II 

108TH CONGRESS 

2D SESSION S. 2328 

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 

APRIL 21, 2004 

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

DASCHLE, Mr. LOTT, Ms. STABENOW, Mr. CHAFEE, Mr. JOHNSON, Mr. 

PRYOR, and Mr. FEINGOLD) 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 2004’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds that— 
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1 (1) Americans unjustly pay up to 5 times more 

2 to fill their prescriptions than consumers in other 

3 countries; 

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

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

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

10 (4) allowing and structuring the importation of 

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

15 (5) 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 of this Act, is further amended 

6 by inserting 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.—The Secretary shall in ac11 cordance with this section provide by regulation 

12 that, in the case of qualifying drugs imported or of13 fered for import into the United States from reg14 istered exporters or by registered importers— 

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

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

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

18 801(a) regarding admission of the drugs are 

19 subject to subsection (g) of this section (includ20 ing with respect to qualifying drugs to which 

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

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

23 be imported under paragraph (1) unless— 

24 ‘‘(A) the drug is imported by a pharmacy 

25 or a wholesaler that is a 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 prescription drug, other than any of the fol8 lowing: 

9 ‘‘(i) A controlled substance, as defined 

10 in section 102 of the Controlled Sub11 stances Act (21 U.S.C. 802). 

12 ‘‘(ii) A biological product, as defined 

13 in section 351 of the Public Health Service 

14 Act (42 U.S.C. 262). 

15 ‘‘(iii) An infused drug, including a 

16 peritoneal dialysis solution. 

17 ‘‘(iv) An intravenously injected drug. 

18 ‘‘(v) A drug that is inhaled during 

19 surgery. 

20 ‘‘(C) OTHER DEFINITIONS.—For purposes 

21 of this section: 

22 ‘‘(i) The term ‘exporter’ means a per23 son that is in the business of exporting a 

24 drug from Canada to individuals in the 

25 United States or that, pursuant to submit-
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1 ting a registration under subsection (b), 

2 seeks to be in such business. 

3 ‘‘(ii) The term ‘importer’ means a 

4 pharmacy, a group of pharmacies, or a 

5 wholesaler that is in the business of im6 porting a drug into the United States or 

7 that, pursuant to submitting a registration 

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

9 business. 

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

11 person licensed by a State to practice 

12 pharmacy, including the dispensing and 

13 selling of prescription drugs. 

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

15 person that— 

16 ‘‘(I) is licensed by a State to en17 gage in the business of selling pre18 scription drugs at retail; and 

19 ‘‘(II) employs 1 or more phar20 macists. 

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

22 means a drug that is described in section 

23 503(b)(1). 

24 ‘‘(vi) The term ‘wholesaler’— 
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1 ‘‘(I) means a person licensed as a 

2 wholesaler or distributor of prescrip3 tion drugs in the United States under 

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

5 ‘‘(II) does not include a person 

6 authorized to import drugs under sec7 tion 801(d)(1). 

8 ‘‘(D) PERMITTED COUNTRY.—The term 

9 ‘permitted country’ means— 

10 ‘‘(i) Australia; 

11 ‘‘(ii) Canada; 

12 ‘‘(iii) a member country of the Euro13 pean Union as of January 1, 2003; 

14 ‘‘(iv) Japan; 

15 ‘‘(v) New Zealand; and 

16 ‘‘(vi) Switzerland. 

17 ‘‘(b) REGISTRATION OF IMPORTERS AND EXPORT18 ERS.— 

19 ‘‘(1) REGISTRATION OF IMPORTERS AND EX20 PORTERS.—A registration condition is that the im21 porter or exporter involved (referred to in this sub22 section as a ‘registrant’) submits to the Secretary a 

23 registration containing the following: 

24 ‘‘(A) The name of the registrant and an 

25 identification of all places of business of the 
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1 registrant that relate to qualifying drugs, in2 cluding each warehouse or other facility owned 

3 or controlled by, or operated for, the registrant. 

4 ‘‘(B) Such information as the Secretary 

5 determines to be necessary to demonstrate that 

6 the registrant is in compliance with registration 

7 conditions under— 

8 ‘‘(i) in the case of an importer, sub9 sections (c), (d), (e), (g), and (j) (relating 

10 to the sources of exported drugs; the in11 spection of facilities of the importer; the 

12 payment of fees; compliance with the 

13 standards referred to in section 801(a); 

14 and maintenance of records and samples); 

15 or 

16 ‘‘(ii) in the case of an exporter, sub17 sections (c), (d), (f), (g), (h), (i), and (j) 

18 (relating to the sources of exported drugs; 

19 the inspection of facilities of the exporter 

20 and the marking of compliant shipments; 

21 the payment of fees; and compliance with 

22 the standards referred to in section 801(a); 

23 being licensed as a pharmacist; conditions 

24 for individual importation from Canada; 

25 and maintenance of records and samples). 
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1 ‘‘(C) An agreement by the registrant that 

2 the registrant will not under subsection (a) im3 port or export any drug that is not a qualifying 

4 drug. 

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

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

7 withdrawal of a drug distributed in a per8 mitted country that the registrant has ex9 ported or imported, or intends to export or 

10 import, to the United States under sub11 section (a); 

12 ‘‘(ii) provide for the return to the reg13 istrant of such drug; and 

14 ‘‘(iii) cease, or not begin, the expor15 tation or importation of such drug unless 

16 the Secretary has notified the registrant 

17 that exportation or importation of such 

18 drug may proceed. 

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

20 ensure and monitor compliance with each reg21 istration condition, to promptly correct any 

22 noncompliance with such a condition, and to 

23 promptly report to the Secretary any such non24 compliance. 
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1 ‘‘(F) A plan describing the manner in 

2 which the registrant will comply with the agree3 ment under subparagraph (E). 

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

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

6 against a party in the chain of custody of a 

7 qualifying drug with respect to the authority of 

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

9 subsection. 

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

11 notify the Secretary of— 

12 ‘‘(i) any change that the registrant in13 tends to make regarding information pro14 vided under subparagraph (A) or (B); and 

15 ‘‘(ii) any change that the registrant 

16 intends to make in the compliance plan 

17 under subparagraph (F). 

18 ‘‘(I) In the case of an exporter— 

19 ‘‘(i) An agreement by the exporter 

20 that a qualifying drug will not under sub21 section (a) be exported to any individual 

22 not authorized pursuant to subsection 

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

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

25 payable to the Treasury of the United 
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1 States if, after opportunity for an informal 

2 hearing, the Secretary determines that the 

3 exporter has exported a drug to the United 

4 States that is not a qualifying drug or that 

5 is not in compliance with subsections (g) 

6 or (i), that is equal in value to the lesser 

7 of— 

8 ‘‘(I) the value of drugs exported 

9 by the exporter to the United States 

10 in a typical 4-week period over the 

11 course of a year under this section; or 

12 ‘‘(II) $1,000,000. 

13 ‘‘(J) Such other provisions as the Sec14 retary may require to protect the public health 

15 while permitting— 

16 ‘‘(i) the importation by pharmacies, 

17 groups of pharmacies, wholesalers as reg18 istered importers of qualifying drugs under 

19 subsection (a); and 

20 ‘‘(ii) importation by individuals of 

21 qualifying drugs under subsection (a). 

22 ‘‘(2) APPROVAL OR DISAPPROVAL OF REGISTRA23 TION.— 

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

25 days after the date on which a registrant sub-
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1 mits to the Secretary a registration under para2 graph (1), the Secretary shall notify the reg3 istrant whether the registration is approved or 

4 is disapproved. The Secretary shall disapprove 

5 a registration if there is reason to believe that 

6 the registrant is not in compliance with one or 

7 more registration conditions, and shall notify 

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

9 disapproved registration, the Secretary shall 

10 subsequently notify the registrant that the reg11 istration is approved if the Secretary deter12 mines that the registrant is in compliance with 

13 such conditions. 

14 ‘‘(B) CHANGES IN REGISTRATION INFOR15 MATION.—Not later than 30 days after receiv16 ing a notice under paragraph (1)(G) from a 

17 registrant, the Secretary shall determine wheth18 er the change involved affects the approval of 

19 the registration of the registrant under para20 graph (1), and shall inform the registrant of 

21 the determination. 

22 ‘‘(3) PUBLICATION OF CONTACT INFORMATION

23 FOR REGISTERED EXPORTERS.—Through the Inter24 net website of the Food and Drug Administration, 

25 the Secretary shall make readily available to the 
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1 public a list of registered exporters, including con2 tact information for the exporters. Promptly after 

3 the approval of a registration submitted under para4 graph (1), the Secretary shall update the Internet 

5 website accordingly. 

