I 

108TH CONGRESS 

2D SESSION H. R. 4790 

To amend the Federal Food, Drug, and Cosmetic Act to authorize the 

importation of prescription drugs from Canada and certain other countries, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 9, 2004 

Mr. JOHN 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 

authorize the importation of prescription drugs from 

Canada and certain other countries, 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 ‘‘Drug Importation Promotion and Safety Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Importation of prescription drugs; Office of Drug Importation Promotion and Safety; other general provisions. 
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Sec. 3. Commercial importation. 

Sec. 4. Personal importation; Internet pharmacies. 

Sec. 5. Personal importation; entering United States in possession of prescription drugs; compassionate use. 

Sec. 6. Particular products; suspension of authority for importation. 

Sec. 7. Registration of importation facilities. 

Sec. 8. Enforcement; regulations; effective dates. 

Sec. 9. Licensing of Internet pharmacies. 

Sec. 10. Chain of custody of prescription drugs; network for notifications regarding counterfeit drugs. 

1 SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS; OFFICE 

2 OF DRUG IMPORTATION PROMOTION AND 

3 SAFETY; OTHER GENERAL PROVISIONS. 

4 Chapter VIII of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 381 et seq.) is amended— 

6 (1) by inserting after the chapter heading the 

7 following: 

8 ‘‘Subchapter A—General Provisions’’; and 

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

10 ‘‘Subchapter B—Importation of Prescription 

11 Drugs 

12 ‘‘SEC. 811. GENERAL PROVISIONS. 

13 ‘‘(a) OFFICE OF DRUG IMPORTATION PROMOTION

14 AND SAFETY.—There is established within the Office of 

15 the Commissioner of Food and Drugs an office to be 

16 known as the Office of Drug Importation Promotion and 

17 Safety, which shall be headed by an Associate Commis18 sioner appointed by the Commissioner. The Commissioner 

19 of Food and Drugs shall carry out this subchapter acting 

20 through such Associate Commissioner. 
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1 ‘‘(b) ANNUAL REPORT.—The Secretary shall annu2 ally submit to the Congress a report on activities carried 

3 out under this subchapter, including a determination by 

4 the Secretary of whether prescription drugs imported 

5 under this subchapter are safe and effective. 

6 ‘‘(c) DEFINITIONS.—For purposes of this subchapter: 

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

8 ‘drug importation facility’ means a person, other 

9 than an individual importing a prescription drug 

10 under section 814, located outside the United States 

11 (other than a transporter) that engages in the dis12 tribution or dispensing of a prescription drug that is 

13 imported or offered for importation into the United 

14 States. 

15 ‘‘(2) INTERNET PHARMACY.—The term ‘Inter16 net pharmacy’ means a person, other than an indi17 vidual importing a prescription drug under section 

18 814, that offers to dispense in the United States a 

19 prescription drug through an Internet website in 

20 interstate commerce, regardless of whether the phys21 ical location of the principal place of business of the 

22 Internet pharmacy is in the United States or in an23 other country. 

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

25 a person, other than an individual importing a pre-
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1 scription drug under section 814, licensed by a State 

2 to dispense prescription drugs or to provide pharma3 ceutical care. 

4 ‘‘(4) PERMITTED COUNTRY.—The term ‘per5 mitted country’ means— 

6 ‘‘(A) Australia; 

7 ‘‘(B) a member country of the European 

8 Union as of January 1, 2003; 

9 ‘‘(C) Japan; 

10 ‘‘(D) New Zealand; 

11 ‘‘(E) Switzerland; and 

12 ‘‘(F) such additional countries as the Sec13 retary may specify. 

14 ‘‘(5) PRESCRIPTION DRUG.— 

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

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

17 that is approved by the Secretary under section 

18 505. 

19 ‘‘(B) EXCLUSIONS.—The term ‘prescrip20 tion drug’ does not include— 

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

22 in section 102 of the Controlled Sub23 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. 3. COMMERCIAL IMPORTATION. 

6 Subchapter B of chapter VIII of the Federal Food, 

7 Drug, and Cosmetic Act, as added by section 2 of this 

8 Act, is amended by adding at the end the following section: 

9 ‘‘SEC. 812. COMMERCIAL IMPORTATION. 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) NO PRESUMPTION AGAINST IMPORTA12 TION.—A drug importation facility, pharmacy, Inter13 net pharmacy, or wholesaler may import a prescrip14 tion drug from Canada or a permitted country into 

15 the United States for dispensing in the United 

16 States unless the importation of the prescription 

17 drug is not in accordance with this subchapter. 

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

19 Secretary may limit the ports of entry in the United 

20 States through which a prescription drug may be 

21 imported under this section to a reasonable number 

22 of ports designated by the Secretary. 

23 ‘‘(b) REQUIREMENTS.—Each prescription drug im24 ported under this subchapter shall— 

25 ‘‘(1) be approved under section 505; 
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1 ‘‘(2) comply with sections 501 and 502; 

2 ‘‘(3) be in a container that bears a label stat3 ing, in prominent and conspicuous type— 

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

5 drug; 

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

7 of the drug importation facility; 

8 ‘‘(C) comply with regulations promulgated 

9 by the Secretary to require labeling regarding 

10 the fact that the drug is imported; and 

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

12 the Secretary that modifies the national drug 

13 code of the prescription drug to indicate that 

14 the drug has been imported; and 

15 ‘‘(4) comply with any other applicable require16 ment of this Act. 

