II 

112TH CONGRESS 

1ST SESSION S. 319 

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

importation of prescription drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 10, 2011 

Ms. SNOWE (for herself, Ms. STABENOW, Mr. VITTER, Mr. MCCAIN, Ms. 

KLOBUCHAR, Mr. GRASSLEY, Mr. KOHL, Ms. COLLINS, Mr. BROWN of 

Ohio, Mr. KERRY, Mr. SANDERS, Mr. LEVIN, Mrs. SHAHEEN, Mr. 

LEAHY, Mr. JOHNSON of South Dakota, Mr. BINGAMAN, Mrs. 

MCCASKILL, Mr. BEGICH, and Mr. NELSON of Florida) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

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 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 


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

2 to fill their prescriptions than consumers in other 

3 countries; 

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

5 pharmaceuticals in the world, yet American con6 sumers pay the highest prices for brand pharma7 ceuticals in the world; 

8 (3) a prescription drug is neither safe nor effec9 tive to an individual who cannot afford it; 

10 (4) allowing and structuring the importation of 

11 prescription drugs to ensure access to safe and af12 fordable drugs approved by the Food and Drug Ad13 ministration will provide a level of safety to Amer14 ican consumers that they do not currently enjoy; 

15 (5) Americans spend more than 

16 $200,000,000,000 on prescription drugs every year; 

17 (6) the Congressional Budget Office has found 

18 that the cost of prescription drugs are between 35 

19 to 55 percent less in other highly-developed coun20 tries than in the United States; and 

21 (7) promoting competitive market pricing would 

22 both contribute to health care savings and allow 

23 greater access to therapy, improving health and sav24 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), the Secretary 

18 shall immediately suspend the registration. 

19 A suspension under the preceding sentence 

20 is not subject to the provision by the Sec21 retary of prior notice, and the Secretary 

22 shall provide to the registrant an oppor23 tunity for a hearing not later than 10 days 

24 after the date on which the registration is 

25 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.—Fees collected by the 

14 Secretary under paragraphs (1) and (2) shall be 

15 credited to the appropriation account for sala16 ries and expenses of the Food and Drug Ad17 ministration until expended (without fiscal year 

18 limitation), and the Secretary may, in consulta19 tion with the Secretary of Homeland Security 

20 and the Secretary of the Treasury, transfer 

21 some proportion of such fees to the appropria22 tion account for salaries and expenses of the 

23 Bureau of Customs and Border Protection until 

24 expended (without fiscal year limitation). 


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1 ‘‘(B) AVAILABILITY.—Fees collected by the 

2 Secretary under paragraphs (1) and (2) shall be 

3 made available to the Food and Drug Adminis4 tration. 

5 ‘‘(C) SOLE PURPOSE.—Fees collected by 

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

7 only available to the Secretary and, if trans8 ferred, to the Secretary of Homeland Security, 

9 and are for the sole purpose of paying the costs 

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

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

12 the Secretary does not receive payment of a fee as13 sessed under paragraph (1) or (2) within 30 days 

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

15 of the United States Government subject to sub16 chapter II of chapter 37 of title 31, United States 

17 Code. 

18 ‘‘(f) EXPORTER FEES.— 

19 ‘‘(1) REGISTRATION FEE.—A registration con20 dition is that the exporter involved pays to the Sec21 retary a fee of $10,000 due on the date on which 

22 the exporter first submits that registration to the 

23 Secretary under subsection (b). 

24 ‘‘(2) INSPECTION FEE.—A registration condi25 tion is that the exporter involved pays a fee to the 


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1 Secretary in accordance with this subsection. Such 

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

3 1 of each fiscal year in the amount provided for 

4 under paragraph (3). 

5 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

6 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

7 later than 30 days before the start of each fis8 cal year, the Secretary, in consultation with the 

9 Secretary of Homeland Security and the Sec10 retary of the Treasury, shall establish an aggre11 gate total of fees to be collected under para12 graph (2) for exporters for that fiscal year that 

13 is sufficient, and not more than necessary, to 

14 pay the costs for that fiscal year of admin15 istering this section with respect to registered 

16 exporters, including the costs associated with— 

17 ‘‘(i) inspecting the facilities of reg18 istered exporters, and of other entities in 

19 the chain of custody of a qualifying drug 

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

21 ‘‘(ii) developing, implementing, and 

22 operating under such subsection a system 

23 to screen marks on shipments of qualifying 

24 drugs under subsection (a) that indicate 

25 compliance with all registration conditions, 


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1 when such shipments are offered for im2 port into the United States; and 

3 ‘‘(iii) screening such markings, and 

4 inspecting such shipments as necessary, 

5 when offered for import into the United 

6 States to determine if such a shipment 

7 should be refused admission under sub8 section (g)(5). 

9 ‘‘(B) LIMITATION.—Subject to subpara10 graph (C), the aggregate total of fees collected 

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

12 exceed 2.5 percent of the total price of quali13 fying drugs imported during that fiscal year 

14 into the United States by registered exporters 

15 under subsection (a). 

16 ‘‘(C) TOTAL PRICE OF DRUGS.— 

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

18 complying with the limitation described in 

19 subparagraph (B) when establishing under 

20 subparagraph (A) the aggregate total of 

21 fees to be collected under paragraph (2) 

22 for a fiscal year, the Secretary shall esti23 mate the total price of qualifying drugs im24 ported into the United States by registered 

25 exporters during that fiscal year by adding 


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1 the total price of qualifying drugs exported 

2 by each registered exporter during the 6- 

3 month period from January 1 through 

4 June 30 of the previous fiscal year, as re5 ported to the Secretary by each registered 

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

7 ‘‘(ii) CALCULATION.—Not later than 

8 March 1 of the fiscal year that follows the 

9 fiscal year for which the estimate under 

10 clause (i) is made, the Secretary shall cal11 culate the total price of qualifying drugs 

12 imported into the United States by reg13 istered exporters during that fiscal year by 

14 adding the total price of qualifying drugs 

15 exported by each registered exporter dur16 ing that fiscal year, as reported to the Sec17 retary by each registered exporter under 

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

19 ‘‘(iii) ADJUSTMENT.—If the total 

20 price of qualifying drugs imported into the 

21 United States by registered exporters dur22 ing a fiscal year as calculated under clause 

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

24 collected under paragraph (2) for that fis25 cal year, the Secretary shall provide for a 


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1 pro-rata reduction in the fee due from each 

2 registered exporter on April 1 of the subse3 quent fiscal year so that the limitation de4 scribed in subparagraph (B) is observed. 

5 ‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub6 ject to the limitation described in subparagraph 

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

8 October 1 and April 1 by an exporter shall be 

9 an amount that is proportional to a reasonable 

10 estimate by the Secretary of the semiannual 

11 share of the exporter of the volume of quali12 fying drugs exported by exporters under sub13 section (a). 

14 ‘‘(4) USE OF FEES.— 

15 ‘‘(A) IN GENERAL.—Fees collected by the 

16 Secretary under paragraphs (1) and (2) shall be 

17 credited to the appropriation account for sala18 ries and expenses of the Food and Drug Ad19 ministration until expended (without fiscal year 

20 limitation), and the Secretary may, in consulta21 tion with the Secretary of Homeland Security 

22 and the Secretary of the Treasury, transfer 

23 some proportion of such fees to the appropria24 tion account for salaries and expenses of the 


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1 Bureau of Customs and Border Protection until 

2 expended (without fiscal year limitation). 

3 ‘‘(B) AVAILABILITY.—Fees collected by the 

4 Secretary under paragraphs (1) and (2) shall be 

5 made available to the Food and Drug Adminis6 tration. 

7 ‘‘(C) SOLE PURPOSE.—Fees collected by 

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

9 only available to the Secretary and, if trans10 ferred, to the Secretary of Homeland Security, 

11 and are for the sole purpose of paying the costs 

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

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

14 the Secretary does not receive payment of a fee as15 sessed under paragraph (1) or (2) within 30 days 

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

17 of the United States Government subject to sub18 chapter II of chapter 37 of title 31, United States 

19 Code. 

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

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

22 that each qualifying drug exported under subsection 

23 (a) by the registered exporter involved or imported 

24 under subsection (a) by the registered importer in25 volved is in compliance with the standards referred 


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

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

3 (3), and (4). 

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

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

6 is imported or offered for import under sub7 section (a) shall comply with the conditions es8 tablished in the approved application under sec9 tion 505(b) for the U.S. label drug as described 

10 under this subsection. 

11 ‘‘(B) NOTICE BY MANUFACTURER; GEN12 ERAL PROVISIONS.— 

13 ‘‘(i) IN GENERAL.—The person that 

14 manufactures a qualifying drug that is, or 

15 will be, introduced for commercial distribu16 tion in a permitted country shall in accord17 ance with this paragraph submit to the 

18 Secretary a notice that— 

19 ‘‘(I) includes each difference in 

20 the qualifying drug from a condition 

21 established in the approved applica22 tion for the U.S. label drug beyond— 

23 ‘‘(aa) the variations provided 

24 for in the application; and 


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1 ‘‘(bb) any difference in label2 ing (except ingredient labeling); 

3 or 

4 ‘‘(II) states that there is no dif5 ference in the qualifying drug from a 

6 condition established in the approved 

7 application for the U.S. label drug be8 yond— 

9 ‘‘(aa) the variations provided 

10 for in the application; and 

11 ‘‘(bb) any difference in label12 ing (except ingredient labeling). 

13 ‘‘(ii) INFORMATION IN NOTICE.—A 

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

15 information that the Secretary may require 

16 under section 506A, any additional infor17 mation the Secretary may require (which 

18 may include data on bioequivalence if such 

19 data are not required under section 506A), 

20 and, with respect to the permitted country 

21 that approved the qualifying drug for com22 mercial distribution, or with respect to 

23 which such approval is sought, include the 

24 following: 


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1 ‘‘(I) The date on which the quali2 fying drug with such difference was, 

3 or will be, introduced for commercial 

4 distribution in the permitted country. 

5 ‘‘(II) Information demonstrating 

6 that the person submitting the notice 

7 has also notified the government of 

8 the permitted country in writing that 

9 the person is submitting to the Sec10 retary a notice under clause (i)(I), 

11 which notice describes the difference 

12 in the qualifying drug from a condi13 tion established in the approved appli14 cation for the U.S. label drug. 

15 ‘‘(III) The information that the 

16 person submitted or will submit to the 

17 government of the permitted country 

18 for purposes of obtaining approval for 

19 commercial distribution of the drug in 

20 the country which, if in a language 

21 other than English, shall be accom22 panied by an English translation 

23 verified to be complete and accurate, 

24 with the name, address, and a brief 


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1 statement of the qualifications of the 

2 person that made the translation. 

3 ‘‘(iii) CERTIFICATIONS.—The chief ex4 ecutive officer and the chief medical officer 

5 of the manufacturer involved shall each 

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

7 ‘‘(I) the information provided in 

8 the notice is complete and true; and 

9 ‘‘(II) a copy of the notice has 

10 been provided to the Federal Trade 

11 Commission and to the State attor12 neys general. 

13 ‘‘(iv) FEE.— 

14 ‘‘(I) IN GENERAL.—If a notice 

15 submitted under clause (i) includes a 

16 difference that would, under section 

17 506A, require the submission of a 

18 supplemental application if made as a 

19 change to the U.S. label drug, the 

20 person that submits the notice shall 

21 pay to the Secretary a fee in the same 

22 amount as would apply if the person 

23 were paying a fee pursuant to section 

24 736(a)(1)(A)(ii). Fees collected by the 

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1 tence are available only to the Sec2 retary and are for the sole purpose of 

3 paying the costs of reviewing notices 

4 submitted under clause (i). 

5 ‘‘(II) FEE AMOUNT FOR CERTAIN

6 YEARS.—If no fee amount is in effect 

7 under section 736(a)(1)(A)(ii) for a 

8 fiscal year, then the amount paid by a 

9 person under subclause (I) shall— 

10 ‘‘(aa) for the first fiscal year 

11 in which no fee amount under 

12 such section in effect, be equal to 

13 the fee amount under section 

14 736(a)(1)(A)(ii) for the most re15 cent fiscal year for which such 

16 section was in effect, adjusted in 

17 accordance with section 736(c); 

18 and 

19 ‘‘(bb) for each subsequent 

20 fiscal year in which no fee 

21 amount under such section is ef22 fect, be equal to the applicable 

23 fee amount for the previous fiscal 

24 year, adjusted in accordance with 

25 section 736(c). 


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1 ‘‘(v) TIMING OF SUBMISSION OF NO2 TICES.— 

3 ‘‘(I) PRIOR APPROVAL NO4 TICES.—A notice under clause (i) to 

5 which subparagraph (C) applies shall 

6 be submitted to the Secretary not 

7 later than 120 days before the quali8 fying drug with the difference is intro9 duced for commercial distribution in a 

10 permitted country, unless the country 

11 requires that distribution of the quali12 fying drug with the difference begin 

13 less than 120 days after the country 

14 requires the difference. 

