II 

109TH CONGRESS 

1ST SESSION S. 334 

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

importation of prescription drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 9, 2005 

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

MCCAIN, Ms. STABENOW, Mr. CHAFEE, Mr. JEFFORDS, Mr. LOTT, Mr. 

DAYTON, Mrs. CLINTON, Mr. BINGAMAN, Mrs. BOXER, Mr. CONRAD, Mr. 

DURBIN, Mr. FEINGOLD, Mrs. FEINSTEIN, Mr. INOUYE, Mr. JOHNSON, 

Mr. KOHL, Mr. LEAHY, Mr. LEVIN, Mr. NELSON of Florida, Mr. OBAMA, 

Mr. PRYOR, Mr. SALAZAR, Mr. SARBANES, Mr. SCHUMER, and Ms. COLLINS) introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

respect to the importation of prescription drugs, and 

for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pharmaceutical Mar5 ket Access and Drug Safety Act of 2005’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 
2 

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

2 to fill their prescriptions than consumers in other 

3 countries; 

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

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

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

10 (4) allowing and structuring the importation of 

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

15 (5) American seniors alone will spend 

16 $1,800,000,000,000 on pharmaceuticals over the 

17 next 10 years; and 

18 (6) allowing open pharmaceutical markets could 

19 save American consumers at least $38,000,000,000 

20 each year. 

21 SEC. 3. REPEAL OF CERTAIN SECTION REGARDING IMPOR22 TATION OF PRESCRIPTION DRUGS. 

23 Chapter VIII of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 381 et seq.) is amended by striking 

25 section 804. 
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1 SEC. 4. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER 

2 OF CERTAIN IMPORT RESTRICTIONS. 

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

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

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

6 after section 803 the following: 

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

8 PRESCRIPTION DRUGS. 

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

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

11 drugs imported or offered for import into the United 

12 States from registered exporters or by registered im13 porters— 

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

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

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

17 801(a) regarding admission of the drugs are 

18 subject to subsection (g) of this section (includ19 ing with respect to qualifying drugs to which 

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

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

22 be imported under paragraph (1) unless— 

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

24 group of pharmacies, or a wholesaler that is a 

25 registered importer; or 
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1 ‘‘(B) the drug is imported by an individual 

2 for personal use or for the use of a family mem3 ber of the individual (not for resale) from a reg4 istered exporter. 

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

6 shall apply only with respect to a drug that is im7 ported or offered for import into the United 

8 States— 

9 ‘‘(A) by a registered importer; or 

10 ‘‘(B) from a registered exporter to an indi11 vidual. 

12 ‘‘(4) DEFINITIONS.— 

13 ‘‘(A) REGISTERED EXPORTER; REG14 ISTERED IMPORTER.—For purposes of this sec15 tion: 

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

17 means an exporter for which a registration 

18 under subsection (b) has been approved 

19 and is in effect. 

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

21 means a pharmacy, group of pharmacies, 

22 or a wholesaler for which a registration 

23 under subsection (b) has been approved 

24 and is in effect. 
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1 ‘‘(iii) The term ‘registration condition’ 

2 means a condition that must exist for a 

3 registration under subsection (b) to be ap4 proved. 

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

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

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

8 label drug. 

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

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

11 a prescription drug that— 

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

13 has the same active ingredient or ingredi14 ents, route of administration, dosage form, 

15 and strength as the qualifying drug; 

16 ‘‘(ii) with respect to the qualifying 

17 drug, is manufactured by or for the person 

18 that manufactures the qualifying drug; 

19 ‘‘(iii) is approved under section 

20 505(c); and 

21 ‘‘(iv) is not— 

22 ‘‘(I) a controlled substance, as 

23 defined in section 102 of the Con24 trolled Substances Act (21 U.S.C. 

25 802); 
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1 ‘‘(II) a biological product, as de2 fined in section 351 of the Public 

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

4 including— 

5 ‘‘(aa) a therapeutic DNA 

6 plasmid product; 

7 ‘‘(bb) a therapeutic synthetic 

8 peptide product; 

9 ‘‘(cc) a monoclonal antibody 

10 product for in vivo use; and 

11 ‘‘(dd) a therapeutic recom12 binant DNA-derived product; 

13 ‘‘(III) an infused drug, including 

14 a peritoneal dialysis solution; 

15 ‘‘(IV) an injected drug; 

16 ‘‘(V) a drug that is inhaled dur17 ing surgery; or 

18 ‘‘(VI) a drug that is the listed 

19 drug referred to in 2 or more abbre20 viated new drug applications under 

21 which the drug is commercially mar22 keted. 

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

24 of this section: 
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1 ‘‘(i)(I) The term ‘exporter’ means a 

2 person that is in the business of exporting 

3 a drug to individuals in the United States 

4 from Canada or from a permitted country 

5 designated by the Secretary under sub6 clause (II), or that, pursuant to submitting 

7 a registration under subsection (b), seeks 

8 to be in such business. 

9 ‘‘(II) The Secretary shall designate a 

10 permitted country under subparagraph (E) 

11 (other than Canada) as a country from 

12 which an exporter may export a drug to in13 dividuals in the United States if the Sec14 retary determines that— 

15 (aa) the country has statutory or 

16 regulatory standards that are equiva17 lent to the standards in the United 

18 States and Canada with respect to— 

19 ‘‘(AA) the training of phar20 macists; 

21 ‘‘(BB) the practice of phar22 macy; and 

23 ‘‘(CC) the protection of the 

24 privacy of personal medical infor25 mation; and 
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1 ‘‘(bb) the importation of drugs to 

2 individuals in the United States from 

3 the country will not adversely affect 

4 public health. 

5 ‘‘(ii) The term ‘importer’ means a 

6 pharmacy, a group of pharmacies, or a 

7 wholesaler that is in the business of im8 porting a drug into the United States or 

9 that, pursuant to submitting a registration 

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

11 business. 

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

13 person licensed by a State to practice 

14 pharmacy, including the dispensing and 

15 selling of prescription drugs. 

16 ‘‘(iv) The term ‘pharmacy’ means a 

17 person that— 

18 ‘‘(I) is licensed by a State to en19 gage in the business of selling pre20 scription drugs at retail; and 

21 ‘‘(II) employs 1 or more phar22 macists. 

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

24 means a drug that is described in section 

25 503(b)(1). 
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1 ‘‘(vi) The term ‘wholesaler’— 

2 ‘‘(I) means a person licensed as a 

3 wholesaler or distributor of prescrip4 tion drugs in the United States under 

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

6 ‘‘(II) does not include a person 

7 authorized to import drugs under sec8 tion 801(d)(1). 

9 ‘‘(E) PERMITTED COUNTRY.—The term 

10 ‘permitted country’ means— 

11 ‘‘(i) Australia; 

12 ‘‘(ii) Canada; 

13 ‘‘(iii) a member country of the Euro14 pean Union, but does not include a mem15 ber country with respect to which— 

16 ‘‘(I) the country’s Annex to the 

17 Treaty of Accession to the European 

18 Union 2003 includes a transitional 

19 measure for the regulation of human 

20 pharmaceutial products that has not 

21 expired; or 

22 ‘‘(II) the Secretary determines 

23 that the requirements described in 

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

25 will not be met by the date on which 
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1 such transitional measure for the reg2 ulation of human pharmaceutial prod3 ucts expires; 

4 ‘‘(iv) Japan; 

5 ‘‘(v) New Zealand; 

6 ‘‘(vi) Switzerland; and 

7 ‘‘(vii) a country in which the Sec8 retary determines the following require9 ments are met: 

10 ‘‘(I) The country has statutory or 

11 regulatory requirements— 

12 ‘‘(aa) that require the review 

13 of drugs for safety and effective14 ness by an entity of the govern15 ment of the country; 

16 ‘‘(bb) that authorize the ap17 proval of only those drugs that 

18 have been determined to be safe 

19 and effective by experts employed 

20 by or acting on behalf of such en21 tity and qualified by scientific 

22 training and experience to evalu23 ate the safety and effectiveness of 

24 drugs on the basis of adequate 

25 and well-controlled investigations, 
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1 including clinical investigations, 

2 conducted by experts qualified by 

3 scientific training and experience 

4 to evaluate the safety and effec5 tiveness of drugs; 

6 ‘‘(cc) that require the meth7 ods used in, and the facilities and 

8 controls used for the manufac9 ture, processing, and packing of 

10 drugs in the country to be ade11 quate to preserve their identity, 

12 quality, purity, and strength; 

13 ‘‘(dd) for the reporting of 

14 adverse reactions to drugs and 

15 procedures to withdraw approval 

16 and remove drugs found not to 

17 be safe or effective; and 

18 ‘‘(ee) that require the label19 ing and promotion of drugs to be 

20 in accordance with the approval 

21 of the drug. 

22 ‘‘(II) The valid marketing au23 thorization system in the country is 

24 equivalent to the systems in the coun-
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1 tries described in clauses (i) through 

2 (vi). 

3 ‘‘(III) The importation of drugs 

4 to the United States from the country 

5 will not adversely affect public health. 

6 ‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT7 ERS.— 

8 ‘‘(1) REGISTRATION OF IMPORTERS AND EX9 PORTERS.—A registration condition is that the im10 porter or exporter involved (referred to in this sub11 section as a ‘registrant’) submits to the Secretary a 

12 registration containing the following: 

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

14 name of the exporter and an identification of all 

15 places of business of the exporter that relate to 

16 qualifying drugs, including each warehouse or 

17 other facility owned or controlled by, or oper18 ated for, the exporter. 

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

20 of the importer and an identification of the 

21 places of business of the importer at which the 

22 importer initially receives a qualifying drug 

23 after importation (which shall not exceed 3 

24 places of business except by permission of the 

25 Secretary). 
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1 ‘‘(B) Such information as the Secretary 

2 determines to be necessary to demonstrate that 

3 the registrant is in compliance with registration 

4 conditions under— 

5 ‘‘(i) in the case of an importer, sub6 sections (c), (d), (e), (g), and (j) (relating 

7 to the sources of imported qualifying 

8 drugs; the inspection of facilities of the im9 porter; the payment of fees; compliance 

10 with the standards referred to in section 

11 801(a); and maintenance of records and 

12 samples); or 

13 ‘‘(ii) in the case of an exporter, sub14 sections (c), (d), (f), (g), (h), (i), and (j) 

15 (relating to the sources of exported quali16 fying drugs; the inspection of facilities of 

17 the exporter and the marking of compliant 

18 shipments; the payment of fees; and com19 pliance with the standards referred to in 

20 section 801(a); being licensed as a phar21 macist; conditions for individual importa22 tion; and maintenance of records and sam23 ples). 

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

25 the registrant will not under subsection (a) im-
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•S 334 IS 

1 port or export any drug that is not a qualifying 

2 drug. 

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

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

5 withdrawal of a qualifying drug distributed 

6 in a permitted country that the registrant 

7 has exported or imported, or intends to ex8 port or import, to the United States under 

9 subsection (a); 

10 ‘‘(ii) provide for the return to the reg11 istrant of such drug; and 

12 ‘‘(iii) cease, or not begin, the expor13 tation or importation of such drug unless 

14 the Secretary has notified the registrant 

15 that exportation or importation of such 

16 drug may proceed. 

