Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Vetting a 503B Outsourcing Facility Before You Order
A hospital, clinic, or practice that orders from a 503B outsourcing facility inherits its compliance record. A buyer-side checklis…
The 503B Bulk Drug Substances List and the Clinical Need Standard
The 503B Bulks List governs outsourcing facilities under its own clinical need standard, separate from the 503A list, with a short…
Insanitary Conditions Findings at Compounding Facilities
FDA uses the insanitary conditions theory under FDCA Section 501(a)(2)(A) to adulterate compounded drugs and drive recalls, withou…
FDA Escalation After a Warning Letter: Injunction, Seizure and Consent Decree
What follows an unresolved FDA warning letter: a voluntary recall request, seizure, a civil injunction, and the consent decree tha…
FDA Inspection of a Compounding Pharmacy: Scope, Records and Refusals
The Form 482 notice, 503A versus 503B records-access authority, sampling, photography, and what a refused inspection triggers.
503B Reporting Obligations After Registration
The recurring FDA duties a 503B outsourcing facility carries after registration: the biannual product report, annual renewal, and…
Brand Manufacturer Lawsuits Over Compounded GLP-1 Drugs
Brand-name GLP-1 manufacturers are suing compounders and telehealth sellers directly, using false advertising and trademark claims…
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…