I 

108TH CONGRESS 

2D SESSION H. R. 4923

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 HOUSE OF REPRESENTATIVES 

JULY 22, 2004

Mr. BRADLEY of New Hampshire introduced the following bill; which was 

referred to the Committee on Energy and Commerce 

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 Prescription 

12 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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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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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 avoid, reduce, or mitigate such in11 creased 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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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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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 

24 ‘‘(ii) includes any fund transfer cov25 ered under Article 4A of the Uniform 
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1 Commercial Code, as in effect in any 

2 State. 

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

4 ‘financial institution’—

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

6 in section 903 of the Electronic Transfer 

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

8 ‘‘(ii) includes a financial institution 

9 (as defined in section 509 of the Gramm10 Leach-Bliley Act (15 U.S.C. 6809)). 

11 ‘‘(D) MONEY TRANSMITTING BUSINESS; 

12 MONEY TRANSMITTING SERVICE.—The terms 

13 ‘money transmitting business’ and ‘money 

14 transmitting service’ have the meaning given 

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

16 States Code. 

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

18 dispense or offer to dispense a prescription drug to a per19 son in the United States in accordance with this section. 

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

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

22 section an Internet pharmacy shall—

23 ‘‘(A) have its principal place of business in 

24 the United States, Canada, or a permitted 

25 country; and 
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1 ‘‘(B) be licensed by the Secretary in ac2 cordance with this section prior to dispensing a 

3 prescription drug to an individual. 

4 ‘‘(2) CONDITIONS FOR LICENSING.—

5 ‘‘(A) APPLICATION REQUIREMENTS.—An 

6 Internet pharmacy shall submit to the Sec7 retary an application that includes—

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

9 pharmacy located in the United States, 

10 verification that, in each State in which 

11 the Internet pharmacy engages in dis12 pensing or offering to dispense prescription 

13 drugs, the Internet pharmacy, and all em14 ployees and agents of the Internet phar15 macy, is in compliance with applicable 

16 Federal and State laws regarding—

17 ‘‘(aa) the practice of pharmacy, 

18 including licensing laws and inspec19 tion requirements; and 

20 ‘‘(bb) the manufacturing and dis21 tribution of controlled substances, in22 cluding with respect to mailing or 

23 shipping controlled substances to con24 sumers; or 
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1 ‘‘(II) in the case of an Internet phar2 macy located in Canada or a permitted 

3 country, verification that—

4 ‘‘(aa) all employees and agents of 

5 the Internet pharmacy are in compli6 ance with applicable laws of Canada 

7 or the permitted country regarding 

8 the practice of pharmacy, including li9 censing laws and inspection require10 ments; and 

11 ‘‘(bb) the Internet pharmacy is in 

12 compliance with applicable Federal 

13 and State laws regarding the practice 

14 of pharmacy, including licensing laws 

15 and inspection requirements; 

16 ‘‘(ii) verification that the person that 

17 owns the Internet pharmacy has not had a 

18 license for an Internet pharmacy termi19 nated by the Secretary, and that no other 

20 Internet pharmacy owned by the person 

21 has had a license under this subsection 

22 that has been terminated by the Secretary; 

23 ‘‘(iii) verification from the person that 

24 owns the Internet pharmacy that the per25 son will permit inspection of the facilities 
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1 and business practices of the Internet 

2 pharmacy by the Secretary to the extent 

3 necessary to determine whether the Inter4 net pharmacy is in compliance with this 

5 subsection; and 

6 ‘‘(iv) in the case of an agreement be7 tween a patient and an Internet pharmacy 

8 that releases the Internet pharmacy, and 

9 any employee or agent of the Internet 

10 pharmacy, from liability for damages aris11 ing out of the negligence of the Internet 

12 pharmacy, an assurance that such a limita13 tion of liability shall be null and void. 

14 ‘‘(B) IDENTIFICATION REQUIREMENTS.—

15 An Internet pharmacy shall provide to any per16 son that accesses the Internet pharmacy 

17 website, on each page of the website of the 

18 Internet pharmacy or by a link to a separate 

19 page, the following information: 

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

21 Code or comparable mail code, State (or 

22 comparable entity), country, and telephone 

23 number of—

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

25 Internet pharmacy; and 
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1 ‘‘(II) the name of the supervising 

2 pharmacist of the Internet pharmacy 

3 and each individual who serves as a 

4 pharmacist for purposes of the Inter5 net pharmacy website. 

6 ‘‘(ii) The names of all States or coun7 tries, as appropriate, in which the Internet 

8 pharmacy and the pharmacists employed 

9 by the Internet pharmacy are licensed or 

10 otherwise authorized to dispense prescrip11 tion drugs. 

12 ‘‘(iii) If the Internet pharmacy makes 

13 referrals to, or solicits on behalf of, a 

14 health care practitioner or group of practi15 tioners in the United States for prescrip16 tion services—

17 ‘‘(I) the name, street address, 

18 city, ZIP Code or comparable mail 

19 code, State, and telephone number of 

20 the practitioner or group; and 

21 ‘‘(II) the name of each State in 

22 which each practitioner is licensed or 

23 otherwise authorized to prescribe 

24 drugs. 
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1 ‘‘(iv) A statement that the Internet 

2 pharmacy will dispense prescription drugs 

3 only after receipt of a valid prescription. 

4 ‘‘(C) PROFESSIONAL SERVICES REQUIRE5 MENTS.—An Internet pharmacy shall carry out 

6 the following: 

7 ‘‘(i) Maintain patient medication pro8 files and other related data in a readily ac9 cessible format organized to facilitate con10 sultation with treating providers, care11 givers, and patients. 

12 ‘‘(ii) Conduct prospective drug use re13 views before dispensing medications or 

14 medical devices. 

15 ‘‘(iii) Ensure patient confidentiality 

16 and the protection of patient identity and 

17 patient-specific information, in accordance 

18 with the regulations promulgated under 

19 section 264(c) of the Health Insurance 

20 Portability and Accountability Act of 1996 

21 (42 U.S.C. 1320d–2 note). 

22 ‘‘(iv) Offer interactive and meaningful 

23 consultation by a licensed pharmacist to 

24 the caregiver or patient prior to and subse-
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1 quent to the time at which the Internet 

2 pharmacy dispenses the drug. 

3 ‘‘(v)(I) Establish a mechanism for pa4 tients to report errors and suspected ad5 verse drug reactions. 

6 ‘‘(II) Document in the reporting 

7 mechanism the response of the Internet 

8 pharmacy to those reports. 

9 ‘‘(vi) Develop a system to inform care10 givers and patients about drug recalls. 

11 ‘‘(vii) Educate caregivers and patients 

12 about the appropriate means of disposing 

13 of expired, damaged, or unusable medica14 tions. 

15 ‘‘(viii) Assure that the sale of a pre16 scription drug is in accordance with a pre17 scription from the treating provider of the 

18 individual. 

19 ‘‘(ix)(I) Verify the validity of the pre20 scription of an individual by using 1 of the 

21 following methods: 

22 ‘‘(aa) Receiving from the indi23 vidual or treating provider of the indi24 vidual the prescription of the indi25 vidual by mail (including a private 
28

•HR 4923 IH 

1 carrier), or receiving from the treating 

2 provider of the individual the prescrip3 tion of the individual by electronic 

4 mail. 

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

6 controlled substance (as defined in 

7 section 102 of the Controlled Sub8 stances Act (21 U.S.C. 802)), con9 firming with the treating provider the 

10 information in subclause (II). 