6 ‘‘(4) SUSPENSION AND TERMINATION.— 

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

8 effectiveness of a registration submitted under 

9 paragraph (1): 

10 ‘‘(i) Subject to clause (ii), if the Sec11 retary determines, after notice and oppor12 tunity for a hearing, that the registrant 

13 has failed to maintain substantial compli14 ance with all registration conditions, the 

15 Secretary may suspend the registration. 

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

17 under color of the registration, the ex18 porter has exported a drug or the importer 

19 has imported a drug that is not a quali20 fying drug, or a drug that does not meet 

21 the criteria under subsection (g)(2)(A), or 

22 has exported a qualifying drug to an indi23 vidual in violation of subsection (i)(1)(F), 

24 the Secretary shall immediately suspend 

25 the registration. A suspension under the 
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1 preceding sentence is not subject to the 

2 provision by the Secretary of prior notice, 

3 and the Secretary shall provide to the reg4 istrant an opportunity for a hearing not 

5 later than 10 days after the date on which 

6 the registration is suspended. 

7 ‘‘(iii) The Secretary may reinstate the 

8 registration, whether suspended under 

9 clause (i) or (ii), if the Secretary deter10 mines that the registrant has demonstrated 

11 that further violations of registration con12 ditions will not occur. 

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

14 notice and opportunity for a hearing, may ter15 minate the registration under paragraph (1) of 

16 a registrant if the Secretary determines that 

17 the registrant has engaged in a pattern or prac18 tice of violating 1 or more registration condi19 tions, or if on 1 or more occasions the Secretary 

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

21 registration of the registrant. The Secretary 

22 may make the termination permanent, or for a 

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

24 period in which the registration is terminated, 

25 any registration submitted under paragraph (1) 
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1 by the registrant, or a person that is a partner 

2 in the export or import enterprise, or a principal 

3 officer in such enterprise, and any registration 

4 prepared with the assistance of the registrant or 

5 such a person, has no legal effect under this sec6 tion. 

7 ‘‘(c) SOURCES OF QUALIFYING DRUGS.—A registra8 tion condition is that the exporter or importer involved 

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

10 exported or imported to the United States only if there 

11 is compliance with the following: 

12 ‘‘(1) The drug was manufactured in an estab13 lishment— 

14 ‘‘(A) required to register under subsection 

15 (h) or (i) of section 510; or 

16 ‘‘(B) inspected by the Secretary as pro17 vided by this section. 

18 ‘‘(2) The establishment is located in the United 

19 States or in any foreign country, and the establish20 ment manufactured the drug for distribution in the 

21 United States or for distribution in 1 or more of the 

22 permitted countries (without regard to whether in 

23 addition the drug was manufactured for distribution 

24 in a foreign country that is not a permitted coun25 try). 
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1 ‘‘(3) The exporter or importer obtained the 

2 drug— 

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

4 ‘‘(B) directly from an entity that, by con5 tract with the exporter or importer— 

6 ‘‘(i) provides to the exporter or im7 porter a statement (in such form and con8 taining such information as the Secretary 

9 may require) that, for the chain of custody 

10 from the establishment, identifies each 

11 prior sale, purchase, or trade of the drug 

12 (including the date of the transaction and 

13 the names and addresses of all parties to 

14 the transaction); 

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

16 inspect such statements and related 

17 records to determine their accuracy; 

18 ‘‘(iii) agrees, with respect to the quali19 fying drugs involved, to permit the Sec20 retary to inspect warehouses and other fa21 cilities of the entity for purposes of deter22 mining whether the facilities are in compli23 ance with any standards under this Act 

24 that are applicable to facilities of that type 

25 in the United States; and 
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1 ‘‘(iv) has ensured, through such con2 tractual relationships as may be necessary, 

3 that the Secretary has the same authority 

4 regarding other parties in the chain of cus5 tody from the establishment that the Sec6 retary has under clauses (ii) and (iii) re7 garding such entity. 

8 ‘‘(4) The foreign country from which the im9 porter will import the drug is a permitted country. 

10 ‘‘(5) The foreign country from which the ex11 porter will export the drug is Canada. 

12 ‘‘(6) During any period in which the drug was 

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

14 the drug did not enter any country that is not a per15 mitted country. 

16 ‘‘(7) The exporter or importer retains a sample 

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

18 Secretary. 

19 ‘‘(d) INSPECTION OF FACILITIES; MARKING OF SHIP20 MENTS.— 

21 ‘‘(1) INSPECTION OF FACILITIES.—A registra22 tion condition is that, for the purpose of assisting 

23 the Secretary in determining whether the exporter 

24 involved is in compliance with all other registration 

25 conditions— 
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1 ‘‘(A) the exporter agrees to permit the Sec2 retary— 

3 ‘‘(i) to conduct onsite inspections, in4 cluding monitoring on a day-to-day basis, 

5 of places of business of the exporter that 

6 relate to qualifying drugs, including each 

7 warehouse or other facility owned or con8 trolled by, or operated for, the exporter; 

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

10 day-to-day basis, to— 

11 ‘‘(I) records of the exporter that 

12 relate to the export of such drugs, in13 cluding financial records; and 

14 ‘‘(II) samples of such drugs; 

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

16 in paragraph (3); and 

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

18 determined by the Secretary to be nec19 essary regarding the compliance of the ex20 porter; and 

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

22 employees of the Secretary to carry out the 

23 functions described in this subsection for the 

24 Secretary not less than every 3 weeks on the 

25 premises of places of businesses referred to in 
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1 subparagraph (A)(i), and such an assignment 

2 remains in effect on a continuous basis. 

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

4 registration condition is that the exporter involved 

5 agrees to affix to each shipping container of quali6 fying drugs exported under subsection (a) such 

7 markings as the Secretary determines to be nec8 essary to identify the shipment as being in compli9 ance with all registration conditions. Markings under 

10 the preceding sentence— 

11 ‘‘(A) shall be designed to prevent affixation 

12 of the markings to any shipping container that 

13 is not authorized to bear the markings; and 

14 ‘‘(B) may include anti-counterfeiting or 

15 track-and-trace technologies. 

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

19 ‘‘(A) Verifying the chain of custody of a 

20 statistically significant sample of qualifying 

21 drugs from the establishment in which the drug 

22 was manufactured to the exporter, which may 

23 be accomplished by the use of anticounterfeiting 

24 or track-and-trace technologies, if available. 
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1 ‘‘(B) 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 ‘‘(C) Monitoring the affixing of markings 

10 under paragraph (2). 

11 ‘‘(D) Inspect as the Secretary determines 

12 is necessary the warehouses and other facilities 

13 of other parties in the chain of custody of quali14 fying drugs. 

15 ‘‘(E) Determine whether the exporter is in 

16 compliance with all other registration condi17 tions. 

18 ‘‘(4) CERTAIN DUTIES RELATING TO IMPORT19 ERS.—Duties of the Secretary with respect to an im20 porter include the following: 

21 ‘‘(A) As authorized under section 704, in22 spect not less than every 3 weeks, the places of 

23 business of the importer that relate to the re24 ceipt and distribution of a qualifying drug, in25 cluding each warehouse or other facility owned 
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1 or controlled by, or operated for, the importer 

2 at which qualifying drugs are received or from 

3 which they are distributed to pharmacies. 

4 ‘‘(B) During the inspections under sub5 paragraph (A), verify the chain of custody of a 

6 statistically significant sample of qualifying 

7 drugs from the establishment in which the drug 

8 was manufactured to the importer, which may 

9 be accomplished by the use of anticounterfeiting 

10 or track-and-trace technologies, if available. 

11 ‘‘(C) Inspect as the Secretary determines 

12 is necessary the warehouses and other facilities 

13 of other parties in the chain of custody of quali14 fying drugs. 

15 ‘‘(D) Determine whether the importer is in 

16 compliance with all other registration condi17 tions. 

18 ‘‘(e) IMPORTER FEES.— 

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

22 the importer first submits the registration to the 

23 Secretary under subsection (b). 

24 ‘‘(2) INSPECTION FEE.—A registration condi25 tion is that the importer involved pays to the Sec-
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1 retary in accordance with this subsection a fee on a 

2 semiannual basis, with the first fee due on the date 

3 that is 6 months after the date on which the reg4 istration of the importer under subsection (b) is first 

5 approved by the Secretary. 

