21 U.S.C. § 356c — Discontinuance or interruption in the production of life-saving drugs

(a) In general. A manufacturer of a drug that is (1) life-supporting, life-sustaining, or intended for preventing or treating a debilitating disease or condition — including drugs used in emergency care, during surgery, or critical to public health during a declared public health emergency — and that (2) isn't a radiopharmaceutical or other product the Secretary designates as excluded, must notify the Secretary of a permanent discontinuance in making the drug, or an interruption likely to cause a meaningful disruption in the U.S. supply of the drug or its active pharmaceutical ingredient, and the reasons for it. The notice must disclose those reasons, including — if an active pharmaceutical ingredient is a cause — its source and any known alternative sources; whether a device used to prepare or give the drug is a cause; the interruption's expected duration; and any other information the Secretary requires. (b) Timing. Notice must be submitted at least 6 months before the discontinuance or interruption, or if that's not possible, as soon as practicable. (c) Distribution. To the maximum extent practicable, the Secretary must distribute information on these discontinuances or interruptions to appropriate organizations — including physician, health provider, and patient organizations — as described in section 356e. (d) Confidentiality. Nothing in this section authorizes the Secretary to disclose trade secrets or confidential information protected under section 552(b)(4) of title 5 or section 1905 of title 18. (e) Coordination with Attorney General. Within 30 days of receiving a notification, the Secretary must determine whether it involves a controlled substance subject to a production quota under section 826, and if necessary: notify the Attorney General of the notification; ask the Attorney General to raise the aggregate and individual production quotas for that substance and any of its ingredients to whatever level the Secretary deems necessary based on the best available market data; and if the Attorney General decides the requested level isn't necessary, the Attorney General must give the Secretary a written explanation, which the Secretary must post publicly on the FDA's website. (f) Failure to meet requirements. If a person fails to submit required information on time, the Secretary must send that person a letter about the failure. Within 30 calendar days of that letter, the person must submit a written response explaining the noncompliance and providing the missing information. Within 45 calendar days of the letter, the Secretary must post the letter and any response online, with appropriate redactions to protect confidential information — unless the Secretary determines the letter was issued in error, or after reviewing the response decides the person had a reasonable basis for not notifying, in which case posting isn't required. (g) Expedited inspections and reviews. If, based on notifications or other relevant information, the Secretary concludes a drug shortage exists or is likely, the Secretary must, as appropriate: prioritize and expedite review of a related supplement or application that could help prevent or mitigate the shortage; or prioritize and expedite an inspection or reinspection of an establishment that could help. (h) Definitions. "Drug" means a drug (as defined in section 321(g)) intended for human use and subject to section 353(b)(1); it doesn't include biological products, unless the Secretary provides otherwise by regulation under subsection (i). "Drug shortage" or "shortage" means a period when U.S. demand or projected demand for a drug exceeds its supply. "Meaningful disruption" means a production change reasonably likely to cause a more-than-negligible reduction in a manufacturer's supply of a drug, affecting the manufacturer's ability to fill orders or meet expected demand — but doesn't include interruptions from routine maintenance or insignificant changes, so long as the manufacturer expects to resume operations quickly. (i) Regulations. Within 18 months of July 9, 2012, the Secretary had to adopt a final regulation implementing this section, defining "life-supporting," "life-sustaining," and "intended for use in the prevention or treatment of a debilitating disease or condition." The Secretary may, by regulation, extend this section to biological products — including plasma-derived products and their recombinant versions — if that would benefit public health, taking into account existing supply-reporting programs and aiming to reduce duplicate notification; if the Secretary applies this to vaccines, the Secretary must consider whether notifying the Centers for Disease Control and Prevention under its vaccine shortage program can satisfy this section's notice requirement, and explain that determination in the regulation. To issue any implementing regulation, the Secretary must: publish a notice of proposed rulemaking; allow at least 60 days for comments; and publish the final regulation at least 30 days before its effective date. Despite any other federal law, the Secretary may only issue regulations under this section following that process. (j) Risk management plans. Each manufacturer of a drug described in subsection (a), or of its active pharmaceutical ingredient or an associated medical device used to prepare or give it, must develop, maintain, and implement, as appropriate, a redundancy risk management plan identifying and evaluating supply risks, for each establishment where the drug or its active ingredient is made. The Secretary may inspect and copy this plan.