After months of deliberating new rules for compounding pharmacies following the fungal meningitis outbreak that began last summer, the Tennessee Board of Pharmacy has approved new regulations for the drug makers.
The new rules allow the state to take quicker action against a compounder’s license when a serious safety issue arises, create a separate licensing category for medicine manufacturers, require proof that a manufacturer is registered with the U.S. Food and Drug Administration and require special registration whenever any pharmacy — whether retailer, manufacturer or wholesaler — performs sterile compounding.
The rules take effect as soon as legal notices are published, which could be as early as July. The board has also beefed up its staff with three pharmacists and an administrative person to enforce the new regulations.
More actions are being considered, said Dr. David Reagan, the chief medical officer for the Tennessee Department of Health. Although the board began looking at its rules following the fungal meningitis outbreak, a new health concern has underscored the need for better regulations.
While the fungal meningitis outbreak was traced to a steroid made by Massachusetts-based New England Compounding Center, another outbreak of what have thus far been less serious illnesses involving the same medicine has been linked to a Tennessee-based operation, Main Street Family Pharmacy in Newbern.
“Work continues in the background to try to do everything that we can do to create the safest environment we can create here in Tennessee,” Reagan said.
The Tennessee legislature with Gov. Bill Haslam’s approval removed one safeguard this year when it eliminated a patient-specific prescription requirement whenever a drug is not commercially available. The state Health Department did not object to the law change.
“It’s a great challenge to strike a thoughtful, protective balance between addressing the daily drug shortages faced by patients and health care providers across Tennessee with the absolute need to assure safety and effectiveness in the compounded product,” said Tennessee Health Commissioner Dr. John Dreyzehner. “While we wish the current situation associated with a Tennessee pharmacy had not happened and that patients had not been affected, the actions taken by the board, along with legislation passed recently, are moving us forward in assuring the safety and availability of important medications.”
The outbreak involving the Tennessee pharmacy, which was announced May 24, has sickened 25 people in four states. The illnesses reported thus far have been injection site infections.
The fungal meningitis outbreak involving New England Compounding Center, which was announced Oct. 1, has sickened 745 people with 58 deaths. Illnesses have been reported from 20 states.
Contact Tom Wilemon at twilemon@tennessean.com or 615-726-5961.
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