1. (1) At the time of dispensing of the sterile product, the dispensing container must bear a label which contains the following information:

   1. (a) Patient's name (if for outpatient use) or healthcare entity name;
   2. (b) Prescriber(s) name (if for outpatient use);
   3. (c) Pharmacy practice site name, address, and phone number (if for outpatient use);
   4. (d) Identification of the pharmacist who compounded the sterile product;
   5. (e) When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product;
   6. (f) Name and amount of drug added;
   7. (g) Expiration date and, when applicable, expiration time, Beyond Use Dating (BUD);
   8. (h) Date of compounding;
   9. (i) Appropriate auxiliary label(s); and
   10. (j) Directions for use (if for outpatient), if applicable.
2. (2) Original medical or prescription orders for sterile products shall comply with applicable state and federal laws and regulations.

Authority: T.C.A. §§ 63-10-204, 63-10-216, 63-10-301, 63-10-304, 63-10-306, 63-10-404(11), (14), (19), (26), (28), (29), (30), (32), and (34), 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-.05, but was renumbered to 1140-07-.06 with the addition of a new 1140-07-.02 filed July 11, 2014; effective October 9, 2014. Amendments 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.