II 

108TH CONGRESS 

2D SESSION S. 2493 

To amend the Federal Food, Drug, and Cosmetic Act to protect the public 

health from the unsafe importation of prescription drugs and from counterfeit prescription drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 2, 2004 

Mr. GREGG (for himself, Mr. SMITH, Ms. COLLINS, Mr. COLEMAN, Mr. SESSIONS, Mr. LOTT, and Mr. ENZI) 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 to 

protect the public health from the unsafe importation 

of prescription drugs and from counterfeit 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Safe Importation of Medical Products and Other Rx 

6 Therapies Act of 2004’’ or the ‘‘Safe IMPORT Act of 

7 2004’’. 
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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Importation. 

Sec. 3. Protection against adulterated prescription drugs. 

Sec. 4. Internet pharmacies. 

Sec. 5. Administrative detention and temporary hold. 

Sec. 6. Suspension. 

Sec. 7. Debarment for repeated or serious prescription drug importation violations. 

Sec. 8. Registration of prescription drug importation facilities. 

Sec. 9. Maintenance and inspection of records for prescription drugs. 

Sec. 10. Advance notice of imported prescription drug shipments. 

Sec. 11. Authority to mark prescription drugs refused admission into the 

United States. 

Sec. 12. Prohibition of port shopping. 

Sec. 13. Authority to commission other Federal and State officials to conduct 

inspections. 

Sec. 14. User fees relating to prescription drug importation. 

Sec. 15. Anticounterfeiting provisions. 

Sec. 16. Conforming amendments. 

3 SEC. 2. IMPORTATION. 

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

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

6 is amended— 

7 (1) by inserting after the chapter heading the 

8 following: 

9 ‘‘SUBCHAPTER A—GENERAL PROVISIONS’’; and 

10 (2) by adding at the end the following: 

11 ‘‘SUBCHAPTER B—IMPORTATION OF 

12 PRESCRIPTION DRUGS 

13 ‘‘SEC. 811. DEFINITIONS. 

14 ‘‘In this subchapter: 

15 ‘‘(1) DRUG IMPORTATION FACILITY.—The term 

16 ‘drug importation facility’ means a person, other 
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•S 2493 IS 

1 than an individual importing a prescription drug 

2 under section 812, located outside the United States 

3 (other than a transporter) that engages in the dis4 tribution or dispensing of a prescription drug that is 

5 imported or offered for importation into the United 

6 States. 

7 ‘‘(2) INTERNET PHARMACY.—The term ‘Inter8 net pharmacy’ means a person, other than an indi9 vidual importing a prescription drug under section 

10 812, that offers to dispense in the United States a 

11 prescription drug through an Internet website in 

12 interstate commerce, regardless of whether the phys13 ical location of the principal place of business of the 

14 Internet pharmacy is in the United States or in an15 other country. 

16 ‘‘(3) PHARMACY.—The term ‘pharmacy’ means 

17 a person, other than an individual importing a pre18 scription drug under section 812, licensed by a State 

19 to dispense prescription drugs or to provide pharma20 ceutical care. 

21 ‘‘(4) PERMITTED COUNTRY.— 

22 ‘‘(A) IN GENERAL.—The term ‘permitted 

23 country’ means a country that— 

24 ‘‘(i) was a member of the European 

25 Union as of December 31, 2003; and 
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1 ‘‘(ii) is designated by the Secretary as 

2 a permitted country under subparagraph 

3 (B). 

4 ‘‘(B) REPORT.—Three years after the date 

5 of enactment of this subchapter, the Secretary 

6 shall submit to the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate and 

8 to the Committee on Energy and Commerce of 

9 the House of Representatives a report that in10 cludes— 

11 ‘‘(i) a list of countries under subpara12 graph (A)(i) designated by the Secretary 

13 from which a prescription drug shall be 

14 permitted to be imported into the United 

15 States under this subchapter, and the basis 

16 for the Secretary’s determination that the 

17 importation of a prescription drug from 

18 such countries would not present an in19 creased risk to the public health; 

20 ‘‘(ii) a list of countries under subpara21 graph (A)(i) from which a prescription 

22 drug shall not be permitted to be imported 

23 into the United States under this sub24 chapter, and the basis for Secretary’s de25 termination that the importation of a pre-
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•S 2493 IS 

1 scription drug from such countries would 

2 present an increased risk to the public 

3 health; 

4 ‘‘(iii) for countries identified in clause 

5 (i), any additional measures that could be 

6 taken to ensure that there will be no in7 creased risk to the public health; and 

8 ‘‘(iv) for countries identified in clause 

9 (ii), any additional measures that could be 

10 taken to a avoid, reduce, or mitigate such 

11 increased risk to the public health. 

12 ‘‘(C) DETERMINATION.—The Secretary 

13 may determine whether to designate a per14 mitted country at any time after submission of 

15 the report under subparagraph (B). 

16 ‘‘(5) PRESCRIPTION DRUG.— 

17 ‘‘(A) IN GENERAL.—The term ‘prescription 

18 drug’ means a drug described in section 503(b) 

19 that is approved by the Secretary under section 

20 505. 

21 ‘‘(B) EXCLUSIONS.—The term ‘prescrip22 tion drug’ does not include— 

23 ‘‘(i) a controlled substance (as defined 

24 in section 102 of the Controlled Sub25 stances Act (21 U.S.C. 802)); 
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•S 2493 IS 

1 ‘‘(ii) a biological product (as defined 

2 in section 351 of the Public Health Service 

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

4 ‘‘(iii) an infused drug (including a 

5 peritoneal dialysis solution); 

6 ‘‘(iv) an intravenously injected drug; 

7 ‘‘(v) a drug that is inhaled during sur8 gery; 

9 ‘‘(vi) a parenteral drug; 

10 ‘‘(vii) a drug manufactured through 1 

11 or more biotechnology processes, includ12 ing— 

13 ‘‘(I) a therapeutic DNA plasmid 

14 product; 

15 ‘‘(II) a therapeutic synthetic 

16 peptide product of not more than 40 

17 amino acids; 

18 ‘‘(III) a monoclonal antibody 

19 product for in vivo use; and 

20 ‘‘(IV) a therapeutic recombinant 

21 DNA-derived product; 

22 ‘‘(viii) a drug required to be refrig23 erated at any time during manufacturing, 

24 packing, processing, or holding; or 

25 ‘‘(ix) a photoreactive drug. 
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1 ‘‘(6) TREATING PROVIDER.—The term ‘treating 

2 provider’ means a licensed health care provider 

3 that— 

4 ‘‘(A)(i) performs a documented patient 

5 evaluation (including a patient history and 

6 physical examination) of an individual to estab7 lish the diagnosis for which a prescription drug 

8 is prescribed; 

9 ‘‘(ii) discusses with the individual the 

10 treatment options of the individual and the 

11 risks and benefits of treatment; and 

12 ‘‘(iii) maintains contemporaneous medical 

13 records concerning the individual; or 

14 ‘‘(B) provides care to an individual as part 

15 of an on-call or cross-coverage arrangement 

16 with a health care provider described in sub17 paragraph (A). 

18 ‘‘(7) WHOLESALER.— 

19 ‘‘(A) IN GENERAL.—The term ‘wholesaler’ 

20 means a person licensed as a wholesaler or dis21 tributor of prescription drugs in the United 

22 States as described in section 503(e)(2). 

23 ‘‘(B) EXCLUSION.—The term ‘wholesaler’ 

24 does not include— 
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1 ‘‘(i) a person authorized to import 

2 drugs under section 801(d)(1); or 

3 ‘‘(ii) an individual importing a pre4 scription drug under section 812. 

5 ‘‘SEC. 812. PERSONAL IMPORTATION. 

6 ‘‘(a) IN GENERAL.—An individual may import a pre7 scription drug from Canada or a permitted country into 

8 the United States for personal use (not for resale), subject 

9 to subsections (b) and (c). 

10 ‘‘(b) IMPORTATION.—An individual may import a 

11 prescription drug if— 

12 ‘‘(1) the prescription drug is purchased from a 

13 licensed pharmacy in Canada or a licensed pharmacy 

14 in a permitted country and dispensed in compliance 

15 with the applicable laws of Canada or the permitted 

16 country regarding the practice of pharmacy; 

17 ‘‘(2) the prescription drug is imported for per18 sonal use (not for resale) by the individual; 

19 ‘‘(3) the prescription drug is imported from 

20 Canada or a permitted country into the United 

21 States; 

22 ‘‘(4) the prescription drug is imported by the 

23 individual on the person of the individual; 
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1 ‘‘(5) the quantity of the prescription drug im2 ported does not exceed a 90-day supply during any 

3 90-day period; and 

4 ‘‘(6) the prescription drug is accompanied by— 

5 ‘‘(A) a copy of a prescription valid in a 

6 State and cosigned by a prescribing physician 

7 in Canada or the permitted country; or 

8 ‘‘(B) if the prescription drug is available in 

9 Canada or the permitted country without a pre10 scription, a copy of the valid prescription signed 

11 by a pharmacist licensed in Canada or the per12 mitted country. 

13 ‘‘(c) COMPASSIONATE USE.—The Secretary may per14 mit an individual to import an up to a 90-day supply of 

15 a drug that is not approved by the Secretary under section 

16 505 if the importation is for continuation of personal use 

17 by the individual for treatment, begun in a foreign coun18 try, of a serious medical condition. 

19 ‘‘SEC. 813. PHARMACY AND WHOLESALER IMPORTATION OF 

20 PRESCRIPTION DRUGS. 

21 ‘‘(a) IN GENERAL.— 

22 ‘‘(1) IMPORTATION.—A drug importation facil23 ity, pharmacy, Internet pharmacy, or wholesaler may 

24 import a prescription drug from Canada or a per25 mitted country into the United States for dispensing 
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1 in the United States in accordance with this sub2 chapter. 

3 ‘‘(2) LIMITATION TO CERTAIN PORTS.—The 

4 Secretary may limit the ports of entry in the United 

5 States through which a prescription drug may be 

6 imported under this section to a reasonable number 

7 of ports designated by the Secretary. 

8 ‘‘(b) REQUIREMENTS.—Each prescription drug im9 ported under this subchapter shall— 

10 ‘‘(1) be approved under section 505; 

11 ‘‘(2) comply with sections 501 and 502; 

12 ‘‘(3) be in a container that bears a label stat13 ing, in prominent and conspicuous type— 

14 ‘‘(A) the lot number of the prescription 

15 drug; 

16 ‘‘(B) the name, address and phone number 

17 of the drug importation facility; 

18 ‘‘(C) the following: ‘This drug has been im19 ported from lllll.’, with the name of the 

20 permitted country from which the prescription 

21 drug is imported in the blank space; and 

22 ‘‘(D) a unique identifier code provided by 

23 the Secretary that modifies the national drug 

24 code of the prescription drug to indicate that 

25 the drug has been imported; and 
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1 ‘‘(4) comply with any other applicable require2 ment of this Act. 

3 ‘‘(c) APPROVED LABELING.— 

4 ‘‘(1) IN GENERAL.—A drug importation facility 

5 that offers for importation a prescription drug under 

6 this subchapter shall submit to the Secretary an ap7 plication for approval that demonstrates that the la8 beling of the prescription drug to be imported into 

9 the United States complies with the requirements of 

10 sections 502 and 503. 

11 ‘‘(2) PROCEDURE.—Not later than 60 days 

12 after receipt of a completed application under para13 graph (1), the Secretary shall— 

14 ‘‘(A) approve or deny the application con15 sistent with the requirements of sections 502 

16 and 503; and 

17 ‘‘(B) notify the applicant of the decision of 

18 the Secretary and, if the application is denied, 

19 the reason for the denial. 

