The FDA has sent warning letters to seven pharmacies ,within the last week regarding false or misleading claims about their made-to-order products, commonly marketed as bio-identical hormone replacement therapy (BHRT).
The FDA has also agreed to create public-awareness campaigns designed to dispel myths about “bio-identicals.”
Some pharmacies that make “bio-identicals” say they are all-natural and have fewer side effects, but “there is no credible scientific support for these claims,” Deborah Autor, compliance director for the FDA’s Center for Drug Evaluation and Research, said on a conference call with reporters.
There are an estimated 3,000 compounding pharmacies in the United States. The seven pharmacies given warning letters are in Pennsylvania, California and Texas.
Patients that use compounded hormone therapy drugs are advised to seek medical advice from their doctors about hormone therapy options.
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