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; (d) Name of the patient; (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.