Tennessee Board of Pharmacy Implements Rule to Facilitate Earlier Responses to Compounding Safety Issues

The Tennessee Board of Pharmacy has implemented a new rule that will effectively enable the Board to act more quickly when a potential safety issue at a facility engaged in compounding is detected. As indicated in a news release from the Board, the rule will “expedite suspension of sterile compounding by a pharmacy or manufacturer when a serious problem is detected,” by allowing an officer of the Board, the Board’s executive director, and the commissioner of the Tennessee Department of Health (TDH) to “jointly suspend for cause a sterile compounder’s license without waiting for a meeting of the full Board of Pharmacy.” Other new rules adopted by the Board will:

• Require manufacturers to be licensed as a separate category, whereas they were previously licensed under a combined manufacturer-wholesaler-distributor category,
• Require manufacturers to show proof of Food and Drug Administration (FDA) registration, and
• Add a sterile compounding registration to the regular pharmacy license, the manufacturer license, and to the wholesaler/distributor license.

A Tennessee Board of Pharmacy work group continues to collaborate with TDH staff on additional improvements to related regulations and procedures, as detailed in the news release.