§ 356c. Discontinuance of life saving product
(a)
In general
A manufacturer that is the sole manufacturer of a drug—
(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;
(3)
a liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period;
(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.