6 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

7 ‘‘(A) AGGREGATE TOTAL OF FEES.—The 

8 Secretary shall ensure that the aggregate total 

9 of fees collected under paragraph (2) for a fis10 cal year from all importers is sufficient, and no 

11 more than necessary, to pay the costs of admin12 istering this section with respect to registered 

13 importers for a fiscal year, including— 

14 ‘‘(i) inspection of the facilities of im15 porters under subsection (d)(4); 

16 ‘‘(ii) reviewing qualifying drugs of17 fered for import to importers; and 

18 ‘‘(iii) determining the compliance of 

19 importers with registration conditions. 

20 ‘‘(B) LIMITATION.—The aggregate total of 

21 fees collected under paragraph (2) shall not ex22 ceed 1 percent of the total price of drugs im23 ported annually to the United States by reg24 istered importers under this section. 
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1 ‘‘(C) INDIVIDUAL IMPORTER FEE.—Sub2 ject to the limitation described in subparagraph 

3 (B), a fee under paragraph (2) for an importer 

4 shall be an amount that is a reasonable esti5 mate by the Secretary of the semiannual share 

6 of the importer of the volume of drugs imported 

7 by importers under this section. 

8 ‘‘(D) ADJUSTMENT OF FEE.—The Sec9 retary shall annually adjust the fees under 

10 paragraph (2) to ensure that the fees accurately 

11 reflect the actual costs referred to in subpara12 graph (A) and do not exceed, in the aggregate, 

13 1 percent of the total price of drugs imported 

14 annually to the United States under this sec15 tion. 

16 ‘‘(4) USE OF FEES.—Subject to appropriations 

17 Acts, fees collected by the Secretary under para18 graphs (1) and (2) are available only to the Sec19 retary and are for the sole purpose of paying the 

20 costs referred to in paragraph (3)(A). 

21 ‘‘(f) EXPORTER FEES.— 

22 ‘‘(1) REGISTRATION FEE.—A registration con23 dition is that the exporter involved pays to the Sec24 retary a fee of $10,000 due on the date on which 
24 

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1 the exporter first submits that registration to the 

2 Secretary under subsection (b). 

3 ‘‘(2) INSPECTION FEE.—A registration condi4 tion is that the exporter involved pays to the Sec5 retary in accordance with this subsection a fee on a 

6 semiannual basis, with the first fee due on the date 

7 that is 6 months after the date on which the reg8 istration of the exporter under subsection (b) is first 

9 approved by the Secretary. 

10 ‘‘(3) AMOUNT OF INSPECTION FEE.— 

11 ‘‘(A) AGGREGATE TOTAL OF FEES.—The 

12 Secretary shall ensure that the aggregate total 

13 of fees collected under paragraph (2) for a fis14 cal year from all exporters is sufficient, and not 

15 more than necessary, to pay the costs of admin16 istering this section with respect to registered 

17 exporters for a fiscal year, including— 

18 ‘‘(i) monitoring foreign facilities under 

19 subsection (d); 

20 ‘‘(ii) developing, implementing, and 

21 maintaining under such subsection a sys22 tem to mark shipments to indicate compli23 ance with all registration conditions; and 

24 ‘‘(iii) conducting under such sub25 section inspections within the United 
25 

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1 States to determine compliance with condi2 tions under subsections (h) and (i). 

3 ‘‘(B) LIMITATION.—The aggregate total of 

4 fees collected under paragraph (2) shall not ex5 ceed 1 percent of the total price of drugs im6 ported annually to the United States by reg7 istered exporters under this section. 

8 ‘‘(C) INDIVIDUAL EXPORTER FEE.—Sub9 ject to the limitation described in subparagraph 

10 (B), a fee under paragraph (2) for an exporter 

11 shall be an amount that is a reasonable esti12 mate by the Secretary of the semiannual share 

13 of the exporter of the volume of drugs exported 

14 by exporters under this section. 

15 ‘‘(D) ADJUSTMENT OF FEE.—The Sec16 retary shall annually adjust the fees under 

17 paragraph (2) to ensure that the fees accurately 

18 reflect the actual costs referred to in subpara19 graph (A) and do not exceed, in the aggregate, 

20 1 percent of the total price of drugs imported 

21 annually to the United States under this sec22 tion. 

23 ‘‘(4) USE OF FEES.—Subject to appropriations 

24 Acts, fees collected by the Secretary under para25 graphs (1) and (2) are only available to the Sec-
26 

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1 retary and are for the sole purpose of paying the 

2 costs referred to in paragraph (3)(A). 

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

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

5 that each qualifying drug exported under subsection 

6 (a) by the registered exporter involved or imported 

7 under subsection (a) by the registered importer in8 volved is in compliance with the standards referred 

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

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

11 (3), and (4). 

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

13 ‘‘(A) IN GENERAL.—For purposes of ad14 ministrative and judicial procedure, there is a 

15 presumption that a drug proposed for export or 

16 import under subsection (a) is an approved 

17 drug under section 505(b) if the following cri18 teria are met: 

19 ‘‘(i) The drug proposed for export or 

20 import is in compliance with subsection 

21 (c). 

22 ‘‘(ii) The drug proposed for export or 

23 import has the same active ingredient or 

24 ingredients, route of administration, dos25 age form, and strength, according to infor-
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1 mation provided by the labeling of the drug 

2 proposed for export or import, as a drug 

3 (referred to in this subsection as a ‘U.S. 

4 label drug’) that— 

5 ‘‘(I) is manufactured by or for 

6 the person that manufactures the 

7 drug proposed for export or import; 

8 and 

9 ‘‘(II) is approved under section 

10 505(b). 

11 ‘‘(B) IMPORTATION.—Subject to subpara12 graphs (D) and (E), a drug meeting the criteria 

13 described in subparagraph (A) may, in accord14 ance with the other subsections of this section, 

15 be imported into the United States. 

16 ‘‘(C) NOTICE BY MANUFACTURER; GEN17 ERAL PROVISIONS.— 

18 ‘‘(i) IN GENERAL.—The person that 

19 manufactures a drug that may be imported 

20 under subsection (a) shall in accordance 

21 with this paragraph submit to the Sec22 retary a notice that— 

23 ‘‘(I) includes each difference in 

24 the drug from a condition established 

25 in the approved application for the 
28 

•S 2328 IS 

1 U.S. label drug beyond the variations 

2 provided for in the application, any 

3 difference in labeling, the date on 

4 which the drug with such difference 

5 was, or will be, introduced for com6 mercial distribution in a permitted 

7 country, and such additional informa8 tion as the Secretary may require; or 

9 ‘‘(II) states that there is no dif10 ference in the drug from a condition 

11 established in the approved applica12 tion for the U.S. label drug beyond 

13 the variations provided for in the ap14 plication and differences in labeling. 

15 ‘‘(ii) INFORMATION REGARDING FOR16 EIGN GOVERNMENT.—A notice under 

17 clause (i)(I) shall with respect to the per18 mitted country that approved the drug for 

19 commercial distribution, or with respect to 

20 which such approval is sought, include the 

21 following: 

22 ‘‘(I) Information demonstrating 

23 that the person submitting the notice 

24 has also notified the government of 

25 the permitted country in writing that 
29 

•S 2328 IS 

1 the person is submitting to the Sec2 retary a notice under clause (i)(I), 

3 which notice describes the difference 

4 in the drug from a condition estab5 lished in the approved application for 

6 the U.S. label drug. 

7 ‘‘(II) The information that the 

8 person submitted or will submit to the 

9 government of the permitted country 

10 for purposes of obtaining approval for 

11 commercial distribution of the drug in 

12 the country which, if in a language 

13 other than English, shall be accom14 panied by an English translation 

15 verified to be complete and accurate, 

16 with the name, address, and a brief 

17 statement of the qualifications of the 

18 person that made the translation. 

19 ‘‘(iii) CERTIFICATIONS.—The chief ex20 ecutive officer and the chief medical officer 

21 of the manufacturer involved shall each 

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

23 ‘‘(I) the information provided in 

24 the notice is complete and true; and 
30 

•S 2328 IS 

1 ‘‘(II) a copy of the notice has 

2 been provided to the Federal Trade 

3 Commission and to the Assistant At4 torney General in charge of the Anti5 trust Division of the Department of 

6 Justice (referred to in this subsection 

7 as the ‘Assistant Attorney General’). 

8 ‘‘(iv) FEE.—If a notice submitted 

9 under clause (i) includes a difference that 

10 would, under section 506A, require the 

11 submission of a supplemental application if 

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

13 the person that submits the notice shall 

14 pay to the Secretary a fee in the same 

15 amount as would apply if the person were 

16 paying a fee pursuant to section 

17 736(a)(1)(A)(ii). Subject to appropriations 

18 Acts, fees collected by the Secretary under 

19 the preceding sentence are available only to 

20 the Secretary and are for the sole purpose 

21 of paying the costs of reviewing notices 

22 submitted under clause (i). 

