FDA Update

Prevention for Drug Shortages Being Addressed

Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” Guidance for Industry

The U.S. Food and Drug Administration announced the availability of a draft guidance to help prevent and mitigate drug shortages, titled: “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act”.

The purpose of this guidance is to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain APIs that may, in turn, help the agency in its efforts to prevent and mitigate drug shortages. While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications to FDA from manufacturers play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages. These notifications allow the agency to evaluate the situation and determine an appropriate course of action.

Comments and suggestions regarding this draft guidance should be submitted within 60 days of publication in the Federal Register to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance. All comments should be identified with the docket number FDA-2020-D-1057 listed in the notice of availability that publishes in the Federal Register. When finalized, this guidance will replace the March 2020 guidance for industry.

Questions?

For more information on Prevention for Drug Shortages please email us at: [email protected] and ref: Prevention for Drug Shortages.