15 ‘‘(II) OTHER APPROVAL NO16 TICES.—A notice under clause (i) to 

17 which subparagraph (D) applies shall 

18 be submitted to the Secretary not 

19 later than the day on which the quali20 fying drug with the difference is intro21 duced for commercial distribution in a 

22 permitted country. 

23 ‘‘(III) OTHER NOTICES.—A no24 tice under clause (i) to which subpara25 graph (E) applies shall be submitted 


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1 to the Secretary on the date that the 

2 qualifying drug is first introduced for 

3 commercial distribution in a permitted 

4 country and annually thereafter. 

5 ‘‘(vi) REVIEW BY SECRETARY.— 

6 ‘‘(I) IN GENERAL.—In this para7 graph, the difference in a qualifying 

8 drug that is submitted in a notice 

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

10 drug shall be treated by the Secretary 

11 as if it were a manufacturing change 

12 to the U.S. label drug under section 

13 506A. 

14 ‘‘(II) STANDARD OF REVIEW.— 

15 Except as provided in subclause (III), 

16 the Secretary shall review and approve 

17 or disapprove the difference in a no18 tice submitted under clause (i), if re19 quired under section 506A, using the 

20 safe and effective standard for ap21 proving or disapproving a manufac22 turing change under section 506A. 

23 ‘‘(III) BIOEQUIVALENCE.—If the 

24 Secretary would approve the dif25 ference in a notice submitted under 


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1 clause (i) using the safe and effective 

2 standard under section 506A and if 

3 the Secretary determines that the 

4 qualifying drug is not bioequivalent to 

5 the U.S. label drug, the Secretary 

6 shall— 

7 ‘‘(aa) include in the labeling 

8 provided under paragraph (3) a 

9 prominent advisory that the 

10 qualifying drug is safe and effec11 tive but is not bioequivalent to 

12 the U.S. label drug if the Sec13 retary determines that such an 

14 advisory is necessary for health 

15 care practitioners and patients to 

16 use the qualifying drug safely 

17 and effectively; or 

18 ‘‘(bb) decline to approve the 

19 difference if the Secretary deter20 mines that the availability of 

21 both the qualifying drug and the 

22 U.S. label drug would pose a 

23 threat to the public health. 

24 ‘‘(IV) REVIEW BY THE SEC25 RETARY.—The Secretary shall review 


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1 and approve or disapprove the dif2 ference in a notice submitted under 

3 clause (i), if required under section 

4 506A, not later than 120 days after 

5 the date on which the notice is sub6 mitted. 

7 ‘‘(V) ESTABLISHMENT INSPEC8 TION.—If review of such difference 

9 would require an inspection of the es10 tablishment in which the qualifying 

11 drug is manufactured— 

12 ‘‘(aa) such inspection by the 

13 Secretary shall be authorized; 

14 and 

15 ‘‘(bb) the Secretary may rely 

16 on a satisfactory report of a good 

17 manufacturing practice inspec18 tion of the establishment from a 

19 permitted country whose regu20 latory system the Secretary rec21 ognizes as equivalent under a 

22 mutual recognition agreement, as 

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

24 section 803, or part 26 of title 

25 21, Code of Federal Regulations 


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1 (or any corresponding successor 

2 rule or regulation). 

3 ‘‘(vii) PUBLICATION OF INFORMATION

4 ON NOTICES.— 

5 ‘‘(I) IN GENERAL.—Through the 

6 Internet website of the Food and 

7 Drug Administration and a toll-free 

8 telephone number, the Secretary shall 

9 readily make available to the public a 

10 list of notices submitted under clause 

11 (i). 

12 ‘‘(II) CONTENTS.—The list under 

13 subclause (I) shall include the date on 

14 which a notice is submitted and 

15 whether— 

16 ‘‘(aa) a notice is under re17 view; 

18 ‘‘(bb) the Secretary has or19 dered that importation of the 

20 qualifying drug from a permitted 

21 country cease; or 

22 ‘‘(cc) the importation of the 

23 drug is permitted under sub24 section (a). 


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1 ‘‘(III) UPDATE.—The Secretary 

2 shall promptly update the Internet 

3 website with any changes to the list. 

4 ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR5 ING PRIOR APPROVAL.—In the case of a notice 

6 under subparagraph (B)(i) that includes a dif7 ference that would, under subsection (c) or 

8 (d)(3)(B)(i) of section 506A, require the ap9 proval of a supplemental application before the 

10 difference could be made to the U.S. label drug 

11 the following shall occur: 

12 ‘‘(i) Promptly after the notice is sub13 mitted, the Secretary shall notify reg14 istered exporters, registered importers, the 

15 Federal Trade Commission, and the State 

16 attorneys general that the notice has been 

17 submitted with respect to the qualifying 

18 drug involved. 

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

20 determination whether such a supple21 mental application regarding the U.S. label 

22 drug would be approved or disapproved by 

23 the date on which the qualifying drug in24 volved is to be introduced for commercial 


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1 distribution in a permitted country, the 

2 Secretary shall— 

3 ‘‘(I) order that the importation of 

4 the qualifying drug involved from the 

5 permitted country not begin until the 

6 Secretary completes review of the no7 tice; and 

8 ‘‘(II) promptly notify registered 

9 exporters, registered importers, the 

10 Federal Trade Commission, and the 

11 State attorneys general of the order. 

12 ‘‘(iii) If the Secretary determines that 

13 such a supplemental application regarding 

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

15 the Secretary shall— 

16 ‘‘(I) order that the importation of 

17 the qualifying drug involved from the 

18 permitted country cease, or provide 

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

20 remains in effect; 

21 ‘‘(II) notify the permitted coun22 try that approved the qualifying drug 

23 for commercial distribution of the de24 termination; and 


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1 ‘‘(III) promptly notify registered 

2 exporters, registered importers, the 

3 Federal Trade Commission, and the 

4 State attorneys general of the deter5 mination. 

6 ‘‘(iv) If the Secretary determines that 

7 such a supplemental application regarding 

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

9 Secretary shall— 

10 ‘‘(I) vacate the order under 

11 clause (ii), if any; 

12 ‘‘(II) consider the difference to 

13 be a variation provided for in the ap14 proved application for the U.S. label 

15 drug; 

16 ‘‘(III) permit importation of the 

17 qualifying drug under subsection (a); 

18 and 

19 ‘‘(IV) promptly notify registered 

20 exporters, registered importers, the 

21 Federal Trade Commission, and the 

22 State attorneys general of the deter23 mination. 

24 ‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE25 QUIRING PRIOR APPROVAL.—In the case of a 


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

2 a difference that would, under section 

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

4 supplemental application before the difference 

5 could be made to the U.S. label drug the fol6 lowing shall occur: 

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

8 notice is being reviewed by the Secretary, 

9 the authority under this subsection to im10 port the qualifying drug involved continues 

11 in effect. 

12 ‘‘(ii) If the Secretary determines that 

13 such a supplemental application regarding 

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

15 the Secretary shall— 

16 ‘‘(I) order that the importation of 

17 the qualifying drug involved from the 

18 permitted country cease; 

19 ‘‘(II) notify the permitted coun20 try that approved the qualifying drug 

21 for commercial distribution of the de22 termination; and 

23 ‘‘(III) promptly notify registered 

24 exporters, registered importers, the 

25 Federal Trade Commission, and the 


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1 State attorneys general of the deter2 mination. 

3 ‘‘(iii) If the Secretary determines that 

4 such a supplemental application regarding 

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

6 difference shall be considered to be a vari7 ation provided for in the approved applica8 tion for the U.S. label drug. 

9 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE10 QUIRING APPROVAL; NO DIFFERENCE.—In the 

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

12 includes a difference for which, under section 

13 506A(d)(1)(A), a supplemental application 

14 would not be required for the difference to be 

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

16 there is no difference, the Secretary— 

17 ‘‘(i) shall consider such difference to 

18 be a variation provided for in the approved 

19 application for the U.S. label drug; 

20 ‘‘(ii) may not order that the importa21 tion of the qualifying drug involved cease; 

22 and 

23 ‘‘(iii) shall promptly notify registered 

24 exporters and registered importers. 


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1 ‘‘(F) DIFFERENCES IN ACTIVE INGRE2 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

3 FORM, OR STRENGTH.— 

4 ‘‘(i) IN GENERAL.—A person who 

5 manufactures a drug approved under sec6 tion 505(b) shall submit an application 

7 under section 505(b) for approval of an8 other drug that is manufactured for dis9 tribution in a permitted country by or for 

10 the person that manufactures the drug ap11 proved under section 505(b) if— 

12 ‘‘(I) there is no qualifying drug 

13 in commercial distribution in per14 mitted countries whose combined pop15 ulation represents at least 50 percent 

16 of the total population of all permitted 

17 countries with the same active ingre18 dient or ingredients, route of adminis19 tration, dosage form, and strength as 

20 the drug approved under section 

21 505(b); and 

22 ‘‘(II) each active ingredient of 

23 the other drug is related to an active 

24 ingredient of the drug approved under 


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1 section 505(b), as defined in clause 

2 (v). 

3 ‘‘(ii) APPLICATION UNDER SECTION

4 505(b).—The application under section 

5 505(b) required under clause (i) shall— 

6 ‘‘(I) request approval of the other 

7 drug for the indication or indications 

8 for which the drug approved under 

9 section 505(b) is labeled; 

10 ‘‘(II) include the information that 

11 the person submitted to the govern12 ment of the permitted country for 

13 purposes of obtaining approval for 

14 commercial distribution of the other 

15 drug in that country, which if in a 

16 language other than English, shall be 

17 accompanied by an English trans18 lation verified to be complete and ac19 curate, with the name, address, and a 

20 brief statement of the qualifications of 

21 the person that made the translation; 

22 ‘‘(III) include a right of reference 

23 to the application for the drug ap24 proved under section 505(b); and 


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1 ‘‘(IV) include such additional in2 formation as the Secretary may re3 quire. 

4 ‘‘(iii) TIMING OF SUBMISSION OF AP5 PLICATION.—An application under section 

6 505(b) required under clause (i) shall be 

7 submitted to the Secretary not later than 

8 the day on which the information referred 

9 to in clause (ii)(II) is submitted to the gov10 ernment of the permitted country. 

11 ‘‘(iv) NOTICE OF DECISION ON APPLI12 CATION.—The Secretary shall promptly no13 tify registered exporters, registered import14 ers, the Federal Trade Commission, and 

15 the State attorneys general of a determina16 tion to approve or to disapprove an appli17 cation under section 505(b) required under 

18 clause (i). 

19 ‘‘(v) RELATED ACTIVE INGREDI20 ENTS.—For purposes of clause (i)(II), 2 

21 active ingredients are related if they are— 

22 ‘‘(I) the same; or 

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

24 complexes of the same moiety. 

25 ‘‘(3) SECTION 502; LABELING.— 


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1 ‘‘(A) IMPORTATION BY REGISTERED IM2 PORTER.— 

3 ‘‘(i) IN GENERAL.—In the case of a 

4 qualifying drug that is imported or offered 

5 for import by a registered importer, such 

6 drug shall be considered to be in compli7 ance with section 502 and the labeling re8 quirements under the approved application 

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

10 drug bears— 

11 ‘‘(I) a copy of the labeling ap12 proved for the U.S. label drug under 

13 section 505, without regard to wheth14 er the copy bears any trademark in15 volved; 

16 ‘‘(II) the name of the manufac17 turer and location of the manufac18 turer; 

19 ‘‘(III) the lot number assigned by 

20 the manufacturer; 

21 ‘‘(IV) the name, location, and 

22 registration number of the importer; 

23 and 


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1 ‘‘(V) the National Drug Code 

2 number assigned to the qualifying 

3 drug by the Secretary. 

4 ‘‘(ii) REQUEST FOR COPY OF THE LA5 BELING.—The Secretary shall provide such 

6 copy to the registered importer involved, 

7 upon request of the importer. 

8 ‘‘(iii) REQUESTED LABELING.—The 

9 labeling provided by the Secretary under 

10 clause (ii) shall— 

11 ‘‘(I) include the established 

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

13 for each active ingredient in the quali14 fying drug; 

15 ‘‘(II) not include the proprietary 

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

17 active ingredient thereof; 

18 ‘‘(III) if required under para19 graph (2)(B)(vi)(III), a prominent ad20 visory that the qualifying drug is safe 

21 and effective but not bioequivalent to 

22 the U.S. label drug; and 

23 ‘‘(IV) if the inactive ingredients 

24 of the qualifying drug are different 


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1 from the inactive ingredients for the 

2 U.S. label drug, include— 

3 ‘‘(aa) a prominent notice 

4 that the ingredients of the quali5 fying drug differ from the ingre6 dients of the U.S. label drug and 

7 that the qualifying drug must be 

8 dispensed with an advisory to 

9 people with allergies about this 

10 difference and a list of ingredi11 ents; and 

12 ‘‘(bb) a list of the ingredi13 ents of the qualifying drug as 

14 would be required under section 

15 502(e). 