23 ‘‘(v) TIMING OF SUBMISSION OF NO24 TICES.— 
31 

•S 2328 IS 

1 ‘‘(I) PRIOR 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 120 days before the drug 

6 with the difference is introduced for 

7 commercial distribution in a permitted 

8 country, unless the country requires 

9 that distribution of the drug with the 

10 difference begin less than 120 days 

11 after the country requires the dif12 ference. 

13 ‘‘(II) OTHER APPROVAL NO14 TICES.—A notice under clause (i) to 

15 which subparagraph (E) applies shall 

16 be submitted to the Secretary not 

17 later than the day on which the drug 

18 with the difference is introduced for 

19 commercial distribution in a permitted 

20 country. 

21 ‘‘(III) OTHER NOTICES.—A no22 tice under clause (i) to which subpara23 graph (F) applies shall be submitted 

24 to the Secretary on the date that the 

25 drug is first introduced for commer-
32 

•S 2328 IS 

1 cial distribution in a permitted coun2 try and annually thereafter. 

3 ‘‘(vi) REVIEW BY SECRETARY.— 

4 ‘‘(I) IN GENERAL.—In this para5 graph, the difference in a drug that 

6 may be imported under subsection (a) 

7 from the U.S. label drug shall be 

8 treated by the Secretary as if it was 

9 a manufacturing change to the U.S. 

10 label drug under section 506A. 

11 ‘‘(II) 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 ‘‘(III) ESTABLISHMENT INSPEC20 TION.—If review of such difference 

21 would require an inspection by the 

22 Secretary of the establishment in 

23 which the drug is manufactured, such 

24 inspection shall be authorized by sec25 tion 704. 
33 

•S 2328 IS 

1 ‘‘(vii) PUBLICATION OF INFORMATION

2 ON NOTICES.— 

3 ‘‘(I) IN GENERAL.—Through the 

4 Internet website of the Food and 

5 Drug Administration, the Secretary 

6 shall readily make available to the 

7 public a list of notices submitted 

8 under clause (i). 

9 ‘‘(II) CONTENTS.—The list under 

10 subclause (I) shall include the date on 

11 which a notice is submitted and 

12 whether— 

13 ‘‘(aa) a notice is under re14 view; 

15 ‘‘(bb) the Secretary has or16 dered that importation of the 

17 drug from a permitted country 

18 cease; or 

19 ‘‘(cc) the importation of the 

20 drug is permitted under sub21 section (a). 

22 ‘‘(III) UPDATE.—The Secretary 

23 shall promptly update the Internet 

24 website with any changes to the list. 
34 

•S 2328 IS 

1 ‘‘(D) NOTICE; DRUG DIFFERENCE REQUIR2 ING PRIOR APPROVAL.—In the case of a notice 

3 under subparagraph (C)(i) that includes a dif4 ference that would, under section 506A(c) or 

5 (d)(3)(B)(i), require the approval of a supple6 mental application before the difference could 

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

8 shall occur: 

9 ‘‘(i) Promptly after the notice is sub10 mitted, the Secretary shall notify reg11 istered exporters, registered importers, the 

12 Federal Trade Commission, and the As13 sistant Attorney General that the notice 

14 has been submitted with respect to the 

15 drug involved. 

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

17 determination whether a supplemental ap18 plication regarding the U.S. label drug 

19 would be approved or disapproved by the 

20 date on which the drug involved is to be in21 troduced for commercial distribution in a 

22 permitted country, the Secretary shall— 

23 ‘‘(I) order that the importation of 

24 the drug involved from the permitted 

25 country cease for the period in which 
35 

•S 2328 IS 

1 the Secretary completes review of the 

2 notice; and 

3 ‘‘(II) promptly notify registered 

4 exporters, registered importers, the 

5 Federal Trade Commission, and the 

6 Attorney General of the order. 

7 ‘‘(iii) If the Secretary determines that 

8 such a supplemental application regarding 

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

10 the Secretary shall— 

11 ‘‘(I) order that the importation of 

12 the drug involved from the permitted 

13 country cease, or provide that an 

14 order under clause (ii), if any, re15 mains in effect; 

16 ‘‘(II) notify the permitted coun17 try that approved the drug for com18 mercial distribution of the determina19 tion; and 

20 ‘‘(III) promptly notify registered 

21 exporters, registered importers, the 

22 Federal Trade Commission, and the 

23 Assistant Attorney General of the de24 termination. 
36 

•S 2328 IS 

1 ‘‘(iv) If the Secretary determines that 

2 such a supplemental application regarding 

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

4 Secretary shall vacate the order under 

5 clause (ii), if any, permit importation of 

6 the drug under subsection (a), and 

7 promptly notify registered exporters, reg8 istered importers, the Federal Trade Com9 mission, and the Assistant Attorney Gen10 eral of the determination. 

11 ‘‘(E) NOTICE; DRUG DIFFERENCE NOT RE12 QUIRING PRIOR APPROVAL.—In the case of a 

13 notice under subparagraph (C)(i) that includes 

14 a difference that would, under section 

15 506A(d)(3)(B)(ii), not require the approval of a 

16 supplemental application before the difference 

17 could be made to the U.S. label drug the fol18 lowing shall occur: 

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

20 notice is being reviewed by the Secretary, 

21 the authority under this subsection to im22 port the drug involved continues in effect. 

23 ‘‘(ii) If the Secretary determines that 

24 such a supplemental application regarding 

25 the U.S. label drug would not be approved, 
37 

•S 2328 IS 

1 the Secretary shall order that the importa2 tion of the drug involved from the per3 mitted country cease, shall notify the per4 mitted country that approved the drug for 

5 commercial distribution of the determina6 tion, and shall promptly notify registered 

7 exporters, registered importers, the Fed8 eral Trade Commission, and the Assistant 

9 Attorney General of the determination. 

10 ‘‘(F) NOTICE; DRUG DIFFERENCE NOT RE11 QUIRING APPROVAL; NO DIFFERENCE.—In the 

12 case of a notice under subparagraph (C)(i) that 

13 includes a difference for which, under section 

14 506A(d)(1)(A), a supplemental application 

15 would not be required for the difference to be 

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

17 there is no difference, the Secretary— 

18 ‘‘(i) may not order that the importa19 tion of the drug involved cease; and 

20 ‘‘(ii) shall promptly notify registered 

21 exporters and registered importers. 

22 ‘‘(G) DIFFERENCES IN ACTIVE INGRE23 DIENT, ROUTE OF ADMINISTRATION, DOSAGE

24 FORM, OR STRENGTH.— 
38 

•S 2328 IS 

1 ‘‘(i) IN GENERAL.—A person who 

2 manufactures a U.S. label drug shall sub3 mit an application under section 505(b) for 

4 a drug that is manufactured for distribu5 tion in a permitted country by or for the 

6 person that manufactures the U.S. label 

7 drug if— 

8 ‘‘(I) there is no drug for export 

9 from at least half of the permitted 

10 countries with the same active ingre11 dient or ingredients, route of adminis12 tration, dosage form, and strength as 

13 the U.S. label drug; and 

14 ‘‘(II) each active ingredient of 

15 the drug is related to an active ingre16 dient of the U.S. label drug, as de17 fined in clause (v). 

18 ‘‘(ii) APPLICATION UNDER SECTION

19 505(b).—The application under section 

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

21 ‘‘(I) request approval of the drug 

22 for the indication or indications for 

23 which the U.S. label drug is approved 

24 under section 505; 
39 

•S 2328 IS 

1 ‘‘(II) include the information that 

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

4 purposes of obtaining approval for 

5 commercial distribution of the drug in 

6 that country, which if in a language 

7 other than English, shall be accom8 panied by an English translation 

9 verified to be complete and accurate, 

10 with the name, address, and a brief 

11 statement of the qualifications of the 

12 person that made the translation; 

13 ‘‘(III) include a right of reference 

14 to the application under section 

15 505(b) for the U.S. label drug; and 

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

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

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

22 submitted to the Secretary not later than 

23 the day on which the information referred 

24 to in clause (ii)(II) is submitted to the gov25 ernment of the permitted country. 
40 

•S 2328 IS 

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

5 the Assistant Attorney General of a deter6 mination to approve or to disapprove an 

7 application under section 505(b) required 

8 under clause (i). 

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

11 active ingredients are related if they are— 

12 ‘‘(I) the same; or 

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

14 complexes of the same moiety. 

