I

108TH CONGRESS

2D SESSION H. R. 3710

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

importation of prescription drugs.

IN THE HOUSE OF REPRESENTATIVES

JANUARY 20, 2004

Mr. WEXLER 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 with

respect to the importation of prescription drugs.

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

3 SECTION 1. IMPORTATION OF PRESCRIPTION DRUGS.

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 by striking section 804 and inserting the fol7 lowing:

8 ‘‘SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

9 ‘‘(a) DEFINITIONS.—In this section:
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1 ‘‘(1) IMPORTER.—The term ‘importer’ means a

2 pharmacist or wholesaler.

3 ‘‘(2) PHARMACIST.—The term ‘pharmacist’

4 means a person licensed by a State to practice phar5 macy, including the dispensing and selling of pre6 scription drugs.

7 ‘‘(3) PRESCRIPTION DRUG.—The term ‘pre8 scription drug’ means a drug subject to section

9 503(b), other than—

10 ‘‘(A) a controlled substance (as defined in

11 section 102 of the Controlled Substances Act

12 (21 U.S.C. 802));

13 ‘‘(B) a biological product (as defined in

14 section 351 of the Public Health Service Act

15 (42 U.S.C. 262));

16 ‘‘(C) an infused drug (including a peri17 toneal dialysis solution);

18 ‘‘(D) an intravenously injected drug;

19 ‘‘(E) a drug that is inhaled during surgery;

20 or

21 ‘‘(F) a drug which is a parenteral drug,

22 the importation of which pursuant to subsection

23 (b) is determined by the Secretary to pose a

24 threat to the public health, in which case sec25 tion 801(d)(1) shall continue to apply.
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1 ‘‘(4) QUALIFYING LABORATORY.—The term

2 ‘qualifying laboratory’ means a laboratory in the

3 United States that has been approved by the Sec4 retary for the purposes of this section.

5 ‘‘(5) WHOLESALER.—

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

7 means a person licensed as a wholesaler or dis8 tributor of prescription drugs in the United

9 States under section 503(e)(2)(A).

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

11 does not include a person authorized to import

12 drugs under section 801(d)(1).

13 ‘‘(b) REGULATIONS.—The Secretary, after consulta14 tion with the United States Trade Representative and the

15 Commissioner of Customs, shall promulgate regulations

16 permitting pharmacists and wholesalers to import pre17 scription drugs from Canada into the United States.

18 ‘‘(c) LIMITATION.—The regulations under subsection

19 (b) shall—

20 ‘‘(1) require that safeguards be in place to en21 sure that each prescription drug imported under the

22 regulations complies with section 505 (including

23 with respect to being safe and effective for the in24 tended use of the prescription drug), with sections
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1 501 and 502, and with other applicable require2 ments of this Act;

3 ‘‘(2) require that an importer of a prescription

4 drug under the regulations comply with subsections

5 (d)(1) and (e); and

6 ‘‘(3) contain any additional provisions deter7 mined by the Secretary to be appropriate as a safe8 guard to protect the public health or as a means to

9 facilitate the importation of prescription drugs.

10 ‘‘(d) INFORMATION AND RECORDS.—

11 ‘‘(1) IN GENERAL.—The regulations under sub12 section (b) shall require an importer of a prescrip13 tion drug under subsection (b) to submit to the Sec14 retary the following information and documentation:

15 ‘‘(A) The name and quantity of the active

16 ingredient of the prescription drug.

17 ‘‘(B) A description of the dosage form of

18 the prescription drug.

19 ‘‘(C) The date on which the prescription

20 drug is shipped.

21 ‘‘(D) The quantity of the prescription drug

22 that is shipped.

23 ‘‘(E) The point of origin and destination of

24 the prescription drug.
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1 ‘‘(F) The price paid by the importer for

2 the prescription drug.

3 ‘‘(G) Documentation from the foreign sell4 er specifying—

5 ‘‘(i) the original source of the pre6 scription drug; and

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

8 prescription drug originally received by the

9 seller from that source.