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

18 ensure and monitor compliance with each reg19 istration condition, to promptly correct any 

20 noncompliance with such a condition, and to 

21 promptly report to the Secretary any such non22 compliance. 

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

24 which the registrant will comply with the agree25 ment under subparagraph (E). 
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1 ‘‘(G) An agreement by the registrant to 

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

3 against a party in the chain of custody of a 

4 qualifying drug with respect to the authority of 

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

6 subsection. 

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

8 notify the Secretary not more than 30 days be9 fore the registrant intends to make the change, 

10 of— 

11 ‘‘(i) any change that the registrant in12 tends to make regarding information pro13 vided under subparagraph (A) or (B); and 

14 ‘‘(ii) any change that the registrant 

15 intends to make in the compliance plan 

16 under subparagraph (F). 

17 ‘‘(I) In the case of an exporter— 

18 ‘‘(i) An agreement by the exporter 

19 that a qualifying drug will not under sub20 section (a) be exported to any individual 

21 not authorized pursuant to subsection 

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

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

24 payable to the Treasury of the United 
16 

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1 States that is equal in value to the lesser 

2 of— 

3 ‘‘(I) the value of drugs exported 

4 by the exporter to the United States 

5 in a typical 4-week period over the 

6 course of a year under this section; or 

7 ‘‘(II) $1,000,000; 

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

9 comply with applicable provisions of Cana10 dian law, or the law of the permitted coun11 try designated under subsection 

12 (a)(4)(D)(i)(II) in which the exporter is lo13 cated, that protect the privacy of personal 

14 information with respect to each individual 

15 importing a prescription drug from the ex16 porter under subsection (a)(2)(B). 

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

18 report to the Secretary— 

19 ‘‘(I) not later than August 1 of 

20 each fiscal year, the total price and 

21 the total volume of drugs exported to 

22 the United States by the exporter dur23 ing the 6-month period from January 

24 1 through June 30 of that year; and 
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1 ‘‘(II) not later than January 1 of 

2 each fiscal year, the total price and 

3 the total volume of drugs exported to 

4 the United States by the exporter dur5 ing the previous fiscal year. 

6 ‘‘(J) In the case of an importer, an agree7 ment by the importer to report to the Sec8 retary— 

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

10 fiscal year, the total price and the total 

11 volume of drugs imported to the United 

12 States by the importer during the 6-month 

13 period from January 1 through June 30 of 

14 that fiscal year; and 

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

16 fiscal year, the total price and the total 

17 volume of drugs imported to the United 

18 States by the importer during the previous 

19 fiscal year. 

20 ‘‘(K) Such other provisions as the Sec21 retary may require by regulation to protect the 

22 public health while permitting— 

23 ‘‘(i) the importation by pharmacies, 

24 groups of pharmacies, and wholesalers as 
18 

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1 registered importers of qualifying drugs 

2 under subsection (a); and 

3 ‘‘(ii) importation by individuals of 

4 qualifying drugs under subsection (a). 

5 ‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA6 TION.— 

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

8 days after the date on which a registrant sub9 mits to the Secretary a registration under para10 graph (1), the Secretary shall notify the reg11 istrant whether the registration is approved or 

12 is disapproved. The Secretary shall disapprove 

13 a registration if there is reason to believe that 

14 the registrant is not in compliance with one or 

15 more registration conditions, and shall notify 

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

17 disapproved registration, the Secretary shall 

18 subsequently notify the registrant that the reg19 istration is approved if the Secretary deter20 mines that the registrant is in compliance with 

21 such conditions. 

22 ‘‘(B) CHANGES IN REGISTRATION INFOR23 MATION.—Not later than 30 days after receiv24 ing a notice under paragraph (1)(H) from a 

25 registrant, the Secretary shall determine wheth-
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1 er the change involved affects the approval of 

2 the registration of the registrant under para3 graph (1), and shall inform the registrant of 

4 the determination. 

5 ‘‘(3) PUBLICATION OF CONTACT INFORMATION

6 FOR REGISTERED EXPORTERS.—Through the Inter7 net website of the Food and Drug Administration 

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

9 make readily available to the public a list of reg10 istered exporters, including contact information for 

11 the exporters. Promptly after the approval of a reg12 istration submitted under paragraph (1), the Sec13 retary shall update the Internet website and the in14 formation provided through the toll-free telephone 

15 number accordingly. 

16 ‘‘(4) SUSPENSION AND TERMINATION.— 

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

18 effectiveness of a registration submitted under 

19 paragraph (1): 

20 ‘‘(i) Subject to clause (ii), the Sec21 retary may suspend the registration if the 

22 Secretary determines, after notice and op23 portunity for a hearing, that the registrant 

24 has failed to maintain substantial compli25 ance with a registration condition. 
20 

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

2 under color of the registration, the ex3 porter has exported a drug or the importer 

4 has imported a drug that is not a quali5 fying drug, or a drug that does not comply 

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

7 exported a qualifying drug to an individual 

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

9 Secretary shall immediately suspend the 

10 registration. A suspension under the pre11 ceding sentence is not subject to the provi12 sion by the Secretary of prior notice, and 

13 the Secretary shall provide to the reg14 istrant an opportunity for a hearing not 

15 later than 10 days after the date on which 

16 the registration is suspended. 

17 ‘‘(iii) The Secretary may reinstate the 

18 registration, whether suspended under 

19 clause (i) or (ii), if the Secretary deter20 mines that the registrant has demonstrated 

21 that further violations of registration con22 ditions will not occur. 

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

24 notice and opportunity for a hearing, may ter25 minate the registration under paragraph (1) of 
21 

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1 a registrant if the Secretary determines that 

2 the registrant has engaged in a pattern or prac3 tice of violating 1 or more registration condi4 tions, or if on 1 or more occasions the Secretary 

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

6 registration of the registrant. The Secretary 

7 may make the termination permanent, or for a 

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

9 period in which the registration is terminated, 

10 any registration submitted under paragraph (1) 

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

12 in the export or import enterprise, or a prin13 cipal officer in such enterprise, and any reg14 istration prepared with the assistance of the 

15 registrant or such a person, has no legal effect 

16 under this section. 

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

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

19 shall be defaulted and paid to the Treasury of the 

20 United States if, after opportunity for an informal 

21 hearing, the Secretary determines that the exporter 

22 has— 

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

24 that is not a qualifying drug or that is not in 
22 

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

2 (i); or 

3 ‘‘(B) failed to permit the Secretary to con4 duct an inspection described under subsection 

5 (d). 

6 ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra7 tion condition is that the exporter or importer involved 

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

9 exported or imported into the United States only if there 

10 is compliance with the following: 

11 ‘‘(1) The drug was manufactured in an estab12 lishment— 

13 ‘‘(A) required to register under subsection 

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

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

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

17 rely on a satisfactory report of a good manufac18 turing practice inspection of the establishment 

19 from a permitted country whose regulatory sys20 tem the Secretary recognizes as equivalent 

21 under a mutual recognition agreement, as pro22 vided for under section 510(i)(3), section 803, 

23 or part 26 of title 21, Code of Federal Regula24 tions (or any corresponding successor rule or 

25 regulation). 
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1 ‘‘(2) The establishment is located in any coun2 try, and the establishment manufactured the drug 

3 for distribution in the United States or for distribu4 tion in 1 or more of the permitted countries (without 

5 regard to whether in addition the drug is manufac6 tured for distribution in a foreign country that is 

7 not a permitted country). 

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

9 drug— 

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

11 ‘‘(B) directly from an entity that, by con12 tract with the exporter or importer— 

13 ‘‘(i) provides to the exporter or im14 porter a statement (in such form and con15 taining such information as the Secretary 

16 may require) that, for the chain of custody 

17 from the establishment, identifies each 

18 prior sale, purchase, or trade of the drug 

19 (including the date of the transaction and 

20 the names and addresses of all parties to 

21 the transaction); 

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

23 inspect such statements and related 

24 records to determine their accuracy; 
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1 ‘‘(iii) agrees, with respect to the quali2 fying drugs involved, to permit the Sec3 retary to inspect warehouses and other fa4 cilities, including records, of the entity for 

5 purposes of determining whether the facili6 ties are in compliance with any standards 

7 under this Act that are applicable to facili8 ties of that type in the United States; and 

9 ‘‘(iv) has ensured, through such con10 tractual relationships as may be necessary, 

11 that the Secretary has the same authority 

12 regarding other parties in the chain of cus13 tody from the establishment that the Sec14 retary has under clauses (ii) and (iii) re15 garding such entity. 

16 ‘‘(4)(A) The foreign country from which the im17 porter will import the drug is a permitted country; 

18 or 

19 ‘‘(B) The foreign country from which the ex20 porter will export the drug is the permitted country 

21 in which the exporter is located. 

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

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

24 the drug did not enter any country that is not a per25 mitted country. 
25 

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

2 of each lot of the drug sufficient for testing by the 

3 Secretary. 

4 ‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP5 MENTS.— 

6 ‘‘(1) INSPECTION OF FACILITIES.—A registra7 tion condition is that, for the purpose of assisting 

8 the Secretary in determining whether the exporter 

9 involved is in compliance with all other registration 

10 conditions— 

11 ‘‘(A) the exporter agrees to permit the Sec12 retary— 

13 ‘‘(i) to conduct onsite inspections, in14 cluding monitoring on a day-to-day basis, 

15 of places of business of the exporter that 

16 relate to qualifying drugs, including each 

17 warehouse or other facility owned or con18 trolled by, or operated for, the exporter; 

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

20 day-to-day basis, to— 

21 ‘‘(I) records of the exporter that 

22 relate to the export of such drugs, in23 cluding financial records; and 

24 ‘‘(II) samples of such drugs; 
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1 ‘‘(iii) to carry out the duties described 

2 in paragraph (3); and 

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

4 determined by the Secretary to be nec5 essary regarding the compliance of the ex6 porter; and 

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

8 employees of the Secretary to carry out the 

9 functions described in this subsection for the 

10 Secretary randomly, but not less than 12 times 

11 annually, on the premises of places of busi12 nesses referred to in subparagraph (A)(i), and 

13 such an assignment remains in effect on a con14 tinuous basis. 

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

16 registration condition is that the exporter involved 

17 agrees to affix to each shipping container of quali18 fying drugs exported under subsection (a) such 

19 markings as the Secretary determines to be nec20 essary to identify the shipment as being in compli21 ance with all registration conditions. Markings under 

22 the preceding sentence shall— 

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

24 the markings to any shipping container that is 

25 not authorized to bear the markings; and 
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1 ‘‘(B) include anticounterfeiting or track2 and-trace technologies, taking into account the 

3 economic and technical feasibility of those tech4 nologies. 

5 ‘‘(3) CERTAIN DUTIES RELATING TO EXPORT6 ERS.—Duties of the Secretary with respect to an ex7 porter include the following: 

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

9 than 12 times annually, the places of business 

10 of the exporter at which qualifying drugs are 

11 stored and from which qualifying drugs are 

12 shipped. 

