FDA Finalizes Guidance on Evaluation of Bulk Drug Substances

March 7, 2019

The FDA issued final guidance on evaluating bulk drug substances that are being considered for the 503B bulks list, which specifies substances that outsourcing facilities may use in drug compounding.

The 503B bulks list — which the agency is still developing — will be comprised solely of substances that are used to compound drug products for which a clinical need exists. Currently, the agency is taking suggestions on substances to include on the list.

The agency said it will rule that there’s “no clinical need to compound using a bulk drug substance unless the nomination identifies a drug product that must be produced from the bulk drug substance rather than from an FDA-approved drug product.”

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