II 

Calendar No. 73 

111TH CONGRESS 

1ST SESSION S. 1232 

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 

JUNE 10, 2009 

Mr. DORGAN (for himself, Ms. SNOWE, Mr. GRASSLEY, Mr. KENNEDY, Mr. 

MCCAIN, Ms. STABENOW, Mr. BINGAMAN, Ms. COLLINS, Mr. DURBIN, 

Mr. NELSON of Florida, Mr. KOHL, Mr. LEVIN, Mr. LEAHY, Mr. SANDERS, Mr. KERRY, Mr. BROWN, Mr. FEINGOLD, Mr. JOHNSON, Mr. 

INOUYE, Mr. TESTER, Mr. CASEY, Mrs. MCCASKILL, Mr. THUNE, Mr. 

BEGICH, Mrs. SHAHEEN, Ms. KLOBUCHAR, Mr. SPECTER, Mrs. BOXER, 

Mr. VITTER, and Mr. CONRAD) introduced the following bill; which was 

read the first time 

JUNE 11, 2009 

Read the second time and placed on the calendar 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Pharmaceutical Mar3 ket Access and Drug Safety Act of 2009’’. 

4 SEC. 2. FINDINGS. 

5 Congress finds that— 

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

7 to fill their prescriptions than consumers in other 

8 countries; 

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

10 pharmaceuticals in the world, yet American con11 sumers pay the highest prices for brand pharma12 ceuticals in the world; 

13 (3) a prescription drug is neither safe nor effec14 tive to an individual who cannot afford it; 

15 (4) allowing and structuring the importation of 

16 prescription drugs to ensure access to safe and af17 fordable drugs approved by the Food and Drug Ad18 ministration will provide a level of safety to Amer19 ican consumers that they do not currently enjoy; 

20 (5) American spend more than 

21 $200,000,000,000 on prescription drugs every year; 

22 (6) the Congressional Budget Office has found 

23 that the cost of prescription drugs are between 35 

24 to 55 percent less in other highly-developed coun25 tries than in the United States; and 


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1 (7) promoting competitive market pricing would 

2 both contribute to health care savings and allow 

3 greater access to therapy, improving health and sav4 ing lives. 

5 SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPOR6 TATION OF PRESCRIPTION DRUGS. 

7 Chapter VIII of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381 et seq.) is amended by striking 

9 section 804. 

10 SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 

11 OF CERTAIN IMPORT RESTRICTIONS. 

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

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

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

15 after section 803 the following: 

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

17 PRESCRIPTION DRUGS. 

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

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

20 drugs imported or offered for import into the United 

21 States from registered exporters or by registered im22 porters— 

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

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


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

2 801(a) regarding admission of the drugs are 

3 subject to subsection (g) of this section (includ4 ing with respect to qualifying drugs to which 

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

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

7 be imported under paragraph (1) unless— 

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

9 group of pharmacies, or a wholesaler that is a 

10 registered importer; or 

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

12 for personal use or for the use of a family mem13 ber of the individual (not for resale) from a reg14 istered exporter. 

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

16 shall apply only with respect to a drug that is im17 ported or offered for import into the United 

18 States— 

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

20 ‘‘(B) from a registered exporter to an indi21 vidual. 

22 ‘‘(4) DEFINITIONS.— 

23 ‘‘(A) REGISTERED EXPORTER; REG24 ISTERED IMPORTER.—For purposes of this sec25 tion: 


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

2 means an exporter for which a registration 

3 under subsection (b) has been approved 

4 and is in effect. 

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

6 means a pharmacy, group of pharmacies, 

7 or a wholesaler for which a registration 

8 under subsection (b) has been approved 

9 and is in effect. 

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

11 means a condition that must exist for a 

12 registration under subsection (b) to be ap13 proved. 

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

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

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

17 label drug. 

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

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

20 a prescription drug that— 

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

22 has the same active ingredient or ingredi23 ents, route of administration, dosage form, 

24 and strength as the qualifying drug; 


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1 ‘‘(ii) with respect to the qualifying 

2 drug, is manufactured by or for the person 

3 that manufactures the qualifying drug; 

4 ‘‘(iii) is approved under section 

5 505(c); and 

6 ‘‘(iv) is not— 

7 ‘‘(I) a controlled substance, as 

8 defined in section 102 of the Con9 trolled Substances Act (21 U.S.C. 

10 802); 

11 ‘‘(II) a biological product, as de12 fined in section 351 of the Public 

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

14 including— 

15 ‘‘(aa) a therapeutic DNA 

16 plasmid product; 

17 ‘‘(bb) a therapeutic synthetic 

18 peptide product; 

19 ‘‘(cc) a monoclonal antibody 

20 product for in vivo use; and 

21 ‘‘(dd) a therapeutic recom22 binant DNA-derived product; 

23 ‘‘(III) an infused drug, including 

24 a peritoneal dialysis solution; 

25 ‘‘(IV) an injected drug; 


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1 ‘‘(V) a drug that is inhaled dur2 ing surgery; 

3 ‘‘(VI) a drug that is the listed 

4 drug referred to in 2 or more abbre5 viated new drug applications under 

6 which the drug is commercially mar7 keted; or 

8 ‘‘(VII) a sterile opthlamic drug 

9 intended for topical use on or in the 

10 eye. 

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

12 of this section: 

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

14 person that is in the business of exporting 

15 a drug to individuals in the United States 

16 from Canada or from a permitted country 

17 designated by the Secretary under sub18 clause (II), or that, pursuant to submitting 

19 a registration under subsection (b), seeks 

20 to be in such business. 

21 ‘‘(II) The Secretary shall designate a 

22 permitted country under subparagraph (E) 

23 (other than Canada) as a country from 

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1 dividuals in the United States if the Sec2 retary determines that— 

3 ‘‘(aa) the country has statutory 

4 or regulatory standards that are 

5 equivalent to the standards in the 

6 United States and Canada with re7 spect to— 

8 ‘‘(AA) the training of phar9 macists; 

10 ‘‘(BB) the practice of phar11 macy; and 

12 ‘‘(CC) the protection of the 

13 privacy of personal medical infor14 mation; and 

15 ‘‘(bb) the importation of drugs to 

16 individuals in the United States from 

17 the country will not adversely affect 

18 public health. 

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

20 pharmacy, a group of pharmacies, or a 

21 wholesaler that is in the business of im22 porting a drug into the United States or 

23 that, pursuant to submitting a registration 

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

25 business. 


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

2 person licensed by a State to practice 

3 pharmacy, including the dispensing and 

4 selling of prescription drugs. 

5 ‘‘(iv) The term ‘pharmacy’ means a 

6 person that— 

7 ‘‘(I) is licensed by a State to en8 gage in the business of selling pre9 scription drugs at retail; and 

10 ‘‘(II) employs 1 or more phar11 macists. 

12 ‘‘(v) The term ‘prescription drug’ 

13 means a drug that is described in section 

14 503(b)(1). 

15 ‘‘(vi) The term ‘wholesaler’— 

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

17 wholesaler or distributor of prescrip18 tion drugs in the United States under 

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

20 ‘‘(II) does not include a person 

21 authorized to import drugs under sec22 tion 801(d)(1). 

23 ‘‘(E) PERMITTED COUNTRY.—The term 

24 ‘permitted country’ means— 

25 ‘‘(i) Australia; 


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1 ‘‘(ii) Canada; 

2 ‘‘(iii) a member country of the Euro3 pean Union, but does not include a mem4 ber country with respect to which— 

5 ‘‘(I) the country’s Annex to the 

6 Treaty of Accession to the European 

7 Union 2003 includes a transitional 

8 measure for the regulation of human 

9 pharmaceutical products that has not 

10 expired; or 

11 ‘‘(II) the Secretary determines 

12 that the requirements described in 

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

14 will not be met by the date on which 

15 such transitional measure for the reg16 ulation of human pharmaceutical 

17 products expires; 

18 ‘‘(iv) Japan; 

19 ‘‘(v) New Zealand; 

20 ‘‘(vi) Switzerland; and 

21 ‘‘(vii) a country in which the Sec22 retary determines the following require23 ments are met: 

24 ‘‘(I) The country has statutory or 

25 regulatory requirements— 


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1 ‘‘(aa) that require the review 

2 of drugs for safety and effective3 ness by an entity of the govern4 ment of the country; 

5 ‘‘(bb) that authorize the ap6 proval of only those drugs that 

7 have been determined to be safe 

8 and effective by experts employed 

9 by or acting on behalf of such en10 tity and qualified by scientific 

11 training and experience to evalu12 ate the safety and effectiveness of 

13 drugs on the basis of adequate 

14 and well-controlled investigations, 

15 including clinical investigations, 

16 conducted by experts qualified by 

17 scientific training and experience 

18 to evaluate the safety and effec19 tiveness of drugs; 

20 ‘‘(cc) that require the meth21 ods used in, and the facilities and 

22 controls used for the manufac23 ture, processing, and packing of 

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1 quate to preserve their identity, 

2 quality, purity, and strength; 

3 ‘‘(dd) for the reporting of 

4 adverse reactions to drugs and 

5 procedures to withdraw approval 

6 and remove drugs found not to 

7 be safe or effective; and 

8 ‘‘(ee) that require the label9 ing and promotion of drugs to be 

10 in accordance with the approval 

11 of the drug. 

12 ‘‘(II) The valid marketing au13 thorization system in the country is 

14 equivalent to the systems in the coun15 tries described in clauses (i) through 

16 (vi). 

17 ‘‘(III) The importation of drugs 

18 to the United States from the country 

19 will not adversely affect public health. 

20 ‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT21 ERS.— 

22 ‘‘(1) REGISTRATION OF IMPORTERS AND EX23 PORTERS.—A registration condition is that the im24 porter or exporter involved (referred to in this subVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 section as a ‘registrant’) submits to the Secretary a 

2 registration containing the following: 

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

4 name of the exporter and an identification of all 

5 places of business of the exporter that relate to 

6 qualifying drugs, including each warehouse or 

7 other facility owned or controlled by, or oper8 ated for, the exporter. 

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

10 of the importer and an identification of the 

11 places of business of the importer at which the 

12 importer initially receives a qualifying drug 

13 after importation (which shall not exceed 3 

14 places of business except by permission of the 

15 Secretary). 

16 ‘‘(B) Such information as the Secretary 

17 determines to be necessary to demonstrate that 

18 the registrant is in compliance with registration 

19 conditions under— 

20 ‘‘(i) in the case of an importer, sub21 sections (c), (d), (e), (g), and (j) (relating 

22 to the sources of imported qualifying 

23 drugs; the inspection of facilities of the im24 porter; the payment of fees; compliance 

25 with the standards referred to in section 


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1 801(a); and maintenance of records and 

2 samples); or 

3 ‘‘(ii) in the case of an exporter, sub4 sections (c), (d), (f), (g), (h), (i), and (j) 

5 (relating to the sources of exported quali6 fying drugs; the inspection of facilities of 

7 the exporter and the marking of compliant 

8 shipments; the payment of fees; and com9 pliance with the standards referred to in 

10 section 801(a); being licensed as a phar11 macist; conditions for individual importa12 tion; and maintenance of records and sam13 ples). 

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

15 the registrant will not under subsection (a) im16 port or export any drug that is not a qualifying 

17 drug. 

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

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

20 withdrawal of a qualifying drug distributed 

21 in a permitted country that the registrant 

22 has exported or imported, or intends to ex23 port or import, to the United States under 

24 subsection (a); 


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1 ‘‘(ii) provide for the return to the reg2 istrant of such drug; and 

3 ‘‘(iii) cease, or not begin, the expor4 tation or importation of such drug unless 

5 the Secretary has notified the registrant 

6 that exportation or importation of such 

7 drug may proceed. 

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

9 ensure and monitor compliance with each reg10 istration condition, to promptly correct any 

11 noncompliance with such a condition, and to 

12 promptly report to the Secretary any such non13 compliance. 

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

15 which the registrant will comply with the agree16 ment under subparagraph (E). 

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

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

19 against a party in the chain of custody of a 

20 qualifying drug with respect to the authority of 

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

22 subsection. 

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

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1 fore the registrant intends to make the change, 

2 of— 

3 ‘‘(i) any change that the registrant in4 tends to make regarding information pro5 vided under subparagraph (A) or (B); and 

6 ‘‘(ii) any change that the registrant 

7 intends to make in the compliance plan 

8 under subparagraph (F). 

9 ‘‘(I) In the case of an exporter: 

10 ‘‘(i) An agreement by the exporter 

11 that a qualifying drug will not under sub12 section (a) be exported to any individual 

13 not authorized pursuant to subsection 

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

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

16 payable to the Treasury of the United 

17 States that is equal in value to the lesser 

18 of— 

19 ‘‘(I) the value of drugs exported 

20 by the exporter to the United States 

21 in a typical 4-week period over the 

22 course of a year under this section; or 

23 ‘‘(II) $1,000,000. 

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

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1 dian law, or the law of the permitted coun2 try designated under subsection 

3 (a)(4)(D)(i)(II) in which the exporter is lo4 cated, that protect the privacy of personal 

5 information with respect to each individual 

6 importing a prescription drug from the ex7 porter under subsection (a)(2)(B). 

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

9 report to the Secretary— 

10 ‘‘(I) not later than August 1 of 

11 each fiscal year, the total price and 

12 the total volume of drugs exported to 

13 the United States by the exporter dur14 ing the 6-month period from January 

15 1 through June 30 of that year; and 

16 ‘‘(II) not later than January 1 of 

17 each fiscal year, the total price and 

18 the total volume of drugs exported to 

19 the United States by the exporter dur20 ing the previous fiscal year. 

21 ‘‘(J) In the case of an importer, an agree22 ment by the importer to report to the Sec23 retary— 

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

25 fiscal year, the total price and the total 


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1 volume of drugs imported to the United 

2 States by the importer during the 6-month 

3 period from January 1 through June 30 of 

4 that fiscal year; and 

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

6 fiscal year, the total price and the total 

7 volume of drugs imported to the United 

8 States by the importer during the previous 

9 fiscal year. 

