On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the Section 506C of the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA guidance discusses the requirement for applicants and manufacturers to notify the FDA of a "permanent discontinuance in the manufacture of certain products or an interruption in the manufacture of certain products that is likely to lead to a meaningful disruption in the supply of that product in the United States." The official guidance can be located here.
This alert provides an overview of the guidance.
Persons Covered
The people who will be affected by this notification procedure are:
- Applicants with an approved new drug application (NDA) or approved abbreviated new drug application (ANDA) for a covered drug product;
- Applicants with an approved biologics license application (BLA) for a covered biological product, other than blood or blood components;
- Applicants with an approved BLA for blood or blood components for transfusion, if the applicant is a manufacturer of a significant percentage of the U.S. blood supply; and
- Manufacturers of a covered drug product marketed without an approved NDA or ANDA.
Notification Requirements
Notifications under section 506C of the FD&C Act must be submitted to the FDA at least 6 months in advance of a permanent discontinuance or interruption in manufacturing. If 6 months' notice to the FDA is not possible because the discontinuance or interrupted was not "reasonably anticipated," then notice must be given as soon as possible, but no later than 5 business days after the discontinuance or interruption happens.
At a minimum, the notifications must specify:
- Name of the product, including the National Drug Code (NDC) number, or, for biological products, an alternative standard for identification and labeling if one has been recognized as acceptable by the Center Director;
- Name of the application holder (for approved products) or manufacturer (for unapproved drugs);
- Whether the notification relates to a permanent discontinuance of or an interruption in manufacturing the product;
- Description of the reason for the permanent discontinuance or interruption in manufacturing; and
- Estimated duration of the interruption in manufacturing.
The FDA recommends providing additional details about the situation and has included a list of non-inclusive questions for manufactures to review as they submit their notification. The list can be found on page 9 of the guidance located here. Providing as much information as possible to the FDA helps potentially mitigate and prevent shortages.
How to Notify the FDA
All initial notifications must be submitted electronically in a form that the FDA can process, review, and archive. A separate notification is required for each instance of discontinuance or interruption. All additional updates should be submitted to the appropriate email, and not through the NextGen Portal.
