Section 0940-05-36-.08 - LABELING AND PACKAGING OF BUPRENORPHINE PRODUCTS(1) The authorized provider shall affix to the buprenorphine package a label showing at least the following information: (a) Name, address and telephone number of the OBOT Plus;(b) Prescription or medication order serial number;(c) Date of initial dispensing and/or refill date;(e) Name of the prescriber;(f) Name of the practitioner dispensing the medication;(g) Directions for use and cautionary statements, if any;(h) Name and expiration date of the product, if applicable;(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(j) Any other appropriate advisory labels.(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.Tenn. Comp. R. & Regs. 0940-05-36-.08
Original rules filed March 29, 2019; effective 6/27/2019.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.