10 ‘‘(H) The lot or control number assigned

11 to the prescription drug by the manufacturer of

12 the prescription drug.

13 ‘‘(I) The name, address, telephone number,

14 and professional license number (if any) of the

15 importer.

16 ‘‘(J)(i) In the case of a prescription drug

17 that is shipped directly from the first foreign

18 recipient of the prescription drug from the

19 manufacturer:

20 ‘‘(I) Documentation demonstrating

21 that the prescription drug was received by

22 the recipient from the manufacturer and

23 subsequently shipped by the first foreign

24 recipient to the importer.
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1 ‘‘(II) Documentation of the quantity

2 of each lot of the prescription drug re3 ceived by the first foreign recipient dem4 onstrating that the quantity being im5 ported into the United States is not more

6 than the quantity that was received by the

7 first foreign recipient.

8 ‘‘(III)(aa) In the case of an initial im9 ported shipment, documentation dem10 onstrating that each batch of the prescrip11 tion drug in the shipment was statistically

12 sampled and tested for authenticity and

13 degradation.

14 ‘‘(bb) In the case of any subsequent

15 shipment, documentation demonstrating

16 that a statistically valid sample of the ship17 ment was tested for authenticity and deg18 radation.

19 ‘‘(ii) In the case of a prescription drug

20 that is not shipped directly from the first for21 eign recipient of the prescription drug from the

22 manufacturer, documentation demonstrating

23 that each batch in each shipment offered for

24 importation into the United States was statis-
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1 tically sampled and tested for authenticity and

2 degradation.

3 ‘‘(K) Certification from the importer or

4 manufacturer of the prescription drug that the

5 prescription drug—

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

7 United States and is not adulterated or

8 misbranded; and

9 ‘‘(ii) meets all labeling requirements

10 under this Act.

11 ‘‘(L) Laboratory records, including com12 plete data derived from all tests necessary to

13 ensure that the prescription drug is in compli14 ance with established specifications and stand15 ards.

16 ‘‘(M) Documentation demonstrating that

17 the testing required by subparagraphs (J) and

18 (L) was conducted at a qualifying laboratory.

19 ‘‘(N) Any other information that the Sec20 retary determines is necessary to ensure the

21 protection of the public health.

22 ‘‘(2) MAINTENANCE BY THE SECRETARY.—The

23 Secretary shall maintain information and docu24 mentation submitted under paragraph (1) for such
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1 period of time as the Secretary determines to be nec2 essary.

3 ‘‘(e) TESTING.—The regulations under subsection (b)

4 shall require—

5 ‘‘(1) that testing described in subparagraphs

6 (J) and (L) of subsection (d)(1) be conducted by the

7 importer or by the manufacturer of the prescription

8 drug at a qualified laboratory;

9 ‘‘(2) if the tests are conducted by the

10 importer—

11 ‘‘(A) that information needed to—

12 ‘‘(i) authenticate the prescription drug

13 being tested; and

14 ‘‘(ii) confirm that the labeling of the

15 prescription drug complies with labeling re16 quirements under this Act;

17 be supplied by the manufacturer of the pre18 scription drug to the pharmacist or wholesaler;

19 and

20 ‘‘(B) that the information supplied under

21 subparagraph (A) be kept in strict confidence

22 and used only for purposes of testing or other23 wise complying with this Act; and

24 ‘‘(3) may include such additional provisions as

25 the Secretary determines to be appropriate to pro-
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1 vide for the protection of trade secrets and commer2 cial or financial information that is privileged or

3 confidential.

4 ‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any es5 tablishment within Canada engaged in the distribution of

6 a prescription drug that is imported or offered for impor7 tation into the United States shall register with the Sec8 retary the name and place of business of the establishment

9 and the name of the United States agent for the establish10 ment.

11 ‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary

12 shall require that importations of a specific prescription

13 drug or importations by a specific importer under sub14 section (b) be immediately suspended on discovery of a

15 pattern of importation of that specific prescription drug

16 or by that specific importer of drugs that are counterfeit

17 or in violation of any requirement under this section, until

18 an investigation is completed and the Secretary deter19 mines that the public is adequately protected from coun20 terfeit and violative prescription drugs being imported

21 under subsection (b).