11 ‘‘(II) When seeking verification of a 

12 prescription of an individual under sub13 clause (I)(bb), an Internet pharmacy shall 

14 provide to the treating provider the fol15 lowing information: 

16 ‘‘(aa) The full name and address 

17 of the individual. 

18 ‘‘(bb) Identification of the pre19 scription drug. 

20 ‘‘(cc) The quantity of the pre21 scription drug to be dispensed. 

22 ‘‘(dd) The date on which the in23 dividual presented the prescription to 

24 the Internet pharmacy. 
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•HR 4923 IH 

1 ‘‘(ee) The date and time of the 

2 verification request. 

3 ‘‘(ff) The name of a contact per4 son at the Internet pharmacy, includ5 ing a voice telephone number, elec6 tronic mail address, and facsimile tele7 phone number. 

8 ‘‘(III) A prescription is verified under 

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

10 occurs: 

11 ‘‘(aa) The treating provider con12 firms, by direct communication with 

13 the Internet pharmacy, that the pre14 scription is accurate. 

15 ‘‘(bb) The treating provider in16 forms the Internet pharmacy that the 

17 prescription is inaccurate and provides 

18 the accurate prescription. 

19 ‘‘(IV) An Internet pharmacy shall not 

20 fill a prescription if—

21 ‘‘(aa) a treating provider informs 

22 the Internet pharmacy within 72 

23 hours after receipt of a communica24 tion under subclause (I)(bb) that the 
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•HR 4923 IH 

1 prescription is inaccurate or expired; 

2 or 

3 ‘‘(bb) the treating provider does 

4 not respond within that time. 

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

6 as the Secretary shall prescribe by regula7 tion, a record of all direct communications 

8 with a treating provider regarding the dis9 pensing of a prescription drug, including 

10 verification of the prescription. 

11 ‘‘(3) LICENSURE PROCEDURE.—

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

13 of a completed licensing application under para14 graph (3), the Secretary shall—

15 ‘‘(i) assign an identification number 

16 to each Internet pharmacy; 

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

18 of the licensure application; and 

19 ‘‘(iii) not later than 60 days after re20 ceipt of the licensure application, issue a li21 cense if the Internet pharmacy is in com22 pliance with conditions under paragraph 

23 (3). 

24 ‘‘(B) ELECTRONIC FILING.—
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•HR 4923 IH 

1 ‘‘(i) IN GENERAL.—For the purpose 

2 of reducing paperwork and reporting bur3 dens, the Secretary shall require the use of 

4 electronic methods of submitting to the 

5 Secretary a licensure application required 

6 under this section and provide for elec7 tronic methods of receiving the applica8 tions. 

9 ‘‘(ii) AUTHENTICATION.—In providing 

10 for the electronic submission of such licen11 sure applications under this section, the 

12 Secretary shall ensure that adequate au13 thentication protocols are used to allow 

14 identification of the Internet pharmacy and 

15 validation of the data as appropriate. 

16 ‘‘(4) LIST.—

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

18 compile, maintain, and periodically update a list 

19 of licensees. 

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

21 make the list described under subparagraph (A) 

22 and information submitted by the licensee 

23 under paragraph (2)(B) available to the public 

24 on an Internet website and through a toll-free 

25 telephone number. 
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•HR 4923 IH 

1 ‘‘(5) LICENSING FEE.—The Secretary shall es2 tablish a licensing fee that an Internet pharmacy li3 censed by the Secretary under this section shall be 

4 required to pay to the Secretary. 

5 ‘‘(A) COLLECTION.—

6 ‘‘(i) COLLECTION OF INITIAL YEAR LI7 CENSING FEE.—A licensing fee of $5,000 

8 shall be payable for the fiscal year in which 

9 the Internet pharmacy first submits a li10 censing application under this section. 

11 ‘‘(ii) COLLECTION IN SUBSEQUENT

12 YEARS.—After the licensing fee is paid for 

13 the first fiscal year, the fee, as modified 

14 under subparagraph (B), shall be payable 

15 on or before October 1 of each year. 

16 ‘‘(iii) ONE FEE PER INTERNET PHAR17 MACY.—The licensing fee shall be paid 

18 only once for each Internet pharmacy for 

19 a fiscal year in which the fee is payable. 

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

21 licensing fee shall be determined each year by 

22 the Secretary based on the anticipated costs to 

23 the Secretary of enforcing the requirements of 

24 this section in the subsequent fiscal year. 

25 ‘‘(C) ANNUAL FEE DETERMINATION.—
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•HR 4923 IH 

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

2 days before the beginning of each fiscal 

3 year beginning after September 30, 2004, 

4 the Secretary shall determine the licensing 

5 fee for that fiscal year. 

6 ‘‘(ii) PUBLICATION OF FEE

7 AMOUNT.—Not later than 60 days before 

8 each fiscal year, the Secretary shall publish 

9 the licensing fee under this section for that 

10 fiscal year and provide for a period of 30 

11 days for the public to provide written com12 ments on the fee. 

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

14 collected under this section shall be used, with15 out further appropriation, to carry out this sec16 tion. 

17 ‘‘(E) FAILURE TO PAY FEE.—

18 ‘‘(i) DUE DATE.—A licensing fee pay19 able under this section shall be paid by the 

20 date that is 30 days after the date on 

21 which the fee is due. 

22 ‘‘(ii) FAILURE TO PAY.—If an Inter23 net pharmacy subject to a fee under this 

24 section fails to pay the fee by the date 

25 specified under clause (i), the Secretary 
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•HR 4923 IH 

1 shall not permit the Internet pharmacy to 

2 engage in the dispensing of drugs as de3 scribed under this section until all such 

4 fees owed by the Internet pharmacy are 

5 paid. 

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

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

8 of each fiscal year during which licensing fees 

9 are collected under this section, the Secretary 

10 shall submit to the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the 

13 House of Representatives a report that de14 scribes—

15 ‘‘(i) implementation of the licensing 

16 fee authority during the fiscal year; and 

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

18 licensing fees collected during the fiscal 

19 year for which the report is made. 

20 ‘‘(6) TERMINATION OF LICENSE.—The Sec21 retary, upon the initiative of the Secretary, may ter22 minate a license issued under subsection (c), after 

23 notice to the Internet pharmacy and an opportunity 

24 for a hearing, and if the Secretary determines that 

25 an Internet pharmacy—
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•HR 4923 IH 

1 ‘‘(A) has demonstrated a pattern of non2 compliance with this section; 

3 ‘‘(B) has made an untrue statement of ma4 terial fact in its license application; or 

5 ‘‘(C) is in violation of any applicable Fed6 eral or State law relating to the dispensing of 

7 a prescription drug. 

8 ‘‘(7) RENEWAL EVALUATION.—

9 ‘‘(A) IN GENERAL.—Before renewing a li10 cense of an Internet pharmacy under this sub11 section pursuant to the submission of a renewal 

12 application, the Secretary shall conduct an eval13 uation to determine whether the Internet phar14 macy is in compliance with this section. 

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

16 the Secretary and as applicable, an evaluation 

17 under subparagraph (A) may include testing of 

18 the Internet pharmacy website or other systems 

19 through which the Internet pharmacy commu20 nicates with consumers, and a physical inspec21 tion of the records and premises of the phar22 macy. 

23 ‘‘(8) CONTRACT FOR OPERATION OF PRO24 GRAM.—
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•HR 4923 IH 

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

2 award a contract under this subsection for the 

3 operation of the licensing program. 

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

5 under subparagraph (A) shall not exceed 5 

6 years and may be renewable. 