20 ‘‘(3) LISTS.— 

21 ‘‘(A) APPLICATIONS.—The Secretary shall 

22 maintain an updated list of applications pend23 ing, applications approved, and applications de24 nied under this subsection. 
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1 ‘‘(B) PORTS.—The Secretary shall main2 tain an updated list of ports through which a 

3 prescription drug may be imported under this 

4 section and make the list available to the public 

5 on an Internet website. 

6 ‘‘(d) PROHIBITION OF IMPORTATION OF A PRESCRIP7 TION DRUG THAT ENTERS OTHER COUNTRIES.— 

8 ‘‘(1) IN GENERAL.—A drug importation facility, 

9 pharmacy, Internet pharmacy, or wholesaler shall 

10 not import a prescription drug if, during any period 

11 in which the prescription drug was not in the control 

12 of the manufacturer, the prescription drug entered a 

13 country other than— 

14 ‘‘(A) Canada; or 

15 ‘‘(B) subject to paragraph (2), a country 

16 that was a member of the European Union as 

17 of December 31, 2003. 

18 ‘‘(2) LIMITATION.—The Secretary may exclude 

19 1 or more of the countries under subparagraph (B) 

20 of paragraph (1) from the application of that sub21 paragraph if the Secretary determines that allowing 

22 a prescription drug to be imported into the United 

23 States after having entered that country outside con24 trol of a manufacturer would present a risk to the 

25 public health. 
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•S 2493 IS 

1 ‘‘(e) PROHIBITION OF COMMINGLING.— 

2 ‘‘(1) IN GENERAL.—A drug importation facility, 

3 pharmacy, Internet pharmacy, or wholesaler shall 

4 not commingle a prescription drug imported into the 

5 United States under this subchapter with a prescrip6 tion drug that is not imported from Canada or a 

7 permitted country. 

8 ‘‘(2) LABEL.—A pharmacy or Internet phar9 macy that dispenses a prescription drug imported 

10 from Canada or a permitted country shall affix on 

11 each dispensed container of the prescription drug 

12 the label required under subsection (b)(3) unless 

13 such a label is already affixed to the container. 

14 ‘‘(f) DRUG RECALLS.—On receipt of notification 

15 from the manufacturer of a prescription drug imported 

16 from Canada or a permitted country under this section 

17 that the prescription drug has been recalled or withdrawn 

18 from the market in Canada or a permitted country, a drug 

19 importation facility shall promptly provide the Secretary 

20 and any person to whom the prescription drug was distrib21 uted a notice that the drug has been recalled or withdrawn 

22 from the market and that includes— 

23 ‘‘(1) information (including the lot number) 

24 that identifies the prescription drug; and 
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1 ‘‘(2) a statement of the reason for the recall or 

2 withdrawal. 

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

5 801(d)(1) continues to apply to a prescription drug that 

6 is donated or otherwise supplied at no charge or a nominal 

7 charge by the manufacturer of the prescription drug to 

8 a charitable or humanitarian organization (including the 

9 United Nations and affiliates) or to a government of a 

10 foreign country. 

11 ‘‘(h) JURISDICTION.—The district courts of the 

12 United States shall have jurisdiction in an action brought 

13 by the United States against a person importing or offer14 ing for importation a prescription drug in violation of the 

15 requirements of this section. 

16 ‘‘(i) EFFECT OF SECTION.—Nothing in this section 

17 limits the authority of the Secretary relating to the impor18 tation of prescription drugs (including the interdiction of 

19 prescription drugs that are unapproved, adulterated, or 

20 misbranded), other than with respect to section 801(d)(1) 

21 as provided in subsection (g).’’. 

22 (b) REGULATIONS.— 

23 (1) PERSONAL IMPORTATION.— 

24 (A) IN GENERAL.—The Secretary of 

25 Health and Human Services may promulgate 
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1 regulations to carry out section 812 of the Fed2 eral Food, Drug, and Cosmetic Act (as added 

3 by this section). 

4 (B) EFFECTIVE DATE.—Section 812 of the 

5 Federal Food, Drug, and Cosmetic Act shall 

6 take effect on the date of enactment of this Act, 

7 without regard to whether the Secretary of 

8 Health and Human Services has promulgated 

9 regulations under paragraph (1). 

10 (2) PHARMACY AND WHOLESALER IMPORTA11 TION OF PRESCRIPTION DRUGS.— 

12 (A) IN GENERAL.—The Secretary of 

13 Health and Human Services shall promulgate 

14 interim final regulations to carry out section 

15 813 of the Federal Food, Drug, and Cosmetic 

16 Act (as added by this section). 

17 (B) EFFECTIVE DATE.—Section 813 of the 

18 Federal Food, Drug, and Cosmetic Act shall 

19 take effect on the date that is 1 year after the 

20 date of enactment of this Act, without regard to 

21 whether the Secretary of Health and Human 

22 Services has promulgated regulations under 

23 paragraph (1). 
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1 (c) PROHIBITED ACT.—Section 301 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend3 ed by adding at the end the following: 

4 ‘‘(hh) Dispensing or offering to dispense a prescrip5 tion drug imported into the United States in violation of 

6 the requirements of section 813.’’. 

7 SEC. 3. PROTECTION AGAINST ADULTERATED PRESCRIP8 TION DRUGS. 

9 Section 801(h) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 381(h)) is amended— 

11 (1) in paragraph (2)— 

12 (A) by inserting ‘‘and prescription drugs’’ 

13 after ‘‘related to foods’’; 

14 (B) by inserting ‘‘and of prescription 

15 drugs’’ after ‘‘adulteration of food,’’; and 

16 (C) by inserting ‘‘and prescription drugs’’ 

17 after ‘‘importation of food’’; and 

18 (2) in paragraph (3), by inserting ‘‘and for en19 suring the safety of imported prescription drugs’’ 

20 after ‘‘food safety’’. 

21 SEC. 4. INTERNET PHARMACIES. 

22 (a) INTERNET PHARMACIES.—Chapter V of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 

24 seq.) is amended by inserting after section 510 the fol25 lowing: 
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1 ‘‘SEC. 511. INTERNET PHARMACIES. 

2 ‘‘(a) DEFINITIONS.—In this section: 

3 ‘‘(1) ADVERTISING SERVICE PROVIDER.—The 

4 term ‘advertising service provider’ means an adver5 tising company that contracts with a provider of an 

6 interactive computer service (as defined in section 

7 230(f) of the Communications Act of 1934 (47 

8 U.S.C. 230(f)) to provide advertising on the Inter9 net. 

10 ‘‘(2) DESIGNATED PAYMENT SYSTEM.— 

11 ‘‘(A) IN GENERAL.—The term ‘designated 

12 payment system’ means a system used by a per13 son to effect a credit transaction, electronic 

14 transfer, or money transmitting service de15 scribed in subparagraph (B) that the Federal 

16 functional regulators determine, by regulation 

17 or order, could be used in connection with, or 

18 to facilitate, a restricted transaction. 

19 ‘‘(B) PERSONS DESCRIBED.—A person re20 ferred to in subparagraph (A) is— 

21 ‘‘(i) a creditor; 

22 ‘‘(ii) a credit card issuer; 

23 ‘‘(iii) a financial institution; 

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

25 which an electronic fund transfer may be 

26 initiated; 
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1 ‘‘(v) a money transmitting business; 

2 or 

3 ‘‘(vi)(I) an international, national, re4 gional, or local network used to effect a 

5 credit transaction, electronic fund transfer, 

6 or money transmitting service; or 

7 ‘‘(II) any participant in a network de8 scribed in subclause (I). 

9 ‘‘(3) FEDERAL FUNCTIONAL REGULATOR.—The 

10 term ‘Federal functional regulator’ has the meaning 

11 given the term in section 509 of the Gramm-Leach12 Bliley Act (15 U.S.C. 6809). 

13 ‘‘(4) PRESCRIPTION DRUG.—The term ‘pre14 scription drug’ means a drug described in section 

15 503(b) that is approved by the Secretary under sec16 tion 505. 

17 ‘‘(5) INTERNET PHARMACY.—The term ‘Inter18 net pharmacy’ means a person that dispenses or of19 fers to dispense a prescription drug through an 

20 Internet website in interstate commerce in the 

21 United States regardless of whether the physical lo22 cation of the principal place of business of the Inter23 net pharmacy is in the United States or in another 

24 country. 
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1 ‘‘(6) RESTRICTED TRANSACTION.—The term 

2 ‘restricted transaction’ means a transaction or trans3 mittal, on behalf of a individual who places an un4 lawful Internet pharmacy request to any person en5 gaged in the operation of an unlicensed Internet 

6 pharmacy, of— 

7 ‘‘(A) credit, or the proceeds of credit, ex8 tended to or on behalf of the individual who 

9 placed the unlawful Internet request (including 

10 credit extended through the use of a credit 

11 card); 

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

13 transmitted by or through a money transmit14 ting business, or the proceeds of an electronic 

15 fund transfer or money transmitting service, 

16 from or on behalf of the individual who placed 

17 the unlawful Internet request; 

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

19 which is drawn by or on behalf of the individual 

20 who placed the unlawful Internet request and is 

21 drawn on or payable at or through any financial 

22 institution; or 

23 ‘‘(D) the proceeds of any other form of fi24 nancial transaction (identified by the Federal 

25 functional regulators by regulation) that in-
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1 volves a financial institution as a payor or fi2 nancial intermediary on behalf of or for the 

3 benefit of the individual who placed the unlaw4 ful Internet request. 

5 ‘‘(7) UNLAWFUL INTERNET PHARMACY RE6 QUEST.—The term ‘unlawful Internet pharmacy re7 quest’ means the request, or transmittal of a re8 quest, made to an unlicensed Internet pharmacy for 

9 a prescription drug by mail (including a private car10 rier), facsimile, phone, or electronic mail, or by a 

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

12 the Internet. 

13 ‘‘(8) OTHER DEFINITIONS.— 

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

15 The terms ‘credit’, ‘creditor’; and ‘credit card’ 

16 have the meanings given the terms in section 

17 103 of the Truth in Lending Act (15 U.S.C. 

18 1602). 

19 ‘‘(B) ELECTRONIC FUND TRANSFER.—The 

20 term ‘electronic fund transfer’— 

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

22 in section 903 of the Electronic Fund 

23 Transfer Act (15 U.S.C. 1693a); and 
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1 ‘‘(ii) includes any fund transfer cov2 ered under Article 4A of the Uniform Com3 mercial Code, as in effect in any State. 

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

5 ‘financial institution’— 

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

7 in section 903 of the Electronic Transfer 

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

9 ‘‘(ii) includes a financial institution 

10 (as defined in section 509 of the Gramm11 Leach-Bliley Act (15 U.S.C. 6809)). 

12 ‘‘(D) MONEY TRANSMITTING BUSINESS; 

13 MONEY TRANSMITTING SERVICE.—The terms 

14 ‘money transmitting business’ and ‘money 

15 transmitting service’ have the meaning given 

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

17 States Code. 

18 ‘‘(b) IN GENERAL.—An Internet pharmacy may only 

19 dispense or offer to dispense a prescription drug to a per20 son in the United States in accordance with this section. 

21 ‘‘(c) LICENSING OF INTERNET PHARMACIES.— 

22 ‘‘(1) IN GENERAL.—To be licensed under this 

23 section an Internet pharmacy shall— 
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1 ‘‘(A) have its principal place of business in 

2 the United States, Canada, or a permitted 

3 country; and 

4 ‘‘(B) be licensed by the Secretary in ac5 cordance with this section prior to dispensing a 

6 prescription drug to an individual. 