17 ‘‘(c) APPROVED LABELING.— 

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

19 that offers for importation a prescription drug under 

20 this subchapter shall submit to the Secretary an ap21 plication for approval that demonstrates that the la22 beling of the prescription drug to be imported into 

23 the United States complies with the requirements of 

24 sections 502 and 503. 
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1 ‘‘(2) PROCEDURE.—Not later than 60 days 

2 after receipt of a completed application under para3 graph (1), the Secretary shall— 

4 ‘‘(A) approve or deny the application con5 sistent with the requirements of sections 502 

6 and 503; and 

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

8 the Secretary and, if the application is denied, 

9 the reason for the denial. 

10 ‘‘(3) LISTS.— 

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

12 maintain an updated list of applications pend13 ing, applications approved, and applications de14 nied under this subsection. 

15 ‘‘(B) PORTS.—The Secretary shall main16 tain an updated list of ports through which a 

17 prescription drug may be imported under this 

18 section and make the list available to the public 

19 on an Internet website. 

20 ‘‘(d) PROHIBITION OF IMPORTATION OF A PRESCRIP21 TION DRUG THAT ENTERS OTHER COUNTRIES.— 

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

23 pharmacy, Internet pharmacy, or wholesaler shall 

24 not import a prescription drug if, during any period 

25 in which the prescription drug was not in the control 
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1 of the manufacturer, the prescription drug entered a 

2 country other than— 

3 ‘‘(A) Canada; or 

4 ‘‘(B) subject to paragraph (2), a permitted 

5 country. 

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

7 one or more of the countries under subparagraph 

8 (B) of paragraph (1) from the application of that 

9 subparagraph if the Secretary determines that allow10 ing a prescription drug to be imported into the 

11 United States after having entered that country out12 side control of a manufacturer would present a risk 

13 to the public health. 

14 ‘‘(e) PROHIBITION OF COMMINGLING.— 

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

16 pharmacy, Internet pharmacy, or wholesaler shall 

17 not commingle a prescription drug imported into the 

18 United States under this subchapter with a prescrip19 tion drug that is not imported from Canada or a 

20 permitted country. 

21 ‘‘(2) LABEL.—A pharmacy or Internet phar22 macy that dispenses a prescription drug imported 

23 from Canada or a permitted country shall affix on 

24 each dispensed container of the prescription drug 
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1 the label required under subsection (b)(3) unless 

2 such a label is already affixed to the container. 

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

4 from the manufacturer of a prescription drug imported 

5 from Canada or a permitted country under this section 

6 that the prescription drug has been recalled or withdrawn 

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

8 importation facility shall promptly provide the Secretary 

9 and any person to whom the prescription drug was distrib10 uted a notice that the drug has been recalled or withdrawn 

11 from the market and that includes— 

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

13 that identifies the prescription drug; and 

14 ‘‘(2) a statement of the reason for the recall or 

15 withdrawal. 

16 ‘‘(g) CHARITABLE CONTRIBUTIONS.—Notwith17 standing any other provision of this section, section 

18 801(d)(1) continues to apply to a prescription drug that 

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

20 charge by the manufacturer of the prescription drug to 

21 a charitable or humanitarian organization (including the 

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

23 foreign country. 

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

25 United States shall have jurisdiction in an action brought 
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1 by the United States against a person importing or offer2 ing for importation a prescription drug in violation of the 

3 requirements of this section. 

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

5 limits the authority of the Secretary relating to the impor6 tation of prescription drugs (including the interdiction of 

7 prescription drugs that are unapproved, adulterated, or 

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

9 as provided in subsection (g).’’. 

10 SEC. 4. PERSONAL IMPORTATION; INTERNET PHARMACIES. 

11 Subchapter B of chapter VIII of the Federal Food, 

12 Drug, and Cosmetic Act, as amended by section 3 of this 

13 Act, is amended by adding at the end the following section: 

14 ‘‘SEC. 813. PERSONAL IMPORTATION; INTERNET PHAR15 MACIES. 

16 ‘‘An individual may, for personal use or for the use 

17 of a family member of the individual (rather than for re18 sale), import a prescription drug into the United States 

19 from any Internet pharmacy that is registered under sec20 tion 816 and licensed under section 503B, except to the 

21 extent that the Secretary determines that importation of 

22 the prescription drug is not in accordance with this sub23 chapter.’’. 
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1 SEC. 5. PERSONAL IMPORTATION; ENTERING UNITED 

2 STATES IN POSSESSION OF PRESCRIPTION 

3 DRUGS; COMPASSIONATE USE. 

4 Subchapter B of chapter VIII of the Federal Food, 

5 Drug, and Cosmetic Act, as amended by section 4 of this 

6 Act, is amended by adding at the end the following section: 

7 ‘‘SEC. 814. PERSONAL IMPORTATION; ENTERING UNITED 

8 STATES IN POSSESSION OF PRESCRIPTION 

9 DRUGS; COMPASSIONATE USE. 

10 ‘‘(a) IN GENERAL.—An individual may, for personal 

11 use or for the use of a family member of the individual 

12 (rather than for resale), import a prescription drug from 

13 Canada or a permitted country into the United States, 

14 subject to subsections (b) and (c). 

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

16 prescription drug if— 

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

18 licensed pharmacy in Canada or a licensed pharmacy 

19 in a permitted country and dispensed in compliance 

20 with the applicable laws of Canada or the permitted 

21 country regarding the practice of pharmacy; 

22 ‘‘(2) the prescription drug is imported from 

23 Canada or a permitted country into the United 

24 States; 

25 ‘‘(3) the prescription drug is imported by the 

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

3 90-day period; and 

4 ‘‘(5) 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. 6. PARTICULAR PRODUCTS; SUSPENSION OF AUTHOR20 ITY FOR IMPORTATION. 