7 ‘‘(C) PERFORMANCE REVIEW.—The Sec8 retary shall annually review performance under 

9 a contract under subparagraph (A). 

10 ‘‘(d) PROVIDERS OF INTERACTIVE COMPUTER SERV11 ICES OR ADVERTISING SERVICES.—A provider of inter12 active computer services (as defined in section 230(f) of 

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

14 an advertising service provider shall be liable under this 

15 section for dispensing or selling prescription drugs in vio16 lation of this section on account of another person’s selling 

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

18 service—

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

20 from an unlicensed Internet pharmacy; or 

21 ‘‘(2) accepts advertising stating that an indi22 vidual does not need a physician’s prescription to ob23 tain a prescription drug. 
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•HR 4923 IH 

1 ‘‘(e) POLICIES AND PROCEDURES REQUIRED TO

2 PREVENT PAYMENTS FOR UNLAWFUL INTERNET PHAR3 MACY REQUESTS.—

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

5 after the date of enactment of this section, the Fed6 eral functional regulators shall promulgate regula7 tions requiring a person described in subsection 

8 (a)(2) to prevent restricted transactions by estab9 lishing policies and procedures that—

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

11 the payment system and any person involved in 

12 the payment system to identify restricted trans13 actions by means of codes in authorization mes14 sages or by other means; and 

15 ‘‘(ii) are reasonably designed to block re16 stricted transactions identified as a result of the 

17 policies and procedures developed under clause 

18 (i); or 

19 ‘‘(B) prevent the acceptance of the prod20 ucts or services of the payment system in con21 nection with a restricted transaction. 

22 ‘‘(2) REQUIREMENTS FOR POLICIES AND PRO23 CEDURES.—In promulgating regulations under para24 graph (1), the Federal functional regulators shall—
38

•HR 4923 IH 

1 ‘‘(A) identify types of policies and proce2 dures, including nonexclusive examples, that 

3 shall be considered to be reasonably designed to 

4 identify and reasonably designed to block or to 

5 prevent the acceptance of the products or serv6 ices in connection with each type of restricted 

7 transaction, including—

8 ‘‘(i) identifying transactions by a code 

9 or codes in the authorization message; and 

10 ‘‘(ii) denying authorization of a credit 

11 card transaction in response to an author12 ization message; and 

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

14 participant in a designated payment system to 

15 choose among alternative means of identifying 

16 and blocking, or otherwise preventing the ac17 ceptance of the products or services of the des18 ignated payment system or participant in con19 nection with, restricted transactions. 

20 ‘‘(3) COMPLIANCE WITH PAYMENT SYSTEM

21 POLICIES AND PROCEDURES.—A person described in 

22 subsection (a)(2)(B) meets the requirement of para23 graph (1) if—

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

25 with the policies and procedures of a designated 
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•HR 4923 IH 

1 payment system of which the person is a mem2 ber or in which the person is a participant, to—

3 ‘‘(i) identify and block restricted 

4 transactions; or 

5 ‘‘(ii) otherwise prevent the acceptance 

6 of the products or services of the payment 

7 system, member, or participant in connec8 tion with restricted transactions; and 

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

10 designated payment system comply with the re11 quirements of regulations promulgated under 

12 paragraph (1). 

13 ‘‘(4) NO LIABILITY FOR BLOCKING OR REFUS14 ING TO HONOR RESTRICTED TRANSACTION.—A per15 son that is subject to a regulation or an order issued 

16 under this section and blocks or otherwise refuses to 

17 honor a restricted transaction (or a transaction that 

18 such person reasonably believes to be a restricted 

19 transaction) or as a member of a designated pay20 ment system, relies on the policies and procedures of 

21 the payment system in an effort to comply with reg22 ulations promulgated under this section, shall not be 

23 liable to any party for such action. 

24 ‘‘(5) ENFORCEMENT.—
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•HR 4923 IH 

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

2 enforced by the Federal functional regulators 

3 and the Federal Trade Commission under appli4 cable law in the manner provided in section 

5 505(a) of the Gramm-Leach-Bliley Act (21 

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

7 ‘‘(B) FACTORS TO BE CONSIDERED.—In 

8 considering any enforcement action under this 

9 subsection against a payment system or person 

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

11 functional regulators and the Federal Trade 

12 Commission shall consider the following factors: 

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

14 extending credit or transmitting funds 

15 knowing the transaction is in connection 

16 with an unlawful Internet pharmacy re17 quest. 

18 ‘‘(ii) The history of the person in ex19 tending credit or transmitting funds know20 ing the transaction is in connection with 

21 an unlawful Internet pharmacy request. 

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

23 has established and is maintaining policies 

24 and procedures in compliance with regula25 tions prescribed under this subsection. 
41

•HR 4923 IH 

1 ‘‘(iv) The feasibility that any specific 

2 remedy prescribed can be implemented by 

3 the person without substantial deviation 

4 from normal business practice. 

5 ‘‘(v) The costs and burdens the spe6 cific remedy will have on the person. 

7 ‘‘(f) REPORTS REGARDING INTERNET-RELATED VIO8 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

9 OF DRUGS.—The Secretary shall, pursuant to the submis10 sion of an application meeting criteria prescribed by the 

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

12 entity with experience in developing and maintaining sys13 tems for the purpose of—

14 ‘‘(1) identifying Internet pharmacy websites 

15 that are not licensed or that appear to be operating 

16 in violation of Federal or State laws concerning the 

17 dispensing of drugs; 

18 ‘‘(2) reporting such Internet pharmacy websites 

19 to State medical licensing boards and State phar20 macy licensing boards, and to the Attorney General 

21 and the Secretary, for further investigation; and 

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

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

24 the Secretary describing investigations undertaken 
42

•HR 4923 IH 

1 with respect to violations described in paragraph 

2 (1).’’. 

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

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

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

6 end the following: 

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

8 or operation of an Internet pharmacy, in violation of sec9 tion 511. 

10 ‘‘(jj) The representation by advertisement, sales pres11 entation, direct communication (including telephone, fac12 simile, or electronic mail), or otherwise by an Internet 

13 pharmacy, that a prescription drug may be obtained from 

14 the Internet pharmacy without a prescription, in violation 

15 of section 511. 

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

17 Internet pharmacy by the provider of an interactive com18 puter service, unless the provider has on file a copy of 

19 the license issued to the Internet pharmacy under section 

20 511.’’. 

21 (c) LINKS TO ILLEGAL INTERNET PHARMACIES.—

22 Section 302 of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 332) is amended by adding at the end the fol24 lowing: 
43

•HR 4923 IH 

1 ‘‘(c)(1) In the case of a violation of section 511 relat2 ing to an illegal Internet pharmacy, the district courts of 

3 the United States and the United States courts of the ter4 ritories shall have jurisdiction to order a provider of an 

5 interactive computer service to remove, or disable access 

6 to, a website violating that section that resides on a com7 puter server that the provider controls or operates. 

8 ‘‘(2) Relief under paragraph (1)—

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

10 the provider of notice and an opportunity to appear; 

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

12 provider to monitor its service or to affirmatively 

13 seek facts indicating activity violating section 511; 

14 and 

15 ‘‘(C) shall specify the provider to which the re16 lief applies.’’. 

17 (d) REGULATIONS.—

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

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

20 Health and Human Services shall promulgate in21 terim final regulations that are consistent with the 

22 Verified Internet Pharmacy Sites certification pro23 gram developed by the National Association of 

24 Boards of Pharmacy to carry out the amendments 

25 made by this section. 
44

•HR 4923 IH 

1 (2) EFFECTIVE DATE.—The requirement of li2 censure under section 511 of the Federal Food, 

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

4 shall take effect on the date determined by the Sec5 retary of Health and Human Services but in no 

6 event later than 90 days after the effective date of 

7 the interim final regulations under paragraph (1). 