13 ‘‘(B) During the inspections under sub14 paragraph (A), verifying the chain of custody of 

15 a statistically significant sample of qualifying 

16 drugs from the establishment in which the drug 

17 was manufactured to the exporter, which shall 

18 be accomplished or supplemented by the use of 

19 anticounterfeiting or track-and-trace tech20 nologies, taking into account the economic and 

21 technical feasibility of those technologies, except 

22 that a drug that lacks such technologies from 

23 the point of manufacture shall not for that rea24 son be excluded from importation by an ex25 porter. 
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1 ‘‘(C) Randomly reviewing records of ex2 ports to individuals for the purpose of deter3 mining whether the drugs are being imported 

4 by the individuals in accordance with the condi5 tions under subsection (i). Such reviews shall be 

6 conducted in a manner that will result in a sta7 tistically significant determination of compli8 ance with all such conditions. 

9 ‘‘(D) Monitoring the affixing of markings 

10 under paragraph (2). 

11 ‘‘(E) Inspecting as the Secretary deter12 mines is necessary the warehouses and other fa13 cilities, including records, of other parties in the 

14 chain of custody of qualifying drugs. 

15 ‘‘(F) Determining whether the exporter is 

16 in compliance with all other registration condi17 tions. 

18 ‘‘(4) PRIOR NOTICE OF SHIPMENTS.—A reg19 istration condition is that, not less than 8 hours and 

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

21 importation of a shipment of qualifying drugs, the 

22 importer involved agrees to submit to the Secretary 

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

24 imported or offered for import into the United 
29 

•S 334 IS 

1 States under subsection (a). A notice under the pre2 ceding sentence shall include— 

3 ‘‘(A) the name and complete contact infor4 mation of the person submitting the notice; 

5 ‘‘(B) the name and complete contact infor6 mation of the importer involved; 

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

8 established name of the drug, the quantity of 

9 the drug, and the lot number assigned by the 

10 manufacturer; 

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

12 the drug, including the identity of the establish13 ment at which the drug was manufactured; 

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

15 shipped; 

16 ‘‘(F) the name and complete contact infor17 mation for the shipper of the drug; 

18 ‘‘(G) anticipated arrival information, in19 cluding the port of arrival and crossing location 

20 within that port, and the date and time; 

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

22 the drug from the establishment in which the 

23 drug was manufactured to the importer; 

24 ‘‘(I) a declaration as to whether the Sec25 retary has ordered that importation of the drug 
30 

•S 334 IS 

1 from the permitted country cease under sub2 section (g)(2)(C) or (D); and 

3 ‘‘(J) such other information as the Sec4 retary may require by regulation. 

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

6 registration condition is that the importer involved 

7 agrees, before wholesale distribution (as defined in 

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

9 imported under subsection (a), to affix to each con10 tainer of such drug such markings or other tech11 nology as the Secretary determines necessary to 

12 identify the shipment as being in compliance with all 

13 registration conditions, except that the markings or 

14 other technology shall not be required on a drug 

15 that bears comparable, compatible markings or tech16 nology from the manufacturer of the drug. Markings 

17 or other technology under the preceding sentence 

18 shall— 

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

20 the markings or other technology to any con21 tainer that is not authorized to bear the mark22 ings; and 

23 ‘‘(B) shall include anticounterfeiting or 

24 track-and-trace technologies, taking into ac-
31 

•S 334 IS 

1 count the economic and technical feasibility of 

2 such technologies. 

3 ‘‘(6) CERTAIN DUTIES RELATING TO IMPORT4 ERS.—Duties of the Secretary with respect to an im5 porter include the following: 

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

7 than 12 times annually, the places of business 

8 of the importer at which a qualifying drug is 

9 initially received after importation. 

10 ‘‘(B) During the inspections under sub11 paragraph (A), verifying the chain of custody of 

12 a statistically significant sample of qualifying 

13 drugs from the establishment in which the drug 

14 was manufactured to the importer, which shall 

15 be accomplished or supplemented by the use of 

16 anticounterfeiting or track-and-trace tech17 nologies, taking into account the economic and 

18 technical feasibility of those technologies, except 

19 that a drug that lacks such technologies from 

20 the point of manufacture shall not for that rea21 son be excluded from importation by an im22 porter. 

23 ‘‘(C) Reviewing notices under paragraph 

24 (4). 
32 

•S 334 IS 

1 ‘‘(D) Inspecting as the Secretary deter2 mines is necessary the warehouses and other fa3 cilities, including records of other parties in the 

4 chain of custody of qualifying drugs. 

5 ‘‘(E) Determining whether the importer is 

6 in compliance with all other registration condi7 tions. 

8 ‘‘(e) IMPORTER FEES.— 

9 ‘‘(1) REGISTRATION FEE.—A registration con10 dition is that the importer involved pays to the Sec11 retary a fee of $10,000 due on the date on which 

12 the importer first submits the registration to the 

13 Secretary under subsection (b). 

14 ‘‘(2) INSPECTION FEE.—A registration condi15 tion is that the importer involved pays a fee to the 

16 Secretary in accordance with this subsection. Such 

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

18 1 of each fiscal year in the amount provided for 

19 under paragraph (3). 

20 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

21 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

22 later than 30 days before the start of each fis23 cal year, the Secretary, in consultation with the 

24 Secretary of Homeland Security and the Sec25 retary of the Treasury, shall establish an aggre-
33 

•S 334 IS 

1 gate total of fees to be collected under para2 graph (2) for importers for that fiscal year that 

3 is sufficient, and not more than necessary, to 

4 pay the costs for that fiscal year of admin5 istering this section with respect to registered 

6 importers, including the costs associated with— 

7 ‘‘(i) inspecting the facilities of reg8 istered importers, and of other entities in 

9 the chain of custody of a qualifying drug 

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

11 ‘‘(ii) developing, implementing, and 

12 operating under such subsection an elec13 tronic system for submission and review of 

14 the notices required under subsection 

15 (d)(4) with respect to shipments of quali16 fying drugs under subsection (a) to assess 

17 compliance with all registration conditions 

18 when such shipments are offered for im19 port into the United States; and 

20 ‘‘(iii) inspecting such shipments as 

21 necessary, when offered for import into the 

22 United States to determine if such a ship23 ment should be refused admission under 

24 subsection (g)(5). 
34 

•S 334 IS 

1 ‘‘(B) LIMITATION.—Subject to subpara2 graph (C), the aggregate total of fees collected 

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

4 exceed 1 percent of the total price of qualifying 

5 drugs imported during that fiscal year into the 

6 United States by registered importers under 

7 subsection (a). 

8 ‘‘(C) TOTAL PRICE OF DRUGS.— 

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

10 complying with the limitation described in 

11 subparagraph (B) when establishing under 

12 subparagraph (A) the aggregate total of 

13 fees to be collected under paragraph (2) 

14 for a fiscal year, the Secretary shall esti15 mate the total price of qualifying drugs im16 ported into the United States by registered 

17 importers during that fiscal year by adding 

18 the total price of qualifying drugs imported 

19 by each registered importer during the 6- 

20 month period from January 1 through 

21 June 30 of the previous fiscal year, as re22 ported to the Secretary by each registered 

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

24 ‘‘(ii) CALCULATION.—Not later than 

25 March 1 of the fiscal year that follows the 
35 

•S 334 IS 

1 fiscal year for which the estimate under 

2 clause (i) is made, the Secretary shall cal3 culate the total price of qualifying drugs 

4 imported into the United States by reg5 istered importers during that fiscal year by 

6 adding the total price of qualifying drugs 

7 imported by each registered importer dur8 ing that fiscal year, as reported to the Sec9 retary by each registered importer under 

10 subsection (b)(1)(J). 

11 ‘‘(iii) ADJUSTMENT.—If the total 

12 price of qualifying drugs imported into the 

13 United States by registered importers dur14 ing a fiscal year as calculated under clause 

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

16 collected under paragraph (2) for that fis17 cal year, the Secretary shall provide for a 

18 pro-rata reduction in the fee due from each 

19 registered importer on April 1 of the sub20 sequent fiscal year so that the limitation 

21 described in subparagraph (B) is observed. 

22 ‘‘(D) INDIVIDUAL IMPORTER FEE.—Sub23 ject to the limitation described in subparagraph 

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

25 October 1 and April 1 by an importer shall be 
36 

•S 334 IS 

1 an amount that is proportional to a reasonable 

2 estimate by the Secretary of the semiannual 

3 share of the importer of the volume of quali4 fying drugs imported by importers under sub5 section (a). 

6 ‘‘(4) USE OF FEES.— 

7 ‘‘(A) IN GENERAL.—Subject to appropria8 tions Acts, fees collected by the Secretary under 

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

10 appropriation account for salaries and expenses 

11 of the Food and Drug Administration until ex12 pended (without fiscal year limitation), and the 

13 Secretary may, in consultation with the Sec14 retary of Homeland Security and the Secretary 

15 of the Treasury, transfer some proportion of 

16 such fees to the appropriation account for sala17 ries and expenses of the Bureau of Customs 

18 and Border Protection until expended (without 

19 fiscal year limitation). 

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

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

22 only available to the Secretary and, if trans23 ferred, to the Secretary of Homeland Security, 

24 and are for the sole purpose of paying the costs 

25 referred to in paragraph (3)(A). 
37 

•S 334 IS 

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

2 the Secretary does not receive payment of a fee as3 sessed under paragraph (1) or (2) within 30 days 

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

5 of the United States Government subject to sub6 chapter II of chapter 37 of title 31, United States 

7 Code. 

8 ‘‘(f) EXPORTER FEES.— 

9 ‘‘(1) REGISTRATION FEE.—A registration con10 dition is that the exporter involved pays to the Sec11 retary a fee of $10,000 due on the date on which 

12 the exporter first submits that registration to the 

13 Secretary under subsection (b). 

14 ‘‘(2) INSPECTION FEE.—A registration condi15 tion is that the exporter involved pays a fee to the 

16 Secretary in accordance with this subsection. Such 

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

18 1 of each fiscal year in the amount provided for 

19 under paragraph (3). 

20 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

21 ‘‘(A) AGGREGATE TOTAL OF FEES.—Not 

22 later than 30 days before the start of each fis23 cal year, the Secretary, in consultation with the 

24 Secretary of Homeland Security and the Sec25 retary of the Treasury, shall establish an aggre-
38 

•S 334 IS 

1 gate total of fees to be collected under para2 graph (2) for exporters for that fiscal year that 

3 is sufficient, and not more than necessary, to 

4 pay the costs for that fiscal year of admin5 istering this section with respect to registered 

6 exporters, including the costs associated with— 

7 ‘‘(i) inspecting the facilities of reg8 istered exporters, and of other entities in 

9 the chain of custody of a qualifying drug 

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

11 ‘‘(ii) developing, implementing, and 

12 operating under such subsection a system 

13 to screen marks on shipments of qualifying 

14 drugs under subsection (a) that indicate 

15 compliance with all registration conditions, 

16 when such shipments are offered for im17 port into the United States; and 

18 ‘‘(iii) screening such markings, and 

19 inspecting such shipments as necessary, 

20 when offered for import into the United 

21 States to determine if such a shipment 

22 should be refused admission under sub23 section (g)(5). 

