Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty […]