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Read More : Considerations for the 503B-to-503A-to-Patient Compounding Model Key Differences Between 503A and 503B: Regulations & Guidelines 503A Have to be registered with the Drug Enforcement Administration (DEA) and as a manufacturer of controlled substances (if manufacturing and distributing controlled substances) Have to meet state pharmacy board regulations and pertinent federal laws (section 503A of FD&C Act) Have to comply with USP , , and as applicable Not required to comply with cGMP Don’t need to be registered with the FDA Facility certifications are required every six months Beyond Use Dating (BUD) is typically shorter per USP limits and may be assigned based on internal or external scientific scientific evidence, not necessarily on product-specific stability testing 503B Regulated primarily by the U.S
