exporters during that fiscal year by adding 

22 the total price of qualifying drugs exported 

23 by each registered exporter during the 6- 

24 month period from January 1 through 

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1 ported to the Secretary by each registered 

2 exporter under subsection (b)(1)(I)(iv). 

3 ‘‘(ii) CALCULATION.—Not later than 

4 March 1 of the fiscal year that follows the 

5 fiscal year for which the estimate under 

6 clause (i) is made, the Secretary shall cal7 culate the total price of qualifying drugs 

8 imported into the United States by reg9 istered exporters during that fiscal year by 

10 adding the total price of qualifying drugs 

11 exported by each registered exporter dur12 ing that fiscal year, as reported to the Sec13 retary by each registered exporter under 

14 subsection (b)(1)(I)(iv). 

15 ‘‘(iii) ADJUSTMENT.—If the total 

16 price of qualifying drugs imported into the 

17 United States by registered exporters dur18 ing a fiscal year as calculated under clause 

19 (ii) is less than the aggregate total of fees 

20 collected under paragraph (2) for that fis21 cal year, the Secretary shall provide for a 

22 pro-rata reduction in the fee due from each 

23 registered exporter on April 1 of the subse24 quent fiscal year so that the limitation de25 scribed in subparagraph (B) is observed. 


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1 ‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub2 ject to the limitation described in subparagraph 

3 (B), the fee under paragraph (2) to be paid on 

4 October 1 and April 1 by an exporter shall be 

5 an amount that is proportional to a reasonable 

6 estimate by the Secretary of the semiannual 

7 share of the exporter of the volume of quali8 fying drugs exported by exporters under sub9 section (a). 

10 ‘‘(4) USE OF FEES.— 

11 ‘‘(A) IN GENERAL.—Subject to appropria12 tions Acts, fees collected by the Secretary under 

13 paragraphs (1) and (2) shall be credited to the 

14 appropriation account for salaries and expenses 

15 of the Food and Drug Administration until ex16 pended (without fiscal year limitation), and the 

17 Secretary may, in consultation with the Sec18 retary of Homeland Security and the Secretary 

19 of the Treasury, transfer some proportion of 

20 such fees to the appropriation account for sala21 ries and expenses of the Bureau of Customs 

22 and Border Protection until expended (without 

23 fiscal year limitation). 

24 ‘‘(B) SOLE PURPOSE.—Fees collected by 

25 the Secretary under paragraphs (1) and (2) are 


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1 only available to the Secretary and, if trans2 ferred, to the Secretary of Homeland Security, 

3 and are for the sole purpose of paying the costs 

4 referred to in paragraph (3)(A). 

5 ‘‘(5) COLLECTION OF FEES.—In any case where 

6 the Secretary does not receive payment of a fee as7 sessed under paragraph (1) or (2) within 30 days 

8 after it is due, such fee shall be treated as a claim 

9 of the United States Government subject to sub10 chapter II of chapter 37 of title 31, United States 

11 Code. 

12 ‘‘(g) COMPLIANCE WITH SECTION 801(a).— 

13 ‘‘(1) IN GENERAL.—A registration condition is 

14 that each qualifying drug exported under subsection 

15 (a) by the registered exporter involved or imported 

16 under subsection (a) by the registered importer in17 volved is in compliance with the standards referred 

18 to in section 801(a) regarding admission of the drug 

19 into the United States, subject to paragraphs (2), 

20 (3), and (4). 

21 ‘‘(2) SECTION 505; APPROVAL STATUS.— 

22 ‘‘(A) IN GENERAL.—A qualifying drug that 

23 is imported or offered for import under sub24 section (a) shall comply with the conditions es25 tablished in the approved application under secVerDate Nov 24 2008 02:36 Mar 06, 2009 Jkt 079200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\H1298.IH H1298

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1 tion 505(b) for the U.S. label drug as described 

2 under this subsection. 

3 ‘‘(B) NOTICE BY MANUFACTURER; GEN4 ERAL PROVISIONS.— 

5 ‘‘(i) IN GENERAL.—The person that 

6 manufactures a qualifying drug that is, or 

7 will be, introduced for commercial distribu8 tion in a permitted country shall in accord9 ance with this paragraph submit to the 

10 Secretary a notice that— 

11 ‘‘(I) includes each difference in 

12 the qualifying drug from a condition 

13 established in the approved applica14 tion for the U.S. label drug beyond— 

15 ‘‘(aa) the variations provided 

16 for in the application; and 

17 ‘‘(bb) any difference in label18 ing (except ingredient labeling); 

19 or 

20 ‘‘(II) states that there is no dif21 ference in the qualifying drug from a 

22 condition established in the approved 

23 application for the U.S. label drug be24 yond— 


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1 ‘‘(aa) the variations provided 

2 for in the application; and 

3 ‘‘(bb) any difference in label4 ing (except ingredient labeling). 

5 ‘‘(ii) INFORMATION IN NOTICE.—A 

6 notice under clause (i)(I) shall include the 

7 information that the Secretary may require 

8 under section 506A, any additional infor9 mation the Secretary may require (which 

10 may include data on bioequivalence if such 

11 data are not required under section 506A), 

12 and, with respect to the permitted country 

13 that approved the qualifying drug for com14 mercial distribution, or with respect to 

15 which such approval is sought, include the 

16 following: 

17 ‘‘(I) The date on which the quali18 fying drug with such difference was, 

19 or will be, introduced for commercial 

20 distribution in the permitted country. 

21 ‘‘(II) Information demonstrating 

22 that the person submitting the notice 

23 has also notified the government of 

24 the permitted country in writing that 

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1 retary a notice under clause (i)(I), 

2 which notice describes the difference 

3 in the qualifying drug from a condi4 tion established in the approved appli5 cation for the U.S. label drug. 

6 ‘‘(III) The information that the 

7 person submitted or will submit to the 

8 government of the permitted country 

9 for purposes of obtaining approval for 

10 commercial distribution of the drug in 

11 the country which, if in a language 

12 other than English, shall be accom13 panied by an English translation 

14 verified to be complete and accurate, 

15 with the name, address, and a brief 

16 statement of the qualifications of the 

17 person that made the translation. 

18 ‘‘(iii) CERTIFICATIONS.—The chief ex19 ecutive officer and the chief medical officer 

20 of the manufacturer involved shall each 

21 certify in the notice under clause (i) that— 

22 ‘‘(I) the information provided in 

23 the notice is complete and true; and 

24 ‘‘(II) a copy of the notice has 

25 been provided to the Federal Trade 


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1 Commission and to the State attor2 neys general. 

3 ‘‘(iv) FEE.—If a notice submitted 

4 under clause (i) includes a difference that 

5 would, under section 506A, require the 

6 submission of a supplemental application if 

7 made as a change to the U.S. label drug, 

8 the person that submits the notice shall 

9 pay to the Secretary a fee in the same 

10 amount as would apply if the person were 

11 paying a fee pursuant to section 

12 736(a)(1)(A)(ii). Subject to appropriations 

13 Acts, fees collected by the Secretary under 

14 the preceding sentence are available only to 

15 the Secretary and are for the sole purpose 

16 of paying the costs of reviewing notices 

17 submitted under clause (i). 

18 ‘‘(v) TIMING OF SUBMISSION OF NO19 TICES.— 

20 ‘‘(I) PRIOR APPROVAL NO21 TICES.—A notice under clause (i) to 

22 which subparagraph (C) applies shall 

23 be submitted to the Secretary not 

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1 duced for commercial distribution in a 

2 permitted country, unless the country 

3 requires that distribution of the quali4 fying drug with the difference begin 

5 less than 120 days after the country 

6 requires the difference. 

7 ‘‘(II) OTHER APPROVAL NO8 TICES.—A notice under clause (i) to 

9 which subparagraph (D) applies shall 

10 be submitted to the Secretary not 

11 later than the day on which the quali12 fying drug with the difference is intro13 duced for commercial distribution in a 

14 permitted country. 

15 ‘‘(III) OTHER NOTICES.—A no16 tice under clause (i) to which subpara17 graph (E) applies shall be submitted 

18 to the Secretary on the date that the 

19 qualifying drug is first introduced for 

20 commercial distribution in a permitted 

21 country and annually thereafter. 

22 ‘‘(vi) REVIEW BY SECRETARY.— 

23 ‘‘(I) IN GENERAL.—In this para24 graph, the difference in a qualifying 

25 drug that is submitted in a notice 


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1 under clause (i) from the U.S. label 

2 drug shall be treated by the Secretary 

3 as if it were a manufacturing change 

4 to the U.S. label drug under section 

5 506A. 

6 ‘‘(II) STANDARD OF REVIEW.— 

7 Except as provided in subclause (III), 

8 the Secretary shall review and approve 

9 or disapprove the difference in a no10 tice submitted under clause (i), if re11 quired under section 506A, using the 

12 safe and effective standard for ap13 proving or disapproving a manufac14 turing change under section 506A. 

15 ‘‘(III) BIOEQUIVALENCE.—If the 

16 Secretary would approve the dif17 ference in a notice submitted under 

18 clause (i) using the safe and effective 

19 standard under section 506A and if 

20 the Secretary determines that the 

21 qualifying drug is not bioequivalent to 

22 the U.S. label drug, the Secretary 

23 shall— 

24 ‘‘(aa) include in the labeling 

25 provided under paragraph (3) a 


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1 prominent advisory that the 

2 qualifying drug is safe and effec3 tive but is not bioequivalent to 

4 the U.S. label drug if the Sec5 retary determines that such an 

6 advisory is necessary for health 

7 care practitioners and patients to 

8 use the qualifying drug safely 

9 and effectively; or 

10 ‘‘(bb) decline to approve the 

11 difference if the Secretary deter12 mines that the availability of 

13 both the qualifying drug and the 

14 U.S. label drug would pose a 

15 threat to the public health. 

16 ‘‘(IV) REVIEW BY THE SEC17 RETARY.—The Secretary shall review 

18 and approve or disapprove the dif19 ference in a notice submitted under 

20 clause (i), if required under section 

21 506A, not later than 120 days after 

22 the date on which the notice is sub23 mitted. 

24 ‘‘(V) ESTABLISHMENT INSPEC25 TION.—If review of such difference 


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1 would require an inspection of the es2 tablishment in which the qualifying 

3 drug is manufactured— 

4 ‘‘(aa) such inspection by the 

5 Secretary shall be authorized; 

6 and 

7 ‘‘(bb) the Secretary may rely 

8 on a satisfactory report of a good 

9 manufacturing practice inspec10 tion of the establishment from a 

11 permitted country whose regu12 latory system the Secretary rec13 ognizes as equivalent under a 

14 mutual recognition agreement, as 

15 provided under section 510(i)(3), 

16 section 803, or part 26 of title 

17 21, Code of Federal Regulations 

18 (or any corresponding successor 

19 rule or regulation). 

20 ‘‘(vii) PUBLICATION OF INFORMATION

21 ON NOTICES.— 

22 ‘‘(I) IN GENERAL.—Through the 

23 Internet website of the Food and 

24 Drug Administration and a toll-free 

25 telephone number, the Secretary shall 


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1 readily make available to the public a 

2 list of notices submitted under clause 

3 (i). 

4 ‘‘(II) CONTENTS.—The list under 

5 subclause (I) shall include the date on 

6 which a notice is submitted and 

7 whether— 

8 ‘‘(aa) a notice is under re9 view; 

10 ‘‘(bb) the Secretary has or11 dered that importation of the 

12 qualifying drug from a permitted 

13 country cease; or 

14 ‘‘(cc) the importation of the 

15 drug is permitted under sub16 section (a). 

17 ‘‘(III) UPDATE.—The Secretary 

18 shall promptly update the Internet 

19 website with any changes to the list. 

20 ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR21 ING PRIOR APPROVAL.—In the case of a notice 

22 under subparagraph (B)(i) that includes a dif23 ference that would, under section 506A(c) or 

24 (d)(3)(B)(i), require the approval of a supple25 mental application before the difference could 


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1 be made to the U.S. label drug the following 

2 shall occur: 

3 ‘‘(i) Promptly after the notice is sub4 mitted, the Secretary shall notify reg5 istered exporters, registered importers, the 

6 Federal Trade Commission, and the State 

7 attorneys general that the notice has been 

8 submitted with respect to the qualifying 

9 drug involved. 

