The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or interruption in manufacturing finished products and active pharmaceutical ingredients (APIs) to reduce the impact of drug shortages.
The guidance, when finalized, will replace an immediately effective guidance on the topic issued in the early days of the COVID-19 pandemic. (RELATED: Notifying FDA of Drug Shortages During the Pandmeic: FDA Offers Guidance, Regulatory Focus 27 March 2020)
The guidance addresses changes made under the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020, which requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain products, an interruption in the manufacture of certain products that is likely to lead to a “meaningful disruption” in the supply of products, or a permanent discontinuance in the manufacture of API for certain products, or an interruption in the manufacture of API for certain products that is likely to lead to a meaningful disruption in the supply of the API for those products…