10 ‘‘(K) Such other provisions as the Sec11 retary may require by regulation to protect the 

12 public health while permitting— 

13 ‘‘(i) the importation by pharmacies, 

14 groups of pharmacies, and wholesalers as 

15 registered importers of qualifying drugs 

16 under subsection (a); and 

17 ‘‘(ii) importation by individuals of 

18 qualifying drugs under subsection (a). 

19 ‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA20 TION.— 

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

22 days after the date on which a registrant sub23 mits to the Secretary a registration under para24 graph (1), the Secretary shall notify the reg25 istrant whether the registration is approved or 


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1 is disapproved. The Secretary shall disapprove 

2 a registration if there is reason to believe that 

3 the registrant is not in compliance with one or 

4 more registration conditions, and shall notify 

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

6 disapproved registration, the Secretary shall 

7 subsequently notify the registrant that the reg8 istration is approved if the Secretary deter9 mines that the registrant is in compliance with 

10 such conditions. 

11 ‘‘(B) CHANGES IN REGISTRATION INFOR12 MATION.—Not later than 30 days after receiv13 ing a notice under paragraph (1)(H) from a 

14 registrant, the Secretary shall determine wheth15 er the change involved affects the approval of 

16 the registration of the registrant under para17 graph (1), and shall inform the registrant of 

18 the determination. 

19 ‘‘(3) PUBLICATION OF CONTACT INFORMATION

20 FOR REGISTERED EXPORTERS.—Through the Inter21 net website of the Food and Drug Administration 

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

23 make readily available to the public a list of reg24 istered exporters, including contact information for 

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1 istration submitted under paragraph (1), the Sec2 retary shall update the Internet website and the in3 formation provided through the toll-free telephone 

4 number accordingly. 

5 ‘‘(4) SUSPENSION AND TERMINATION.— 

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

7 effectiveness of a registration submitted under 

8 paragraph (1): 

9 ‘‘(i) Subject to clause (ii), the Sec10 retary may suspend the registration if the 

11 Secretary determines, after notice and op12 portunity for a hearing, that the registrant 

13 has failed to maintain substantial compli14 ance with a registration condition. 

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

16 under color of the registration, the ex17 porter has exported a drug or the importer 

18 has imported a drug that is not a quali19 fying drug, or a drug that does not comply 

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

21 exported a qualifying drug to an individual 

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

23 Secretary shall immediately suspend the 

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1 sion by the Secretary of prior notice, and 

2 the Secretary shall provide to the reg3 istrant an opportunity for a hearing not 

4 later than 10 days after the date on which 

5 the registration is suspended. 

6 ‘‘(iii) The Secretary may reinstate the 

7 registration, whether suspended under 

8 clause (i) or (ii), if the Secretary deter9 mines that the registrant has demonstrated 

10 that further violations of registration con11 ditions will not occur. 

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

13 notice and opportunity for a hearing, may ter14 minate the registration under paragraph (1) of 

15 a registrant if the Secretary determines that 

16 the registrant has engaged in a pattern or prac17 tice of violating 1 or more registration condi18 tions, or if on 1 or more occasions the Secretary 

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

20 registration of the registrant. The Secretary 

21 may make the termination permanent, or for a 

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

23 period in which the registration is terminated, 

24 any registration submitted under paragraph (1) 

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


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1 in the export or import enterprise, or a prin2 cipal officer in such enterprise, and any reg3 istration prepared with the assistance of the 

4 registrant or such a person, has no legal effect 

5 under this section. 

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

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

8 shall be defaulted and paid to the Treasury of the 

9 United States if, after opportunity for an informal 

10 hearing, the Secretary determines that the exporter 

11 has— 

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

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

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

15 (i); or 

16 ‘‘(B) failed to permit the Secretary to con17 duct an inspection described under subsection 

18 (d). 

19 ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra20 tion condition is that the exporter or importer involved 

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

22 exported or imported into the United States only if there 

23 is compliance with the following: 

24 ‘‘(1) The drug was manufactured in an estab25 lishment— 


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1 ‘‘(A) required to register under subsection 

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

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

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

5 rely on a satisfactory report of a good manufac6 turing practice inspection of the establishment 

7 from a permitted country whose regulatory sys8 tem the Secretary recognizes as equivalent 

9 under a mutual recognition agreement, as pro10 vided for under section 510(i)(3), section 803, 

11 or part 26 of title 21, Code of Federal Regula12 tions (or any corresponding successor rule or 

13 regulation). 

14 ‘‘(2) The establishment is located in any coun15 try, and the establishment manufactured the drug 

16 for distribution in the United States or for distribu17 tion in 1 or more of the permitted countries (without 

18 regard to whether in addition the drug is manufac19 tured for distribution in a foreign country that is 

20 not a permitted country). 

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

22 drug— 

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

24 ‘‘(B) directly from an entity that, by con25 tract with the exporter or importer— 


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1 ‘‘(i) provides to the exporter or im2 porter a statement (in such form and con3 taining such information as the Secretary 

4 may require) that, for the chain of custody 

5 from the establishment, identifies each 

6 prior sale, purchase, or trade of the drug 

7 (including the date of the transaction and 

8 the names and addresses of all parties to 

9 the transaction); 

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

11 inspect such statements and related 

12 records to determine their accuracy; 

13 ‘‘(iii) agrees, with respect to the quali14 fying drugs involved, to permit the Sec15 retary to inspect warehouses and other fa16 cilities, including records, of the entity for 

17 purposes of determining whether the facili18 ties are in compliance with any standards 

19 under this Act that are applicable to facili20 ties of that type in the United States; and 

21 ‘‘(iv) has ensured, through such con22 tractual relationships as may be necessary, 

23 that the Secretary has the same authority 

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1 retary has under clauses (ii) and (iii) re2 garding such entity. 

3 ‘‘(4)(A) The foreign country from which the im4 porter will import the drug is a permitted country; 

5 or 

6 ‘‘(B) The foreign country from which the ex7 porter will export the drug is the permitted country 

8 in which the exporter is located. 

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

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

11 the drug did not enter any country that is not a per12 mitted country. 

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

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

15 ‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP16 MENTS.— 

17 ‘‘(1) INSPECTION OF FACILITIES.—A registra18 tion condition is that, for the purpose of assisting 

19 the Secretary in determining whether the exporter 

20 involved is in compliance with all other registration 

21 conditions— 

22 ‘‘(A) the exporter agrees to permit the Sec23 retary— 

24 ‘‘(i) to conduct onsite inspections, in25 cluding monitoring on a day-to-day basis, 


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1 of places of business of the exporter that 

2 relate to qualifying drugs, including each 

3 warehouse or other facility owned or con4 trolled by, or operated for, the exporter; 

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

6 day-to-day basis, to— 

7 ‘‘(I) records of the exporter that 

8 relate to the export of such drugs, in9 cluding financial records; and 

10 ‘‘(II) samples of such drugs; 

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

12 in paragraph (3); and 

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

14 determined by the Secretary to be nec15 essary regarding the compliance of the ex16 porter; and 

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

18 employees of the Secretary to carry out the 

19 functions described in this subsection for the 

20 Secretary randomly, but not less than 12 times 

21 annually, on the premises of places of busi22 nesses referred to in subparagraph (A)(i), and 

23 such an assignment remains in effect on a con24 tinuous basis. 


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

2 registration condition is that the exporter involved 

3 agrees to affix to each shipping container of quali4 fying drugs exported under subsection (a) such 

5 markings as the Secretary determines to be nec6 essary to identify the shipment as being in compli7 ance with all registration conditions. Markings under 

8 the preceding sentence shall— 

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

10 the markings to any shipping container that is 

11 not authorized to bear the markings; and 

12 ‘‘(B) include anticounterfeiting or track13 and-trace technologies, taking into account the 

14 economic and technical feasibility of those tech15 nologies. 

16 ‘‘(3) CERTAIN DUTIES RELATING TO EXPORT17 ERS.—Duties of the Secretary with respect to an ex18 porter include the following: 

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

20 than 12 times annually, the places of business 

21 of the exporter at which qualifying drugs are 

22 stored and from which qualifying drugs are 

23 shipped. 

24 ‘‘(B) During the inspections under sub25 paragraph (A), verifying the chain of custody of 


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1 a statistically significant sample of qualifying 

2 drugs from the establishment in which the drug 

3 was manufactured to the exporter, which shall 

4 be accomplished or supplemented by the use of 

5 anticounterfeiting or track-and-trace tech6 nologies, taking into account the economic and 

7 technical feasibility of those technologies, except 

8 that a drug that lacks such technologies from 

9 the point of manufacture shall not for that rea10 son be excluded from importation by an ex11 porter. 

12 ‘‘(C) Randomly reviewing records of ex13 ports to individuals for the purpose of deter14 mining whether the drugs are being imported 

15 by the individuals in accordance with the condi16 tions under subsection (i). Such reviews shall be 

17 conducted in a manner that will result in a sta18 tistically significant determination of compli19 ance with all such conditions. 

20 ‘‘(D) Monitoring the affixing of markings 

21 under paragraph (2). 

22 ‘‘(E) Inspecting as the Secretary deter23 mines is necessary the warehouses and other fa24 cilities, including records, of other parties in the 

25 chain of custody of qualifying drugs. 


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1 ‘‘(F) Determining whether the exporter is 

2 in compliance with all other registration condi3 tions. 

4 ‘‘(4) PRIOR NOTICE OF SHIPMENTS.—A reg5 istration condition is that, not less than 8 hours and 

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

7 importation of a shipment of qualifying drugs, the 

8 importer involved agrees to submit to the Secretary 

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

10 imported or offered for import into the United 

11 States under subsection (a). A notice under the pre12 ceding sentence shall include— 

13 ‘‘(A) the name and complete contact infor14 mation of the person submitting the notice; 

15 ‘‘(B) the name and complete contact infor16 mation of the importer involved; 

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

18 established name of the drug, the quantity of 

19 the drug, and the lot number assigned by the 

20 manufacturer; 

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

22 the drug, including the identity of the establish23 ment at which the drug was manufactured; 

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

25 shipped; 


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1 ‘‘(F) the name and complete contact infor2 mation for the shipper of the drug; 

3 ‘‘(G) anticipated arrival information, in4 cluding the port of arrival and crossing location 

5 within that port, and the date and time; 

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

7 the drug from the establishment in which the 

8 drug was manufactured to the importer; 

9 ‘‘(I) a declaration as to whether the Sec10 retary has ordered that importation of the drug 

11 from the permitted country cease under sub12 section (g)(2)(C) or (D); and 

13 ‘‘(J) such other information as the Sec14 retary may require by regulation. 

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

16 registration condition is that the importer involved 

17 agrees, before wholesale distribution (as defined in 

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

19 imported under subsection (a), to affix to each con20 tainer of such drug such markings or other tech21 nology as the Secretary determines necessary to 

22 identify the shipment as being in compliance with all 

23 registration conditions, except that the markings or 

24 other technology shall not be required on a drug 

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1 nology from the manufacturer of the drug. Markings 

2 or other technology under the preceding sentence 

3 shall— 

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

5 the markings or other technology to any con6 tainer that is not authorized to bear the mark7 ings; and 

8 ‘‘(B) shall include anticounterfeiting or 

9 track-and-trace technologies, taking into ac10 count the economic and technical feasibility of 

11 such technologies. 

12 ‘‘(6) CERTAIN DUTIES RELATING TO IMPORT13 ERS.—Duties of the Secretary with respect to an im14 porter include the following: 

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

16 than 12 times annually, the places of business 

17 of the importer at which a qualifying drug is 

18 initially received after importation. 

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 importer, 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 im6 porter. 

7 ‘‘(C) Reviewing notices under paragraph 

8 (4). 

9 ‘‘(D) Inspecting as the Secretary deter10 mines is necessary the warehouses and other fa11 cilities, including records of other parties in the 

12 chain of custody of qualifying drugs. 

13 ‘‘(E) Determining whether the importer is 

14 in compliance with all other registration condi15 tions. 

16 ‘‘(e) IMPORTER FEES.— 

17 ‘‘(1) REGISTRATION FEE.—A registration con18 dition is that the importer involved pays to the Sec19 retary a fee of $10,000 due on the date on which 

20 the importer first submits the registration to the 

21 Secretary under subsection (b). 

22 ‘‘(2) INSPECTION FEE.—A registration condi23 tion is that the importer involved pays a fee to the 

24 Secretary in accordance with this subsection. Such 

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


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1 1 of each fiscal year in the amount provided for 

2 under paragraph (3). 

3 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

4 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

5 later than 30 days before the start of each fis6 cal year, the Secretary, in consultation with the 

7 Secretary of Homeland Security and the Sec8 retary of the Treasury, shall establish an aggre9 gate total of fees to be collected under para10 graph (2) for importers for that fiscal year that 

11 is sufficient, and not more than necessary, to 

12 pay the costs for that fiscal year of admin13 istering this section with respect to registered 

14 importers, including the costs associated with— 

15 ‘‘(i) inspecting the facilities of reg16 istered importers, and of other entities in 

17 the chain of custody of a qualifying drug 

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

19 ‘‘(ii) developing, implementing, and 

20 operating under such subsection an elec21 tronic system for submission and review of 

22 the notices required under subsection 

23 (d)(4) with respect to shipments of quali24 fying drugs under subsection (a) to assess 

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) inspecting such shipments as 

4 necessary, when offered for import into the 

5 United States to determine if such a ship6 ment should be refused admission under 

7 subsection (g)(5). 

8 ‘‘(B) LIMITATION.—Subject to subpara9 graph (C), the aggregate total of fees collected 

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

11 exceed 2.5 percent of the total price of quali12 fying drugs imported during that fiscal year 

13 into the United States by registered importers 

14 under subsection (a). 

15 ‘‘(C) TOTAL PRICE OF DRUGS.— 

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

17 complying with the limitation described in 

18 subparagraph (B) when establishing under 

19 subparagraph (A) the aggregate total of 

20 fees to be collected under paragraph (2) 

21 for a fiscal year, the Secretary shall esti22 mate the total price of qualifying drugs im23 ported into the United States by registered 

24 importers during that fiscal year by adding 

25 the total price of qualifying drugs imported 


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1 by each registered importer during the 6- 

2 month period from January 1 through 

3 June 30 of the previous fiscal year, as re4 ported to the Secretary by each registered 

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

6 ‘‘(ii) CALCULATION.—Not later than 

7 March 1 of the fiscal year that follows the 

8 fiscal year for which the estimate under 

9 clause (i) is made, the Secretary shall cal10 culate the total price of qualifying drugs 

11 imported into the United States by reg12 istered importers during that fiscal year by 

13 adding the total price of qualifying drugs 

14 imported by each registered importer dur15 ing that fiscal year, as reported to the Sec16 retary by each registered importer under 

17 subsection (b)(1)(J). 