15 ‘‘(3) SECTION 502; LABELING.— 

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

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

19 qualifying drug that is imported or offered 

20 for import by a registered importer, such 

21 drug shall be considered to be in compli22 ance with section 502 if the drug bears— 

23 ‘‘(I) a copy of the labeling ap24 proved for the drug under section 
41 

•S 2328 IS 

1 505, without regard to whether the 

2 copy bears the trademark involved; 

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

6 ‘‘(III) the lot number assigned by 

7 the manufacturer; and 

8 ‘‘(IV) the name, location, and 

9 registration number of the importer. 

10 ‘‘(ii) REQUEST FOR COPY OF THE LA11 BELING.—The Secretary shall provide such 

12 copy to the registered importer involved, 

13 upon request of the importer. 

14 ‘‘(B) IMPORTATION BY INDIVIDUAL.—In 

15 the case of a qualifying drug that is imported 

16 or offered for import by a registered exporter to 

17 an individual, such drug shall be considered to 

18 be in compliance with section 502 if the drug 

19 bears a label providing the directions for use by 

20 the consumer, and bears a copy of any special 

21 labeling that would be required by the Secretary 

22 had the drug been dispensed by a pharmacist in 

23 the United States, without regard to whether 

24 the special labeling bears the trademark in25 volved. The Secretary shall provide to the reg-
42 

•S 2328 IS 

1 istered exporter involved a copy of the special 

2 labeling, upon request of the exporter. 

3 ‘‘(4) SECTION 501; STANDARDS FOR REFUSING

4 ADMISSION.— 

5 ‘‘(A) IN GENERAL.—For purposes of ad6 ministrative and judicial procedure, there is a 

7 presumption that a drug proposed for export or 

8 import under subsection (a) is in compliance 

9 with section 501 if the drug is in compliance 

10 with subsection (c). 

11 ‘‘(B) STANDARDS FOR REFUSING ADMIS12 SION.—A qualifying drug exported under sub13 section (a) from a registered exporter or im14 ported by a registered importer may be refused 

15 admission into the United States if 1 or more 

16 of the following applies: 

17 ‘‘(i) The shipping container appears 

18 damaged in a way that may affect the 

19 strength, quality, or purity of the drug. 

20 ‘‘(ii) The Secretary becomes aware 

21 that— 

22 ‘‘(I) the drug may be counterfeit; 

23 ‘‘(II) the drug may have been 

24 prepared, packed, or held under in25 sanitary conditions; or 
43 

•S 2328 IS 

1 ‘‘(III) the methods used in, or 

2 the facilities or controls used for, the 

3 manufacturing, processing, packing, 

4 or holding of the drug do not conform 

5 to good manufacturing practice. 

6 ‘‘(iii) The Secretary has obtained an 

7 injunction under section 302 that prohibits 

8 the distribution of the drug in interstate 

9 commerce. 

10 ‘‘(iv) The Secretary has under section 

11 505(e) withdrawn approval of the drug. 

12 ‘‘(v) The manufacturer of the drug 

13 has instituted a recall of the drug. 

14 ‘‘(vi) If the qualifying drug is ex15 ported from a registered exporter to an in16 dividual and 1 or more of the following ap17 plies: 

18 ‘‘(I) The shipping container for 

19 such drug does not bear the markings 

20 required under subsection (d)(2). 

21 ‘‘(II) The markings on the ship22 ping container appear to be counter23 feit. 
44 

•S 2328 IS 

1 ‘‘(III) The shipping container or 

2 markings appear to have been tam3 pered with. 

4 ‘‘(h) LICENSING AS PHARMACIST.—A registration 

5 condition is that the exporter involved agrees that a quali6 fying drug will be exported to an individual only if the 

7 Secretary has verified that— 

8 ‘‘(1) the exporter is authorized under Canadian 

9 law to dispense prescription drugs; and 

10 ‘‘(2) the exporter employs persons that are li11 censed under Canadian law to dispense prescription 

12 drugs in sufficient number to dispense safely the 

13 qualifying drugs exported by the exporter to individ14 uals, and the exporter assigns to those persons re15 sponsibility for dispensing such qualifying drugs to 

16 individuals. 

17 ‘‘(i) INDIVIDUALS; CONDITIONS FOR IMPORTATION

18 FROM CANADA.— 

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

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

21 an individual is in accordance with this subsection if 

22 the following conditions are met: 

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

24 a prescription for the drug, which prescrip25 tion— 
45 

•S 2328 IS 

1 ‘‘(i) is valid under applicable Federal 

2 and State laws; and 

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

4 under the law of a State of which the indi5 vidual is a resident, or in which the indi6 vidual receives care from the practitioner 

7 who issues the prescription, is authorized 

8 to administer prescription drugs. 

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

10 of the documentation that was required under 

11 the law or regulations of Canada as a condition 

12 of dispensing the drug to the individual. 

13 ‘‘(C) The copies referred to in subpara14 graphs (A)(i) and (B) are marked in a manner 

15 sufficient— 

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

17 and the equivalent document in Canada, 

18 have been filled; and 

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

20 another pharmacist. 

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

22 registered exporter a complete list of all drugs 

23 used by the individual for review by the individ24 uals who dispense the drug. 
46 

•S 2328 IS 

1 ‘‘(E) The quantity of the drug does not ex2 ceed a 90-day supply. 

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

4 H drug. For purposes of this section, a pre5 scription drug is an ‘ineligible subpart H drug’ 

6 if the drug was approved by the Secretary 

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

8 of Federal Regulations (relating to accelerated 

9 approval), with restrictions under section 520 of 

10 such part to assure safe use, and the Secretary 

11 has published in the Federal Register a notice 

12 that the Secretary has determined that good 

13 cause exists to prohibit the drug from being im14 ported pursuant to this subsection. 

15 ‘‘(2) NOTICE REGARDING DRUG REFUSED AD16 MISSION.—If a registered exporter ships a drug to 

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

18 the drug is refused admission to the United States, 

19 a written notice shall be sent to the individual and 

20 to the exporter that informs the individual and the 

21 exporter of such refusal and the reason for the re22 fusal. 

23 ‘‘(j) MAINTENANCE OF RECORDS AND SAMPLES.—A 

24 registration condition is that the importer or exporter in25 volved shall— 
47 

•S 2328 IS 

1 ‘‘(1) maintain records required under this sec2 tion for not less than 2 years; and 

3 ‘‘(2) maintain samples of each lot of a drug re4 quired under this section for not less than 2 years. 

5 ‘‘(k) DRUG RECALLS.— 

6 ‘‘(1) MANUFACTURERS.—A person that manu7 factures a prescription drug imported from a per8 mitted country under this section shall promptly in9 form the Secretary— 

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

11 from the market in a permitted country; 

12 ‘‘(B) how the drug may be identified, in13 cluding lot number; and 

14 ‘‘(C) the reason for the recall or with15 drawal. 

16 ‘‘(2) SECRETARY.—With respect to each per17 mitted country, the Secretary shall— 

18 ‘‘(A) enter into an agreement with the gov19 ernment of the country to receive information 

20 about recalls and withdrawals of prescription 

21 drugs in the country; or 

22 ‘‘(B) monitor recalls and withdrawals of 

23 prescription drugs in the country using any in24 formation that is available to the public in any 

25 media. 
48 

•S 2328 IS 

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

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

4 or withdrawal of a prescription drug in a permitted 

5 country.’’. 

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

7 and Cosmetic Act is amended— 

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

9 paragraph (aa) and inserting the following: 

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

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

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

13 imported by the pharmacist, other than— 

14 ‘‘(A) a sale at retail made pursuant to dis15 pensing the drug to a customer of the pharmacist or 

16 organization; or 

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

18 or a wholesaler registered to import drugs under sec19 tion 804. 

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

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

22 individual. 

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

24 fraudulent statement or representation, or a material 

25 omission, in a notice under clause (i) of section 
49 

•S 2328 IS 

1 804(g)(2)(C) or in an application required under section 

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

3 application. 

4 ‘‘(4) The importation of a drug in violation of a re5 quirement under section 804.’’; and 

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

7 striking paragraph (6) and inserting the following: 

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

9 knowingly violates section 301(aa) (3) or (4) shall be im10 prisoned not more than 10 years, or fined in accordance 

11 with title 18, United States Code, or both.’’. 

