[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1767 Introduced in Senate (IS)]







105th CONGRESS
  2d Session
                                S. 1767

     To amend the Federal Food, Drug, and Cosmetic Act to require 
 notification of recalls of drugs and devices, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 16, 1998

   Mr. Dodd 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 require 
 notification of recalls of drugs and devices, 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 ``Drug and Device Recall Reporting Act 
of 1998''.

SEC. 2. RECALLS.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 564. NOTIFICATION OF RECALLS.

    ``(a) Notification to Customers.--A pharmacy that receives notice 
from a recalling firm regarding a Class I or Class II recall of a drug 
or device shall provide notification about the recall to customers that 
received the drug or device as follows:
            ``(1) In the case of a drug or device dispensed by the 
        pharmacy to customers on the prescription of a licensed 
        practitioner, by providing, at a minimum, written notification 
        to each of the customers.
            ``(2) In the case of another drug or device, by public 
        display in the pharmacy of a notice regarding the recall.
    ``(b) Civil Penalty.--Any pharmacy that violates subsection (a) 
shall be liable to the United States for a civil penalty in an amount 
not to exceed $10,000 for each such violation.
    ``(c) Definitions.--In this section:
            ``(1) Class i or class ii.--The term `Class I' or `Class 
        II' refers to the corresponding designation given recalls in 
        subpart A of part 7 of title 21, Code of Federal Regulations, 
        or a successor regulation.
            ``(2) Recall.--The term `recall' means--
                    ``(A) a recall, as defined in subpart A of part 7 
                of title 21, Code of Federal Regulations, or a 
                successor regulation; and
                    ``(B) a recall under section 518(e).
            ``(3) Recalling firm.--The term `recalling firm' means--
                    ``(A) a recalling firm, as defined in subpart A of 
                part 7 of title 21, Code of Federal Regulations, or a 
                successor regulation; and
                    ``(B) a person subject to an order issued under 
                section 518(e)(1).''.
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