18 ‘‘(iii) ADJUSTMENT.—If the total 

19 price of qualifying drugs imported into the 

20 United States by registered importers dur21 ing a fiscal year as calculated under clause 

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

23 collected under paragraph (2) for that fis24 cal year, the Secretary shall provide for a 

25 pro-rata reduction in the fee due from each 


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1 registered importer on April 1 of the sub2 sequent fiscal year so that the limitation 

3 described in subparagraph (B) is observed. 

4 ‘‘(D) INDIVIDUAL IMPORTER FEE.—Sub5 ject to the limitation described in subparagraph 

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

7 October 1 and April 1 by an importer shall be 

8 an amount that is proportional to a reasonable 

9 estimate by the Secretary of the semiannual 

10 share of the importer of the volume of quali11 fying drugs imported by importers under sub12 section (a). 

13 ‘‘(4) USE OF FEES.— 

14 ‘‘(A) IN GENERAL.—Subject to appropria15 tions Acts, fees collected by the Secretary under 

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

17 appropriation account for salaries and expenses 

18 of the Food and Drug Administration until ex19 pended (without fiscal year limitation), and the 

20 Secretary may, in consultation with the Sec21 retary of Homeland Security and the Secretary 

22 of the Treasury, transfer some proportion of 

23 such fees to the appropriation account for sala24 ries and expenses of the Bureau of Customs 


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1 and Border Protection until expended (without 

2 fiscal year limitation). 

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

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

5 only available to the Secretary and, if trans6 ferred, to the Secretary of Homeland Security, 

7 and are for the sole purpose of paying the costs 

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

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

10 the Secretary does not receive payment of a fee as11 sessed under paragraph (1) or (2) within 30 days 

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

13 of the United States Government subject to sub14 chapter II of chapter 37 of title 31, United States 

15 Code. 

16 ‘‘(f) EXPORTER FEES.— 

17 ‘‘(1) REGISTRATION FEE.—A registration con18 dition is that the exporter involved pays to the Sec19 retary a fee of $10,000 due on the date on which 

20 the exporter first submits that registration to the 

21 Secretary under subsection (b). 

22 ‘‘(2) INSPECTION FEE.—A registration condi23 tion is that the exporter involved pays a fee to the 

24 Secretary in accordance with this subsection. Such 

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


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1 1 of each fiscal year in the amount provided for 

2 under paragraph (3). 

3 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

4 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

5 later than 30 days before the start of each fis6 cal year, the Secretary, in consultation with the 

7 Secretary of Homeland Security and the Sec8 retary of the Treasury, shall establish an aggre9 gate total of fees to be collected under para10 graph (2) for exporters for that fiscal year that 

11 is sufficient, and not more than necessary, to 

12 pay the costs for that fiscal year of admin13 istering this section with respect to registered 

14 exporters, including the costs associated with— 

15 ‘‘(i) inspecting the facilities of reg16 istered exporters, and of other entities in 

17 the chain of custody of a qualifying drug 

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

19 ‘‘(ii) developing, implementing, and 

20 operating under such subsection a system 

21 to screen marks on shipments of qualifying 

22 drugs under subsection (a) that indicate 

23 compliance with all registration conditions, 

24 when such shipments are offered for im25 port into the United States; and 


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1 ‘‘(iii) screening such markings, and 

2 inspecting such shipments as necessary, 

3 when offered for import into the United 

4 States to determine if such a shipment 

5 should be refused admission under sub6 section (g)(5). 

7 ‘‘(B) LIMITATION.—Subject to subpara8 graph (C), the aggregate total of fees collected 

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

10 exceed 2.5 percent of the total price of quali11 fying drugs imported during that fiscal year 

12 into the United States by registered exporters 

13 under subsection (a). 

14 ‘‘(C) TOTAL PRICE OF DRUGS.— 

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

16 complying with the limitation described in 

17 subparagraph (B) when establishing under 

18 subparagraph (A) the aggregate total of 

19 fees to be collected under paragraph (2) 

20 for a fiscal year, the Secretary shall esti21 mate the total price of qualifying drugs im22 ported into the United States by registered 

23 exporters during that fiscal year by adding 

24 the total price of qualifying drugs exported 

25 by each registered exporter during the 6- 


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1 month period from January 1 through 

2 June 30 of the previous fiscal year, as re3 ported to the Secretary by each registered 

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

5 ‘‘(ii) CALCULATION.—Not later than 

6 March 1 of the fiscal year that follows the 

7 fiscal year for which the estimate under 

8 clause (i) is made, the Secretary shall cal9 culate the total price of qualifying drugs 

10 imported into the United States by reg11 istered exporters during that fiscal year by 

12 adding the total price of qualifying drugs 

13 exported by each registered exporter dur14 ing that fiscal year, as reported to the Sec15 retary by each registered exporter under 

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

17 ‘‘(iii) ADJUSTMENT.—If the total 

18 price of qualifying drugs imported into the 

19 United States by registered exporters dur20 ing a fiscal year as calculated under clause 

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

22 collected under paragraph (2) for that fis23 cal year, the Secretary shall provide for a 

24 pro-rata reduction in the fee due from each 

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1 quent fiscal year so that the limitation de2 scribed in subparagraph (B) is observed. 

3 ‘‘(D) INDIVIDUAL EXPORTER 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 exporter shall be 

7 an amount that is proportional to a reasonable 

8 estimate by the Secretary of the semiannual 

9 share of the exporter of the volume of quali10 fying drugs exported by exporters under sub11 section (a). 

12 ‘‘(4) USE OF FEES.— 

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

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

16 appropriation account for salaries and expenses 

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

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

21 of the Treasury, transfer some proportion of 

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

24 and Border Protection until expended (without 

25 fiscal year limitation). 


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

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

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

5 and are for the sole purpose of paying the costs 

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

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

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

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

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

13 Code. 

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

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

16 that each qualifying drug exported under subsection 

17 (a) by the registered exporter involved or imported 

18 under subsection (a) by the registered importer in19 volved is in compliance with the standards referred 

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

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

22 (3), and (4). 

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

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

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1 section (a) shall comply with the conditions es2 tablished in the approved application under sec3 tion 505(b) for the U.S. label drug as described 

4 under this subsection. 

5 ‘‘(B) NOTICE BY MANUFACTURER; GEN6 ERAL PROVISIONS.— 

7 ‘‘(i) IN GENERAL.—The person that 

8 manufactures a qualifying drug that is, or 

9 will be, introduced for commercial distribu10 tion in a permitted country shall in accord11 ance with this paragraph submit to the 

12 Secretary a notice that— 

13 ‘‘(I) includes each difference in 

14 the qualifying drug from a condition 

15 established in the approved applica16 tion for the U.S. label drug beyond— 

17 ‘‘(aa) the variations provided 

18 for in the application; and 

19 ‘‘(bb) any difference in label20 ing (except ingredient labeling); 

21 or 

22 ‘‘(II) states that there is no dif23 ference in the qualifying drug from a 

24 condition established in the approved 


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1 application for the U.S. label drug be2 yond— 

3 ‘‘(aa) the variations provided 

4 for in the application; and 

5 ‘‘(bb) any difference in label6 ing (except ingredient labeling). 

7 ‘‘(ii) INFORMATION IN NOTICE.—A 

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

9 information that the Secretary may require 

10 under section 506A, any additional infor11 mation the Secretary may require (which 

12 may include data on bioequivalence if such 

13 data are not required under section 506A), 

14 and, with respect to the permitted country 

15 that approved the qualifying drug for com16 mercial distribution, or with respect to 

17 which such approval is sought, include the 

18 following: 

19 ‘‘(I) The date on which the quali20 fying drug with such difference was, 

21 or will be, introduced for commercial 

22 distribution in the permitted country. 

23 ‘‘(II) Information demonstrating 

24 that the person submitting the notice 

25 has also notified the government of 


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1 the permitted country in writing that 

2 the person is submitting to the Sec3 retary a notice under clause (i)(I), 

4 which notice describes the difference 

5 in the qualifying drug from a condi6 tion established in the approved appli7 cation for the U.S. label drug. 

8 ‘‘(III) The information that the 

9 person submitted or will submit to the 

10 government of the permitted country 

11 for purposes of obtaining approval for 

12 commercial distribution of the drug in 

13 the country which, if in a language 

14 other than English, shall be accom15 panied by an English translation 

16 verified to be complete and accurate, 

17 with the name, address, and a brief 

18 statement of the qualifications of the 

19 person that made the translation. 

20 ‘‘(iii) CERTIFICATIONS.—The chief ex21 ecutive officer and the chief medical officer 

22 of the manufacturer involved shall each 

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

24 ‘‘(I) the information provided in 

25 the notice is complete and true; and 


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1 ‘‘(II) a copy of the notice has 

2 been provided to the Federal Trade 

3 Commission and to the State attor4 neys general. 

5 ‘‘(iv) FEE.—If a notice submitted 

6 under clause (i) includes a difference that 

7 would, under section 506A, require the 

8 submission of a supplemental application if 

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

10 the person that submits the notice shall 

11 pay to the Secretary a fee in the same 

12 amount as would apply if the person were 

13 paying a fee pursuant to section 

14 736(a)(1)(A)(ii). Subject to appropriations 

15 Acts, fees collected by the Secretary under 

16 the preceding sentence are available only to 

17 the Secretary and are for the sole purpose 

18 of paying the costs of reviewing notices 

19 submitted under clause (i). 

20 ‘‘(v) TIMING OF SUBMISSION OF NO21 TICES.— 

22 ‘‘(I) PRIOR APPROVAL NO23 TICES.—A notice under clause (i) to 

24 which subparagraph (C) applies shall 

25 be submitted to the Secretary not 


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1 later than 120 days before the quali2 fying drug with the difference is intro3 duced for commercial distribution in a 

4 permitted country, unless the country 

5 requires that distribution of the quali6 fying drug with the difference begin 

7 less than 120 days after the country 

8 requires the difference. 

9 ‘‘(II) OTHER APPROVAL NO10 TICES.—A notice under clause (i) to 

11 which subparagraph (D) applies shall 

12 be submitted to the Secretary not 

13 later than the day on which the quali14 fying drug with the difference is intro15 duced for commercial distribution in a 

16 permitted country. 

17 ‘‘(III) OTHER NOTICES.—A no18 tice under clause (i) to which subpara19 graph (E) applies shall be submitted 

20 to the Secretary on the date that the 

21 qualifying drug is first introduced for 

22 commercial distribution in a permitted 

23 country and annually thereafter. 

24 ‘‘(vi) REVIEW BY SECRETARY.— 


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1 ‘‘(I) IN GENERAL.—In this para2 graph, the difference in a qualifying 

3 drug that is submitted in a notice 

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

5 drug shall be treated by the Secretary 

6 as if it were a manufacturing change 

7 to the U.S. label drug under section 

8 506A. 

9 ‘‘(II) STANDARD OF REVIEW.— 

10 Except as provided in subclause (III), 

11 the Secretary shall review and approve 

12 or disapprove the difference in a no13 tice submitted under clause (i), if re14 quired under section 506A, using the 

15 safe and effective standard for ap16 proving or disapproving a manufac17 turing change under section 506A. 

18 ‘‘(III) BIOEQUIVALENCE.—If the 

19 Secretary would approve the dif20 ference in a notice submitted under 

21 clause (i) using the safe and effective 

22 standard under section 506A and if 

23 the Secretary determines that the 

24 qualifying drug is not bioequivalent to 


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1 the U.S. label drug, the Secretary 

2 shall— 

3 ‘‘(aa) include in the labeling 

4 provided under paragraph (3) a 

5 prominent advisory that the 

6 qualifying drug is safe and effec7 tive but is not bioequivalent to 

8 the U.S. label drug if the Sec9 retary determines that such an 

10 advisory is necessary for health 

11 care practitioners and patients to 

12 use the qualifying drug safely 

13 and effectively; or 

14 ‘‘(bb) decline to approve the 

15 difference if the Secretary deter16 mines that the availability of 

17 both the qualifying drug and the 

18 U.S. label drug would pose a 

19 threat to the public health. 

20 ‘‘(IV) REVIEW BY THE SEC21 RETARY.—The Secretary shall review 

22 and approve or disapprove the dif23 ference in a notice submitted under 

24 clause (i), if required under section 

25 506A, not later than 120 days after 


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1 the date on which the notice is sub2 mitted. 

3 ‘‘(V) ESTABLISHMENT INSPEC4 TION.—If review of such difference 

5 would require an inspection of the es6 tablishment in which the qualifying 

7 drug is manufactured— 

8 ‘‘(aa) such inspection by the 

9 Secretary shall be authorized; 

10 and 

11 ‘‘(bb) the Secretary may rely 

12 on a satisfactory report of a good 

13 manufacturing practice inspec14 tion of the establishment from a 

15 permitted country whose regu16 latory system the Secretary rec17 ognizes as equivalent under a 

18 mutual recognition agreement, as 

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

20 section 803, or part 26 of title 

21 21, Code of Federal Regulations 

22 (or any corresponding successor 

23 rule or regulation). 

24 ‘‘(vii) PUBLICATION OF INFORMATION

25 ON NOTICES.— 


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1 ‘‘(I) IN GENERAL.—Through the 

2 Internet website of the Food and 

3 Drug Administration and a toll-free 

4 telephone number, the Secretary shall 

5 readily make available to the public a 

6 list of notices submitted under clause 

7 (i). 

8 ‘‘(II) CONTENTS.—The list under 

9 subclause (I) shall include the date on 

10 which a notice is submitted and 

11 whether— 

12 ‘‘(aa) a notice is under re13 view; 

14 ‘‘(bb) the Secretary has or15 dered that importation of the 

16 qualifying drug from a permitted 

17 country cease; or 

18 ‘‘(cc) the importation of the 

19 drug is permitted under sub20 section (a). 

