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.