24 ‘‘(B) LIMITATION.—Subject to subpara25 graph (C), the aggregate total of fees collected 
39 

•S 334 IS 

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

2 exceed 1 percent of the total price of qualifying 

3 drugs imported during that fiscal year into the 

4 United States by registered exporters under 

5 subsection (a). 

6 ‘‘(C) TOTAL PRICE OF DRUGS.— 

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

8 complying with the limitation described in 

9 subparagraph (B) when establishing under 

10 subparagraph (A) the aggregate total of 

11 fees to be collected under paragraph (2) 

12 for a fiscal year, the Secretary shall esti13 mate the total price of qualifying drugs im14 ported into the United States by registered 

15 exporters during that fiscal year by adding 

16 the total price of qualifying drugs exported 

17 by each registered exporter during the 6- 

18 month period from January 1 through 

19 June 30 of the previous fiscal year, as re20 ported to the Secretary by each registered 

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

22 ‘‘(ii) CALCULATION.—Not later than 

23 March 1 of the fiscal year that follows the 

24 fiscal year for which the estimate under 

25 clause (i) is made, the Secretary shall cal-
40 

•S 334 IS 

1 culate the total price of qualifying drugs 

2 imported into the United States by reg3 istered exporters during that fiscal year by 

4 adding the total price of qualifying drugs 

5 exported by each registered exporter dur6 ing that fiscal year, as reported to the Sec7 retary by each registered exporter under 

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

9 ‘‘(iii) ADJUSTMENT.—If the total 

10 price of qualifying drugs imported into the 

11 United States by registered exporters dur12 ing a fiscal year as calculated under clause 

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

14 collected under paragraph (2) for that fis15 cal year, the Secretary shall provide for a 

16 pro-rata reduction in the fee due from each 

17 registered exporter on April 1 of the subse18 quent fiscal year so that the limitation de19 scribed in subparagraph (B) is observed. 

20 ‘‘(D) INDIVIDUAL EXPORTER FEE.—Sub21 ject to the limitation described in subparagraph 

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

23 October 1 and April 1 by an exporter shall be 

24 an amount that is proportional to a reasonable 

25 estimate by the Secretary of the semiannual 
41 

•S 334 IS 

1 share of the exporter of the volume of quali2 fying drugs exported by exporters under sub3 section (a). 

4 ‘‘(4) USE OF FEES.— 

5 ‘‘(A) IN GENERAL.—Subject to appropria6 tions Acts, fees collected by the Secretary under 

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

8 appropriation account for salaries and expenses 

9 of the Food and Drug Administration until ex10 pended (without fiscal year limitation), and the 

11 Secretary may, in consultation with the Sec12 retary of Homeland Security and the Secretary 

13 of the Treasury, transfer some proportion of 

14 such fees to the appropriation account for sala15 ries and expenses of the Bureau of Customs 

16 and Border Protection until expended (without 

17 fiscal year limitation). 

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

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

20 only available to the Secretary and, if trans21 ferred, to the Secretary of Homeland Security, 

22 and are for the sole purpose of paying the costs 

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

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

25 the Secretary does not receive payment of a fee as-
42 

•S 334 IS 

1 sessed under paragraph (1) or (2) within 30 days 

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

3 of the United States Government subject to sub4 chapter II of chapter 37 of title 31, United States 

5 Code. 

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

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

8 that each qualifying drug exported under subsection 

9 (a) by the registered exporter involved or imported 

10 under subsection (a) by the registered importer in11 volved is in compliance with the standards referred 

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

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

14 (3), and (4). 

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

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

17 is imported or offered for import under sub18 section (a) shall comply with the conditions es19 tablished in the approved application under sec20 tion 505(b) for the U.S. label drug as described 

21 under this subsection. 

22 ‘‘(B) NOTICE BY MANUFACTURER; GEN23 ERAL PROVISIONS.— 

24 ‘‘(i) IN GENERAL.—The person that 

25 manufactures a qualifying drug that is, or 
43 

•S 334 IS 

1 will be, introduced for commercial distribu2 tion in a permitted country shall in accord3 ance with this paragraph submit to the 

4 Secretary a notice that— 

5 ‘‘(I) includes each difference in 

6 the qualifying drug from a condition 

7 established in the approved applica8 tion for the U.S. label drug beyond— 

9 ‘‘(aa) the variations provided 

10 for in the application; and 

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

13 or 

14 ‘‘(II) states that there is no dif15 ference in the qualifying drug from a 

16 condition established in the approved 

17 application for the U.S. label drug be18 yond— 

19 ‘‘(aa) the variations provided 

20 for in the application; and 

21 ‘‘(bb) any difference in label22 ing (except ingredient labeling). 

23 ‘‘(ii) INFORMATION IN NOTICE.—A 

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

25 information that the Secretary may require 
44 

•S 334 IS 

1 under section 506A, any additional infor2 mation the Secretary may require (which 

3 may include data on bioequivalence if such 

4 data are not required under section 506A), 

5 and, with respect to the permitted country 

6 that approved the qualifying drug for com7 mercial distribution, or with respect to 

8 which such approval is sought, include the 

9 following: 

10 ‘‘(I) The date on which the quali11 fying drug with such difference was, 

12 or will be, introduced for commercial 

13 distribution in the permitted country. 

14 ‘‘(II) Information demonstrating 

15 that the person submitting the notice 

16 has also notified the government of 

17 the permitted country in writing that 

18 the person is submitting to the Sec19 retary a notice under clause (i)(I), 

20 which notice describes the difference 

21 in the qualifying drug from a condi22 tion established in the approved appli23 cation for the U.S. label drug. 

24 ‘‘(III) The information that the 

25 person submitted or will submit to the 
45 

•S 334 IS 

1 government of the permitted country 

2 for purposes of obtaining approval for 

3 commercial distribution of the drug in 

4 the country which, if in a language 

5 other than English, shall be accom6 panied by an English translation 

7 verified to be complete and accurate, 

8 with the name, address, and a brief 

9 statement of the qualifications of the 

10 person that made the translation. 

11 ‘‘(iii) CERTIFICATIONS.—The chief ex12 ecutive officer and the chief medical officer 

13 of the manufacturer involved shall each 

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

15 ‘‘(I) the information provided in 

16 the notice is complete and true; and 

17 ‘‘(II) a copy of the notice has 

18 been provided to the Federal Trade 

19 Commission and to the State attor20 neys general. 

21 ‘‘(iv) FEE.—If a notice submitted 

22 under clause (i) includes a difference that 

23 would, under section 506A, require the 

24 submission of a supplemental application if 

25 made as a change to the U.S. label drug, 
46 

•S 334 IS 

1 the person that submits the notice shall 

2 pay to the Secretary a fee in the same 

3 amount as would apply if the person were 

4 paying a fee pursuant to section 

5 736(a)(1)(A)(ii). Subject to appropriations 

6 Acts, fees collected by the Secretary under 

7 the preceding sentence are available only to 

8 the Secretary and are for the sole purpose 

9 of paying the costs of reviewing notices 

10 submitted under clause (i). 

11 ‘‘(v) TIMING OF SUBMISSION OF NO12 TICES.— 

13 ‘‘(I) PRIOR APPROVAL NO14 TICES.—A notice under clause (i) to 

15 which subparagraph (C) applies shall 

16 be submitted to the Secretary not 

17 later than 120 days before the quali18 fying drug with the difference is intro19 duced for commercial distribution in a 

20 permitted country, unless the country 

21 requires that distribution of the quali22 fying drug with the difference begin 

23 less than 120 days after the country 

24 requires the difference. 
47 

•S 334 IS 

1 ‘‘(II) OTHER APPROVAL NO2 TICES.—A notice under clause (i) to 

3 which subparagraph (D) applies shall 

4 be submitted to the Secretary not 

5 later than the day on which the quali6 fying drug with the difference is intro7 duced for commercial distribution in a 

8 permitted country. 

9 ‘‘(III) OTHER NOTICES.—A no10 tice under clause (i) to which subpara11 graph (E) applies shall be submitted 

12 to the Secretary on the date that the 

13 qualifying drug is first introduced for 

14 commercial distribution in a permitted 

15 country and annually thereafter. 

16 ‘‘(vi) REVIEW BY SECRETARY.— 

17 ‘‘(I) IN GENERAL.—In this para18 graph, the difference in a qualifying 

19 drug that is submitted in a notice 

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

21 drug shall be treated by the Secretary 

22 as if it were a manufacturing change 

23 to the U.S. label drug under section 

24 506A. 
48 

•S 334 IS 

1 ‘‘(II) STANDARD OF REVIEW.— 

2 Except as provided in subclause (III), 

3 the Secretary shall review and approve 

4 or disapprove the difference in a no5 tice submitted under clause (i), if re6 quired under section 506A, using the 

7 safe and effective standard for ap8 proving or disapproving a manufac9 turing change under section 506A. 

10 ‘‘(III) BIOEQUIVALENCE.—If the 

11 Secretary would approve the dif12 ference in a notice submitted under 

13 clause (i) using the safe and effective 

14 standard under section 506A and if 

15 the Secretary determines that the 

16 qualifying drug is not bioequivalent to 

17 the U.S. label drug, the Secretary 

18 may— 

19 ‘‘(aa) include in the labeling 

20 provided under paragraph (3) a 

21 prominent advisory that the 

22 qualifying drug is safe and effec23 tive but is not bioequivalent to 

24 the U.S. label drug if the Sec25 retary determines that such an 
49 

•S 334 IS 

1 advisory is necessary for health 

2 care practitioners and patients to 

3 use the qualifying drug safely 

4 and effectively; or 

5 ‘‘(bb) decline to approve the 

6 difference if the Secretary deter7 mines that the availability of 

8 both the qualifying drug and the 

9 U.S. label drug would pose a 

10 threat to the public health. 

11 ‘‘(IV) REVIEW BY THE SEC12 RETARY.—The Secretary shall review 

13 and approve or disapprove the dif14 ference in a notice submitted under 

15 clause (i), if required under section 

16 506A, not later than 120 days after 

17 the date on which the notice is sub18 mitted. 

19 ‘‘(V) ESTABLISHMENT INSPEC20 TION.—If review of such difference 

21 would require an inspection of the es22 tablishment in which the qualifying 

23 drug is manufactured— 
50 

•S 334 IS 

1 ‘‘(aa) such inspection by the 

2 Secretary shall be authorized; 

3 and 

4 ‘‘(bb) the Secretary may rely 

5 on a satisfactory report of a good 

6 manufacturing practice inspec7 tion of the establishment from a 

8 permitted country whose regu9 latory system the Secretary rec10 ognizes as equivalent under a 

11 mutual recognition agreement, as 

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

13 section 803, or part 26 of title 

14 21, Code of Federal Regulations 

15 (or any corresponding successor 

16 rule or regulation). 

