FDA updates guidance on reporting manufacturing disruptions for finished products and APIs

The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or interruption in manufacturing finished products and active pharmaceutical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.

The following groups must provide such notifications: Applicants with approved new drug applications (NDAs) or approved abbreviated new drug applications (ANDAs); applicants with approved biologics license applications (BLAs); applicants with approved BLAs for blood or blood components for transfusion that manufacture a significant percentage of the US blood supply, and manufacturers of certain finished drug products marketed without approved NDAs or ANDAs.

The guidance specifies that manufacturers must notify FDA at least six months in advance of a permanent discontinuance in manufacturing of a finished product or an API if an interruption in manufacturing of a finished product or API is likely to lead to a “meaningful disruption” in supplying a product in the United States.

Notifications concerning a permanent discontinuance or interruption of a covered finished product must include:

Name of the product, including the National Drug Code (NDC) number, or, for biological products, an alternative standard for identification and labeling.

Name of the applicant (for approved products) or manufacturer (for unapproved drugs).

Whether the notification relates to a permanent discontinuance of the product or an interruption in manufacturing of the product.

Description of the reason for the discontinuation or interruption in manufacturing.

If an API is a reason for, or risk factor in, the discontinuation or interruption, the source of the API.

In addition, FDA recommends that the following information be provided, but such reporting is optional:

Whether the notification concerns an unavoidable supply disruption or a supply disruption that may be preventable.

The underlying reason or root cause leading to this notification. FDA states that “a detailed and thorough explanation beyond ‘manufacturing delay’ … is especially important and allows FDA to identify and use the most appropriate and effective mitigation tools.”

For APIs, manufacturers must provide the following information regarding discontinuances:

Disclose the reasons for the discontinuation or interruption in the manufacturing of the API.

The source of the API and any alternative sources for the API known by the finished product manufacturer.

The expected duration of the interruption in manufacturing of the API.

The deadline for submitting comment is 5 June 2022.

Draft guidance

FDA updates guidance on reporting manufacturing disruptions for finished products and APIs

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