8 (e) RETURN TO SENDER.—Section 801 of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) is 

10 amended by adding at the end the following: 

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

12 Internet pharmacy is not licensed by the Secretary in ac13 cordance with section 511, any shipment of a prescription 

14 drug from such an Internet pharmacy to an individual 

15 shall be refused admission into the United States and the 

16 Secretary shall return the prescription drug, other than 

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

18 the Internet pharmacy at the expense of the Internet phar19 macy. 

20 ‘‘(q) LICENSED INTERNET PHARMACY.—If a ship21 ment of a prescription drug from an Internet pharmacy 

22 licensed by the Secretary in accordance with section 511 

23 to an individual is refused admission into the United 

24 States, the Secretary shall—
45

•HR 4923 IH 

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

2 prescription drug that is required to be destroyed, to 

3 the Internet pharmacy at the expense of the Internet 

4 pharmacy; and 

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

6 pharmacy with a written notice that informs the in7 dividual and the Internet pharmacy of the refusal 

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

9 SEC. 5. ADMINISTRATIVE DETENTION AND TEMPORARY 

10 HOLD. 

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

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

13 added by section 9) the following: 

14 ‘‘SEC. 816. ADMINISTRATIVE DETENTION. 

15 ‘‘(a) ADMINISTRATIVE DETENTION OF PRESCRIP16 TION DRUGS.—

17 ‘‘(1) DETENTION AUTHORITY.—

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

19 employee of the Food and Drug Administration 

20 may order the detention, in accordance with 

21 this subsection, of any prescription drug that is 

22 found during an inspection, examination, or in23 vestigation under this Act conducted by the of24 ficer or qualified employee, if the officer or 

25 qualified employee has credible evidence or in-
46

•HR 4923 IH 

1 formation indicating that the prescription drug 

2 presents a risk to the public health. 

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

4 may be detained under subparagraph (A) only 

5 if the Secretary or an official designated by the 

6 Secretary approves the order of detention. 

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

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

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

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

11 to enable the Secretary to commence an action 

12 under this subsection or section 302. 

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

14 ‘‘(A) IN GENERAL.—An order under para15 graph (1) with respect to a prescription drug—

16 ‘‘(i) may require that the prescription 

17 drug be labeled or marked as detained; and 

18 ‘‘(ii) shall require that the prescrip19 tion drug be removed to a secure facility, 

20 as appropriate. 

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

22 subject to an order under paragraph (1) shall 

23 not be transferred by any person from the place 

24 at which the prescription drug is ordered de25 tained or from the place to which the prescrip-
47

•HR 4923 IH 

1 tion drug is removed, until released by the Sec2 retary or until the expiration of the detention 

3 period applicable under the order, whichever oc4 curs first. 

5 ‘‘(C) EFFECT OF PARAGRAPH.—This para6 graph does not authorize the delivery of a pre7 scription drug pursuant to the execution of a 

8 bond while the prescription drug is subject to 

9 an order under paragraph (1). 

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

11 Section 801(b) does not authorize the delivery 

12 of a prescription drug pursuant to the execution 

13 of a bond while the prescription drug is subject 

14 to an order under paragraph (1). 

15 ‘‘(4) APPEAL OF DETENTION ORDER.—

16 ‘‘(A) IN GENERAL.—With respect to a pre17 scription drug detained under paragraph (1), 

18 any person that would be entitled to be a claim19 ant for the prescription drug if the prescription 

20 drug were seized under paragraph (1) may ap21 peal the order of detention to the Secretary. 

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

23 later than 5 days after an appeal is filed, the 

24 Secretary, after providing opportunity for an in25 formal hearing, shall confirm or terminate the 
48

•HR 4923 IH 

1 order, and confirmation by the Secretary shall 

2 be considered to be a final agency action for 

3 purposes of section 702 of title 5, United States 

4 Code. 

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

6 day period specified in subparagraph (B), the 

7 Secretary fails to provide an opportunity for 

8 hearing or to confirm or terminate the order, 

9 the order shall be deemed to be terminated. 

10 ‘‘(D) EFFECT OF COMMENCEMENT OF

11 COURT ACTION.—The process under this para12 graph for the appeal of an order under para13 graph (1) with respect to a prescription drug 

14 terminates if the Secretary commences an ac15 tion under subsection (a) or section 302 regard16 ing the prescription drug. 

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

18 applies to a prescription drug imported by an individual 

19 under section 812 or to a commercial transaction con20 ducted between an Internet pharmacy and an individual.’’. 

21 (b) TEMPORARY HOLD AT PORT OF ENTRY.—Sec22 tion 801 of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 381) (as amended by section 4(e)) is amended 

24 by adding at the end the following: 

25 ‘‘(r) TEMPORARY HOLD AT PORT OF ENTRY.—
49

•HR 4923 IH 

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

2 employee of the Food and Drug Administration has 

3 credible evidence or information indicating that a 

4 prescription drug presents a risk to the public 

5 health, and the officer or qualified employee is un6 able to inspect, examine, or investigate the prescrip7 tion drug upon the prescription drug’s being offered 

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

9 the officer or qualified employee shall request the 

10 Secretary of the Treasury to hold the prescription 

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

12 time, not to exceed 24 hours, for the purpose of ena13 bling the Secretary to inspect, examine, or inves14 tigate the prescription drug as appropriate. 

15 ‘‘(2) APPROVAL.—

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

17 employee of the Food and Drug Administration 

18 may make a request under paragraph (1) only 

19 if the Secretary or an official designated by the 

20 Secretary approves the request. 

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

22 designated under subparagraph (A) unless the 

23 official is the director of the district under this 

24 Act in which the prescription drug is located, or 

25 is an official senior to that director. 
50

•HR 4923 IH 

1 ‘‘(3) NOTIFICATION.—With respect to a pre2 scription drug for which a request under paragraph 

3 (1) is made, the Secretary, promptly after the re4 quest is made, shall notify the State in which the 

5 port of entry involved is located that the request has 

6 been made, and as applicable, that the prescription 

7 drug, is being held under this subsection. 

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

9 under paragraph (1) shall be removed to a secure fa10 cility, as appropriate. 

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

12 which a prescription drug is held under this sub13 section, the prescription drug shall not be trans14 ferred by any person from the port of entry into the 

15 United States for the prescription drug or from the 

16 secure facility to which the prescription drug has 

17 been removed. 

18 ‘‘(6) EFFECT OF BONDING PROVISION.—Sub19 section (b) does not authorize the delivery of a pre20 scription drug held under this subsection pursuant 

21 to the execution of a bond while the prescription 

22 drug is held under this subsection. 

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

24 subsection applies to a prescription drug imported 

25 by an individual under section 812 or to a commer-
51

•HR 4923 IH 

1 cial transaction conducted between an Internet phar2 macy and an individual.’’. 

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

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

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

6 end the following: 

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

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

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

10 prescription drug as detained.’’. 

11 SEC. 6. SUSPENSION. 

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

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

14 added by section 5) the following: 

15 ‘‘SEC. 817. SUSPENSION OF IMPORTATION. 

16 ‘‘(a) PRESCRIPTION DRUG.—If the Secretary deter17 mines that the importation of a particular prescription 

18 drug or particular dosage form of a prescription drug into 

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

20 Secretary may immediately order the suspension of the 

21 importation of the particular prescription drug or par22 ticular dosage form of the prescription drug. 

