International Prescription Drug Parity Act

International Prescription Drug Parity Act - Amends the Federal Food, Drug, and Cosmetic Act to replace certain drug reimportation provisions with provisions requiring manufacturers of prescription drugs, or drugs containing insulin, manufactured in a State and domestically approved and then exported, or domestically approved and manufactured in a registered foreign establishment, to maintain specified shipment records, provide required labeling, and make the records available to U.S. importers.

Directs the Secretary of Health and Human Services to establish related criteria to facilitate importation into the United States of such drugs.

[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1191 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                S. 1191

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 facilitating the importation into the United States of certain drugs 
 that have been approved by the Food and Drug Administration, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 9, 1999

  Mr. Dorgan (for himself, Mr. Wellstone, Ms. Snowe, and Mr. Johnson) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 facilitating the importation into the United States of certain drugs 
 that have been approved by the Food and Drug Administration, and for 
                            other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``International Prescription Drug 
Parity Act''.

SEC. 2. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND DRUG 
              ADMINISTRATION.

    (a) In General.--Section 801(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively; and
            (2) by striking ``(d)(1)'' and all that follows through the 
        end of paragraph (2) and inserting the following:
    ``(d)(1) If a covered drug is domestically approved and is 
manufactured in a State and exported, or such drug is domestically 
approved and is for commercial distribution and is manufactured in a 
foreign establishment registered under section 510(i), the manufacturer 
shall, as a condition of maintaining the domestic approval of the drug, 
comply with the following:
            ``(A) Without regard to whether a shipment of such drug is 
        intended for importation into the United States, for each 
        shipment of such drug, the manufacturer shall--
                    ``(i) maintain a record that identifies the 
                shipment of such drug;
                    ``(ii) maintain a record that details how such 
                shipment of such drug complies with current good 
                manufacturing practice and section 501; and
                    ``(iii) provide the labeling required for any such 
                drug pursuant to section 502 and pursuant to the 
                application for domestic approval.
            ``(B) Upon the request of a person who intends to import 
        into the United States drugs from such shipment (and who meets 
        applicable legal requirements to be an importer of covered 
        drugs), the manufacturer shall provide to the person a copy of 
        each of the records maintained under subparagraph (A) with 
        respect to the shipment.
    ``(2) For the purpose of facilitating the importation into the 
United States of covered drugs, the Secretary shall promulgate by 
regulation the following:
            ``(A) Criteria regarding the records described in paragraph 
        (1) and use of the records to demonstrate domestic approval of 
        the drugs and compliance with sections 501 and 502.
            ``(B) Criteria regarding labeling requirements for the 
        drugs that the Secretary determines to be appropriate.
            ``(C) Criteria regarding the amount of charges that may be 
        imposed by manufacturers of the drugs for maintaining and 
        providing the records specified in subparagraph (A).
    ``(3) In this subsection:
            ``(A) The term `covered drug' means a drug that is 
        described in section 503(b)(1) or is composed wholly or partly 
        of insulin.
            ``(B) The term `domestically approved', with respect to a 
        drug, means a drug for which an application is approved under 
        section 505, or as applicable, under section 351 of the Public 
        Health Service Act (42 U.S.C. 262). The term `domestic 
        approval', with respect to a drug, means approval of an 
        application for a drug under such a section.''.
    (b) Conforming Amendments.--
            (1) Section 801(d) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 381(d)) is amended in paragraph (5) (as 
        redesignated by subsection (a)(1)) by striking ``paragraph 
        (3)'' each place such term appears and inserting ``paragraph 
        (4)''.
            (2) Section 301(w) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 331(w)) is amended--
                    (A) by striking ``801(d)(3)'' each place it appears 
                and inserting ``801(d)(4)'';
                    (B) by striking ``801(d)(3)(A)'' and inserting 
                ``801(d)(4)(A)''; and
                    (C) by striking ``801(d)(3)(B)'' and inserting 
                ``801(d)(4)(B)''.
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