10 ‘‘(ii) If the Secretary has not made a 

11 determination whether such a supple12 mental application regarding the U.S. label 

13 drug would be approved or disapproved by 

14 the date on which the qualifying drug in15 volved is to be introduced for commercial 

16 distribution in a permitted country, the 

17 Secretary shall— 

18 ‘‘(I) order that the importation of 

19 the qualifying drug involved from the 

20 permitted country not begin until the 

21 Secretary completes review of the no22 tice; and 

23 ‘‘(II) promptly notify registered 

24 exporters, registered importers, the 


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1 Federal Trade Commission, and the 

2 State attorneys general of the order. 

3 ‘‘(iii) If the Secretary determines that 

4 such a supplemental application regarding 

5 the U.S. label drug would not be approved, 

6 the Secretary shall— 

7 ‘‘(I) order that the importation of 

8 the qualifying drug involved from the 

9 permitted country cease, or provide 

10 that an order under clause (ii), if any, 

11 remains in effect; 

12 ‘‘(II) notify the permitted coun13 try that approved the qualifying drug 

14 for commercial distribution of the de15 termination; and 

16 ‘‘(III) promptly notify registered 

17 exporters, registered importers, the 

18 Federal Trade Commission, and the 

19 State attorneys general of the deter20 mination. 

21 ‘‘(iv) If the Secretary determines that 

22 such a supplemental application regarding 

23 the U.S. label drug would be approved, the 

24 Secretary shall— 


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1 ‘‘(I) vacate the order under 

2 clause (ii), if any; 

3 ‘‘(II) consider the difference to 

4 be a variation provided for in the ap5 proved application for the U.S. label 

6 drug; 

7 ‘‘(III) permit importation of the 

8 qualifying drug under subsection (a); 

9 and 

10 ‘‘(IV) promptly notify registered 

11 exporters, registered importers, the 

12 Federal Trade Commission, and the 

13 State attorneys general of the deter14 mination. 

15 ‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE16 QUIRING PRIOR APPROVAL.—In the case of a 

17 notice under subparagraph (B)(i) that includes 

18 a difference that would, under section 

19 506A(d)(3)(B)(ii), not require the approval of a 

20 supplemental application before the difference 

21 could be made to the U.S. label drug the fol22 lowing shall occur: 

23 ‘‘(i) During the period in which the 

24 notice is being reviewed by the Secretary, 

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1 port the qualifying drug involved continues 

2 in effect. 

3 ‘‘(ii) If the Secretary determines that 

4 such a supplemental application regarding 

5 the U.S. label drug would not be approved, 

6 the Secretary shall— 

7 ‘‘(I) order that the importation of 

8 the qualifying drug involved from the 

9 permitted country cease; 

10 ‘‘(II) notify the permitted coun11 try that approved the qualifying drug 

12 for commercial distribution of the de13 termination; and 

14 ‘‘(III) promptly notify registered 

15 exporters, registered importers, the 

16 Federal Trade Commission, and the 

17 State attorneys general of the deter18 mination. 

19 ‘‘(iii) If the Secretary determines that 

20 such a supplemental application regarding 

21 the U.S. label drug would be approved, the 

22 difference shall be considered to be a vari23 ation provided for in the approved applica24 tion for the U.S. label drug. 


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1 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE2 QUIRING APPROVAL; NO DIFFERENCE.—In the 

3 case of a notice under subparagraph (B)(i) that 

4 includes a difference for which, under section 

5 506A(d)(1)(A), a supplemental application 

6 would not be required for the difference to be 

7 made to the U.S. label drug, or that states that 

8 there is no difference, the Secretary— 

9 ‘‘(i) shall consider such difference to 

10 be a variation provided for in the approved 

11 application for the U.S. label drug; 

12 ‘‘(ii) may not order that the importa13 tion of the qualifying drug involved cease; 

14 and 

15 ‘‘(iii) shall promptly notify registered 

16 exporters and registered importers. 

17 ‘‘(F) DIFFERENCES IN ACTIVE INGRE18 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

19 FORM, OR STRENGTH.— 

20 ‘‘(i) IN GENERAL.—A person who 

21 manufactures a drug approved under sec22 tion 505(b) shall submit an application 

23 under section 505(b) for approval of an24 other drug that is manufactured for dis25 tribution in a permitted country by or for 


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1 the person that manufactures the drug ap2 proved under section 505(b) if— 

3 ‘‘(I) there is no qualifying drug 

4 in commercial distribution in per5 mitted countries whose combined pop6 ulation represents at least 50 percent 

7 of the total population of all permitted 

8 countries with the same active ingre9 dient or ingredients, route of adminis10 tration, dosage form, and strength as 

11 the drug approved under section 

12 505(b); and 

13 ‘‘(II) each active ingredient of 

14 the other drug is related to an active 

15 ingredient of the drug approved under 

16 section 505(b), as defined in clause 

17 (v). 

18 ‘‘(ii) APPLICATION UNDER SECTION

19 505(b).—The application under section 

20 505(b) required under clause (i) shall— 

21 ‘‘(I) request approval of the other 

22 drug for the indication or indications 

23 for which the drug approved under 

24 section 505(b) is labeled; 


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1 ‘‘(II) include the information that 

2 the person submitted to the govern3 ment of the permitted country for 

4 purposes of obtaining approval for 

5 commercial distribution of the other 

6 drug in that country, which if in a 

7 language other than English, shall be 

8 accompanied by an English trans9 lation verified to be complete and ac10 curate, with the name, address, and a 

11 brief statement of the qualifications of 

12 the person that made the translation; 

13 ‘‘(III) include a right of reference 

14 to the application for the drug ap15 proved under section 505(b); and 

16 ‘‘(IV) include such additional in17 formation as the Secretary may re18 quire. 

19 ‘‘(iii) TIMING OF SUBMISSION OF AP20 PLICATION.—An application under section 

21 505(b) required under clause (i) shall be 

22 submitted to the Secretary not later than 

23 the day on which the information referred 

24 to in clause (ii)(II) is submitted to the gov25 ernment of the permitted country. 


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1 ‘‘(iv) NOTICE OF DECISION ON APPLI2 CATION.—The Secretary shall promptly no3 tify registered exporters, registered import4 ers, the Federal Trade Commission, and 

5 the State attorneys general of a determina6 tion to approve or to disapprove an appli7 cation under section 505(b) required under 

8 clause (i). 

9 ‘‘(v) RELATED ACTIVE INGREDI10 ENTS.—For purposes of clause (i)(II), 2 

11 active ingredients are related if they are— 

12 ‘‘(I) the same; or 

13 ‘‘(II) different salts, esters, or 

14 complexes of the same moiety. 

15 ‘‘(3) SECTION 502; LABELING.— 

16 ‘‘(A) IMPORTATION BY REGISTERED IM17 PORTER.— 

18 ‘‘(i) IN GENERAL.—In the case of a 

19 qualifying drug that is imported or offered 

20 for import by a registered importer, such 

21 drug shall be considered to be in compli22 ance with section 502 and the labeling re23 quirements under the approved application 

24 for the U.S. label drug if the qualifying 

25 drug bears— 


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1 ‘‘(I) a copy of the labeling ap2 proved for the U.S. label drug under 

3 section 505, without regard to wheth4 er the copy bears any trademark in5 volved; 

6 ‘‘(II) the name of the manufac7 turer and location of the manufac8 turer; 

9 ‘‘(III) the lot number assigned by 

10 the manufacturer; 

11 ‘‘(IV) the name, location, and 

12 registration number of the importer; 

13 and 

14 ‘‘(V) the National Drug Code 

15 number assigned to the qualifying 

16 drug by the Secretary. 

17 ‘‘(ii) REQUEST FOR COPY OF THE LA18 BELING.—The Secretary shall provide such 

19 copy to the registered importer involved, 

20 upon request of the importer. 

21 ‘‘(iii) REQUESTED LABELING.—The 

22 labeling provided by the Secretary under 

23 clause (ii) shall— 

24 ‘‘(I) include the established 

25 name, as defined in section 502(e)(3), 


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1 for each active ingredient in the quali2 fying drug; 

3 ‘‘(II) not include the proprietary 

4 name of the U.S. label drug or any 

5 active ingredient thereof; 

6 ‘‘(III) if required under para7 graph (2)(B)(vi)(III), a prominent ad8 visory that the qualifying drug is safe 

9 and effective but not bioequivalent to 

10 the U.S. label drug; and 

11 ‘‘(IV) if the inactive ingredients 

12 of the qualifying drug are different 

13 from the inactive ingredients for the 

14 U.S. label drug, include— 

15 ‘‘(aa) a prominent notice 

16 that the ingredients of the quali17 fying drug differ from the ingre18 dients of the U.S. label drug and 

19 that the qualifying drug must be 

20 dispensed with an advisory to 

21 people with allergies about this 

22 difference and a list of ingredi23 ents; and 

24 ‘‘(bb) a list of the ingredi25 ents of the qualifying drug as 


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1 would be required under section 

2 502(e). 

3 ‘‘(B) IMPORTATION BY INDIVIDUAL.— 

4 ‘‘(i) IN GENERAL.—In the case of a 

5 qualifying drug that is imported or offered 

6 for import by a registered exporter to an 

7 individual, such drug shall be considered to 

8 be in compliance with section 502 and the 

9 labeling requirements under the approved 

10 application for the U.S. label drug if the 

11 packaging and labeling of the qualifying 

12 drug complies with all applicable regula13 tions promulgated under sections 3 and 4 

14 of the Poison Prevention Packaging Act of 

15 1970 (15 U.S.C. 1471 et seq.) and the la16 beling of the qualifying drug includes— 

17 ‘‘(I) directions for use by the 

18 consumer; 

19 ‘‘(II) the lot number assigned by 

20 the manufacturer; 

21 ‘‘(III) the name and registration 

22 number of the exporter; 

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1 tive but not bioequivalent to the U.S. 

2 label drug; 

3 ‘‘(V) if the inactive ingredients of 

4 the drug are different from the inac5 tive ingredients for the U.S. label 

6 drug— 

7 ‘‘(aa) a prominent advisory 

8 that persons with an allergy 

9 should check the ingredient list 

10 of the drug because the ingredi11 ents of the drug differ from the 

12 ingredients of the U.S. label 

13 drug; and 

14 ‘‘(bb) a list of the ingredi15 ents of the drug as would be re16 quired under section 502(e); and 

17 ‘‘(VI) a copy of any special label18 ing that would be required by the Sec19 retary had the U.S. label drug been 

20 dispensed by a pharmacist in the 

21 United States, without regard to 

22 whether the special labeling bears any 

23 trademark involved. 

24 ‘‘(ii) PACKAGING.—A qualifying drug 

25 offered for import to an individual by an 


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1 exporter under this section that is pack2 aged in a unit-of-use container (as those 

3 items are defined in the United States 

4 Pharmacopeia and National Formulary) 

5 shall not be repackaged, provided that— 

6 ‘‘(I) the packaging complies with 

7 all applicable regulations under sec8 tions 3 and 4 of the Poison Preven9 tion Packaging Act of 1970 (15 

10 U.S.C. 1471 et seq.); or 

11 ‘‘(II) the consumer consents to 

12 waive the requirements of such Act, 

13 after being informed that the pack14 aging does not comply with such Act 

15 and that the exporter will provide the 

16 drug in packaging that is compliant at 

17 no additional cost. 

18 ‘‘(iii) REQUEST FOR COPY OF SPECIAL

19 LABELING AND INGREDIENT LIST.—The 

20 Secretary shall provide to the registered 

21 exporter involved a copy of the special la22 beling, the advisory, and the ingredient list 

23 described under clause (i), upon request of 

24 the exporter. 


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1 ‘‘(iv) REQUESTED LABELING AND IN2 GREDIENT LIST.—The labeling and ingre3 dient list provided by the Secretary under 

4 clause (iii) shall— 

5 ‘‘(I) include the established 

6 name, as defined in section 502(e)(3), 

7 for each active ingredient in the drug; 

8 and 

9 ‘‘(II) not include the proprietary 

10 name of the U.S. label drug or any 

11 active ingredient thereof. 

12 ‘‘(4) SECTION 501; ADULTERATION.—A quali13 fying drug that is imported or offered for import 

14 under subsection (a) shall be considered to be in 

15 compliance with section 501 if the drug is in compli16 ance with subsection (c). 

17 ‘‘(5) STANDARDS FOR REFUSING ADMISSION.— 

18 A drug exported under subsection (a) from a reg19 istered exporter or imported by a registered importer 

20 may be refused admission into the United States if 

21 1 or more of the following applies: 

22 ‘‘(A) The drug is not a qualifying drug. 

23 ‘‘(B) A notice for the drug required under 

24 paragraph (2)(B) has not been submitted to the 

25 Secretary. 


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1 ‘‘(C) The Secretary has ordered that im2 portation of the drug from the permitted coun3 try cease under paragraph (2) (C) or (D). 

4 ‘‘(D) The drug does not comply with para5 graph (3) or (4). 

6 ‘‘(E) The shipping container appears dam7 aged in a way that may affect the strength, 

8 quality, or purity of the drug. 

9 ‘‘(F) The Secretary becomes aware that— 

10 ‘‘(i) the drug may be counterfeit; 

11 ‘‘(ii) the drug may have been pre12 pared, packed, or held under insanitary 

13 conditions; or 

14 ‘‘(iii) the methods used in, or the fa15 cilities or controls used for, the manufac16 turing, processing, packing, or holding of 

17 the drug do not conform to good manufac18 turing practice. 

19 ‘‘(G) The Secretary has obtained an in20 junction under section 302 that prohibits the 

21 distribution of the drug in interstate commerce. 

22 ‘‘(H) The Secretary has under section 

23 505(e) withdrawn approval of the drug. 

24 ‘‘(I) The manufacturer of the drug has in25 stituted a recall of the drug. 


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1 ‘‘(J) If the drug is imported or offered for 

2 import by a registered importer without submis3 sion of a notice in accordance with subsection 

4 (d)(4). 

5 ‘‘(K) If the drug is imported or offered for 

6 import from a registered exporter to an indi7 vidual and 1 or more of the following applies: 

8 ‘‘(i) The shipping container for such 

9 drug does not bear the markings required 

10 under subsection (d)(2). 