7 ‘‘(2) CONDITIONS FOR LICENSING.— 

8 ‘‘(A) APPLICATION REQUIREMENTS.—An 

9 Internet pharmacy shall submit to the Sec10 retary an application that includes— 

11 ‘‘(i)(I) in the case of an Internet 

12 pharmacy located in the United States, 

13 verification that, in each State in which 

14 the Internet pharmacy engages in dis15 pensing or offering to dispense prescription 

16 drugs, the Internet pharmacy, and all em17 ployees and agents of the Internet phar18 macy, is in compliance with applicable 

19 Federal and State laws regarding— 

20 ‘‘(aa) the practice of pharmacy, 

21 including licensing laws and inspec22 tion requirements; and 

23 ‘‘(bb) the manufacturing and dis24 tribution of controlled substances, in25 cluding with respect to mailing or 
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1 shipping controlled substances to con2 sumers; or 

3 ‘‘(II) in the case of an Internet phar4 macy located in Canada or a permitted 

5 country, verification that— 

6 ‘‘(aa) all employees and agents of 

7 the Internet pharmacy are in compli8 ance with applicable laws of Canada 

9 or the permitted country regarding 

10 the practice of pharmacy, including li11 censing laws and inspection require12 ments; and 

13 ‘‘(bb) the Internet pharmacy is in 

14 compliance with applicable Federal 

15 and State laws regarding the practice 

16 of pharmacy, including licensing laws 

17 and inspection requirements; 

18 ‘‘(ii) verification that the person that 

19 owns the Internet pharmacy has not had a 

20 license for an Internet pharmacy termi21 nated by the Secretary, and that no other 

22 Internet pharmacy owned by the person 

23 has had a license under this subsection 

24 that has been terminated by the Secretary; 
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1 ‘‘(iii) verification from the person that 

2 owns the Internet pharmacy that the per3 son will permit inspection of the facilities 

4 and business practices of the Internet 

5 pharmacy by the Secretary to the extent 

6 necessary to determine whether the Inter7 net pharmacy is in compliance with this 

8 subsection; and 

9 ‘‘(iv) in the case of an agreement be10 tween a patient and an Internet pharmacy 

11 that releases the Internet pharmacy, and 

12 any employee or agent of the Internet 

13 pharmacy, from liability for damages aris14 ing out of the negligence of the Internet 

15 pharmacy, an assurance that such a limita16 tion of liability shall be null and void. 

17 ‘‘(B) IDENTIFICATION REQUIREMENTS.— 

18 An Internet pharmacy shall provide to any per19 son that accesses the Internet pharmacy 

20 website, on each page of the website of the 

21 Internet pharmacy or by a link to a separate 

22 page, the following information: 

23 ‘‘(i) The street address, city, ZIP 

24 Code or comparable mail code, State (or 
25 

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1 comparable entity), country, and telephone 

2 number of— 

3 ‘‘(I) each place of business of the 

4 Internet pharmacy; and 

5 ‘‘(II) the name of the supervising 

6 pharmacist of the Internet pharmacy 

7 and each individual who serves as a 

8 pharmacist for purposes of the Inter9 net pharmacy website. 

10 ‘‘(ii) The names of all States or coun11 tries, as appropriate, in which the Internet 

12 pharmacy and the pharmacists employed 

13 by the Internet pharmacy are licensed or 

14 otherwise authorized to dispense prescrip15 tion drugs. 

16 ‘‘(iii) If the Internet pharmacy makes 

17 referrals to, or solicits on behalf of, a 

18 health care practitioner or group of practi19 tioners in the United States for prescrip20 tion services— 

21 ‘‘(I) the name, street address, 

22 city, ZIP Code or comparable mail 

23 code, State, and telephone number of 

24 the practitioner or group; and 
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1 ‘‘(II) the name of each State in 

2 which each practitioner is licensed or 

3 otherwise authorized to prescribe 

4 drugs. 

5 ‘‘(iv) A statement that the Internet 

6 pharmacy will dispense prescription drugs 

7 only after receipt of a valid prescription. 

8 ‘‘(C) PROFESSIONAL SERVICES REQUIRE9 MENTS.—An Internet pharmacy shall carry out 

10 the following: 

11 ‘‘(i) Maintain patient medication pro12 files and other related data in a readily ac13 cessible format organized to facilitate con14 sultation with treating providers, care15 givers, and patients. 

16 ‘‘(ii) Conduct prospective drug use re17 views before dispensing medications or 

18 medical devices. 

19 ‘‘(iii) Ensure patient confidentiality 

20 and the protection of patient identity and 

21 patient-specific information, in accordance 

22 with the regulations promulgated under 

23 section 264(c) of the Health Insurance 

24 Portability and Accountability Act of 1996 

25 (42 U.S.C. 1320d–2 note). 
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1 ‘‘(iv) Offer interactive and meaningful 

2 consultation by a licensed pharmacist to 

3 the caregiver or patient prior to and subse4 quent to the time at which the Internet 

5 pharmacy dispenses the drug. 

6 ‘‘(v)(I) Establish a mechanism for pa7 tients to report errors and suspected ad8 verse drug reactions. 

9 ‘‘(II) Document in the reporting 

10 mechanism the response of the Internet 

11 pharmacy to those reports. 

12 ‘‘(vi) Develop a system to inform care13 givers and patients about drug recalls. 

14 ‘‘(vii) Educate caregivers and patients 

15 about the appropriate means of disposing 

16 of expired, damaged, or unusable medica17 tions. 

18 ‘‘(viii) Assure that the sale of a pre19 scription drug is in accordance with a pre20 scription from the treating provider of the 

21 individual. 

22 ‘‘(ix)(I) Verify the validity of the pre23 scription of an individual by using 1 of the 

24 following methods: 
28 

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1 ‘‘(aa) Receiving from the indi2 vidual or treating provider of the indi3 vidual the prescription of the indi4 vidual by mail (including a private 

5 carrier), or receiving from the treating 

6 provider of the individual the prescrip7 tion of the individual by electronic 

8 mail. 

9 ‘‘(bb) If the prescription is for a 

10 controlled substance (as defined in 

11 section 102 of the Controlled Sub12 stances Act (21 U.S.C. 802)), con13 firming with the treating provider the 

14 information in subclause (II). 

15 ‘‘(II) When seeking verification of a 

16 prescription of an individual under sub17 clause (I)(bb), an Internet pharmacy shall 

18 provide to the treating provider the fol19 lowing information: 

20 ‘‘(aa) The full name and address 

21 of the individual. 

22 ‘‘(bb) Identification of the pre23 scription drug. 

24 ‘‘(cc) The quantity of the pre25 scription drug to be dispensed. 
29 

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1 ‘‘(dd) The date on which the in2 dividual presented the prescription to 

3 the Internet pharmacy. 

4 ‘‘(ee) The date and time of the 

5 verification request. 

6 ‘‘(ff) The name of a contact per7 son at the Internet pharmacy, includ8 ing a voice telephone number, elec9 tronic mail address, and facsimile tele10 phone number. 

11 ‘‘(III) A prescription is verified under 

12 subclause (I)(bb) only if 1 of the following 

13 occurs: 

14 ‘‘(aa) The treating provider con15 firms, by direct communication with 

16 the Internet pharmacy, that the pre17 scription is accurate. 

18 ‘‘(bb) The treating provider in19 forms the Internet pharmacy that the 

20 prescription is inaccurate and provides 

21 the accurate prescription. 

22 ‘‘(IV) An Internet pharmacy shall not 

23 fill a prescription if— 

24 ‘‘(aa) a treating provider informs 

25 the Internet pharmacy within 72 
30 

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1 hours after receipt of a communica2 tion under subclause (I)(bb) that the 

3 prescription is inaccurate or expired; 

4 or 

5 ‘‘(bb) the treating provider does 

6 not respond within that time. 

7 ‘‘(x) Maintain, for such period of time 

8 as the Secretary shall prescribe by regula9 tion, a record of all direct communications 

10 with a treating provider regarding the dis11 pensing of a prescription drug, including 

12 verification of the prescription. 

13 ‘‘(3) LICENSURE PROCEDURE.— 

14 ‘‘(A) ACTION BY SECRETARY.—On receipt 

15 of a completed licensing application under para16 graph (3), the Secretary shall— 

17 ‘‘(i) assign an identification number 

18 to each Internet pharmacy; 

19 ‘‘(ii) notify the applicant of the receipt 

20 of the licensure application; and 

21 ‘‘(iii) not later than 60 days after re22 ceipt of the licensure application, issue a li23 cense if the Internet pharmacy is in com24 pliance with conditions under paragraph 

25 (3). 
31 

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1 ‘‘(B) ELECTRONIC FILING.— 

2 ‘‘(i) IN GENERAL.—For the purpose 

3 of reducing paperwork and reporting bur4 dens, the Secretary shall require the use of 

5 electronic methods of submitting to the 

6 Secretary a licensure application required 

7 under this section and provide for elec8 tronic methods of receiving the applica9 tions. 

10 ‘‘(ii) AUTHENTICATION.—In providing 

11 for the electronic submission of such licen12 sure applications under this section, the 

13 Secretary shall ensure that adequate au14 thentication protocols are used to allow 

15 identification of the Internet pharmacy and 

16 validation of the data as appropriate. 

17 ‘‘(4) LIST.— 

18 ‘‘(A) IN GENERAL.—The Secretary shall 

19 compile, maintain, and periodically update a list 

20 of licensees. 

21 ‘‘(B) AVAILABILITY.—The Secretary shall 

22 make the list described under subparagraph (A) 

23 and information submitted by the licensee 

24 under paragraph (2)(B) available to the public 
32 

•S 2493 IS 

1 on an Internet website and through a toll-free 

2 telephone number. 

3 ‘‘(5) LICENSING FEE.—The Secretary shall es4 tablish a licensing fee that an Internet pharmacy li5 censed by the Secretary under this section shall be 

6 required to pay to the Secretary. 

7 ‘‘(A) COLLECTION.— 

8 ‘‘(i) COLLECTION OF INITIAL YEAR LI9 CENSING FEE.—A licensing fee of $5,000 

10 shall be payable for the fiscal year in which 

11 the Internet pharmacy first submits a li12 censing application under this section. 

13 ‘‘(ii) COLLECTION IN SUBSEQUENT

14 YEARS.—After the licensing fee is paid for 

15 the first fiscal year, the fee, as modified 

16 under subparagraph (B), shall be payable 

17 on or before October 1 of each year. 

18 ‘‘(iii) ONE FEE PER INTERNET PHAR19 MACY.—The licensing fee shall be paid 

20 only once for each Internet pharmacy for 

21 a fiscal year in which the fee is payable. 

22 ‘‘(B) FEE AMOUNT.—The amount of the 

23 licensing fee shall be determined each year by 

24 the Secretary based on the anticipated costs to 
33 

•S 2493 IS 

1 the Secretary of enforcing the requirements of 

2 this section in the subsequent fiscal year. 

3 ‘‘(C) ANNUAL FEE DETERMINATION.— 

4 ‘‘(i) IN GENERAL.—Not later than 60 

5 days before the beginning of each fiscal 

6 year beginning after September 30, 2004, 

7 the Secretary shall determine the licensing 

8 fee for that fiscal year. 

9 ‘‘(ii) PUBLICATION OF FEE

10 AMOUNT.—Not later than 60 days before 

11 each fiscal year, the Secretary shall publish 

12 the licensing fee under this section for that 

13 fiscal year and provide for a period of 30 

14 days for the public to provide written com15 ments on the fee. 

16 ‘‘(D) USE OF FEES.—The licensing fees 

17 collected under this section shall be used, with18 out further appropriation, to carry out this sec19 tion. 

20 ‘‘(E) FAILURE TO PAY FEE.— 

21 ‘‘(i) DUE DATE.—A licensing fee pay22 able under this section shall be paid by the 

23 date that is 30 days after the date on 

24 which the fee is due. 
34 

•S 2493 IS 

1 ‘‘(ii) FAILURE TO PAY.—If an Inter2 net pharmacy subject to a fee under this 

3 section fails to pay the fee by the date 

4 specified under clause (i), the Secretary 

5 shall not permit the Internet pharmacy to 

6 engage in the dispensing of drugs as de7 scribed under this section until all such 

8 fees owed by the Internet pharmacy are 

9 paid. 

