FDA: Know your bulks and excipients suppliers

Earlier this week, FDA issued a new guidance to compounders, Know Your Bulks and Excipients Suppliers.

In the document, FDA reminds compounders that sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act contain provisions regarding bulk drug substances (APIs) use in compounding, including:

• API compliance with applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph standards
• Sourcing API from FDA-registered facilities, and valid certificates of analysis. 

The announcement also points out provisions regarding excipient compliance with applicable USP or NF monograph standards.