Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
The Demonstrably Difficult to Compound List
FDA has proposed three drug categories that could no longer be legally compounded under 503A or 503B. What the list covers, and ho…
Telehealth Partnership Models for Compounding Pharmacies
How telehealth platform fees to compounding pharmacies can cross into Anti-Kickback Statute exposure, and how to structure the agr…
Marketing Claims for Compounded Drugs
FDA and FTC apply separate rules to compounded drug marketing, and a single ad can trigger both. What claims are permitted, and wh…
State Professional Licensing Boards Take Aim at Peptides
State medical, nursing and pharmacy boards are taking an aggressive stance against clinical use of peptides despite FDA’s recent…
Veterinary Compounding Under the New FDA Guidance
GFI #256 narrows when compounded veterinary office stock is lawful, and state veterinary and pharmacy boards add a second layer of…
Writing an FDA Warning Letter Response That Works
A compounding pharmacy's FDA warning letter response has to show root cause analysis, a dated corrective action plan, and commitme…
USP 800 Hazardous Drug Compliance for Pharmacies
Containment requirements, the assessment of risk exception, and the inspection findings that follow a USP 800 compliance gap.
USP 795 Nonsterile Compounding Standards
What USP 795 requires for nonsterile compounding: master formulation records, beyond-use dating, and where FDA and state board ins…
Sterility Testing Failures and Your Response
A failed USP <797> sterility test triggers a root cause probe, a recall decision, and separate state board and FDA reporting dutie…