Glossary / Regulatory / 503A bulk drug substances list

503A bulk drug substances list

The list of bulk drug substances that may be used in compounding by pharmacies under section 503A. Inclusion follows a process of nomination, evaluation, and FDA action; a committee recommendation is a step in that process, not the outcome.

The list of bulk drug substances that may be used in compounding by pharmacies under section 503A. Inclusion follows a process of nomination, evaluation, and FDA action; a committee recommendation is a step in that process, not the outcome.

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