21 U.S.C. § 356c : US Code - Section 356C: Discontinuance of life saving product

Search 21 U.S.C. § 356c : US Code - Section 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.