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