16 ‘‘(B) IMPORTATION BY INDIVIDUAL.— 

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

18 qualifying drug that is imported or offered 

19 for import by a registered exporter to an 

20 individual, such drug shall be considered to 

21 be in compliance with section 502 and the 

22 labeling requirements under the approved 

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

24 packaging and labeling of the qualifying 

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1 tions promulgated under sections 3 and 4 

2 of the Poison Prevention Packaging Act of 

3 1970 (15 U.S.C. 1471 et seq.) and the la4 beling of the qualifying drug includes— 

5 ‘‘(I) directions for use by the 

6 consumer; 

7 ‘‘(II) the lot number assigned by 

8 the manufacturer; 

9 ‘‘(III) the name and registration 

10 number of the exporter; 

11 ‘‘(IV) if required under para12 graph (2)(B)(vi)(III), a prominent ad13 visory that the drug is safe and effec14 tive but not bioequivalent to the U.S. 

15 label drug; 

16 ‘‘(V) if the inactive ingredients of 

17 the drug are different from the inac18 tive ingredients for the U.S. label 

19 drug— 

20 ‘‘(aa) a prominent advisory 

21 that persons with an allergy 

22 should check the ingredient list 

23 of the drug because the ingredi24 ents of the drug differ from the 


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1 ingredients of the U.S. label 

2 drug; and 

3 ‘‘(bb) a list of the ingredi4 ents of the drug as would be re5 quired under section 502(e); and 

6 ‘‘(VI) a copy of any special label7 ing that would be required by the Sec8 retary had the U.S. label drug been 

9 dispensed by a pharmacist in the 

10 United States, without regard to 

11 whether the special labeling bears any 

12 trademark involved. 

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

14 offered for import to an individual by an 

15 exporter under this section that is pack16 aged in a unit-of-use container (as those 

17 items are defined in the United States 

18 Pharmacopeia and National Formulary) 

19 shall not be repackaged, provided that— 

20 ‘‘(I) the packaging complies with 

21 all applicable regulations under sec22 tions 3 and 4 of the Poison Preven23 tion Packaging Act of 1970 (15 

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


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1 ‘‘(II) the consumer consents to 

2 waive the requirements of such Act, 

3 after being informed that the pack4 aging does not comply with such Act 

5 and that the exporter will provide the 

6 drug in packaging that is compliant at 

7 no additional cost. 

8 ‘‘(iii) REQUEST FOR COPY OF SPECIAL

9 LABELING AND INGREDIENT LIST.—The 

10 Secretary shall provide to the registered 

11 exporter involved a copy of the special la12 beling, the advisory, and the ingredient list 

13 described under clause (i), upon request of 

14 the exporter. 

15 ‘‘(iv) REQUESTED LABELING AND IN16 GREDIENT LIST.—The labeling and ingre17 dient list provided by the Secretary under 

18 clause (iii) shall— 

19 ‘‘(I) include the established 

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

21 for each active ingredient in the drug; 

22 and 

23 ‘‘(II) not include the proprietary 

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

25 active ingredient thereof. 


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1 ‘‘(4) SECTION 501; ADULTERATION.—A quali2 fying drug that is imported or offered for import 

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

4 compliance with section 501 if the drug is in compli5 ance with subsection (c). 

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

7 A drug exported under subsection (a) from a reg8 istered exporter or imported by a registered importer 

9 may be refused admission into the United States if 

10 1 or more of the following applies: 

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

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

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

14 Secretary. 

15 ‘‘(C) The Secretary has ordered that im16 portation of the drug from the permitted coun17 try cease under subparagraph (C) or (D) of 

18 paragraph (2). 

19 ‘‘(D) The drug does not comply with para20 graph (3) or (4). 

21 ‘‘(E) The shipping container appears dam22 aged in a way that may affect the strength, 

23 quality, or purity of the drug. 

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

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


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1 ‘‘(ii) the drug may have been pre2 pared, packed, or held under insanitary 

3 conditions; or 

4 ‘‘(iii) the methods used in, or the fa5 cilities or controls used for, the manufac6 turing, processing, packing, or holding of 

7 the drug do not conform to good manufac8 turing practice. 

9 ‘‘(G) The Secretary has obtained an in10 junction under section 302 that prohibits the 

11 distribution of the drug in interstate commerce. 

12 ‘‘(H) The Secretary has under section 

13 505(e) withdrawn approval of the drug. 

14 ‘‘(I) The manufacturer of the drug has in15 stituted a recall of the drug. 

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

17 import by a registered importer without submis18 sion of a notice in accordance with subsection 

19 (d)(4). 

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

21 import from a registered exporter to an indi22 vidual and 1 or more of the following applies: 

23 ‘‘(i) The shipping container for such 

24 drug does not bear the markings required 

25 under subsection (d)(2). 


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1 ‘‘(ii) The markings on the shipping 

2 container appear to be counterfeit. 

3 ‘‘(iii) The shipping container or mark4 ings appear to have been tampered with. 

5 ‘‘(h) EXPORTER LICENSURE IN PERMITTED COUN6 TRY.—A registration condition is that the exporter in7 volved agrees that a qualifying drug will be exported to 

8 an individual only if the Secretary has verified that— 

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

10 the permitted country in which the exporter is lo11 cated to dispense prescription drugs; and 

12 ‘‘(2) the exporter employs persons that are li13 censed under the law of the permitted country in 

14 which the exporter is located to dispense prescription 

15 drugs in sufficient number to dispense safely the 

16 drugs exported by the exporter to individuals, and 

17 the exporter assigns to those persons responsibility 

18 for dispensing such drugs to individuals. 

19 ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTA20 TION.— 

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

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

23 an individual is in accordance with this subsection if 

24 the following conditions are met: 


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

2 a prescription for the drug, which prescrip3 tion— 

4 ‘‘(i) is valid under applicable Federal 

5 and State laws; and 

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

7 under the law of a State of which the indi8 vidual is a resident, or in which the indi9 vidual receives care from the practitioner 

10 who issues the prescription, is authorized 

11 to administer prescription drugs. 

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

13 of the documentation that was required under 

14 the law or regulations of the permitted country 

15 in which the exporter is located, as a condition 

16 of dispensing the drug to the individual. 

17 ‘‘(C) The copies referred to in subpara18 graphs (A)(i) and (B) are marked in a manner 

19 sufficient— 

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

21 and the equivalent document in the per22 mitted country in which the exporter is lo23 cated, have been filled; and 

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

25 another pharmacist. 


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

2 registered exporter a complete list of all drugs 

3 used by the individual for review by the individ4 uals who dispense the drug. 

5 ‘‘(E) The quantity of the drug does not ex6 ceed a 90-day supply. 

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

8 H drug. For purposes of this section, a pre9 scription drug is an ‘ineligible subpart H drug’ 

10 if the drug was approved by the Secretary 

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

12 of Federal Regulations (relating to accelerated 

13 approval), with restrictions under section 520 of 

14 such part to assure safe use, and the Secretary 

15 has published in the Federal Register a notice 

16 that the Secretary has determined that good 

17 cause exists to prohibit the drug from being im18 ported pursuant to this subsection. 

19 ‘‘(2) NOTICE REGARDING DRUG REFUSED AD20 MISSION.—If a registered exporter ships a drug to 

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

22 the drug is refused admission to the United States, 

23 a written notice shall be sent to the individual and 

24 to the exporter that informs the individual and the 


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1 exporter of such refusal and the reason for the re2 fusal. 

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

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

5 that the importer or exporter involved shall— 

6 ‘‘(A) maintain records required under this 

7 section for not less than 2 years; and 

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

9 qualifying drug required under this section for 

10 not more than 2 years. 

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

12 records described under paragraph (1) shall be 

13 maintained— 

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

15 place of business of the importer at which the 

16 importer initially receives the qualifying drug 

17 after importation; or 

18 ‘‘(B) in the case of an exporter, at the fa19 cility from which the exporter ships the quali20 fying drug to the United States. 

21 ‘‘(k) DRUG RECALLS.— 

22 ‘‘(1) MANUFACTURERS.—A person that manu23 factures a qualifying drug imported from a per24 mitted country under this section shall promptly in25 form the Secretary— 


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

2 from the market in a permitted country; 

3 ‘‘(B) how the drug may be identified, in4 cluding lot number; and 

5 ‘‘(C) the reason for the recall or with6 drawal. 

7 ‘‘(2) SECRETARY.—With respect to each per8 mitted country, the Secretary shall— 

9 ‘‘(A) enter into an agreement with the gov10 ernment of the country to receive information 

11 about recalls and withdrawals of qualifying 

12 drugs in the country; or 

13 ‘‘(B) monitor recalls and withdrawals of 

14 qualifying drugs in the country using any infor15 mation that is available to the public in any 

16 media. 

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

18 appropriate, registered exporters, registered import19 ers, wholesalers, pharmacies, or the public of a recall 

20 or withdrawal of a qualifying drug in a permitted 

21 country. 

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

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

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1 macist to an individual, the pharmacist shall provide 

2 that the packaging and labeling of the drug complies 

3 with all applicable regulations promulgated under 

4 sections 3 and 4 of the Poison Prevention Packaging 

5 Act of 1970 (15 U.S.C. 1471 et seq.) and shall in6 clude with any other labeling provided to the indi7 vidual the following: 

8 ‘‘(A) The lot number assigned by the man9 ufacturer. 

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

11 the importer. 

12 ‘‘(C) If required under paragraph 

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

14 advisory that the drug is safe and effective but 

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

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

17 are different from the inactive ingredients for 

18 the U.S. label drug— 

19 ‘‘(i) a prominent advisory that persons 

20 with allergies should check the ingredient 

21 list of the drug because the ingredients of 

22 the drug differ from the ingredients of the 

23 U.S. label drug; and 


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

2 drug as would be required under section 

3 502(e). 

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

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

6 are defined in the United States Pharmacopeia and 

7 National Formulary) shall not be repackaged, pro8 vided that— 

9 ‘‘(A) the packaging complies with all appli10 cable regulations under sections 3 and 4 of the 

11 Poison Prevention Packaging Act of 1970 (15 

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

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

14 requirements of such Act, after being informed 

15 that the packaging does not comply with such 

16 Act and that the pharmacist will provide the 

17 drug in packaging that is compliant at no addi18 tional cost. 

19 ‘‘(m) CHARITABLE CONTRIBUTIONS.—Notwith20 standing any other provision of this section, this section 

21 does not authorize the importation into the United States 

22 of a qualifying drug donated or otherwise supplied for free 

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

24 a charitable or humanitarian organization, including the 


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1 United Nations and affiliates, or to a government of a for2 eign country. 

3 ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC4 TICES.— 

5 ‘‘(1) IN GENERAL.—It is unlawful for a manu6 facturer, directly or indirectly (including by being a 

7 party to a licensing agreement or other agreement), 

8 to— 

9 ‘‘(A) discriminate by charging a higher 

10 price for a prescription drug sold to a registered 

11 exporter or other person in a permitted country 

12 that exports a qualifying drug to the United 

13 States under this section than the price that is 

14 charged, inclusive of rebates or other incentives 

15 to the permitted country or other person, to an16 other person that is in the same country and 

17 that does not export a qualifying drug into the 

18 United States under this section; 

19 ‘‘(B) discriminate by charging a higher 

20 price for a prescription drug sold to a registered 

21 importer or other person that distributes, sells, 

22 or uses a qualifying drug imported into the 

23 United States under this section than the price 

24 that is charged to another person in the United 

25 States that does not import a qualifying drug 


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1 under this section, or that does not distribute, 

2 sell, or use such a drug; 

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

4 or delaying supplies of a prescription drug to a 

5 registered exporter or other person in a per6 mitted country that exports a qualifying drug to 

7 the United States under this section or to a 

8 registered importer or other person that distrib9 utes, sells, or uses a qualifying drug imported 

10 into the United States under this section; 

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

12 otherwise refusing to do business with a reg13 istered exporter or other person in a permitted 

14 country that exports a qualifying drug to the 

15 United States under this section or with a reg16 istered importer or other person that distrib17 utes, sells, or uses a qualifying drug imported 

18 into the United States under this section; 

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

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

21 submit such a notice on or before the date spec22 ified in subsection (g)(2)(B)(v) or as otherwise 

23 required under paragraphs (3), (4), and (5) of 

24 section 4(e) of the Pharmaceutical Market Ac25 cess and Drug Safety Act of 2011, knowingly 


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1 submit such a notice that makes a materially 

2 false, fictitious, or fraudulent statement, or 

3 knowingly fail to provide promptly any informa4 tion requested by the Secretary to review such 

5 a notice; 

6 ‘‘(F) knowingly fail to submit an applica7 tion required under subsection (g)(2)(F), know8 ingly fail to submit such an application on or 

9 before the date specified in subsection 

10 (g)(2)(F)(iii), knowingly submit such an appli11 cation that makes a materially false, fictitious, 

12 or fraudulent statement, or knowingly fail to 

13 provide promptly any information requested by 

14 the Secretary to review such an application; 

15 ‘‘(G) cause there to be a difference (includ16 ing a difference in active ingredient, route of 

17 administration, dosage form, strength, formula18 tion, manufacturing establishment, manufac19 turing process, or person that manufactures the 

20 drug) between a prescription drug for distribu21 tion in the United States and the drug for dis22 tribution in a permitted country; 

23 ‘‘(H) refuse to allow an inspection author24 ized under this section of an establishment that 

25 manufactures a qualifying drug that is, or will 


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1 be, introduced for commercial distribution in a 

2 permitted country; 

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

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

5 processing, packing, or holding of a qualifying 

6 drug that is, or will be, introduced for commer7 cial distribution in a permitted country to good 

8 manufacturing practice under this Act; 

9 ‘‘(J) become a party to a licensing agree10 ment or other agreement related to a qualifying 

11 drug that fails to provide for compliance with 

12 all requirements of this section with respect to 

13 such drug; 

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

15 prohibits, or delays the importation of a quali16 fying drug under this section; 

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

18 prohibit, or delay the importation of a quali19 fying drug under this section; or 

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

21 Federal Trade Commission determines to dis22 criminate against a person that engages or at23 tempts to engage in the importation of a quali24 fying drug under this section. 


