U.S. CODE

U.S. Code

§ 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

(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.

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.

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