21 Subchapter B of chapter VIII of the Federal Food, 

22 Drug, and Cosmetic Act, as amended by section 5 of this 

23 Act, is amended by adding at the end the following section: 
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1 ‘‘SEC. 815. PARTICULAR PRODUCTS; SUSPENSION OF AU2 THORITY FOR IMPORTATION. 

3 ‘‘(a) PRESCRIPTION DRUG.—If the Secretary deter4 mines that the importation of a particular prescription 

5 drug or particular dosage form of a prescription drug into 

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

7 Secretary may immediately order the suspension of the 

8 importation of the particular prescription drug or par9 ticular dosage form of the prescription drug. 

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

11 a drug importation facility, pharmacy, Internet pharmacy, 

12 or wholesaler is engaged in a pattern of importing or offer13 ing for importation a prescription drug into the United 

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

15 the Secretary may immediately order the suspension of 

16 that person from engaging in the importation or offering 

17 for importation of prescription drugs into the United 

18 States. 

19 ‘‘(c) CANADA OR PERMITTED COUNTRY.—If the Sec20 retary determines that there is a pattern of prescription 

21 drugs being imported or offered for importation into the 

22 United States from Canada or a permitted country in vio23 lation of any of the requirements of this Act, the Secretary 

24 may immediately order the suspension of the importation 

25 or offering for importation into the United States of pre-
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1 scription drugs from Canada or that permitted country, 

2 as appropriate. 

3 ‘‘(d) APPEAL OF SUSPENSION ORDER.— 

4 ‘‘(1) IN GENERAL.— 

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

6 to the importation of a prescription drug, the 

7 importation of which is suspended under sub8 section (a), any person that would be entitled to 

9 be a claimant for the prescription drug may ap10 peal the suspension order to the Secretary. 

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

12 to a drug importation facility, pharmacy, Inter13 net pharmacy, or wholesaler subject to a sus14 pension order under subsection (b) or (c), the 

15 drug importation facility, pharmacy, Internet 

16 pharmacy or wholesaler may appeal the suspen17 sion order to the Secretary. 

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

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

20 after providing opportunity for an informal hearing, 

21 shall confirm or terminate the order. 

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

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

24 to provide an opportunity for a hearing or to con-
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1 firm or terminate the order, the order shall be 

2 deemed to be terminated. 

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

4 section shall not be subject to judicial review. 

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

6 applies to a prescription drug imported by an individual 

7 under section 812 or to a commercial transaction con8 ducted between an Internet pharmacy and an individual.’’. 

9 SEC. 7. REGISTRATION OF IMPORTATION FACILITIES. 

10 (a) IN GENERAL.—Subchapter B of chapter VIII of 

11 the Federal Food, Drug, and Cosmetic Act, as amended 

12 by section 6 of this Act, is amended by adding after sec13 tion 815 the following section: 

14 ‘‘SEC. 816. REGISTRATION OF CERTAIN IMPORTERS. 

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

16 pharmacy, Internet pharmacy, or wholesaler engaged in 

17 the importation or offering for importation of prescription 

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

19 drugs, shall register with the Secretary in accordance with 

20 this section. 

21 ‘‘(b) REGISTRATION.— 

22 ‘‘(1) IN GENERAL.—To register, the owner, op23 erator, or agent in charge of a drug importation fa24 cility, pharmacy, Internet pharmacy, or wholesaler 
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1 shall submit to the Secretary a registration that dis2 closes— 

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

4 importation facility, pharmacy, Internet phar5 macy, or wholesaler at which, and all trade 

6 names under which, the registrant conducts 

7 business; 

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

9 be imported into the United States by each 

10 drug importation facility, pharmacy, Internet 

11 pharmacy, or wholesaler; and 

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

13 service of process in the United States. 

14 ‘‘(2) CHANGE IN INFORMATION.—The reg15 istrant shall notify the Secretary in a timely manner 

16 of any change in the information provided under 

17 paragraph (1). 

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

19 after receipt of a completed registration under para20 graph (1), the Secretary shall— 

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

22 registered drug importation facility, pharmacy, 

23 Internet pharmacy, and wholesaler; and 

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

25 the registration. 
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1 ‘‘(4) LIST.— 

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

3 compile, maintain, and periodically update a list 

4 of registrants. 

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

6 make the list described under subparagraph (A) 

7 and information submitted by a registrant 

8 under paragraph (1) available to the public on 

9 an Internet website and through a toll-free tele10 phone number. 

11 ‘‘(c) ELECTRONIC FILING.— 

12 ‘‘(1) IN GENERAL.—For the purpose of reduc13 ing paperwork and reporting burdens, the Secretary 

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

15 methods of submitting to the Secretary registrations 

16 required under this section and shall provide for 

17 electronic methods of receiving the registrations. 

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

19 electronic submission of such registrations under 

20 this section, the Secretary shall ensure that ade21 quate authentication protocols are used to allow 

22 identification of the registrant and validation of the 

23 data as appropriate. 

24 ‘‘(d) EFFECT OF SECTION.— 
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1 ‘‘(1) AUTHORITY.—Nothing in this section au2 thorizes the Secretary to require an application, re3 view, or licensing process for a drug importation fa4 cility, pharmacy, or wholesaler. 

