The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on the list of bulk drug substances that can be used in compounding under section 503B.
Document
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Bulk Drug Substances Nominated for ...
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83 FR 12952
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“Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability,” thefederalregister.org (March 26, 2018), https://thefederalregister.org/documents/2018-06046/evaluation-of-bulk-drug-substances-nominated-for-use-in-compounding-under-section-503b-of-the-federal-food-drug-and-cosm.