12 (c) IMPLEMENTATION.— 

13 (1) RULEMAKING.— 

14 (A) IN GENERAL.— 

15 (i) PROMULGATION BY SECRETARY.— 

16 Not later than 90 days after the date of 

17 the enactment of this Act, the Secretary of 

18 Health and Human Services shall promul19 gate an interim rule for implementing sec20 tion 804 of the Federal Food, Drug, and 

21 Cosmetic Act, as added by subsection (a) 

22 of this section. Such rule shall be devel23 oped and promulgated by the Secretary 

24 without providing general notice of pro25 posed rulemaking. Not later than 1 year 
50 

•S 2328 IS 

1 after the date on which the interim rule is 

2 promulgated, the Secretary shall, in accord3 ance with procedures under section 553 of 

4 title 5, United States Code, promulgate a 

5 final rule for implementing such section 

6 804, which may incorporate by reference 

7 provisions of the interim rule, to the extent 

8 that such provisions are not modified. 

9 (ii) EFFECT OF RULES.—The rules 

10 promulgated under clause (i) shall permit 

11 the importation of prescription drugs— 

12 (I) from registered exporters by 

13 individuals effective on the date of the 

14 promulgation of the interim rule; 

15 (II) from Canada by registered 

16 importers effective on the date of the 

17 promulgation of the interim rule; and 

18 (III) from Australia, a member 

19 country of the European Union as of 

20 January 1, 2003, Japan, New Zea21 land, or Switzerland by registered im22 porters on the date that is 1 year 

23 after the date of the enactment of this 

24 Act. 
51 

•S 2328 IS 

1 (B) CERTAIN EXPORTERS.—The interim 

2 rule under subparagraph (A) shall provide that, 

3 in the review of registrations submitted under 

4 subsection (b) of the section 804 referred to in 

5 such subparagraph, registrations submitted by 

6 entities in Canada that are significant exporters 

7 of prescription drugs to individuals in the 

8 United States as of the date of the enactment 

9 of this Act will have priority during the period 

10 in which the interim rule under subparagraph 

11 (A) is in effect. During such period, the ref12 erence in subsection (b)(2)(A) of such section 

13 804 to 90 days (relating to approval or dis14 approval of registrations) is, as applied to such 

15 entities, deemed to be 30 days. 

16 (C) DRUGS FOR IMPORT FROM CANADA.— 

17 The notices with respect to drugs to be im18 ported from Canada that are required under 

19 subsection (g)(2)(C)(i)(I) of such section 804 

20 and that require approval under subsection 

21 (g)(2)(D) or (E) of such section 804 shall be 

22 submitted to the Secretary not later than 30 

23 days after the date of enactment of this Act. 

24 The notices with respect to drugs to be im25 ported from Canada that are required under 
52 

•S 2328 IS 

1 subsection (g)(2)(C)(i) of such section 804 and 

2 that do not require approval under subsection 

3 (g)(2)(D) or (E) of such section 804 shall be 

4 submitted to the Secretary not later than 90 

5 days after the date of enactment of this Act. 

6 (D) DRUGS FOR IMPORT FROM OTHER

7 COUNTRIES.—The notices with respect to drugs 

8 to be imported from Australia, a member coun9 try of the European Union as of January 1, 

10 2003, Japan, New Zealand, or Switzerland that 

11 are required under subsection (g)(2)(C)(i)(I) of 

12 such section 804 and that require approval 

13 under subsection (g)(2)(D) or (E) of such sec14 tion 804 shall be submitted to the Secretary not 

15 later than 180 days after the date of enactment 

16 of this Act. The notices with respect to drugs 

17 to be imported from such countries that are re18 quired under subsection (g)(2)(C)(i)(II) of such 

19 section 804 and that do not require approval 

20 under subsection (g)(2)(D) or (E) of such sec21 tion 804 shall be submitted to the Secretary not 

22 later than 270 days after the date of enactment 

23 of this Act. 

24 (2) PERSONAL IMPORTATION FROM CANADA.— 

25 Until the expiration of the 60-day period beginning 
53 

•S 2328 IS 

1 on the date on which the interim rule under para2 graph (1)(A) is promulgated, an individual may im3 port a prescription drug from Canada for personal 

4 use or for the use of a family member of the indi5 vidual (rather than for resale), subject to compliance 

6 with the following conditions: 

7 (A) The drug is not— 

8 (i) a controlled substance, as defined 

9 in section 102 of the Controlled Sub10 stances Act (21 U.S.C. 802); 

11 (ii) a biological product, as defined in 

12 section 351 of the Public Health Service 

13 Act (42 U.S.C. 262); 

14 (iii) an infused drug, including a peri15 toneal dialysis solution; 

16 (iv) an intravenously injected drug; 

17 (v) a drug that is inhaled during sur18 gery; or 

19 (vi) a drug approved by the Secretary 

20 under subpart H of part 314 of title 21, 

21 Code of Federal Regulations (relating to 

22 accelerated approval) with restrictions 

23 under section 520 of such part to assure 

24 safe use. 
54 

•S 2328 IS 

1 (B) The drug is dispensed by a person li2 censed in Canada to dispense such drugs. 

3 (C) The drug is accompanied by a copy of 

4 the prescription for the drug, which prescrip5 tion— 

6 (i) is valid under applicable Federal 

7 and State laws; and 

8 (ii) was issued by a practitioner who, 

9 under the law of a State of which the indi10 vidual is a resident, or in which the indi11 vidual receives care from the practitioner 

12 who issues the prescription, is authorized 

13 to administer prescription drugs. 

14 (D) The drug is accompanied by a copy of 

15 the document that was required in Canada as 

16 a condition of dispensing the drug to the indi17 vidual. 

18 (E) The copies referred to in subpara19 graphs (C) and (D) are marked in a manner 

20 sufficient— 

21 (i) to indicate that the prescription, 

22 and the equivalent document in Canada, 

23 have been filled; and 

24 (ii) to prevent a duplicative filling by 

25 another pharmacist. 
55 

•S 2328 IS 

1 (F) The quantity of the drug does not ex2 ceed a 90-day supply. 

3 (3) FACILITATION OF CANADIAN IMPORTS.— 

4 Not less than 15 days after the enactment of this 

5 Act and until the expiration of the 60-day period 

6 that begins on the date on which the interim rule 

7 under paragraph (1)(A) is promulgated, the Sec8 retary shall, through the Internet website of the 

9 Food and Drug Administration, make readily avail10 able to the public a list of persons licensed in Can11 ada to dispense prescription drugs who are willing to 

12 export drugs under paragraph (2) to individuals in 

13 the United States. 

14 (4) EFFECT OF PROVISIONS.—The amendments 

15 made in subsection (d), section 6, and section 7 of 

16 this Act shall have no effect with respect to imports 

17 made under paragraph (2). 

18 (d) AMENDMENT OF CERTAIN PROVISION.—Section 

19 801 of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 381) is amended by striking subsection (g) and in21 serting the following: 

22 ‘‘(g) With respect to a prescription drug that is im23 ported or offered for import into the United States by an 

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

25 that is not shipped by a registered exporter under section 
56 

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1 804, and that is refused admission under subsection (a), 

2 the Secretary shall notify the individual that— 

3 ‘‘(1) the drug has been refused admission be4 cause the drug was not a lawful import under sec5 tion 804; 

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

7 waiver of the requirements of subsection (a); 

8 ‘‘(3) the individual may under section 804 law9 fully import certain prescription drugs from Cana10 dian exporters registered with the Secretary; and 

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

12 such importation, including a list of registered ex13 porters, on the Internet website of the Food and 

14 Drug Administration.’’. 

15 (e) ANTICOMPETITIVE PRACTICES RELATING TO IM16 PORTING AND EXPORTING DRUGS TO THE UNITED

17 STATES.— 

18 (1) IN GENERAL.—The Clayton Act (15 U.S.C. 

19 12 et seq.) is amended by adding at the end the fol20 lowing: 

21 ‘‘SEC. 27. RESTRAINT OF TRADE REGARDING PRESCRIP22 TION DRUGS. 