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

2 The Secretary shall promptly refer to the Federal 

3 Trade Commission each potential violation of sub4 paragraph (E), (F), (G), (H), or (I) of paragraph 

5 (1) that becomes known to the Secretary. 

6 ‘‘(3) AFFIRMATIVE DEFENSE.— 

7 ‘‘(A) DISCRIMINATION.—It shall be an af8 firmative defense to a charge that a manufac9 turer has discriminated under subparagraph 

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

11 the higher price charged for a prescription drug 

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

13 of supplies of a prescription drug to a person, 

14 the refusal to do business with a person, or 

15 other discriminatory activity against a person, 

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

17 ‘‘(i) the person exporting or importing 

18 a qualifying drug into the United States 

19 under this section; or 

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

21 or using a qualifying drug imported into 

22 the United States under this section. 

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

24 affirmative defense to a charge that a manufac25 turer has caused there to be a difference deVerDate Mar 15 2010 01:16 Feb 12, 2011 Jkt 099200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\S319.IS S319

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1 scribed in subparagraph (G) of paragraph (1) 

2 that— 

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

4 country in which the drug is distributed; 

5 ‘‘(ii) the Secretary has determined 

6 that the difference was necessary to im7 prove the safety or effectiveness of the 

8 drug; 

9 ‘‘(iii) the person manufacturing the 

10 drug for distribution in the United States 

11 has given notice to the Secretary under 

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

13 distribution in the United States is not dif14 ferent from a drug for distribution in per15 mitted countries whose combined popu16 lation represents at least 50 percent of the 

17 total population of all permitted countries; 

18 or 

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

20 whole or in part, for the purpose of re21 stricting importation of the drug into the 

22 United States under this section. 

23 ‘‘(4) EFFECT OF SUBSECTION.— 

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

25 subsection applies only to the sale or distribuVerDate Mar 15 2010 01:16 Feb 12, 2011 Jkt 099200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\S319.IS S319

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1 tion of a prescription drug in a country if the 

2 manufacturer of the drug chooses to sell or dis3 tribute the drug in the country. Nothing in this 

4 subsection shall be construed to compel the 

5 manufacturer of a drug to distribute or sell the 

6 drug in a country. 

7 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

8 PLANS, PHARMACY BENEFIT MANAGERS, AND

9 COVERED ENTITIES.—Nothing in this sub10 section shall be construed to— 

11 ‘‘(i) prevent or restrict a manufac12 turer of a prescription drug from providing 

13 discounts to an insurer, health plan, phar14 macy benefit manager in the United 

15 States, or covered entity in the drug dis16 count program under section 340B of the 

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

18 256b) in return for inclusion of the drug 

19 on a formulary; 

20 ‘‘(ii) require that such discounts be 

21 made available to other purchasers of the 

22 prescription drug; or 

23 ‘‘(iii) prevent or restrict any other 

24 measures taken by an insurer, health plan, 


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1 or pharmacy benefit manager to encourage 

2 consumption of such prescription drug. 

3 ‘‘(C) CHARITABLE CONTRIBUTIONS.— 

4 Nothing in this subsection shall be construed 

5 to— 

6 ‘‘(i) prevent a manufacturer from do7 nating a prescription drug, or supplying a 

8 prescription drug at nominal cost, to a 

9 charitable or humanitarian organization, 

10 including the United Nations and affili11 ates, or to a government of a foreign coun12 try; or 

13 ‘‘(ii) apply to such donations or sup14 plying of a prescription drug. 

15 ‘‘(5) ENFORCEMENT.— 

16 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC17 TICE.—A violation of this subsection shall be 

18 treated as a violation of a rule defining an un19 fair or deceptive act or practice prescribed 

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

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

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

23 Federal Trade Commission— 

24 ‘‘(i) shall enforce this subsection in 

25 the same manner, by the same means, and 


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1 with the same jurisdiction, powers, and du2 ties as though all applicable terms and pro3 visions of the Federal Trade Commission 

4 Act (15 U.S.C. 41 et seq.) were incor5 porated into and made a part of this sec6 tion; and 

7 ‘‘(ii) may seek monetary relief three8 fold the damages sustained, in addition to 

9 any other remedy available to the Federal 

10 Trade Commission under the Federal 

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

12 seq.). 

13 ‘‘(6) ACTIONS BY STATES.— 

14 ‘‘(A) IN GENERAL.— 

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

16 which the attorney general of a State has 

17 reason to believe that an interest of the 

18 residents of that State have been adversely 

19 affected by any manufacturer that violates 

20 paragraph (1), the attorney general of a 

21 State may bring a civil action on behalf of 

22 the residents of the State, and persons 

23 doing business in the State, in a district 

24 court of the United States of appropriate 

25 jurisdiction to— 


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1 ‘‘(I) enjoin that practice; 

2 ‘‘(II) enforce compliance with 

3 this subsection; 

4 ‘‘(III) obtain damages, restitu5 tion, or other compensation on behalf 

6 of residents of the State and persons 

7 doing business in the State, including 

8 threefold the damages; or 

9 ‘‘(IV) obtain such other relief as 

10 the court may consider to be appro11 priate. 

12 ‘‘(ii) NOTICE.— 

13 ‘‘(I) IN GENERAL.—Before filing 

14 an action under clause (i), the attor15 ney general of the State involved shall 

16 provide to the Federal Trade Commis17 sion— 

18 ‘‘(aa) written notice of that 

19 action; and 

20 ‘‘(bb) a copy of the com21 plaint for that action. 

22 ‘‘(II) EXEMPTION.—Subclause 

23 (I) shall not apply with respect to the 

24 filing of an action by an attorney gen25 eral of a State under this paragraph, 


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1 if the attorney general determines 

2 that it is not feasible to provide the 

3 notice described in that subclause be4 fore filing of the action. In such case, 

5 the attorney general of a State shall 

6 provide notice and a copy of the com7 plaint to the Federal Trade Commis8 sion at the same time as the attorney 

9 general files the action. 

10 ‘‘(B) INTERVENTION.— 

11 ‘‘(i) IN GENERAL.—On receiving no12 tice under subparagraph (A)(ii), the Fed13 eral Trade Commission shall have the right 

14 to intervene in the action that is the sub15 ject of the notice. 

16 ‘‘(ii) EFFECT OF INTERVENTION.—If 

17 the Federal Trade Commission intervenes 

18 in an action under subparagraph (A), it 

19 shall have the right— 

20 ‘‘(I) to be heard with respect to 

21 any matter that arises in that action; 

22 and 

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

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

25 bringing any civil action under subparagraph 


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1 (A), nothing in this subsection shall be con2 strued to prevent an attorney general of a State 

3 from exercising the powers conferred on the at4 torney general by the laws of that State to— 

5 ‘‘(i) conduct investigations; 

6 ‘‘(ii) administer oaths or affirmations; 

7 or 

8 ‘‘(iii) compel the attendance of wit9 nesses or the production of documentary 

10 and other evidence. 

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

12 any case in which an action is instituted by or 

13 on behalf of the Federal Trade Commission for 

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

15 during the pendency of that action, institute an 

16 action under subparagraph (A) for the same 

17 violation against any defendant named in the 

18 complaint in that action. 

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

20 subparagraph (A) may be brought in the dis21 trict court of the United States that meets ap22 plicable requirements relating to venue under 

23 section 1391 of title 28, United States Code. 

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

25 brought under subparagraph (A), process may 


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1 be served in any district in which the defend2 ant— 

3 ‘‘(i) is an inhabitant; or 

4 ‘‘(ii) may be found. 

5 ‘‘(G) MEASUREMENT OF DAMAGES.—In 

6 any action under this paragraph to enforce a 

7 cause of action under this subsection in which 

8 there has been a determination that a defend9 ant has violated a provision of this subsection, 

10 damages may be proved and assessed in the ag11 gregate by statistical or sampling methods, by 

12 the computation of illegal overcharges or by 

13 such other reasonable system of estimating ag14 gregate damages as the court in its discretion 

15 may permit without the necessity of separately 

16 proving the individual claim of, or amount of 

17 damage to, persons on whose behalf the suit 

18 was brought. 

19 ‘‘(H) EXCLUSION ON DUPLICATIVE RE20 LIEF.—The district court shall exclude from the 

21 amount of monetary relief awarded in an action 

22 under this paragraph brought by the attorney 

23 general of a State any amount of monetary re24 lief which duplicates amounts which have been 

25 awarded for the same injury. 


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

2 in this subsection shall be construed to modify, im3 pair, or supersede the operation of the antitrust 

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

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

6 section of the Clayton Act, except that it includes 

7 section 5 of the Federal Trade Commission Act to 

8 the extent that such section 5 applies to unfair 

9 methods of competition. 

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

11 term ‘manufacturer’ means any entity, including any 

12 affiliate or licensee of that entity, that is engaged 

13 in— 

14 ‘‘(A) the production, preparation, propaga15 tion, compounding, conversion, or processing of 

16 a prescription drug, either directly or indirectly 

17 by extraction from substances of natural origin, 

18 or independently by means of chemical syn19 thesis, or by a combination of extraction and 

20 chemical synthesis; or 

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

22 relabeling, or distribution of a prescription 

23 drug.’’. 

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

25 and Cosmetic Act is amended— 


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

2 paragraph (aa) and inserting the following: 

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

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

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

6 imported by the pharmacist, other than— 

7 ‘‘(A) a sale at retail made pursuant to dis8 pensing the drug to a customer of the pharmacist or 

9 organization; or 

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

11 or a wholesaler registered to import drugs under sec12 tion 804. 

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

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

15 individual. 

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

17 fraudulent statement or representation, or a material 

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

19 804(g)(2)(B) or in an application required under section 

20 804(g)(2)(F), or the failure to submit such a notice or 

21 application. 

22 ‘‘(4) The importation of a drug in violation of a reg23 istration condition or other requirement under section 

24 804, the falsification of any record required to be main25 tained, or provided to the Secretary, under such section, 


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1 or the violation of any registration condition or other re2 quirement under such section.’’; and 

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

4 striking paragraph (6) and inserting the following: 

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

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

7 301(aa)(4) shall be imprisoned not more than 10 years, 

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

9 or both.’’. 

10 (c) AMENDMENT OF CERTAIN PROVISIONS.— 

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

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

13 amended by striking subsection (g) and inserting the 

14 following: 

15 ‘‘(g) With respect to a prescription drug that is im16 ported or offered for import into the United States by an 

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

18 that is not shipped by a registered exporter under section 

19 804, and that is refused admission under subsection (a), 

20 the Secretary shall notify the individual that— 

21 ‘‘(1) the drug has been refused admission be22 cause the drug was not a lawful import under sec23 tion 804; 

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

25 waiver of the requirements of subsection (a); 


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1 ‘‘(3) the individual may under section 804 law2 fully import certain prescription drugs from export3 ers registered with the Secretary under section 804; 

4 and 

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

6 such importation, including a list of registered ex7 porters, on the Internet website of the Food and 

8 Drug Administration or through a toll-free telephone 

9 number required under section 804.’’. 

10 (2) ESTABLISHMENT REGISTRATION.—Section 

11 510(i) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 360(i)) is amended in paragraph (1) by 

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

14 following: ‘‘, including a drug that is, or may be, im15 ported or offered for import into the United States 

16 under section 804,’’. 

17 (3) EFFECTIVE DATE.—The amendments made 

18 by this subsection shall take effect on the date that 

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

20 (d) EXHAUSTION.— 

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

22 United States Code, is amended— 

23 (A) by redesignating subsections (h) and 

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


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

2 following: 

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

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

5 into the United States any patented invention under sec6 tion 804 of the Federal Food, Drug, and Cosmetic Act 

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

8 owner or licensee of such patent.’’. 