5 ‘‘(2) IMPORTATION BY INDIVIDUALS.—Nothing 

6 in this section applies to a prescription drug im7 ported by an individual under section 814 or to a 

8 commercial transaction conducted between an Inter9 net pharmacy and an individual.’’. 

10 (b) IMPORTATION; FAILURE TO REGISTER.—Section 

11 801 of the Federal Food, Drug, and Cosmetic Act is 

12 amended by adding at the end the following: 

13 ‘‘(p) FAILURE TO REGISTER.— 

14 ‘‘(1) IN GENERAL.—If a drug importation facil15 ity, pharmacy, Internet pharmacy, or wholesaler en16 gaged in the importation or offering for importation 

17 of prescription drugs into the United States has not 

18 submitted a registration to the Secretary in accord19 ance with section 816, a prescription drug that is 

20 being imported or offered for importation into the 

21 United States shall not be delivered to the importer, 

22 owner, or consignee of the prescription drug until 

23 the drug importation facility, pharmacy, Internet 

24 pharmacy, or wholesaler is registered in accordance 

25 with section 816. 
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1 ‘‘(2) EFFECT OF SUBSECTION (B).—Subsection 

2 (b) does not authorize the delivery of the prescrip3 tion drug pursuant to the execution of a bond while 

4 the prescription drug is held under this subsection. 

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

6 under this subsection shall be removed to a secure 

7 facility, as appropriate. 

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

9 which a prescription drug is held under this sub10 section, the prescription drug shall not be trans11 ferred by any person from the port of entry into the 

12 United States for the prescription drug or from the 

13 secure facility to which the prescription drug has 

14 been removed.’’. 

15 SEC. 8. ENFORCEMENT; REGULATIONS; EFFECTIVE DATES. 

16 (a) PROHIBITED ACTS.—Section 301 of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend18 ed by adding at the end the following: 

19 ‘‘(hh) Dispensing or offering to dispense a prescrip20 tion drug imported into the United States in violation of 

21 the requirements of section 812. 

22 ‘‘(ii) The importation or offering for importation of 

23 a prescription drug in violation of an order under section 

24 815. 
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1 ‘‘(jj) The failure of a drug importation facility, phar2 macy, Internet pharmacy, or wholesaler engaged in the 

3 importation or offering for importation of prescription 

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

5 drugs, to register in accordance with section 816. ’’. 

6 (b) REGULATIONS; EFFECTIVE DATES.— 

7 (1) COMMERCIAL IMPORTATION.—With respect 

8 to carrying out section 812 of the Federal Food, 

9 Drug, and Cosmetic Act (as added by section 3 of 

10 this Act): 

11 (A) The Secretary of Health and Human 

12 Services (referred to in this subsection as the 

13 ‘‘Secretary’’) shall promulgate interim final reg14 ulations regarding importation of prescription 

15 drugs from Canada not later than 30 days after 

16 the date of the enactment of this Act. Such sec17 tion 812 takes effect regarding the importation 

18 of prescription drugs from Canada upon the ex19 piration of such 30 days, without regard to 

20 whether the Secretary has promulgated such 

21 regulations. 

22 (B) The Secretary shall promulgate in23 terim final regulations regarding importation of 

24 prescription drugs from permitted countries not 

25 later than one year after the date of the enact-
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1 ment of this Act. Such section 812 takes effect 

2 regarding importation of prescription drugs 

3 from permitted countries upon the expiration of 

4 such one-year period, without regard to whether 

5 the Secretary has promulgated such regula6 tions. 

7 (2) PERSONAL IMPORTATION; ENTERING

8 UNITED STATES IN POSSESSION OF PRESCRIPTION

9 DRUG; COMPASSIONATE USE.—The Secretary may 

10 promulgate regulations to carry out section 814 of 

11 the Federal Food, Drug, and Cosmetic Act (as 

12 added by section 5 of this Act). Such section 813 

13 takes effect upon the date of enactment of this Act, 

14 without regard to whether the Secretary has promul15 gated such regulations. 

16 (3) REGISTRATION OF IMPORTATION FACILI17 TIES.—Not later than one year after the date of the 

18 enactment of this Act, the Secretary shall promul19 gate regulations to carry out section 816 of the Fed20 eral Food, Drug, and Cosmetic Act (as added by 

21 section 7(a) of this Act). The requirement of reg22 istration under such section takes effect— 

23 (A) on the effective date of such final regu24 lations; or 
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1 (B) if the final regulations have not been 

2 made effective as of the expiration of such one3 year period, on the date that is one year after 

4 the date of the enactment of this Act, subject 

5 to compliance with the final regulations when 

6 the final regulations are made effective. 

7 SEC. 9. LICENSING OF INTERNET PHARMACIES. 

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

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 503A the following section: 

11 ‘‘SEC. 503B. LICENSING OF INTERNET PHARMACIES. 

12 ‘‘(a) IN GENERAL.—An Internet pharmacy that is li13 censed in accordance with this section may dispense or 

14 offer to dispense a prescription drug to a person in the 

15 United States. An Internet pharmacy may not dispense 

16 or offer to dispense a prescription drug to such a person 

17 prior to obtaining a license under this section. 

18 ‘‘(b) DEFINITIONS.—For purposes of this section: 

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

20 term ‘advertising service provider’ means an adver21 tising company that contracts with a provider of an 

22 interactive computer service (as defined in section 

23 230(f) of the Communications Act of 1934 (47 

24 U.S.C. 230(f)) to provide advertising on the Inter25 net. 
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1 ‘‘(2) PERMITTED COUNTRY.—The term ‘per2 mitted country’ has the meaning given such term in 

3 section 811(c). 