11 ‘‘(ii) The markings on the shipping 

12 container appear to be counterfeit. 

13 ‘‘(iii) The shipping container or mark14 ings appear to have been tampered with. 

15 ‘‘(h) EXPORTER LICENSURE IN PERMITTED COUN16 TRY.—A registration condition is that the exporter in17 volved agrees that a qualifying drug will be exported to 

18 an individual only if the Secretary has verified that— 

19 ‘‘(1) the exporter is authorized under the law of 

20 the permitted country in which the exporter is lo21 cated to dispense prescription drugs; and 

22 ‘‘(2) the exporter employs persons that are li23 censed under the law of the permitted country in 

24 which the exporter is located to dispense prescription 

25 drugs in sufficient number to dispense safely the 


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1 drugs exported by the exporter to individuals, and 

2 the exporter assigns to those persons responsibility 

3 for dispensing such drugs to individuals. 

4 ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTA5 TION.— 

6 ‘‘(1) IN GENERAL.—For purposes of subsection 

7 (a)(2)(B), the importation of a qualifying drug by 

8 an individual is in accordance with this subsection if 

9 the following conditions are met: 

10 ‘‘(A) The drug is accompanied by a copy of 

11 a prescription for the drug, which prescrip12 tion— 

13 ‘‘(i) is valid under applicable Federal 

14 and State laws; and 

15 ‘‘(ii) was issued by a practitioner who, 

16 under the law of a State of which the indi17 vidual is a resident, or in which the indi18 vidual receives care from the practitioner 

19 who issues the prescription, is authorized 

20 to administer prescription drugs. 

21 ‘‘(B) The drug is accompanied by a copy 

22 of the documentation that was required under 

23 the law or regulations of the permitted country 

24 in which the exporter is located, as a condition 

25 of dispensing the drug to the individual. 


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1 ‘‘(C) The copies referred to in subpara2 graphs (A)(i) and (B) are marked in a manner 

3 sufficient— 

4 ‘‘(i) to indicate that the prescription, 

5 and the equivalent document in the per6 mitted country in which the exporter is lo7 cated, have been filled; and 

8 ‘‘(ii) to prevent a duplicative filling by 

9 another pharmacist. 

10 ‘‘(D) The individual has provided to the 

11 registered exporter a complete list of all drugs 

12 used by the individual for review by the individ13 uals who dispense the drug. 

14 ‘‘(E) The quantity of the drug does not ex15 ceed a 90-day supply. 

16 ‘‘(F) The drug is not an ineligible subpart 

17 H drug. For purposes of this section, a pre18 scription drug is an ‘ineligible subpart H drug’ 

19 if the drug was approved by the Secretary 

20 under subpart H of part 314 of title 21, Code 

21 of Federal Regulations (relating to accelerated 

22 approval), with restrictions under section 520 of 

23 such part to assure safe use, and the Secretary 

24 has published in the Federal Register a notice 

25 that the Secretary has determined that good 


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1 cause exists to prohibit the drug from being im2 ported pursuant to this subsection. 

3 ‘‘(2) NOTICE REGARDING DRUG REFUSED AD4 MISSION.—If a registered exporter ships a drug to 

5 an individual pursuant to subsection (a)(2)(B) and 

6 the drug is refused admission to the United States, 

7 a written notice shall be sent to the individual and 

8 to the exporter that informs the individual and the 

9 exporter of such refusal and the reason for the re10 fusal. 

11 ‘‘(j) MAINTENANCE OF RECORDS AND SAMPLES.— 

12 ‘‘(1) IN GENERAL.—A registration condition is 

13 that the importer or exporter involved shall— 

14 ‘‘(A) maintain records required under this 

15 section for not less than 2 years; and 

16 ‘‘(B) maintain samples of each lot of a 

17 qualifying drug required under this section for 

18 not more than 2 years. 

19 ‘‘(2) PLACE OF RECORD MAINTENANCE.—The 

20 records described under paragraph (1) shall be 

21 maintained— 

22 ‘‘(A) in the case of an importer, at the 

23 place of business of the importer at which the 

24 importer initially receives the qualifying drug 

25 after importation; or 


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1 ‘‘(B) in the case of an exporter, at the fa2 cility from which the exporter ships the quali3 fying drug to the United States. 

4 ‘‘(k) DRUG RECALLS.— 

5 ‘‘(1) MANUFACTURERS.—A person that manu6 factures a qualifying drug imported from a per7 mitted country under this section shall promptly in8 form the Secretary— 

9 ‘‘(A) if the drug is recalled or withdrawn 

10 from the market in a permitted country; 

11 ‘‘(B) how the drug may be identified, in12 cluding lot number; and 

13 ‘‘(C) the reason for the recall or with14 drawal. 

15 ‘‘(2) SECRETARY.—With respect to each per16 mitted country, the Secretary shall— 

17 ‘‘(A) enter into an agreement with the gov18 ernment of the country to receive information 

19 about recalls and withdrawals of qualifying 

20 drugs in the country; or 

21 ‘‘(B) monitor recalls and withdrawals of 

22 qualifying drugs in the country using any infor23 mation that is available to the public in any 

24 media. 


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1 ‘‘(3) NOTICE.—The Secretary may notify, as 

2 appropriate, registered exporters, registered import3 ers, wholesalers, pharmacies, or the public of a recall 

4 or withdrawal of a qualifying drug in a permitted 

5 country. 

6 ‘‘(l) DRUG LABELING AND PACKAGING.— 

7 ‘‘(1) IN GENERAL.—When a qualifying drug 

8 that is imported into the United States by an im9 porter under subsection (a) is dispensed by a phar10 macist to an individual, the pharmacist shall provide 

11 that the packaging and labeling of the drug complies 

12 with all applicable regulations promulgated under 

13 sections 3 and 4 of the Poison Prevention Packaging 

14 Act of 1970 (15 U.S.C. 1471 et seq.) and shall in15 clude with any other labeling provided to the indi16 vidual the following: 

17 ‘‘(A) The lot number assigned by the man18 ufacturer. 

19 ‘‘(B) The name and registration number of 

20 the importer. 

21 ‘‘(C) If required under paragraph 

22 (2)(B)(vi)(III) of subsection (g), a prominent 

23 advisory that the drug is safe and effective but 

24 not bioequivalent to the U.S. label drug. 


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1 ‘‘(D) If the inactive ingredients of the drug 

2 are different from the inactive ingredients for 

3 the U.S. label drug— 

4 ‘‘(i) a prominent advisory that persons 

5 with allergies should check the ingredient 

6 list of the drug because the ingredients of 

7 the drug differ from the ingredients of the 

8 U.S. label drug; and 

9 ‘‘(ii) a list of the ingredients of the 

10 drug as would be required under section 

11 502(e). 

12 ‘‘(2) PACKAGING.—A qualifying drug that is 

13 packaged in a unit-of-use container (as those terms 

14 are defined in the United States Pharmacopeia and 

15 National Formulary) shall not be repackaged, pro16 vided that— 

17 ‘‘(A) the packaging complies with all appli18 cable regulations under sections 3 and 4 of the 

19 Poison Prevention Packaging Act of 1970 (15 

20 U.S.C. 1471 et seq.); or 

21 ‘‘(B) the consumer consents to waive the 

22 requirements of such Act, after being informed 

23 that the packaging does not comply with such 

24 Act and that the pharmacist will provide the 


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1 drug in packaging that is compliant at no addi2 tional cost. 

3 ‘‘(m) CHARITABLE CONTRIBUTIONS.—Notwith4 standing any other provision of this section, this section 

5 does not authorize the importation into the United States 

6 of a qualifying drug donated or otherwise supplied for free 

7 or at nominal cost by the manufacturer of the drug to 

8 a charitable or humanitarian organization, including the 

9 United Nations and affiliates, or to a government of a for10 eign country. 

11 ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC12 TICES.— 

13 ‘‘(1) IN GENERAL.—It is unlawful for a manu14 facturer, directly or indirectly (including by being a 

15 party to a licensing agreement or other agreement), 

16 to— 

17 ‘‘(A) discriminate by charging a higher 

18 price for a prescription drug sold to a registered 

19 exporter or other person in a permitted country 

20 that exports a qualifying drug to the United 

21 States under this section than the price that is 

22 charged, inclusive of rebates or other incentives 

23 to the permitted country or other person, to an24 other person that is in the same country and 


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1 that does not export a qualifying drug into the 

2 United States under this section; 

3 ‘‘(B) discriminate by charging a higher 

4 price for a prescription drug sold to a registered 

5 importer or other person that distributes, sells, 

6 or uses a qualifying drug imported into the 

7 United States under this section than the price 

8 that is charged to another person in the United 

9 States that does not import a qualifying drug 

10 under this section, or that does not distribute, 

11 sell, or use such a drug; 

12 ‘‘(C) discriminate by denying, restricting, 

13 or delaying supplies of a prescription drug to a 

14 registered exporter or other person in a per15 mitted country that exports a qualifying drug to 

16 the United States under this section or to a 

17 registered importer or other person that distrib18 utes, sells, or uses a qualifying drug imported 

19 into the United States under this section; 

20 ‘‘(D) discriminate by publicly, privately, or 

21 otherwise refusing to do business with a reg22 istered exporter or other person in a permitted 

23 country that exports a qualifying drug to the 

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1 utes, sells, or uses a qualifying drug imported 

2 into the United States under this section; 

3 ‘‘(E) knowingly fail to submit a notice 

4 under subsection (g)(2)(B)(i), knowingly fail to 

5 submit such a notice on or before the date spec6 ified in subsection (g)(2)(B)(v) or as otherwise 

7 required under subsection (e) (3), (4), and (5) 

8 of section 4 of the Pharmaceutical Market Ac9 cess and Drug Safety Act of 2009, knowingly 

10 submit such a notice that makes a materially 

11 false, fictitious, or fraudulent statement, or 

12 knowingly fail to provide promptly any informa13 tion requested by the Secretary to review such 

14 a notice; 

15 ‘‘(F) knowingly fail to submit an applica16 tion required under subsection (g)(2)(F), know17 ingly fail to submit such an application on or 

18 before the date specified in subsection 

19 (g)(2)(F)(ii), knowingly submit such an applica20 tion that makes a materially false, fictitious, or 

21 fraudulent statement, or knowingly fail to pro22 vide promptly any information requested by the 

23 Secretary to review such an application; 

24 ‘‘(G) cause there to be a difference (includ25 ing a difference in active ingredient, route of 


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1 administration, dosage form, strength, formula2 tion, manufacturing establishment, manufac3 turing process, or person that manufactures the 

4 drug) between a prescription drug for distribu5 tion in the United States and the drug for dis6 tribution in a permitted country; 

7 ‘‘(H) refuse to allow an inspection author8 ized under this section of an establishment that 

9 manufactures a qualifying drug that is, or will 

10 be, introduced for commercial distribution in a 

11 permitted country; 

12 ‘‘(I) fail to conform to the methods used 

13 in, or the facilities used for, the manufacturing, 

14 processing, packing, or holding of a qualifying 

15 drug that is, or will be, introduced for commer16 cial distribution in a permitted country to good 

17 manufacturing practice under this Act; 

18 ‘‘(J) become a party to a licensing agree19 ment or other agreement related to a qualifying 

20 drug that fails to provide for compliance with 

21 all requirements of this section with respect to 

22 such drug; 

23 ‘‘(K) enter into a contract that restricts, 

24 prohibits, or delays the importation of a quali25 fying drug under this section; 


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1 ‘‘(L) engage in any other action to restrict, 

2 prohibit, or delay the importation of a quali3 fying drug under this section; or 

4 ‘‘(M) engage in any other action that the 

5 Federal Trade Commission determines to dis6 criminate against a person that engages or at7 tempts to engage in the importation of a quali8 fying drug under this section. 

9 ‘‘(2) REFERRAL OF POTENTIAL VIOLATIONS.— 

10 The Secretary shall promptly refer to the Federal 

11 Trade Commission each potential violation of sub12 paragraph (E), (F), (G), (H), or (I) of paragraph 

13 (1) that becomes known to the Secretary. 

14 ‘‘(3) AFFIRMATIVE DEFENSE.— 

15 ‘‘(A) DISCRIMINATION.—It shall be an af16 firmative defense to a charge that a manufac17 turer has discriminated under subparagraph 

18 (A), (B), (C), (D), or (M) of paragraph (1) that 

19 the higher price charged for a prescription drug 

20 sold to a person, the denial, restriction, or delay 

21 of supplies of a prescription drug to a person, 

22 the refusal to do business with a person, or 

23 other discriminatory activity against a person, 

24 is not based, in whole or in part, on— 


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1 ‘‘(i) the person exporting or importing 

2 a qualifying drug into the United States 

3 under this section; or 

4 ‘‘(ii) the person distributing, selling, 

5 or using a qualifying drug imported into 

6 the United States under this section. 