10 ‘‘(F) REPORTS.—Beginning with fiscal 

11 year 2005, not later than 60 days after the end 

12 of each fiscal year during which licensing fees 

13 are collected under this section, the Secretary 

14 shall submit to the Committee on Health, Edu15 cation, Labor, and Pensions of the Senate and 

16 the Committee on Energy and Commerce of the 

17 House of Representatives a report that de18 scribes— 

19 ‘‘(i) implementation of the licensing 

20 fee authority during the fiscal year; and 

21 ‘‘(ii) the use by the Secretary of the 

22 licensing fees collected during the fiscal 

23 year for which the report is made. 

24 ‘‘(6) TERMINATION OF LICENSE.—The Sec25 retary, upon the initiative of the Secretary, may ter-
35 

•S 2493 IS 

1 minate a license issued under subsection (c), after 

2 notice to the Internet pharmacy and an opportunity 

3 for a hearing, and if the Secretary determines that 

4 an Internet pharmacy— 

5 ‘‘(A) has demonstrated a pattern of non6 compliance with this section; 

7 ‘‘(B) has made an untrue statement of ma8 terial fact in its license application; or 

9 ‘‘(C) is in violation of any applicable Fed10 eral or State law relating to the dispensing of 

11 a prescription drug. 

12 ‘‘(7) RENEWAL EVALUATION.— 

13 ‘‘(A) IN GENERAL.—Before renewing a li14 cense of an Internet pharmacy under this sub15 section pursuant to the submission of a renewal 

16 application, the Secretary shall conduct an eval17 uation to determine whether the Internet phar18 macy is in compliance with this section. 

19 ‘‘(B) EVALUATION.—At the discretion of 

20 the Secretary and as applicable, an evaluation 

21 under subparagraph (A) may include testing of 

22 the Internet pharmacy website or other systems 

23 through which the Internet pharmacy commu24 nicates with consumers, and a physical inspec-
36 

•S 2493 IS 

1 tion of the records and premises of the phar2 macy. 

3 ‘‘(8) CONTRACT FOR OPERATION OF PRO4 GRAM.— 

5 ‘‘(A) IN GENERAL.—The Secretary may 

6 award a contract under this subsection for the 

7 operation of the licensing program. 

8 ‘‘(B) TERM.—The duration of a contract 

9 under subparagraph (A) shall not exceed 5 

10 years and may be renewable. 

11 ‘‘(C) PERFORMANCE REVIEW.—The Sec12 retary shall annually review performance under 

13 a contract under subparagraph (A). 

14 ‘‘(d) PROVIDERS OF INTERACTIVE COMPUTER SERV15 ICES OR ADVERTISING SERVICES.—A provider of inter16 active computer services (as defined in section 230(f) of 

17 the Communications Act of 1934 (47 U.S.C. 230(f))) or 

18 an advertising service provider shall be liable under this 

19 section for dispensing or selling prescription drugs in vio20 lation of this section on account of another person’s selling 

21 or dispensing of a prescription drug if the provider of the 

22 service— 

23 ‘‘(1) accepts advertising for a prescription drug 

24 from an unlicensed Internet pharmacy; or 
37 

•S 2493 IS 

1 ‘‘(2) accepts advertising stating that an indi2 vidual does not need a physician’s prescription to ob3 tain a prescription drug. 

4 ‘‘(e) POLICIES AND PROCEDURES REQUIRED TO

5 PREVENT PAYMENTS FOR UNLAWFUL INTERNET PHAR6 MACY REQUESTS.— 

7 ‘‘(1) REGULATIONS.—Not later than 1 year 

8 after the date of enactment of this section, the Fed9 eral functional regulators shall promulgate regula10 tions requiring a person described in subsection 

11 (a)(2) to prevent restricted transactions by estab12 lishing policies and procedures that— 

13 ‘‘(A)(i) are reasonably designed to allow 

14 the payment system and any person involved in 

15 the payment system to identify restricted trans16 actions by means of codes in authorization mes17 sages or by other means; and 

18 ‘‘(ii) are reasonably designed to block re19 stricted transactions identified as a result of the 

20 policies and procedures developed under clause 

21 (i); or 

22 ‘‘(B) prevent the acceptance of the prod23 ucts or services of the payment system in con24 nection with a restricted transaction. 
38 

•S 2493 IS 

1 ‘‘(2) REQUIREMENTS FOR POLICIES AND PRO2 CEDURES.—In promulgating regulations under para3 graph (1), the Federal functional regulators shall— 

4 ‘‘(A) identify types of policies and proce5 dures, including nonexclusive examples, that 

6 shall be considered to be reasonably designed to 

7 identify and reasonably designed to block or to 

8 prevent the acceptance of the products or serv9 ices in connection with each type of restricted 

10 transaction, including— 

11 ‘‘(i) identifying transactions by a code 

12 or codes in the authorization message; and 

13 ‘‘(ii) denying authorization of a credit 

14 card transaction in response to an author15 ization message; and 

16 ‘‘(B) to the extent practicable, permit any 

17 participant in a designated payment system to 

18 choose among alternative means of identifying 

19 and blocking, or otherwise preventing the ac20 ceptance of the products or services of the des21 ignated payment system or participant in con22 nection with, restricted transactions. 

23 ‘‘(3) COMPLIANCE WITH PAYMENT SYSTEM

24 POLICIES AND PROCEDURES.—A person described in 
39 

•S 2493 IS 

1 subsection (a)(2)(B) meets the requirement of para2 graph (1) if— 

3 ‘‘(A) the person relies on and complies 

4 with the policies and procedures of a designated 

5 payment system of which the person is a mem6 ber or in which the person is a participant, to— 

7 ‘‘(i) identify and block restricted 

8 transactions; or 

9 ‘‘(ii) otherwise prevent the acceptance 

10 of the products or services of the payment 

11 system, member, or participant in connec12 tion with restricted transactions; and 

13 ‘‘(B) such policies and procedures of the 

14 designated payment system comply with the re15 quirements of regulations promulgated under 

16 paragraph (1). 

17 ‘‘(4) NO LIABILITY FOR BLOCKING OR REFUS18 ING TO HONOR RESTRICTED TRANSACTION.—A per19 son that is subject to a regulation or an order issued 

20 under this section and blocks or otherwise refuses to 

21 honor a restricted transaction (or a transaction that 

22 such person reasonably believes to be a restricted 

23 transaction) or as a member of a designated pay24 ment system, relies on the policies and procedures of 

25 the payment system in an effort to comply with reg-
40 

•S 2493 IS 

1 ulations promulgated under this section, shall not be 

2 liable to any party for such action. 

3 ‘‘(5) ENFORCEMENT.— 

4 ‘‘(A) IN GENERAL.—This section shall be 

5 enforced by the Federal functional regulators 

6 and the Federal Trade Commission under appli7 cable law in the manner provided in section 

8 505(a) of the Gramm-Leach-Bliley Act (21 

9 U.S.C. 6805(a)). 

10 ‘‘(B) FACTORS TO BE CONSIDERED.—In 

11 considering any enforcement action under this 

12 subsection against a payment system or person 

13 described in subsection (a)(2)(B), the Federal 

14 functional regulators and the Federal Trade 

15 Commission shall consider the following factors: 

16 ‘‘(i) The extent to which the person is 

17 extending credit or transmitting funds 

18 knowing the transaction is in connection 

19 with an unlawful Internet pharmacy re20 quest. 

21 ‘‘(ii) The history of the person in ex22 tending credit or transmitting funds know23 ing the transaction is in connection with 

24 an unlawful Internet pharmacy request. 
41 

•S 2493 IS 

1 ‘‘(iii) The extent to which the person 

2 has established and is maintaining policies 

3 and procedures in compliance with regula4 tions prescribed under this subsection. 

5 ‘‘(iv) The feasibility that any specific 

6 remedy prescribed can be implemented by 

7 the person without substantial deviation 

8 from normal business practice. 

9 ‘‘(v) The costs and burdens the spe10 cific remedy will have on the person. 

11 ‘‘(f) REPORTS REGARDING INTERNET-RELATED VIO12 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

13 OF DRUGS.—The Secretary shall, pursuant to the submis14 sion of an application meeting criteria prescribed by the 

15 Secretary, make an award of a grant or contract to an 

16 entity with experience in developing and maintaining sys17 tems for the purpose of— 

18 ‘‘(1) identifying Internet pharmacy websites 

19 that are not licensed or that appear to be operating 

20 in violation of Federal or State laws concerning the 

21 dispensing of drugs; 

22 ‘‘(2) reporting such Internet pharmacy websites 

23 to State medical licensing boards and State phar24 macy licensing boards, and to the Attorney General 

25 and the Secretary, for further investigation; and 
42 

•S 2493 IS 

1 ‘‘(3) submitting, for each fiscal year for which 

2 the award under this subsection is made, a report to 

3 the Secretary describing investigations undertaken 

4 with respect to violations described in paragraph 

5 (1).’’. 

6 (b) PROHIBITED ACT.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

8 amended by section 2(b)) is amended by adding at the 

9 end the following: 

10 ‘‘(ii) The sale of a prescription drug, or the ownership 

11 or operation of an Internet pharmacy, in violation of sec12 tion 511. 

13 ‘‘(jj) The representation by advertisement, sales pres14 entation, direct communication (including telephone, fac15 simile, or electronic mail), or otherwise by an Internet 

16 pharmacy, that a prescription drug may be obtained from 

17 the Internet pharmacy without a prescription, in violation 

18 of section 511. 

19 ‘‘(kk) The acceptance of an advertisement from an 

20 Internet pharmacy by the provider of an interactive com21 puter service, unless the provider has on file a copy of 

22 the license issued to the Internet pharmacy under section 

23 511.’’. 

24 (c) LINKS TO ILLEGAL INTERNET PHARMACIES.— 

25 Section 302 of the Federal Food, Drug, and Cosmetic Act 
43 

•S 2493 IS 

1 (21 U.S.C. 332) is amended by adding at the end the fol2 lowing: 

3 ‘‘(c)(1) In the case of a violation of section 511 relat4 ing to an illegal Internet pharmacy, the district courts of 

5 the United States and the United States courts of the ter6 ritories shall have jurisdiction to order a provider of an 

7 interactive computer service to remove, or disable access 

8 to, a website violating that section that resides on a com9 puter server that the provider controls or operates. 

10 ‘‘(2) Relief under paragraph (1)— 

11 ‘‘(A) shall be available only after provision to 

12 the provider of notice and an opportunity to appear; 

13 ‘‘(B) shall not impose any obligation on the 

14 provider to monitor its service or to affirmatively 

15 seek facts indicating activity violating section 511; 

16 and 

17 ‘‘(C) shall specify the provider to which the re18 lief applies.’’. 

19 (d) REGULATIONS.— 

20 (1) IN GENERAL.—Not later than 1 year after 

21 the date of enactment of this Act, the Secretary of 

22 Health and Human Services shall promulgate in23 terim final regulations that are consistent with the 

24 Verified Internet Pharmacy Sites certification pro25 gram developed by the National Association of 
44 

•S 2493 IS 

1 Boards of Pharmacy to carry out the amendments 

2 made by this section. 

3 (2) EFFECTIVE DATE.—The requirement of li4 censure under section 511 of the Federal Food, 

5 Drug, and Cosmetic Act (as added by this section) 

6 shall take effect on the date determined by the Sec7 retary of Health and Human Services but in no 

8 event later than 90 days after the effective date of 

9 the interim final regulations under paragraph (1). 

