Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
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…
Texas Moves to Rein in Ketamine Therapy: And Other States are Likely Next
The regulatory environment surrounding ketamine therapy is entering a new phase of maturity and enforcement. Recently, the Texas M…
Ketamine Marketing Risks for Mental Health Providers
Ketamine marketing is under increasing regulatory scrutiny, with providers facing risk over claims, off-label promotion, and patie…