What do you believe the current state of the law is with regard to the FDA's jurisdiction to inspect compounding pharmacies? If the current law allows the FDA to go in with the state boards of pharmacy and inspect when they suspect a compounding pharmacy is manufacturing, then does the FDA in fact have authority to inspect a pharmacy merely because it is "high-risk." What do you think the test should be?
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Subscribe to:
Post Comments (Atom)
1 comment:
The state boards of pharmacy clearly have inspection authority over pharmacies. If those boards "invited" FDA inspectors to come along, they could do a joint inspection. But, unless a pharmacy was also registered with the FDA as a manufacturer (which they aren't), the FDA can't inspect them without willing participation by the pharmacy (or a search warrant).
What is a BIGGER question, however, "Does the FDA have any enforcement power over pharmacies that fail inspections or have been identified as doing "manufacturing activities?" The answer to that question, despite what several Republican members of Congress believe, is NO. Franck's Compounding Lab was found not guilty (or had it's case thrown out of court, something like that), by pleading "Federalism" issues. "We're regulated by the states and the Federal Government (FDA) has no power over us. Nanny-nanny-poo-poo. Stick your head in doo-doo."
Unless Congress re-writes Section 353A of the FFDCA in such a way that is constitutional, the FDA simply has no teeth when it comes to compounding pharmacies. The most they can do is publish a redacted 383 inspection report, and hope a whistleblower-type community activist files a complaint with the state board of pharmacy, and that the over-worked employees in the state department of health will actually process the complaint (eventually), and the inexperienced and outmatched lawyers at the department of health will prosecute the complaint successfully (against the more-experienced, higher-paid defense lawyers these pharmacies hire), and that the state boards of pharmacy will eventually discipline these rogue pharmacies for the violations the FDA found 36 months prior.
Kenneth Woliner, MD
www.holisticfamilymed.com
www.holisticfamilymed.com
Post a Comment