[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3672 Introduced in House (IH)]







104th CONGRESS
  2d Session
                                H. R. 3672

    To amend the Federal Food, Drug, and Cosmetic Act to repeal the 
   provisions for the certification of drugs containing insulin and 
                              antibiotics.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 18, 1996

  Mr. Waxman introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to repeal the 
   provisions for the certification of drugs containing insulin and 
                              antibiotics.

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

SECTION 1. REPEAL OF CERTIFICATION OF DRUGS CONTAINING INSULIN.

    Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 
356) is repealed.

SEC. 2. REPEAL OF CERTIFICATION OF ANTIBIOTICS.

    Section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
357) is repealed.

SEC. 3. CONFORMING AMENDMENT.

    Section 505 (21 U.S.C. 355) is amended by adding at the end the 
following:
    ``(n)(1) On and after the date of the enactment of this subsection, 
antibiotic drugs shall be considered new drugs subject to this section. 
Except as provided in paragraph (2), an antibiotic drug certified 
pursuant to section 507 before such date of enactment or exempted from 
certification pursuant to such section before such date of enactment 
shall be considered a new drug for which an application has been filed 
pursuant to subsection (b) and approved for safety and effectiveness 
pursuant to subsection (c) or, in the case of an abbreviated 
application under section 507, shall be considered a new drug for which 
an application has been filed and approved pursuant to subsection (j).
    ``(2) Subsection (c)(3)(D) or (j)(4)D) shall not apply to an 
antibiotic drug certified or exempted from certification pursuant to 
section 507 before the date of the enactment of this subsection. 
Subsection (c)(3)(D) or (j)(4)(D) shall apply to such antibiotic drug 
if, subsequent to the date of the enactment of this subsection, the 
conditions of approval of such drug are changed.''.
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