4 ‘‘(3) PRESCRIPTION DRUG.—The term ‘pre5 scription drug’ means a drug described in section 

6 503(b) that is approved by the Secretary under sec7 tion 505. 

8 ‘‘(4) INTERNET PHARMACY.—The term ‘Inter9 net pharmacy’ means a person that dispenses or of10 fers to dispense a prescription drug through an 

11 Internet website in interstate commerce in the 

12 United States regardless of whether the physical lo13 cation of the principal place of business of the Inter14 net pharmacy is in the United States or in another 

15 country. 

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

17 ‘‘(1) IN GENERAL.—The Secretary may issue a 

18 license under this section to an Internet pharmacy 

19 only if such pharmacy— 

20 ‘‘(A) has its principal place of business in 

21 the United States, Canada, or a permitted 

22 country; and 

23 ‘‘(B) meets the requirements of paragraph 

24 (2). 

25 ‘‘(2) CONDITIONS FOR LICENSING.— 
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1 ‘‘(A) APPLICATION REQUIREMENTS.—An 

2 Internet pharmacy shall submit to the Sec3 retary an application for a license under this 

4 section that includes— 

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

6 pharmacy located in the United States, 

7 verification that, in each State in which 

8 the Internet pharmacy engages in dis9 pensing or offering to dispense prescription 

10 drugs, the Internet pharmacy, and all em11 ployees and agents of the Internet phar12 macy, is in compliance with applicable 

13 Federal and State laws regarding— 

14 ‘‘(aa) the practice of pharmacy, 

15 including licensing laws and inspec16 tion requirements; and 

17 ‘‘(bb) the manufacturing and dis18 tribution of controlled substances, in19 cluding with respect to mailing or 

20 shipping controlled substances to con21 sumers; or 

22 ‘‘(II) in the case of an Internet phar23 macy located in Canada or a permitted 

24 country, verification that— 
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1 ‘‘(aa) all employees and agents of 

2 the Internet pharmacy are in compli3 ance with applicable laws of Canada 

4 or the permitted country regarding 

5 the practice of pharmacy, including li6 censing laws and inspection require7 ments; and 

8 ‘‘(bb) the Internet pharmacy is in 

9 compliance with applicable Federal 

10 and State laws regarding the practice 

11 of pharmacy, including licensing laws 

12 and inspection requirements; 

13 ‘‘(ii) verification that the person that 

14 owns the Internet pharmacy has not had a 

15 license for an Internet pharmacy termi16 nated by the Secretary, and that no other 

17 Internet pharmacy owned by the person 

18 has had a license under this subsection 

19 that has been terminated by the Secretary; 

20 ‘‘(iii) verification from the person that 

21 owns the Internet pharmacy that the per22 son will permit inspection of the facilities 

23 and business practices of the Internet 

24 pharmacy by the Secretary to the extent 

25 necessary to determine whether the Inter-
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1 net pharmacy is in compliance with this 

2 subsection; and 

3 ‘‘(iv) in the case of an agreement be4 tween a patient and an Internet pharmacy 

5 that releases the Internet pharmacy, and 

6 any employee or agent of the Internet 

7 pharmacy, from liability for damages aris8 ing out of the negligence of the Internet 

9 pharmacy, an assurance that such a limita10 tion of liability shall be null and void. 

11 ‘‘(B) IDENTIFICATION REQUIREMENTS.— 

12 An Internet pharmacy shall provide to any per13 son that accesses the Internet pharmacy 

14 website, on each page of the website of the 

15 Internet pharmacy or by a link to a separate 

16 page, the following information: 

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

18 Code or comparable mail code, State (or 

19 comparable entity), country, and telephone 

20 number of— 

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

22 Internet pharmacy; and 

23 ‘‘(II) the name of the supervising 

24 pharmacist of the Internet pharmacy 

25 and each individual who serves as a 
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1 pharmacist for purposes of the Inter2 net pharmacy website. 

3 ‘‘(ii) The names of all States or coun4 tries, as appropriate, in which the Internet 

5 pharmacy and the pharmacists employed 

6 by the Internet pharmacy are licensed or 

7 otherwise authorized to dispense prescrip8 tion drugs. 

9 ‘‘(iii) If the Internet pharmacy makes 

10 referrals to, or solicits on behalf of, a 

11 health care practitioner or group of practi12 tioners in the United States for prescrip13 tion services— 

14 ‘‘(I) the name, street address, 

15 city, ZIP Code or comparable mail 

16 code, State, and telephone number of 

17 the practitioner or group; and 

18 ‘‘(II) the name of each State in 

19 which each practitioner is licensed or 

20 otherwise authorized to prescribe 

21 drugs. 

22 ‘‘(iv) A statement that the Internet 

23 pharmacy will dispense prescription drugs 

24 only after receipt of a valid prescription. 
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1 ‘‘(C) PROFESSIONAL SERVICES REQUIRE2 MENTS.—An Internet pharmacy shall carry out 

3 the following: 

4 ‘‘(i) Maintain patient medication pro5 files and other related data in a readily ac6 cessible format organized to facilitate con7 sultation with treating providers, care8 givers, and patients. 

9 ‘‘(ii) Conduct prospective drug use re10 views before dispensing medications or 

11 medical devices. 

12 ‘‘(iii) Ensure patient confidentiality 

13 and the protection of patient identity and 

14 patient-specific information, in accordance 

15 with the regulations promulgated under 

16 section 264(c) of the Health Insurance 

17 Portability and Accountability Act of 1996 

18 (42 U.S.C. 1320d–2 note). 

