Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
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…
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…
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…
FDA and Novo’s Uncharted Waters to Exert Pressure on Hims & Hers and GLP-1 Compounders
Novo’s lawsuit against Hims & Hers, coupled with FDA’s referral to the DOJ, marks a direct escalation against 503A compounded sema…
What Wells Pharma v. Zyla Life Sciences Means for Compounding Pharmacies and Outsourcing Facilities
A pending Supreme Court case could reshape how compounding pharmacies face litigation under state unfair competition laws tied to…
Health Law Alliance Welcomes Compounding Expert Pharmacist-Attorney Dr. Martha Rumore as Of Counsel
Health Law Alliance adds powerhouse Pharmacist/Attorney Dr. Martha Rumore to their team of boutique healthcare attorneys.
FDA Targets GLP-1 and Peptide Compounding, Advertising and ‘Research Use Only’ Labeling
FDA ramps up enforcement on GLP-1s, peptides, RUO labeling, and compounding practices. See how 503A and 503B facilities are affect…
Darmerica - FDA Issues Warning Letter Targeting GLP-1 API Supply Chain Manufacturer
FDA issued a Warning Letter to Darmerica citing cGMP violations and improper distribution of GLP-1 and peptide APIs. Learn what th…