[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3462 Introduced in House (IH)]







105th CONGRESS
  2d Session
                                H. R. 3462

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 12, 1998

Mr. Shays (for himself and Mr. Kucinich) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 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 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) 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
                    ``(B) a person subject to an order issued under 
                section 518(e)(1).''.
            ``(2) Class i or class ii.--The term Class I or Class II 
        refers to the designation given recalls in subpart A of part 7 
        of title 21, Code of Federal Regulations.
            ``(3) Recall.--The term `recall' means--
                    ``(A) a recall as defined in subpart A of part 7 of 
                title 21, Code of Federal Regulations; or
                    ``(B) a recall under section 518(e).
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