NASHVILLE -- The Tennessee Board of Pharmacy has taken action to strengthen its efforts to better assure safe, sterile compounding of drugs by entities licensed by the state. The measures collectively address the need for safe, effective and available medications for patients who need them.
"The board is working cooperatively to identify solutions to improve safeguards for public health while not placing unnecessary barriers on sterile compounding pharmacies that would hamper production of much-needed drugs already in short supply," said Tennessee Board of Pharmacy President Charles E. "Buddy" Stephens, D.Ph. "We believe our actions enhance existing safeguards and offer new steps to ensure safe and effective medications are there when needed."
The board has taken action to:
* Expedite suspension of sterile compounding by a pharmacy or manufacturer when a serious problem is discovered. New rules allow the officer of the Board of Pharmacy, its authorized executive director and the commissioner of the Tennessee Department of Health to jointly suspend for cause a sterile compounder's license without waiting for a meeting of the full Board of Pharmacy.
* Enhance oversight and regulation of drug manufacturing operations in the state. Licensed manufacturers will be a separate license category; previously manufacturers were included in the combined manufacturer-wholesaler-distributor classification.
* Work more closely with the U.S. Food and Drug Administration. Under new Board of Pharmacy requirements, drug manufacturers doing business in Tennessee will be required to show proof their operations are registered with the FDA.
* Add a sterile compounding registration to the regular pharmacy license, to the manufacturer license and to the wholesaler/distributor license.
These actions follow a recent outbreak in which physicians and clinics in 14 states received suspect medication from the Main Street Family Pharmacy, LLC, in Newbern, Tenn. The facility is licensed as both a pharmacy and a manufacturer/wholesaler/distributor.
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