19 ‘‘(iv) Offer interactive and meaningful 

20 consultation by a licensed pharmacist to 

21 the caregiver or patient prior to and subse22 quent to the time at which the Internet 

23 pharmacy dispenses the drug. 
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1 ‘‘(v)(I) Establish a mechanism for pa2 tients to report errors and suspected ad3 verse drug reactions. 

4 ‘‘(II) Document in the reporting 

5 mechanism the response of the Internet 

6 pharmacy to those reports. 

7 ‘‘(vi) Develop a system to inform care8 givers and patients about drug recalls. 

9 ‘‘(vii) Educate caregivers and patients 

10 about the appropriate means of disposing 

11 of expired, damaged, or unusable medica12 tions. 

13 ‘‘(viii) Assure that the sale of a pre14 scription drug is in accordance with a pre15 scription from the treating provider of the 

16 individual. 

17 ‘‘(ix)(I) Verify the validity of the pre18 scription of an individual by using 1 of the 

19 following methods: 

20 ‘‘(aa) Receiving from the indi21 vidual or treating provider of the indi22 vidual the prescription of the indi23 vidual by mail (including a private 

24 carrier), or receiving from the treating 

25 provider of the individual the prescrip-
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1 tion of the individual by electronic 

2 mail. 

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

4 controlled substance (as defined in 

5 section 102 of the Controlled Sub6 stances Act (21 U.S.C. 802)), con7 firming with the treating provider the 

8 information in subclause (II). 

9 ‘‘(II) When seeking verification of a 

10 prescription of an individual under sub11 clause (I)(bb), an Internet pharmacy shall 

12 provide to the treating provider the fol13 lowing information: 

14 ‘‘(aa) The full name and address 

15 of the individual. 

16 ‘‘(bb) Identification of the pre17 scription drug. 

18 ‘‘(cc) The quantity of the pre19 scription drug to be dispensed. 

20 ‘‘(dd) The date on which the in21 dividual presented the prescription to 

22 the Internet pharmacy. 

23 ‘‘(ee) The date and time of the 

24 verification request. 
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1 ‘‘(ff) The name of a contact per2 son at the Internet pharmacy, includ3 ing a voice telephone number, elec4 tronic mail address, and facsimile tele5 phone number. 

6 ‘‘(III) A prescription is verified under 

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

8 occurs: 

9 ‘‘(aa) The treating provider con10 firms, by direct communication with 

11 the Internet pharmacy, that the pre12 scription is accurate. 

13 ‘‘(bb) The treating provider in14 forms the Internet pharmacy that the 

15 prescription is inaccurate and provides 

16 the accurate prescription. 

17 ‘‘(IV) An Internet pharmacy shall not 

18 fill a prescription if— 

19 ‘‘(aa) a treating provider informs 

20 the Internet pharmacy within 72 

21 hours after receipt of a communica22 tion under subclause (I)(bb) that the 

23 prescription is inaccurate or expired; 

24 or 
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1 ‘‘(bb) the treating provider does 

2 not respond within that time. 

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

4 as the Secretary shall prescribe by regula5 tion, a record of all direct communications 

6 with a treating provider regarding the dis7 pensing of a prescription drug, including 

8 verification of the prescription. 

9 ‘‘(3) LICENSURE PROCEDURE.— 

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

11 of a completed licensing application under para12 graph (2), the Secretary shall— 

13 ‘‘(i) assign an identification number 

14 to each Internet pharmacy; 

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

16 of the licensure application; and 

17 ‘‘(iii) not later than 60 days after re18 ceipt of the licensure application, issue a li19 cense if the Internet pharmacy is in com20 pliance with conditions under paragraph 

21 (3). 

22 ‘‘(B) ELECTRONIC FILING.— 

23 ‘‘(i) IN GENERAL.—For the purpose 

24 of reducing paperwork and reporting bur25 dens, the Secretary shall require the use of 
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1 electronic methods of submitting to the 

2 Secretary a licensure application required 

3 under this section and provide for elec4 tronic methods of receiving the applica5 tions. 

6 ‘‘(ii) AUTHENTICATION.—In providing 

7 for the electronic submission of such licen8 sure applications under this section, the 

9 Secretary shall ensure that adequate au10 thentication protocols are used to allow 

11 identification of the Internet pharmacy and 

12 validation of the data as appropriate. 

13 ‘‘(4) LIST.— 

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

15 compile, maintain, and periodically update a list 

16 of licensees. 

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

18 make the list described under subparagraph (A) 

19 and information submitted by the licensee 

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

21 on an Internet website and through a toll-free 

22 telephone number. 

23 ‘‘(5) TERMINATION OF LICENSE.—The Sec24 retary, upon the initiative of the Secretary, may ter25 minate a license issued under subsection (c), after 
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•HR 4790 IH 

1 notice to the Internet pharmacy and an opportunity 

2 for a hearing, and if the Secretary determines that 

3 an Internet pharmacy— 

4 ‘‘(A) has demonstrated a pattern of non5 compliance with this section; 

6 ‘‘(B) has made an untrue statement of ma7 terial fact in its license application; or 

8 ‘‘(C) is in violation of any applicable Fed9 eral or State law relating to the dispensing of 

10 a prescription drug. 

11 ‘‘(6) RENEWAL EVALUATION.— 

12 ‘‘(A) IN GENERAL.—Before renewing a li13 cense of an Internet pharmacy under this sub14 section pursuant to the submission of a renewal 

15 application, the Secretary shall conduct an eval16 uation to determine whether the Internet phar17 macy is in compliance with this section. 

