Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
State Board Compounding Inspections: Preparation and Response
State boards inspect compounding pharmacies under USP 797/800 standards, and a deficiency notice in one state can trigger multi-st…
Tirzepatide Compounding: Enforcement Risk After the Shortage List
Tirzepatide's shortage exemption closed in 2024. Eli Lilly's litigation campaign and FDA's Bulks List proposal now define compound…
Compounding Semaglutide After the Shortage Delisting: The Legal Landscape
FDA resolved the semaglutide shortage on February 21, 2025. What compounding pharmacies can still lawfully make now turns on docum…
Peptide Compounding: Regulatory Status and the Gray Market
Most peptides remain outside FDA's 503A Bulks List even as Category 2 status shifts, exposing compounding pharmacies to marketing…
GLP-1 Telehealth and Compounding Arrangements: Structuring for Compliance
GLP-1 telehealth fee arrangements are drawing Anti-Kickback Statute and corporate practice of medicine scrutiny for platforms, pre…
FDA Warning Letters to Compounders: The Response That Closes the File
FDA escalates unresolved Form 483 findings to a warning letter with its own 15 business day deadline, and reinspection decides whe…
Beyond-Use Dating: Where Compounders Get Cited
USP <795> and <797> set default beyond-use date limits for compounded drugs, and exceeding them without stability data is a common…
FDA Form 483 Observations: The 15-Day Response
FDA's 2026 guidance recommends a written Form 483 response within 15 business days, outlining the corrective-action evidence that…
503A vs 503B: Which Framework Governs Your Compounding
Section 503A and 503B compounding rules differ sharply on cGMP, registration, and prescription requirements pharmacies must weigh…