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

10 amendment made by paragraph (1) shall be con11 strued to affect the ability of a patent owner or li12 censee to enforce their patent, subject to such 

13 amendment. 

14 (e) EFFECT OF SECTION 804.— 

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

16 Food, Drug, and Cosmetic Act, as added by sub17 section (a), shall permit the importation of quali18 fying drugs (as defined in such section 804) into the 

19 United States without regard to the status of the 

20 issuance of implementing regulations— 

21 (A) from exporters registered under such 

22 section 804 on the date that is 90 days after 

23 the date of enactment of this Act; and 

24 (B) from permitted countries, as defined in 

25 such section 804, by importers registered under 


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1 such section 804 on the date that is 1 year 

2 after the date of enactment of this Act. 

3 (2) REVIEW OF REGISTRATION BY CERTAIN EX4 PORTERS.— 

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

6 registrations submitted under subsection (b) of 

7 such section 804, registrations submitted by en8 tities in Canada that are significant exporters 

9 of prescription drugs to individuals in the 

10 United States as of the date of enactment of 

11 this Act will have priority during the 90 day pe12 riod that begins on such date of enactment. 

13 (B) PERIOD FOR REVIEW.—During such 

14 90-day period, the reference in subsection 

15 (b)(2)(A) of such section 804 to 90 days (relat16 ing to approval or disapproval of registrations) 

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

18 days. 

19 (C) LIMITATION.—That an exporter in 

20 Canada exports, or has exported, prescription 

21 drugs to individuals in the United States on or 

22 before the date that is 90 days after the date 

23 of enactment of this Act shall not serve as a 

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


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1 registration under such section 804 from the 

2 exporter. 

3 (D) FIRST YEAR LIMIT ON NUMBER OF

4 EXPORTERS.—During the 1-year period begin5 ning on the date of enactment of this Act, the 

6 Secretary of Health and Human Services (re7 ferred to in this section as the ‘‘Secretary’’) 

8 may limit the number of registered exporters 

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

10 long as the Secretary gives priority to those ex11 porters with demonstrated ability to process a 

12 high volume of shipments of drugs to individ13 uals in the United States. 

14 (E) SECOND YEAR LIMIT ON NUMBER OF

15 EXPORTERS.—During the 1-year period begin16 ning on the date that is 1 year after the date 

17 of enactment of this Act, the Secretary may 

18 limit the number of registered exporters under 

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

20 as the Secretary gives priority to those export21 ers with demonstrated ability to process a high 

22 volume of shipments of drugs to individuals in 

23 the United States. 

24 (F) FURTHER LIMIT ON NUMBER OF EX25 PORTERS.—During any 1-year period beginning 


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1 on a date that is 2 or more years 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 25 more than 

5 the number of such exporters during the pre6 vious 1-year period, so long as the Secretary 

7 gives priority to those exporters with dem8 onstrated ability to process a high volume of 

9 shipments of drugs to individuals in the United 

10 States. 

11 (3) LIMITS ON NUMBER OF IMPORTERS.— 

12 (A) FIRST YEAR LIMIT ON NUMBER OF IM13 PORTERS.—During the 1-year period beginning 

14 on the date that is 1 year after the date of en15 actment of this Act, the Secretary may limit the 

16 number of registered importers under such sec17 tion 804 to not less than 100 (of which at least 

18 a significant number shall be groups of phar19 macies, to the extent feasible given the applica20 tions submitted by such groups), so long as the 

21 Secretary gives priority to those importers with 

22 demonstrated ability to process a high volume 

23 of shipments of drugs imported into the United 

24 States. 


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1 (B) SECOND YEAR LIMIT ON NUMBER OF

2 IMPORTERS.—During the 1-year period begin3 ning on the date that is 2 years after the date 

4 of enactment of this Act, the Secretary may 

5 limit the number of registered importers under 

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

7 at least a significant number shall be groups of 

8 pharmacies, to the extent feasible given the ap9 plications submitted by such groups), so long as 

10 the Secretary gives priority to those importers 

11 with demonstrated ability to process a high vol12 ume of shipments of drugs into the United 

13 States. 

14 (C) FURTHER LIMIT ON NUMBER OF IM15 PORTERS.—During any 1-year period beginning 

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

17 of enactment of this Act, the Secretary may 

18 limit the number of registered importers under 

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

20 which at least a significant number shall be 

21 groups of pharmacies, to the extent feasible 

22 given the applications submitted by such 

23 groups) than the number of such importers 

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

25 the Secretary gives priority to those importers 


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1 with demonstrated ability to process a high vol2 ume of shipments of drugs to the United 

3 States. 

4 (4) NOTICES FOR DRUGS FOR IMPORT FROM

5 CANADA.—The notice with respect to a qualifying 

6 drug introduced for commercial distribution in Can7 ada as of the date of enactment of this Act that is 

8 required under subsection (g)(2)(B)(i) of such sec9 tion 804 shall be submitted to the Secretary not 

10 later than 30 days after the date of enactment of 

11 this Act if— 

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

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

14 100 prescription drugs with the highest dollar 

15 volume of sales in the United States based on 

16 the 12 calendar month period most recently 

17 completed before the date of enactment of this 

18 Act; or 

19 (B) the notice is a notice under subsection 

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

21 (5) NOTICE FOR DRUGS FOR IMPORT FROM

22 OTHER COUNTRIES.—The notice with respect to a 

23 qualifying drug introduced for commercial distribu24 tion in a permitted country other than Canada as of 

25 the date of enactment of this Act that is required 


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

2 shall be submitted to the Secretary not later than 

3 180 days after the date of enactment of this Act 

4 if— 

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

6 drug is 1 of the 100 prescription drugs with the 

7 highest dollar volume of sales in the United 

8 States based on the 12 calendar month period 

9 that is first completed on the date that is 120 

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

11 (B) the notice is a notice under subsection 

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

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

14 (A) GUIDANCE ON SUBMISSION DATES.— 

15 The Secretary shall by guidance establish a se16 ries of submission dates for the notices under 

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

18 respect to qualifying drugs introduced for com19 mercial distribution as of the date of enactment 

20 of this Act and that are not required to be sub21 mitted under paragraph (4) or (5). 

22 (B) CONSISTENT AND EFFICIENT USE OF

23 RESOURCES.—The Secretary shall establish the 

24 dates described under subparagraph (A) so that 

25 such notices described under subparagraph (A) 


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1 are submitted and reviewed at a rate that al2 lows consistent and efficient use of the re3 sources and staff available to the Secretary for 

4 such reviews. The Secretary may condition the 

5 requirement to submit such a notice, and the 

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

7 registered exporter or a registered importer to 

8 the Secretary of a notice that such exporter or 

9 importer intends to import such qualifying drug 

10 to the United States under such section 804. 

11 (C) PRIORITY FOR DRUGS WITH HIGHER

12 SALES.—The Secretary shall establish the dates 

13 described under subparagraph (A) so that the 

14 Secretary reviews the notices described under 

15 such subparagraph with respect to qualifying 

16 drugs with higher dollar volume of sales in the 

17 United States before the notices with respect to 

18 drugs with lower sales in the United States. 

19 (7) NOTICES FOR DRUGS APPROVED AFTER EF20 FECTIVE DATE.—The notice required under sub21 section (g)(2)(B)(i) of such section 804 for a quali22 fying drug first introduced for commercial distribu23 tion in a permitted country (as defined in such sec24 tion 804) after the date of enactment of this Act 

25 shall be submitted to and reviewed by the Secretary 


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1 as provided under subsection (g)(2)(B) of such sec2 tion 804, without regard to paragraph (4), (5), or 

3 (6). 

4 (8) REPORT.—Beginning with the first full fis5 cal year after the date of enactment of this Act, not 

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

7 during which the Secretary reviews a notice referred 

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

9 submit a report to Congress concerning the progress 

10 of the Food and Drug Administration in reviewing 

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

12 (6). 

13 (9) USER FEES.— 

14 (A) EXPORTERS.—When establishing an 

15 aggregate total of fees to be collected from ex16 porters under subsection (f)(2) of such section 

17 804, the Secretary shall, under subsection 

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

19 total price of drugs imported under subsection 

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

21 by registered exporters during the first fiscal 

22 year in which this Act takes effect to be an 

23 amount equal to the amount which bears the 

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


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1 days in such fiscal year during which this Act 

2 is effective bears to 365. 

3 (B) IMPORTERS.—When establishing an 

4 aggregate total of fees to be collected from im5 porters under subsection (e)(2) of such section 

6 804, the Secretary shall, under subsection 

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

8 total price of drugs imported under subsection 

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

10 by registered importers during— 

11 (i) the first fiscal year in which this 

12 Act takes effect to be an amount equal to 

13 the amount which bears the same ratio to 

14 $1,000,000,000 as the number of days in 

15 such fiscal year during which this Act is 

16 effective bears to 365; and 

17 (ii) the second fiscal year in which 

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

19 (C) SECOND YEAR ADJUSTMENT.— 

20 (i) REPORTS.—Not later than Feb21 ruary 20 of the second fiscal year in which 

22 this Act is in effect, registered importers 

23 shall report to the Secretary the total price 

24 and the total volume of drugs imported to 

25 the United States by the importer during 


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1 the 4-month period from October 1 

2 through January 31 of such fiscal year. 

3 (ii) REESTIMATE.—Notwithstanding 

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

5 or subparagraph (B), the Secretary shall 

6 reestimate the total price of qualifying 

7 drugs imported under subsection (a) of 

8 such section 804 into the United States by 

9 registered importers during the second fis10 cal year in which this Act is in effect. Such 

11 reestimate shall be equal to— 

12 (I) the total price of qualifying 

13 drugs imported by each importer as 

14 reported under clause (i); multiplied 

15 by 

16 (II) 3. 

17 (iii) ADJUSTMENT.—The Secretary 

18 shall adjust the fee due on April 1 of the 

19 second fiscal year in which this Act is in 

20 effect, from each importer so that the ag21 gregate total of fees collected under sub22 section (e)(2) for such fiscal year does not 

23 exceed the total price of qualifying drugs 

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1 istered importers during such fiscal year as 

2 reestimated under clause (ii). 

3 (D) FAILURE TO PAY FEES.—Notwith4 standing any other provision of this section, the 

5 Secretary may prohibit a registered importer or 

6 exporter that is required to pay user fees under 

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

8 that fails to pay such fees within 30 days after 

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

10 offering for importation a qualifying drug under 

11 such section 804 until such fee is paid. 

12 (E) ANNUAL REPORT.— 

13 (i) FOOD AND DRUG ADMINISTRA14 TION.—Not later than 180 days after the 

15 end of each fiscal year during which fees 

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

17 (g)(2)(B)(iv) of such section 804, the Sec18 retary shall prepare and submit to the 

19 House of Representatives and the Senate a 

20 report on the implementation of the au21 thority for such fees during such fiscal 

22 year and the use, by the Food and Drug 

23 Administration, of the fees collected for the 

24 fiscal year for which the report is made 


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1 and credited to the Food and Drug Admin2 istration. 

3 (ii) CUSTOMS AND BORDER PROTEC4 TION.—Not later than 180 days after the 

5 end of each fiscal year during which fees 

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

7 such section 804, the Secretary of Home8 land Security, in consultation with the Sec9 retary of the Treasury, shall prepare and 

10 submit to the House of Representatives 

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

12 Bureau of Customs and Border Protection, 

13 of the fees, if any, transferred by the Sec14 retary to the Bureau of Customs and Bor15 der Protection for the fiscal year for which 

16 the report is made. 

17 (10) SPECIAL RULE REGARDING IMPORTATION

18 BY INDIVIDUALS.— 

19 (A) IN GENERAL.—Notwithstanding any 

20 provision of this Act (or an amendment made 

21 by this Act), the Secretary shall expedite the 

22 designation of any additional permitted coun23 tries from which an individual may import a 

24 qualifying drug into the United States under 

25 such section 804 if any action implemented by 


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1 the Government of Canada has the effect of 

2 limiting or prohibiting the importation of quali3 fying drugs into the United States from Can4 ada. 

5 (B) TIMING AND CRITERIA.—The Sec6 retary shall designate such additional permitted 

7 countries under subparagraph (A)— 

8 (i) not later than 6 months after the 

9 date of the action by the Government of 

10 Canada described under such subpara11 graph; and 

12 (ii) using the criteria described under 

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

14 804. 

15 (f) IMPLEMENTATION OF SECTION 804.— 

16 (1) INTERIM RULE.—The Secretary may pro17 mulgate an interim rule for implementing section 

18 804 of the Federal Food, Drug, and Cosmetic Act, 

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

20 (2) NO NOTICE OF PROPOSED RULEMAKING.— 

21 The interim rule described under paragraph (1) may 

22 be developed and promulgated by the Secretary with23 out providing general notice of proposed rulemaking. 