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

24 a drug importation facility, pharmacy, Internet pharmacy, 

25 or wholesaler is engaged in a pattern of importing or offer-
52

•HR 4923 IH 

1 ing for importation a prescription drug into the United 

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

3 the Secretary may immediately order the suspension of 

4 that person from engaging in the importation or offering 

5 for importation of prescription drugs into the United 

6 States. 

7 ‘‘(c) CANADA OR PERMITTED COUNTRY.—If the Sec8 retary determines that there is a pattern of prescription 

9 drugs being imported or offered for importation into the 

10 United States from Canada or a permitted country in vio11 lation of any of the requirements of this Act, the Secretary 

12 may immediately order the suspension of the importation 

13 or offering for importation into the United States of pre14 scription drugs from Canada or that permitted country, 

15 as appropriate. 

16 ‘‘(d) APPEAL OF SUSPENSION ORDER.—

17 ‘‘(1) IN GENERAL.—

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

19 to the importation of a prescription drug, the 

20 importation of which is suspended under sub21 section (a), any person that would be entitled to 

22 be a claimant for the prescription drug may ap23 peal the suspension order to the Secretary. 

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

25 to a drug importation facility, pharmacy, Inter-
53

•HR 4923 IH 

1 net pharmacy, or wholesaler subject to a sus2 pension order under subsection (b) or (c), the 

3 drug importation facility, pharmacy, Internet 

4 pharmacy or wholesaler may appeal the suspen5 sion order to the Secretary. 

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

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

8 after providing opportunity for an informal hearing, 

9 shall confirm or terminate the order. 

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

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

12 to provide an opportunity for a hearing or to con13 firm or terminate the order, the order shall be 

14 deemed to be terminated. 

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

16 section shall not be subject to judicial review. 

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

18 applies to a prescription drug imported by an individual 

19 under section 812 or to a commercial transaction con20 ducted between an Internet pharmacy and an individual.’’. 

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

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

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

24 the following: 
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•HR 4923 IH 

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

2 of a prescription drug in violation of an order under sec3 tion 817.’’. 

4 SEC. 7. DEBARMENT FOR REPEATED OR SERIOUS PRE5 SCRIPTION DRUG IMPORTATION VIOLA6 TIONS. 

7 (a) DEBARMENT AUTHORITY.—

8 (1) PERMISSIVE DEBARMENT.—Section 

9 306(b)(1) of the Federal Food, Drug, and Cosmetic 

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

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

12 at the end; 

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

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

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

16 ‘‘(D) a person from importing a prescrip17 tion drug or offering a prescription drug for im18 portation into the United States.’’. 

19 (2) AMENDMENT REGARDING DEBARMENT

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

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

22 amended—

23 (A) by redesignating paragraph (4) as 

24 paragraph (5); and 
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1 (B) by inserting after paragraph (3) the 

2 following: 

3 ‘‘(4) PERSONS SUBJECT TO PERMISSIVE DE4 BARMENT; PRESCRIPTION DRUG IMPORTATION.—

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

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

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

8 a felony for conduct relating to the impor9 tation into the United States of any pre10 scription drug; or 

11 ‘‘(ii) the person has engaged in a pat12 tern of importing or offering for import a 

13 prescription drug that presents a risk to 

14 the public health. 

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

16 in this paragraph applies to a prescription drug 

17 imported by an individual under section 812 or 

18 to a commercial transaction conducted between 

19 an Internet pharmacy and an individual.’’. 

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

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

22 is amended—

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

24 heading and inserting the following: 
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•HR 4923 IH 

1 ‘‘(b) PERMISSIVE DEBARMENT; CERTAIN DRUG AP2 PLICATIONS; IMPORTS.—’’; 

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

4 ‘‘paragraph (2) or (3) of subsection (b)’’ and insert5 ing ‘‘paragraph (2), (3), or (4) of subsection (b)’’; 

6 and 

7 (3) in subsection (d)(3)—

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

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

10 inserting ‘‘paragraph (2)(A), (3), or (4) of sub11 section (b)’’; 

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

13 (B), by striking ‘‘or subsection (b)(3)’’ and in14 serting ‘‘paragraph (3) or (4) of subsection 

15 (b)’’; and 

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

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

18 may be’’ and inserting ‘‘, or the food or pre19 scription drug importation process, as the case 

20 may be’’. 

21 (c) EFFECTIVE DATE.—Section 306(l)(2) of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) 

23 is amended—
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1 (1) in the first sentence, by striking ‘‘and sub2 section (b)(3)(A)’’ and inserting ‘‘subsection 

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

4 (2) in the second sentence, by inserting ‘‘, sub5 section (b)(4)(B),’’ after ‘‘subsection (b)(3)(B)’’. 

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

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

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

9 end the following: 

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

11 the United States of a prescription drug by, with the as12 sistance of, or at the direction of a person debarred under 

13 section 306(b)(4).’’. 

14 (e) IMPORTATION BY DEBARRED PERSONS.—Section 

15 801 of the Federal Food, Drug, and Cosmetic Act (21 

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

17 adding at the end the following: 

18 ‘‘(s) IMPORTATION OF PRESCRIPTION DRUGS BY

19 DEBARRED PERSONS.—

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

21 imported or offered for importation into the United 

22 States, and the importer, owner, or consignee of the 

23 prescription drug is a person that has been debarred 

24 under section 306(b)(4), the prescription drug—
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1 ‘‘(A) shall be held at the port of entry for 

2 the prescription drug; and 

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

4 ‘‘(2) EFFECT OF BONDING PROVISION.—Sub5 section (b) does not authorize the delivery of a pre6 scription drug pursuant to the execution of a bond 

7 while the prescription drug is held under this sub8 section. 

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

10 under this subsection shall be removed to a secure 

11 facility, as appropriate. 

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

13 a prescription drug is held under this subsection, the 

14 prescription drug shall not be transferred by any 

15 person from the port of entry into the United States 

16 for the prescription drug or from the secure facility 

17 to which the prescription drug has been removed. 

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

19 drug held under this subsection may be delivered to 

20 a person that is not a debarred person under section 

21 306(b)(4) if the person affirmatively establishes, at 

22 the expense of the person, that the prescription drug 

23 complies with the requirements of this Act, as deter24 mined by the Secretary.’’. 
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1 SEC. 8. REGISTRATION OF PRESCRIPTION DRUG IMPORTA2 TION FACILITIES. 

3 (a) REGISTRATION OF CERTAIN IMPORTERS.—The 

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

5 adding after section 813 (as added by section 2) the fol6 lowing: 

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

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

9 pharmacy, Internet pharmacy, or wholesaler engaged in 

10 the importation or offering for importation of prescription 

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

12 drugs, shall register with the Secretary in accordance with 

13 this section. 

14 ‘‘(b) REGISTRATION.—

15 ‘‘(1) IN GENERAL.—To register, the owner, op16 erator, or agent in charge of a drug importation fa17 cility, pharmacy, Internet pharmacy, or wholesaler 

18 shall submit to the Secretary a registration that dis19 closes—

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

21 importation facility, pharmacy, Internet phar22 macy, or wholesaler at which, and all trade 

23 names under which, the registrant conducts 

24 business; 

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

26 be imported into the United States by each 
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1 drug importation facility, pharmacy, Internet 

2 pharmacy, or wholesaler; and 

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

4 service of process in the United States. 