21 ‘‘(III) UPDATE.—The Secretary 

22 shall promptly update the Internet 

23 website with any changes to the list. 

24 ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR25 ING PRIOR APPROVAL.—In the case of a notice 


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1 under subparagraph (B)(i) that includes a dif2 ference that would, under section 506A(c) or 

3 (d)(3)(B)(i), require the approval of a supple4 mental application before the difference could 

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

6 shall occur: 

7 ‘‘(i) Promptly after the notice is sub8 mitted, the Secretary shall notify reg9 istered exporters, registered importers, the 

10 Federal Trade Commission, and the State 

11 attorneys general that the notice has been 

12 submitted with respect to the qualifying 

13 drug involved. 

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

15 determination whether such a supple16 mental application regarding the U.S. label 

17 drug would be approved or disapproved by 

18 the date on which the qualifying drug in19 volved is to be introduced for commercial 

20 distribution in a permitted country, the 

21 Secretary shall— 

22 ‘‘(I) order that the importation of 

23 the qualifying drug involved from the 

24 permitted country not begin until the 


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1 Secretary completes review of the no2 tice; and 

3 ‘‘(II) promptly notify registered 

4 exporters, registered importers, the 

5 Federal Trade Commission, and the 

6 State attorneys general of the order. 

7 ‘‘(iii) If the Secretary determines that 

8 such a supplemental application regarding 

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

10 the Secretary shall— 

11 ‘‘(I) order that the importation of 

12 the qualifying drug involved from the 

13 permitted country cease, or provide 

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

15 remains in effect; 

16 ‘‘(II) notify the permitted coun17 try that approved the qualifying drug 

18 for commercial distribution of the de19 termination; and 

20 ‘‘(III) promptly notify registered 

21 exporters, registered importers, the 

22 Federal Trade Commission, and the 

23 State attorneys general of the deter24 mination. 


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1 ‘‘(iv) If the Secretary determines that 

2 such a supplemental application regarding 

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

4 Secretary shall— 

5 ‘‘(I) vacate the order under 

6 clause (ii), if any; 

7 ‘‘(II) consider the difference to 

8 be a variation provided for in the ap9 proved application for the U.S. label 

10 drug; 

11 ‘‘(III) permit importation of the 

12 qualifying drug under subsection (a); 

13 and 

14 ‘‘(IV) promptly notify registered 

15 exporters, registered importers, the 

16 Federal Trade Commission, and the 

17 State attorneys general of the deter18 mination. 

19 ‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE20 QUIRING PRIOR APPROVAL.—In the case of a 

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

22 a difference that would, under section 

23 506A(d)(3)(B)(ii), not require the approval of a 

24 supplemental application before the difference 


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1 could be made to the U.S. label drug the fol2 lowing shall occur: 

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

4 notice is being reviewed by the Secretary, 

5 the authority under this subsection to im6 port the qualifying drug involved continues 

7 in effect. 

8 ‘‘(ii) If the Secretary determines that 

9 such a supplemental application regarding 

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

11 the Secretary shall— 

12 ‘‘(I) order that the importation of 

13 the qualifying drug involved from the 

14 permitted country cease; 

15 ‘‘(II) notify the permitted coun16 try that approved the qualifying drug 

17 for commercial distribution of the de18 termination; and 

19 ‘‘(III) promptly notify registered 

20 exporters, registered importers, the 

21 Federal Trade Commission, and the 

22 State attorneys general of the deter23 mination. 

24 ‘‘(iii) If the Secretary determines that 

25 such a supplemental application regarding 


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

2 difference shall be considered to be a vari3 ation provided for in the approved applica4 tion for the U.S. label drug. 

5 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE6 QUIRING APPROVAL; NO DIFFERENCE.—In the 

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

8 includes a difference for which, under section 

9 506A(d)(1)(A), a supplemental application 

10 would not be required for the difference to be 

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

12 there is no difference, the Secretary— 

13 ‘‘(i) shall consider such difference to 

14 be a variation provided for in the approved 

15 application for the U.S. label drug; 

16 ‘‘(ii) may not order that the importa17 tion of the qualifying drug involved cease; 

18 and 

19 ‘‘(iii) shall promptly notify registered 

20 exporters and registered importers. 

21 ‘‘(F) DIFFERENCES IN ACTIVE INGRE22 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

23 FORM, OR STRENGTH.— 

24 ‘‘(i) IN GENERAL.—A person who 

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1 tion 505(b) shall submit an application 

2 under section 505(b) for approval of an3 other drug that is manufactured for dis4 tribution in a permitted country by or for 

5 the person that manufactures the drug ap6 proved under section 505(b) if— 

7 ‘‘(I) there is no qualifying drug 

8 in commercial distribution in per9 mitted countries whose combined pop10 ulation represents at least 50 percent 

11 of the total population of all permitted 

12 countries with the same active ingre13 dient or ingredients, route of adminis14 tration, dosage form, and strength as 

15 the drug approved under section 

16 505(b); and 

17 ‘‘(II) each active ingredient of 

18 the other drug is related to an active 

19 ingredient of the drug approved under 

20 section 505(b), as defined in clause 

21 (v). 

22 ‘‘(ii) APPLICATION UNDER SECTION

23 505(b).—The application under section 

24 505(b) required under clause (i) shall— 


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1 ‘‘(I) request approval of the other 

2 drug for the indication or indications 

3 for which the drug approved under 

4 section 505(b) is labeled; 

5 ‘‘(II) include the information that 

6 the person submitted to the govern7 ment of the permitted country for 

8 purposes of obtaining approval for 

9 commercial distribution of the other 

10 drug in that country, which if in a 

11 language other than English, shall be 

12 accompanied by an English trans13 lation verified to be complete and ac14 curate, with the name, address, and a 

15 brief statement of the qualifications of 

16 the person that made the translation; 

17 ‘‘(III) include a right of reference 

18 to the application for the drug ap19 proved under section 505(b); and 

20 ‘‘(IV) include such additional in21 formation as the Secretary may re22 quire. 

23 ‘‘(iii) TIMING OF SUBMISSION OF AP24 PLICATION.—An application under section 

25 505(b) required under clause (i) shall be 


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1 submitted to the Secretary not later than 

2 the day on which the information referred 

3 to in clause (ii)(II) is submitted to the gov4 ernment of the permitted country. 

5 ‘‘(iv) NOTICE OF DECISION ON APPLI6 CATION.—The Secretary shall promptly no7 tify registered exporters, registered import8 ers, the Federal Trade Commission, and 

9 the State attorneys general of a determina10 tion to approve or to disapprove an appli11 cation under section 505(b) required under 

12 clause (i). 

13 ‘‘(v) RELATED ACTIVE INGREDI14 ENTS.—For purposes of clause (i)(II), 2 

15 active ingredients are related if they are— 

16 ‘‘(I) the same; or 

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

18 complexes of the same moiety. 

19 ‘‘(3) SECTION 502; LABELING.— 

20 ‘‘(A) IMPORTATION BY REGISTERED IM21 PORTER.— 

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

23 qualifying drug that is imported or offered 

24 for import by a registered importer, such 

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1 ance with section 502 and the labeling re2 quirements under the approved application 

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

4 drug bears— 

5 ‘‘(I) a copy of the labeling ap6 proved for the U.S. label drug under 

7 section 505, without regard to wheth8 er the copy bears any trademark in9 volved; 

10 ‘‘(II) the name of the manufac11 turer and location of the manufac12 turer; 

13 ‘‘(III) the lot number assigned by 

14 the manufacturer; 

15 ‘‘(IV) the name, location, and 

16 registration number of the importer; 

17 and 

18 ‘‘(V) the National Drug Code 

19 number assigned to the qualifying 

20 drug by the Secretary. 

21 ‘‘(ii) REQUEST FOR COPY OF THE LA22 BELING.—The Secretary shall provide such 

23 copy to the registered importer involved, 

24 upon request of the importer. 


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1 ‘‘(iii) REQUESTED LABELING.—The 

2 labeling provided by the Secretary under 

3 clause (ii) shall— 

4 ‘‘(I) include the established 

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

6 for each active ingredient in the quali7 fying drug; 

8 ‘‘(II) not include the proprietary 

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

10 active ingredient thereof; 

11 ‘‘(III) if required under para12 graph (2)(B)(vi)(III), a prominent ad13 visory that the qualifying drug is safe 

14 and effective but not bioequivalent to 

15 the U.S. label drug; and 

16 ‘‘(IV) if the inactive ingredients 

17 of the qualifying drug are different 

18 from the inactive ingredients for the 

19 U.S. label drug, include— 

20 ‘‘(aa) a prominent notice 

21 that the ingredients of the quali22 fying drug differ from the ingre23 dients of the U.S. label drug and 

24 that the qualifying drug must be 

25 dispensed with an advisory to 


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1 people with allergies about this 

2 difference and a list of ingredi3 ents; and 

4 ‘‘(bb) a list of the ingredi5 ents of the qualifying drug as 

6 would be required under section 

7 502(e). 

8 ‘‘(B) IMPORTATION BY INDIVIDUAL.— 

9 ‘‘(i) IN GENERAL.—In the case of a 

10 qualifying drug that is imported or offered 

11 for import by a registered exporter to an 

12 individual, such drug shall be considered to 

13 be in compliance with section 502 and the 

14 labeling requirements under the approved 

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

16 packaging and labeling of the qualifying 

17 drug complies with all applicable regula18 tions promulgated under sections 3 and 4 

19 of the Poison Prevention Packaging Act of 

20 1970 (15 U.S.C. 1471 et seq.) and the la21 beling of the qualifying drug includes— 

22 ‘‘(I) directions for use by the 

23 consumer; 

24 ‘‘(II) the lot number assigned by 

25 the manufacturer; 


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1 ‘‘(III) the name and registration 

2 number of the exporter; 

3 ‘‘(IV) if required under para4 graph (2)(B)(vi)(III), a prominent ad5 visory that the drug is safe and effec6 tive but not bioequivalent to the U.S. 

7 label drug; 

8 ‘‘(V) if the inactive ingredients of 

9 the drug are different from the inac10 tive ingredients for the U.S. label 

11 drug— 

12 ‘‘(aa) a prominent advisory 

13 that persons with an allergy 

14 should check the ingredient list 

15 of the drug because the ingredi16 ents of the drug differ from the 

17 ingredients of the U.S. label 

18 drug; and 

19 ‘‘(bb) a list of the ingredi20 ents of the drug as would be re21 quired under section 502(e); and 

22 ‘‘(VI) a copy of any special label23 ing that would be required by the Sec24 retary had the U.S. label drug been 

25 dispensed by a pharmacist in the 


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1 United States, without regard to 

2 whether the special labeling bears any 

3 trademark involved. 

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

5 offered for import to an individual by an 

6 exporter under this section that is pack7 aged in a unit-of-use container (as those 

8 items are defined in the United States 

9 Pharmacopeia and National Formulary) 

10 shall not be repackaged, provided that— 

11 ‘‘(I) the packaging complies with 

12 all applicable regulations under sec13 tions 3 and 4 of the Poison Preven14 tion Packaging Act of 1970 (15 

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

16 ‘‘(II) the consumer consents to 

17 waive the requirements of such Act, 

18 after being informed that the pack19 aging does not comply with such Act 

20 and that the exporter will provide the 

21 drug in packaging that is compliant at 

22 no additional cost. 

23 ‘‘(iii) REQUEST FOR COPY OF SPECIAL

24 LABELING AND INGREDIENT LIST.—The 

25 Secretary shall provide to the registered 


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1 exporter involved a copy of the special la2 beling, the advisory, and the ingredient list 

3 described under clause (i), upon request of 

4 the exporter. 

5 ‘‘(iv) REQUESTED LABELING AND IN6 GREDIENT LIST.—The labeling and ingre7 dient list provided by the Secretary under 

8 clause (iii) shall— 

9 ‘‘(I) include the established 

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

11 for each active ingredient in the drug; 

12 and 

13 ‘‘(II) not include the proprietary 

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

15 active ingredient thereof. 

16 ‘‘(4) SECTION 501; ADULTERATION.—A quali17 fying drug that is imported or offered for import 

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

19 compliance with section 501 if the drug is in compli20 ance with subsection (c). 

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

22 A drug exported under subsection (a) from a reg23 istered exporter or imported by a registered importer 

24 may be refused admission into the United States if 

25 1 or more of the following applies: 


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

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

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

4 Secretary. 

5 ‘‘(C) The Secretary has ordered that im6 portation of the drug from the permitted coun7 try cease under paragraph (2) (C) or (D). 

8 ‘‘(D) The drug does not comply with para9 graph (3) or (4). 

10 ‘‘(E) The shipping container appears dam11 aged in a way that may affect the strength, 

12 quality, or purity of the drug. 

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

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

15 ‘‘(ii) the drug may have been pre16 pared, packed, or held under insanitary 

17 conditions; or 

18 ‘‘(iii) the methods used in, or the fa19 cilities or controls used for, the manufac20 turing, processing, packing, or holding of 

21 the drug do not conform to good manufac22 turing practice. 

23 ‘‘(G) The Secretary has obtained an in24 junction under section 302 that prohibits the 

25 distribution of the drug in interstate commerce. 


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1 ‘‘(H) The Secretary has under section 

2 505(e) withdrawn approval of the drug. 

3 ‘‘(I) The manufacturer of the drug has in4 stituted a recall of the drug. 

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

6 import by a registered importer without submis7 sion of a notice in accordance with subsection 

8 (d)(4). 

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

10 import from a registered exporter to an indi11 vidual and 1 or more of the following applies: 

12 ‘‘(i) The shipping container for such 

13 drug does not bear the markings required 

14 under subsection (d)(2). 

15 ‘‘(ii) The markings on the shipping 

16 container appear to be counterfeit. 

17 ‘‘(iii) The shipping container or mark18 ings appear to have been tampered with. 

