[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1885 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 1885

   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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 20, 1999

Mr. Berry (for himself, Mr. Sanders, Mrs. Emerson, Mr. Rohrabacher, Mr. 
 Abercrombie, and Mr. Lewis of Georgia) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 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.

    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 (as defined in paragraph (3)) is 
domestically approved and is manufactured in a State and then exported, 
or is domestically approved and is for commercial distribution 
manufactured in a foreign establishment registered under section 510, 
the manufacturer shall, as a condition of maintaining the domestic 
approval of the drug, comply with the following:
            ``(A) For each shipment of the drug that is manufactured in 
        compliance with current good manufacturing practice and other 
        standards under section 501, the manufacturer shall maintain a 
        record that identifies the shipment and states the fact of such 
        compliance, without regard to whether the shipment is intended 
        for importation into the United States.
            ``(B) For each such shipment, the manufacturer shall 
        maintain a record that identifies the shipment and provides the 
        labeling required for the drug pursuant to section 501 and 
        pursuant to the application for domestic approval, without 
        regard to whether the shipment is intended for importation into 
        the United States.
            ``(C) 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 subparagraphs (A) and (B) 
        with respect to the shipment.
    ``(2) For the purpose of facilitating the importation into the 
United States of covered drugs, the Secretary shall by regulation 
establish the following criteria:
            ``(A) Criteria regarding the records required in paragraph 
        (1) and the use of the records to demonstrate the domestic 
        approval of the drugs and compliance of the drugs with sections 
        501 and 502.
            ``(B) Such criteria regarding the labeling of the drugs as 
        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) For purposes of this subsection:
            ``(A) The term `covered drug' means a drug that is 
        described in section 503(b) 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. The term `domestic approval', with respect 
        to a drug, means approval of an application for a drug under 
        such a section.''.
    (b) Conforming Amendment.--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) of this section) by striking 
``paragraph (3)'' each place such term appears and inserting 
``paragraph (4)''.
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