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Pharmaceuticals / Regulatory Affairs

FDA Denies Petition to Leave Testosterone Pellets off Difficult to Compound List

Nov. 15, 2018

The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it.

The agency has received more than 70 nominations of drugs to add to its list of meds that can’t be compounded under exemptions in sections 503A and 503B of the Food, Drug and Cosmetic Act.

The petition, submitted in 2015, argued that the pellets do not present compounding difficulties but were recommended for inclusion on the list by parties (like Auxilium, manufacturer of the only currently FDA-approved pellets) with a financial interest in keeping them from being compounded.

In denying the petition, the FDA noted that there’s a docket allowing public comments about newly or previously nominated products for the list and that’s where petitioners should submit comments.

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