On December 15, 2016 the FDA issued a proposed rule that proposes:
- Six substances for inclusion on the 503A bulks list;
- Criteria for evaluating nominating substances for inclusion on the list; and
- Four substance not be included on the list.
For more information, see CDER’s statement and the full proposed rule in the Federal Register. The public comment period on the proposed rule closes in 90 days. The Federal Register notice has information on how to submit comments.
The FDA’s website has more information on compounding.