10 (e) RETURN TO SENDER.—Section 801 of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 

12 amended by adding at the end the following: 

13 ‘‘(p) UNLICENSED INTERNET PHARMACY.—If an 

14 Internet pharmacy is not licensed by the Secretary in ac15 cordance with section 511, any shipment of a prescription 

16 drug from such an Internet pharmacy to an individual 

17 shall be refused admission into the United States and the 

18 Secretary shall return the prescription drug, other than 

19 a prescription drug that is required to be destroyed, to 

20 the Internet pharmacy at the expense of the Internet phar21 macy. 

22 ‘‘(q) LICENSED INTERNET PHARMACY.—If a ship23 ment of a prescription drug from an Internet pharmacy 

24 licensed by the Secretary in accordance with section 511 
45 

•S 2493 IS 

1 to an individual is refused admission into the United 

2 States, the Secretary shall— 

3 ‘‘(1) return the prescription drug, other than a 

4 prescription drug that is required to be destroyed, to 

5 the Internet pharmacy at the expense of the Internet 

6 pharmacy; and 

7 ‘‘(2) provide the individual and the Internet 

8 pharmacy with a written notice that informs the in9 dividual and the Internet pharmacy of the refusal 

10 and of the reason for the refusal.’’. 

11 SEC. 5. ADMINISTRATIVE DETENTION AND TEMPORARY 

12 HOLD. 

13 (a) IN GENERAL.—The Federal Food, Drug, and 

14 Cosmetic Act is amended by adding after section 815 (as 

15 added by section 9) the following: 

16 ‘‘SEC. 816. ADMINISTRATIVE DETENTION. 

17 ‘‘(a) ADMINISTRATIVE DETENTION OF PRESCRIP18 TION DRUGS.— 

19 ‘‘(1) DETENTION AUTHORITY.— 

20 ‘‘(A) IN GENERAL.—An officer or qualified 

21 employee of the Food and Drug Administration 

22 may order the detention, in accordance with 

23 this subsection, of any prescription drug that is 

24 found during an inspection, examination, or in25 vestigation under this Act conducted by the of-
46 

•S 2493 IS 

1 ficer or qualified employee, if the officer or 

2 qualified employee has credible evidence or in3 formation indicating that the prescription drug 

4 presents a risk to the public health. 

5 ‘‘(B) APPROVAL.—A prescription drug 

6 may be detained under subparagraph (A) only 

7 if the Secretary or an official designated by the 

8 Secretary approves the order of detention. 

9 ‘‘(2) PERIOD OF DETENTION.—A prescription 

10 drug may be detained under paragraph (1) for a 

11 reasonable period, not to exceed 20 days, unless a 

12 greater period, not to exceed 30 days, is necessary, 

13 to enable the Secretary to commence an action 

14 under this subsection or section 302. 

15 ‘‘(3) SECURITY OF DETAINED ARTICLE.— 

16 ‘‘(A) IN GENERAL.—An order under para17 graph (1) with respect to a prescription drug— 

18 ‘‘(i) may require that the prescription 

19 drug be labeled or marked as detained; and 

20 ‘‘(ii) shall require that the prescrip21 tion drug be removed to a secure facility, 

22 as appropriate. 

23 ‘‘(B) NO TRANSFER.—A prescription drug 

24 subject to an order under paragraph (1) shall 

25 not be transferred by any person from the place 
47 

•S 2493 IS 

1 at which the prescription drug is ordered de2 tained or from the place to which the prescrip3 tion drug is removed, until released by the Sec4 retary or until the expiration of the detention 

5 period applicable under the order, whichever oc6 curs first. 

7 ‘‘(C) EFFECT OF PARAGRAPH.—This para8 graph does not authorize the delivery of a pre9 scription drug pursuant to the execution of a 

10 bond while the prescription drug is subject to 

11 an order under paragraph (1). 

12 ‘‘(D) EFFECT OF BONDING PROVISION.— 

13 Section 801(b) does not authorize the delivery 

14 of a prescription drug pursuant to the execution 

15 of a bond while the prescription drug is subject 

16 to an order under paragraph (1). 

17 ‘‘(4) APPEAL OF DETENTION ORDER.— 

18 ‘‘(A) IN GENERAL.—With respect to a pre19 scription drug detained under paragraph (1), 

20 any person that would be entitled to be a claim21 ant for the prescription drug if the prescription 

22 drug were seized under paragraph (1) may ap23 peal the order of detention to the Secretary. 

24 ‘‘(B) ACTION BY THE SECRETARY.—Not 

25 later than 5 days after an appeal is filed, the 
48 

•S 2493 IS 

1 Secretary, after providing opportunity for an in2 formal hearing, shall confirm or terminate the 

3 order, and confirmation by the Secretary shall 

4 be considered to be a final agency action for 

5 purposes of section 702 of title 5, United States 

6 Code. 

7 ‘‘(C) FAILURE TO ACT.—If, during the 5- 

8 day period specified in subparagraph (B), the 

9 Secretary fails to provide an opportunity for 

10 hearing or to confirm or terminate the order, 

11 the order shall be deemed to be terminated. 

12 ‘‘(D) EFFECT OF COMMENCEMENT OF

13 COURT ACTION.—The process under this para14 graph for the appeal of an order under para15 graph (1) with respect to a prescription drug 

16 terminates if the Secretary commences an ac17 tion under subsection (a) or section 302 regard18 ing the prescription drug. 

19 ‘‘(b) EFFECT OF SECTION.—Nothing in this section 

20 applies to a prescription drug imported by an individual 

21 under section 812 or to a commercial transaction con22 ducted between an Internet pharmacy and an individual.’’. 

23 (b) TEMPORARY HOLD AT PORT OF ENTRY.—Sec24 tion 801 of the Federal Food, Drug, and Cosmetic Act 
49 

•S 2493 IS 

1 (21 U.S.C. 381) (as amended by section 4(e)) is amended 

2 by adding at the end the following: 

3 ‘‘(r) TEMPORARY HOLD AT PORT OF ENTRY.— 

4 ‘‘(1) IN GENERAL.—If an officer or qualified 

5 employee of the Food and Drug Administration has 

6 credible evidence or information indicating that a 

7 prescription drug presents a risk to the public 

8 health, and the officer or qualified employee is un9 able to inspect, examine, or investigate the prescrip10 tion drug upon the prescription drug’s being offered 

11 for import at a port of entry into the United States, 

12 the officer or qualified employee shall request the 

13 Secretary of the Treasury to hold the prescription 

14 drug at the port of entry for a reasonable period of 

15 time, not to exceed 24 hours, for the purpose of ena16 bling the Secretary to inspect, examine, or inves17 tigate the prescription drug as appropriate. 

18 ‘‘(2) APPROVAL.— 

19 ‘‘(A) IN GENERAL.—An officer or qualified 

20 employee of the Food and Drug Administration 

21 may make a request under paragraph (1) only 

22 if the Secretary or an official designated by the 

23 Secretary approves the request. 

24 ‘‘(B) DESIGNEES.—An official may not be 

25 designated under subparagraph (A) unless the 
50 

•S 2493 IS 

1 official is the director of the district under this 

2 Act in which the prescription drug is located, or 

3 is an official senior to that director. 

4 ‘‘(3) NOTIFICATION.—With respect to a pre5 scription drug for which a request under paragraph 

6 (1) is made, the Secretary, promptly after the re7 quest is made, shall notify the State in which the 

8 port of entry involved is located that the request has 

9 been made, and as applicable, that the prescription 

10 drug, is being held under this subsection. 

11 ‘‘(4) REMOVAL.—A prescription drug held 

12 under paragraph (1) shall be removed to a secure fa13 cility, as appropriate. 

14 ‘‘(5) NO TRANSFER.—During the period in 

15 which a prescription drug is held under this sub16 section, the prescription drug shall not be trans17 ferred by any person from the port of entry into the 

18 United States for the prescription drug or from the 

19 secure facility to which the prescription drug has 

20 been removed. 

21 ‘‘(6) EFFECT OF BONDING PROVISION.—Sub22 section (b) does not authorize the delivery of a pre23 scription drug held under this subsection pursuant 

24 to the execution of a bond while the prescription 

25 drug is held under this subsection. 
51 

•S 2493 IS 

1 ‘‘(7) EFFECT OF SUBSECTION.—Nothing in this 

2 subsection applies to a prescription drug imported 

3 by an individual under section 812 or to a commer4 cial transaction conducted between an Internet phar5 macy and an individual.’’. 

6 (c) PROHIBITED ACT.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

8 amended by section 4(b)) is amended by adding at the 

9 end the following: 

10 ‘‘(ll) The transfer of a prescription drug in violation 

11 of an order under section 816, or the removal or alteration 

12 of any mark or label required by the order to identify the 

13 prescription drug as detained.’’. 

14 SEC. 6. SUSPENSION. 

15 (a) IN GENERAL.—The Federal Food, Drug, and 

16 Cosmetic Act is amended by adding after section 816 (as 

17 added by section 5) the following: 

18 ‘‘SEC. 817. SUSPENSION OF IMPORTATION. 

19 ‘‘(a) PRESCRIPTION DRUG.—If the Secretary deter20 mines that the importation of a particular prescription 

21 drug or particular dosage form of a prescription drug into 

22 the United States presents a risk to the public health, the 

23 Secretary may immediately order the suspension of the 

24 importation of the particular prescription drug or par25 ticular dosage form of the prescription drug. 
52 

•S 2493 IS 

1 ‘‘(b) SUSPENSION.—If the Secretary determines that 

2 a drug importation facility, pharmacy, Internet pharmacy, 

3 or wholesaler is engaged in a pattern of importing or offer4 ing for importation a prescription drug into the United 

5 States in violation of any of the requirements of this Act, 

6 the Secretary may immediately order the suspension of 

7 that person from engaging in the importation or offering 

8 for importation of prescription drugs into the United 

9 States. 

10 ‘‘(c) CANADA OR PERMITTED COUNTRY.—If the Sec11 retary determines that there is a pattern of prescription 

12 drugs being imported or offered for importation into the 

13 United States from Canada or a permitted country in vio14 lation of any of the requirements of this Act, the Secretary 

15 may immediately order the suspension of the importation 

16 or offering for importation into the United States of pre17 scription drugs from Canada or that permitted country, 

18 as appropriate. 

19 ‘‘(d) APPEAL OF SUSPENSION ORDER.— 

20 ‘‘(1) IN GENERAL.— 

21 ‘‘(A) PRESCRIPTION DRUGS.—With respect 

22 to the importation of a prescription drug, the 

23 importation of which is suspended under sub24 section (a), any person that would be entitled to 
53 

•S 2493 IS 

1 be a claimant for the prescription drug may ap2 peal the suspension order to the Secretary. 

3 ‘‘(B) SUSPENDED PERSONS.—With respect 

4 to a drug importation facility, pharmacy, Inter5 net pharmacy, or wholesaler subject to a sus6 pension order under subsection (b) or (c), the 

7 drug importation facility, pharmacy, Internet 

8 pharmacy or wholesaler may appeal the suspen9 sion order to the Secretary. 

10 ‘‘(2) ACTION BY THE SECRETARY.—Not later 

11 than 30 days after an appeal is filed, the Secretary, 

12 after providing opportunity for an informal hearing, 

13 shall confirm or terminate the order. 

14 ‘‘(3) FAILURE TO ACT.—If, during the 30-day 

15 period specified in paragraph (2), the Secretary fails 

16 to provide an opportunity for a hearing or to con17 firm or terminate the order, the order shall be 

18 deemed to be terminated. 

19 ‘‘(e) NO JUDICIAL REVIEW.—An order under this 

20 section shall not be subject to judicial review. 