23 ‘‘(a) IN GENERAL.—It shall be unlawful for any per24 son engaged in commerce, directly or indirectly to— 
57 

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1 ‘‘(1) charge a higher price for prescription 

2 drugs sold to a registered exporter or other person 

3 that exports prescription drugs to the United States 

4 under section 804 of the Federal Food, Drug, and 

5 Cosmetic Act than the price that is charged to an6 other person that is in the same country and that 

7 does not export prescription drugs into the United 

8 States under section 804 of such Act; 

9 ‘‘(2) charge a higher price for prescription 

10 drugs sold to a registered importer or other person 

11 that distributes, sells, or uses prescription drugs im12 ported to the United States under section 804 of 

13 such Act than the price that is charged to another 

14 person in the United States that does not import 

15 prescription drugs under section 804 of such Act, or 

16 that does not distribute, sell, or use such drugs; 

17 ‘‘(3) deny supplies of prescription drugs to a 

18 registered exporter or other person that exports pre19 scription drugs to the United States under section 

20 804 of such Act or to a registered importer or other 

21 person that distributes, sells, or uses prescription 

22 drugs imported to the United States under section 

23 804 of such Act; 

24 ‘‘(4) publicly, privately, or otherwise refuse to 

25 do business with a registered exporter or other per-
58 

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1 son that exports prescription drugs to the United 

2 States under section 804 of such Act or with a reg3 istered importer or other person that distributes, 

4 sells, or uses prescription drugs imported to the 

5 United States under section 804 of such Act; 

6 ‘‘(5) specifically restrict supplies of prescription 

7 drugs to a registered exporter or other person that 

8 exports prescription drugs to the United States 

9 under section 804 of such Act or to a registered im10 porter or other person that distributes, sells, or uses 

11 prescription drugs imported to the United States 

12 under section 804 of such Act; 

13 ‘‘(6) fail to submit a notice under subsection 

14 (g)(2)(C)(i) of section 804 of such Act, fail to sub15 mit such a notice on or before the date specified in 

16 subsection (g)(2)(C)(v) of section 804 of such Act, 

17 submit such a notice that makes a materially false, 

18 fictitious, or fraudulent statement, or fail to provide 

19 promptly any information requested by the Secretary 

20 of Health and Human Services to review such a no21 tice; 

22 ‘‘(7) fail to submit an application required 

23 under subsection (g)(2)(G) of section 804 of such 

24 Act, fail to submit such an application on or before 

25 the date specified in subsection (g)(2)(G)(ii) of sec-
59 

•S 2328 IS 

1 tion 804 of such Act, submit such an application 

2 that makes a materially false, fictitious, or fraudu3 lent statement, or fail to provide promptly any infor4 mation requested by the Secretary of Health and 

5 Human Services to review such an application; 

6 ‘‘(8) cause there to be a difference (including a 

7 difference in active ingredient, route of administra8 tion, dosage form, strength, formulation, manufac9 turing establishment, manufacturing process, or per10 son that manufactures the drug) between a prescrip11 tion drug for distribution in the United States and 

12 a prescription drug for distribution in Australia, 

13 Canada, a member country of the European Union 

14 as of January 1, 2003, Japan, New Zealand, or 

15 Switzerland for the purpose of restricting importa16 tion of the drug to the United States under section 

17 804 of such Act; 

18 ‘‘(9) refuse to allow an inspection authorized 

19 under section 804 of such Act of an establishment 

20 that manufactures a prescription drug that is of21 fered for import under such section; 

22 ‘‘(10) fail to conform to the methods used in, 

23 or the facilities used for, the manufacturing, proc24 essing, packing, or holding of a prescription drug of-
60 

•S 2328 IS 

1 fered for import under section 804 to good manufac2 turing practice under such Act; or 

3 ‘‘(11) engage in any other action that the Fed4 eral Trade Commission determines to unfairly re5 strict competition under section 804 of such Act. 

6 ‘‘(b) PRESUMPTION.—A difference (including a dif7 ference in active ingredient, route of administration, dos8 age form, strength, formulation, manufacturing establish9 ment, manufacturing process, or person that manufac10 tures the drug) between a prescription drug for distribu11 tion in the United States and a prescription drug for dis12 tribution in Australia, Canada, a member country of the 

13 European Union as of January 1, 2003, Japan, New Zea14 land, or Switzerland made after January 1, 2004, shall 

15 be presumed to be for the purpose of restricting importa16 tion of the drug to the United States under section 804 

17 of the Federal Food, Drug, and Cosmetic Act unless— 

18 ‘‘(1) the person manufacturing the drug for dis19 tribution in the United States proves that the dif20 ference was required by the country in which the 

21 drug is distributed; 

22 ‘‘(2) the Secretary of Health and Human Serv23 ices, acting through the Commissioner of Food and 

24 Drug, determines that the difference was necessary 

25 to improve the safety or efficacy of the drug; or 
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1 ‘‘(3) the person manufacturing the drug for dis2 tribution in the United States has given notice to 

3 the Secretary of Health and Human Services under 

4 subsection (g)(2)(C)(i) of section 804 of such Act 

5 that the drug for distribution in the United States 

6 is not different from a drug for distribution in not 

7 fewer than half of those countries. 

8 ‘‘(c) AFFIRMATIVE DEFENSE.—It shall be an affirm9 ative defense to a charge that a person has violated para10 graph (1), (2), (3), (4), or (5) of subsection (a) that the 

11 higher prices charged for prescription drugs sold to a per12 son, the denial of supplies of prescription drugs to a per13 son, the refusal to do business with a person, or the spe14 cific restriction or delay of supplies to a person is not 

15 based, in whole or in part, on— 

16 ‘‘(1) the person exporting or importing pre17 scription drugs to the United States under section 

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

19 or 

20 ‘‘(2) the person distributing, selling, or using 

21 prescription drugs imported to the United States 

22 under section 804 of such Act. 

23 ‘‘(d) DEFINITIONS.—In this section: 

24 ‘‘(1) PRESCRIPTION DRUG.—The term ‘pre25 scription drug’ means a drug that is described in 
62 

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1 section 503(b)(1) of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 353(b)(1)). 

3 ‘‘(2) REGISTERED IMPORTER.—The term ‘reg4 istered importer’ has the meaning given such term 

5 in section 804 of the Federal Food, Drug, and Cos6 metic Act. 

7 ‘‘(3) REGISTERED EXPORTER.—The term ‘reg8 istered exporter’ has the same meaning as in section 

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

10 (2) APPLICABILITY OF AMENDMENTS TO IM11 PORTATION UNDER THE PHARMACEUTICAL MARKET

12 ACCESS AND FAIR TRADE ACT OF 2004.— 

13 (A) PERSONAL IMPORTATION FROM CAN14 ADA.—Paragraphs (1) through (5) and (11) of 

15 subsection (a) of section 27 of the Clayton Act 

16 (15 U.S.C. et seq.) (as amended by paragraph 

17 (1)) shall apply with respect to the importation 

18 of drugs from Canada under subsection (c)(2). 

19 (B) NOTICES RESPECTING DRUG FOR IM20 PORT.—Paragraph (6) of subsection (a) of sec21 tion 27 of the Clayton Act (15 U.S.C. et seq.) 

22 (as amended by paragraph (1)) shall apply with 

23 respect to notices required under section 

24 804(g)(2)(C)(i) of the Federal Food Drug and 

25 Cosmetic Act (21 U.S.C. 384(g)(2)(C)(i)) that 
63 

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1 are not submitted by the dates required under 

2 subsections (c)(1)(C) and (D). 

3 (f) EXHAUSTION.— 

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

5 United States Code, is amended— 

6 (A) by redesignating subsections (h) and 

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

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

9 following: 

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

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

12 into the United States any patented invention under sec13 tion 804 of the Federal Food, Drug, and Cosmetic Act 

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

15 owner or licensee of such patent.’’. 

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

17 amendment made by paragraph (1) shall be con18 strued to affect the ability of a patent owner or li19 censee to enforce their patent, subject to such 

20 amendment. 
64 

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1 SEC. 5. ADDITIONAL WAIVERS REGARDING PERSONAL IM2 PORTATION; ENFORCEMENT POLICIES OF 

3 SECRETARY. 

4 (a) IN GENERAL.—Section 801 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

6 adding at the end the following: 

7 ‘‘(p)(1) Waivers under this subsection are in addition 

8 to, and independent of, the waiver pursuant to section 

9 804(a)(2)(B). 

10 ‘‘(2) With respect to the standards referred to in sub11 section (d)(1), the Secretary shall establish by regulation 

12 a waiver of such standards in the case of the importation 

13 by an individual of a drug into the United States in the 

14 following circumstances: 

15 ‘‘(A) The drug was dispensed to the individual 

16 while the individual was in the United States, the 

17 drug was dispensed by a pharmacist or by a practi18 tioner licensed by law to administer the drug, and 

19 the individual traveled from the United States with 

20 the drug. 

21 ‘‘(B) The individual is entering the United 

22 States and the drug accompanies the individual at 

23 the time of entry. 

24 ‘‘(C) The drug does not appear to the Secretary 

25 to be adulterated. 
65 

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1 ‘‘(D) The quantity of the drug does not exceed 

2 a 90-day supply. 

