FDA and state regulatory developments affecting peptides, including which bulk drug substances may be used in compounding.
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Every new official record on the Pharmacy, Compounding & Regulatory Intelligence desk since this morning, each linked to its primary source.
Automated from official records6 sources1 min read
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when…
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (…
