Sec. 4. Distributions from essential pediatric cancer drug reserve supplies
222 words·~1 min read·
/bill/118/hr/6963/ih/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
If a covered pediatric cancer drug is in shortage (as defined in section 506C(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c(h) )), or the Secretary has reason to believe that such a drug may be at risk of such a shortage, the Secretary may order a manufacturer with whom the Secretary has entered into an agreement under section 2 to distribute such drug from the reserve supply in accordance with such agreement in an effort to alleviate or prevent the shortage. The Secretary shall require a recipient of a covered pediatric cancer drug distributed under subsection
(a)to pay the Secretary for such drug. The amount of such payment shall not exceed the price for which the Secretary purchased such drug pursuant to an agreement under section 2. The Secretary may use payments received pursuant to paragraph
(1)only to replenish the reserve supply of the drugs distributed under subsection (a). If a manufacturer is not able or willing to distribute drugs in accordance with an order of the Secretary under subsection (a), the Secretary may take possession of and distribute such drugs. If a manufacturer can no longer hold or manage a reserve supply of covered pediatric cancer drugs in accordance with an agreement under section 2, the Secretary may take possession of the reserve supply.
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 4
Distributions from essential pediatric cancer drug reserve supplies
Cites 1Cited by 0 across 0 sources