Bulk Drugs List

08
Jul

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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