South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which organization issues the necessary waiver to prescribe buprenorphine?

1. FDA

2. CMS

3. DEA

4. SAMHSA

The correct answer is: SAMHSA

The correct answer is the Substance Abuse and Mental Health Services Administration (SAMHSA) because it is the agency responsible for overseeing the treatment of substance use disorders, including the regulation of medications like buprenorphine used in the treatment of opioid dependence. Specifically, SAMHSA provides the necessary waiver, known as the DATA waiver, allowing qualified practitioners to prescribe buprenorphine in an office-based setting for the treatment of opioid use disorder. Understanding this role is essential for healthcare professionals because prescribing buprenorphine is not allowed without this waiver, ensuring that only trained and certified providers can offer this treatment. This regulatory structure is designed to support effective treatment while maintaining oversight of potentially addictive medications. In contrast, while the FDA is involved in approving medications and will have regulatory authority over the general use of buprenorphine, it does not issue waivers specifically for prescribing purposes. The Centers for Medicare & Medicaid Services (CMS) focuses on providing and overseeing healthcare coverage rather than prescribing regulations. The Drug Enforcement Administration (DEA) regulates the distribution and control of controlled substances but does not grant the specific waivers for prescribing buprenorphine. Thus, the unique role of SAMHSA in the context of medication-assisted treatment for opioid use disorder makes it the