21 ‘‘(f) EFFECT OF SECTION.—Nothing in this section 

22 applies to a prescription drug imported by an individual 

23 under section 812 or to a commercial transaction con24 ducted between an Internet pharmacy and an individual.’’. 
54 

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1 (b) PROHIBITED ACT.—Section 301 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

3 amended by section 5(c)) is amended by adding at the end 

4 the following: 

5 ‘‘(mm) The importation or offering for importation 

6 of a prescription drug in violation of an order under sec7 tion 817.’’. 

8 SEC. 7. DEBARMENT FOR REPEATED OR SERIOUS PRE9 SCRIPTION DRUG IMPORTATION VIOLA10 TIONS. 

11 (a) DEBARMENT AUTHORITY.— 

12 (1) PERMISSIVE DEBARMENT.—Section 

13 306(b)(1) of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 335a(b)(1)) is amended— 

15 (A) in subparagraph (B), by striking ‘‘or’’ 

16 at the end; 

17 (B) in subparagraph (C), by striking the 

18 period at the end and inserting ‘‘, or’’; and 

19 (C) by adding at the end the following: 

20 ‘‘(D) a person from importing a prescrip21 tion drug or offering a prescription drug for im22 portation into the United States.’’. 

23 (2) AMENDMENT REGARDING DEBARMENT

24 GROUNDS.—Section 306(b) of the Federal Food, 
55 

•S 2493 IS 

1 Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 

2 amended— 

3 (A) by redesignating paragraph (4) as 

4 paragraph (5); and 

5 (B) by inserting after paragraph (3) the 

6 following: 

7 ‘‘(4) PERSONS SUBJECT TO PERMISSIVE DE8 BARMENT; PRESCRIPTION DRUG IMPORTATION.— 

9 ‘‘(A) IN GENERAL.—A person is subject to 

10 debarment under paragraph (1)(D) if— 

11 ‘‘(i) the person has been convicted of 

12 a felony for conduct relating to the impor13 tation into the United States of any pre14 scription drug; or 

15 ‘‘(ii) the person has engaged in a pat16 tern of importing or offering for import a 

17 prescription drug that presents a risk to 

18 the public health. 

19 ‘‘(B) EFFECT OF PARAGRAPH.—Nothing 

20 in this paragraph applies to a prescription drug 

21 imported by an individual under section 812 or 

22 to a commercial transaction conducted between 

23 an Internet pharmacy and an individual.’’. 
56 

•S 2493 IS 

1 (b) CONFORMING AMENDMENTS.—Section 306 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) 

3 is amended— 

4 (1) in subsection (b), by striking the subsection 

5 heading and inserting the following: 

6 ‘‘(b) PERMISSIVE DEBARMENT; CERTAIN DRUG AP7 PLICATIONS; IMPORTS.—’’; 

8 (2) in subsection (c)(2)(A)(iii), by striking 

9 ‘‘paragraph (2) or (3) of subsection (b)’’ and insert10 ing ‘‘paragraph (2), (3), or (4) of subsection (b)’’; 

11 and 

12 (3) in subsection (d)(3)— 

13 (A) in subparagraph (A)(i), by striking ‘‘or 

14 paragraph (2)(A) or (3) of subsection (b)’’ and 

15 inserting ‘‘paragraph (2)(A), (3), or (4) of sub16 section (b)’’; 

17 (B) in clauses (i) and (ii) of subparagraph 

18 (B), by striking ‘‘or subsection (b)(3)’’ and in19 serting ‘‘paragraph (3) or (4) of subsection 

20 (b)’’; and 

21 (C) in subparagraph (B)(ii), by striking 

22 ‘‘or the food importation process, as the case 

23 may be’’ and inserting ‘‘, or the food or pre24 scription drug importation process, as the case 

25 may be’’. 
57 

•S 2493 IS 

1 (c) EFFECTIVE DATE.—Section 306(l)(2) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) 

3 is amended— 

4 (1) in the first sentence, by striking ‘‘and sub5 section (b)(3)(A)’’ and inserting ‘‘subsection 

6 (b)(3)(A), and subsection (b)(4)(A)’’; and 

7 (2) in the second sentence, by inserting ‘‘, sub8 section (b)(4)(B),’’ after ‘‘subsection (b)(3)(B)’’. 

9 (d) PROHIBITED ACT.—Section 301 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

11 amended by section 6(b)) is amended by adding at the 

12 end the following: 

13 ‘‘(nn) The importing or offering for importation into 

14 the United States of a prescription drug by, with the as15 sistance of, or at the direction of a person debarred under 

16 section 306(b)(4).’’. 

17 (e) IMPORTATION BY DEBARRED PERSONS.—Section 

18 801 of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 381) (as amended by section 5(b)) is amended by 

20 adding at the end the following: 

21 ‘‘(s) IMPORTATION OF PRESCRIPTION DRUGS BY

22 DEBARRED PERSONS.— 

23 ‘‘(1) IN GENERAL.—If a prescription drug is 

24 imported or offered for importation into the United 

25 States, and the importer, owner, or consignee of the 
58 

•S 2493 IS 

1 prescription drug is a person that has been debarred 

2 under section 306(b)(4), the prescription drug— 

3 ‘‘(A) shall be held at the port of entry for 

4 the prescription drug; and 

5 ‘‘(B) may not be delivered to the person. 

6 ‘‘(2) EFFECT OF BONDING PROVISION.—Sub7 section (b) does not authorize the delivery of a pre8 scription drug pursuant to the execution of a bond 

9 while the prescription drug is held under this sub10 section. 

11 ‘‘(3) REMOVAL.—A prescription drug held 

12 under this subsection shall be removed to a secure 

13 facility, as appropriate. 

14 ‘‘(4) NO TRANSFER.—During a period in which 

15 a prescription drug is held under this subsection, the 

16 prescription drug shall not be transferred by any 

17 person from the port of entry into the United States 

18 for the prescription drug or from the secure facility 

19 to which the prescription drug has been removed. 

20 ‘‘(5) PERMISSIBLE DELIVERY.—A prescription 

21 drug held under this subsection may be delivered to 

22 a person that is not a debarred person under section 

23 306(b)(4) if the person affirmatively establishes, at 

24 the expense of the person, that the prescription drug 
59 

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1 complies with the requirements of this Act, as deter2 mined by the Secretary.’’. 

3 SEC. 8. REGISTRATION OF PRESCRIPTION DRUG IMPORTA4 TION FACILITIES. 

5 (a) REGISTRATION OF CERTAIN IMPORTERS.—The 

6 Federal Food, Drug, and Cosmetic Act is amended by 

7 adding after section 813 (as added by section 2) the fol8 lowing: 

9 ‘‘SEC. 814. REGISTRATION OF CERTAIN IMPORTERS. 

10 ‘‘(a) IN GENERAL.—A drug importation facility, 

11 pharmacy, Internet pharmacy, or wholesaler engaged in 

12 the importation or offering for importation of prescription 

13 drugs into the United States, or in the dispensing of such 

14 drugs, shall register with the Secretary in accordance with 

15 this section. 

16 ‘‘(b) REGISTRATION.— 

17 ‘‘(1) IN GENERAL.—To register, the owner, op18 erator, or agent in charge of a drug importation fa19 cility, pharmacy, Internet pharmacy, or wholesaler 

20 shall submit to the Secretary a registration that dis21 closes— 

22 ‘‘(A) the name and address of each drug 

23 importation facility, pharmacy, Internet phar24 macy, or wholesaler at which, and all trade 
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1 names under which, the registrant conducts 

2 business; 

3 ‘‘(B) the name of each prescription drug to 

4 be imported into the United States by each 

5 drug importation facility, pharmacy, Internet 

6 pharmacy, or wholesaler; and 

7 ‘‘(C) the name and address of an agent for 

8 service of process in the United States. 

9 ‘‘(2) CHANGE IN INFORMATION.—The reg10 istrant shall notify the Secretary in a timely manner 

11 of any change in the information provided under 

12 paragraph (1). 

13 ‘‘(3) PROCEDURE.—Not later than 60 days 

14 after receipt of a completed registration under para15 graph (1), the Secretary shall— 

16 ‘‘(A) assign a registration number to each 

17 registered drug importation facility, pharmacy, 

18 Internet pharmacy, and wholesaler; and 

19 ‘‘(B) notify the registrant of the receipt of 

20 the registration. 

21 ‘‘(4) LIST.— 

22 ‘‘(A) IN GENERAL.—The Secretary shall 

23 compile, maintain, and periodically update a list 

24 of registrants. 
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•S 2493 IS 

1 ‘‘(B) AVAILABILITY.—The Secretary shall 

2 make the list described under subparagraph (A) 

3 and information submitted by a registrant 

4 under paragraph (1) available to the public on 

5 an Internet website and through a toll-free tele6 phone number. 

7 ‘‘(c) ELECTRONIC FILING.— 

8 ‘‘(1) IN GENERAL.—For the purpose of reduc9 ing paperwork and reporting burdens, the Secretary 

10 shall provide for, and require the use of, electronic 

11 methods of submitting to the Secretary registrations 

12 required under this section and shall provide for 

13 electronic methods of receiving the registrations. 

14 ‘‘(2) AUTHENTICATION.—In providing for the 

15 electronic submission of such registrations under 

16 this section, the Secretary shall ensure that ade17 quate authentication protocols are used to allow 

18 identification of the registrant and validation of the 

19 data as appropriate. 

20 ‘‘(d) EFFECT OF SECTION.— 

21 ‘‘(1) AUTHORITY.—Nothing in this section 

22 authorizes the Secretary to require an applica23 tion, review, or licensing process for a drug im24 portation facility, pharmacy, or wholesaler. 
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•S 2493 IS 

1 ‘‘(2) IMPORTATION BY INDIVIDUALS.— 

2 Nothing in this section applies to a prescription 

3 drug imported by an individual under section 

4 812 or to a commercial transaction conducted 

5 between an Internet pharmacy and an indi6 vidual.’’. 

7 (b) REGULATIONS.— 

8 (1) IN GENERAL.—Not later than 1 year after 

9 the date of enactment of this Act, the Secretary of 

10 Health and Human Services shall promulgate regu11 lations to carry out section 814 of the Federal Food, 

12 Drug, and Cosmetic Act (as added by this section). 

13 (2) EFFECTIVE DATE.—The requirement of 

14 registration under section 814 of the Federal Food, 

15 Drug, and Cosmetic Act takes effect— 

16 (A) on the effective date of the final regu17 lations under paragraph (1); or 

18 (B) if the final regulations have not been 

19 made effective as of the expiration of that pe20 riod, on the date that is 1 year after the date 

21 of enactment of this Act, subject to compliance 

22 with the final regulations when the final regula23 tions are made effective. 

24 (c) IMPORTATION; FAILURE TO REGISTER.—Section 

25 801 of the Federal Food, Drug, and Cosmetic Act (21 
63 

•S 2493 IS 

1 U.S.C. 381) (as amended by section 7(e)) is amended by 

2 adding at the end the following: 

3 ‘‘(t) FAILURE TO REGISTER.— 

4 ‘‘(1) IN GENERAL.—If a drug importation facil5 ity, pharmacy, Internet pharmacy, or wholesaler en6 gaged in the importation or offering for importation 

7 of prescription drugs into the United States has not 

8 submitted a registration to the Secretary in accord9 ance with section 814, a prescription drug that is 

10 being imported or offered for importation into the 

11 United States shall not be delivered to the importer, 

12 owner, or consignee of the prescription drug until 

13 the drug importation facility, pharmacy, Internet 

14 pharmacy, or wholesaler is registered in accordance 

15 with section 814. 

16 ‘‘(2) EFFECT OF SUBSECTION (b).—Subsection 

17 (b) does not authorize the delivery of the prescrip18 tion drug pursuant to the execution of a bond while 

19 the prescription drug is held under this subsection. 

20 ‘‘(3) REMOVAL.—A prescription drug held 

21 under this subsection shall be removed to a secure 

22 facility, as appropriate. 

