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Food and Drug Administration (FDA) Must register with the FDA Have to meet applicable state regulations in states they are licensed in Required to adhere to 21 CFR Part 210 and 211 under current Good Manufacturing Practices (cGMP) Facility, utilities, and equipment must be validated at start-up and routinely re-validated Environmental monitoring programs in 503B settings are typically more extensive and frequent than those required for 503A sterile compounding, reflecting cGMP expectations

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