17 ‘‘(vii) PUBLICATION OF INFORMATION

18 ON NOTICES.— 

19 ‘‘(I) IN GENERAL.—Through the 

20 Internet website of the Food and 

21 Drug Administration and a toll-free 

22 telephone number, the Secretary shall 

23 readily make available to the public a 

24 list of notices submitted under clause 

25 (i). 
51 

•S 334 IS 

1 ‘‘(II) CONTENTS.—The list under 

2 subclause (I) shall include the date on 

3 which a notice is submitted and 

4 whether— 

5 ‘‘(aa) a notice is under re6 view; 

7 ‘‘(bb) the Secretary has or8 dered that importation of the 

9 qualifying drug from a permitted 

10 country cease; or 

11 ‘‘(cc) the importation of the 

12 drug is permitted under sub13 section (a). 

14 ‘‘(III) UPDATE.—The Secretary 

15 shall promptly update the Internet 

16 website with any changes to the list. 

17 ‘‘(C) NOTICE; DRUG DIFFERENCE REQUIR18 ING PRIOR APPROVAL.—In the case of a notice 

19 under subparagraph (B)(i) that includes a dif20 ference that would, under section 506A(c) or 

21 (d)(3)(B)(i), require the approval of a supple22 mental application before the difference could 

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

24 shall occur: 
52 

•S 334 IS 

1 ‘‘(i) Promptly after the notice is sub2 mitted, the Secretary shall notify reg3 istered exporters, registered importers, the 

4 Federal Trade Commission, and the State 

5 attorneys general that the notice has been 

6 submitted with respect to the qualifying 

7 drug involved. 

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

9 determination whether such a supple10 mental application regarding the U.S. label 

11 drug would be approved or disapproved by 

12 the date on which the qualifying drug in13 volved is to be introduced for commercial 

14 distribution in a permitted country, the 

15 Secretary shall— 

16 ‘‘(I) order that the importation of 

17 the qualifying drug involved from the 

18 permitted country not begin until the 

19 Secretary completes review of the no20 tice; and 

21 ‘‘(II) promptly notify registered 

22 exporters, registered importers, the 

23 Federal Trade Commission, and the 

24 State attorneys general of the order. 
53 

•S 334 IS 

1 ‘‘(iii) If the Secretary determines that 

2 such a supplemental application regarding 

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

4 the Secretary shall— 

5 ‘‘(I) order that the importation of 

6 the qualifying drug involved from the 

7 permitted country cease, or provide 

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

9 remains in effect; 

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

12 for commercial distribution of the de13 termination; and 

14 ‘‘(III) promptly notify registered 

15 exporters, registered importers, the 

16 Federal Trade Commission, and the 

17 State attorneys general of the deter18 mination. 

19 ‘‘(iv) If the Secretary determines that 

20 such a supplemental application regarding 

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

22 Secretary shall— 

23 ‘‘(I) vacate the order under 

24 clause (ii), if any; 
54 

•S 334 IS 

1 ‘‘(II) consider the difference to 

2 be a variation provided for in the ap3 proved application for the U.S. label 

4 drug; 

5 ‘‘(III) permit importation of the 

6 qualifying drug under subsection (a); 

7 and 

8 ‘‘(IV) promptly notify registered 

9 exporters, registered importers, the 

10 Federal Trade Commission, and the 

11 State attorneys general of the deter12 mination. 

13 ‘‘(D) NOTICE; DRUG DIFFERENCE NOT RE14 QUIRING PRIOR APPROVAL.—In the case of a 

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

16 a difference that would, under section 

17 506A(d)(3)(B)(ii), not require the approval of a 

18 supplemental application before the difference 

19 could be made to the U.S. label drug the fol20 lowing shall occur: 

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

22 notice is being reviewed by the Secretary, 

23 the authority under this subsection to im24 port the qualifying drug involved continues 

25 in effect. 
55 

•S 334 IS 

1 ‘‘(ii) If the Secretary determines that 

2 such a supplemental application regarding 

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

4 the Secretary shall— 

5 ‘‘(I) order that the importation of 

6 the qualifying drug involved from the 

7 permitted country cease; 

8 ‘‘(II) notify the permitted coun9 try that approved the qualifying drug 

10 for commercial distribution of the de11 termination; and 

12 ‘‘(III) promptly notify registered 

13 exporters, registered importers, the 

14 Federal Trade Commission, and the 

15 State attorneys general of the deter16 mination. 

17 ‘‘(iii) If the Secretary determines that 

18 such a supplemental application regarding 

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

20 difference shall be considered to be a vari21 ation provided for in the approved applica22 tion for the U.S. label drug. 

23 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE24 QUIRING APPROVAL; NO DIFFERENCE.—In the 

25 case of a notice under subparagraph (B)(i) that 
56 

•S 334 IS 

1 includes a difference for which, under section 

2 506A(d)(1)(A), a supplemental application 

3 would not be required for the difference to be 

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

5 there is no difference, the Secretary— 

6 ‘‘(i) shall consider such difference to 

7 be a variation provided for in the approved 

8 application for the U.S. label drug; 

9 ‘‘(ii) may not order that the importa10 tion of the qualifying drug involved cease; 

11 and 

12 ‘‘(iii) shall promptly notify registered 

13 exporters and registered importers. 

14 ‘‘(F) DIFFERENCES IN ACTIVE INGRE15 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

16 FORM, OR STRENGTH.— 

17 ‘‘(i) IN GENERAL.—A person who 

18 manufactures a drug approved under sec19 tion 505(b) shall submit an application 

20 under section 505(b) for approval of an21 other drug that is manufactured for dis22 tribution in a permitted country by or for 

23 the person that manufactures the drug ap24 proved under section 505(b) if— 
57 

•S 334 IS 

1 ‘‘(I) there is no qualifying drug 

2 in commercial distribution in per3 mitted countries whose combined pop4 ulation represents at least 50 percent 

5 of the total population of all permitted 

6 countries with the same active ingre7 dient or ingredients, route of adminis8 tration, dosage form, and strength as 

9 the drug approved under section 

10 505(b); and 

11 ‘‘(II) each active ingredient of 

12 the other drug is related to an active 

13 ingredient of the drug approved under 

14 section 505(b), as defined in clause 

15 (v). 

16 ‘‘(ii) APPLICATION UNDER SECTION

17 505(b).—The application under section 

18 505(b) required under clause (i) shall— 

19 ‘‘(I) request approval of the other 

20 drug for the indication or indications 

21 for which the drug approved under 

22 section 505(b) is labeled; 

23 ‘‘(II) include the information that 

24 the person submitted to the govern25 ment of the permitted country for 
58 

•S 334 IS 

1 purposes of obtaining approval for 

2 commercial distribution of the other 

3 drug in that country, which if in a 

4 language other than English, shall be 

5 accompanied by an English trans6 lation verified to be complete and ac7 curate, with the name, address, and a 

8 brief statement of the qualifications of 

9 the person that made the translation; 

10 ‘‘(III) include a right of reference 

11 to the application for the drug ap12 proved under section 505(b); and 

13 ‘‘(IV) include such additional in14 formation as the Secretary may re15 quire. 

16 ‘‘(iii) TIMING OF SUBMISSION OF AP17 PLICATION.—An application under section 

18 505(b) required under clause (i) shall be 

19 submitted to the Secretary not later than 

20 the day on which the information referred 

21 to in clause (ii)(II) is submitted to the gov22 ernment of the permitted country. 

23 ‘‘(iv) NOTICE OF DECISION ON APPLI24 CATION.—The Secretary shall promptly no25 tify registered exporters, registered import-
59 

•S 334 IS 

1 ers, the Federal Trade Commission, and 

2 the State attorneys general of a determina3 tion to approve or to disapprove an appli4 cation under section 505(b) required under 

5 clause (i). 

6 ‘‘(v) RELATED ACTIVE INGREDI7 ENTS.—For purposes of clause (i)(II), 2 

8 active ingredients are related if they are— 

9 ‘‘(I) the same; or 

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

11 complexes of the same moiety. 

12 ‘‘(3) SECTION 502; LABELING.— 

13 ‘‘(A) IMPORTATION BY REGISTERED IM14 PORTER.— 

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

16 qualifying drug that is imported or offered 

17 for import by a registered importer, such 

18 drug shall be considered to be in compli19 ance with section 502 and the labeling re20 quirements under the approved application 

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

22 drug bears— 

23 ‘‘(I) a copy of the labeling ap24 proved for the U.S. label drug under 

25 section 505, without regard to wheth-
60 

•S 334 IS 

1 er the copy bears any trademark in2 volved; 

3 ‘‘(II) the name of the manufac4 turer and location of the manufac5 turer; 

6 ‘‘(III) the lot number assigned by 

7 the manufacturer; 

8 ‘‘(IV) the name, location, and 

9 registration number of the importer; 

10 and 

11 ‘‘(V) the National Drug Code 

12 number assigned to the qualifying 

13 drug by the Secretary. 

14 ‘‘(ii) REQUEST FOR COPY OF THE LA15 BELING.—The Secretary shall provide such 

16 copy to the registered importer involved, 

17 upon request of the importer. 

18 ‘‘(iii) REQUESTED LABELING.—The 

19 labeling provided by the Secretary under 

20 clause (ii) shall— 

21 ‘‘(I) include the established 

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

23 for each active ingredient in the quali24 fying drug; 
61 

•S 334 IS 

1 ‘‘(II) not include the proprietary 

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

3 active ingredient thereof; 

4 ‘‘(III) if required under para5 graph (2)(B)(vi)(III), a prominent ad6 visory that the qualifying drug is safe 

7 and effective but not bioequivalent to 

8 the U.S. label drug; and 

9 ‘‘(IV) if the inactive ingredients 

10 of the qualifying drug are different 

11 from the inactive ingredients for the 

12 U.S. label drug, include— 

13 ‘‘(aa) a prominent notice 

14 that the ingredients of the quali15 fying drug differ from the ingre16 dients of the U.S. label drug and 

17 that the qualifying drug must be 

18 dispensed with an advisory to 

19 people with allergies about this 

20 difference and a list of ingredi21 ents; and 

22 ‘‘(bb) a list of the ingredi23 ents of the qualifying drug as 

24 would be required under section 

25 502(e). 
62 

•S 334 IS 

1 ‘‘(B) IMPORTATION BY INDIVIDUAL.— 

2 ‘‘(i) IN GENERAL.—In the case of a 

3 qualifying drug that is imported or offered 

4 for import by a registered exporter to an 

5 individual, such drug shall be considered to 

6 be in compliance with section 502 and the 

7 labeling requirements under the approved 

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

9 packaging and labeling of the qualifying 

10 drug complies with all applicable regula11 tions promulgated under sections 3 and 4 

12 of the Poison Prevention Packaging Act of 

13 1970 (15 U.S.C. 1471 et seq.) and the la14 beling of the qualifying drug includes— 

15 ‘‘(I) directions for use by the 

16 consumer; 

17 ‘‘(II) the lot number assigned by 

18 the manufacturer; 

19 ‘‘(III) the name and registration 

20 number of the exporter; 

21 ‘‘(IV) if required under para22 graph (2)(B)(vi)(III), a prominent ad23 visory that the drug is safe and effec24 tive but not bioequivalent to the U.S. 