7 ‘‘(B) DRUG DIFFERENCES.—It shall be an 

8 affirmative defense to a charge that a manufac9 turer has caused there to be a difference de10 scribed in subparagraph (G) of paragraph (1) 

11 that— 

12 ‘‘(i) the difference was required by the 

13 country in which the drug is distributed; 

14 ‘‘(ii) the Secretary has determined 

15 that the difference was necessary to im16 prove the safety or effectiveness of the 

17 drug; 

18 ‘‘(iii) the person manufacturing the 

19 drug for distribution in the United States 

20 has given notice to the Secretary under 

21 subsection (g)(2)(B)(i) that the drug for 

22 distribution in the United States is not dif23 ferent from a drug for distribution in per24 mitted countries whose combined popu25 lation represents at least 50 percent of the 


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1 total population of all permitted countries; 

2 or 

3 ‘‘(iv) the difference was not caused, in 

4 whole or in part, for the purpose of re5 stricting importation of the drug into the 

6 United States under this section. 

7 ‘‘(4) EFFECT OF SUBSECTION.— 

8 ‘‘(A) SALES IN OTHER COUNTRIES.—This 

9 subsection applies only to the sale or distribu10 tion of a prescription drug in a country if the 

11 manufacturer of the drug chooses to sell or dis12 tribute the drug in the country. Nothing in this 

13 subsection shall be construed to compel the 

14 manufacturer of a drug to distribute or sell the 

15 drug in a country. 

16 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

17 PLANS, PHARMACY BENEFIT MANAGERS, AND

18 COVERED ENTITIES.—Nothing in this sub19 section shall be construed to— 

20 ‘‘(i) prevent or restrict a manufac21 turer of a prescription drug from providing 

22 discounts to an insurer, health plan, phar23 macy benefit manager in the United 

24 States, or covered entity in the drug dis25 count program under section 340B of the 


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1 Public Health Service Act (42 U.S.C. 

2 256b) in return for inclusion of the drug 

3 on a formulary; 

4 ‘‘(ii) require that such discounts be 

5 made available to other purchasers of the 

6 prescription drug; or 

7 ‘‘(iii) prevent or restrict any other 

8 measures taken by an insurer, health plan, 

9 or pharmacy benefit manager to encourage 

10 consumption of such prescription drug. 

11 ‘‘(C) CHARITABLE CONTRIBUTIONS.— 

12 Nothing in this subsection shall be construed 

13 to— 

14 ‘‘(i) prevent a manufacturer from do15 nating a prescription drug, or supplying a 

16 prescription drug at nominal cost, to a 

17 charitable or humanitarian organization, 

18 including the United Nations and affili19 ates, or to a government of a foreign coun20 try; or 

21 ‘‘(ii) apply to such donations or sup22 plying of a prescription drug. 

23 ‘‘(5) ENFORCEMENT.— 

24 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC25 TICE.—A violation of this subsection shall be 


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1 treated as a violation of a rule defining an un2 fair or deceptive act or practice prescribed 

3 under section 18(a)(1)(B) of the Federal Trade 

4 Commission Act (15 U.S.C. 57a(a)(1)(B)). 

5 ‘‘(B) ACTIONS BY THE COMMISSION.—The 

6 Federal Trade Commission— 

7 ‘‘(i) shall enforce this subsection in 

8 the same manner, by the same means, and 

9 with the same jurisdiction, powers, and du10 ties as though all applicable terms and pro11 visions of the Federal Trade Commission 

12 Act (15 U.S.C. 41 et seq.) were incor13 porated into and made a part of this sec14 tion; and 

15 ‘‘(ii) may seek monetary relief three16 fold the damages sustained, in addition to 

17 any other remedy available to the Federal 

18 Trade Commission under the Federal 

19 Trade Commission Act (15 U.S.C. 41 et 

20 seq.). 

21 ‘‘(6) ACTIONS BY STATES.— 

22 ‘‘(A) IN GENERAL.— 

23 ‘‘(i) CIVIL ACTIONS.—In any case in 

24 which the attorney general of a State has 

25 reason to believe that an interest of the 


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1 residents of that State have been adversely 

2 affected by any manufacturer that violates 

3 paragraph (1), the attorney general of a 

4 State may bring a civil action on behalf of 

5 the residents of the State, and persons 

6 doing business in the State, in a district 

7 court of the United States of appropriate 

8 jurisdiction to— 

9 ‘‘(I) enjoin that practice; 

10 ‘‘(II) enforce compliance with 

11 this subsection; 

12 ‘‘(III) obtain damages, restitu13 tion, or other compensation on behalf 

14 of residents of the State and persons 

15 doing business in the State, including 

16 threefold the damages; or 

17 ‘‘(IV) obtain such other relief as 

18 the court may consider to be appro19 priate. 

20 ‘‘(ii) NOTICE.— 

21 ‘‘(I) IN GENERAL.—Before filing 

22 an action under clause (i), the attor23 ney general of the State involved shall 

24 provide to the Federal Trade Commis25 sion— 


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1 ‘‘(aa) written notice of that 

2 action; and 

3 ‘‘(bb) a copy of the com4 plaint for that action. 

5 ‘‘(II) EXEMPTION.—Subclause 

6 (I) shall not apply with respect to the 

7 filing of an action by an attorney gen8 eral of a State under this paragraph, 

9 if the attorney general determines 

10 that it is not feasible to provide the 

11 notice described in that subclause be12 fore filing of the action. In such case, 

13 the attorney general of a State shall 

14 provide notice and a copy of the com15 plaint to the Federal Trade Commis16 sion at the same time as the attorney 

17 general files the action. 

18 ‘‘(B) INTERVENTION.— 

19 ‘‘(i) IN GENERAL.—On receiving no20 tice under subparagraph (A)(ii), the Fed21 eral Trade Commission shall have the right 

22 to intervene in the action that is the sub23 ject of the notice. 

24 ‘‘(ii) EFFECT OF INTERVENTION.—If 

25 the Federal Trade Commission intervenes 


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1 in an action under subparagraph (A), it 

2 shall have the right— 

3 ‘‘(I) to be heard with respect to 

4 any matter that arises in that action; 

5 and 

6 ‘‘(II) to file a petition for appeal. 

7 ‘‘(C) CONSTRUCTION.—For purposes of 

8 bringing any civil action under subparagraph 

9 (A), nothing in this subsection shall be con10 strued to prevent an attorney general of a State 

11 from exercising the powers conferred on the at12 torney general by the laws of that State to— 

13 ‘‘(i) conduct investigations; 

14 ‘‘(ii) administer oaths or affirmations; 

15 or 

16 ‘‘(iii) compel the attendance of wit17 nesses or the production of documentary 

18 and other evidence. 

19 ‘‘(D) ACTIONS BY THE COMMISSION.—In 

20 any case in which an action is instituted by or 

21 on behalf of the Federal Trade Commission for 

22 a violation of paragraph (1), a State may not, 

23 during the pendency of that action, institute an 

24 action under subparagraph (A) for the same 


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1 violation against any defendant named in the 

2 complaint in that action. 

3 ‘‘(E) VENUE.—Any action brought under 

4 subparagraph (A) may be brought in the dis5 trict court of the United States that meets ap6 plicable requirements relating to venue under 

7 section 1391 of title 28, United States Code. 

8 ‘‘(F) SERVICE OF PROCESS.—In an action 

9 brought under subparagraph (A), process may 

10 be served in any district in which the defend11 ant— 

12 ‘‘(i) is an inhabitant; or 

13 ‘‘(ii) may be found. 

14 ‘‘(G) MEASUREMENT OF DAMAGES.—In 

15 any action under this paragraph to enforce a 

16 cause of action under this subsection in which 

17 there has been a determination that a defend18 ant has violated a provision of this subsection, 

19 damages may be proved and assessed in the ag20 gregate by statistical or sampling methods, by 

21 the computation of illegal overcharges or by 

22 such other reasonable system of estimating ag23 gregate damages as the court in its discretion 

24 may permit without the necessity of separately 

25 proving the individual claim of, or amount of 


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1 damage to, persons on whose behalf the suit 

2 was brought. 

3 ‘‘(H) EXCLUSION ON DUPLICATIVE RE4 LIEF.—The district court shall exclude from the 

5 amount of monetary relief awarded in an action 

6 under this paragraph brought by the attorney 

7 general of a State any amount of monetary re8 lief which duplicates amounts which have been 

9 awarded for the same injury. 

10 ‘‘(7) EFFECT ON ANTITRUST LAWS.—Nothing 

11 in this subsection shall be construed to modify, im12 pair, or supersede the operation of the antitrust 

13 laws. For the purpose of this subsection, the term 

14 ‘antitrust laws’ has the meaning given it in the first 

15 section of the Clayton Act, except that it includes 

16 section 5 of the Federal Trade Commission Act to 

17 the extent that such section 5 applies to unfair 

18 methods of competition. 

19 ‘‘(8) MANUFACTURER.—In this subsection, the 

20 term ‘manufacturer’ means any entity, including any 

21 affiliate or licensee of that entity, that is engaged 

22 in— 

23 ‘‘(A) the production, preparation, propaga24 tion, compounding, conversion, or processing of 

25 a prescription drug, either directly or indirectly 


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1 by extraction from substances of natural origin, 

2 or independently by means of chemical syn3 thesis, or by a combination of extraction and 

4 chemical synthesis; or 

5 ‘‘(B) the packaging, repackaging, labeling, 

6 relabeling, or distribution of a prescription 

7 drug.’’. 

8 (b) PROHIBITED ACTS.—The Federal Food, Drug, 

9 and Cosmetic Act is amended— 

10 (1) in section 301 (21 U.S.C. 331), by striking 

11 paragraph (aa) and inserting the following: 

12 ‘‘(aa)(1) The sale or trade by a pharmacist, or by 

13 a business organization of which the pharmacist is a part, 

14 of a qualifying drug that under section 804(a)(2)(A) was 

15 imported by the pharmacist, other than— 

16 ‘‘(A) a sale at retail made pursuant to dis17 pensing the drug to a customer of the pharmacist or 

18 organization; or 

19 ‘‘(B) a sale or trade of the drug to a pharmacy 

20 or a wholesaler registered to import drugs under sec21 tion 804. 

22 ‘‘(2) The sale or trade by an individual of a qualifying 

23 drug that under section 804(a)(2)(B) was imported by the 

24 individual. 


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1 ‘‘(3) The making of a materially false, fictitious, or 

2 fraudulent statement or representation, or a material 

3 omission, in a notice under clause (i) of section 

4 804(g)(2)(B) or in an application required under section 

5 804(g)(2)(F), or the failure to submit such a notice or 

6 application. 

7 ‘‘(4) The importation of a drug in violation of a reg8 istration condition or other requirement under section 

9 804, the falsification of any record required to be main10 tained, or provided to the Secretary, under such section, 

11 or the violation of any registration condition or other re12 quirement under such section.’’; and 

13 (2) in section 303(a) (21 U.S.C. 333(a)), by 

14 striking paragraph (6) and inserting the following: 

15 ‘‘(6) Notwithstanding subsection (a), any person that 

16 knowingly violates section 301(i) (2) or (3) or section 

17 301(aa)(4) shall be imprisoned not more than 10 years, 

18 or fined in accordance with title 18, United States Code, 

19 or both.’’. 

20 (c) AMENDMENT OF CERTAIN PROVISIONS.— 

21 (1) IN GENERAL.—Section 801 of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 

23 amended by striking subsection (g) and inserting the 

24 following: 


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1 ‘‘(g) With respect to a prescription drug that is im2 ported or offered for import into the United States by an 

3 individual who is not in the business of such importation, 

4 that is not shipped by a registered exporter under section 

5 804, and that is refused admission under subsection (a), 

6 the Secretary shall notify the individual that— 

7 ‘‘(1) the drug has been refused admission be8 cause the drug was not a lawful import under sec9 tion 804; 

10 ‘‘(2) the drug is not otherwise subject to a 

11 waiver of the requirements of subsection (a); 

12 ‘‘(3) the individual may under section 804 law13 fully import certain prescription drugs from export14 ers registered with the Secretary under section 804; 

15 and 

16 ‘‘(4) the individual can find information about 

17 such importation, including a list of registered ex18 porters, on the Internet website of the Food and 

19 Drug Administration or through a toll-free telephone 

20 number required under section 804.’’. 

21 (2) ESTABLISHMENT REGISTRATION.—Section 

22 510(i) of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 360(i)) is amended in paragraph (1) by 

24 inserting after ‘‘import into the United States’’ the 

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1 ported or offered for import into the United States 

2 under section 804,’’. 

3 (3) EFFECTIVE DATE.—The amendments made 

4 by this subsection shall take effect on the date that 

5 is 90 days after the date of enactment of this Act. 

6 (d) EXHAUSTION.— 

7 (1) IN GENERAL.—Section 271 of title 35, 

8 United States Code, is amended— 

9 (A) by redesignating subsections (h) and 

10 (i) as (i) and (j), respectively; and 

11 (B) by inserting after subsection (g) the 

12 following: 

13 ‘‘(h) It shall not be an act of infringement to use, 

14 offer to sell, or sell within the United States or to import 

15 into the United States any patented invention under sec16 tion 804 of the Federal Food, Drug, and Cosmetic Act 

17 that was first sold abroad by or under authority of the 

18 owner or licensee of such patent.’’. 

19 (2) RULE OF CONSTRUCTION.—Nothing in the 

20 amendment made by paragraph (1) shall be con21 strued to affect the ability of a patent owner or li22 censee to enforce their patent, subject to such 

23 amendment. 

