1. (1) The authorized provider shall affix to the buprenorphine package a label showing at least the following information:

   1. (a) Name, address and telephone number of the OBOT Plus;
   2. (b) Prescription or medication order serial number;
   3. (c) Date of initial dispensing and/or refill date;
   4. (d) Name of the patient;
   5. (e) Name of the prescriber;
   6. (f) Name of the practitioner dispensing the medication;
   7. (g) Directions for use and cautionary statements, if any;
   8. (h) Name and expiration date of the product, if applicable;
   9. (i) The following controlled substance warning: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for who it was prescribed.”; and
   10. (j) Any other appropriate advisory labels.
2. (2) OBOT Plus facilities must ensure that buprenorphine products are packaged in a manner that is designed to reduce the risk of accidental ingestion, including the use of child-proof containers.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-402, 33-2-403, 33-2-404, 33-2-407, and Chapter 978 of the Public Acts of 2018. Administrative History: Original rules filed March 29, 2019; effective June 27, 2019.