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

19 the Secretary and as applicable, an evaluation 

20 under subparagraph (A) may include testing of 

21 the Internet pharmacy website or other systems 

22 through which the Internet pharmacy commu23 nicates with consumers, and a physical inspec24 tion of the records and premises of the phar25 macy. 
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•HR 4790 IH 

1 ‘‘(7) CONTRACT FOR OPERATION OF PRO2 GRAM.— 

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

4 award a contract under this subsection for the 

5 operation of the licensing program. 

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

7 under subparagraph (A) shall not exceed 5 

8 years and may be renewable. 

9 ‘‘(C) PERFORMANCE REVIEW.—The Sec10 retary shall annually review performance under 

11 a contract under subparagraph (A). 

12 ‘‘(d) PROVIDERS OF INTERACTIVE COMPUTER SERV13 ICES OR ADVERTISING SERVICES.—A provider of inter14 active computer services (as defined in section 230(f) of 

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

16 an advertising service provider shall be liable under this 

17 section for dispensing or selling prescription drugs in vio18 lation of this section on account of another person’s selling 

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

20 service— 

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

22 from an Internet pharmacy that is not licensed in 

23 accordance with this section; or 
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1 ‘‘(2) accepts advertising stating that an indi2 vidual does not need a physician’s prescription to ob3 tain a prescription drug. 

4 ‘‘(e) REPORTS REGARDING INTERNET-RELATED VIO5 LATIONS OF FEDERAL AND STATE LAWS ON DISPENSING

6 OF DRUGS.—The Secretary shall, pursuant to the submis7 sion of an application meeting criteria prescribed by the 

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

9 entity with experience in developing and maintaining sys10 tems for the purpose of— 

11 ‘‘(1) identifying Internet pharmacy websites 

12 that are not licensed in accordance with this section 

13 or that appear to be operating in violation of Fed14 eral or State laws concerning the dispensing of 

15 drugs; 

16 ‘‘(2) reporting such Internet pharmacy websites 

17 to State medical licensing boards and State phar18 macy licensing boards, and to the Attorney General 

19 and the Secretary, for further investigation; and 

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

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

22 the Secretary describing investigations undertaken 

23 with respect to violations described in paragraph 

24 (1).’’. 
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1 (b) PROHIBITED ACTS.—Section 301 of the Federal 

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

3 amended by section 8(a) of this Act, is amended by adding 

4 at the end the following: 

5 ‘‘(kk) The sale of a prescription drug, or the owner6 ship or operation of an Internet pharmacy, in violation of 

7 section 503B. 

8 ‘‘(ll) The representation by advertisement, sales pres9 entation, direct communication (including telephone, fac10 simile, or electronic mail), or otherwise by an Internet 

11 pharmacy, that a prescription drug may be obtained from 

12 the Internet pharmacy without a prescription, in violation 

13 of section 503B. 

14 ‘‘(mm) The acceptance of an advertisement from an 

15 Internet pharmacy by the provider of an interactive com16 puter service, unless the provider has on file a copy of 

17 the license issued to the Internet pharmacy under section 

18 503B.’’. 

19 (c) INJUNCTIVE PROCEEDINGS; LINKS TO ILLEGAL

20 INTERNET PHARMACIES.—Section 302 of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 332) is amend22 ed by adding at the end the following: 

23 ‘‘(c)(1) In the case of a violation of section 503B re24 lating to an illegal Internet pharmacy, the district courts 

25 of the United States and the United States courts of the 
40 

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1 territories shall have jurisdiction to order a provider of 

2 an interactive computer service to remove, or disable ac3 cess to, an Internet website violating that section that re4 sides on a computer server that the provider controls or 

5 operates. 

6 ‘‘(2) Relief under paragraph (1)— 

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

8 the provider of notice and an opportunity to appear; 

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

10 provider to monitor its service or to affirmatively 

11 seek facts indicating activity violating section 503B; 

12 and 

13 ‘‘(C) shall specify the provider to which the re14 lief applies.’’. 

15 (d) IMPORTATION; RETURN TO SENDER.—Section 

16 801 of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 381), as amended by section 7(b) of this Act, is 

18 amended by adding at the end the following: 

19 ‘‘(q) UNLICENSED INTERNET PHARMACY.—If an 

20 Internet pharmacy is not licensed by the Secretary in ac21 cordance with section 503B, any shipment of a prescrip22 tion drug from such an Internet pharmacy to an individual 

23 shall be refused admission into the United States and the 

24 Secretary shall return the prescription drug, other than 

25 a prescription drug that is required to be destroyed, to 
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1 the Internet pharmacy at the expense of the Internet phar2 macy. 

3 ‘‘(r) LICENSED INTERNET PHARMACY.—If a ship4 ment of a prescription drug from an Internet pharmacy 

5 licensed by the Secretary in accordance with section 503B 

6 to an individual is refused admission into the United 

7 States, the Secretary shall— 

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

9 prescription drug that is required to be destroyed, to 

10 the Internet pharmacy at the expense of the Internet 

11 pharmacy; and 

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

13 pharmacy with a written notice that informs the in14 dividual and the Internet pharmacy of the refusal 

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

16 (e) REGULATIONS.—With respect to section 503B of 

17 the Federal Food, Drug, and Cosmetic Act (as added by 

18 subsection (a) of this section): 

19 (1) Not later than one year after the date of 

20 the enactment of this Act, the Secretary of Health 

21 and Human Services shall promulgate interim final 

22 regulations that are consistent with the Verified 

23 Internet Pharmacy Sites certification program devel24 oped by the National Association of Boards of Phar-
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1 macy to carry out the amendments made by this sec2 tion. 

