Tennessee Pharmacists Association

Today, the Tennessee Board of Pharmacy released its Gap Analysis for sterile compounding pharmacy inspections. This Gap Analysis is the culmination of many months of work led by Dr. Nina Smothers, Dr. Scott Denaburg, and Board of Pharmacy members and staff, along with input from TPA members and staff. Sterile compounding pharmacists should use this Gap Analysis to review their sterile compounding operating procedures, to ensure ongoing compliance with currently recognized Board rules and nationally-accepted standards. 

The Tennessee Board of Pharmacy’s Gap Analysis can be found by clicking on the following link: https://www.tn.gov/assets/entities/health/attachments/GAP_analysis_03122014.pdf.

TPA reminds pharmacists of the previous information regarding waivers, which was sent to TPA members on February 5, 2014. This notice may be viewed below.

Board of Pharmacy Sterile Compounding Rules in Effect

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.

Questions regarding the Gap Analysis or waiver process should be directed to the Board of Pharmacy at 615-741-2718