FDA and the US Congress have taken action to curb false and misleading claims about compounded “bioidentical” hormone therapy (BHT) and to make compounded drugs safer. In 2008, FDA took action against seven compounders of BHT for false and misleading claims.
In 2013, after an outbreak of infections and some resulting deaths from a compounded drug, Congress passed the Drug Quality and Security Act. Signed into law in November 2013, the act gives FDA more regulatory powers over compounding pharmacies.
In addition to contamination, FDA is concerned about compounded hormone therapy drugs because there is no evidence that these “bioidentical” combinations are safer and more effective than or have side effects different from FDA-approved menopausal hormone therapy drugs. Furthermore, FDA tested a number of compounded hormones and found that the levels of hormones were not what was stated on the prescription.
Today, large-volume compounding operations producing sterile preparations may volunteer to come under FDA regulation as “outsourcing facilities,” but this does not apply to traditional compounders, which do most of the hormone compounding business. However, compounders that make up any hormone prescription containing estriol (which is not an FDA-approved drug) must obtain an investigational new drug application (IND) for it, which requires patients to receive information about the risks and benefits of the drug so they can give their informed consent and to be monitored. In addition, under the new law, FDA will be enhancing its communication with state boards of pharmacy (which regulate compounders) regarding actions against or concerns about compounders.
The North American Menopause Society (NAMS) confirms its support of the FDA and other scientific organizations that have warned women about the potential harm from custom-compounded hormone therapy products.