Tennessee Tightens Regulations on Compounding Pharmacies

The Tennessee Board of Pharmacy said it has adopted new regulations for compounding pharmacies licensed by the state following recent outbreaks of illnesses associated with tainted medicines created at these specialty pharmacies.

The Pharmacy Board said in a news release that the new rules will improve safeguards for public health while also ensuring that drugs in short supply will be available. Compounding pharmacies mix custom formulations of drugs based on doctors’ specifications.

The board said the changes include expedited suspension of sterile compounding by a pharmacy or manufacturer after a serious problem is discovered and adding sterile compounding registration to licenses issued by the state.

Drug manufacturers doing business in Tennessee will also be required to show they are registered with the U.S. Food and Drug Administration.