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Alliance for Pharmacy Compounding Reacts to Release of NASEM Studies


The Alliance for Pharmacy Compounding (APC) reacted to the release of two FDA-commissioned studies concerning compounded medications by the National Academies of Science, Engineering and Medicine (NASEM).

Reacting to the release of the first study, Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use, APC’s statement said that “There’s not much new here. It gets some things right but misses some essential nuance, too.” APC noted that “One substantive shortcoming of the study is its failure to look at the relative risks of topical pain gels comparing them to other treatment options, particularly narcotic medications. While compounded pain gels are not without risks, we note that deaths related to topical pain gels are almost negligible by comparison to those from many FDA-approved oral narcotic products.”

In its announcement of the second study, The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use, NASEM concluded that “prescribers should restrict the use of non-FDA-approved compounded bioidentical hormones, except for specific medical circumstances.” APC’s statement said the NASEM study “feels a lot like the movie Groundhog Day, only without Bill Murray for laughs. Which is to say: We’ve seen this sort of thing before.” The statement noted that “NASEM’s recommendations on cBHT hew conveniently close to FDA’s stated concerns about cBHT … but that doesn’t mean all of [the] recommendations … are reasonable or based on a thorough exploration of evidence and outcomes.”

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