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

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1 terim rule under paragraph (1), the Secretary shall, 

2 in accordance with procedures under section 553 of 

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

4 for implementing such section 804, which may incor5 porate by reference provisions of the interim rule 

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

7 such provisions are not modified. 

8 (g) CONSUMER EDUCATION.—The Secretary shall 

9 carry out activities that educate consumers— 

10 (1) with regard to the availability of qualifying 

11 drugs for import for personal use from an exporter 

12 registered with and approved by the Food and Drug 

13 Administration under section 804 of the Federal 

14 Food, Drug, and Cosmetic Act, as added by this sec15 tion, including information on how to verify whether 

16 an exporter is registered and approved by use of the 

17 Internet website of the Food and Drug Administra18 tion and the toll-free telephone number required by 

19 this Act; 

20 (2) that drugs that consumers attempt to im21 port from an exporter that is not registered with and 

22 approved by the Food and Drug Administration can 

23 be seized by the United States Customs Service and 

24 destroyed, and that such drugs may be counterfeit, 

25 unapproved, unsafe, or ineffective; 


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1 (3) with regard to the suspension and termi2 nation of any registration of a registered importer or 

3 exporter under such section 804; and 

4 (4) with regard to the availability at domestic 

5 retail pharmacies of qualifying drugs imported under 

6 such section 804 by domestic wholesalers and phar7 macies registered with and approved by the Food 

8 and Drug Administration. 

9 (h) EFFECT ON ADMINISTRATION PRACTICES.—Not10 withstanding any provision of this Act (and the amend11 ments made by this Act), the practices and policies of the 

12 Food and Drug Administration and Bureau of Customs 

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

14 respect to the importation of prescription drugs into the 

15 United States by an individual, on the person of such indi16 vidual, for personal use, shall remain in effect. 

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

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

19 a report that describes any action taken during the period 

20 for which the report is being prepared to enforce the provi21 sions of section 804(n) of the Federal Food, Drug, and 

22 Cosmetic Act (as added by this Act), including any pend23 ing investigations or civil actions under such section. 


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1 SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS2 SION INTO UNITED STATES. 

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

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

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

6 at the end the following section: 

7 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD8 MISSION. 

9 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se10 curity shall deliver to the Secretary a shipment of drugs 

11 that is imported or offered for import into the United 

12 States if— 

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

14 than $10,000; and 

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

16 does not bear the markings required under section 

17 804(d)(2); or 

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

19 such shipment of drugs. 

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

21 not authorize the delivery to the owner or consignee of 

22 drugs delivered to the Secretary under subsection (a) pur23 suant to the execution of a bond, and such drugs may not 

24 be exported. 

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

26 Secretary shall destroy a shipment of drugs delivered by 


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1 the Secretary of Homeland Security to the Secretary 

2 under subsection (a) if— 

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

4 offered for import from a registered exporter under 

5 section 804, the drugs are in violation of any stand6 ard described in section 804(g)(5); or 

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

8 or offered for import from a registered exporter 

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

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

11 ‘‘(d) CERTAIN PROCEDURES.— 

12 ‘‘(1) IN GENERAL.—The delivery and destruc13 tion of drugs under this section may be carried out 

14 without notice to the importer, owner, or consignee 

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

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

17 drugs, and recordkeeping activities regarding the 

18 drugs, may be carried out on a summary basis. 

19 ‘‘(2) OBJECTIVE OF PROCEDURES.—Procedures 

20 promulgated under paragraph (1) shall be designed 

21 toward the objective of ensuring that, with respect to 

22 efficiently utilizing Federal resources available for 

23 carrying out this section, a substantial majority of 

24 shipments of drugs subject to described in sub25 section (c) are identified and destroyed. 


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1 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de2 stroyed under subsection (c) to the extent that the Attor3 ney General of the United States determines that the 

4 drugs should be preserved as evidence or potential evi5 dence with respect to an offense against the United States. 

6 ‘‘(f) RULE OF CONSTRUCTION.—This section may 

7 not be construed as having any legal effect on applicable 

8 law with respect to a shipment of drugs that is imported 

9 or offered for import into the United States and has a 

10 declared value equal to or greater than $10,000.’’. 

11 (b) PROCEDURES.—Procedures for carrying out sec12 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

13 as added by subsection (a), shall be established not later 

14 than 90 days after the date of the enactment of this Act. 

15 (c) EFFECTIVE DATE.—The amendments made by 

16 this section shall take effect on the date that is 90 days 

17 after the date of enactment of this Act. 

18 SEC. 6. WHOLESALE DISTRIBUTION OF DRUGS; STATE19 MENTS REGARDING PRIOR SALE, PURCHASE, 

20 OR TRADE. 

21 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

22 REGISTERED EXPORTERS.—Section 503(e) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) is 

24 amended— 

25 (1) in paragraph (1)— 


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1 (A) by striking ‘‘and who is not the manu2 facturer or an authorized distributor of record 

3 of such drug’’; 

4 (B) by striking ‘‘to an authorized dis5 tributor of record or’’; and 

6 (C) by striking subparagraph (B) and in7 serting the following: 

8 ‘‘(B) The fact that a drug subject to subsection (b) 

9 is exported from the United States does not with respect 

10 to such drug exempt any person that is engaged in the 

11 business of the wholesale distribution of the drug from 

12 providing the statement described in subparagraph (A) to 

13 the person that receives the drug pursuant to the export 

14 of the drug. 

15 ‘‘(C)(i) The Secretary shall by regulation establish re16 quirements that supersede subparagraph (A) (referred to 

17 in this subparagraph as ‘alternative requirements’) to 

18 identify the chain of custody of a drug subject to sub19 section (b) from the manufacturer of the drug throughout 

20 the wholesale distribution of the drug to a pharmacist who 

21 intends to sell the drug at retail if the Secretary deter22 mines that the alternative requirements, which may in23 clude standardized anti-counterfeiting or track-and-trace 

24 technologies, will identify such chain of custody or the 

25 identity of the discrete package of the drug from which 


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1 the drug is dispensed with equal or greater certainty to 

2 the requirements of subparagraph (A), and that the alter3 native requirements are economically and technically fea4 sible. 

5 ‘‘(ii) When the Secretary promulgates a final rule to 

6 establish such alternative requirements, the final rule in 

7 addition shall, with respect to the registration condition 

8 established in clause (i) of section 804(c)(3)(B), establish 

9 a condition equivalent to the alternative requirements, and 

10 such equivalent condition may be met in lieu of the reg11 istration condition established in such clause (i).’’; 

12 (2) in paragraph (2)(A), by adding at the end 

13 the following: ‘‘The preceding sentence may not be 

14 construed as having any applicability with respect to 

15 a registered exporter under section 804.’’; and 

16 (3) in paragraph (3), by striking ‘‘and sub17 section (d)—’’ in the matter preceding subparagraph 

18 (A) and all that follows through ‘‘the term ‘whole19 sale distribution’ means’’ in subparagraph (B) and 

20 inserting the following: ‘‘and subsection (d), the 

21 term ‘wholesale distribution’ means’’. 

22 (b) CONFORMING AMENDMENT.—Section 503(d) of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 353(d)) is amended by adding at the end the following: 


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1 ‘‘(4) Each manufacturer of a drug subject to sub2 section (b) shall maintain at its corporate offices a current 

3 list of the authorized distributors of record of such drug. 

4 ‘‘(5) For purposes of this subsection, the term ‘au5 thorized distributors of record’ means those distributors 

6 with whom a manufacturer has established an ongoing re7 lationship to distribute such manufacturer’s products.’’. 

8 (c) EFFECTIVE DATE.— 

9 (1) IN GENERAL.—The amendments made by 

10 paragraphs (1) and (3) of subsection (a) and by sub11 section (b) shall take effect on January 1, 2013. 

12 (2) DRUGS IMPORTED BY REGISTERED IMPORT13 ERS UNDER SECTION 804.—Notwithstanding para14 graph (1), the amendments made by paragraphs (1) 

15 and (3) of subsection (a) and by subsection (b) shall 

16 take effect on the date that is 90 days after the date 

17 of enactment of this Act with respect to qualifying 

18 drugs imported under section 804 of the Federal 

19 Food, Drug, and Cosmetic Act, as added by section 

20 4. 

21 (3) EFFECT WITH RESPECT TO REGISTERED

22 EXPORTERS.—The amendment made by subsection 

23 (a)(2) shall take effect on the date that is 90 days 

24 after the date of enactment of this Act. 


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1 (4) ALTERNATIVE REQUIREMENTS.—The Sec2 retary shall issue regulations to establish the alter3 native requirements, referred to in the amendment 

4 made by subsection (a)(1), that take effect not later 

5 than January 1, 2013. 

6 (5) INTERMEDIATE REQUIREMENTS.—The Sec7 retary shall by regulation require the use of stand8 ardized anti-counterfeiting or track-and-trace tech9 nologies on prescription drugs at the case and pallet 

10 level effective not later than 1 year after the date of 

11 enactment of this Act. 

12 (6) ADDITIONAL REQUIREMENTS.— 

13 (A) IN GENERAL.—Notwithstanding any 

14 other provision of this section, the Secretary 

15 shall, not later than 18 months after the date 

16 of enactment of this Act, require that the pack17 aging of any prescription drug incorporates— 

18 (i) a standardized numerical identifier 

19 unique to each package of such drug, ap20 plied at the point of manufacturing and re21 packaging (in which case the numerical 

22 identifier shall be linked to the numerical 

23 identifier applied at the point of manufac24 turing); and 


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1 (ii)(I) overt optically variable counter2 feit-resistant technologies that— 

3 (aa) are visible to the naked eye, 

4 providing for visual identification of 

5 product authenticity without the need 

6 for readers, microscopes, lighting de7 vices, or scanners; 

8 (bb) are similar to that used by 

9 the Bureau of Engraving and Printing 

10 to secure United States currency; 

11 (cc) are manufactured and dis12 tributed in a highly secure, tightly 

13 controlled environment; and 

14 (dd) incorporate additional layers 

15 of nonvisible convert security features 

16 up to and including forensic capa17 bility, as described in subparagraph 

18 (B); or 

19 (II) technologies that have a function 

20 of security comparable to that described in 

21 subclause (I), as determined by the Sec22 retary. 

23 (B) STANDARDS FOR PACKAGING.—For 

24 the purpose of making it more difficult to coun25 terfeit the packaging of drugs subject to this 


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1 paragraph, the manufacturers of such drugs 

2 shall incorporate the technologies described in 

3 subparagraph (A) into at least 1 additional ele4 ment of the physical packaging of the drugs, in5 cluding blister packs, shrink wrap, package la6 bels, package seals, bottles, and boxes. 

7 SEC. 7. INTERNET SALES OF PRESCRIPTION DRUGS. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 503B the following: 

11 ‘‘SEC. 503C. INTERNET SALES OF PRESCRIPTION DRUGS. 

12 ‘‘(a) REQUIREMENTS REGARDING INFORMATION ON

13 INTERNET SITE.— 

14 ‘‘(1) IN GENERAL.—A person may not dispense 

15 a prescription drug pursuant to a sale of the drug 

16 by such person if— 

17 ‘‘(A) the purchaser of the drug submitted 

18 the purchase order for the drug, or conducted 

19 any other part of the sales transaction for the 

20 drug, through an Internet site; 

21 ‘‘(B) the person dispenses the drug to the 

22 purchaser by mailing or shipping the drug to 

23 the purchaser; and 

24 ‘‘(C) such site, or any other Internet site 

25 used by such person for purposes of sales of a 


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1 prescription drug, fails to meet each of the re2 quirements specified in paragraph (2), other 

3 than a site or pages on a site that— 

4 ‘‘(i) are not intended to be accessed 

5 by purchasers or prospective purchasers; or 

6 ‘‘(ii) provide an Internet information 

7 location tool within the meaning of section 

8 231(e)(5) of the Communications Act of 

9 1934 (47 U.S.C. 231(e)(5)). 

10 ‘‘(2) REQUIREMENTS.—With respect to an 

11 Internet site, the requirements referred to in sub12 paragraph (C) of paragraph (1) for a person to 

13 whom such paragraph applies are as follows: 

14 ‘‘(A) Each page of the site shall include ei15 ther the following information or a link to a 

16 page that provides the following information: 

17 ‘‘(i) The name of such person. 

18 ‘‘(ii) Each State in which the person 

19 is authorized by law to dispense prescrip20 tion drugs. 

21 ‘‘(iii) The address and telephone num22 ber of each place of business of the person 

23 with respect to sales of prescription drugs 

24 through the Internet, other than a place of 


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1 business that does not mail or ship pre2 scription drugs to purchasers. 

3 ‘‘(iv) The name of each individual who 

4 serves as a pharmacist for prescription 

5 drugs that are mailed or shipped pursuant 

6 to the site, and each State in which the in7 dividual is authorized by law to dispense 

8 prescription drugs. 

