Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
FDA Warning Letters to Telehealth Companies Selling Compounded Drugs
FDA warning letters now name the telehealth company, not just the pharmacy, over false or misleading claims about compounded semag…
FDA Inspection Classifications for Compounders: NAI, VAI and OAI
What FDA's NAI, VAI and OAI inspection classifications mean for a compounding pharmacy, and what an OAI finding can trigger next.
Compounded Pain Creams and Federal Fraud Prosecutions
DOJ has pursued civil settlements and criminal convictions over compounded pain and scar cream billing to TRICARE and Medicare Par…
Compounded GLP-1 Dosing Errors and Syringe Instructions
FDA has linked compounded semaglutide overdoses to mg-to-unit syringe confusion. The labeling and counseling records that protect…
California Sterile Compounding License and Board Inspection Issues
California requires a separate sterile compounding license, a pre-renewal inspection, and new rules for nonresident pharmacies shi…
Buying a Compounding Pharmacy: FDA and Board Due Diligence
A buyer's pre-closing checklist: FDA 483s, warning letters, EIRs, board inspection records, sterility failure history, and license…
Research Use Only Peptides Sold to Clinics: The Legal Risk
Clinics that inject patients with research use only peptides carry the same FDCA exposure as the supplier, and FDA's letters say t…
Peptide Compounding: Which Substances Are on FDA's Category 2 List
Five peptides carry FDA's Category 2 safety flag. A different set FDA's committee reviewed in July 2026 remains unlisted nominatio…
Compounded GLP-1 Marketing After the Shortage Ended
FDA warning letters to telehealth sellers and a compounding pharmacy show what GLP-1 marketing claims and compounding are still la…