5 ‘‘(2) CHANGE IN INFORMATION.—The reg6 istrant shall notify the Secretary in a timely manner 

7 of any change in the information provided under 

8 paragraph (1). 

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

10 after receipt of a completed registration under para11 graph (1), the Secretary shall—

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

13 registered drug importation facility, pharmacy, 

14 Internet pharmacy, and wholesaler; and 

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

16 the registration. 

17 ‘‘(4) LIST.—

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

19 compile, maintain, and periodically update a list 

20 of registrants. 

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

22 make the list described under subparagraph (A) 

23 and information submitted by a registrant 

24 under paragraph (1) available to the public on 
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1 an Internet website and through a toll-free tele2 phone number. 

3 ‘‘(c) ELECTRONIC FILING.—

4 ‘‘(1) IN GENERAL.—For the purpose of reduc5 ing paperwork and reporting burdens, the Secretary 

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

7 methods of submitting to the Secretary registrations 

8 required under this section and shall provide for 

9 electronic methods of receiving the registrations. 

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

11 electronic submission of such registrations under 

12 this section, the Secretary shall ensure that ade13 quate authentication protocols are used to allow 

14 identification of the registrant and validation of the 

15 data as appropriate. 

16 ‘‘(d) EFFECT OF SECTION.—

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

18 authorizes the Secretary to require an applica19 tion, review, or licensing process for a drug im20 portation facility, pharmacy, or wholesaler. 

21 ‘‘(2) IMPORTATION BY INDIVIDUALS.—

22 Nothing in this section applies to a prescription 

23 drug imported by an individual under section 

24 812 or to a commercial transaction conducted 
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1 between an Internet pharmacy and an indi2 vidual.’’. 

3 (b) REGULATIONS.—

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

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

6 Health and Human Services shall promulgate regu7 lations to carry out section 814 of the Federal Food, 

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

9 (2) EFFECTIVE DATE.—The requirement of 

10 registration under section 814 of the Federal Food, 

11 Drug, and Cosmetic Act takes effect—

12 (A) on the effective date of the final regu13 lations under paragraph (1); or 

14 (B) if the final regulations have not been 

15 made effective as of the expiration of that pe16 riod, on the date that is 1 year after the date 

17 of enactment of this Act, subject to compliance 

18 with the final regulations when the final regula19 tions are made effective. 

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

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

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

23 adding at the end the following: 

24 ‘‘(t) FAILURE TO REGISTER.—
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1 ‘‘(1) IN GENERAL.—If a drug importation facil2 ity, pharmacy, Internet pharmacy, or wholesaler en3 gaged in the importation or offering for importation 

4 of prescription drugs into the United States has not 

5 submitted a registration to the Secretary in accord6 ance with section 814, a prescription drug that is 

7 being imported or offered for importation into the 

8 United States shall not be delivered to the importer, 

9 owner, or consignee of the prescription drug until 

10 the drug importation facility, pharmacy, Internet 

11 pharmacy, or wholesaler is registered in accordance 

12 with section 814. 

13 ‘‘(2) EFFECT OF SUBSECTION (B).—Subsection 

14 (b) does not authorize the delivery of the prescrip15 tion drug pursuant to the execution of a bond while 

16 the prescription drug is held under this subsection. 

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

18 under this subsection shall be removed to a secure 

19 facility, as appropriate. 

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

21 which a prescription drug is held under this sub22 section, the prescription drug shall not be trans23 ferred by any person from the port of entry into the 

24 United States for the prescription drug or from the 
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1 secure facility to which the prescription drug has 

2 been removed.’’. 

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

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

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

6 end the following: 

7 ‘‘(oo) The failure of a drug importation facility, phar8 macy, Internet pharmacy, or wholesaler engaged in the 

9 importation or offering for importation of prescription 

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

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

12 SEC. 9. MAINTENANCE AND INSPECTION OF RECORDS FOR 

13 PRESCRIPTION DRUGS. 

14 The Federal Food, Drug, and Cosmetic Act is amend15 ed by adding after section 814 (as added by section 8) 

16 the following: 

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

18 FOR PRESCRIPTION DRUGS. 

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

20 establish requirements relating to the establishment and 

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

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

23 Internet pharmacy, or wholesaler engaged in the im24 portation of prescription drugs into the United 

25 States, or in the dispensing of such drugs; and 
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1 ‘‘(2) any person that processes, packages, dis2 tributes, receives, holds, or transports a prescription 

3 drug imported under this subchapter. 

4 ‘‘(b) INSPECTION.—

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

6 to believe that a prescription drug imported under 

7 this subchapter presents a risk to the public health, 

8 the drug importation facility, pharmacy, Internet 

9 pharmacy, or wholesaler that imports the prescrip10 tion drug, and each person that processes, packages, 

11 distributes, receives, holds, or transports the pre12 scription drug shall, at the request of an officer or 

13 employee duly designated by the Secretary, permit 

14 the officer or employee, upon presentation of appro15 priate credentials and a written notice to such phar16 macy or person, at reasonable times, within reason17 able limits and in a reasonable manner, to have ac18 cess to and copy all records relating to the prescrip19 tion drug that are needed to enable the Secretary to 

20 determine whether the prescription drug presents a 

21 risk to the public health. 

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

23 all records maintained by or on behalf of the drug 

24 importation facility, pharmacy, Internet pharmacy, 

25 or wholesaler or such other person in any format 
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1 (including paper and electronic formats) and at any 

2 location. 

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

4 The Secretary shall take appropriate measures to ensure 

5 that there are in effect effective procedures to prevent the 

6 unauthorized disclosure of any trade secret or confidential 

7 information that is obtained by the Secretary under this 

8 section or any commercial or financial information that 

9 is privileged or confidential. 

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

11 applies to a prescription drug imported by an individual 

12 under section 812 or to a commercial transaction con13 ducted between an Internet pharmacy and an individual.’’. 

14 SEC. 10. ADVANCE NOTICE OF IMPORTED PRESCRIPTION 

15 DRUG SHIPMENTS. 

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

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

18 amended by adding at the end the following: 

19 ‘‘(u) ADVANCE NOTICE OF IMPORTED PRESCRIPTION

20 DRUG SHIPMENTS.—

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

22 the Secretary to inspect at ports of entry a prescrip23 tion drug that is being imported or offered for im24 portation into the United States, the person import25 ing or offering for importation the prescription drug 
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1 shall, in advance, provide to the Secretary a notice 

2 that includes—

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

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

5 the prescription drug; 

6 ‘‘(B) the name of the shipper of the pre7 scription drug; 

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

9 the prescription drug originates; 

10 ‘‘(D) the country from which the prescrip11 tion drug is shipped; 

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

13 prescription drug; 

14 ‘‘(F) documentation from the drug impor15 tation facility located in Canada or a permitted 

16 country specifying—

17 ‘‘(i) the original source of the pre18 scription drug; and 

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

20 prescription drug originally received by the 

21 facility from that source; 

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

23 the prescription drug by the manufacturer of 

24 the prescription drug; 
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1 ‘‘(H) the name, address, telephone num2 ber, and professional license number of the 

3 drug importation facility located in Canada or 

4 a permitted country; and 

5 ‘‘(I) certification from the drug importa6 tion facility located in a foreign country or from 

7 the manufacturer of the prescription drug that 

8 the prescription drug—

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

10 United States and is not adulterated or 

11 misbranded; and 

12 ‘‘(ii) meets all labeling requirements 

13 under this Act. 

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

15 drug imported or offered for importation without 

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

17 refused admission into the United States. 

