Napa, Calif. — Attendees learned about potential advantages of FDA-registered compounding facilities at the fall Cosmetic Bootcamp (CBC).
Many combination products available through FDA 503B-registered outsourcing facilities are unavailable from traditional drug developers, said Wm. Philip Werschler, M.D. That’s because commercial drugs must stick to the claims approved by the FDA through the new drug application (NDA) and abbreviated new drug application (ANDA) approval processes.
Conversely, he said, outsourcing facilities don’t tell physicians how to use their products. “A compounded medication doesn’t have a label with an indication. That is up to the prescribing doctor.” Dr. Werschler is a Spokane, Washington-based dermatologist in private practice and a clinical teaching professor at the University of Washington.
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