USP <797>
Where a compounded drug parts company with an FDA-approved one, where 503A parts company with 503B, and which accreditation programs tell them apart.
Definition
The US Pharmacopeia chapter governing sterile compounding for humans — air quality, garbing, surface sampling and beyond-use dating. A 503A must demonstrate compliance to dispense sterile injectables such as compounded semaglutide. Inspections look at ISO Class 5 primary engineering controls, anteroom pressure differentials and operator media-fill testing.
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