Another Compounding Pharmacy in Trouble
Operations at Boca Raton facility shut down by Fla. health department
Published: November 12, 2012
Recent headlines have to make you question the safety of ordering drugs from compounding pharmacies.
We all know about the recent deadly fungal meningitis outbreak, which appears to have been caused by shoddy practices at New England Compounding Center. Now another compounding pharmacy is in the news.
The Florida Department of Health has issued Rejuvi Pharmaceuticals in Boca Raton, Fla., an emergency suspension order (ESO) for a variety of practice violations.
A routine inspection found Rejuvi in violation of statutes relating to cleanliness of the prescription department, the dispensing of medications, the compounding of medications and record keeping. A few of the violations turned up at the Oct. 2 inspection, according to inspection documents provided by the Florida DOH:
- In the clean room, in violation of USP 797, open containers of products were observed next to brooms and dust pans; the sink had dirty sitting water and hoses connected to the faucet; and dead bugs and bug or rodent fecal matter were observed.
- Rejuvi was unable to produce dispensing records; the incorrect pharmacist was listed on most prescriptions; and the owner he "probably throws [invoices and pedigrees] away."
- One pharmacist arrived an hour after opening, presented an expired consultant license to the DOH, indicated he "did not know" the strengths of compounds made at the pharmacy, and described his duties as "'checking logs' without further explanation of additional duties."
What's more, a review of previous inspections revealed that Rejuvi had previously been notified of many of these violations and had failed to correct them. During inspections in 2009, daily logs were not properly maintained, medications were missing lot numbers and expiration dates, and the pharmacist on duty was sleeping in the prescription department, among other violations. In 2010, daily logs were still missing signatures, dates, invoices, pedigrees and prescriptions; and compounded drugs were missing lot numbers and expiration dates. Patient information and physicians' instructions were also missing, according to Florida DOH documentation.
The ESO isn't a final action, but is "imposed when the subject's actions pose an immediate serious danger to public health," according to a DOH press release.
When reached by phone, a man at Rejuvi refused to comment. No patient injuries have been associated with conditions at Rejuvi.
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