24 (e) EFFECT OF SECTION 804.— 


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1 (1) IN GENERAL.—Section 804 of the Federal 

2 Food, Drug, and Cosmetic Act, as added by sub3 section (a), shall permit the importation of quali4 fying drugs (as defined in such section 804) into the 

5 United States without regard to the status of the 

6 issuance of implementing regulations— 

7 (A) from exporters registered under such 

8 section 804 on the date that is 90 days after 

9 the date of enactment of this Act; and 

10 (B) from permitted countries, as defined in 

11 such section 804, by importers registered under 

12 such section 804 on the date that is 1 year 

13 after the date of enactment of this Act. 

14 (2) REVIEW OF REGISTRATION BY CERTAIN EX15 PORTERS.— 

16 (A) REVIEW PRIORITY.—In the review of 

17 registrations submitted under subsection (b) of 

18 such section 804, registrations submitted by en19 tities in Canada that are significant exporters 

20 of prescription drugs to individuals in the 

21 United States as of the date of enactment of 

22 this Act will have priority during the 90-day pe23 riod that begins on such date of enactment. 

24 (B) PERIOD FOR REVIEW.—During such 

25 90-day period, the reference in subsection 


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1 (b)(2)(A) of such section 804 to 90 days (relat2 ing to approval or disapproval of registrations) 

3 is, as applied to such entities, deemed to be 30 

4 days. 

5 (C) LIMITATION.—That an exporter in 

6 Canada exports, or has exported, prescription 

7 drugs to individuals in the United States on or 

8 before the date that is 90 days after the date 

9 of enactment of this Act shall not serve as a 

10 basis, in whole or in part, for disapproving a 

11 registration under such section 804 from the 

12 exporter. 

13 (D) FIRST YEAR LIMIT ON NUMBER OF

14 EXPORTERS.—During the 1-year period begin15 ning on the date of enactment of this Act, the 

16 Secretary of Health and Human Services (re17 ferred to in this section as the ‘‘Secretary’’) 

18 may limit the number of registered exporters 

19 under such section 804 to not less than 50, so 

20 long as the Secretary gives priority to those ex21 porters with demonstrated ability to process a 

22 high volume of shipments of drugs to individ23 uals in the United States. 

24 (E) SECOND YEAR LIMIT ON NUMBER OF

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1 ning on the date that is 1 year after the date 

2 of enactment of this Act, the Secretary may 

3 limit the number of registered exporters under 

4 such section 804 to not less than 100, so long 

5 as the Secretary gives priority to those export6 ers with demonstrated ability to process a high 

7 volume of shipments of drugs to individuals in 

8 the United States. 

9 (F) FURTHER LIMIT ON NUMBER OF EX10 PORTERS.—During any 1-year period beginning 

11 on a date that is 2 or more years after the date 

12 of enactment of this Act, the Secretary may 

13 limit the number of registered exporters under 

14 such section 804 to not less than 25 more than 

15 the number of such exporters during the pre16 vious 1-year period, so long as the Secretary 

17 gives priority to those exporters with dem18 onstrated ability to process a high volume of 

19 shipments of drugs to individuals in the United 

20 States. 

21 (3) LIMITS ON NUMBER OF IMPORTERS.— 

22 (A) FIRST YEAR LIMIT ON NUMBER OF IM23 PORTERS.—During the 1-year period beginning 

24 on the date that is 1 year after the date of en25 actment of this Act, the Secretary may limit the 


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1 number of registered importers under such sec2 tion 804 to not less than 100 (of which at least 

3 a significant number shall be groups of phar4 macies, to the extent feasible given the applica5 tions submitted by such groups), so long as the 

6 Secretary gives priority to those importers with 

7 demonstrated ability to process a high volume 

8 of shipments of drugs imported into the United 

9 States. 

10 (B) SECOND YEAR LIMIT ON NUMBER OF

11 IMPORTERS.—During the 1-year period begin12 ning on the date that is 2 years after the date 

13 of enactment of this Act, the Secretary may 

14 limit the number of registered importers under 

15 such section 804 to not less than 200 (of which 

16 at least a significant number shall be groups of 

17 pharmacies, to the extent feasible given the ap18 plications submitted by such groups), so long as 

19 the Secretary gives priority to those importers 

20 with demonstrated ability to process a high vol21 ume of shipments of drugs into the United 

22 States. 

23 (C) FURTHER LIMIT ON NUMBER OF IM24 PORTERS.—During any 1-year period beginning 

25 on a date that is 3 or more years after the date 


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1 of enactment of this Act, the Secretary may 

2 limit the number of registered importers under 

3 such section 804 to not less than 50 more (of 

4 which at least a significant number shall be 

5 groups of pharmacies, to the extent feasible 

6 given the applications submitted by such 

7 groups) than the number of such importers 

8 during the previous 1-year period, so long as 

9 the Secretary gives priority to those importers 

10 with demonstrated ability to process a high vol11 ume of shipments of drugs to the United 

12 States. 

13 (4) NOTICES FOR DRUGS FOR IMPORT FROM

14 CANADA.—The notice with respect to a qualifying 

15 drug introduced for commercial distribution in Can16 ada as of the date of enactment of this Act that is 

17 required under subsection (g)(2)(B)(i) of such sec18 tion 804 shall be submitted to the Secretary not 

19 later than 30 days after the date of enactment of 

20 this Act if— 

21 (A) the U.S. label drug (as defined in such 

22 section 804) for the qualifying drug is 1 of the 

23 100 prescription drugs with the highest dollar 

24 volume of sales in the United States based on 

25 the 12-calendar-month period most recently 


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1 completed before the date of enactment of this 

2 Act; or 

3 (B) the notice is a notice under subsection 

4 (g)(2)(B)(i)(II) of such section 804. 

5 (5) NOTICE FOR DRUGS FOR IMPORT FROM

6 OTHER COUNTRIES.—The notice with respect to a 

7 qualifying drug introduced for commercial distribu8 tion in a permitted country other than Canada as of 

9 the date of enactment of this Act that is required 

10 under subsection (g)(2)(B)(i) of such section 804 

11 shall be submitted to the Secretary not later than 

12 180 days after the date of enactment of this Act 

13 if— 

14 (A) the U.S. label drug for the qualifying 

15 drug is 1 of the 100 prescription drugs with the 

16 highest dollar volume of sales in the United 

17 States based on the 12-calendar-month period 

18 that is first completed on the date that is 120 

19 days after the date of enactment of this Act; or 

20 (B) the notice is a notice under subsection 

21 (g)(2)(B)(i)(II) of such section 804. 

22 (6) NOTICE FOR OTHER DRUGS FOR IMPORT.— 

23 (A) GUIDANCE ON SUBMISSION DATES.— 

24 The Secretary shall by guidance establish a se25 ries of submission dates for the notices under 


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1 subsection (g)(2)(B)(i) of such section 804 with 

2 respect to qualifying drugs introduced for com3 mercial distribution as of the date of enactment 

4 of this Act and that are not required to be sub5 mitted under paragraph (4) or (5). 

6 (B) CONSISTENT AND EFFICIENT USE OF

7 RESOURCES.—The Secretary shall establish the 

8 dates described under subparagraph (A) so that 

9 such notices described under subparagraph (A) 

10 are submitted and reviewed at a rate that al11 lows consistent and efficient use of the re12 sources and staff available to the Secretary for 

13 such reviews. The Secretary may condition the 

14 requirement to submit such a notice, and the 

15 review of such a notice, on the submission by a 

16 registered exporter or a registered importer to 

17 the Secretary of a notice that such exporter or 

18 importer intends to import such qualifying drug 

19 to the United States under such section 804. 

20 (C) PRIORITY FOR DRUGS WITH HIGHER

21 SALES.—The Secretary shall establish the dates 

22 described under subparagraph (A) so that the 

23 Secretary reviews the notices described under 

24 such subparagraph with respect to qualifying 

25 drugs with higher dollar volume of sales in the 


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1 United States before the notices with respect to 

2 drugs with lower sales in the United States. 

3 (7) NOTICES FOR DRUGS APPROVED AFTER EF4 FECTIVE DATE.—The notice required under sub5 section (g)(2)(B)(i) of such section 804 for a quali6 fying drug first introduced for commercial distribu7 tion in a permitted country (as defined in such sec8 tion 804) after the date of enactment of this Act 

9 shall be submitted to and reviewed by the Secretary 

10 as provided under subsection (g)(2)(B) of such sec11 tion 804, without regard to paragraph (4), (5), or 

12 (6). 

13 (8) REPORT.—Beginning with the first full fis14 cal year after the date of enactment of this Act, not 

15 later than 90 days after the end of each fiscal year 

16 during which the Secretary reviews a notice referred 

17 to in paragraph (4), (5), or (6), the Secretary shall 

18 submit a report to Congress concerning the progress 

19 of the Food and Drug Administration in reviewing 

20 the notices referred to in paragraphs (4), (5), and 

21 (6). 

22 (9) USER FEES.— 

23 (A) EXPORTERS.—When establishing an 

24 aggregate total of fees to be collected from ex25 porters under subsection (f)(2) of such section 


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1 804, the Secretary shall, under subsection 

2 (f)(3)(C)(i) of such section 804, estimate the 

3 total price of drugs imported under subsection 

4 (a) of such section 804 into the United States 

5 by registered exporters during the first fiscal 

6 year in which this Act takes effect to be an 

7 amount equal to the amount which bears the 

8 same ratio to $1,000,000,000 as the number of 

9 days in such fiscal year during which this Act 

10 is effective bears to 365. 

11 (B) IMPORTERS.—When establishing an 

12 aggregate total of fees to be collected from im13 porters under subsection (e)(2) of such section 

14 804, the Secretary shall, under subsection 

15 (e)(3)(C)(i) of such section 804, estimate the 

16 total price of drugs imported under subsection 

17 (a) of such section 804 into the United States 

18 by registered importers during— 

19 (i) the first fiscal year in which this 

20 Act takes effect to be an amount equal to 

21 the amount which bears the same ratio to 

22 $1,000,000,000 as the number of days in 

23 such fiscal year during which this Act is 

24 effective bears to 365; and 


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1 (ii) the second fiscal year in which 

2 this Act is in effect to be $3,000,000,000. 

3 (C) SECOND YEAR ADJUSTMENT.— 

4 (i) REPORTS.—Not later than Feb5 ruary 20 of the second fiscal year in which 

6 this Act is in effect, registered importers 

7 shall report to the Secretary the total price 

8 and the total volume of drugs imported to 

9 the United States by the importer during 

10 the 4-month period from October 1 

11 through January 31 of such fiscal year. 

12 (ii) REESTIMATE.—Notwithstanding 

13 subsection (e)(3)(C)(ii) of such section 804 

14 or subparagraph (B), the Secretary shall 

15 reestimate the total price of qualifying 

16 drugs imported under subsection (a) of 

17 such section 804 into the United States by 

18 registered importers during the second fis19 cal year in which this Act is in effect. Such 

20 reestimate shall be equal to— 

21 (I) the total price of qualifying 

22 drugs imported by each importer as 

23 reported under clause (i); multiplied 

24 by 

25 (II) 3. 


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1 (iii) ADJUSTMENT.—The Secretary 

2 shall adjust the fee due on April 1 of the 

3 second fiscal year in which this Act is in 

4 effect, from each importer so that the ag5 gregate total of fees collected under sub6 section (e)(2) for such fiscal year does not 

7 exceed the total price of qualifying drugs 

8 imported under subsection (a) of such sec9 tion 804 into the United States by reg10 istered importers during such fiscal year as 

11 reestimated under clause (ii). 

12 (D) FAILURE TO PAY FEES.—Notwith13 standing any other provision of this section, the 

14 Secretary may prohibit a registered importer or 

15 exporter that is required to pay user fees under 

16 subsection (e) or (f) of such section 804 and 

17 that fails to pay such fees within 30 days after 

18 the date on which it is due, from importing or 

19 offering for importation a qualifying drug under 

20 such section 804 until such fee is paid. 

21 (E) ANNUAL REPORT.— 

22 (i) FOOD AND DRUG ADMINISTRA23 TION.—Not later than 180 days after the 

24 end of each fiscal year during which fees 

25 are collected under subsection (e), (f), or 


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1 (g)(2)(B)(iv) of such section 804, the Sec2 retary shall prepare and submit to the 

3 House of Representatives and the Senate a 

4 report on the implementation of the au5 thority for such fees during such fiscal 

6 year and the use, by the Food and Drug 

7 Administration, of the fees collected for the 

8 fiscal year for which the report is made 

9 and credited to the Food and Drug Admin10 istration. 

11 (ii) CUSTOMS AND BORDER CON12 TROL.—Not later than 180 days after the 

13 end of each fiscal year during which fees 

14 are collected under subsection (e) or (f) of 

15 such section 804, the Secretary of Home16 land Security, in consultation with the Sec17 retary of the Treasury, shall prepare and 

18 submit to the House of Representatives 

19 and the Senate a report on the use, by the 

20 Bureau of Customs and Border Protection, 

21 of the fees, if any, transferred by the Sec22 retary to the Bureau of Customs and Bor23 der Protection for the fiscal year for which 

24 the report is made. 


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1 (10) SPECIAL RULE REGARDING IMPORTATION

2 BY INDIVIDUALS.— 

3 (A) IN GENERAL.—Notwithstanding any 

4 provision of this Act (or an amendment made 

5 by this Act), the Secretary shall expedite the 

6 designation of any additional countries from 

7 which an individual may import a qualifying 

8 drug into the United States under such section 

9 804 if any action implemented by the Govern10 ment of Canada has the effect of limiting or 

11 prohibiting the importation of qualifying drugs 

12 into the United States from Canada. 

