To dispense buprenorphine, Opioid Treatment Programs (OTPs) must be SAMHSA-certified. OTPs use their Drug Enforcement Administration (DEA) registration to order the medication, and should modify their registration with DEA to add Schedule III narcotics to their registration certificates.
Patients receiving buprenorphine administered or dispensed by an OTP, from medication ordered under the program’s DEA registration, are patients of the OTP and do not count toward any practitioners patient limit.
OTPs providing approved buprenorphine products for opioid maintenance or detoxification treatment must conform to the federal opioid treatment standards under the Federal Opioid Treatment Standards, 42 CFR 8.12. These regulations require that OTPs provide medical services, counseling, drug testing, and other services to patients admitted to treatment.
The 2015 modification of 42 CFR 8.12 waives OTPs from the time in treatment requirements for patients receiving buprenorphine products, if an OTP practitioner determines the patient is suitable for unsupervised use (take home supplies).
Several federal laws and regulations permit practitioners to administer medications approved by FDA for the treatment of OUD under special circumstances without a buprenorphine waiver. Learn about these special circumstances.
Under the Confidentiality Regulation, 42 Code of Federal Regulations (CFR) 2, information relating to substance use and alcohol treatment must be handled with a higher degree of confidentiality than other medical information. As with the use of other medication-assisted treatment (MAT) medications to treat opioid use disorder (OUD), policies and procedures should be in place to guarantee patient privacy and the confidentiality of personally identifiable health information.