Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
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…
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…
Ketamine Clinics & Compounders Now the Focus of Increased DEA Enforcement
The DEA is increasingly targeting ketamine providers with record-keeping inspections and audits, making expert Medicare and DEA co…
Seized Ozempic Shipments Highlight Rising Demand and Safety Concerns
Ozempic, a well-known medication for type 2 diabetes, has gained popularity for its off-label use in weight loss, leading to incre…