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While 503B outsourcing facilities are licensed or registered by state regulators, they additionally have to comply with the FDAs more rigorous cGMP regulations (21 CFR Part 210 and 211)the same regulations as major human pharmaceutical manufacturers

Comparing 30-Day and Extended-Stability Formulations Licensed 503A pharmacies may offer both standard 30-day formulations and extended-stability options reaching 90 days

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