[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 593 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                 S. 593

  To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
              export of new drugs and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               March 22 (legislative day, March 16), 1995

  Mr. Hatch (for himself, Mr. Gregg, Mrs. Kassebaum, Mr. Abraham, Mr. 
  Frist, and Mr. Coats) introduced the following bill; which was read 
    twice and referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
              export of new drugs 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 ``FDA Export Reform and Enhancement 
Act of 1995''.

SEC. 2. EXPORT OF NEW DRUGS.

    Section 801(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e)) is amended--
            (1) in paragraph (1), by inserting after ``under this Act'' 
        the following: ``or in violation of section 505 or section 351 
        of the Public Health Service Act'',
            (2) in paragraph (1), by striking the last sentence, and
            (3) by amending paragraph (2) to read as follows:
    ``(2) Paragraph (1) does not apply to the export of--
            ``(A) any device--
                    ``(i) which does not comply with an applicable 
                requirement under section 514 or 515,
                    ``(ii) which under section 520(g) is exempt from 
                either such section, or
                    ``(iii) which is a banned device under section 516, 
                or
            ``(B) any drug (including a biological product) which does 
        not comply with an applicable requirement under section 505 or 
        512 or section 351 of the Public Health Service Act,
unless the device or drug is in compliance with the requirements of 
paragraph (1) and if the device or drug is to be exported to a country 
which is not a member of the World Trade Organization, the person 
exporting it has notified the Secretary of the export at least 30 days 
before the export and has included in such notice the name of the 
product, the country to which the product is being exported, and a 
brief description of the medical need for the device or drug in the 
country. In the case of a device or drug for which an export notice is 
required under this paragraph, the Secretary may prohibit the export of 
the device or drug if the Secretary determines that the possibility of 
the reimportation of the device or drug into the United States presents 
an imminent hazard to the public health and safety of the United States 
and the only means of limiting the hazard is to prohibit the export of 
the device or drug.''.

SEC. 3. EXPORT OF CERTAIN UNAPPROVED PRODUCTS.

    Section 802 (21 U.S.C. 382) is repealed.

SEC. 4. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

    Subsection (h) of section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended to read as follows:
    ``(h) A partially-processed biological product which--
            ``(1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man,
            ``(2) is not intended for sale in the United States, and
            ``(3) is intended for further manufacture into final dosage 
        form outside the United States,
shall be subject to no restriction on its export under this Act or the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).''
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