13 (B) TIMING AND CRITERIA.—The Sec14 retary shall designate such additional countries 

15 under subparagraph (A)— 

16 (i) not later than 6 months after the 

17 date of the action by the Government of 

18 Canada described under such subpara19 graph; and 

20 (ii) using the criteria described under 

21 subsection (a)(4)(D)(i)(II) of such section 

22 804. 

23 (f) IMPLEMENTATION OF SECTION 804.— 

24 (1) INTERIM RULE.—The Secretary may pro25 mulgate an interim rule for implementing section 


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1 804 of the Federal Food, Drug, and Cosmetic Act, 

2 as added by subsection (a) of this section. 

3 (2) NO NOTICE OF PROPOSED RULEMAKING.— 

4 The interim rule described under paragraph (1) may 

5 be developed and promulgated by the Secretary with6 out providing general notice of proposed rulemaking. 

7 (3) FINAL RULE.—Not later than 1 year after 

8 the date on which the Secretary promulgates an in9 terim rule under paragraph (1), the Secretary shall, 

10 in accordance with procedures under section 553 of 

11 title 5, United States Code, promulgate a final rule 

12 for implementing such section 804, which may incor13 porate by reference provisions of the interim rule 

14 provided for under paragraph (1), to the extent that 

15 such provisions are not modified. 

16 (g) CONSUMER EDUCATION.—The Secretary shall 

17 carry out activities that educate consumers— 

18 (1) with regard to the availability of qualifying 

19 drugs for import for personal use from an exporter 

20 registered with and approved by the Food and Drug 

21 Administration under section 804 of the Federal 

22 Food, Drug, and Cosmetic Act, as added by this sec23 tion, including information on how to verify whether 

24 an exporter is registered and approved by use of the 

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1 tion and the toll-free telephone number required by 

2 this Act; 

3 (2) that drugs that consumers attempt to im4 port from an exporter that is not registered with and 

5 approved by the Food and Drug Administration can 

6 be seized by the United States Customs Service and 

7 destroyed, and that such drugs may be counterfeit, 

8 unapproved, unsafe, or ineffective; 

9 (3) with regard to the suspension and termi10 nation of any registration of a registered importer or 

11 exporter under such section 804; and 

12 (4) with regard to the availability at domestic 

13 retail pharmacies of qualifying drugs imported under 

14 such section 804 by domestic wholesalers and phar15 macies registered with and approved by the Food 

16 and Drug Administration. 

17 (h) EFFECT ON ADMINISTRATION PRACTICES.—Not18 withstanding any provision of this Act (and the amend19 ments made by this Act), the practices and policies of the 

20 Food and Drug Administration and Bureau of Customs 

21 and Border Protection, in effect on January 1, 2004, with 

22 respect to the importation of prescription drugs into the 

23 United States by an individual, on the person of such indi24 vidual, for personal use, shall remain in effect. 


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1 (i) REPORT TO CONGRESS.—The Federal Trade 

2 Commission shall, on an annual basis, submit to Congress 

3 a report that describes any action taken during the period 

4 for which the report is being prepared to enforce the provi5 sions of section 804(n) of the Federal Food, Drug, and 

6 Cosmetic Act (as added by this Act), including any pend7 ing investigations or civil actions under such section. 

8 SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS9 SION INTO UNITED STATES. 

10 (a) IN GENERAL.—Chapter VIII of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 

12 as amended by section 4, is further amended by adding 

13 at the end the following section: 

14 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD15 MISSION. 

16 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se17 curity shall deliver to the Secretary a shipment of drugs 

18 that is imported or offered for import into the United 

19 States if— 

20 ‘‘(1) the shipment has a declared value of less 

21 than $10,000; and 

22 ‘‘(2)(A) the shipping container for such drugs 

23 does not bear the markings required under section 

24 804(d)(2); or 


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1 ‘‘(B) the Secretary has requested delivery of 

2 such shipment of drugs. 

3 ‘‘(b) NO BOND OR EXPORT.—Section 801(b) does 

4 not authorize the delivery to the owner or consignee of 

5 drugs delivered to the Secretary under subsection (a) pur6 suant to the execution of a bond, and such drugs may not 

7 be exported. 

8 ‘‘(c) DESTRUCTION OF VIOLATIVE SHIPMENT.—The 

9 Secretary shall destroy a shipment of drugs delivered by 

10 the Secretary of Homeland Security to the Secretary 

11 under subsection (a) if— 

12 ‘‘(1) in the case of drugs that are imported or 

13 offered for import from a registered exporter under 

14 section 804, the drugs are in violation of any stand15 ard described in section 804(g)(5); or 

16 ‘‘(2) in the case of drugs that are not imported 

17 or offered for import from a registered exporter 

18 under section 804, the drugs are in violation of a 

19 standard referred to in section 801(a) or 801(d)(1). 

20 ‘‘(d) CERTAIN PROCEDURES.— 

21 ‘‘(1) IN GENERAL.—The delivery and destruc22 tion of drugs under this section may be carried out 

23 without notice to the importer, owner, or consignee 

24 of the drugs except as required by section 801(g) or 

25 section 804(i)(2). The issuance of receipts for the 


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1 drugs, and recordkeeping activities regarding the 

2 drugs, may be carried out on a summary basis. 

3 ‘‘(2) OBJECTIVE OF PROCEDURES.—Procedures 

4 promulgated under paragraph (1) shall be designed 

5 toward the objective of ensuring that, with respect to 

6 efficiently utilizing Federal resources available for 

7 carrying out this section, a substantial majority of 

8 shipments of drugs subject to described in sub9 section (c) are identified and destroyed. 

10 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de11 stroyed under subsection (c) to the extent that the Attor12 ney General of the United States determines that the 

13 drugs should be preserved as evidence or potential evi14 dence with respect to an offense against the United States. 

15 ‘‘(f) RULE OF CONSTRUCTION.—This section may 

16 not be construed as having any legal effect on applicable 

17 law with respect to a shipment of drugs that is imported 

18 or offered for import into the United States and has a 

19 declared value equal to or greater than $10,000.’’. 

20 (b) PROCEDURES.—Procedures for carrying out sec21 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

22 as added by subsection (a), shall be established not later 

23 than 90 days after the date of the enactment of this Act. 


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1 (c) EFFECTIVE DATE.—The amendments made by 

2 this section shall take effect on the date that is 90 days 

3 after the date of enactment of this Act. 

4 SEC. 6. WHOLESALE DISTRIBUTION OF DRUGS; STATE5 MENTS REGARDING PRIOR SALE, PURCHASE, 

6 OR TRADE. 

7 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

8 REGISTERED EXPORTERS.—Section 503(e) of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 

10 amended— 

11 (1) in paragraph (1)— 

12 (A) by striking ‘‘and who is not the manu13 facturer or an authorized distributor of record 

14 of such drug’’; 

15 (B) by striking ‘‘to an authorized dis16 tributor of record or’’; and 

17 (C) by striking subparagraph (B) and in18 serting the following: 

19 ‘‘(B) The fact that a drug subject to subsection (b) 

20 is exported from the United States does not with respect 

21 to such drug exempt any person that is engaged in the 

22 business of the wholesale distribution of the drug from 

23 providing the statement described in subparagraph (A) to 

24 the person that receives the drug pursuant to the export 

25 of the drug. 


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1 ‘‘(C)(i) The Secretary shall by regulation establish re2 quirements that supersede subparagraph (A) (referred to 

3 in this subparagraph as ‘alternative requirements’) to 

4 identify the chain of custody of a drug subject to sub5 section (b) from the manufacturer of the drug throughout 

6 the wholesale distribution of the drug to a pharmacist who 

7 intends to sell the drug at retail if the Secretary deter8 mines that the alternative requirements, which may in9 clude standardized anti-counterfeiting or track-and-trace 

10 technologies, will identify such chain of custody or the 

11 identity of the discrete package of the drug from which 

12 the drug is dispensed with equal or greater certainty to 

13 the requirements of subparagraph (A), and that the alter14 native requirements are economically and technically fea15 sible. 

16 ‘‘(ii) When the Secretary promulgates a final rule to 

17 establish such alternative requirements, the final rule in 

18 addition shall, with respect to the registration condition 

19 established in clause (i) of section 804(c)(3)(B), establish 

20 a condition equivalent to the alternative requirements, and 

21 such equivalent condition may be met in lieu of the reg22 istration condition established in such clause (i).’’; 

23 (2) in paragraph (2)(A), by adding at the end 

24 the following: ‘‘The preceding sentence may not be 


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1 construed as having any applicability with respect to 

2 a registered exporter under section 804.’’; and 

3 (3) in paragraph (3), by striking ‘‘and sub4 section (d)—’’ in the matter preceding subparagraph 

5 (A) and all that follows through ‘‘the term ‘whole6 sale distribution’ means’’ in subparagraph (B) and 

7 inserting the following: ‘‘and subsection (d), the 

8 term ‘wholesale distribution’ means’’. 

9 (b) CONFORMING AMENDMENT.—Section 503(d) of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 353(d)) is amended by adding at the end the following: 

12 ‘‘(4) Each manufacturer of a drug subject to sub13 section (b) shall maintain at its corporate offices a current 

14 list of the authorized distributors of record of such drug. 

15 ‘‘(5) For purposes of this subsection, the term ‘au16 thorized distributors of record’ means those distributors 

17 with whom a manufacturer has established an ongoing re18 lationship to distribute such manufacturer’s products.’’. 

19 (c) EFFECTIVE DATE.— 

20 (1) IN GENERAL.—The amendments made by 

21 paragraphs (1) and (3) of subsection (a) and by sub22 section (b) shall take effect on January 1, 2012. 

23 (2) DRUGS IMPORTED BY REGISTERED IMPORT24 ERS UNDER SECTION 804.—Notwithstanding para25 graph (1), the amendments made by paragraphs (1) 


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1 and (3) of subsection (a) and by subsection (b) shall 

2 take effect on the date that is 90 days after the date 

3 of enactment of this Act with respect to qualifying 

4 drugs imported under section 804 of the Federal 

5 Food, Drug, and Cosmetic Act, as added by section 

6 4. 

7 (3) EFFECT WITH RESPECT TO REGISTERED

8 EXPORTERS.—The amendment made by subsection 

9 (a)(2) shall take effect on the date that is 90 days 

10 after the date of enactment of this Act. 

11 (4) ALTERNATIVE REQUIREMENTS.—The Sec12 retary shall issue regulations to establish the alter13 native requirements, referred to in the amendment 

14 made by subsection (a)(1), that take effect not later 

15 than January 1, 2012. 

16 (5) INTERMEDIATE REQUIREMENTS.—The Sec17 retary shall by regulation require the use of stand18 ardized anti-counterfeiting or track-and-trace tech19 nologies on prescription drugs at the case and pallet 

20 level effective not later than 1 year after the date of 

21 enactment of this Act. 

22 (6) ADDITIONAL REQUIREMENTS.— 

23 (A) IN GENERAL.—Notwithstanding any 

24 other provision of this section, the Secretary 

25 shall, not later than 18 months after the date 


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1 of enactment of this Act, require that the pack2 aging of any prescription drug incorporates— 

3 (i) a standardized numerical identifier 

4 unique to each package of such drug, ap5 plied at the point of manufacturing and re6 packaging (in which case the numerical 

7 identifier shall be linked to the numerical 

8 identifier applied at the point of manufac9 turing); and 

10 (ii)(I) overt optically variable counter11 feit-resistant technologies that— 

12 (aa) are visible to the naked eye, 

13 providing for visual identification of 

14 product authenticity without the need 

15 for readers, microscopes, lighting de16 vices, or scanners; 

17 (bb) are similar to that used by 

18 the Bureau of Engraving and Printing 

19 to secure United States currency; 

20 (cc) are manufactured and dis21 tributed in a highly secure, tightly 

22 controlled environment; and 

23 (dd) incorporate additional layers 

24 of nonvisible convert security features 

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1 bility, as described in subparagraph 

2 (B); or 

3 (II) technologies that have a function 

4 of security comparable to that described in 

5 subclause (I), as determined by the Sec6 retary. 

7 (B) STANDARDS FOR PACKAGING.—For 

8 the purpose of making it more difficult to coun9 terfeit the packaging of drugs subject to this 

10 paragraph, the manufacturers of such drugs 

11 shall incorporate the technologies described in 

12 subparagraph (A) into at least 1 additional ele13 ment of the physical packaging of the drugs, in14 cluding blister packs, shrink wrap, package la15 bels, package seals, bottles, and boxes. 

16 SEC. 7. INTERNET SALES OF PRESCRIPTION DRUGS. 

17 (a) IN GENERAL.—Chapter V of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend19 ed by inserting after section 503B the following: 

20 ‘‘SEC. 503C. INTERNET SALES OF PRESCRIPTION DRUGS. 