19 ‘‘(h) EXPORTER LICENSURE IN PERMITTED COUN20 TRY.—A registration condition is that the exporter in21 volved agrees that a qualifying drug will be exported to 

22 an individual only if the Secretary has verified that— 

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

24 the permitted country in which the exporter is lo25 cated to dispense prescription drugs; and 


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1 ‘‘(2) the exporter employs persons that are li2 censed under the law of the permitted country in 

3 which the exporter is located to dispense prescription 

4 drugs in sufficient number to dispense safely the 

5 drugs exported by the exporter to individuals, and 

6 the exporter assigns to those persons responsibility 

7 for dispensing such drugs to individuals. 

8 ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTA9 TION.— 

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

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

12 an individual is in accordance with this subsection if 

13 the following conditions are met: 

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

15 a prescription for the drug, which prescrip16 tion— 

17 ‘‘(i) is valid under applicable Federal 

18 and State laws; and 

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

20 under the law of a State of which the indi21 vidual is a resident, or in which the indi22 vidual receives care from the practitioner 

23 who issues the prescription, is authorized 

24 to administer prescription drugs. 


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

2 of the documentation that was required under 

3 the law or regulations of the permitted country 

4 in which the exporter is located, as a condition 

5 of dispensing the drug to the individual. 

6 ‘‘(C) The copies referred to in subpara7 graphs (A)(i) and (B) are marked in a manner 

8 sufficient— 

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

10 and the equivalent document in the per11 mitted country in which the exporter is lo12 cated, have been filled; and 

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

14 another pharmacist. 

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

16 registered exporter a complete list of all drugs 

17 used by the individual for review by the individ18 uals who dispense the drug. 

19 ‘‘(E) The quantity of the drug does not ex20 ceed a 90-day supply. 

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

22 H drug. For purposes of this section, a pre23 scription drug is an ‘ineligible subpart H drug’ 

24 if the drug was approved by the Secretary 

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


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1 of Federal Regulations (relating to accelerated 

2 approval), with restrictions under section 520 of 

3 such part to assure safe use, and the Secretary 

4 has published in the Federal Register a notice 

5 that the Secretary has determined that good 

6 cause exists to prohibit the drug from being im7 ported pursuant to this subsection. 

8 ‘‘(2) NOTICE REGARDING DRUG REFUSED AD9 MISSION.—If a registered exporter ships a drug to 

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

11 the drug is refused admission to the United States, 

12 a written notice shall be sent to the individual and 

13 to the exporter that informs the individual and the 

14 exporter of such refusal and the reason for the re15 fusal. 

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

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

18 that the importer or exporter involved shall— 

19 ‘‘(A) maintain records required under this 

20 section for not less than 2 years; and 

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

22 qualifying drug required under this section for 

23 not more than 2 years. 


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

2 records described under paragraph (1) shall be 

3 maintained— 

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

5 place of business of the importer at which the 

6 importer initially receives the qualifying drug 

7 after importation; or 

8 ‘‘(B) in the case of an exporter, at the fa9 cility from which the exporter ships the quali10 fying drug to the United States. 

11 ‘‘(k) DRUG RECALLS.— 

12 ‘‘(1) MANUFACTURERS.—A person that manu13 factures a qualifying drug imported from a per14 mitted country under this section shall promptly in15 form the Secretary— 

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

17 from the market in a permitted country; 

18 ‘‘(B) how the drug may be identified, in19 cluding lot number; and 

20 ‘‘(C) the reason for the recall or with21 drawal. 

22 ‘‘(2) SECRETARY.—With respect to each per23 mitted country, the Secretary shall— 

24 ‘‘(A) enter into an agreement with the gov25 ernment of the country to receive information 


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1 about recalls and withdrawals of qualifying 

2 drugs in the country; or 

3 ‘‘(B) monitor recalls and withdrawals of 

4 qualifying drugs in the country using any infor5 mation that is available to the public in any 

6 media. 

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

8 appropriate, registered exporters, registered import9 ers, wholesalers, pharmacies, or the public of a recall 

10 or withdrawal of a qualifying drug in a permitted 

11 country. 

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

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

14 that is imported into the United States by an im15 porter under subsection (a) is dispensed by a phar16 macist to an individual, the pharmacist shall provide 

17 that the packaging and labeling of the drug complies 

18 with all applicable regulations promulgated under 

19 sections 3 and 4 of the Poison Prevention Packaging 

20 Act of 1970 (15 U.S.C. 1471 et seq.) and shall in21 clude with any other labeling provided to the indi22 vidual the following: 

23 ‘‘(A) The lot number assigned by the man24 ufacturer. 


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

2 the importer. 

3 ‘‘(C) If required under paragraph 

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

5 advisory that the drug is safe and effective but 

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

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

8 are different from the inactive ingredients for 

9 the U.S. label drug— 

10 ‘‘(i) a prominent advisory that persons 

11 with allergies should check the ingredient 

12 list of the drug because the ingredients of 

13 the drug differ from the ingredients of the 

14 U.S. label drug; and 

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

16 drug as would be required under section 

17 502(e). 

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

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

20 are defined in the United States Pharmacopeia and 

21 National Formulary) shall not be repackaged, pro22 vided that— 

23 ‘‘(A) the packaging complies with all appli24 cable regulations under sections 3 and 4 of the 


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1 Poison Prevention Packaging Act of 1970 (15 

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

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

4 requirements of such Act, after being informed 

5 that the packaging does not comply with such 

6 Act and that the pharmacist will provide the 

7 drug in packaging that is compliant at no addi8 tional cost. 

9 ‘‘(m) CHARITABLE CONTRIBUTIONS.—Notwith10 standing any other provision of this section, this section 

11 does not authorize the importation into the United States 

12 of a qualifying drug donated or otherwise supplied for free 

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

14 a charitable or humanitarian organization, including the 

15 United Nations and affiliates, or to a government of a for16 eign country. 

17 ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC18 TICES.— 

19 ‘‘(1) IN GENERAL.—It is unlawful for a manu20 facturer, directly or indirectly (including by being a 

21 party to a licensing agreement or other agreement), 

22 to— 

23 ‘‘(A) discriminate by charging a higher 

24 price for a prescription drug sold to a registered 

25 exporter or other person in a permitted country 


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1 that exports a qualifying drug to the United 

2 States under this section than the price that is 

3 charged, inclusive of rebates or other incentives 

4 to the permitted country or other person, to an5 other person that is in the same country and 

6 that does not export a qualifying drug into the 

7 United States under this section; 

8 ‘‘(B) discriminate by charging a higher 

9 price for a prescription drug sold to a registered 

10 importer or other person that distributes, sells, 

11 or uses a qualifying drug imported into the 

12 United States under this section than the price 

13 that is charged to another person in the United 

14 States that does not import a qualifying drug 

15 under this section, or that does not distribute, 

16 sell, or use such a drug; 

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

18 or delaying supplies of a prescription drug to a 

19 registered exporter or other person in a per20 mitted country that exports a qualifying drug to 

21 the United States under this section or to a 

22 registered importer or other person that distrib23 utes, sells, or uses a qualifying drug imported 

24 into the United States under this section; 


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

2 otherwise refusing to do business with a reg3 istered exporter or other person in a permitted 

4 country that exports a qualifying drug to the 

5 United States under this section or with a reg6 istered importer or other person that distrib7 utes, sells, or uses a qualifying drug imported 

8 into the United States under this section; 

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

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

11 submit such a notice on or before the date spec12 ified in subsection (g)(2)(B)(v) or as otherwise 

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

14 of section 4 of the Pharmaceutical Market Ac15 cess and Drug Safety Act of 2009, knowingly 

16 submit such a notice that makes a materially 

17 false, fictitious, or fraudulent statement, or 

18 knowingly fail to provide promptly any informa19 tion requested by the Secretary to review such 

20 a notice; 

21 ‘‘(F) knowingly fail to submit an applica22 tion required under subsection (g)(2)(F), know23 ingly fail to submit such an application on or 

24 before the date specified in subsection 

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1 tion that makes a materially false, fictitious, or 

2 fraudulent statement, or knowingly fail to pro3 vide promptly any information requested by the 

4 Secretary to review such an application; 

5 ‘‘(G) cause there to be a difference (includ6 ing a difference in active ingredient, route of 

7 administration, dosage form, strength, formula8 tion, manufacturing establishment, manufac9 turing process, or person that manufactures the 

10 drug) between a prescription drug for distribu11 tion in the United States and the drug for dis12 tribution in a permitted country; 

13 ‘‘(H) refuse to allow an inspection author14 ized under this section of an establishment that 

15 manufactures a qualifying drug that is, or will 

16 be, introduced for commercial distribution in a 

17 permitted country; 

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

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

20 processing, packing, or holding of a qualifying 

21 drug that is, or will be, introduced for commer22 cial distribution in a permitted country to good 

23 manufacturing practice under this Act; 

24 ‘‘(J) become a party to a licensing agree25 ment or other agreement related to a qualifying 


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1 drug that fails to provide for compliance with 

2 all requirements of this section with respect to 

3 such drug; 

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

5 prohibits, or delays the importation of a quali6 fying drug under this section; 

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

8 prohibit, or delay the importation of a quali9 fying drug under this section; or 

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

11 Federal Trade Commission determines to dis12 criminate against a person that engages or at13 tempts to engage in the importation of a quali14 fying drug under this section. 

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

16 The Secretary shall promptly refer to the Federal 

17 Trade Commission each potential violation of sub18 paragraph (E), (F), (G), (H), or (I) of paragraph 

19 (1) that becomes known to the Secretary. 

20 ‘‘(3) AFFIRMATIVE DEFENSE.— 

21 ‘‘(A) DISCRIMINATION.—It shall be an af22 firmative defense to a charge that a manufac23 turer has discriminated under subparagraph 

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

25 the higher price charged for a prescription drug 


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

2 of supplies of a prescription drug to a person, 

3 the refusal to do business with a person, or 

4 other discriminatory activity against a person, 

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

6 ‘‘(i) the person exporting or importing 

7 a qualifying drug into the United States 

8 under this section; or 

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

10 or using a qualifying drug imported into 

11 the United States under this section. 

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

13 affirmative defense to a charge that a manufac14 turer has caused there to be a difference de15 scribed in subparagraph (G) of paragraph (1) 

16 that— 

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

18 country in which the drug is distributed; 

19 ‘‘(ii) the Secretary has determined 

20 that the difference was necessary to im21 prove the safety or effectiveness of the 

22 drug; 

23 ‘‘(iii) the person manufacturing the 

24 drug for distribution in the United States 

25 has given notice to the Secretary under 


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

2 distribution in the United States is not dif3 ferent from a drug for distribution in per4 mitted countries whose combined popu5 lation represents at least 50 percent of the 

6 total population of all permitted countries; 

7 or 

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

9 whole or in part, for the purpose of re10 stricting importation of the drug into the 

11 United States under this section. 

12 ‘‘(4) EFFECT OF SUBSECTION.— 

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

14 subsection applies only to the sale or distribu15 tion of a prescription drug in a country if the 

16 manufacturer of the drug chooses to sell or dis17 tribute the drug in the country. Nothing in this 

18 subsection shall be construed to compel the 

19 manufacturer of a drug to distribute or sell the 

20 drug in a country. 

21 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

22 PLANS, PHARMACY BENEFIT MANAGERS, AND

23 COVERED ENTITIES.—Nothing in this sub24 section shall be construed to— 


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1 ‘‘(i) prevent or restrict a manufac2 turer of a prescription drug from providing 

3 discounts to an insurer, health plan, phar4 macy benefit manager in the United 

5 States, or covered entity in the drug dis6 count program under section 340B of the 

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

8 256b) in return for inclusion of the drug 

9 on a formulary; 

10 ‘‘(ii) require that such discounts be 

11 made available to other purchasers of the 

12 prescription drug; or 

13 ‘‘(iii) prevent or restrict any other 

14 measures taken by an insurer, health plan, 

15 or pharmacy benefit manager to encourage 

16 consumption of such prescription drug. 

17 ‘‘(C) CHARITABLE CONTRIBUTIONS.— 

18 Nothing in this subsection shall be construed 

19 to— 

20 ‘‘(i) prevent a manufacturer from do21 nating a prescription drug, or supplying a 

22 prescription drug at nominal cost, to a 

23 charitable or humanitarian organization, 

24 including the United Nations and affiliVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 ates, or to a government of a foreign coun2 try; or 

3 ‘‘(ii) apply to such donations or sup4 plying of a prescription drug. 

5 ‘‘(5) ENFORCEMENT.— 

6 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC7 TICE.—A violation of this subsection shall be 

8 treated as a violation of a rule defining an un9 fair or deceptive act or practice prescribed 

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

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

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

13 Federal Trade Commission— 

14 ‘‘(i) shall enforce this subsection in 

15 the same manner, by the same means, and 

16 with the same jurisdiction, powers, and du17 ties as though all applicable terms and pro18 visions of the Federal Trade Commission 

19 Act (15 U.S.C. 41 et seq.) were incor20 porated into and made a part of this sec21 tion; and 

22 ‘‘(ii) may seek monetary relief three23 fold the damages sustained, in addition to 

24 any other remedy available to the Federal 

25 Trade Commission under the Federal 


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

2 seq.). 

3 ‘‘(6) ACTIONS BY STATES.— 

4 ‘‘(A) IN GENERAL.— 

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

6 which the attorney general of a State has 

7 reason to believe that an interest of the 

8 residents of that State have been adversely 

9 affected by any manufacturer that violates 

10 paragraph (1), the attorney general of a 

11 State may bring a civil action on behalf of 

12 the residents of the State, and persons 

13 doing business in the State, in a district 

14 court of the United States of appropriate 

15 jurisdiction to— 

16 ‘‘(I) enjoin that practice; 

17 ‘‘(II) enforce compliance with 

18 this subsection; 

19 ‘‘(III) obtain damages, restitu20 tion, or other compensation on behalf 

21 of residents of the State and persons 

22 doing business in the State, including 

23 threefold the damages; or 


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1 ‘‘(IV) obtain such other relief as 

2 the court may consider to be appro3 priate. 

4 ‘‘(ii) NOTICE.— 

5 ‘‘(I) IN GENERAL.—Before filing 

6 an action under clause (i), the attor7 ney general of the State involved shall 

8 provide to the Federal Trade Commis9 sion— 

10 ‘‘(aa) written notice of that 

11 action; and 

12 ‘‘(bb) a copy of the com13 plaint for that action. 