18 ‘‘(3) PERIOD OF ADVANCE NOTICE.—The pe19 riod in which the notice under paragraph (1) is re20 quired to be made in advance of the time of the im21 portation of a prescription drug or the offering of a 

22 prescription drug for importation shall be not less 

23 than 24 hours and not more than 5 days. 

24 ‘‘(4) FAILURE TO PROVIDE NOTICE.—
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1 ‘‘(A) IN GENERAL.—If a prescription drug 

2 is being imported or offered for importation 

3 into the United States and notice is not pro4 vided in advance in accordance with paragraph 

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

6 port of entry for the prescription drug, and may 

7 not be delivered to the importer, owner, or con8 signee of the prescription drug, until the notice 

9 is submitted to the Secretary and the Secretary 

10 examines the notice and determines that the no11 tice is in accordance with the requirements 

12 under paragraph (1). 

13 ‘‘(5) EFFECT OF BONDING PROVISION.—Sub14 section (b) does not authorize the delivery of a pre15 scription drug pursuant to the execution of a bond 

16 while the prescription drug is held under this sub17 section. 

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

19 under this subsection shall be removed to a secure 

20 facility, as appropriate. 

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

22 a prescription drug is held under this subsection, the 

23 prescription drug shall not be transferred by any 

24 person from the port of entry into the United States 
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1 for the article or from the secure facility to which 

2 the prescription drug has been removed. 

3 ‘‘(8) EFFECT OF SUBSECTION.—

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

5 not limit the authority of the Secretary to ob6 tain information under any other provision of 

7 this Act. 

8 ‘‘(B) IMPORTATION BY INDIVIDUALS.—

9 Nothing in this subsection applies to a prescrip10 tion drug imported by an individual under sec11 tion 812 or to a commercial transaction con12 ducted between an Internet pharmacy and an 

13 individual.’’. 

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

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

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

17 the following: 

18 ‘‘(pp) The failure to submit prior notice of the impor19 tation of a prescription drug in violation of section 

20 801(s).’’. 

21 SEC. 11. AUTHORITY TO MARK PRESCRIPTION DRUGS RE22 FUSED ADMISSION INTO THE UNITED 

23 STATES. 

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

25 Drug, and Cosmetic Act (21 U.S.C. 381) (as amended by 
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1 section 10(a)) is amended by adding at the end the fol2 lowing: 

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

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

5 been refused admission under subsection (a), other 

6 than such a prescription drug that is required to be 

7 destroyed, the Secretary may require the owner or 

8 consignee of the prescription drug to affix to the 

9 container of the prescription drug a label that clear10 ly and conspicuously bears the statement: ‘UNITED 

11 STATES: REFUSED ENTRY’. 

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

13 with affixing a label under paragraph (1)—

14 ‘‘(A) shall be paid by the owner or con15 signee of the prescription drug; and 

16 ‘‘(B) in default of such payment, shall con17 stitute a lien against future importations made 

18 by the owner or consignee. 

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

20 under paragraph (1) with respect to a prescription 

21 drug remains in effect until the Secretary deter22 mines that the prescription drug has been brought 

23 into compliance with this Act. 

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

25 subsection applies to a prescription drug imported 
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1 by an individual under section 812 or to a commer2 cial transaction conducted between an Internet phar3 macy and an individual.’’. 

4 (b) MISBRANDED PRESCRIPTION DRUGS.—Section 

5 502 of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 352) is amended by adding at the end the fol7 lowing: 

8 ‘‘(w) If—

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

10 into the United States that fails to bear a label re11 quired by the Secretary under section 801(v); 

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

13 drug presents a risk to the public health; and 

14 ‘‘(3) on or after notifying the owner or con15 signee of the prescription drug that the label is re16 quired under section 801(v), the Secretary informs 

17 the owner or consignee that the prescription drug 

18 presents such a risk.’’. 

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

20 prescription drug that is imported or offered for importa21 tion into the United States, nothing in this section limits 

22 the authority of the Secretary of Health and Human Serv23 ices or the Secretary of the Treasury to require the mark24 ing of prescription drugs refused admission under any 

25 other provision of law. 
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1 SEC. 12. PROHIBITION OF PORT SHOPPING. 

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

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

4 amended by adding at the end the following: 

5 ‘‘(x) PORT SHOPPING.—

6 ‘‘(1) IN GENERAL.—If—

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

8 offered for importation into the United States; 

9 and 

10 ‘‘(B) the prescription drug has previously 

11 been refused admission under section 801(a); 

12 unless the person reoffering the prescription drug af13 firmatively establishes, at the expense of the owner 

14 or consignee of the prescription drug, that the pre15 scription drug complies with the applicable require16 ments of this Act, as determined by the Secretary. 

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

18 paragraph applies to importation of a prescription 

19 drug under section 812 or to a commercial trans20 action conducted between an Internet pharmacy and 

21 an individual.’’. 

22 SEC. 13. AUTHORITY TO COMMISSION OTHER FEDERAL 

23 AND STATE OFFICIALS TO CONDUCT INSPEC24 TIONS. 

25 Section 702(a) of the Federal Food, Drug, and Cos26 metic Act (21 U.S.C. 372(a)) is amended—
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1 (1) by redesignating paragraphs (3) and (4) as 

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

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

4 ‘‘(3)(A) The Secretary, pursuant to a memo5 randum of understanding between the Secretary and 

6 the head of another Federal agency, may conduct 

7 examinations and investigations for the purposes of 

8 enforcing compliance with the amendments made by 

9 the Safe IMPORT Act of 2004 through the officers 

10 and employees of the other agency. 

11 ‘‘(B) A memorandum of understanding under 

12 subparagraph (A) shall include—

13 ‘‘(i) provisions to ensure adequate training 

14 of officers and employees to conduct the exami15 nations and investigations; and 

16 ‘‘(ii) provisions regarding reimbursement 

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

18 other agency, require reimbursement, in whole 

19 or in part, from the Secretary for the examina20 tions or investigations performed under this 

21 paragraph by the officers or employees of the 

22 other agency. 

23 ‘‘(C) A memorandum of understanding under 

24 subparagraph (A) shall be effective only with respect 

25 to examinations or inspections at facilities or other 
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1 locations that are jointly regulated by the Secretary 

2 and the other agency. 

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

4 each fiscal year in which the head of a Federal agen5 cy carries out 1 or more examinations or inspections 

6 under a memorandum of understanding under sub7 paragraph (A), the Secretary and the agency head 

8 shall submit to the Committee on Health, Edu9 cation, Labor, and Pensions of the Senate and to 

10 the Committee on Energy and Commerce of the 

11 House of Representatives, a report that discloses, 

12 for that year—

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

14 that carried out 1 or more programs, projects, 

15 or activities under the memorandum of under16 standing; 

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

18 were inspected or examined as a result of the 

19 memorandum of understanding; and 

20 ‘‘(iii) the number of additional examina21 tions or investigations that were carried out 

22 pursuant to the memorandum of understanding. 

23 ‘‘(4)(A) The Secretary may enter into a con24 tract with a State to use the State Board of Phar25 macy personnel of the State to conduct examinations 
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1 and inspection for the purpose of carrying out the 

2 amendments made by the Safe IMPORT Act of 

3 2004. 

4 ‘‘(B) A contract entered into under subpara5 graph (A) shall—

6 ‘‘(i) ensure adequate training of officers 

7 and employees to conduct the examinations and 

8 investigations; and 

9 ‘‘(ii) be effective only with respect to ex10 aminations or inspections of drug importation 

11 facilities, pharmacies, Internet pharmacies, and 

12 wholesalers located in the State.’’. 

