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The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in production of finished drug products, biological products, and APIs. The guidance is part of the agency’s efforts to prevent drug shortages. How FDA communicates with the public about drug shortages is also addressed in the document.
Notification of manufacturing interruptions are required under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s regulations. Applicants and manufacturers of certain finished drugs are required to notify FDA of permanent discontinuance of such drugs or an interruption in manufacturing that may lead to a disruption of the supply of the drug in the United States. The agency must also be notified of permanent discontinuance or a disruption of manufacture of certain APIs that may lead to a shortage of supply. Applicants and manufacturers should provide additional details with FDA and follow procedures to ensure the agency has the information needed to prevent a shortage.
The guidance document details who must notify FDA and which products are subject to the requirements. It also details when FDA should be notified and what information should be included in the notifications. It also provides information on how to notify the agency and what happens if the agency is not notified.
More information on the agency’s strategies for preventing drug shortages, including a drug shortages database, can be found on its website at https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.