Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Pharmacist Liability for Prescriptions Written by Telehealth Doctors
A pharmacist's corresponding-responsibility duty to evaluate a prescription's legitimacy applies to telehealth scripts, and federa…
FDA Office of Criminal Investigations Interviews With Pharmacists
How FDA OCI agents approach compounding pharmacists, what a voluntary interview means, and why counsel belongs in the room first.
Copay Waivers and Patient Inducements at Compounding Pharmacies
Routine copay waivers and free product offers at compounding pharmacies can trigger Anti-Kickback Statute, civil penalty, and Fals…
Target Letters to Pharmacists in Compounding Fraud Cases
What a federal target letter means for a compounding pharmacist, how it differs from subject status, and the risk of speaking to a…
Search Warrants at Compounding Pharmacies and What Staff Should Do
A practical staff protocol for a search warrant at a compounding pharmacy: scope, interviews, privilege, and records to request ba…
Research Use Only GLP-1 Products Sold to Clinics and Criminal Risk
Two federal prosecutions and an FDA warning letter show a research use only label does not shield clinics that inject patients wit…
Qui Tam Suits Against Compounding Pharmacies
Qui tam suits against compounding pharmacies can start with an employee relator and stay sealed under the False Claims Act for mon…
Payment Suspensions and Asset Freezes in Compounding Pharmacy Cases
Medicare, Medicaid, federal courts and the FDA can suspend a pharmacy's payments, freeze its accounts, or seize its drugs before a…
Misbranding and Adulteration Charges Against Compounding Pharmacists
Misbranding and adulteration charges under the FDCA turn on intent: a documented inspection finding can turn a misdemeanor into a…