3 (2) The requirement of licensure under such 

4 section 503B takes effect on the date determined by 

5 the Secretary of Health and Human Services, but in 

6 no event later than 90 days after the effective date 

7 of the interim final regulations under paragraph (1). 

8 (3) Section 801(q) of such Act (as added by 

9 subsection (d) of this section) takes effect on the ef10 fective date that applies under paragraph (2) of this 

11 subsection. 

12 (4) For purposes of section 813 of such Act (as 

13 added by section 4 of this Act), an Internet phar14 macy located in Canada is deemed to be licensed 

15 under such section 503B pending the effective date 

16 that applies under paragraph (2) of this subsection. 

17 SEC. 10. CHAIN OF CUSTODY OF PRESCRIPTION DRUGS; 

18 NETWORK FOR NOTIFICATIONS REGARDING 

19 COUNTERFEIT DRUGS. 

20 (a) ELECTRONIC TRACK AND TRACE TECHNOLOGY; 

21 NETWORK FOR NOTIFICATIONS REGARDING COUNTER22 FEIT DRUGS.— 

23 (1) ELECTRONIC TRACK AND TRACE TECH24 NOLOGY.—Not later than December 31, 2007, the 

25 Secretary of Health and Human Services shall re-
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1 quire the adoption and use of electronic track and 

2 trace technology for a prescription drug at the case 

3 and pallet level that will identify each sale, purchase, 

4 or trade of that case or pallet (including the date of 

5 transmission and the names and addresses of all 

6 parties to the transaction). 

7 (2) NETWORK FOR NOTIFICATIONS REGARDING

8 COUNTERFEIT DRUGS.—Section 503(e) of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

10 353(e)) is amended by adding at the end the fol11 lowing: 

12 ‘‘(4) The Secretary shall— 

13 ‘‘(A) establish a network for the purpose of pro14 viding prompt notification to health professionals 

15 and the public of counterfeit drugs subject to sub16 section (b); 

17 ‘‘(B)(i) develop and publish an Internet acces18 sible-reference document to facilitate the positive 

19 identification by health professionals and regulatory 

20 agency personnel of prescription drugs marketed in 

21 the United States and Canada; and 

22 ‘‘(ii) update the materials described under 

23 clause (i) quarterly and when a new permitted coun24 try is designated by the Secretary; 
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1 ‘‘(C) develop and publish educational materials 

2 to health professionals and consumers identify and 

3 report cases of counterfeit drugs subject to sub4 section (b); 

5 ‘‘(D) develop and publish secure business prac6 tice guidelines for the sale and distribution of such 

7 drugs in cooperation with members of a drug supply 

8 chain; and 

9 ‘‘(E) in cooperation with the National Associa10 tion of Boards of Pharmacy, develop and publish re11 vised model rules for licensure of drug wholesalers 

12 for adoption by the States.’’. 

13 (3) AUTHORIZATION OF APPROPRIATIONS.—For 

14 the purpose of carrying out this subsection and the 

15 amendments made by this subsection, there are au16 thorized to be appropriated such sums as may be 

17 necessary for each fiscal year, in addition to other 

18 authorizations of appropriations that are available 

19 for such purpose. 

20 (b) REQUIRED RECORDS.—Section 503(e) of the 

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

22 is amended by striking ‘‘(e)(1)(A)’’ and all that follows 

23 through the end of paragraph (1) and inserting the fol24 lowing: 
45 

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

2 wholesale distribution of a drug subject to subsection (b) 

3 shall— 

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

5 drug— 

6 ‘‘(i) with respect to each wholesale dis7 tribution of a drug subject to subsection (b), 

8 provide the person that receives the drug a 

9 statement that identifies the immediately pre10 vious distributor of record from which the drug 

11 was purchased; and 

12 ‘‘(ii) with respect to a drug subject to sub13 section (b) that is imported to the United 

14 States, provide the person that receives the 

15 drug a statement (in such form and containing 

16 such information as the Secretary may require) 

17 identifying each prior sale, purchase, or trade of 

18 the drug (including the date of transmission 

19 and the names and addresses of all parties to 

20 the transaction); and 

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

22 available to the Secretary for inspection at reason23 able time, records that— 
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1 ‘‘(i) with respect to each wholesale dis2 tribution of a drug subject to subsection (b), 

3 identifies— 

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

6 purchased; and 

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

9 sold or otherwise transferred; and 

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

12 States, identifies— 

13 ‘‘(I) each previous distributor of 

14 record from which the drug was purchased 

15 or otherwise transferred; and 

16 ‘‘(II) each subsequent distributor of 

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

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

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

21 353(e)) is amended by striking paragraph (3) and insert22 ing the following: 

23 ‘‘(3) For the purposes of this subsection and sub24 section (d)— 

25 ‘‘(A) the term ‘distributor of record’— 
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1 ‘‘(i) means a person that takes title to or 

2 possession of a drug subject to subsection (b) 

3 from manufacture to retail sale; 

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

5 processes, packs, distributes, receives, holds, 

6 imports, or offers for importation a drug sub7 ject to subsection (b); and 

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

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

10 States Postal Service, or equivalent governmental 

11 service of a foreign country, or a private carrier en12 gaged in the business of transporting packages for 

13 hire; and 

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

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

16 to other than the consumer or patient but not in17 cluding an intracompany sale or distribution of a 

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

Æ