Tennessee Pharmacists Association

The Tennessee Board of Pharmacy newly revised rules, issued as emergency rules, primarily focusing on regulation of sterile compounding, became effective on January 31, 2014, and remain in effect until July 30, 2014. These emergency rules also contain other provisions, including increases in licensure and registration fees. The rules are posted on the Tennessee Secretary of State website at http://state.tn.us/sos/rules_filings/01-17-14.pdf.

In the interim time period, in accordance with requirements regarding promulgation of permanent rules, a public rules hearing will be held and comments on the proposed rules will be accepted. TPA will monitor this process and make its members aware of when the rules hearing will be held.

The rules regarding sterile compounding require preparation in compliance with applicable USP standards for pharmaceutical compounding [1140-07-.02(1)]. The Board of Pharmacy may waive the requirements of any applicable portion of USP standards. All waiver requests must be submitted to the Board of Pharmacy in writing [1140-07-.02(2)].

All pharmacies compounding sterile products are advised to review and comply with all requirements contained in the emergency rules. If a pharmacy is not in complete compliance with all rules, a waiver request will need to be submitted to the Board of Pharmacy.

TPA has been advised the Board of Pharmacy will be issuing more information regarding the waiver process in the near future. Board of Pharmacy Executive Director Reggie Dilliard indicated more information will be provided during the U.T. Pharmacy Update programs and during the TPA MidYear Meeting on Monday, February 24, 2014.

Questions should be directed to the Board of Pharmacy at 615-741-2718