Bulk Drugs List


Like the NBA -The Draft of Five (5) Bulk Drug Products Reviewed, but Only One Selected to Compete in the Big Arena

The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products.  The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate.  Only quinacrine HCL for compounding for oral products for the treatment of […]

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503A Compounders May Get Another Bulk Substance Permitted, But For Now, Enforcement Discretion

In a Federal Register Notice (here) published today, the FDA announced a Compliance Policy which will exercise enforcement discretion relative to 503A compounders using the bulk drug, Oxitriptan, for compounding oral forms of the drug.  Remember, “FDA issued a final rule (84 FR 4696) (“February 19, 2019, final rule”), which established the list of bulk […]

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