25 label drug; 
63 

•S 334 IS 

1 ‘‘(V) if the inactive ingredients of 

2 the drug are different from the inac3 tive ingredients for the U.S. label 

4 drug— 

5 ‘‘(aa) a prominent advisory 

6 that persons with an allergy 

7 should check the ingredient list 

8 of the drug because the ingredi9 ents of the drug differ from the 

10 ingredients of the U.S. label 

11 drug; and 

12 ‘‘(bb) a list of the ingredi13 ents of the drug as would be re14 quired under section 502(e); and 

15 ‘‘(VI) a copy of any special label16 ing that would be required by the Sec17 retary had the U.S. label drug been 

18 dispensed by a pharmacist in the 

19 United States, without regard to 

20 whether the special labeling bears any 

21 trademark involved. 

22 ‘‘(ii) REQUEST FOR COPY OF SPECIAL

23 LABELING AND INGREDIENT LIST.—The 

24 Secretary shall provide to the registered 

25 exporter involved a copy of the special la-
64 

•S 334 IS 

1 beling, the advisory, and the ingredient list 

2 of the drug, upon request of the exporter. 

3 ‘‘(iii) REQUESTED LABELING AND IN4 GREDIENT LIST.—The labeling and ingre5 dient list provided by the Secretary under 

6 clause (ii) shall— 

7 ‘‘(I) include the established 

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

9 for each active ingredient in the drug; 

10 and 

11 ‘‘(II) not include the proprietary 

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

13 active ingredient thereof. 

14 ‘‘(4) SECTION 501; ADULTERATION.—A quali15 fying drug that is imported or offered for import 

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

17 compliance with section 501 if the drug is in compli18 ance with subsection (c). 

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

20 A drug exported under subsection (a) from a reg21 istered exporter or imported by a registered importer 

22 may be refused admission into the United States if 

23 1 or more of the following applies: 

24 ‘‘(A) The drug is not a qualifying drug. 
65 

•S 334 IS 

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

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

3 Secretary. 

4 ‘‘(C) The Secretary has ordered that im5 portation of the drug from the permitted coun6 try cease under paragraph (2) (C) or (D). 

7 ‘‘(D) The drug does not comply with para8 graph (3) or (4). 

9 ‘‘(E) The shipping container appears dam10 aged in a way that may affect the strength, 

11 quality, or purity of the drug. 

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

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

14 ‘‘(ii) the drug may have been pre15 pared, packed, or held under insanitary 

16 conditions; or 

17 ‘‘(iii) the methods used in, or the fa18 cilities or controls used for, the manufac19 turing, processing, packing, or holding of 

20 the drug do not conform to good manufac21 turing practice. 

22 ‘‘(G) The Secretary has obtained an in23 junction under section 302 that prohibits the 

24 distribution of the drug in interstate commerce. 
66 

•S 334 IS 

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) LICENSING AS PHARMACIST.—A registration 

20 condition is that the exporter involved agrees that a quali21 fying drug will be exported to an individual only if the 

22 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 
67 

•S 334 IS 

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. 
68 

•S 334 IS 

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 
69 

•S 334 IS 

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 less than 2 years. 
70 

•S 334 IS 

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 
71 

•S 334 IS 

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.—When a qualifying drug that 

13 is imported into the United States by an importer under 

14 subsection (a) is dispensed by a pharmacist to an indi15 vidual, the pharmacist shall provide that the packaging 

16 and labeling of the drug complies with all applicable regu17 lations promulgated under sections 3 and 4 of the Poison 

18 Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 

19 seq.) and include with any other labeling provided to the 

20 individual the following: 

21 ‘‘(1) The lot number assigned by the manufac22 turer. 

23 ‘‘(2) The name and registration number of the 

24 importer. 
72 

•S 334 IS 

1 ‘‘(3) If the inactive ingredients of the drug are 

2 different from the inactive ingredients for the U.S. 

3 label drug— 

4 ‘‘(A) a prominent advisory that persons 

5 with allergies should check the ingredient list of 

6 the drug because the ingredients of the drug 

7 differ from the ingredients of the U.S. label 

8 drug; and 

9 ‘‘(B) a list of the ingredients of the drug 

10 as would be required under section 502(e). 

11 ‘‘(4) If required under paragraph 

12 (2)(B)(vi)(III) of subsection (g), a prominent advi13 sory that the drug is safe and effective but not bio14 equivalent to the U.S. label drug. 

15 ‘‘(m) CHARITABLE CONTRIBUTIONS.—Notwith16 standing any other provision of this section, this section 

17 does not authorize the importation into the United States 

18 of a qualifying drug donated or otherwise supplied for free 

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

20 a charitable or humanitarian organization, including the 

21 United Nations and affiliates, or to a government of a for22 eign country. 

23 ‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC24 TICES.— 
73 

•S 334 IS 

1 ‘‘(1) IN GENERAL.—It is unlawful for a manu2 facturer, directly or indirectly (including by being a 

3 party to a licensing agreement or other agreement), 

4 to— 

5 ‘‘(A) discriminate by charging a higher 

6 price for a prescription drug sold to a registered 

7 exporter or other person in a permitted country 

8 that exports a qualifying drug to the United 

9 States under this section than the price that is 

10 charged, inclusive of rebates or other incentives 

11 to the permitted country or other person, to an12 other person that is in the same country and 

13 that does not export a qualifying drug into the 

14 United States under this section; 

15 ‘‘(B) discriminate by charging a higher 

16 price for a prescription drug sold to a registered 

17 importer or other person that distributes, sells, 

18 or uses a qualifying drug imported into the 

19 United States under this section than the price 

20 that is charged to another person in the United 

21 States that does not import a qualifying drug 

22 under this section, or that does not distribute, 

23 sell, or use such a drug; 

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

25 or delaying supplies of a prescription drug to a 
74 

•S 334 IS 

1 registered exporter or other person in a per2 mitted country that exports a qualifying drug to 

3 the United States under this section or to a 

4 registered importer or other person that distrib5 utes, sells, or uses a qualifying drug imported 

6 into the United States under this section; 

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

8 otherwise refusing to do business with a reg9 istered exporter or other person in a permitted 

10 country that exports a qualifying drug to the 

11 United States under this section or with a reg12 istered importer or other person that distrib13 utes, sells, or uses a qualifying drug imported 

14 into the United States under this section; 

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

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

17 submit such a notice on or before the date spec18 ified in subsection (g)(2)(B)(v) or as otherwise 

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

20 of section 4 of the Pharmaceutical Market Ac21 cess and Drug Safety Act of 2005, knowingly 

22 submit such a notice that makes a materially 

23 false, fictitious, or fraudulent statement, or 

24 knowingly fail to provide promptly any informa-
75 

•S 334 IS 

1 tion requested by the Secretary to review such 

2 a notice; 

3 ‘‘(F) knowingly fail to submit an applica4 tion required under subsection (g)(2)(F), know5 ingly fail to submit such an application on or 

6 before the date specified in subsection 

7 (g)(2)(F)(ii), knowingly submit such an applica8 tion that makes a materially false, fictitious, or 

9 fraudulent statement, or knowingly fail to pro10 vide promptly any information requested by the 

11 Secretary to review such an application; 

12 ‘‘(G) cause there to be a difference (includ13 ing a difference in active ingredient, route of 

14 administration, dosage form, strength, formula15 tion, manufacturing establishment, manufac16 turing process, or person that manufactures the 

17 drug) between a prescription drug for distribu18 tion in the United States and the drug for dis19 tribution in a permitted country; 

20 ‘‘(H) refuse to allow an inspection author21 ized under this section of an establishment that 

22 manufactures a qualifying drug that is, or will 

23 be, introduced for commercial distribution in a 

24 permitted country; 
76 

•S 334 IS 

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

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

3 processing, packing, or holding of a qualifying 

4 drug that is, or will be, introduced for commer5 cial distribution in a permitted country to good 

6 manufacturing practice under this Act; 

7 ‘‘(J) become a party to a licensing agree8 ment or other agreement related to a qualifying 

9 drug that fails to provide for compliance with 

10 all requirements of this section with respect to 

11 such drug; 

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

13 prohibits, or delays the importation of a quali14 fying drug under this section; 

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

16 prohibit, or delay the importation of a quali17 fying drug under this section; or 

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

19 Federal Trade Commission determines to dis20 criminate against a person that engages or at21 tempts to engage in the importation of a quali22 fying drug under this section. 

23 ‘‘(2) AFFIRMATIVE DEFENSE.— 

24 ‘‘(A) DISCRIMINATION.—It shall be an af25 firmative defense to a charge that a manufac-
77 

•S 334 IS 

1 turer has discriminated under subparagraph 

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

3 the higher price charged for a prescription drug 

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

5 of supplies of a prescription drug to a person, 

6 the refusal to do business with a person, or 

7 other discriminatory activity against a person, 

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

9 ‘‘(i) the person exporting or importing 

10 a qualifying drug into the United States 

11 under this section; or 

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

13 or using a qualifying drug imported into 

14 the United States under this section. 

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

16 affirmative defense to a charge that a manufac17 turer has caused there to be a difference de18 scribed in subparagraph (G) of paragraph (1) 

19 that— 

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

21 country in which the drug is distributed; 

22 ‘‘(ii) the Secretary has determined 

23 that the difference was necessary to im24 prove the safety or effectiveness of the 

25 drug; 
78 

•S 334 IS 

1 ‘‘(iii) the person manufacturing the 

2 drug for distribution in the United States 

3 has given notice to the Secretary under 

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

5 distribution in the United States is not dif6 ferent from a drug for distribution in per7 mitted countries whose combined popu8 lation represents at least 50 percent of the 

9 total population of all permitted countries; 

10 or 

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

12 whole or in part, for the purpose of re13 stricting importation of the drug into the 

14 United States under this section. 

15 ‘‘(3) EFFECT OF SUBSECTION.— 

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

17 subsection applies only to the sale or distribu18 tion of a prescription drug in a country if the 

19 manufacturer of the drug chooses to sell or dis20 tribute the drug in the country. Nothing in this 

21 subsection shall be construed to compel the 

22 manufacturer of a drug to distribute or sell the 

23 drug in a country. 

24 ‘‘(B) DISCOUNTS TO INSURERS, HEALTH

25 PLANS, PHARMACY BENEFIT MANAGERS, AND
79 

•S 334 IS 

1 COVERED ENTITIES.—Nothing in this sub2 section shall be construed to— 

3 ‘‘(i) prevent or restrict a manufac4 turer of a prescription drug from providing 

5 discounts to an insurer, health plan, phar6 macy benefit manager in the United 

7 States, or covered entity in the drug dis8 count program under section 340B of the 

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

10 256b) in return for inclusion of the drug 

11 on a formulary; 

12 ‘‘(ii) require that such discounts be 

13 made available to other purchasers of the 

14 prescription drug; or 

15 ‘‘(iii) prevent or restrict any other 

16 measures taken by an insurer, health plan, 

17 or pharmacy benefit manager to encourage 

18 consumption of such prescription drug. 

