Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
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…
Peptides: Legal and Regulatory Risks 503A Compounding Pharmacies Must Understand
FDA scrutiny of peptide compounding is intensifying, and 503A pharmacies are squarely in focus. If you compound, source, or dispen…
Building a Regulatory Compliance Checklist for Ketamine Therapy Providers
Ketamine providers face growing regulatory scrutiny across prescribing, marketing, and care models. A focused compliance checklist…