FDA Plans Rules On 503A Compounding, Product Classification, Tobacco

By Beth Wang / December 13, 2021 at 6:38 PM
FDA plans to issue a handful of new proposed and final rules over the next year that would amend the agency’s list of substances that can and cannot be used by 503A compounders, establish new requirements for importers of electronic nicotine delivery systems, and exempt all manufacturers, repackers, relabelers or salvagers of certain medicated feeds from drug establishment registration requirements. The agency also has again pushed back its expected release dates for regulations that would clarify when the review period...

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