14 ‘‘(II) EXEMPTION.—Subclause 

15 (I) shall not apply with respect to the 

16 filing of an action by an attorney gen17 eral of a State under this paragraph, 

18 if the attorney general determines 

19 that it is not feasible to provide the 

20 notice described in that subclause be21 fore filing of the action. In such case, 

22 the attorney general of a State shall 

23 provide notice and a copy of the com24 plaint to the Federal Trade CommisVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 sion at the same time as the attorney 

2 general files the action. 

3 ‘‘(B) INTERVENTION.— 

4 ‘‘(i) IN GENERAL.—On receiving no5 tice under subparagraph (A)(ii), the Fed6 eral Trade Commission shall have the right 

7 to intervene in the action that is the sub8 ject of the notice. 

9 ‘‘(ii) EFFECT OF INTERVENTION.—If 

10 the Federal Trade Commission intervenes 

11 in an action under subparagraph (A), it 

12 shall have the right— 

13 ‘‘(I) to be heard with respect to 

14 any matter that arises in that action; 

15 and 

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

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

18 bringing any civil action under subparagraph 

19 (A), nothing in this subsection shall be con20 strued to prevent an attorney general of a State 

21 from exercising the powers conferred on the at22 torney general by the laws of that State to— 

23 ‘‘(i) conduct investigations; 

24 ‘‘(ii) administer oaths or affirmations; 

25 or 


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1 ‘‘(iii) compel the attendance of wit2 nesses or the production of documentary 

3 and other evidence. 

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

5 any case in which an action is instituted by or 

6 on behalf of the Federal Trade Commission for 

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

8 during the pendency of that action, institute an 

9 action under subparagraph (A) for the same 

10 violation against any defendant named in the 

11 complaint in that action. 

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

13 subparagraph (A) may be brought in the dis14 trict court of the United States that meets ap15 plicable requirements relating to venue under 

16 section 1391 of title 28, United States Code. 

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

18 brought under subparagraph (A), process may 

19 be served in any district in which the defend20 ant— 

21 ‘‘(i) is an inhabitant; or 

22 ‘‘(ii) may be found. 

23 ‘‘(G) MEASUREMENT OF DAMAGES.—In 

24 any action under this paragraph to enforce a 

25 cause of action under this subsection in which 


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1 there has been a determination that a defend2 ant has violated a provision of this subsection, 

3 damages may be proved and assessed in the ag4 gregate by statistical or sampling methods, by 

5 the computation of illegal overcharges or by 

6 such other reasonable system of estimating ag7 gregate damages as the court in its discretion 

8 may permit without the necessity of separately 

9 proving the individual claim of, or amount of 

10 damage to, persons on whose behalf the suit 

11 was brought. 

12 ‘‘(H) EXCLUSION ON DUPLICATIVE RE13 LIEF.—The district court shall exclude from the 

14 amount of monetary relief awarded in an action 

15 under this paragraph brought by the attorney 

16 general of a State any amount of monetary re17 lief which duplicates amounts which have been 

18 awarded for the same injury. 

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

20 in this subsection shall be construed to modify, im21 pair, or supersede the operation of the antitrust 

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

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

24 section of the Clayton Act, except that it includes 

25 section 5 of the Federal Trade Commission Act to 


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1 the extent that such section 5 applies to unfair 

2 methods of competition. 

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

4 term ‘manufacturer’ means any entity, including any 

5 affiliate or licensee of that entity, that is engaged 

6 in— 

7 ‘‘(A) the production, preparation, propaga8 tion, compounding, conversion, or processing of 

9 a prescription drug, either directly or indirectly 

10 by extraction from substances of natural origin, 

11 or independently by means of chemical syn12 thesis, or by a combination of extraction and 

13 chemical synthesis; or 

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

15 relabeling, or distribution of a prescription 

16 drug.’’. 

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

18 and Cosmetic Act is amended— 

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

20 paragraph (aa) and inserting the following: 

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

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

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

24 imported by the pharmacist, other than— 


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1 ‘‘(A) a sale at retail made pursuant to dis2 pensing the drug to a customer of the pharmacist or 

3 organization; or 

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

5 or a wholesaler registered to import drugs under sec6 tion 804. 

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

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

9 individual. 

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

11 fraudulent statement or representation, or a material 

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

13 804(g)(2)(B) or in an application required under section 

14 804(g)(2)(F), or the failure to submit such a notice or 

15 application. 

16 ‘‘(4) The importation of a drug in violation of a reg17 istration condition or other requirement under section 

18 804, the falsification of any record required to be main19 tained, or provided to the Secretary, under such section, 

20 or the violation of any registration condition or other re21 quirement under such section.’’; and 

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

23 striking paragraph (6) and inserting the following: 

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

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


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1 301(aa)(4) shall be imprisoned not more than 10 years, 

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

3 or both.’’. 

4 (c) AMENDMENT OF CERTAIN PROVISIONS.— 

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

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

7 amended by striking subsection (g) and inserting the 

8 following: 

9 ‘‘(g) With respect to a prescription drug that is im10 ported or offered for import into the United States by an 

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

12 that is not shipped by a registered exporter under section 

13 804, and that is refused admission under subsection (a), 

14 the Secretary shall notify the individual that— 

15 ‘‘(1) the drug has been refused admission be16 cause the drug was not a lawful import under sec17 tion 804; 

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

19 waiver of the requirements of subsection (a); 

20 ‘‘(3) the individual may under section 804 law21 fully import certain prescription drugs from export22 ers registered with the Secretary under section 804; 

23 and 

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

25 such importation, including a list of registered exVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 porters, on the Internet website of the Food and 

2 Drug Administration or through a toll-free telephone 

3 number required under section 804.’’. 

4 (2) ESTABLISHMENT REGISTRATION.—Section 

5 510(i) of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 360(i)) is amended in paragraph (1) by 

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

8 following: ‘‘, including a drug that is, or may be, im9 ported or offered for import into the United States 

10 under section 804,’’. 

11 (3) EFFECTIVE DATE.—The amendments made 

12 by this subsection shall take effect on the date that 

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

14 (d) EXHAUSTION.— 

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

16 United States Code, is amended— 

17 (A) by redesignating subsections (h) and 

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

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

20 following: 

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

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

23 into the United States any patented invention under sec24 tion 804 of the Federal Food, Drug, and Cosmetic Act 


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

2 owner or licensee of such patent.’’. 

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

4 amendment made by paragraph (1) shall be con5 strued to affect the ability of a patent owner or li6 censee to enforce their patent, subject to such 

7 amendment. 

8 (e) EFFECT OF SECTION 804.— 

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

10 Food, Drug, and Cosmetic Act, as added by sub11 section (a), shall permit the importation of quali12 fying drugs (as defined in such section 804) into the 

13 United States without regard to the status of the 

14 issuance of implementing regulations— 

15 (A) from exporters registered under such 

16 section 804 on the date that is 90 days after 

17 the date of enactment of this Act; and 

18 (B) from permitted countries, as defined in 

19 such section 804, by importers registered under 

20 such section 804 on the date that is 1 year 

21 after the date of enactment of this Act. 

22 (2) REVIEW OF REGISTRATION BY CERTAIN EX23 PORTERS.— 

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

25 registrations submitted under subsection (b) of 


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1 such section 804, registrations submitted by en2 tities in Canada that are significant exporters 

3 of prescription drugs to individuals in the 

4 United States as of the date of enactment of 

5 this Act will have priority during the 90 day pe6 riod that begins on such date of enactment. 

7 (B) PERIOD FOR REVIEW.—During such 

8 90-day period, the reference in subsection 

9 (b)(2)(A) of such section 804 to 90 days (relat10 ing to approval or disapproval of registrations) 

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

12 days. 

13 (C) LIMITATION.—That an exporter in 

14 Canada exports, or has exported, prescription 

15 drugs to individuals in the United States on or 

16 before the date that is 90 days after the date 

17 of enactment of this Act shall not serve as a 

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

19 registration under such section 804 from the 

20 exporter. 

21 (D) FIRST YEAR LIMIT ON NUMBER OF

22 EXPORTERS.—During the 1-year period begin23 ning on the date of enactment of this Act, the 

24 Secretary of Health and Human Services (re25 ferred to in this section as the ‘‘Secretary’’) 


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1 may limit the number of registered exporters 

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

3 long as the Secretary gives priority to those ex4 porters with demonstrated ability to process a 

5 high volume of shipments of drugs to individ6 uals in the United States. 

7 (E) SECOND YEAR LIMIT ON NUMBER OF

8 EXPORTERS.—During the 1-year period begin9 ning on the date that is 1 year after the date 

10 of enactment of this Act, the Secretary may 

11 limit the number of registered exporters under 

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

13 as the Secretary gives priority to those export14 ers with demonstrated ability to process a high 

15 volume of shipments of drugs to individuals in 

16 the United States. 

17 (F) FURTHER LIMIT ON NUMBER OF EX18 PORTERS.—During any 1-year period beginning 

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

20 of enactment of this Act, the Secretary may 

21 limit the number of registered exporters under 

22 such section 804 to not less than 25 more than 

23 the number of such exporters during the pre24 vious 1-year period, so long as the Secretary 

25 gives priority to those exporters with demVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00094 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 onstrated ability to process a high volume of 

2 shipments of drugs to individuals in the United 

3 States. 

4 (3) LIMITS ON NUMBER OF IMPORTERS.— 

5 (A) FIRST YEAR LIMIT ON NUMBER OF IM6 PORTERS.—During the 1-year period beginning 

7 on the date that is 1 year after the date of en8 actment of this Act, the Secretary may limit the 

9 number of registered importers under such sec10 tion 804 to not less than 100 (of which at least 

11 a significant number shall be groups of phar12 macies, to the extent feasible given the applica13 tions submitted by such groups), so long as the 

14 Secretary gives priority to those importers with 

15 demonstrated ability to process a high volume 

16 of shipments of drugs imported into the United 

17 States. 

18 (B) SECOND YEAR LIMIT ON NUMBER OF

19 IMPORTERS.—During the 1-year period begin20 ning on the date that is 2 years after the date 

21 of enactment of this Act, the Secretary may 

22 limit the number of registered importers under 

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

24 at least a significant number shall be groups of 

25 pharmacies, to the extent feasible given the apVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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1 plications submitted by such groups), so long as 

2 the Secretary gives priority to those importers 

3 with demonstrated ability to process a high vol4 ume of shipments of drugs into the United 

5 States. 

6 (C) FURTHER LIMIT ON NUMBER OF IM7 PORTERS.—During any 1-year period beginning 

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

9 of enactment of this Act, the Secretary may 

10 limit the number of registered importers under 

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

12 which at least a significant number shall be 

13 groups of pharmacies, to the extent feasible 

14 given the applications submitted by such 

15 groups) than the number of such importers 

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

17 the Secretary gives priority to those importers 

18 with demonstrated ability to process a high vol19 ume of shipments of drugs to the United 

20 States. 

21 (4) NOTICES FOR DRUGS FOR IMPORT FROM

22 CANADA.—The notice with respect to a qualifying 

23 drug introduced for commercial distribution in Can24 ada as of the date of enactment of this Act that is 

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1 tion 804 shall be submitted to the Secretary not 

2 later than 30 days after the date of enactment of 

3 this Act if— 

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

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

6 100 prescription drugs with the highest dollar 

7 volume of sales in the United States based on 

8 the 12 calendar month period most recently 

9 completed before the date of enactment of this 

10 Act; or 

11 (B) the notice is a notice under subsection 

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

13 (5) NOTICE FOR DRUGS FOR IMPORT FROM

14 OTHER COUNTRIES.—The notice with respect to a 

15 qualifying drug introduced for commercial distribu16 tion in a permitted country other than Canada as of 

17 the date of enactment of this Act that is required 

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

19 shall be submitted to the Secretary not later than 

20 180 days after the date of enactment of this Act 

21 if— 

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

23 drug is 1 of the 100 prescription drugs with the 

24 highest dollar volume of sales in the United 

25 States based on the 12 calendar month period 


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1 that is first completed on the date that is 120 

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

3 (B) the notice is a notice under subsection 

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

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

6 (A) GUIDANCE ON SUBMISSION DATES.— 

7 The Secretary shall by guidance establish a se8 ries of submission dates for the notices under 

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

10 respect to qualifying drugs introduced for com11 mercial distribution as of the date of enactment 

12 of this Act and that are not required to be sub13 mitted under paragraph (4) or (5). 

14 (B) CONSISTENT AND EFFICIENT USE OF

15 RESOURCES.—The Secretary shall establish the 

16 dates described under subparagraph (A) so that 

17 such notices described under subparagraph (A) 

18 are submitted and reviewed at a rate that al19 lows consistent and efficient use of the re20 sources and staff available to the Secretary for 

21 such reviews. The Secretary may condition the 

22 requirement to submit such a notice, and the 

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

24 registered exporter or a registered importer to 

25 the Secretary of a notice that such exporter or 


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1 importer intends to import such qualifying drug 

2 to the United States under such section 804. 

3 (C) PRIORITY FOR DRUGS WITH HIGHER

4 SALES.—The Secretary shall establish the dates 

5 described under subparagraph (A) so that the 

6 Secretary reviews the notices described under 

7 such subparagraph with respect to qualifying 

8 drugs with higher dollar volume of sales in the 

9 United States before the notices with respect to 

10 drugs with lower sales in the United States. 

11 (7) NOTICES FOR DRUGS APPROVED AFTER EF12 FECTIVE DATE.—The notice required under sub13 section (g)(2)(B)(i) of such section 804 for a quali14 fying drug first introduced for commercial distribu15 tion in a permitted country (as defined in such sec16 tion 804) after the date of enactment of this Act 

17 shall be submitted to and reviewed by the Secretary 

18 as provided under subsection (g)(2)(B) of such sec19 tion 804, without regard to paragraph (4), (5), or 

20 (6). 

21 (8) REPORT.—Beginning with the first full fis22 cal year after the date of enactment of this Act, not 

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

24 during which the Secretary reviews a notice referred 

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


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1 submit a report to Congress concerning the progress 

2 of the Food and Drug Administration in reviewing 

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

4 (6). 

