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
Saturday, June 8, 2013
Florida DOH issues Emergency Restriction Order vs HVVP Rx (d/b/a Prime Rx Pharmacy for compounding medications without a Prescription Department Manager (Supervising Pharmacist)
The owner of the pharmacy however, Mr. Vikas Ghiya, a licensed pharmacist himself, does NOT have an active Administrative Complaint against him, even though, as described in the Emergency Restriction Orders above, he owned a Pharmacy that did NOT have an active Prescription Department Manager, and that he was compounding sterile/injectable drugs, including chemotherapy drugs (which are given to immunocompromised patients), even though he was not properly qualified to do so (he didn't do media-filled tests to ensure sterility).
The questions that come to mind:
1. Will Florida's DOH Bureau of Enforcement file a complaint against Mr. Ghiya, a pharmacist:
- who was working in a pharmacy that did not have an active Prescription Department Manager;
- who lied to investigators by saying the prescription department manager (J.J.) was "out of town" as opposed to saying the truth that "J.J. no longer worked for the pharmacy and would not be returning", thereby making false and misleading statements in his role as a licensed pharmacist AND interfered with an investigative or disciplinary hearing;
- who was compounding sterile/injectable drugs outside of his training and licensure; and
- who possibly violated laws/rules of the Department or the Board of Pharmacy.