19 ‘‘(C) CHARITABLE CONTRIBUTIONS.— 

20 Nothing in this subsection shall be construed 

21 to— 

22 ‘‘(i) prevent a manufacturer from do23 nating a prescription drug, or supplying a 

24 prescription drug at nominal cost, to a 

25 charitable or humanitarian organization, 
80 

•S 334 IS 

1 including the United Nations and affili2 ates, or to a government of a foreign coun3 try; or 

4 ‘‘(ii) apply to such donations or sup5 plying of a prescription drug. 

6 ‘‘(4) ENFORCEMENT.— 

7 ‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC8 TICE.—A violation of this subsection shall be 

9 treated as a violation of a rule defining an un10 fair or deceptive act or practice prescribed 

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

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

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

14 Federal Trade Commission— 

15 ‘‘(i) shall enforce this subsection in 

16 the same manner, by the same means, and 

17 with the same jurisdiction, powers, and du18 ties as though all applicable terms and pro19 visions of the Federal Trade Commission 

20 Act (15 U.S.C. 41 et seq.) were incor21 porated into and made a part of this sec22 tion; and 

23 ‘‘(ii) may seek monetary relief three24 fold the damages sustained, in addition to 

25 any other remedy available to the Federal 
81 

•S 334 IS 

1 Trade Commission under the Federal 

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

3 seq.). 

4 ‘‘(5) ACTIONS BY STATES.— 

5 ‘‘(A) IN GENERAL.— 

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

7 which the attorney general of a State has 

8 reason to believe that an interest of the 

9 residents of that State have been adversely 

10 affected by any manufacturer that violates 

11 paragraph (1), the attorney general of a 

12 State may bring a civil action on behalf of 

13 the residents of the State, and persons 

14 doing business in the State, in a district 

15 court of the United States of appropriate 

16 jurisdiction to— 

17 ‘‘(I) enjoin that practice; 

18 ‘‘(II) enforce compliance with 

19 this subsection; 

20 ‘‘(III) obtain damages, restitu21 tion, or other compensation on behalf 

22 of residents of the State and persons 

23 doing business in the State, including 

24 threefold the damages; or 
82 

•S 334 IS 

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 Commis-
83 

•S 334 IS 

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 
84 

•S 334 IS 

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 
85 

•S 334 IS 

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 ‘‘(6) 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 
86 

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1 the extent that such section 5 applies to unfair 

2 methods of competition. 

3 ‘‘(7) 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— 
87 

•S 334 IS 

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 
88 

•S 334 IS 

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 ex-
89 

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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 
90 

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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 
91 

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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’’) 
92 

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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.—The Secretary shall report to Con19 gress to request the authority to impose a limi20 tation on the number of registered exporters 

21 under such section 804 during any period be22 ginning on a date that is not less than 2 years 

23 after the date of enactment of this Act if the 

24 Secretary determines that— 
93 

•S 334 IS 

1 (i) a limitation on the number of reg2 istered exporters is necessary for the effec3 tive and efficient enforcement of the re4 quirements of such section 804 with re5 spect to such exporters; and 

6 (ii) such limitation will not restrict 

7 the ability of individuals to import pre8 scription drugs for personal use from reg9 istered exporters under such section 804. 

10 (3) LIMITS ON NUMBER OF IMPORTERS.— 

11 (A) FIRST YEAR LIMIT ON NUMBER OF IM12 PORTERS.—During the 1-year period beginning 

13 on the date that is 1 year after the date of en14 actment of this Act, the Secretary may limit the 

15 number of registered importers under such sec16 tion 804 to not less than 100 (of which at least 

17 a significant number shall be groups of phar18 macies, to the extent feasible given the applica19 tions submitted by such groups), so long as the 

20 Secretary gives priority to those importers with 

21 demonstrated ability to process a high volume 

22 of shipments of drugs imported into the United 

23 States. 

24 (B) SECOND YEAR LIMIT ON NUMBER OF

25 IMPORTERS.—During the 1-year period begin-
94 

•S 334 IS 

1 ning on the date that is 2 years after the date 

2 of enactment of this Act, the Secretary may 

3 limit the number of registered importers under 

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

5 at least a significant number shall be groups of 

6 pharmacies, to the extent feasible given the ap7 plications submitted by such groups), so long as 

8 the Secretary gives priority to those importers 

9 with demonstrated ability to process a high vol10 ume of shipments of drugs to individuals in the 

11 United States. 

12 (C) FURTHER LIMIT ON NUMBER OF IM13 PORTERS.—The Secretary shall report to Con14 gress to request the authority to impose a limi15 tation on the number of registered importers 

16 under such section 804 during any period be17 ginning on a date that is not less than 3 years 

18 after the date of enactment of this Act if the 

19 Secretary determines that— 

20 (i) a limitation on the number of reg21 istered importers is necessary for the effec22 tive and efficient enforcement of the re23 quirements of such section 804 with re24 spect to such importers; and 
95 

•S 334 IS 

1 (ii) such limitation will not restrict 

2 the ability of individuals to purchase quali3 fying drugs imported under such section 

4 804 or savings available to individuals by 

5 purchasing such qualifying drugs. 

6 (4) NOTICES FOR DRUGS FOR IMPORT FROM

7 CANADA.—The notice with respect to a qualifying 

8 drug introduced for commercial distribution in Can9 ada as of the date of enactment of this Act that is 

10 required under subsection (g)(2)(B)(i) of such sec11 tion 804 shall be submitted to the Secretary not 

12 later than 30 days after the date of enactment of 

13 this Act if— 

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

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

16 100 prescription drugs with the highest dollar 

17 volume of sales in the United States based on 

18 the 12 calendar month period most recently 

19 completed before the date of enactment of this 

20 Act; or 

21 (B) the notice is a notice under subsection 

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

23 (5) NOTICE FOR DRUGS FOR IMPORT FROM

24 OTHER COUNTRIES.—The notice with respect to a 

25 qualifying drug introduced for commercial distribu-
96 

•S 334 IS 

1 tion in a permitted country other than Canada as of 

2 the date of enactment of this Act that is required 

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

4 shall be submitted to the Secretary not later than 

5 180 days after the date of enactment of this Act 

6 if— 

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

8 drug is 1 of the 100 prescription drugs with the 

9 highest dollar volume of sales in the United 

10 States based on the 12 calendar month period 

11 that is first completed on the date that is 120 

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

13 (B) the notice is a notice under subsection 

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

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

16 (A) GUIDANCE ON SUBMISSION DATES.— 

17 The Secretary shall by guidance establish a se18 ries of submission dates for the notices under 

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

20 respect to qualifying drugs introduced for com21 mercial distribution as of the date of enactment 

22 of this Act and that are not required to be sub23 mitted under paragraph (4) or (5). 

24 (B) CONSISTENT AND EFFICIENT USE OF

25 RESOURCES.—The Secretary shall establish the 
97 

•S 334 IS 

1 dates described under subparagraph (A) so that 

2 such notices described under subparagraph (A) 

3 are submitted and reviewed at a rate that al4 lows consistent and efficient use of the re5 sources and staff available to the Secretary for 

6 such reviews. Review of all such notices shall be 

7 completed not later than 5 years after the date 

8 of enactment of this Act. 

9 (C) PRIORITY FOR DRUGS WITH HIGHER

10 SALES.—The Secretary shall establish the dates 

11 described under subparagraph (A) so that the 

12 Secretary reviews the notices described under 

13 such subparagraph with respect to qualifying 

14 drugs with higher dollar volume of sales in the 

15 United States before the notices with respect to 

16 drugs with lower sales in the United States. 

17 (7) NOTICES FOR DRUGS APPROVED AFTER EF18 FECTIVE DATE.—The notice required under sub19 section (g)(2)(B)(i) of such section 804 for a quali20 fying drug first introduced for commercial distribu21 tion in a permitted country (as defined in such sec22 tion 804) after the date of enactment of this Act 

23 shall be submitted to and reviewed by the Secretary 

24 as provided under subsection (g)(2)(B) of such sec-
98 

•S 334 IS 

1 tion 804, without regard to paragraph (4), (5), or 

2 (6). 

3 (8) REPORT.—Beginning with fiscal year 2006, 

4 not later than 90 days after the end of each fiscal 

5 year during which the Secretary reviews a notice re6 ferred to in paragraph (4), (5), or (6), the Secretary 

7 shall submit a report to Congress concerning the 

8 progress of the Food and Drug Administration in re9 viewing the notices referred to in paragraphs (4), 

10 (5), and (6). 

11 (9) USER FEES.— 

12 (A) EXPORTERS.—When establishing an 

13 aggregate total of fees to be collected from ex14 porters under subsection (f)(2) of such section 

15 804, the Secretary shall, under subsection 

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

17 total price of drugs imported under subsection 

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

19 by registered exporters during fiscal year 2006 

20 to be $1,000,000,000. 

21 (B) IMPORTERS.—When establishing an 

22 aggregate total of fees to be collected from im23 porters under subsection (e)(2) of such section 

24 804, the Secretary shall, under subsection 

25 (e)(3)(C)(i) of such section 804, estimate the 
99 

•S 334 IS 

1 total price of drugs imported under subsection 

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

3 by registered importers during— 

4 (i) fiscal year 2006 to be 

5 $1,000,000,000; and 

6 (ii) fiscal year 2007 to be 

7 $10,000,000,000. 

8 (C) FISCAL YEAR 2007 ADJUSTMENT.— 

9 (i) REPORTS.—Not later than Feb10 ruary 20, 2007, registered importers shall 

11 report to the Secretary the total price and 

12 the total volume of drugs imported to the 

13 United States by the importer during the 

14 4-month period from October 1, 2006, 

15 through January 31, 2007. 

16 (ii) REESTIMATE.—Notwithstanding 

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

18 or subparagraph (B), the Secretary shall 

19 reestimate the total price of qualifying 

20 drugs imported under subsection (a) of 

21 such section 804 into the United States by 

22 registered importers during fiscal year 

23 2007. Such reestimate shall be equal to— 

24 (I) the total price of qualifying 

25 drugs imported by each importer as 
100 

•S 334 IS 

1 reported under clause (i); multiplied 

2 by 

3 (II) 3. 

4 (iii) ADJUSTMENT.—The Secretary 

5 shall adjust the fee due on April 1, 2007, 

6 from each importer so that the aggregate 

7 total of fees collected under subsection 

8 (e)(2) for fiscal year 2007 does not exceed 

9 the total price of qualifying drugs imported 

10 under subsection (a) of such section 804 

11 into the United States by registered im12 porters during fiscal year 2007 as reesti13 mated under clause (ii). 

14 (D) ANNUAL REPORT.— 

15 (i) FOOD AND DRUG ADMINISTRA16 TION.—Beginning with fiscal year 2006, 

17 not later than 180 days after the end of 

18 each fiscal year during which fees are col19 lected under subsection (e), (f), or 

20 (g)(2)(B)(iv) of such section 804, the Sec21 retary shall prepare and submit to the 

22 House of Representatives and the Senate a 

23 report on the implementation of the au24 thority for such fees during such fiscal 

25 year and the use, by the Food and Drug 
101 

•S 334 IS 

1 Administration, of the fees collected for the 

2 fiscal year for which the report is made 

3 and credited to the Food and Drug Admin4 istration. 

