Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
BPC-157 and Compounding: The Regulatory Position
BPC-157 left FDA's Category 2 safety-risk list after its nominations were withdrawn, but it still is not on the approved 503A bulk…
Sterility Testing Under USP 797: When It Is Required
USP 797 ties sterility testing to a CSP's category, its beyond-use date, batch size and starting components, not to every preparat…
Segregated Compounding Areas Under USP 797: What Inspectors Cite
USP 797 limits segregated compounding areas to Category 1 preparations. Here is what inspectors cite on placement, certification,…
FDA's Bulk Drug Substance Categories 1, 2 and 3 for Compounders
FDA sorts nominated bulk drug substances into three interim categories, each carrying a different compounding posture and legal ex…
Owning Both a 503A Pharmacy and a 503B Outsourcing Facility
What FDA's guidance says, and does not say, about sharing an address, separating records, moving product, and interstate distribut…
Records to Have Ready for an FDA Inspection of a 503A Pharmacy
A records readiness checklist for 503A pharmacies: the prescription, formulation, distribution, complaint, and supplier files FDA…
Master Formulation Records and Compounding Records Under Inspection
What a master formulation record and a compounding record must contain, who has to sign off, and the documentation gaps inspectors…
Labeling Compounded Drugs: What FDA and Board Inspectors Check
A compounded drug's label must show required content, a compounded statement, and a beyond-use date, which differ between 503A and…
Florida Permits for Compounding Pharmacies and Outsourcing Facilities
Florida requires its own permits, separate from FDA registration, for sterile compounding pharmacies, outsourcing facilities, and…