On July 7, 2014, beginning at 9 a.m., the Tennessee Board of Pharmacy held a rulemaking hearing regarding the emergency rules that became effective on January 31, 2014. Board members present were Michael Dickenson, Kevin Eidson, Jason Kizer, Joyce McDaniel, Charles (Buddy) Stephens, and (via telephone) Will Bunch. Also present were Board of Pharmacy Executive Director Reginald (Reggie) Dilliard and Assistant General Counsel Stefan Cange, assisted by other Department of Health attorneys.
The emergency rules deal with sections of Board of Pharmacy rules as follows: Chapter 1140-01, Introductory Rules; Chapter 1140-07, Sterile Product Preparation in Pharmacy Practice; and Chapter 1140-09 Manufacturers and Wholesalers.
During the hearing, many members of the pharmacy community made formal presentations to the Board. All presenters commended and expressed support to the Board of Pharmacy for their efforts to update the rules in order to better serve and protect the public. The presenters asked for interpretations of certain sections of the rules, offered suggestions for simple changes in wording to address technicalities, expressed numerous concerns, and made suggestions to address many of those concerns. Comments came from Jim Hinkle (UT Knoxville), Richard Green (Cardinal Health), Brenda Warren (Accredo), Mark Binkley (Health and Wellness Compounding), Mark Sullivan (Vanderbilt), Bill Greene (St. Jude), and Baeteena Black (TPA). Board attorney Stefan Cange also reviewed comments submitted from Dennis Roberts (Baptist), Chuck Ashley (Methodist-Oak Ridge), Jeanne Ezell (Blount Memorial), Claudia Ogburn (LeConte), and Nina Smothers, a Board of Pharmacy member who was unable to attend.
The emergency rules set in place on January 31, 2014, expire 180 days from that date. Due to the need to have permanent rules in place, and the concern expressed by legal staff about the ability to make major revisions to the rules, the Board decided to make minimal changes at this time and then review comments and evaluate the need to make further changes at a future time. There was extensive discussion in regards to documentation, record keeping and reporting for low- and medium-risk compounds versus high-risk compounds and the difference between “inpatient” and “outpatient” in regards to application of the rules, among other items.
The Board of Pharmacy members approved the following changes from the original emergency rules to the newly approved rules:
1140-07-.02 (4)- Original (4) Any licensed pharmacy which compounds sterile products, except hospital pharmacies compounding for inpatients of a hospital, shall submit to the Board of Pharmacy, on a quarterly basis, a report listing the quantity of sterile products compounded and dispensed during the previous quarterly period and any other information as required by USP standards.
1140-07-.02 (4)-Revised(4) Any licensed pharmacy which compounds high-risk or batch sterile products, except hospital pharmacies compounding for inpatients of a hospital, shall submit to the Board of Pharmacy, on a quarterly basis, a report listing the quantity of sterile products compounded and dispensed during the previous quarterly period and any other information as required by
USP standards the Board of Pharmacy.
Although there was extensive discussion regarding the definition of “outpatient,” no clarification was made between “inpatient” versus “outpatient” at the hearing; however, the Board indicated their plans to create a policy which will provide their definitions of these terms as they apply to the rules.
Also discussed was the need for clarification on 1140-07-.02 (6), which requires licensed pharmacies to have the source and lot numbers of the components used in compounded sterile products and how this applies to hospital pharmacies. The Board provided clarification that this information must be on file with the pharmacy for access by the Board of Pharmacy. The Board indicated this does not mean that a pharmacy must know specifically which lot number each individual patient received under certain circumstances, such as batch prepared sterile compounds that are made available in the hospital, but that the pharmacy should be able to determine there were certain lot numbers in the pharmacy in a particular range of time, and which patients received products in that same range of time.
The rule changes will take effect in 90 days from their being finalized, which will be in early October, 2014.