23 ‘‘(4) NO TRANSFER.—During the period in 

24 which a prescription drug is held under this sub25 section, the prescription drug shall not be trans-
64 

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1 ferred by any person from the port of entry into the 

2 United States for the prescription drug or from the 

3 secure facility to which the prescription drug has 

4 been removed.’’. 

5 (d) PROHIBITED ACT.—Section 301 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

7 amended by section 7(d)) is amended by adding at the 

8 end the following: 

9 ‘‘(oo) The failure of a drug importation facility, phar10 macy, Internet pharmacy, or wholesaler engaged in the 

11 importation or offering for importation of prescription 

12 drugs into the United States, or in the dispensing of such 

13 drugs, to register in accordance with section 814.’’. 

14 SEC. 9. MAINTENANCE AND INSPECTION OF RECORDS FOR 

15 PRESCRIPTION DRUGS. 

16 The Federal Food, Drug, and Cosmetic Act is amend17 ed by adding after section 814 (as added by section 8) 

18 the following: 

19 ‘‘SEC. 815. MAINTENANCE AND INSPECTION OF RECORDS 

20 FOR PRESCRIPTION DRUGS. 

21 ‘‘(a) IN GENERAL.—The Secretary may by regulation 

22 establish requirements relating to the establishment and 

23 maintenance, for not longer than 2 years, of records by— 

24 ‘‘(1) a drug importation facility, pharmacy, 

25 Internet pharmacy, or wholesaler engaged in the im-
65 

•S 2493 IS 

1 portation of prescription drugs into the United 

2 States, or in the dispensing of such drugs; and 

3 ‘‘(2) any person that processes, packages, dis4 tributes, receives, holds, or transports a prescription 

5 drug imported under this subchapter. 

6 ‘‘(b) INSPECTION.— 

7 ‘‘(1) IN GENERAL.—If the Secretary has reason 

8 to believe that a prescription drug imported under 

9 this subchapter presents a risk to the public health, 

10 the drug importation facility, pharmacy, Internet 

11 pharmacy, or wholesaler that imports the prescrip12 tion drug, and each person that processes, packages, 

13 distributes, receives, holds, or transports the pre14 scription drug shall, at the request of an officer or 

15 employee duly designated by the Secretary, permit 

16 the officer or employee, upon presentation of appro17 priate credentials and a written notice to such phar18 macy or person, at reasonable times, within reason19 able limits and in a reasonable manner, to have ac20 cess to and copy all records relating to the prescrip21 tion drug that are needed to enable the Secretary to 

22 determine whether the prescription drug presents a 

23 risk to the public health. 

24 ‘‘(2) APPLICABILITY.—Paragraph (1) applies to 

25 all records maintained by or on behalf of the drug 
66 

•S 2493 IS 

1 importation facility, pharmacy, Internet pharmacy, 

2 or wholesaler or such other person in any format 

3 (including paper and electronic formats) and at any 

4 location. 

5 ‘‘(c) PROTECTION OF SENSITIVE INFORMATION.— 

6 The Secretary shall take appropriate measures to ensure 

7 that there are in effect effective procedures to prevent the 

8 unauthorized disclosure of any trade secret or confidential 

9 information that is obtained by the Secretary under this 

10 section or any commercial or financial information that 

11 is privileged or confidential. 

12 ‘‘(d) EFFECT OF SECTION.—Nothing in this section 

13 applies to a prescription drug imported by an individual 

14 under section 812 or to a commercial transaction con15 ducted between an Internet pharmacy and an individual.’’. 

16 SEC. 10. ADVANCE NOTICE OF IMPORTED PRESCRIPTION 

17 DRUG SHIPMENTS. 

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

19 Drug, and Cosmetic Act (as amended by section 8(b)) is 

20 amended by adding at the end the following: 

21 ‘‘(u) ADVANCE NOTICE OF IMPORTED PRESCRIPTION

22 DRUG SHIPMENTS.— 

23 ‘‘(1) IN GENERAL.—For purposes of enabling 

24 the Secretary to inspect at ports of entry a prescrip25 tion drug that is being imported or offered for im-
67 

•S 2493 IS 

1 portation into the United States, the person import2 ing or offering for importation the prescription drug 

3 shall, in advance, provide to the Secretary a notice 

4 that includes— 

5 ‘‘(A) the established name (as defined by 

6 section 502(e)), dosage form, and quantity of 

7 the prescription drug; 

8 ‘‘(B) the name of the shipper of the pre9 scription drug; 

10 ‘‘(C) the name of the country from which 

11 the prescription drug originates; 

12 ‘‘(D) the country from which the prescrip13 tion drug is shipped; 

14 ‘‘(E) the name of the port of entry of the 

15 prescription drug; 

16 ‘‘(F) documentation from the drug impor17 tation facility located in Canada or a permitted 

18 country specifying— 

19 ‘‘(i) the original source of the pre20 scription drug; and 

21 ‘‘(ii) the quantity of each lot of the 

22 prescription drug originally received by the 

23 facility from that source; 
68 

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1 ‘‘(G) the lot or control number assigned to 

2 the prescription drug by the manufacturer of 

3 the prescription drug; 

4 ‘‘(H) the name, address, telephone num5 ber, and professional license number of the 

6 drug importation facility located in Canada or 

7 a permitted country; and 

8 ‘‘(I) certification from the drug importa9 tion facility located in a foreign country or from 

10 the manufacturer of the prescription drug that 

11 the prescription drug— 

12 ‘‘(i) is approved for marketing in the 

13 United States and is not adulterated or 

14 misbranded; and 

15 ‘‘(ii) meets all labeling requirements 

16 under this Act. 

17 ‘‘(2) REFUSAL OF ADMISSION.—A prescription 

18 drug imported or offered for importation without 

19 submission of a notice under paragraph (1) shall be 

20 refused admission into the United States. 

21 ‘‘(3) PERIOD OF ADVANCE NOTICE.—The pe22 riod in which the notice under paragraph (1) is re23 quired to be made in advance of the time of the im24 portation of a prescription drug or the offering of a 
69 

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1 prescription drug for importation shall be not less 

2 than 24 hours and not more than 5 days. 

3 ‘‘(4) FAILURE TO PROVIDE NOTICE.— 

4 ‘‘(A) IN GENERAL.—If a prescription drug 

5 is being imported or offered for importation 

6 into the United States and notice is not pro7 vided in advance in accordance with paragraph 

8 (1), the prescription drug shall be held at the 

9 port of entry for the prescription drug, and may 

10 not be delivered to the importer, owner, or con11 signee of the prescription drug, until the notice 

12 is submitted to the Secretary and the Secretary 

13 examines the notice and determines that the no14 tice is in accordance with the requirements 

15 under paragraph (1). 

16 ‘‘(5) EFFECT OF BONDING PROVISION.—Sub17 section (b) does not authorize the delivery of a pre18 scription drug pursuant to the execution of a bond 

19 while the prescription drug is held under this sub20 section. 

21 ‘‘(6) REMOVAL.—A prescription drug held 

22 under this subsection shall be removed to a secure 

23 facility, as appropriate. 

24 ‘‘(7) NO TRANSFER.—During a period in which 

25 a prescription drug is held under this subsection, the 
70 

•S 2493 IS 

1 prescription drug shall not be transferred by any 

2 person from the port of entry into the United States 

3 for the article or from the secure facility to which 

4 the prescription drug has been removed. 

5 ‘‘(8) EFFECT OF SUBSECTION.— 

6 ‘‘(A) AUTHORITY.—This subsection does 

7 not limit the authority of the Secretary to ob8 tain information under any other provision of 

9 this Act. 

10 ‘‘(B) IMPORTATION BY INDIVIDUALS.— 

11 Nothing in this subsection applies to a prescrip12 tion drug imported by an individual under sec13 tion 812 or to a commercial transaction con14 ducted between an Internet pharmacy and an 

15 individual.’’. 

16 (b) PROHIBITED ACT.—Section 301 of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 331) (as 

18 amended by section 8(c)) is amended by adding at the end 

19 the following: 

20 ‘‘(pp) The failure to submit prior notice of the impor21 tation of a prescription drug in violation of section 

22 801(s).’’. 
71 

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1 SEC. 11. AUTHORITY TO MARK PRESCRIPTION DRUGS RE2 FUSED ADMISSION INTO THE UNITED 

3 STATES. 

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

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

6 section 10(a)) is amended by adding at the end the fol7 lowing: 

8 ‘‘(v) PRESCRIPTION DRUGS REFUSED ADMISSION.— 

9 ‘‘(1) IN GENERAL.—If a prescription drug has 

10 been refused admission under subsection (a), other 

11 than such a prescription drug that is required to be 

12 destroyed, the Secretary may require the owner or 

13 consignee of the prescription drug to affix to the 

14 container of the prescription drug a label that clear15 ly and conspicuously bears the statement: ‘UNITED 

16 STATES: REFUSED ENTRY’. 

17 ‘‘(2) EXPENSES.—All expenses in connection 

18 with affixing a label under paragraph (1)— 

19 ‘‘(A) shall be paid by the owner or con20 signee of the prescription drug; and 

21 ‘‘(B) in default of such payment, shall con22 stitute a lien against future importations made 

23 by the owner or consignee. 

24 ‘‘(3) EFFECTIVE PERIOD.—A requirement 

25 under paragraph (1) with respect to a prescription 

26 drug remains in effect until the Secretary deter-
72 

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1 mines that the prescription drug has been brought 

2 into compliance with this Act. 

3 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

4 subsection applies to a prescription drug imported 

5 by an individual under section 812 or to a commer6 cial transaction conducted between an Internet phar7 macy and an individual.’’. 

8 (b) MISBRANDED PRESCRIPTION DRUGS.—Section 

9 502 of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 352) is amended by adding at the end the fol11 lowing: 

12 ‘‘(w) If— 

13 ‘‘(1) it is a prescription drug refused admission 

14 into the United States that fails to bear a label re15 quired by the Secretary under section 801(v); 

16 ‘‘(2) the Secretary finds that the prescription 

17 drug presents a risk to the public health; and 

18 ‘‘(3) on or after notifying the owner or con19 signee of the prescription drug that the label is re20 quired under section 801(v), the Secretary informs 

21 the owner or consignee that the prescription drug 

22 presents such a risk.’’. 

23 (c) RULE OF CONSTRUCTION.—With respect to a 

24 prescription drug that is imported or offered for importa25 tion into the United States, nothing in this section limits 
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1 the authority of the Secretary of Health and Human Serv2 ices or the Secretary of the Treasury to require the mark3 ing of prescription drugs refused admission under any 

4 other provision of law. 

5 SEC. 12. PROHIBITION OF PORT SHOPPING. 

6 Section 502 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 352) (as amended by section 11(b)) is 

8 amended by adding at the end the following: 

9 ‘‘(x) PORT SHOPPING.— 

10 ‘‘(1) IN GENERAL.—If— 

11 ‘‘(A) it is a prescription drug imported or 

12 offered for importation into the United States; 

13 and 

14 ‘‘(B) the prescription drug has previously 

15 been refused admission under section 801(a); 

16 unless the person reoffering the prescription drug af17 firmatively establishes, at the expense of the owner 

18 or consignee of the prescription drug, that the pre19 scription drug complies with the applicable require20 ments of this Act, as determined by the Secretary. 

21 ‘‘(2) EFFECT OF PARAGRAPH.—Nothing in this 

22 paragraph applies to importation of a prescription 

23 drug under section 812 or to a commercial trans24 action conducted between an Internet pharmacy and 

25 an individual.’’. 
74 

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1 SEC. 13. AUTHORITY TO COMMISSION OTHER FEDERAL 

2 AND STATE OFFICIALS TO CONDUCT INSPEC3 TIONS. 

4 Section 702(a) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 372(a)) is amended— 

6 (1) by redesignating paragraphs (3) and (4) as 

7 paragraphs (5) and (6), respectively; and 

8 (2) inserting after paragraph (2) the following: 

9 ‘‘(3)(A) The Secretary, pursuant to a memo10 randum of understanding between the Secretary and 

11 the head of another Federal agency, may conduct 

12 examinations and investigations for the purposes of 

13 enforcing compliance with the amendments made by 

14 the Safe IMPORT Act of 2004 through the officers 

15 and employees of the other agency. 