3 ‘‘(E) The drug is accompanied by a statement 

4 that the individual seeks to import the drug into the 

5 United States under a personal importation waiver. 

6 ‘‘(F) Such additional standards as the Sec7 retary determines to be appropriate to protect the 

8 public health. 

9 ‘‘(3) With respect to the standards referred to in sub10 sections (a) and (d)(1), the Secretary shall establish by 

11 regulation a waiver of such standards in the case of the 

12 importation by an individual of a drug into the United 

13 States in the following circumstances: 

14 ‘‘(A) The drug was dispensed to the individual 

15 while the individual was in a foreign country, and 

16 the drug was dispensed in accordance with the laws 

17 and regulations of such country. 

18 ‘‘(B) The individual is entering the United 

19 States and the drug accompanies the individual at 

20 the time of entry. 

21 ‘‘(C) The drug is approved for commercial dis22 tribution in the foreign country in which the drug 

23 was obtained. 

24 ‘‘(D) The drug does not appear to the Secretary 

25 to be adulterated. 
66 

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1 ‘‘(E) The quantity of the drug does not ex2 ceed— 

3 ‘‘(i) a 90-day supply if the drug is dis4 pensed in Australia, Canada, a member country 

5 of the European Union as of January 1, 2003, 

6 Japan, New Zealand, or Switzerland; or 

7 ‘‘(ii) a 14-day supply otherwise. 

8 ‘‘(F) The drug is accompanied by a statement 

9 that the individual seeks to import the drug into the 

10 United States under a personal importation waiver. 

11 ‘‘(G) Such additional standards as the Sec12 retary determines to be appropriate to protect the 

13 public health. 

14 ‘‘(q) The Secretary may not administer any enforce15 ment policy that has the effect of permitting the importa16 tion of a prescription drug into the United States in viola17 tion of this Act or section 351 of the Public Health Service 

18 Act.’’. 

19 (b) ADDITIONAL WAIVER.—This Act and the amend20 ments made by this Act shall not be construed as limiting 

21 the authority of the Secretary of Health and Human Serv22 ices to establish a waiver of the standards referred to in 

23 section 801(a) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 381(a)) with respect to the importation 

25 by an individual of a drug into the United States that does 
67 

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1 not meet such standards, provided that such waiver is no 

2 more permissive than the guidance, as in effect on Janu3 ary 1, 2004, that is provided in the item numbered 2 (re4 lating to a specific situation, consisting of conditions (a) 

5 through (d)) under the heading ‘‘Drugs, Biologics, and 

6 Devices’’ in chapter 9 of the FDA/ORA Regulatory Proce7 dures Manual (relating to import operations/actions), in 

8 the subchapter relating to coverage of personal importa9 tions. 

10 SEC. 6. DISPOSITION OF CERTAIN DRUGS DENIED ADMIS11 SION INTO UNITED STATES. 

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

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

14 as amended by section 3 of this Act, is further amended 

15 by adding at the end the following section: 

16 ‘‘SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED AD17 MISSION. 

18 ‘‘(a) IN GENERAL.—The Secretary of Homeland Se19 curity shall refuse admission to a shipment of drugs that 

20 is imported or offered for import into the United States 

21 if the shipment has a declared value of less than $10,000 

22 and the drugs are in violation of any standard referred 

23 to in section 801(a) or 801(d)(1), including any drugs im24 ported or offered for import under enforcement policies 

25 prohibited under section 801(q). 
68 

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1 ‘‘(b) IMPORTATION UNDER SECTION 804.—In the 

2 case of a drug that under section 804 is imported or of3 fered for import from a registered exporter, the reference 

4 in subsection (a) to standards referred to in section 801(a) 

5 or 801(d)(1) shall be considered a reference to standards 

6 referred to in section 804(g)(4)(B). 

7 ‘‘(c) DESTRUCTION OF VIOLATIVE SHIPMENTS.— 

8 Drugs refused admission under subsection (a) or (b) shall 

9 be destroyed, subject to subsection (e). Section 801(b) 

10 does not authorize the delivery of the drugs pursuant to 

11 the execution of a bond, and the drugs may not be ex12 ported. 

13 ‘‘(d) CERTAIN PROCEDURES.— 

14 ‘‘(1) IN GENERAL.—The refusal of admission 

15 and destruction of drugs under this section may be 

16 carried out without notice to the importer, owner, or 

17 consignee of the drugs except as required by section 

18 801(g) or section 804(i)(2). The issuance of receipts 

19 for the drugs, and recordkeeping activities regarding 

20 the drugs, may be carried out on a summary basis. 

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

22 promulgated under paragraph (1) shall be designed 

23 toward the objective of ensuring that, with respect to 

24 efficiently utilizing Federal resources available for 

25 carrying out this section, a substantial majority of 
69 

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1 shipments of drugs subject to subsection (a) or (b) 

2 are identified and refused admission and destroyed. 

3 ‘‘(e) EVIDENCE EXCEPTION.—Drugs may not be de4 stroyed under subsection (c) to the extent that the Attor5 ney General of the United States determines that the 

6 drugs should be preserved as evidence or potential evi7 dence with respect to an offense against the United States. 

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

9 not be construed as having any legal effect on applicable 

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

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

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

13 (b) PROCEDURES.—Procedures for carrying out sec14 tion 805 of the Federal Food, Drug, and Cosmetic Act, 

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

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

17 SEC. 7. CIVIL ACTIONS REGARDING PROPERTY. 

18 Section 303 of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 333) is amended by adding at the end the 

20 following subsection: 

21 ‘‘(g)(1) If a person is alienating or disposing of prop22 erty, or intends to alienate or dispose of property, that 

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

24 in violation of section 801(a) or 801(d), the Attorney Gen25 eral may commence a civil action in any Federal court— 
70 

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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 SEC. 8. WHOLESALE DISTRIBUTION OF DRUGS; STATE14 MENTS REGARDING PRIOR SALE, PURCHASE, 

15 OR TRADE. 

16 (a) STRIKING OF EXEMPTIONS; APPLICABILITY TO

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

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

19 amended— 

20 (1) in paragraph (1)— 

21 (A) by striking ‘‘and who is not the manu22 facturer or an authorized distributor of record 

23 of such drug’’; 

24 (B) by striking ‘‘to an authorized dis25 tributor of record or’’; and 
71 

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1 (C) by striking subparagraph (B) and in2 serting the following: 

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

4 is exported from the United States does not with respect 

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

6 business of the wholesale distribution of the drug from 

7 providing the statement described in subparagraph (A) to 

8 the person that receives the drug pursuant to the export 

9 of the drug. 

10 ‘‘(C)(i) The Secretary may by regulation establish re11 quirements that supersede subparagraph (A) (referred to 

12 in this subparagraph as ‘alternative requirements’) to 

13 identify the chain of custody of a drug subject to sub14 section (b) from the manufacturer of the drug throughout 

15 the wholesale distribution of the drug to a pharmacist who 

16 intends to sell the drug at retail if the Secretary deter17 mines that the alternative requirements, which may in18 clude anti-counterfeiting or track-and-trace technologies, 

19 will identify such chain of custody or the identity of the 

20 drug with equal certainty to the requirements of subpara21 graph (A), and that the alternative requirements are eco22 nomically and technically feasible. 

23 ‘‘(ii) If the Secretary promulgates a final rule to es24 tablish such alternative requirements, the final rule in ad25 dition shall, with respect to the registration condition es-
72 

•S 2328 IS 

1 tablished in clause (i) of section 804(c)(3)(B), establish 

2 a condition equivalent to the alternative requirements, and 

3 such equivalent condition supersedes such clause (i).’’; 

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

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

6 construed as having any applicability with respect to 

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

8 (3) in paragraph (3), by striking ‘‘and sub9 section (d)—’’ in the matter preceding subparagraph 

10 (A) and all that follows through ‘‘the term ‘whole11 sale distribution’ means’’ in subparagraph (B) and 

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

13 term ‘wholesale distribution’ means’’. 

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

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

16 353(d)) is amended by adding at the end the following: 

17 ‘‘(4) Each manufacturer of a drug subject to sub18 section (b) shall maintain at its corporate offices a current 

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

20 ‘‘(5) For purposes of this subsection, the term ‘au21 thorized distributors of record’ means those distributors 

22 with whom a manufacturer has established an ongoing re23 lationship to distribute such manufacturer’s products.’’. 
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1 SEC. 9. REPEAL OF IMPORTATION EXEMPTION UNDER CON2 TROLLED SUBSTANCES IMPORT AND EXPORT 

3 ACT. 

4 Section 1006 of the Controlled Substances Import 

5 and Export Act (21 U.S.C. 956) is repealed. 

Æ