21 ‘‘(a) REQUIREMENTS REGARDING INFORMATION ON

22 INTERNET SITE.— 

23 ‘‘(1) IN GENERAL.—A person may not dispense 

24 a prescription drug pursuant to a sale of the drug 

25 by such person if— 


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1 ‘‘(A) the purchaser of the drug submitted 

2 the purchase order for the drug, or conducted 

3 any other part of the sales transaction for the 

4 drug, through an Internet site; 

5 ‘‘(B) the person dispenses the drug to the 

6 purchaser by mailing or shipping the drug to 

7 the purchaser; and 

8 ‘‘(C) such site, or any other Internet site 

9 used by such person for purposes of sales of a 

10 prescription drug, fails to meet each of the re11 quirements specified in paragraph (2), other 

12 than a site or pages on a site that— 

13 ‘‘(i) are not intended to be accessed 

14 by purchasers or prospective purchasers; or 

15 ‘‘(ii) provide an Internet information 

16 location tool within the meaning of section 

17 231(e)(5) of the Communications Act of 

18 1934 (47 U.S.C. 231(e)(5)). 

19 ‘‘(2) REQUIREMENTS.—With respect to an 

20 Internet site, the requirements referred to in sub21 paragraph (C) of paragraph (1) for a person to 

22 whom such paragraph applies are as follows: 

23 ‘‘(A) Each page of the site shall include ei24 ther the following information or a link to a 

25 page that provides the following information: 


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1 ‘‘(i) The name of such person. 

2 ‘‘(ii) Each State in which the person 

3 is authorized by law to dispense prescrip4 tion drugs. 

5 ‘‘(iii) The address and telephone num6 ber of each place of business of the person 

7 with respect to sales of prescription drugs 

8 through the Internet, other than a place of 

9 business that does not mail or ship pre10 scription drugs to purchasers. 

11 ‘‘(iv) The name of each individual who 

12 serves as a pharmacist for prescription 

13 drugs that are mailed or shipped pursuant 

14 to the site, and each State in which the in15 dividual is authorized by law to dispense 

16 prescription drugs. 

17 ‘‘(v) If the person provides for medical 

18 consultations through the site for purposes 

19 of providing prescriptions, the name of 

20 each individual who provides such con21 sultations; each State in which the indi22 vidual is licensed or otherwise authorized 

23 by law to provide such consultations or 

24 practice medicine; and the type or types of 


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1 health professions for which the individual 

2 holds such licenses or other authorizations. 

3 ‘‘(B) A link to which paragraph (1) applies 

4 shall be displayed in a clear and prominent 

5 place and manner, and shall include in the cap6 tion for the link the words ‘licensing and con7 tact information’. 

8 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

9 MEDICAL RELATIONSHIPS.— 

10 ‘‘(1) IN GENERAL.—Except as provided in para11 graph (2), a person may not dispense a prescription 

12 drug, or sell such a drug, if— 

13 ‘‘(A) for purposes of such dispensing or 

14 sale, the purchaser communicated with the per15 son through the Internet; 

16 ‘‘(B) the patient for whom the drug was 

17 dispensed or purchased did not, when such 

18 communications began, have a prescription for 

19 the drug that is valid in the United States; 

20 ‘‘(C) pursuant to such communications, the 

21 person provided for the involvement of a practi22 tioner, or an individual represented by the per23 son as a practitioner, and the practitioner or 

24 such individual issued a prescription for the 

25 drug that was purchased; 


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1 ‘‘(D) the person knew, or had reason to 

2 know, that the practitioner or the individual re3 ferred to in subparagraph (C) did not, when 

4 issuing the prescription, have a qualifying med5 ical relationship with the patient; and 

6 ‘‘(E) the person received payment for the 

7 dispensing or sale of the drug. 

8 For purposes of subparagraph (E), payment is re9 ceived if money or other valuable consideration is re10 ceived. 

11 ‘‘(2) EXCEPTIONS.—Paragraph (1) does not 

12 apply to— 

13 ‘‘(A) the dispensing or selling of a pre14 scription drug pursuant to telemedicine prac15 tices sponsored by— 

16 ‘‘(i) a hospital that has in effect a 

17 provider agreement under title XVIII of 

18 the Social Security Act (relating to the 

19 Medicare program); or 

20 ‘‘(ii) a group practice that has not 

21 fewer than 100 physicians who have in ef22 fect provider agreements under such title; 

23 or 

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1 mote the public health, as determined by the 

2 Secretary by regulation. 

3 ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— 

4 ‘‘(A) IN GENERAL.—With respect to 

5 issuing a prescription for a drug for a patient, 

6 a practitioner has a qualifying medical relation7 ship with the patient for purposes of this sec8 tion if— 

9 ‘‘(i) at least one in-person medical 

10 evaluation of the patient has been con11 ducted by the practitioner; or 

12 ‘‘(ii) the practitioner conducts a med13 ical evaluation of the patient as a covering 

14 practitioner. 

15 ‘‘(B) IN-PERSON MEDICAL EVALUATION.— 

16 A medical evaluation by a practitioner is an in17 person medical evaluation for purposes of this 

18 section if the practitioner is in the physical 

19 presence of the patient as part of conducting 

20 the evaluation, without regard to whether por21 tions of the evaluation are conducted by other 

22 health professionals. 

23 ‘‘(C) COVERING PRACTITIONER.—With re24 spect to a patient, a practitioner is a covering 

25 practitioner for purposes of this section if the 


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1 practitioner conducts a medical evaluation of 

2 the patient at the request of a practitioner who 

3 has conducted at least one in-person medical 

4 evaluation of the patient and is temporarily un5 available to conduct the evaluation of the pa6 tient. A practitioner is a covering practitioner 

7 without regard to whether the practitioner has 

8 conducted any in-person medical evaluation of 

9 the patient involved. 

10 ‘‘(4) RULES OF CONSTRUCTION.— 

11 ‘‘(A) INDIVIDUALS REPRESENTED AS

12 PRACTITIONERS.—A person who is not a practi13 tioner (as defined in subsection (e)(1)) lacks 

14 legal capacity under this section to have a 

15 qualifying medical relationship with any patient. 

16 ‘‘(B) STANDARD PRACTICE OF PHAR17 MACY.—Paragraph (1) may not be construed as 

18 prohibiting any conduct that is a standard prac19 tice in the practice of pharmacy. 

20 ‘‘(C) APPLICABILITY OF REQUIRE21 MENTS.—Paragraph (3) may not be construed 

22 as having any applicability beyond this section, 

23 and does not affect any State law, or interpre24 tation of State law, concerning the practice of 

25 medicine. 


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1 ‘‘(c) ACTIONS BY STATES.— 

2 ‘‘(1) IN GENERAL.—Whenever an attorney gen3 eral of any State has reason to believe that the in4 terests of the residents of that State have been or 

5 are being threatened or adversely affected because 

6 any person has engaged or is engaging in a pattern 

7 or practice that violates section 301(l), the State 

8 may bring a civil action on behalf of its residents in 

9 an appropriate district court of the United States to 

10 enjoin such practice, to enforce compliance with such 

11 section (including a nationwide injunction), to obtain 

12 damages, restitution, or other compensation on be13 half of residents of such State, to obtain reasonable 

14 attorneys fees and costs if the State prevails in the 

15 civil action, or to obtain such further and other relief 

16 as the court may deem appropriate. 

17 ‘‘(2) NOTICE.—The State shall serve prior writ18 ten notice of any civil action under paragraph (1) or 

19 (5)(B) upon the Secretary and provide the Secretary 

20 with a copy of its complaint, except that if it is not 

21 feasible for the State to provide such prior notice, 

22 the State shall serve such notice immediately upon 

23 instituting such action. Upon receiving a notice re24 specting a civil action, the Secretary shall have the 

25 right— 


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1 ‘‘(A) to intervene in such action; 

2 ‘‘(B) upon so intervening, to be heard on 

3 all matters arising therein; and 

4 ‘‘(C) to file petitions for appeal. 

5 ‘‘(3) CONSTRUCTION.—For purposes of bring6 ing any civil action under paragraph (1), nothing in 

7 this chapter shall prevent an attorney general of a 

8 State from exercising the powers conferred on the 

9 attorney general by the laws of such State to con10 duct investigations or to administer oaths or affir11 mations or to compel the attendance of witnesses or 

12 the production of documentary and other evidence. 

13 ‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 

14 action brought under paragraph (1) in a district 

15 court of the United States may be brought in the 

16 district in which the defendant is found, is an inhab17 itant, or transacts business or wherever venue is 

18 proper under section 1391 of title 28, United States 

19 Code. Process in such an action may be served in 

20 any district in which the defendant is an inhabitant 

21 or in which the defendant may be found. 

22 ‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.— 

23 ‘‘(A) Nothing contained in this section 

24 shall prohibit an authorized State official from 

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1 leged violation of any civil or criminal statute of 

2 such State. 

3 ‘‘(B) In addition to actions brought by an 

4 attorney general of a State under paragraph 

5 (1), such an action may be brought by officers 

6 of such State who are authorized by the State 

7 to bring actions in such State on behalf of its 

8 residents. 

9 ‘‘(d) EFFECT OF SECTION.—This section shall not 

10 apply to a person that is a registered exporter under sec11 tion 804. 

12 ‘‘(e) GENERAL DEFINITIONS.—For purposes of this 

13 section: 

14 ‘‘(1) The term ‘practitioner’ means a practi15 tioner referred to in section 503(b)(1) with respect 

16 to issuing a written or oral prescription. 

17 ‘‘(2) The term ‘prescription drug’ means a drug 

18 that is described in section 503(b)(1). 

19 ‘‘(3) The term ‘qualifying medical relationship’, 

20 with respect to a practitioner and a patient, has the 

21 meaning indicated for such term in subsection (b). 

22 ‘‘(f) INTERNET-RELATED DEFINITIONS.— 

23 ‘‘(1) IN GENERAL.—For purposes of this sec24 tion: 


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1 ‘‘(A) The term ‘Internet’ means collectively 

2 the myriad of computer and telecommunications 

3 facilities, including equipment and operating 

4 software, which comprise the interconnected 

5 world-wide network of networks that employ the 

6 transmission control protocol/internet protocol, 

7 or any predecessor or successor protocols to 

8 such protocol, to communicate information of 

9 all kinds by wire or radio. 

10 ‘‘(B) The term ‘link’, with respect to the 

11 Internet, means one or more letters, words, 

12 numbers, symbols, or graphic items that appear 

13 on a page of an Internet site for the purpose 

14 of serving, when activated, as a method for exe15 cuting an electronic command— 

16 ‘‘(i) to move from viewing one portion 

17 of a page on such site to another portion 

18 of the page; 

19 ‘‘(ii) to move from viewing one page 

20 on such site to another page on such site; 

21 or 

22 ‘‘(iii) to move from viewing a page on 

23 one Internet site to a page on another 

24 Internet site. 


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1 ‘‘(C) The term ‘page’, with respect to the 

2 Internet, means a document or other file 

3 accessed at an Internet site. 

4 ‘‘(D)(i) The terms ‘site’ and ‘address’, with 

5 respect to the Internet, mean a specific location 

6 on the Internet that is determined by Internet 

7 Protocol numbers. Such term includes the do8 main name, if any. 

9 ‘‘(ii) The term ‘domain name’ means a 

10 method of representing an Internet address 

11 without direct reference to the Internet Protocol 

12 numbers for the address, including methods 

13 that use designations such as ‘.com’, ‘.edu’, 

14 ‘.gov’, ‘.net’, or ‘.org’. 

15 ‘‘(iii) The term ‘Internet Protocol num16 bers’ includes any successor protocol for deter17 mining a specific location on the Internet. 

18 ‘‘(2) AUTHORITY OF SECRETARY.—The Sec19 retary may by regulation modify any definition 

20 under paragraph (1) to take into account changes in 

21 technology. 

22 ‘‘(g) INTERACTIVE COMPUTER SERVICE; ADVER23 TISING.—No provider of an interactive computer service, 

24 as defined in section 230(f)(2) of the Communications Act 

25 of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 


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1 shall be liable under this section for dispensing or selling 

2 prescription drugs in violation of this section on account 

3 of another person’s selling or dispensing such drugs, pro4 vided that the provider of the interactive computer service 

5 or of advertising services does not own or exercise cor6 porate control over such person.’’. 

7 (b) INCLUSION AS PROHIBITED ACT.—Section 301 of 

8 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 331) is amended by inserting after paragraph (k) the fol10 lowing: 

11 ‘‘(l) The dispensing or selling of a prescription drug 

12 in violation of section 503C.’’. 

13 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

14 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO15 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI16 NESSES.—In carrying out section 503C of the Federal 

17 Food, Drug, and Cosmetic Act (as added by subsection 

18 (a) of this section), the Secretary of Health and Human 

19 Services shall take into consideration the practices and 

20 procedures of public or private entities that certify that 

21 businesses selling prescription drugs through Internet 

22 sites are legitimate businesses, including practices and 

23 procedures regarding disclosure formats and verification 

24 programs. 


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1 (d) REPORTS REGARDING INTERNET-RELATED VIO2 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

3 OF DRUGS.— 

4 (1) IN GENERAL.—The Secretary of Health and 

5 Human Services (referred to in this subsection as 

6 the ‘‘Secretary’’) shall, pursuant to the submission 

7 of an application meeting the criteria of the Sec8 retary, make an award of a grant or contract to the 

9 National Clearinghouse on Internet Prescribing (op10 erated by the Federation of State Medical Boards) 

11 for the purpose of— 

12 (A) identifying Internet sites that appear 

13 to be in violation of Federal or State laws con14 cerning the dispensing of drugs; 

15 (B) reporting such sites to State medical 

16 licensing boards and State pharmacy licensing 

17 boards, and to the Attorney General and the 

18 Secretary, for further investigation; and 

19 (C) submitting, for each fiscal year for 

20 which the award under this subsection is made, 

21 a report to the Secretary describing investiga22 tions undertaken with respect to violations de23 scribed in subparagraph (A). 

