FDA Preparing a List of Bulk Drug Substances for Compound Drug Products

The Food and Drug Administration (FDA) is preparing a list of bulk drug substances that outsourcing facilities may use to compound drug products in accordance with Section 503B of the Food, Drug and Cosmetic Act (FDC Act).  Requests for electronic and written nominations ended in early March 2014.

Section 503B of the FDC Act defines “bulk drug substance” as:

“any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.”

To qualify for specific exemptions under Section 503B, an outsourcing facility may not compound a bulk drug substance unless:

1. The bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, or the drug compounded from such bulk substances appears on the drug shortage list in effect under Section 506E of the FDC Act at the time of the compounding, distribution and dispensing;
2. “If an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, bulk drug (substances complies) with the monograph;”
3. The bulk drug substance is manufactured by an establishment that is registered under Section 510 of the FDC Act; and
4. The bulk drug substance is accompanied by a valid certificate of analysis (Section 503B(a)(2) of the FDC Act.