Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Common FDA Form 483 Observations at 503A Compounding Pharmacies
The categories of observation FDA investigators record on 503A Form 483s, from gowning and airflow to component records and beyond…
Ampules, Single-Dose Vials and Multiple-Dose Containers Under USP 797
USP 797 assigns a different in-use time to ampules, single-dose vials and multiple-dose containers, a separate clock from a prepar…
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…