
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC356c]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 356c. Discontinuance of life saving product


(a) In general

    A manufacturer that is the sole manufacturer of a drug--
        (1) that is--
            (A) life-supporting;
            (B) life-sustaining; or
            (C) intended for use in the prevention of a debilitating 
        disease or condition;

        (2) for which an application has been approved under section 
    355(b) or 355(j) of this title; and
        (3) that is not a product that was originally derived from human 
    tissue and was replaced by a recombinant product,

shall notify the Secretary of a discontinuance of the manufacture of the 
drug at least 6 months prior to the date of the discontinuance.

(b) Reduction in notification period

    The notification period required under subsection (a) of this 
section for a manufacturer may be reduced if the manufacturer certifies 
to the Secretary that good cause exists for the reduction, such as a 
situation in which--
        (1) a public health problem may result from continuation of the 
    manufacturing for the 6-month period;
        (2) a biomaterials shortage prevents the continuation of the 
    manufacturing for the 6-month period;
        (3) a liability problem may exist for the manufacturer if the 
    manufacturing is continued for the 6-month period;
        (4) continuation of the manufacturing for the 6-month period may 
    cause substantial economic hardship for the manufacturer;
        (5) the manufacturer has filed for bankruptcy under chapter 7 or 
    11 of title 11; or
        (6) the manufacturer can continue the distribution of the drug 
    involved for 6 months.

(c) Distribution

    To the maximum extent practicable, the Secretary shall distribute 
information on the discontinuation of the drugs described in subsection 
(a) of this section to appropriate physician and patient organizations.

(June 25, 1938, ch. 675, Sec. 506C, as added Pub. L. 105-115, title I, 
Sec. 131(a), Nov. 21, 1997, 111 Stat. 2332.)


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as an Effective 
Date of 1997 Amendment note under section 321 of this title.