5 (ii) CUSTOMS AND BORDER CON6 TROL.—Beginning with fiscal year 2006, 

7 not later than 180 days after the end of 

8 each fiscal year during which fees are col9 lected under subsection (e) or (f) of such 

10 section 804, the Secretary of Homeland 

11 Security, in consultation with the Sec12 retary of the Treasury, shall prepare and 

13 submit to the House of Representatives 

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

15 Bureau of Customs and Border Protection, 

16 of the fees, if any, transferred by the Sec17 retary to the Bureau of Customs and Bor18 der Protection for the fiscal year for which 

19 the report is made. 

20 (f) IMPLEMENTATION OF SECTION 804.— 

21 (1) INTERIM RULE.—The Secretary may pro22 mulgate an interim rule for implementing section 

23 804 of the Federal Food, Drug, and Cosmetic Act, 

24 as added by subsection (a) of this section. 
102 

•S 334 IS 

1 (2) NO NOTICE OF PROPOSED RULEMAKING.— 

2 The interim rule described under paragraph (1) may 

3 be developed and promulgated by the Secretary with4 out providing general notice of proposed rulemaking. 

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

6 the date on which the Secretary promulgates an in7 terim rule under paragraph (1), the Secretary shall, 

8 in accordance with procedures under section 553 of 

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

10 for implementing such section 804, which may incor11 porate by reference provisions of the interim rule 

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

13 such provisions are not modified. 

14 (g) CONSUMER EDUCATION.—The Secretary shall 

15 carry out activities that educate consumers— 

16 (1) with regard to the availability of qualifying 

17 drugs for import for personal use from an exporter 

18 registered with and approved by the Food and Drug 

19 Administration under section 804 of the Federal 

20 Food, Drug, and Cosmetic Act, as added by this sec21 tion, including information on how to verify whether 

22 an exporter is registered and approved by use of the 

23 Internet website of the Food and Drug Administra24 tion and the toll-free telephone number required by 

25 this Act; 
103 

•S 334 IS 

1 (2) that drugs that consumers attempt to im2 port from an exporter that is not registered with and 

3 approved by the Food and Drug Administration can 

4 be seized by the United States Customs Service and 

5 destroyed, and that such drugs may be counterfeit, 

6 unapproved, unsafe, or ineffective; and 

7 (3) with regard to the availability at domestic 

8 retail pharmacies of qualifying drugs imported under 

9 such section 804 by domestic wholesalers and phar10 macies registered with and approved by the Food 

11 and Drug Administration. 

12 (h) EFFECT ON ADMINISTRATION PRACTICES.—Not13 withstanding any provision of this Act (and the amend14 ments made by this Act), nothing in this Act (or the 

15 amendments made by this Act) shall be construed to 

16 change, limit, or restrict the practices of the Food and 

17 Drug Administration or the Bureau of Customs and Bor18 der Protection in effect on January 1, 2004, with respect 

19 to the importation of prescription drugs into the United 

20 States by an individual, on the person of such individual, 

21 for personal use. 

22 SEC. 5. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS23 SION INTO UNITED STATES. 

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

25 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), 
104 

•S 334 IS 

1 as amended by section 3, is further amended by adding 

2 at the end the following section: 

3 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD4 MISSION. 

5 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se6 curity shall deliver to the Secretary a shipment of drugs 

7 that is imported or offered for import into the United 

8 States if— 

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

10 than $10,000; and 

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

12 does not bear the markings required under section 

13 804(d)(2); or 

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

15 such shipment of drugs. 

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

17 not authorize the delivery to the owner or consignee of 

18 drugs delivered to the Secretary under subsection (a) pur19 suant to the execution of a bond, and such drugs may not 

20 be exported. 

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

22 Secretary shall destroy a shipment of drugs delivered by 

23 the Secretary of Homeland Security to the Secretary 

24 under subsection (a) if— 
105 

•S 334 IS 

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

2 offered for import from a registered exporter under 

3 section 804, the drugs are in violation of any stand4 ard described in section 804(g)(5); or 

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

6 or offered for import from a registered exporter 

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

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

9 ‘‘(d) CERTAIN PROCEDURES.— 

10 ‘‘(1) IN GENERAL.—The delivery and destruc11 tion of drugs under this section may be carried out 

12 without notice to the importer, owner, or consignee 

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

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

15 drugs, and recordkeeping activities regarding the 

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

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

18 promulgated under paragraph (1) shall be designed 

19 toward the objective of ensuring that, with respect to 

20 efficiently utilizing Federal resources available for 

21 carrying out this section, a substantial majority of 

22 shipments of drugs subject to described in sub23 section (c) are identified and destroyed. 

24 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de25 stroyed under subsection (c) to the extent that the Attor-
106 

•S 334 IS 

1 ney General of the United States determines that the 

2 drugs should be preserved as evidence or potential evi3 dence with respect to an offense against the United States. 

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

5 not be construed as having any legal effect on applicable 

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

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

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

9 (b) PROCEDURES.—Procedures for carrying out sec10 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

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

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

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

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

15 after the date of enactment of this Act. 

16 SEC. 6. CIVIL ACTIONS REGARDING PROPERTY. 

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

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

19 adding at the end the following subsection: 

20 ‘‘(g)(1) If a person is alienating or disposing of prop21 erty, or intends to alienate or dispose of property, that 

22 is obtained as a result of or is traceable to a drug imported 

23 in violation of section 801(a) or 801(d), the Attorney Gen24 eral may commence a civil action in any Federal court— 
107 

•S 334 IS 

1 ‘‘(A) to enjoin such alienation or disposition of 

2 property; or 

3 ‘‘(B) for a restraining order to— 

4 ‘‘(i) prohibit any person from withdrawing, 

5 transferring, removing, dissipating, or disposing 

6 of any such property or property of equivalent 

7 value; and 

8 ‘‘(ii) appoint a temporary receiver to ad9 minister such restraining order. 

10 ‘‘(2) Proceedings under paragraph (1) shall be car11 ried out in the same manner as applies under section 1345 

12 of title 18, United States Code.’’. 

13 (b) EFFECTIVE DATE.—The amendment made by 

14 this section shall take effect on the day that is 90 days 

15 after the date of enactment of this Act. 

16 SEC. 7. WHOLESALE DISTRIBUTION OF DRUGS; STATE17 MENTS REGARDING PRIOR SALE, PURCHASE, 

18 OR TRADE. 

19 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

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

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

22 amended— 

23 (1) in paragraph (1)— 
108 

•S 334 IS 

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

3 of such drug’’; 

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

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

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

9 is exported from the United States does not with respect 

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

11 business of the wholesale distribution of the drug from 

12 providing the statement described in subparagraph (A) to 

13 the person that receives the drug pursuant to the export 

14 of the drug. 

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

17 in this subparagraph as ‘alternative requirements’) to 

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

20 the wholesale distribution of the drug to a pharmacist who 

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

24 technologies, will identify such chain of custody or the 

25 identity of the discrete package of the drug from which 
109 

•S 334 IS 

1 the drug is dispensed with equal or greater certainty to 

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

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

6 establish such alternative requirements, the final rule in 

7 addition shall, with respect to the registration condition 

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

9 a condition equivalent to the alternative requirements, and 

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

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

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

14 construed as having any applicability with respect to 

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

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

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

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

21 term ‘wholesale distribution’ means’’. 

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

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

24 353(d)) is amended by adding at the end the following: 
110 

•S 334 IS 

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

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

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

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

8 (c) EFFECTIVE DATE.— 

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

10 paragraphs (1) and (3) of subsection (a) and by sub11 section (b) shall take effect on January 1, 2010. 

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

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

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

17 of enactment of this Act with respect to qualifying 

18 drugs imported under section 804 of the Federal 

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

20 4. 

21 (3) HIGH-RISK DRUGS.— 

22 (A) IN GENERAL.—Notwithstanding para23 graph (1), the Secretary of Health and Human 

24 Services (referred to in this section as the ‘‘Sec25 retary’’) may apply the amendments made by 
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1 paragraphs (1) and (3) of subsection (a) and by 

2 subsection (b) before January 1, 2010, with re3 spect to a prescription drug if the Secretary— 

4 (i) determines that the drug is at high 

5 risk for being counterfeited; and 

6 (ii) publishes the determination and 

7 the basis for the determination in the Fed8 eral Register. 

9 (B) PEDIGREE NOT REQUIRED.—Notwith10 standing a determination under subparagraph 

11 (A) with respect to a prescription drug, the 

12 amendments described in such subparagraph 

13 shall not apply with respect to a wholesale dis14 tribution of such drug if the drug is distributed 

15 by the manufacturer of the drug to a person 

16 that distributes the drug to a retail pharmacy 

17 for distribution to the consumer or patient, with 

18 no other intervening transactions. 

19 (C) LIMITATION.—The Secretary may 

20 make the determination under subparagraph 

21 (A) with respect to not more than 50 drugs be22 fore January 1, 2010. 

23 (4) EFFECT WITH RESPECT TO REGISTERED

24 EXPORTERS.—The amendment made by subsection 
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1 (a)(2) shall take effect on the date that is 90 days 

2 after the date of enactment of this Act. 

3 (5) ALTERNATIVE REQUIREMENTS.—The Sec4 retary shall issue regulations to establish the alter5 native requirements, referred to in the amendment 

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

7 than— 

8 (A) January 1, 2008, with respect to a 

9 prescription drug determined under paragraph 

10 (3)(A) to be at high risk for being counter11 feited; and 

12 (B) January 1, 2010, with respect to all 

13 other prescription drugs. 

14 (6) INTERMEDIATE REQUIREMENTS.—With re15 spect to the prescription drugs described under para16 graph (5)(B), the Secretary shall by regulation re17 quire the use of standardized anti-counterfeiting or 

18 track-and-trace technologies on such prescription 

19 drugs at the case and pallet level effective not later 

20 than January 1, 2008. 

21 SEC. 8. INTERNET SALES OF PRESCRIPTION DRUGS. 

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

23 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend24 ed by inserting after section 503A the following: 
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1 ‘‘SEC. 503B. 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 

26 Internet site, the requirements referred to in sub-
114 

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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 

25 each individual who provides such con-
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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 

25 person provided for the involvement of a practi-
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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 other valuable consideration 

14 is received. 

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 

25 fewer than 100 physicians who have in ef-
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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 

24 the evaluation, without regard to whether por-
118 

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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 503B.’’. 

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 503B 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 fiscal years 2005 through 2007. 

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

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

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

11 rule to implement such amendments has been promulgated 

12 by the Secretary of Health and Human Services under 

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

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

16 a final rule. 

17 SEC. 9. IMPORTATION EXEMPTION UNDER CONTROLLED 

18 SUBSTANCES IMPORT AND EXPORT ACT. 

19 Section 1006(a)(2) of the Controlled Substances Im20 port and Export Act (21 U.S.C. 956(a)(2)) is amended 

21 by striking ‘‘not import the controlled substance into the 

22 United States in an amount that exceeds 50 dosage units 

23 of the controlled substance.’’ and inserting ‘‘import into 
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1 the United States not more than 10 dosage units com2 bined of all such controlled substances.’’. 

Æ