13 SEC. 14. USER FEES RELATING TO PRESCRIPTION DRUG 

14 IMPORTATION. 

15 Subchapter C of chapter VII of the Federal Food, 

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

17 amended by adding at the end the following: 

18 ‘‘PART 5—FEES RELATING TO PRESCRIPTION 

19 DRUG IMPORTATION 

20 ‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM21 PORTATION. 

22 ‘‘(a) REGISTRATION FEE.—The Secretary shall es23 tablish a user fee program under which a drug importation 

24 facility, pharmacy, Internet pharmacy, or wholesaler reg-
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•HR 4923 IH 

1 istering with the Secretary under section 814 shall be re2 quired to pay a fee to the Secretary. 

3 ‘‘(b) COLLECTION.—

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

5 A fee under this section shall be payable for the fis6 cal year in which the drug importation facility, phar7 macy, Internet pharmacy, or wholesaler first reg8 isters under section 814 (or reregisters under that 

9 section if that person has withdrawn its registration 

10 and subsequently reregisters). 

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

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

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

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

15 paid only once for each drug importation facility, 

16 pharmacy, Internet pharmacy, or wholesaler reg17 istered for a fiscal year in which the fee is payable. 

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

19 determined each year by the Secretary and shall be based 

20 on the anticipated costs to the Secretary of enforcing the 

21 amendments made by the Safe IMPORT Act of 2004 in 

22 the subsequent fiscal year. 

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

24 section shall be used, without further appropriation, to en-
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1 force the amendments made by the Safe IMPORT Act of 

2 2004. 

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

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

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

6 registration fees. 

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

8 ‘‘(1) DUE DATE.—A fee payable under this sec9 tion shall be paid by the date that is 30 days after 

10 the date on which the fee is due. 

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

12 importation facility, pharmacy, Internet pharmacy, 

13 or wholesaler subject to a fee under this section fails 

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

15 drug importation facility pharmacy, Internet phar16 macy, or wholesaler to engage in importation or of17 fering for importation prescription drugs under this 

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

19 ‘‘(g) REPORTS.—

20 ‘‘(1) FEE ESTABLISHMENT.—Not later than 60 

21 days before each fiscal year, the Secretary shall—

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

23 for that fiscal year; 

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

25 may comment on the recommendations; and 
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1 ‘‘(C) provide for a period of 30 days for 

2 the public to provide written comments on the 

3 recommendations. 

4 ‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be5 ginning with fiscal year 2005, not later than 60 days 

6 after the end of each fiscal year during which fees 

7 are collected under this section, the Secretary shall 

8 submit to the Committee on Health, Education, 

9 Labor, and Pensions of the Senate and the Com10 mittee on Energy and Commerce of the House of 

11 Representatives a report that describes—

12 ‘‘(A) implementation of the user fee au13 thority during the fiscal year; and 

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

15 collected during the fiscal year for which the re16 port is made.’’. 

17 SEC. 15. ANTICOUNTERFEITING PROVISIONS. 

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

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

20 is amended by striking paragraph (1) and inserting the 

21 following: 

22 ‘‘(1) A distributor of record that is engaged in 

23 the wholesale distribution of a drug subject to sub24 section (b), shall—
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1 ‘‘(A) before each wholesale distribution of the 

2 drug—

3 ‘‘(i) with respect to each wholesale dis4 tribution of a drug subject to subsection (b), 

5 provide the person that receives the drug a 

6 statement that identifies the immediately pre7 vious distributor of record from which the drug 

8 was purchased; and 

9 ‘‘(ii) with respect to a drug subject to sub10 section (b) that is imported to the United 

11 States, provide the person that receives the 

12 drug a statement (in such form and containing 

13 such information as the Secretary may require) 

14 identifying each prior sale, purchase, or trade of 

15 the drug (including the date of transmission 

16 and the names and addresses of all parties to 

17 the transaction); and 

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

19 available to the Secretary for inspection at reason20 able time, records that—

21 ‘‘(i) with respect to each wholesale dis22 tribution of a drug subject to subsection (b), 

23 identifies—
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1 ‘‘(I) the immediately previous dis2 tributor of record from which the drug was 

3 purchased; and 

4 ‘‘(II) the immediately subsequent dis5 tributor of record to which the drug was 

6 sold or otherwise transferred; and 

7 ‘‘(ii) with respect to a drug subject to sub8 section (b) that is imported to the United 

9 States, identifies—

10 ‘‘(I) each previous distributor of 

11 record from which the drug was purchased 

12 or otherwise transferred; and 

13 ‘‘(II) each subsequent distributor of 

14 record to which the drug was sold or other15 wise transferred, to the extent feasible.’’. 

16 (b) ELECTRONIC TRACK AND TRACE TECH17 NOLOGY.—Not later than December 31, 2007, the Sec18 retary of Health and Human Services shall require the 

19 adoption and use of electronic track and trace technology 

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

21 will identify each sale, purchase, or trade of that case or 

22 pallet (including the date of transmission and the names 

23 and addresses of all parties to the transaction) . 

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

25 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 353(e)) is amended by striking paragraph (3) and insert2 ing the following: 

3 ‘‘(3) For the purposes of this subsection and sub4 section (d)—

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

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

7 possession of a drug subject to subsection (b) 

8 from manufacture to retail sale; 

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

10 processes, packs, distributes, receives, holds, 

11 imports, or offers for importation a drug sub12 ject to subsection (b); and 

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

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

15 States Postal Service, or equivalent governmental 

16 service of a foreign country, or a private carrier en17 gaged in the business of transporting packages for 

18 hire; and 

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

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

21 to other than the consumer or patient but not in22 cluding an intracompany sale or distribution of a 

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

24 (d) ANTICOUNTERFEITING PROGRAMS.—Section 

25 503(e) of the Federal Food, Drug, and Cosmetic Act (21 
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1 U.S.C. 353(e)) is amended by adding at the end the fol2 lowing: 

3 ‘‘(4) The Secretary shall—

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

5 ‘Counterfeit Alert Network’ for the purpose of pro6 viding prompt notification to health professionals 

7 and the public of counterfeit drugs subject to sub8 section (b); 

9 ‘‘(B)(i) develop and publish an Internet acces10 sible-reference document to facilitate the positive 

11 identification by health professionals and regulatory 

12 agency personnel of prescription drugs marketed in 

13 the United States and Canada; and 

14 ‘‘(ii) update the materials described under 

15 clause (i) quarterly and when a new permitted coun16 try is designated by the Secretary; 

17 ‘‘(C) develop and publish educational materials 

18 to help health professionals and consumers identify 

19 and report cases of counterfeit drugs subject to sub20 section (b); 

21 ‘‘(D) develop and publish secure business prac22 tice guidelines for the sale and distribution of such 

23 drugs in cooperation with members of a drug supply 

24 chain; and 
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1 ‘‘(E) in cooperation with the National Associa2 tion of Boards of Pharmacy, develop and publish re3 vised model rules for licensure of drug wholesalers 

4 for adoption by the States.’’. 

5 SEC. 16. CONFORMING AMENDMENTS. 

6 (a) Section 1006 of the Controlled Substances Import 

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

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

9 U.S.C. 301 et seq.) is amended—

10 (1) in section 301(aa)—

11 (A) by striking ‘‘section 804’’ and insert12 ing ‘‘subchapter B of chapter VIII’’; and 

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

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

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

16 804’’ and inserting ‘‘subchapter B’’; and 

17 (3) by striking section 804.

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