16 ‘‘(B) A memorandum of understanding under 

17 subparagraph (A) shall include— 

18 ‘‘(i) provisions to ensure adequate training 

19 of officers and employees to conduct the exami20 nations and investigations; and 

21 ‘‘(ii) provisions regarding reimbursement 

22 that may, in the discretion of the head of the 

23 other agency, require reimbursement, in whole 

24 or in part, from the Secretary for the examina25 tions or investigations performed under this 
75 

•S 2493 IS 

1 paragraph by the officers or employees of the 

2 other agency. 

3 ‘‘(C) A memorandum of understanding under 

4 subparagraph (A) shall be effective only with respect 

5 to examinations or inspections at facilities or other 

6 locations that are jointly regulated by the Secretary 

7 and the other agency. 

8 ‘‘(D) Not later than 60 days after the end of 

9 each fiscal year in which the head a Federal agency 

10 carries out 1 or more examinations or inspections 

11 under a memorandum of understanding under sub12 paragraph (A), the Secretary and the agency head 

13 shall submit to the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate and to 

15 the Committee on Energy and Commerce of the 

16 House of Representatives, a report that discloses, 

17 for that year— 

18 ‘‘(i) the number of officers or employees 

19 that carried out 1 or more programs, projects, 

20 or activities under the memorandum of under21 standing; 

22 ‘‘(ii) the number of additional articles that 

23 were inspected or examined as a result of the 

24 memorandum of understanding; and 
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•S 2493 IS 

1 ‘‘(iii) the number of additional examina2 tions or investigations that were carried out 

3 pursuant to the memorandum of understanding. 

4 ‘‘(4)(A) The Secretary may enter into a con5 tract with a State to use the State Board of Phar6 macy personnel of the State to conduct examinations 

7 and inspection for the purpose of carrying out the 

8 amendments made by the Safe IMPORT Act of 

9 2004. 

10 ‘‘(B) A contract entered into under subpara11 graph (A) shall— 

12 ‘‘(i) ensure adequate training of officers 

13 and employees to conduct the examinations and 

14 investigations; and 

15 ‘‘(ii) be effective only with respect to ex16 aminations or inspections of drug importation 

17 facilities, pharmacies, Internet pharmacies, and 

18 wholesalers located in the State.’’. 

19 SEC. 14. USER FEES RELATING TO PRESCRIPTION DRUG 

20 IMPORTATION. 

21 Subchapter C of chapter VII of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 397f et seq.) is 

23 amended by adding at the end the following: 
77 

•S 2493 IS 

1 ‘‘PART 5—FEES RELATING TO PRESCRIPTION 

2 DRUG IMPORTATION 

3 ‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM4 PORTATION. 

5 ‘‘(a) REGISTRATION FEE.—The Secretary shall es6 tablish a user fee program under which a drug importation 

7 facility, pharmacy, Internet pharmacy, or wholesaler reg8 istering with the Secretary under section 814 shall be re9 quired to pay a fee to the Secretary. 

10 ‘‘(b) COLLECTION.— 

11 ‘‘(1) COLLECTION ON INITIAL REGISTRATION.— 

12 A fee under this section shall be payable for the fis13 cal year in which the drug importation facility, phar14 macy, Internet pharmacy, or wholesaler first reg15 isters under section 814 (or reregisters under that 

16 section if that person has withdrawn its registration 

17 and subsequently reregisters). 

18 ‘‘(2) COLLECTION IN SUBSEQUENT YEARS.— 

19 After the fee is paid for that fiscal year, the fee shall 

20 be payable on or before October 1 of each year. 

21 ‘‘(3) ONE FEE PER FACILITY.—The fee shall be 

22 paid only once for each drug importation facility, 

23 pharmacy, Internet pharmacy, or wholesaler reg24 istered for a fiscal year in which the fee is payable. 

25 ‘‘(c) FEE AMOUNT.—The amount of the fee shall be 

26 determined each year by the Secretary and shall be based 
78 

•S 2493 IS 

1 on the anticipated costs to the Secretary of enforcing the 

2 amendments made by the Safe IMPORT Act of 2004 in 

3 the subsequent fiscal year. 

4 ‘‘(d) USE OF FEES.—The fees collected under this 

5 section shall be used, without further appropriation, to en6 force the amendments made by the Safe IMPORT Act of 

7 2004. 

8 ‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 

9 establish, 60 days before the beginning of each fiscal year 

10 beginning after September 30, 2004, for that fiscal year, 

11 registration fees. 

12 ‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 

13 ‘‘(1) DUE DATE.—A fee payable under this sec14 tion shall be paid by the date that is 30 days after 

15 the date on which the fee is due. 

16 ‘‘(2) FAILURE TO PAY.—If a registered drug 

17 importation facility, pharmacy, Internet pharmacy, 

18 or wholesaler subject to a fee under this section fails 

19 to pay the fee, the Secretary shall not permit the 

20 drug importation facility pharmacy, Internet phar21 macy, or wholesaler to engage in importation or of22 fering for importation prescription drugs under this 

23 Act until all such fees owed by that person are paid. 

24 ‘‘(g) REPORTS.— 
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1 ‘‘(1) FEE ESTABLISHMENT.—Not later than 60 

2 days before each fiscal year, the Secretary shall— 

3 ‘‘(A) publish user fees under this section 

4 for that fiscal year; 

5 ‘‘(B) hold a meeting at which the public 

6 may comment on the recommendations; and 

7 ‘‘(C) provide for a period of 30 days for 

8 the public to provide written comments on the 

9 recommendations. 

10 ‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be11 ginning with fiscal year 2005, not later than 60 days 

12 after the end of each fiscal year during which fees 

13 are collected under this section, the Secretary shall 

14 submit to the Committee on Health, Education, 

15 Labor, and Pensions of the Senate and the Com16 mittee on Energy and Commerce of the House of 

17 Representatives a report that describes— 

18 ‘‘(A) implementation of the user fee au19 thority during the fiscal year; and 

20 ‘‘(B) the use by the Secretary of the fees 

21 collected during the fiscal year for which the re22 port is made.’’. 

23 SEC. 15. ANTICOUNTERFEITING PROVISIONS. 

24 (a) REQUIRED RECORDS.—Section 503(e) of the 

25 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) 
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1 is amended by striking paragraph (1) and inserting the 

2 following: ‘‘(1) A distributor of record that is engaged in 

3 the wholesale distribution of a drug subject to subsection 

4 (b), shall— 

5 ‘‘(A) before each wholesale distribution of the 

6 drug— 

7 ‘‘(i) with respect to each wholesale dis8 tribution of a drug subject to subsection (b), 

9 provide the person that receives the drug a 

10 statement that identifies the immediately pre11 vious distributor of record from which the drug 

12 was purchased; and 

13 ‘‘(ii) with respect to a drug subject to sub14 section (b) that is imported to the United 

15 States, provide the person that receives the 

16 drug a statement (in such form and containing 

17 such information as the Secretary may require) 

18 identifying each prior sale, purchase, or trade of 

19 the drug (including the date of transmission 

20 and the names and addresses of all parties to 

21 the transaction); and 

22 ‘‘(B) create, maintain for 2 years, and make 

23 available to the Secretary for inspection at reason24 able time, records that— 
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1 ‘‘(i) with respect to each wholesale dis2 tribution of a drug subject to subsection (b), 

3 identifies— 

4 ‘‘(I) the immediately previous dis5 tributor of record from which the drug was 

6 purchased; and 

7 ‘‘(II) the immediately subsequent dis8 tributor of record to which the drug was 

9 sold or otherwise transferred; and 

10 ‘‘(ii) with respect to a drug subject to sub11 section (b) that is imported to the United 

12 States, identifies— 

13 ‘‘(I) each previous distributor of 

14 record from which the drug was purchased 

15 or otherwise transferred; and 

16 ‘‘(II) each subsequent distributor of 

17 record to which the drug was sold or other18 wise transferred, to the extent feasible.’’. 

19 (b) ELECTRONIC TRACK AND TRACE TECH20 NOLOGY.—Not later than December 31, 2007, the Sec21 retary of Health and Human Services shall require the 

22 adoption and use of electronic track and trace technology 

23 for a prescription drug at the case and pallet level that 

24 will identify each sale, purchase, or trade of that case or 
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1 pallet (including the date of transmission and the names 

2 and addresses of all parties to the transaction) . 

3 (c) DISTRIBUTORS OF RECORD.—Section 503(e) of 

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

5 353(e)) is amended by striking paragraph (3) and insert6 ing the following: 

7 ‘‘(3) For the purposes of this subsection and sub8 section (d)— 

9 ‘‘(A) the term ‘distributor of record’— 

10 ‘‘(i) means a person that takes title to or 

11 possession of a drug subject to subsection (b) 

12 from manufacture to retail sale; 

13 ‘‘(ii) includes a person that manufacturers, 

14 processes, packs, distributes, receives, holds, 

15 imports, or offers for importation a drug sub16 ject to subsection (b); and 

17 ‘‘(iii) does not include a transporter; 

18 ‘‘(B) the term ‘transporter’ means the United 

19 States Postal Service, or equivalent governmental 

20 service of a foreign country, or a private carrier en21 gaged in the business of transporting packages for 

22 hire; and 

23 ‘‘(C) the term ‘wholesale distribution’ means 

24 the distribution of a drug subject to subsection (b) 

25 to other than the consumer or patient but not in-
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1 cluding an intracompany sale or distribution of a 

2 drug described in subsection (c)(3)(B).’’. 

3 (d) ANTICOUNTERFEITING PROGRAMS.—Section 

4 503(e) of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 353(e)) is amended by adding at the end the fol6 lowing: 

7 ‘‘(4) The Secretary shall— 

8 ‘‘(A) establish a network to be known as the 

9 ‘Counterfeit Alert Network’ for the purpose of pro10 viding prompt notification to health professionals 

11 and the public of counterfeit drugs subject to sub12 section (b); 

13 ‘‘(B)(i) develop and publish an Internet acces14 sible-reference document to facilitate the positive 

15 identification by health professionals and regulatory 

16 agency personnel of prescription drugs marketed in 

17 the United States and Canada; and 

18 ‘‘(ii) update the materials described under 

19 clause (i) quarterly and when a new permitted coun20 try is designated by the Secretary; 

21 ‘‘(C) develop and publish educational materials 

22 to health professionals and consumers identify and 

23 report cases of counterfeit drugs subject to sub24 section (b); 
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1 ‘‘(D) develop and publish secure business prac2 tice guidelines for the sale and distribution of such 

3 drugs in cooperation with members of a drug supply 

4 chain; and 

5 ‘‘(E) in cooperation with the National Associa6 tion of Boards of Pharmacy, develop and publish re7 vised model rules for licensure of drug wholesalers 

8 for adoption by the States.’’. 

9 SEC. 16. CONFORMING AMENDMENTS. 

10 (a) Section 1006 of the Controlled Substances Import 

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

12 (b) The Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 301 et seq.) is amended— 

14 (1) in section 301(aa)— 

15 (A) by striking ‘‘section 804’’ and insert16 ing ‘‘subchapter B of chapter VIII’’; and 

17 (B) by striking ‘‘such section’’ each place 

18 it appears and inserting ‘‘that subchapter’’; 

19 (2) in section 801(d)(1), by striking ‘‘section 

20 804’’ and inserting ‘‘subchapter B’’; and 

21 (3) by striking section 804. 

Æ