9 ‘‘(v) If the person provides for medical 

10 consultations through the site for purposes 

11 of providing prescriptions, the name of 

12 each individual who provides such con13 sultations; each State in which the indi14 vidual is licensed or otherwise authorized 

15 by law to provide such consultations or 

16 practice medicine; and the type or types of 

17 health professions for which the individual 

18 holds such licenses or other authorizations. 

19 ‘‘(B) A link to which paragraph (1) applies 

20 shall be displayed in a clear and prominent 

21 place and manner, and shall include in the cap22 tion for the link the words ‘licensing and con23 tact information’. 

24 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

25 MEDICAL RELATIONSHIPS.— 


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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), a person may not dispense a prescription 

3 drug, or sell such a drug, if— 

4 ‘‘(A) for purposes of such dispensing or 

5 sale, the purchaser communicated with the per6 son through the Internet; 

7 ‘‘(B) the patient for whom the drug was 

8 dispensed or purchased did not, when such 

9 communications began, have a prescription for 

10 the drug that is valid in the United States; 

11 ‘‘(C) pursuant to such communications, the 

12 person provided for the involvement of a practi13 tioner, or an individual represented by the per14 son as a practitioner, and the practitioner or 

15 such individual issued a prescription for the 

16 drug that was purchased; 

17 ‘‘(D) the person knew, or had reason to 

18 know, that the practitioner or the individual re19 ferred to in subparagraph (C) did not, when 

20 issuing the prescription, have a qualifying med21 ical relationship with the patient; and 

22 ‘‘(E) the person received payment for the 

23 dispensing or sale of the drug. 


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1 For purposes of subparagraph (E), payment is re2 ceived if money or other valuable consideration is re3 ceived. 

4 ‘‘(2) EXCEPTIONS.—Paragraph (1) does not 

5 apply to— 

6 ‘‘(A) the dispensing or selling of a pre7 scription drug pursuant to telemedicine prac8 tices sponsored by— 

9 ‘‘(i) a hospital that has in effect a 

10 provider agreement under title XVIII of 

11 the Social Security Act (relating to the 

12 Medicare program); or 

13 ‘‘(ii) a group practice that has not 

14 fewer than 100 physicians who have in ef15 fect provider agreements under such title; 

16 or 

17 ‘‘(B) the dispensing or selling of a pre18 scription drug pursuant to practices that pro19 mote the public health, as determined by the 

20 Secretary by regulation. 

21 ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— 

22 ‘‘(A) IN GENERAL.—With respect to 

23 issuing a prescription for a drug for a patient, 

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1 ship with the patient for purposes of this sec2 tion if— 

3 ‘‘(i) at least one in-person medical 

4 evaluation of the patient has been con5 ducted by the practitioner; or 

6 ‘‘(ii) the practitioner conducts a med7 ical evaluation of the patient as a covering 

8 practitioner. 

9 ‘‘(B) IN-PERSON MEDICAL EVALUATION.— 

10 A medical evaluation by a practitioner is an in11 person medical evaluation for purposes of this 

12 section if the practitioner is in the physical 

13 presence of the patient as part of conducting 

14 the evaluation, without regard to whether por15 tions of the evaluation are conducted by other 

16 health professionals. 

17 ‘‘(C) COVERING PRACTITIONER.—With re18 spect to a patient, a practitioner is a covering 

19 practitioner for purposes of this section if the 

20 practitioner conducts a medical evaluation of 

21 the patient at the request of a practitioner who 

22 has conducted at least one in-person medical 

23 evaluation of the patient and is temporarily un24 available to conduct the evaluation of the pa25 tient. A practitioner is a covering practitioner 


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1 without regard to whether the practitioner has 

2 conducted any in-person medical evaluation of 

3 the patient involved. 

4 ‘‘(4) RULES OF CONSTRUCTION.— 

5 ‘‘(A) INDIVIDUALS REPRESENTED AS

6 PRACTITIONERS.—A person who is not a practi7 tioner (as defined in subsection (e)(1)) lacks 

8 legal capacity under this section to have a 

9 qualifying medical relationship with any patient. 

10 ‘‘(B) STANDARD PRACTICE OF PHAR11 MACY.—Paragraph (1) may not be construed as 

12 prohibiting any conduct that is a standard prac13 tice in the practice of pharmacy. 

14 ‘‘(C) APPLICABILITY OF REQUIRE15 MENTS.—Paragraph (3) may not be construed 

16 as having any applicability beyond this section, 

17 and does not affect any State law, or interpre18 tation of State law, concerning the practice of 

19 medicine. 

20 ‘‘(c) ACTIONS BY STATES.— 

21 ‘‘(1) IN GENERAL.—Whenever an attorney gen22 eral of any State has reason to believe that the in23 terests of the residents of that State have been or 

24 are being threatened or adversely affected because 

25 any person has engaged or is engaging in a pattern 


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1 or practice that violates section 301(l), the State 

2 may bring a civil action on behalf of its residents in 

3 an appropriate district court of the United States to 

4 enjoin such practice, to enforce compliance with such 

5 section (including a nationwide injunction), to obtain 

6 damages, restitution, or other compensation on be7 half of residents of such State, to obtain reasonable 

8 attorneys fees and costs if the State prevails in the 

9 civil action, or to obtain such further and other relief 

10 as the court may deem appropriate. 

11 ‘‘(2) NOTICE.—The State shall serve prior writ12 ten notice of any civil action under paragraph (1) or 

13 (5)(B) upon the Secretary and provide the Secretary 

14 with a copy of its complaint, except that if it is not 

15 feasible for the State to provide such prior notice, 

16 the State shall serve such notice immediately upon 

17 instituting such action. Upon receiving a notice re18 specting a civil action, the Secretary shall have the 

19 right— 

20 ‘‘(A) to intervene in such action; 

21 ‘‘(B) upon so intervening, to be heard on 

22 all matters arising therein; and 

23 ‘‘(C) to file petitions for appeal. 

24 ‘‘(3) CONSTRUCTION.—For purposes of bring25 ing any civil action under paragraph (1), nothing in 


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1 this chapter shall prevent an attorney general of a 

2 State from exercising the powers conferred on the 

3 attorney general by the laws of such State to con4 duct investigations or to administer oaths or affir5 mations or to compel the attendance of witnesses or 

6 the production of documentary and other evidence. 

7 ‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 

8 action brought under paragraph (1) in a district 

9 court of the United States may be brought in the 

10 district in which the defendant is found, is an inhab11 itant, or transacts business or wherever venue is 

12 proper under section 1391 of title 28, United States 

13 Code. Process in such an action may be served in 

14 any district in which the defendant is an inhabitant 

15 or in which the defendant may be found. 

16 ‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.— 

17 ‘‘(A) Nothing contained in this section 

18 shall prohibit an authorized State official from 

19 proceeding in State court on the basis of an al20 leged violation of any civil or criminal statute of 

21 such State. 

22 ‘‘(B) In addition to actions brought by an 

23 attorney general of a State under paragraph 

24 (1), such an action may be brought by officers 

25 of such State who are authorized by the State 


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1 to bring actions in such State on behalf of its 

2 residents. 

3 ‘‘(d) EFFECT OF SECTION.—This section shall not 

4 apply to a person that is a registered exporter under sec5 tion 804. 

6 ‘‘(e) GENERAL DEFINITIONS.—For purposes of this 

7 section: 

8 ‘‘(1) The term ‘practitioner’ means a practi9 tioner referred to in section 503(b)(1) with respect 

10 to issuing a written or oral prescription. 

11 ‘‘(2) The term ‘prescription drug’ means a drug 

12 that is described in section 503(b)(1). 

13 ‘‘(3) The term ‘qualifying medical relationship’, 

14 with respect to a practitioner and a patient, has the 

15 meaning indicated for such term in subsection (b). 

16 ‘‘(f) INTERNET-RELATED DEFINITIONS.— 

17 ‘‘(1) IN GENERAL.—For purposes of this sec18 tion: 

19 ‘‘(A) The term ‘Internet’ means collectively 

20 the myriad of computer and telecommunications 

21 facilities, including equipment and operating 

22 software, which comprise the interconnected 

23 world-wide network of networks that employ the 

24 transmission control protocol/internet protocol, 

25 or any predecessor or successor protocols to 


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1 such protocol, to communicate information of 

2 all kinds by wire or radio. 

3 ‘‘(B) The term ‘link’, with respect to the 

4 Internet, means one or more letters, words, 

5 numbers, symbols, or graphic items that appear 

6 on a page of an Internet site for the purpose 

7 of serving, when activated, as a method for exe8 cuting an electronic command— 

9 ‘‘(i) to move from viewing one portion 

10 of a page on such site to another portion 

11 of the page; 

12 ‘‘(ii) to move from viewing one page 

13 on such site to another page on such site; 

14 or 

15 ‘‘(iii) to move from viewing a page on 

16 one Internet site to a page on another 

17 Internet site. 

18 ‘‘(C) The term ‘page’, with respect to the 

19 Internet, means a document or other file 

20 accessed at an Internet site. 

21 ‘‘(D)(i) The terms ‘site’ and ‘address’, with 

22 respect to the Internet, mean a specific location 

23 on the Internet that is determined by Internet 

24 Protocol numbers. Such term includes the do25 main name, if any. 


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1 ‘‘(ii) The term ‘domain name’ means a 

2 method of representing an Internet address 

3 without direct reference to the Internet Protocol 

4 numbers for the address, including methods 

5 that use designations such as ‘.com’, ‘.edu’, 

6 ‘.gov’, ‘.net’, or ‘.org’. 

7 ‘‘(iii) The term ‘Internet Protocol num8 bers’ includes any successor protocol for deter9 mining a specific location on the Internet. 

10 ‘‘(2) AUTHORITY OF SECRETARY.—The Sec11 retary may by regulation modify any definition 

12 under paragraph (1) to take into account changes in 

13 technology. 

14 ‘‘(g) INTERACTIVE COMPUTER SERVICE; ADVER15 TISING.—No provider of an interactive computer service, 

16 as defined in section 230(f)(2) of the Communications Act 

17 of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 

18 shall be liable under this section for dispensing or selling 

19 prescription drugs in violation of this section on account 

20 of another person’s selling or dispensing such drugs, pro21 vided that the provider of the interactive computer service 

22 or of advertising services does not own or exercise cor23 porate control over such person. 

24 ‘‘(h) NO EFFECT ON OTHER REQUIREMENTS; CO25 ORDINATION.—The requirements of this section are in adVerDate Mar 15 2010 01:16 Feb 12, 2011 Jkt 099200 PO 00000 Frm 00128 Fmt 6652 Sfmt 6201 E:\BILLS\S319.IS S319

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1 dition to, and do not supersede, any requirements under 

2 the Controlled Substances Act or the Controlled Sub3 stances Import and Export Act (or any regulation promul4 gated under either such Act) regarding Internet phar5 macies and controlled substances. In promulgating regula6 tions to carry out this section, the Secretary shall coordi7 nate with the Attorney General to ensure that such regula8 tions do not duplicate or conflict with the requirements 

9 described in the previous sentence, and that such regula10 tions and requirements coordinate to the extent prac11 ticable.’’. 

12 (b) INCLUSION AS PROHIBITED ACT.—Section 301 of 

13 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 331) is amended by inserting after paragraph (k) the fol15 lowing: 

16 ‘‘(l) The dispensing or selling of a prescription drug 

17 in violation of section 503C.’’. 

18 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

19 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO20 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI21 NESSES.—In carrying out section 503C of the Federal 

22 Food, Drug, and Cosmetic Act (as added by subsection 

23 (a) of this section), the Secretary of Health and Human 

24 Services shall take into consideration the practices and 

25 procedures of public or private entities that certify that 


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1 businesses selling prescription drugs through Internet 

2 sites are legitimate businesses, including practices and 

3 procedures regarding disclosure formats and verification 

4 programs. 

5 (d) REPORTS REGARDING INTERNET-RELATED VIO6 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

7 OF DRUGS.— 

8 (1) IN GENERAL.—The Secretary of Health and 

9 Human Services (referred to in this subsection as 

10 the ‘‘Secretary’’) shall, pursuant to the submission 

11 of an application meeting the criteria of the Sec12 retary, make an award of a grant or contract to the 

13 National Clearinghouse on Internet Prescribing (op14 erated by the Federation of State Medical Boards) 

15 for the purpose of— 

16 (A) identifying Internet sites that appear 

17 to be in violation of Federal or State laws con18 cerning the dispensing of drugs; 

19 (B) reporting such sites to State medical 

20 licensing boards and State pharmacy licensing 

21 boards, and to the Attorney General and the 

22 Secretary, for further investigation; and 

23 (C) submitting, for each fiscal year for 

24 which the award under this subsection is made, 

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1 tions undertaken with respect to violations de2 scribed in subparagraph (A). 

3 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

4 the purpose of carrying out paragraph (1), there is 

5 authorized to be appropriated $100,000 for each of 

6 the first 3 fiscal years in which this section is in ef7 fect. 