22 ‘‘(h) APPROVED LABELING.—The manufacturer of a

23 prescription drug shall provide an importer written au24 thorization for the importer to use, at no cost, the ap25 proved labeling for the prescription drug.
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1 ‘‘(i) CHARITABLE CONTRIBUTIONS.—Notwith2 standing any other provision of this section, section

3 801(d)(1) continues to apply to a prescription drug that

4 is donated or otherwise supplied at no charge by the man5 ufacturer of the drug to a charitable or humanitarian or6 ganization (including the United Nations and affiliates)

7 or to a government of a foreign country.

8 ‘‘(j) WAIVER AUTHORITY FOR IMPORTATION BY IN9 DIVIDUALS.—

10 ‘‘(1) DECLARATIONS.—Congress declares that

11 in the enforcement against individuals of the prohi12 bition of importation of prescription drugs and de13 vices, the Secretary should—

14 ‘‘(A) focus enforcement on cases in which

15 the importation by an individual poses a signifi16 cant threat to public health; and

17 ‘‘(B) exercise discretion to permit individ18 uals to make such importations in cir19 cumstances in which—

20 ‘‘(i) the importation is clearly for per21 sonal use; and

22 ‘‘(ii) the prescription drug or device

23 imported does not appear to present an

24 unreasonable risk to the individual.

25 ‘‘(2) WAIVER AUTHORITY.—
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1 ‘‘(A) IN GENERAL.—The Secretary may

2 grant to individuals, by regulation or on a case3 by-case basis, a waiver of the prohibition of im4 portation of a prescription drug or device or

5 class of prescription drugs or devices, under

6 such conditions as the Secretary determines to

7 be appropriate.

8 ‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV9 ERS.—The Secretary shall publish, and update

10 as necessary, guidance that accurately describes

11 circumstances in which the Secretary will con12 sistently grant waivers on a case-by-case basis

13 under subparagraph (A), so that individuals

14 may know with the greatest practicable degree

15 of certainty whether a particular importation

16 for personal use will be permitted.

17 ‘‘(3) DRUGS IMPORTED FROM CANADA.—In

18 particular, the Secretary shall by regulation grant

19 individuals a waiver to permit individuals to import

20 into the United States a prescription drug that—

21 ‘‘(A) is imported from a licensed pharmacy

22 for personal use by an individual, not for resale,

23 in quantities that do not exceed a 90-day sup24 ply;
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1 ‘‘(B) is accompanied by a copy of a valid

2 prescription;

3 ‘‘(C) is imported from Canada, from a sell4 er registered with the Secretary;

5 ‘‘(D) is a prescription drug approved by

6 the Secretary under chapter V;

7 ‘‘(E) is in the form of a final finished dos8 age that was manufactured in an establishment

9 registered under section 510; and

10 ‘‘(F) is imported under such other condi11 tions as the Secretary determines to be nec12 essary to ensure public safety.

13 ‘‘(k) CONSTRUCTION.—Nothing in this section limits

14 the authority of the Secretary relating to the importation

15 of prescription drugs, other than with respect to section

16 801(d)(1) as provided in this section.

17 ‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—There

18 are authorized to be appropriated such sums as are nec19 essary to carry out this section.’’.

20 (b) CONFORMING AMENDMENTS.—The Federal

21 Food, Drug, and Cosmetic Act is amended—

22 (1) in section 301(aa) (21 U.S.C. 331(aa)), by

23 striking ‘‘covered product in violation of section

24 804’’ and inserting ‘‘prescription drug in violation of

25 section 804’’; and
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1 (2) in section 303(a)(6) (21 U.S.C. 333(a)(6),

2 by striking ‘‘covered product pursuant to section

3 804(a)’’ and inserting ‘‘prescription drug under sec4 tion 804(b)’’.

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