Are There Any Regulatory Challenges with Bioidentical Compounds?
Bioidentical compounds present several regulatory challenges. Since many of these compounds are compounded in pharmacies, they fall outside the purview of the Food and Drug Administration (FDA). This regulatory gap means that the quality, safety, and efficacy of bioidentical hormone therapies can vary widely. Toxicologists and regulatory bodies are working to develop guidelines and standards to ensure that bioidentical compounds meet safety requirements similar to those of conventional hormone therapies.
