SEC. 506C. [21 USC §356c] Discontinuance of a Lifesaving 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 505(b) or 505(j); 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) 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, United States Code; 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) to appropriate physician and patient organizations.

[Section 507 repealed by Pub. L. 105–115, November 21, 1997.]