21 USC 356c - Discontinuance of life saving product
Sec. 356c. Discontinuance of life saving product(a)
A manufacturer that is the sole manufacturer of a drug—
(1) that is—
(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.
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.
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.
Last modified: July 21, 2011