Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Ophthalmic Compounding: Heightened Sterility Scrutiny
A 2013 endophthalmitis outbreak and a January 2026 FDA warning letter show why ophthalmic compounding faces close sterility scruti…
Office Use Compounding: The State-by-State Problem
Section 503A requires a patient-specific prescription for compounded drugs, but state boards of pharmacy diverge sharply on office…
Nonresident Pharmacy Licensure for Compounders
Compounding pharmacies must secure a nonresident pharmacy license in every state they ship into, with inspection rules and penalti…
Media Fill Testing and Personnel Qualification
USP 797 sets media fill test frequency, the failure investigation process, and requalification rules for compounding pharmacy pers…
IV Admixture and TPN Compounding Compliance
USP 797 requires daily accuracy checks on automated compounding devices and specific documentation for gravimetric TPN verificatio…
Hormone Pellet Therapy and Compounding Enforcement
Compounded hormone pellets raise two enforcement risks at once: the 503A office-use prescription gap and FTC marketing claim expos…
Interstate Shipping Limits and the 5 Percent MOU
The FDA's 503A interstate distribution MOU is suspended, not signed by any state. Here is what the 5 percent cap requires until ru…
Extending Beyond-Use Dates: What Justifies It
USP <795> and <797> set default beyond-use dates, but extending them requires stability data meeting specific testing requirements…
FDA Form 483 Versus Warning Letter: What Each Means
How FDA's Form 483 inspection observations differ from a Warning Letter, and why a weak 483 response can trigger the more serious…