The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide timely notification to the FDA in an effort to help mitigate drug shortages.
The entities that must make notification are listed as:
- Applicants with approved new drug applications (NDAs) or approved abbreviated new drug applications (ANDAs) for certain finished drug products.
- Applicants with approved biologics license applications (BLAs) for certain finished biological products other than blood or blood components.
- Applicants with approved BLAs for blood or blood components for transfusion that manufacture a significant percentage of the U.S. blood supply.
- Manufacturers of certain finished drug products marketed without approved NDAs or ANDAs.
The guidance also explains when to notify, suggesting that six (6) months before a known upcoming event however, if six (6) months is not possible then FDA expects notification as soon as practical. The document also contains a listing of what information to include in the notification of either finished dosage forms or active pharmaceutical ingredients. There is also a section on how to notify the FDA and the consequences of failure to notify. Lastly, it identifies how the FDA communicates information about drug and biologic shortages.