Federal Law - DATA 2000
There are two major federal laws that, among other provisions, permit the prescribing of buprenorphine in the office-based setting and describe the requirements and limitations:
- The Drug Addiction Treatment Act (DATA 2000)
- The Comprehensive Addiction and Recovery Act of 2016 (CARA)
The Drug Addiction Treatment Act (DATA 2000) was an amendment to the Controlled Substances Act signed into law in 2000. DATA made it possible for qualified physicians to prescribe buprenorphine for opioid detoxification and maintenance therapy. The law allowed physicians to be granted a waiver from the special registration requirements of that act, which allows them to prescribe, dispense, or administer buprenorphine to patients in their office, greatly expanding the availability and accessibility of opioid addiction treatment. It also described regulations that govern this prescribing.
The waiver applies to Schedule III, IV, or V medications approved by the FDA for treating opioid use disorder, however, this currently only applies to buprenorphine products (SAMHSA, 2016).
DATA 2000 in Nontraditional Settings: Under DATA 2000, treatment for opioid use disorder can take place in nontraditional settings, such as primary care offices (Pade et al., 2012; Alford et al., 2011; Kahan et al., 2011). An advantage is that, in the past, some patients may have avoided treatment at substance abuse clinics due to worries about stigma and confidentiality.
- DATA described specific guidelines that physicians must follow before starting to prescribe buprenorphine. These include an 8 hour equivalent training.
- DATA does not include methadone—only a licensed opioid treatment program can prescribe methadone (DATA, 2000).
Some provisions of the DATA 2000 act were revised by CARA 2016, which is described in the following pages.