8 (e) EFFECTIVE DATE.—The amendments made by 

9 subsections (a) and (b) take effect 90 days after the date 

10 of enactment of this Act, without regard to whether a final 

11 rule to implement such amendments has been promulgated 

12 by the Secretary of Health and Human Services under 

13 section 701(a) of the Federal Food, Drug, and Cosmetic 

14 Act. The preceding sentence may not be construed as af15 fecting the authority of such Secretary to promulgate such 

16 a final rule. 

17 SEC. 8. PROHIBITING PAYMENTS TO UNREGISTERED FOR18 EIGN PHARMACIES. 

19 (a) IN GENERAL.—Section 303 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 

21 adding at the end the following: 

22 ‘‘(h) RESTRICTED TRANSACTIONS.— 

23 ‘‘(1) IN GENERAL.—The introduction of re24 stricted transactions into a payment system or the 


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1 completion of restricted transactions using a pay2 ment system is prohibited. 

3 ‘‘(2) PAYMENT SYSTEM.— 

4 ‘‘(A) IN GENERAL.—The term ‘payment 

5 system’ means a system used by a person de6 scribed in subparagraph (B) to effect a credit 

7 transaction, electronic fund transfer, or money 

8 transmitting service that may be used in con9 nection with, or to facilitate, a restricted trans10 action, and includes— 

11 ‘‘(i) a credit card system; 

12 ‘‘(ii) an international, national, re13 gional, or local network used to effect a 

14 credit transaction, an electronic fund 

15 transfer, or a money transmitting service; 

16 and 

17 ‘‘(iii) any other system that is cen18 trally managed and is primarily engaged in 

19 the transmission and settlement of credit 

20 transactions, electronic fund transfers, or 

21 money transmitting services. 

22 ‘‘(B) PERSONS DESCRIBED.—A person re23 ferred to in subparagraph (A) is— 

24 ‘‘(i) a creditor; 

25 ‘‘(ii) a credit card issuer; 


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1 ‘‘(iii) a financial institution; 

2 ‘‘(iv) an operator of a terminal at 

3 which an electronic fund transfer may be 

4 initiated; 

5 ‘‘(v) a money transmitting business; 

6 or 

7 ‘‘(vi) a participant in an international, 

8 national, regional, or local network used to 

9 effect a credit transaction, electronic fund 

10 transfer, or money transmitting service. 

11 ‘‘(3) RESTRICTED TRANSACTION.—The term 

12 ‘restricted transaction’ means a transaction or trans13 mittal, on behalf of an individual who places an un14 lawful drug importation request to any person en15 gaged in the operation of an unregistered foreign 

16 pharmacy, of— 

17 ‘‘(A) credit, or the proceeds of credit, ex18 tended to or on behalf of the individual for the 

19 purpose of the unlawful drug importation re20 quest (including credit extended through the 

21 use of a credit card); 

22 ‘‘(B) an electronic fund transfer or funds 

23 transmitted by or through a money transmit24 ting business, or the proceeds of an electronic 

25 fund transfer or money transmitting service, 


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1 from or on behalf of the individual for the pur2 pose of the unlawful drug importation request; 

3 ‘‘(C) a check, draft, or similar instrument 

4 which is drawn by or on behalf of the individual 

5 for the purpose of the unlawful drug importa6 tion request and is drawn on or payable at or 

7 through any financial institution; or 

8 ‘‘(D) the proceeds of any other form of fi9 nancial transaction (identified by the Board by 

10 regulation) that involves a financial institution 

11 as a payor or financial intermediary on behalf 

12 of or for the benefit of the individual for the 

13 purpose of the unlawful drug importation re14 quest. 

15 ‘‘(4) UNLAWFUL DRUG IMPORTATION RE16 QUEST.—The term ‘unlawful drug importation re17 quest’ means the request, or transmittal of a re18 quest, made to an unregistered foreign pharmacy for 

19 a prescription drug by mail (including a private car20 rier), facsimile, phone, or electronic mail, or by a 

21 means that involves the use, in whole or in part, of 

22 the Internet. 

23 ‘‘(5) UNREGISTERED FOREIGN PHARMACY.— 

24 The term ‘unregistered foreign pharmacy’ means a 


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1 person in a country other than the United States 

2 that is not a registered exporter under section 804. 

3 ‘‘(6) OTHER DEFINITIONS.— 

4 ‘‘(A) CREDIT; CREDITOR; CREDIT CARD.— 

5 The terms ‘credit’, ‘creditor’, and ‘credit card’ 

6 have the meanings given the terms in section 

7 103 of the Truth in Lending Act (15 U.S.C. 

8 1602). 

9 ‘‘(B) ACCESS DEVICE; ELECTRONIC FUND

10 TRANSFER.—The terms ‘access device’ and 

11 ‘electronic fund transfer’— 

12 ‘‘(i) have the meaning given the term 

13 in section 903 of the Electronic Fund 

14 Transfer Act (15 U.S.C. 1693a); and 

15 ‘‘(ii) the term ‘electronic fund trans16 fer’ also includes any fund transfer covered 

17 under Article 4A of the Uniform Commer18 cial Code, as in effect in any State. 

19 ‘‘(C) FINANCIAL INSTITUTION.—The term 

20 ‘financial institution’— 

21 ‘‘(i) has the meaning given the term 

22 in section 903 of the Electronic Transfer 

23 Fund Act (15 U.S.C. 1693a); and 


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1 ‘‘(ii) includes a financial institution 

2 (as defined in section 509 of the Gramm3 Leach-Bliley Act (15 U.S.C. 6809)). 

4 ‘‘(D) MONEY TRANSMITTING BUSINESS; 

5 MONEY TRANSMITTING SERVICE.—The terms 

6 ‘money transmitting business’ and ‘money 

7 transmitting service’ have the meaning given 

8 the terms in section 5330(d) of title 31, United 

9 States Code. 

10 ‘‘(E) BOARD.—The term ‘Board’ means 

11 the Board of Governors of the Federal Reserve 

12 System. 

13 ‘‘(7) POLICIES AND PROCEDURES REQUIRED TO

14 PREVENT RESTRICTED TRANSACTIONS.— 

15 ‘‘(A) REGULATIONS.—The Board shall 

16 promulgate regulations requiring— 

17 ‘‘(i) an operator of a credit card sys18 tem; 

19 ‘‘(ii) an operator of an international, 

20 national, regional, or local network used to 

21 effect a credit transaction, an electronic 

22 fund transfer, or a money transmitting 

23 service; 

24 ‘‘(iii) an operator of any other pay25 ment system that is centrally managed and 


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1 is primarily engaged in the transmission 

2 and settlement of credit transactions, elec3 tronic transfers or money transmitting 

4 services where at least one party to the 

5 transaction or transfer is an individual; 

6 and 

7 ‘‘(iv) any other person described in 

8 paragraph (2)(B) and specified by the 

9 Board in such regulations, 

10 to establish policies and procedures that are 

11 reasonably designed to prevent the introduction 

12 of a restricted transaction into a payment sys13 tem or the completion of a restricted trans14 action using a payment system. 

15 ‘‘(B) REQUIREMENTS FOR POLICIES AND

16 PROCEDURES.—In promulgating regulations 

17 under subparagraph (A), the Board shall— 

18 ‘‘(i) identify types of policies and pro19 cedures, including nonexclusive examples, 

20 that shall be considered to be reasonably 

21 designed to prevent the introduction of re22 stricted transactions into a payment sys23 tem or the completion of restricted trans24 actions using a payment system; and 


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1 ‘‘(ii) to the extent practicable, permit 

2 any payment system, or person described 

3 in paragraph (2)(B), as applicable, to 

4 choose among alternative means of pre5 venting the introduction or completion of 

6 restricted transactions. 

7 ‘‘(C) NO LIABILITY FOR BLOCKING OR RE8 FUSING TO HONOR RESTRICTED TRANS9 ACTION.— 

10 ‘‘(i) IN GENERAL.—A payment sys11 tem, or a person described in paragraph 

12 (2)(B) that is subject to a regulation 

13 issued under this subsection, and any par14 ticipant in such payment system that pre15 vents or otherwise refuses to honor trans16 actions in an effort to implement the poli17 cies and procedures required under this 

18 subsection or to otherwise comply with this 

19 subsection shall not be liable to any party 

20 for such action. 

21 ‘‘(ii) COMPLIANCE.—A person de22 scribed in paragraph (2)(B) meets the re23 quirements of this subsection if the person 

24 relies on and complies with the policies and 

25 procedures of a payment system of which 


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1 the person is a member or in which the 

2 person is a participant, and such policies 

3 and procedures of the payment system 

4 comply with the requirements of the regu5 lations promulgated under subparagraph 

6 (A). 

7 ‘‘(D) ENFORCEMENT.— 

8 ‘‘(i) IN GENERAL.—This subsection, 

9 and the regulations promulgated under 

10 this subsection, shall be enforced exclu11 sively by the Federal functional regulators 

12 and the Federal Trade Commission under 

13 applicable law in the manner provided in 

14 section 505(a) of the Gramm-Leach-Bliley 

15 Act (15 U.S.C. 6805(a)). 

16 ‘‘(ii) FACTORS TO BE CONSIDERED.— 

17 In considering any enforcement action 

18 under this subsection against a payment 

19 system or person described in paragraph 

20 (2)(B), the Federal functional regulators 

21 and the Federal Trade Commission shall 

22 consider the following factors: 

23 ‘‘(I) The extent to which the pay24 ment system or person knowingly per25 mits restricted transactions. 


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1 ‘‘(II) The history of the payment 

2 system or person in connection with 

3 permitting restricted transactions. 

4 ‘‘(III) The extent to which the 

5 payment system or person has estab6 lished and is maintaining policies and 

7 procedures in compliance with regula8 tions prescribed under this subsection. 

9 ‘‘(8) TRANSACTIONS PERMITTED.—A payment 

10 system, or a person described in paragraph (2)(B) 

11 that is subject to a regulation issued under this sub12 section, is authorized to engage in transactions with 

13 foreign pharmacies in connection with investigating 

14 violations or potential violations of any rule or re15 quirement adopted by the payment system or person 

16 in connection with complying with paragraph (7). A 

17 payment system, or such a person, and its agents 

18 and employees shall not be found to be in violation 

19 of, or liable under, any Federal, State or other law 

20 by virtue of engaging in any such transaction. 

21 ‘‘(9) RELATION TO STATE LAWS.—No require22 ment, prohibition, or liability may be imposed on a 

23 payment system, or a person described in paragraph 

24 (2)(B) that is subject to a regulation issued under 

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1 spect to any payment transaction by an individual 

2 because the payment transaction involves a payment 

3 to a foreign pharmacy. 

4 ‘‘(10) TIMING OF REQUIREMENTS.—A payment 

5 system, or a person described in paragraph (2)(B) 

6 that is subject to a regulation issued under this sub7 section, must adopt policies and procedures reason8 ably designed to comply with any regulations re9 quired under paragraph (7) within 60 days after 

10 such regulations are issued in final form. 

11 ‘‘(11) COMPLIANCE.—A payment system, and 

12 any person described in paragraph (2)(B), shall not 

13 be deemed to be in violation of paragraph (1)— 

14 ‘‘(A)(i) if an alleged violation of paragraph 

15 (1) occurs prior to the mandatory compliance 

16 date of the regulations issued under paragraph 

17 (7); and 

18 ‘‘(ii) such entity has adopted or relied on 

19 policies and procedures that are reasonably de20 signed to prevent the introduction of restricted 

21 transactions into a payment system or the com22 pletion of restricted transactions using a pay23 ment system; or 


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1 ‘‘(B)(i) if an alleged violation of paragraph 

2 (1) occurs after the mandatory compliance date 

3 of such regulations; and 

4 ‘‘(ii) such entity is in compliance with such 

5 regulations.’’. 

6 (b) EFFECTIVE DATE.—The amendment made by 

7 this section shall take effect on the day that is 90 days 

8 after the date of enactment of this Act. 

9 (c) IMPLEMENTATION.—The Board of Governors of 

10 the Federal Reserve System shall promulgate regulations 

11 as required by subsection (h)(7) of section 303 of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 

13 added by subsection (a), not later than 90 days after the 

14 date of enactment of this Act. 

15 SEC. 9. IMPORTATION EXEMPTION UNDER CONTROLLED 

16 SUBSTANCES IMPORT AND EXPORT ACT. 

17 Section 1006(a)(2) of the Controlled Substances Im18 port and Export Act (21 U.S.C. 956(a)(2)) is amended 

19 by striking ‘‘not import the controlled substance into the 

20 United States in an amount that exceeds 50 dosage units 

21 of the controlled substance.’’ and inserting ‘‘import into 

22 the United States not more than 10 dosage units com23 bined of all such controlled substances.’’. 


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1 SEC. 10. SEVERABILITY. 

2 If any provision of this Act, an amendment by this 

3 Act, or the application of such provision or amendment 

4 to any person or circumstance is held to be unconstitu5 tional, the remainder of this Act, the amendments made 

6 by this Act, and the application of the provisions of such 

7 to any person or circumstance shall not affected thereby. 

Æ 


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