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Friday, July 4, 2014
Eighth Question of the Day July 4, 2014 Which state has passed the most aggressive compounding pharmacy legislation in an attempt to clean up an industry gone bad? Michigan? Florida? Which state has done the best job of stepping up enforcement of the compounding pharmacy laws? Which states have made no attempt to pass new, better legislation? Which states have drug their heals on enforcing compounding phamacy regulations?
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Not Florida. They might say, "compounding pharmacies cannot distribute compounding drugs to physician offices for further resale/distribution/dispensing", nut they do not enforce it. I am registered as a dispensing practitioner, but once have they inspected my office. And myself, as a patient, was offered, by both my family doctor and dermatologist, compounded prescriptions dispensed directly from their offices. No enforcement, no protection of patients.
Now, due to some pretty vigorous complaining about the lack of enforcement and the lack of protection of patients,there has been a shakeup at the Florida Department of Health Bureau of Enforcement. Over the last two (2) years, several DOH employees have been replaced. Gone are Susie Love (Chief, Bureau of Enforcement ); Amie Rice (Chief, Consumer Services Unit); Jeanne Clyne (Chief, Investigative Services Unit); and Renne Alsobrook (Chief, Prosecution Services Unit). Does this mean that the Department of Health will start enforcing the laws and rules of the State of Florida? Or does it mean that when the Florida Lefislature starts holding investigative hearings, each new director can say, "I don't know anything about that. What you're asking about was before I got here"?
Until fines for pharmacies are in the $50,000 - $200,000 range, a rogue pharmacy that has a chance to gross over $5 million/year (and net 30-50% of that) won't blink an eye. Until investigations/prosecutions get completed in less than 2 years (as opposed to over 5 years, or longer (i.e., "never")), the compounding pharmacies will continue to hire the lawyers to delay prosecution and chalk it up to the cost of doing business. And nothing will change if the DOH does not bar an owner of a pharmacy who "voluntarily closes", "voluntarily relinquishes" or "gets their license revoked" from opening up another pharmacy down the street (e.g., Franck's Lab --> Trinity Care Pharmacy), in the same building with the same equipment and staff (e.g., ApotheCure --> NuVision Pharmacy Inc.), or under a straw owner (Don Poerce, an unlicensed person with a Cocaine possession arrest, signed a cease and desist order to shut down US Injectables (d/b/a www.ushcginjections.com), but he only shut down the corporation, kept the website(s) in operation,and used his lawyer, Russell Cheatham III, as a "straw owner" of a new pharmacy (Sterile Compounding Pharmacy) he registered on the same day he signed the C&D letter).
As you can see, Florida has a long way to go.
Autocorrect makes it hard to catch typos. Sorry about that ...
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