503a Bulk List Guidance from the FDA


The FDA issued a guidance on May 24, 2019, in response to questions about a final rule from February 2019 on bulk drug substances that can be used to compound drugs under 503a of the federal Food, Drug and Cosmetic Act. The rule placed six substances on the bulks list for 503a facilities and excluded four others.

The newest guidance provides answers to questions about the list from February and what to do if you receive a prescription for or want to use one of the four bulk drug substances not included in the final rule: oxitriptan, piracetam, silver protein mild, and tranilast.

Download the FDA’s full guidance document >

One of the substances excluded from the February rule was oral oxitriptan for depression or insomnia – after several pharmacies and physicians contacted the FDA about compounding oral drugs with oxitriptan for tetrahydrobiopterin (BH4) deficiency, the FDA released a statement saying it does not object to oral oxitriptan for patients with BH4 deficiency.

Compounders are invited to respond to the FDA’s latest guidance document

Your comments are important
The FDA needs to hear from compounders – for more information on how to respond to the FDA’s rule, review their guidance document. You can also join with others in the compounding industry and provide your comments to the IACP (International Academy of Compounding Pharmacists).

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