Compounded Hormone Therapies Lack Evidence Of Safety And Effectiveness, Say National Academies

 
• By Joanne S. Eglovitch
  
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The US Food and Drug Administration should require that outsourcing facilities collect bioavailability data for compounded bioidentical hormone replacement therapy products, while compounding pharmacies should be required to report adverse events to state pharmacy boards and the FDA. Such actions would help resolve some of the safety concerns for these products, says a 1 July report from the National Academy of Sciences, Engineering and Medicine.

USP 800 Compounding pharmacy during business hours
how bioavailable are bioidentical hormone therapies? • Source: Shutterstock

Because there is insufficient “high-quality” evidence to establish the safety and effectiveness of bioidentical compounded hormone replacement therapy products (cBHT) for their prescribed uses, a new report by the National Academies of Sciences, Engineering and Medicines (NASEM) says the US Food and Drug Administration should require outsourcing facilities conduct bioavailability studies to assess their safety and effectiveness, and require compounding pharmacies to report adverse events to state boards of pharmacy and the agency.

The report also concluded that because compounders lack the specialized equipment needed to make complex pellet formulations used in some...

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