24 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

25 the purpose of carrying out paragraph (1), there is 


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1 authorized to be appropriated $100,000 for each of 

2 the first 3 fiscal years in which this section is in ef3 fect. 

4 (e) EFFECTIVE DATE.—The amendments made by 

5 subsections (a) and (b) take effect 90 days after the date 

6 of enactment of this Act, without regard to whether a final 

7 rule to implement such amendments has been promulgated 

8 by the Secretary of Health and Human Services under 

9 section 701(a) of the Federal Food, Drug, and Cosmetic 

10 Act. The preceding sentence may not be construed as af11 fecting the authority of such Secretary to promulgate such 

12 a final rule. 

13 SEC. 8. PROHIBITING PAYMENTS TO UNREGISTERED FOR14 EIGN PHARMACIES. 

15 (a) IN GENERAL.—Section 303 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

17 adding at the end the following: 

18 ‘‘(h) RESTRICTED TRANSACTIONS.— 

19 ‘‘(1) IN GENERAL.—The introduction of re20 stricted transactions into a payment system or the 

21 completion of restricted transactions using a pay22 ment system is prohibited. 

23 ‘‘(2) PAYMENT SYSTEM.— 

24 ‘‘(A) IN GENERAL.—The term ‘payment 

25 system’ means a system used by a person deVerDate Nov 24 2008 02:36 Mar 06, 2009 Jkt 079200 PO 00000 Frm 00129 Fmt 6652 Sfmt 6201 E:\BILLS\H1298.IH H1298

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1 scribed in subparagraph (B) to effect a credit 

2 transaction, electronic fund transfer, or money 

3 transmitting service that may be used in con4 nection with, or to facilitate, a restricted trans5 action, and includes— 

6 ‘‘(i) a credit card system; 

7 ‘‘(ii) an international, national, re8 gional, or local network used to effect a 

9 credit transaction, an electronic fund 

10 transfer, or a money transmitting service; 

11 and 

12 ‘‘(iii) any other system that is cen13 trally managed and is primarily engaged in 

14 the transmission and settlement of credit 

15 transactions, electronic fund transfers, or 

16 money transmitting services. 

17 ‘‘(B) PERSONS DESCRIBED.—A person re18 ferred to in subparagraph (A) is— 

19 ‘‘(i) a creditor; 

20 ‘‘(ii) a credit card issuer; 

21 ‘‘(iii) a financial institution; 

22 ‘‘(iv) an operator of a terminal at 

23 which an electronic fund transfer may be 

24 initiated; 


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1 ‘‘(v) a money transmitting business; 

2 or 

3 ‘‘(vi) a participant in an international, 

4 national, regional, or local network used to 

5 effect a credit transaction, electronic fund 

6 transfer, or money transmitting service. 

7 ‘‘(3) RESTRICTED TRANSACTION.—The term 

8 ‘restricted transaction’ means a transaction or trans9 mittal, on behalf of an individual who places an un10 lawful drug importation request to any person en11 gaged in the operation of an unregistered foreign 

12 pharmacy, of— 

13 ‘‘(A) credit, or the proceeds of credit, ex14 tended to or on behalf of the individual for the 

15 purpose of the unlawful drug importation re16 quest (including credit extended through the 

17 use of a credit card); 

18 ‘‘(B) an electronic fund transfer or funds 

19 transmitted by or through a money transmit20 ting business, or the proceeds of an electronic 

21 fund transfer or money transmitting service, 

22 from or on behalf of the individual for the pur23 pose of the unlawful drug importation request; 

24 ‘‘(C) a check, draft, or similar instrument 

25 which is drawn by or on behalf of the individual 


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1 for the purpose of the unlawful drug importa2 tion request and is drawn on or payable at or 

3 through any financial institution; or 

4 ‘‘(D) the proceeds of any other form of fi5 nancial transaction (identified by the Board by 

6 regulation) that involves a financial institution 

7 as a payor or financial intermediary on behalf 

8 of or for the benefit of the individual for the 

9 purpose of the unlawful drug importation re10 quest. 

11 ‘‘(4) UNLAWFUL DRUG IMPORTATION RE12 QUEST.—The term ‘unlawful drug importation re13 quest’ means the request, or transmittal of a re14 quest, made to an unregistered foreign pharmacy for 

15 a prescription drug by mail (including a private car16 rier), facsimile, phone, or electronic mail, or by a 

17 means that involves the use, in whole or in part, of 

18 the Internet. 

19 ‘‘(5) UNREGISTERED FOREIGN PHARMACY.— 

20 The term ‘unregistered foreign pharmacy’ means a 

21 person in a country other than the United States 

22 that is not a registered exporter under section 804. 

23 ‘‘(6) OTHER DEFINITIONS.— 

24 ‘‘(A) CREDIT; CREDITOR; CREDIT CARD.— 

25 The terms ‘credit’, ‘creditor’, and ‘credit card’ 


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1 have the meanings given the terms in section 

2 103 of the Truth in Lending Act (15 U.S.C. 

3 1602). 

4 ‘‘(B) ACCESS DEVICE; ELECTRONIC FUND

5 TRANSFER.—The terms ‘access device’ and 

6 ‘electronic fund transfer’— 

7 ‘‘(i) have the meaning given the term 

8 in section 903 of the Electronic Fund 

9 Transfer Act (15 U.S.C. 1693a); and 

10 ‘‘(ii) the term ‘electronic fund trans11 fer’ also includes any fund transfer covered 

12 under Article 4A of the Uniform Commer13 cial Code, as in effect in any State. 

14 ‘‘(C) FINANCIAL INSTITUTION.—The term 

15 ‘financial institution’— 

16 ‘‘(i) has the meaning given the term 

17 in section 903 of the Electronic Transfer 

18 Fund Act (15 U.S.C. 1693a); and 

19 ‘‘(ii) includes a financial institution 

20 (as defined in section 509 of the Gramm21 Leach-Bliley Act (15 U.S.C. 6809)). 

22 ‘‘(D) MONEY TRANSMITTING BUSINESS; 

23 MONEY TRANSMITTING SERVICE.—The terms 

24 ‘money transmitting business’ and ‘money 

25 transmitting service’ have the meaning given 


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1 the terms in section 5330(d) of title 31, United 

2 States Code. 

3 ‘‘(E) BOARD.—The term ‘Board’ means 

4 the Board of Governors of the Federal Reserve 

5 System. 

6 ‘‘(7) POLICIES AND PROCEDURES REQUIRED TO

7 PREVENT RESTRICTED TRANSACTIONS.— 

8 ‘‘(A) REGULATIONS.—The Board shall 

9 promulgate regulations requiring— 

10 ‘‘(i) an operator of a credit card sys11 tem; 

12 ‘‘(ii) an operator of an international, 

13 national, regional, or local network used to 

14 effect a credit transaction, an electronic 

15 fund transfer, or a money transmitting 

16 service; 

17 ‘‘(iii) an operator of any other pay18 ment system that is centrally managed and 

19 is primarily engaged in the transmission 

20 and settlement of credit transactions, elec21 tronic transfers or money transmitting 

22 services where at least one party to the 

23 transaction or transfer is an individual; 

24 and 


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1 ‘‘(iv) any other person described in 

2 paragraph (2)(B) and specified by the 

3 Board in such regulations, 

4 to establish policies and procedures that are 

5 reasonably designed to prevent the introduction 

6 of a restricted transaction into a payment sys7 tem or the completion of a restricted trans8 action using a payment system 

9 ‘‘(B) REQUIREMENTS FOR POLICIES AND

10 PROCEDURES.—In promulgating regulations 

11 under subparagraph (A), the Board shall— 

12 ‘‘(i) identify types of policies and pro13 cedures, including nonexclusive examples, 

14 that shall be considered to be reasonably 

15 designed to prevent the introduction of re16 stricted transactions into a payment sys17 tem or the completion of restricted trans18 actions using a payment system; and 

19 ‘‘(ii) to the extent practicable, permit 

20 any payment system, or person described 

21 in paragraph (2)(B), as applicable, to 

22 choose among alternative means of pre23 venting the introduction or completion of 

24 restricted transactions. 


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1 ‘‘(C) NO LIABILITY FOR BLOCKING OR RE2 FUSING TO HONOR RESTRICTED TRANS3 ACTION.— 

4 ‘‘(i) IN GENERAL.—A payment sys5 tem, or a person described in paragraph 

6 (2)(B) that is subject to a regulation 

7 issued under this subsection, and any par8 ticipant in such payment system that pre9 vents or otherwise refuses to honor trans10 actions in an effort to implement the poli11 cies and procedures required under this 

12 subsection or to otherwise comply with this 

13 subsection shall not be liable to any party 

14 for such action. 

15 ‘‘(ii) COMPLIANCE.—A person de16 scribed in paragraph (2)(B) meets the re17 quirements of this subsection if the person 

18 relies on and complies with the policies and 

19 procedures of a payment system of which 

20 the person is a member or in which the 

21 person is a participant, and such policies 

22 and procedures of the payment system 

23 comply with the requirements of the regu24 lations promulgated under subparagraph 

25 (A). 


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1 ‘‘(D) ENFORCEMENT.— 

2 ‘‘(i) IN GENERAL.—This section shall 

3 be enforced by the Federal functional regu4 lators and the Federal Trade Commission 

5 under applicable law in the manner pro6 vided in section 505(a) of the Gramm7 Leach-Bliley Act (15 U.S.C. 6805(a)). 

8 ‘‘(ii) FACTORS TO BE CONSIDERED.— 

9 In considering any enforcement action 

10 under this subsection against a payment 

11 system or person described in paragraph 

12 (2)(B), the Federal functional regulators 

13 and the Federal Trade Commission shall 

14 consider the following factors: 

15 ‘‘(I) The extent to which the pay16 ment system or person knowingly per17 mits restricted transactions. 

18 ‘‘(II) The history of the payment 

19 system or person in connection with 

20 permitting restricted transactions. 

21 ‘‘(III) The extent to which the 

22 payment system or person has estab23 lished and is maintaining policies and 

24 procedures in compliance with regula25 tions prescribed under this subsection. 


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1 ‘‘(8) TRANSACTIONS PERMITTED.—A payment 

2 system, or a person described in paragraph (2)(B) 

3 that is subject to a regulation issued under this sub4 section, is authorized to engage in transactions with 

5 foreign pharmacies in connection with investigating 

6 violations or potential violations of any rule or re7 quirement adopted by the payment system or person 

8 in connection with complying with paragraph (7). A 

9 payment system, or such a person, and its agents 

10 and employees shall not be found to be in violation 

11 of, or liable under, any Federal, State or other law 

12 by virtue of engaging in any such transaction. 

13 ‘‘(9) RELATION TO STATE LAWS.—No require14 ment, prohibition, or liability may be imposed on a 

15 payment system, or a person described in paragraph 

16 (2)(B) that is subject to a regulation issued under 

17 this subsection, under the laws of any State with re18 spect to any payment transaction by an individual 

19 because the payment transaction involves a payment 

20 to a foreign pharmacy. 

21 ‘‘(10) TIMING OF REQUIREMENTS.—A payment 

22 system, or a person described in paragraph (2)(B) 

23 that is subject to a regulation issued under this sub24 section, must adopt policies and procedures reason25 ably designed to comply with any regulations reVerDate Nov 24 2008 02:36 Mar 06, 2009 Jkt 079200 PO 00000 Frm 00138 Fmt 6652 Sfmt 6201 E:\BILLS\H1298.IH H1298

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1 quired under paragraph (7) within 60 days after 

2 such regulations are issued in final form.’’. 

3 (b) EFFECTIVE DATE.—The amendment made by 

4 this section shall take effect on the day that is 90 days 

5 after the date of enactment of this Act. 

6 (c) IMPLEMENTATION.—The Board of Governors of 

7 the Federal Reserve System shall promulgate regulations 

8 as required by subsection (h)(7) of section 303 of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 

10 added by subsection (a), not later than 90 days after the 

11 date of enactment of this Act. 

12 SEC. 9. IMPORTATION EXEMPTION UNDER CONTROLLED 

13 SUBSTANCES IMPORT AND EXPORT ACT. 

14 Section 1006(a)(2) of the Controlled Substances Im15 port and Export Act (21 U.S.C. 956(a)(2)) is amended 

16 by striking ‘‘not import the controlled substance into the 

17 United States in an amount that exceeds 50 dosage units 

18 of the controlled substance.’’ and inserting ‘‘import into 

19 the United States not more than 10 dosage units com20 bined of all such controlled substances.’’. 

21 SEC. 10. SEVERABILITY. 

22 If any provision of this Act, an amendment by this 

23 Act, or the application of such provision or amendment 

24 to any person or circumstance is held to be unconstitu25 tional, the remainder of this Act, the amendments made 


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1 by this Act, and the application of the provisions of such 

2 to any person or circumstance shall not affected thereby. 

Æ 


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