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M.DixonD

Policy recommendations We have applauded the announcement of more no-warning international manufacturing inspections, and for 503Bs, we suggest the following: Inspect every 503B within two months of registration Theres no such thing as a pop up 503B. It doesnt make sense to allow 503Bs to make drug products when other manufacturers in our system must have an inspection before shipping medicine

Performance benchmarks should include third-party test reports for efficacy claims like collagen production stimulation

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No medical, therapeutic, cosmetic, diagnostic, or performancerelated claims are made or implied.

When medical necessity does not require immediate treatment, the safest option is to wait