1. (1) Physical Requirements.

   1. (a) If the pharmacy practice site is engaged in the compounding of hazardous sterile products, a suitable facility to prepare such products and minimize the risk associated with such products shall be provided.
   2. (b) Such pharmacy practice site shall be designed and equipped for storage and have a procedure for disposal of materials containing hazardous residues in accordance with state and federal laws.
2. (1) A dedicated Class II, Type A contained vertical flow biohazard cabinet is the minimally acceptable compounding site for the routine compounding of hazardous sterile products.
3. (2) Hazardous sterile products shall be segregated within the pharmacy practice site and storage areas so identified.

4. (2) Dispensing.

   1. (a) Prepared doses of hazardous sterile products for patients shall be placed in an appropriate outer wrap to minimize the risk exposure in case of accidental rupture of the primary container.
   2. (b) Reasonable effort shall be made to assure that all hazardous sterile product primary containers and waste are removed from the site of use and disposed of as hazardous waste in accordance with applicable state and federal laws.

5. (3) Training.

   1. (a) As part of the training for all pharmacists, pharmacy interns and pharmacy technicians involved in compounding of hazardous sterile products, an annual certification must be made by each pharmacist, pharmacy intern and pharmacy technician and the pharmacist in charge that each has read and understands the latest editions of:

      1. 1. Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs (Occupational); and
      2. 2. The American Society of Health-System Pharmacists (ASHP) technical assistance bulletin on handling cytotoxic and hazardous substances.
6. (4) Hazardous sterile products dispensed shall bear a distinctive warning label with an appropriate caution statement thereon.
7. (5) Gloving and gowning shall be required in the compounding of hazardous sterile products. Gloves should be rinsed frequently with a sanitizing agent (e.g., seventy percent (70%) isopropyl alcohol) and shall be changed when the integrity of the gloves is compromised.
8. (6) In the compounding of hazardous sterile products, a protective disposable gown made of lint-free low permeability fabric with a closed front, long sleeves and elastic or knit closed cuffs with cuffs tucked under the gloves shall be worn. Gowns and gloves used in the compounding of hazardous sterile products shall not be worn outside the sterile product compounding area.

Authority: T.C.A. §§ 63-10-404(4), (11), (26), (27), (28), (29), and (30), and 63-10-504(b)(1), (2). Administrative History: Original rule filed October 1, 1987; effective November 15, 1987. Amendment filed March 30, 1994; effective June 13, 1994. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Emergency rules filed January 31, 2014; effective through July 30, 2014. Emergency rules expired effective July 31, 2014, and the rules reverted to their previous statuses. Rule was previously numbered 1140-07-.06, but was renumbered to 1140-07-.07 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments filed December 15, 2023; effective March 14, 2024. Amendments expired pursuant to Chapter 827, § 1 of the 2024 Public Acts, effective May 1, 2024, and the rules reverted to their previous statuses.