Find information pharmacists need to verify physician waivers to prescribe or dispense buprenorphine under the Drug Addiction Treatment Act (DATA 2000).
Buprenorphine products approved by the Food and Drug Administration (FDA) are available in pharmacies throughout the United States. Pharmacies and physicians can obtain the medication by contacting a pharmaceutical wholesaler directly.
While qualified physicians are required to have waivers to prescribe or dispense buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000), pharmacists and pharmacies are not required to have any credentials for dispensing these medications beyond those for other Schedule III medications. Certain federal laws and regulations, however, do affect pharmacy practice with regard to opioid dependency treatment prescriptions.
The Drug Enforcement Administration (DEA) categorizes buprenorphine in Schedule III of the Controlled Substances Act. Schedule III substances have a potential for abuse, but it is less than substances in Schedule II that include methadone, morphine, oxycodone, hydrocodone, and cocaine. The abuse of Schedule III substances, however, may still lead to physical dependence or psychological dependence. Review DEA’s drug scheduling definitions to learn more.
Tools and Guidance for Verifying Physician DATA 2000 Waivers
Pharmacists should go to the Buprenorphine Pharmacy Lookup to verify a physician's certification for buprenorphine.
Also, effective July 25, 2005, qualified physicians must include their DATA 2000 waiver identification number on prescriptions for opioid dependency treatment medications. Both their DEA registration and unique identification numbers must appear on prescriptions. When prescriptions are phoned in, pharmacists must have both these numbers on the prescription record. Physicians must provide these numbers if they are not already on file.
Guidance on the Clinical Use of Buprenorphine
Approved buprenorphine products have received FDA approval only for the treatment of opioid dependency. However, once approved, a medication may be prescribed by a licensed physician for any use that, based on the physician’s professional opinion, is deemed appropriate. Neither the FDA nor the federal government regulates the practice of medicine.
A licensed physician can use the approved product for uses other than those stated in the product label. Off-label use is not illegal, but it means that the data to support that use has not been independently reviewed by the FDA. Information on FDA policy regarding the off-label use of medications is available on the FDA website.