A bill to amend the Federal Food, Drug, and Cosmetic Act relating to the distribution chain of prescription drugs.

Amends the Federal Food, Drug, and Cosmetic Act to change the meaning of "authorized distributor" of a prescription drug from a distributor with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products to any distributor to which a manufacturer sells a prescription drug.

Requires the wholesale distributor of certain drugs who is not the manufacturer or an authorized distributor to provide to a drug recipient a statement that the drug was first purchased from or through an authorized distributor.

[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1132 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                S. 1132

   To amend the Federal Food, Drug, and Cosmetic Act relating to the 
               distribution chain of prescription drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 28, 2001

   Mr. Crapo 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 relating to the 
               distribution chain of prescription drugs.

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

SECTION 1. PRESCRIPTION DRUG DISTRIBUTION.

    (a) Definition of Authorized Distributor.--
            (1) In general.--Section 503(e)(4) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 353(e)(4)) is amended by 
        striking ``(4) For the purposes'' and all that follows through 
        ``means distribution'' in subparagraph (B) and inserting the 
        following:
            ``(4) Definitions.--In this subsection and subsection (d):
                    ``(A) Authorized distributor.--
                            ``(i) In general.--The term `authorized 
                        distributor' means a distributor to which a 
                        manufacturer sells a prescription drug.
                            ``(ii) Effective time period.--A 
                        distributor that purchases a prescription drug 
                        from a manufacturer shall be treated as an 
                        authorized distributor with respect to that 
                        prescription drug for a period of 12 months 
                        following the date of the purchase.
                    ``(B) Wholesale distribution.--The term `wholesale 
                distribution' means distribution.''.
            (2) Conforming amendments.--Section 503 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)(4)(A)) is 
        amended in subsections (d) and (e)--
                    (A) by striking ``authorized distributor of 
                record'' each place it appears and inserting 
                ``authorized distributor''; and
                    (B) by striking ``authorized distributors of 
                record'' each place it appears and inserting 
                ``authorized distributors''.
    (b) Required Statement.--Section 503(e)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(e)(1)(A)) is amended by inserting 
``a statement that the drug was first purchased from or through an 
authorized distributor or'' after ``who receives the drug''.
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