5 (9) USER FEES.— 

6 (A) EXPORTERS.—When establishing an 

7 aggregate total of fees to be collected from ex8 porters under subsection (f)(2) of such section 

9 804, the Secretary shall, under subsection 

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

11 total price of drugs imported under subsection 

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

13 by registered exporters during the first fiscal 

14 year in which this Act takes effect to be an 

15 amount equal to the amount which bears the 

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

17 days in such fiscal year during which this Act 

18 is effective bears to 365. 

19 (B) IMPORTERS.—When establishing an 

20 aggregate total of fees to be collected from im21 porters under subsection (e)(2) of such section 

22 804, the Secretary shall, under subsection 

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

24 total price of drugs imported under subsection 


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

2 by registered importers during— 

3 (i) the first fiscal year in which this 

4 Act takes effect to be an amount equal to 

5 the amount which bears the same ratio to 

6 $1,000,000,000 as the number of days in 

7 such fiscal year during which this Act is 

8 effective bears to 365; and 

9 (ii) the second fiscal year in which 

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

11 (C) SECOND YEAR ADJUSTMENT.— 

12 (i) REPORTS.—Not later than Feb13 ruary 20 of the second fiscal year in which 

14 this Act is in effect, registered importers 

15 shall report to the Secretary the total price 

16 and the total volume of drugs imported to 

17 the United States by the importer during 

18 the 4-month period from October 1 

19 through January 31 of such fiscal year. 

20 (ii) REESTIMATE.—Notwithstanding 

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

22 or subparagraph (B), the Secretary shall 

23 reestimate the total price of qualifying 

24 drugs imported under subsection (a) of 

25 such section 804 into the United States by 


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1 registered importers during the second fis2 cal year in which this Act is in effect. Such 

3 reestimate shall be equal to— 

4 (I) the total price of qualifying 

5 drugs imported by each importer as 

6 reported under clause (i); multiplied 

7 by 

8 (II) 3. 

9 (iii) ADJUSTMENT.—The Secretary 

10 shall adjust the fee due on April 1 of the 

11 second fiscal year in which this Act is in 

12 effect, from each importer so that the ag13 gregate total of fees collected under sub14 section (e)(2) for such fiscal year does not 

15 exceed the total price of qualifying drugs 

16 imported under subsection (a) of such sec17 tion 804 into the United States by reg18 istered importers during such fiscal year as 

19 reestimated under clause (ii). 

20 (D) FAILURE TO PAY FEES.—Notwith21 standing any other provision of this section, the 

22 Secretary may prohibit a registered importer or 

23 exporter that is required to pay user fees under 

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

25 that fails to pay such fees within 30 days after 


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

2 offering for importation a qualifying drug under 

3 such section 804 until such fee is paid. 

4 (E) ANNUAL REPORT.— 

5 (i) FOOD AND DRUG ADMINISTRA6 TION.—Not later than 180 days after the 

7 end of each fiscal year during which fees 

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

9 (g)(2)(B)(iv) of such section 804, the Sec10 retary shall prepare and submit to the 

11 House of Representatives and the Senate a 

12 report on the implementation of the au13 thority for such fees during such fiscal 

14 year and the use, by the Food and Drug 

15 Administration, of the fees collected for the 

16 fiscal year for which the report is made 

17 and credited to the Food and Drug Admin18 istration. 

19 (ii) CUSTOMS AND BORDER CON20 TROL.—Not later than 180 days after the 

21 end of each fiscal year during which fees 

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

23 such section 804, the Secretary of Home24 land Security, in consultation with the Sec25 retary of the Treasury, shall prepare and 


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1 submit to the House of Representatives 

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

3 Bureau of Customs and Border Protection, 

4 of the fees, if any, transferred by the Sec5 retary to the Bureau of Customs and Bor6 der Protection for the fiscal year for which 

7 the report is made. 

8 (10) SPECIAL RULE REGARDING IMPORTATION

9 BY INDIVIDUALS.— 

10 (A) IN GENERAL.—Notwithstanding any 

11 provision of this Act (or an amendment made 

12 by this Act), the Secretary shall expedite the 

13 designation of any additional countries from 

14 which an individual may import a qualifying 

15 drug into the United States under such section 

16 804 if any action implemented by the Govern17 ment of Canada has the effect of limiting or 

18 prohibiting the importation of qualifying drugs 

19 into the United States from Canada. 

20 (B) TIMING AND CRITERIA.—The Sec21 retary shall designate such additional countries 

22 under subparagraph (A)— 

23 (i) not later than 6 months after the 

24 date of the action by the Government of 


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1 Canada described under such subpara2 graph; and 

3 (ii) using the criteria described under 

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

5 804. 

6 (f) IMPLEMENTATION OF SECTION 804.— 

7 (1) INTERIM RULE.—The Secretary may pro8 mulgate an interim rule for implementing section 

9 804 of the Federal Food, Drug, and Cosmetic Act, 

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

11 (2) NO NOTICE OF PROPOSED RULEMAKING.— 

12 The interim rule described under paragraph (1) may 

13 be developed and promulgated by the Secretary with14 out providing general notice of proposed rulemaking. 

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

16 the date on which the Secretary promulgates an in17 terim rule under paragraph (1), the Secretary shall, 

18 in accordance with procedures under section 553 of 

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

20 for implementing such section 804, which may incor21 porate by reference provisions of the interim rule 

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

23 such provisions are not modified. 

24 (g) CONSUMER EDUCATION.—The Secretary shall 

25 carry out activities that educate consumers— 


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1 (1) with regard to the availability of qualifying 

2 drugs for import for personal use from an exporter 

3 registered with and approved by the Food and Drug 

4 Administration under section 804 of the Federal 

5 Food, Drug, and Cosmetic Act, as added by this sec6 tion, including information on how to verify whether 

7 an exporter is registered and approved by use of the 

8 Internet website of the Food and Drug Administra9 tion and the toll-free telephone number required by 

10 this Act; 

11 (2) that drugs that consumers attempt to im12 port from an exporter that is not registered with and 

13 approved by the Food and Drug Administration can 

14 be seized by the United States Customs Service and 

15 destroyed, and that such drugs may be counterfeit, 

16 unapproved, unsafe, or ineffective; 

17 (3) with regard to the suspension and termi18 nation of any registration of a registered importer or 

19 exporter under such section 804; and 

20 (4) with regard to the availability at domestic 

21 retail pharmacies of qualifying drugs imported under 

22 such section 804 by domestic wholesalers and phar23 macies registered with and approved by the Food 

24 and Drug Administration. 


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1 (h) EFFECT ON ADMINISTRATION PRACTICES.—Not2 withstanding any provision of this Act (and the amend3 ments made by this Act), the practices and policies of the 

4 Food and Drug Administration and Bureau of Customs 

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

6 respect to the importation of prescription drugs into the 

7 United States by an individual, on the person of such indi8 vidual, for personal use, shall remain in effect. 

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

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

11 a report that describes any action taken during the period 

12 for which the report is being prepared to enforce the provi13 sions of section 804(n) of the Federal Food, Drug, and 

14 Cosmetic Act (as added by this Act), including any pend15 ing investigations or civil actions under such section. 

16 SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS17 SION INTO UNITED STATES. 

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

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

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

21 at the end the following section: 

22 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD23 MISSION. 

24 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se25 curity shall deliver to the Secretary a shipment of drugs 


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1 that is imported or offered for import into the United 

2 States if— 

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

4 than $10,000; and 

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

6 does not bear the markings required under section 

7 804(d)(2); or 

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

9 such shipment of drugs. 

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

11 not authorize the delivery to the owner or consignee of 

12 drugs delivered to the Secretary under subsection (a) pur13 suant to the execution of a bond, and such drugs may not 

14 be exported. 

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

16 Secretary shall destroy a shipment of drugs delivered by 

17 the Secretary of Homeland Security to the Secretary 

18 under subsection (a) if— 

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

20 offered for import from a registered exporter under 

21 section 804, the drugs are in violation of any stand22 ard described in section 804(g)(5); or 

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

24 or offered for import from a registered exporter 


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

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

3 ‘‘(d) CERTAIN PROCEDURES.— 

4 ‘‘(1) IN GENERAL.—The delivery and destruc5 tion of drugs under this section may be carried out 

6 without notice to the importer, owner, or consignee 

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

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

9 drugs, and recordkeeping activities regarding the 

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

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

12 promulgated under paragraph (1) shall be designed 

13 toward the objective of ensuring that, with respect to 

14 efficiently utilizing Federal resources available for 

15 carrying out this section, a substantial majority of 

16 shipments of drugs subject to described in sub17 section (c) are identified and destroyed. 

18 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de19 stroyed under subsection (c) to the extent that the Attor20 ney General of the United States determines that the 

21 drugs should be preserved as evidence or potential evi22 dence with respect to an offense against the United States. 

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

24 not be construed as having any legal effect on applicable 

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


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

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

3 (b) PROCEDURES.—Procedures for carrying out sec4 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

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

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

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

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

9 after the date of enactment of this Act. 

10 SEC. 6. WHOLESALE DISTRIBUTION OF DRUGS; STATE11 MENTS REGARDING PRIOR SALE, PURCHASE, 

12 OR TRADE. 

13 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

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

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

16 amended— 

17 (1) in paragraph (1)— 

18 (A) by striking ‘‘and who is not the manu19 facturer or an authorized distributor of record 

20 of such drug’’; 

21 (B) by striking ‘‘to an authorized dis22 tributor of record or’’; and 

23 (C) by striking subparagraph (B) and in24 serting the following: 


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

2 is exported from the United States does not with respect 

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

4 business of the wholesale distribution of the drug from 

5 providing the statement described in subparagraph (A) to 

6 the person that receives the drug pursuant to the export 

7 of the drug. 

8 ‘‘(C)(i) The Secretary shall by regulation establish re9 quirements that supersede subparagraph (A) (referred to 

10 in this subparagraph as ‘alternative requirements’) to 

11 identify the chain of custody of a drug subject to sub12 section (b) from the manufacturer of the drug throughout 

13 the wholesale distribution of the drug to a pharmacist who 

14 intends to sell the drug at retail if the Secretary deter15 mines that the alternative requirements, which may in16 clude standardized anti-counterfeiting or track-and-trace 

17 technologies, will identify such chain of custody or the 

18 identity of the discrete package of the drug from which 

19 the drug is dispensed with equal or greater certainty to 

20 the requirements of subparagraph (A), and that the alter21 native requirements are economically and technically fea22 sible. 

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

24 establish such alternative requirements, the final rule in 

25 addition shall, with respect to the registration condition 


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

2 a condition equivalent to the alternative requirements, and 

3 such equivalent condition may be met in lieu of the reg4 istration condition established in such clause (i).’’; 

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

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

7 construed as having any applicability with respect to 

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

9 (3) in paragraph (3), by striking ‘‘and sub10 section (d)—’’ in the matter preceding subparagraph 

11 (A) and all that follows through ‘‘the term ‘whole12 sale distribution’ means’’ in subparagraph (B) and 

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

14 term ‘wholesale distribution’ means’’. 

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

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

17 353(d)) is amended by adding at the end the following: 

18 ‘‘(4) Each manufacturer of a drug subject to sub19 section (b) shall maintain at its corporate offices a current 

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

21 ‘‘(5) For purposes of this subsection, the term ‘au22 thorized distributors of record’ means those distributors 

23 with whom a manufacturer has established an ongoing re24 lationship to distribute such manufacturer’s products.’’. 

25 (c) EFFECTIVE DATE.— 


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

2 paragraphs (1) and (3) of subsection (a) and by sub3 section (b) shall take effect on January 1, 2012. 

4 (2) DRUGS IMPORTED BY REGISTERED IMPORT5 ERS UNDER SECTION 804.—Notwithstanding para6 graph (1), the amendments made by paragraphs (1) 

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

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

9 of enactment of this Act with respect to qualifying 

10 drugs imported under section 804 of the Federal 

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

12 4. 

13 (3) EFFECT WITH RESPECT TO REGISTERED

14 EXPORTERS.—The amendment made by subsection 

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

16 after the date of enactment of this Act. 

17 (4) ALTERNATIVE REQUIREMENTS.—The Sec18 retary shall issue regulations to establish the alter19 native requirements, referred to in the amendment 

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

21 than January 1, 2012. 

22 (5) INTERMEDIATE REQUIREMENTS.—The Sec23 retary shall by regulation require the use of stand24 ardized anti-counterfeiting or track-and-trace tech25 nologies on prescription drugs at the case and pallet 


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

2 enactment of this Act. 

3 (6) ADDITIONAL REQUIREMENTS.— 

4 (A) IN GENERAL.—Notwithstanding any 

5 other provision of this section, the Secretary 

6 shall, not later than 18 months after the date 

7 of enactment of this Act, require that the pack8 aging of any prescription drug incorporates— 

9 (i) a standardized numerical identifier 

10 unique to each package of such drug, ap11 plied at the point of manufacturing and re12 packaging (in which case the numerical 

13 identifier shall be linked to the numerical 

14 identifier applied at the point of manufac15 turing); and 

16 (ii)(I) overt optically variable counter17 feit-resistant technologies that— 

18 (aa) are visible to the naked eye, 

19 providing for visual identification of 

20 product authenticity without the need 

21 for readers, microscopes, lighting de22 vices, or scanners; 

23 (bb) are similar to that used by 

24 the Bureau of Engraving and Printing 

25 to secure United States currency; 


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1 (cc) are manufactured and dis2 tributed in a highly secure, tightly 

3 controlled environment; and 

4 (dd) incorporate additional layers 

5 of nonvisible convert security features 

6 up to and including forensic capa7 bility, as described in subparagraph 

8 (B); or 

9 (II) technologies that have a function 

10 of security comparable to that described in 

11 subclause (I), as determined by the Sec12 retary. 

13 (B) STANDARDS FOR PACKAGING.—For 

14 the purpose of making it more difficult to coun15 terfeit the packaging of drugs subject to this 

16 paragraph, the manufacturers of such drugs 

17 shall incorporate the technologies described in 

18 subparagraph (A) into at least 1 additional ele19 ment of the physical packaging of the drugs, in20 cluding blister packs, shrink wrap, package la21 bels, package seals, bottles, and boxes. 

22 SEC. 7. INTERNET SALES OF PRESCRIPTION DRUGS. 

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

24 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend25 ed by inserting after section 503B the following: 


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

2 ‘‘(a) REQUIREMENTS REGARDING INFORMATION ON

3 INTERNET SITE.— 

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

5 a prescription drug pursuant to a sale of the drug 

6 by such person if— 

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

8 the purchase order for the drug, or conducted 

9 any other part of the sales transaction for the 

10 drug, through an Internet site; 

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

12 purchaser by mailing or shipping the drug to 

13 the purchaser; and 

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

15 used by such person for purposes of sales of a 

16 prescription drug, fails to meet each of the re17 quirements specified in paragraph (2), other 

18 than a site or pages on a site that— 

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

20 by purchasers or prospective purchasers; or 

21 ‘‘(ii) provide an Internet information 

22 location tool within the meaning of section 

23 231(e)(5) of the Communications Act of 

24 1934 (47 U.S.C. 231(e)(5)). 

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

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1 paragraph (C) of paragraph (1) for a person to 

2 whom such paragraph applies are as follows: 

3 ‘‘(A) Each page of the site shall include ei4 ther the following information or a link to a 

5 page that provides the following information: 

6 ‘‘(i) The name of such person. 

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

8 is authorized by law to dispense prescrip9 tion drugs. 

10 ‘‘(iii) The address and telephone num11 ber of each place of business of the person 

12 with respect to sales of prescription drugs 

13 through the Internet, other than a place of 

14 business that does not mail or ship pre15 scription drugs to purchasers. 

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

17 serves as a pharmacist for prescription 

18 drugs that are mailed or shipped pursuant 

19 to the site, and each State in which the in20 dividual is authorized by law to dispense 

21 prescription drugs. 

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

23 consultations through the site for purposes 

24 of providing prescriptions, the name of 

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1 sultations; each State in which the indi2 vidual is licensed or otherwise authorized 

3 by law to provide such consultations or 

4 practice medicine; and the type or types of 

5 health professions for which the individual 

6 holds such licenses or other authorizations. 

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

8 shall be displayed in a clear and prominent 

9 place and manner, and shall include in the cap10 tion for the link the words ‘licensing and con11 tact information’. 

12 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

13 MEDICAL RELATIONSHIPS.— 

14 ‘‘(1) IN GENERAL.—Except as provided in para15 graph (2), a person may not dispense a prescription 

16 drug, or sell such a drug, if— 

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

18 sale, the purchaser communicated with the per19 son through the Internet; 

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

21 dispensed or purchased did not, when such 

22 communications began, have a prescription for 

23 the drug that is valid in the United States; 

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

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1 tioner, or an individual represented by the per2 son as a practitioner, and the practitioner or 

3 such individual issued a prescription for the 

4 drug that was purchased; 

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

6 know, that the practitioner or the individual re7 ferred to in subparagraph (C) did not, when 

8 issuing the prescription, have a qualifying med9 ical relationship with the patient; and 

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

11 dispensing or sale of the drug. 

12 For purposes of subparagraph (E), payment is re13 ceived if money or other valuable consideration is re14 ceived. 

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

16 apply to— 

17 ‘‘(A) the dispensing or selling of a pre18 scription drug pursuant to telemedicine prac19 tices sponsored by— 

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

21 provider agreement under title XVIII of 

22 the Social Security Act (relating to the 

23 Medicare program); or 

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

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1 fect provider agreements under such title; 

2 or 

3 ‘‘(B) the dispensing or selling of a pre4 scription drug pursuant to practices that pro5 mote the public health, as determined by the 

6 Secretary by regulation. 

7 ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— 

8 ‘‘(A) IN GENERAL.—With respect to 

9 issuing a prescription for a drug for a patient, 

10 a practitioner has a qualifying medical relation11 ship with the patient for purposes of this sec12 tion if— 

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

14 evaluation of the patient has been con15 ducted by the practitioner; or 

16 ‘‘(ii) the practitioner conducts a med17 ical evaluation of the patient as a covering 

18 practitioner. 

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

20 A medical evaluation by a practitioner is an in21 person medical evaluation for purposes of this 

22 section if the practitioner is in the physical 

23 presence of the patient as part of conducting 

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1 tions of the evaluation are conducted by other 

2 health professionals. 

3 ‘‘(C) COVERING PRACTITIONER.—With re4 spect to a patient, a practitioner is a covering 

5 practitioner for purposes of this section if the 

6 practitioner conducts a medical evaluation of 

7 the patient at the request of a practitioner who 

8 has conducted at least one in-person medical 

9 evaluation of the patient and is temporarily un10 available to conduct the evaluation of the pa11 tient. A practitioner is a covering practitioner 

12 without regard to whether the practitioner has 

13 conducted any in-person medical evaluation of 

14 the patient involved. 

15 ‘‘(4) RULES OF CONSTRUCTION.— 

16 ‘‘(A) INDIVIDUALS REPRESENTED AS

17 PRACTITIONERS.—A person who is not a practi18 tioner (as defined in subsection (e)(1)) lacks 

19 legal capacity under this section to have a 

20 qualifying medical relationship with any patient. 

21 ‘‘(B) STANDARD PRACTICE OF PHAR22 MACY.—Paragraph (1) may not be construed as 

23 prohibiting any conduct that is a standard prac24 tice in the practice of pharmacy. 


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1 ‘‘(C) APPLICABILITY OF REQUIRE2 MENTS.—Paragraph (3) may not be construed 

3 as having any applicability beyond this section, 

4 and does not affect any State law, or interpre5 tation of State law, concerning the practice of 

6 medicine. 

7 ‘‘(c) ACTIONS BY STATES.— 

8 ‘‘(1) IN GENERAL.—Whenever an attorney gen9 eral of any State has reason to believe that the in10 terests of the residents of that State have been or 

11 are being threatened or adversely affected because 

12 any person has engaged or is engaging in a pattern 

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

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

15 an appropriate district court of the United States to 

16 enjoin such practice, to enforce compliance with such 

17 section (including a nationwide injunction), to obtain 

18 damages, restitution, or other compensation on be19 half of residents of such State, to obtain reasonable 

20 attorneys fees and costs if the State prevails in the 

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

22 as the court may deem appropriate. 

23 ‘‘(2) NOTICE.—The State shall serve prior writ24 ten notice of any civil action under paragraph (1) or 

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


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

2 feasible for the State to provide such prior notice, 

3 the State shall serve such notice immediately upon 

4 instituting such action. Upon receiving a notice re5 specting a civil action, the Secretary shall have the 

6 right— 

7 ‘‘(A) to intervene in such action; 

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

9 all matters arising therein; and 

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

11 ‘‘(3) CONSTRUCTION.—For purposes of bring12 ing any civil action under paragraph (1), nothing in 

13 this chapter shall prevent an attorney general of a 

14 State from exercising the powers conferred on the 

15 attorney general by the laws of such State to con16 duct investigations or to administer oaths or affir17 mations or to compel the attendance of witnesses or 

18 the production of documentary and other evidence. 

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

20 action brought under paragraph (1) in a district 

21 court of the United States may be brought in the 

22 district in which the defendant is found, is an inhab23 itant, or transacts business or wherever venue is 

24 proper under section 1391 of title 28, United States 

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


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1 any district in which the defendant is an inhabitant 

2 or in which the defendant may be found. 

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

4 ‘‘(A) Nothing contained in this section 

5 shall prohibit an authorized State official from 

6 proceeding in State court on the basis of an al7 leged violation of any civil or criminal statute of 

8 such State. 

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

10 attorney general of a State under paragraph 

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

12 of such State who are authorized by the State 

13 to bring actions in such State on behalf of its 

14 residents. 

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

16 apply to a person that is a registered exporter under sec17 tion 804. 

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

19 section: 

20 ‘‘(1) The term ‘practitioner’ means a practi21 tioner referred to in section 503(b)(1) with respect 

22 to issuing a written or oral prescription. 

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

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


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

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

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

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

5 ‘‘(1) IN GENERAL.—For purposes of this sec6 tion: 

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

8 the myriad of computer and telecommunications 

9 facilities, including equipment and operating 

10 software, which comprise the interconnected 

11 world-wide network of networks that employ the 

12 transmission control protocol/internet protocol, 

13 or any predecessor or successor protocols to 

14 such protocol, to communicate information of 

15 all kinds by wire or radio. 

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

17 Internet, means one or more letters, words, 

18 numbers, symbols, or graphic items that appear 

19 on a page of an Internet site for the purpose 

20 of serving, when activated, as a method for exe21 cuting an electronic command— 

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

23 of a page on such site to another portion 

24 of the page; 


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

2 on such site to another page on such site; 

3 or 

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

5 one Internet site to a page on another 

6 Internet site. 

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

8 Internet, means a document or other file 

9 accessed at an Internet site. 

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

11 respect to the Internet, mean a specific location 

12 on the Internet that is determined by Internet 

13 Protocol numbers. Such term includes the do14 main name, if any. 

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

16 method of representing an Internet address 

17 without direct reference to the Internet Protocol 

18 numbers for the address, including methods 

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

20 ‘.gov’, ‘.net’, or ‘.org’. 

21 ‘‘(iii) The term ‘Internet Protocol num22 bers’ includes any successor protocol for deter23 mining a specific location on the Internet. 

24 ‘‘(2) AUTHORITY OF SECRETARY.—The Sec25 retary may by regulation modify any definition 


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

2 technology. 

3 ‘‘(g) INTERACTIVE COMPUTER SERVICE; ADVER4 TISING.—No provider of an interactive computer service, 

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

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

7 shall be liable under this section for dispensing or selling 

8 prescription drugs in violation of this section on account 

9 of another person’s selling or dispensing such drugs, pro10 vided that the provider of the interactive computer service 

11 or of advertising services does not own or exercise cor12 porate control over such person.’’. 

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

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

15 331) is amended by inserting after paragraph (k) the fol16 lowing: 

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

18 in violation of section 503C.’’. 

19 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

20 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO21 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI22 NESSES.—In carrying out section 503C of the Federal 

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

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

25 Services shall take into consideration the practices and 


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1 procedures of public or private entities that certify that 

2 businesses selling prescription drugs through Internet 

3 sites are legitimate businesses, including practices and 

4 procedures regarding disclosure formats and verification 

5 programs. 

6 (d) REPORTS REGARDING INTERNET-RELATED VIO7 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

8 OF DRUGS.— 

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

10 Human Services (referred to in this subsection as 

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

12 of an application meeting the criteria of the Sec13 retary, make an award of a grant or contract to the 

14 National Clearinghouse on Internet Prescribing (op15 erated by the Federation of State Medical Boards) 

16 for the purpose of— 

17 (A) identifying Internet sites that appear 

18 to be in violation of Federal or State laws con19 cerning the dispensing of drugs; 

20 (B) reporting such sites to State medical 

21 licensing boards and State pharmacy licensing 

22 boards, and to the Attorney General and the 

23 Secretary, for further investigation; and 

24 (C) submitting, for each fiscal year for 

25 which the award under this subsection is made, 


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1 a report to the Secretary describing investiga2 tions undertaken with respect to violations de3 scribed in subparagraph (A). 

4 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

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

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

7 the first 3 fiscal years in which this section is in ef8 fect. 

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

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

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

12 rule to implement such amendments has been promulgated 

13 by the Secretary of Health and Human Services under 

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

15 Act. The preceding sentence may not be construed as af16 fecting the authority of such Secretary to promulgate such 

17 a final rule. 

18 SEC. 8. PROHIBITING PAYMENTS TO UNREGISTERED FOR19 EIGN PHARMACIES. 

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

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

22 adding at the end the following: 

23 ‘‘(h) RESTRICTED TRANSACTIONS.— 

24 ‘‘(1) IN GENERAL.—The introduction of re25 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 section shall 

9 be enforced by the Federal functional regu10 lators and the Federal Trade Commission 

11 under applicable law in the manner pro12 vided in section 505(a) of the Gramm13 Leach-Bliley Act (15 U.S.C. 6805(a)). 

14 ‘‘(ii) FACTORS TO BE CONSIDERED.— 

15 In considering any enforcement action 

16 under this subsection against a payment 

17 system or person described in paragraph 

18 (2)(B), the Federal functional regulators 

19 and the Federal Trade Commission shall 

20 consider the following factors: 

21 ‘‘(I) The extent to which the pay22 ment system or person knowingly per23 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 

25 this subsection, under the laws of any state with reVerDate Nov 24 2008 22:40 Jun 11, 2009 Jkt 079200 PO 00000 Frm 00138 Fmt 6652 Sfmt 6201 E:\BILLS\S1232.PCS S1232

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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 (b) EFFECTIVE DATE.—The amendment made by 

12 this section shall take effect on the day that is 90 days 

13 after the date of enactment of this Act. 

14 (c) IMPLEMENTATION.—The Board of Governors of 

15 the Federal Reserve System shall promulgate regulations 

16 as required by subsection (h)(7) of section 303 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 

18 added by subsection (a), not later than 90 days after the 

19 date of enactment of this Act. 

20 SEC. 9. IMPORTATION EXEMPTION UNDER CONTROLLED 

21 SUBSTANCES IMPORT AND EXPORT ACT. 

22 Section 1006(a)(2) of the Controlled Substances Im23 port and Export Act (21 U.S.C. 956(a)(2)) is amended 

24 by striking ‘‘not import the controlled substance into the 

25 United States in an amount that exceeds 50 dosage units 


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1 of the controlled substance.’’ and inserting ‘‘import into 

2 the United States not more than 10 dosage units com3 bined of all such controlled substances.’’. 

4 SEC. 10. SEVERABILITY. 

5 If any provision of this Act, an amendment by this 

6 Act, or the application of such provision or amendment 

7 to any person or circumstance is held to be unconstitu8 tional, the remainder of this Act, the amendments made 

9 by this Act, and the application of the provisions of such 

10 to any person or circumstance shall not affected thereby. 


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Calendar No. 73 

111TH CONGRESS 

1ST SESSION S. 1232 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

tion drugs, and for other purposes. Act with respect to the importation of prescripJUNE 11, 2009 

Read the second time and placed on the calendar 


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