Federal (DEA) Recordkeeping Requirements for Buprenorphine Treatment

Physicians who are conducting office-based buprenorphine treatment should adhere to specific DEA medical recordkeeping requirements. Note that some of these requirements go beyond the standard Schedule III requirements.

Buprenorphine treatment records should include a log identifying patients (by name or ID number), name of drug prescribed or dispensed, strength/quantity of medication prescribed, and date of issuance. One way to comply with this requirement is by keeping a photocopy of the prescription within each patient's record. These records should be kept for at least 2 years.

Practitioners can decide if they want to keep these records within standard patient charts or if they want to keep separate buprenorphine treatment records. When the physician keeps separate records then only these records would be subject to review during a DEA audit. The DEA does recommend keeping buprenorphine records separate, but it is not required.

State requirements should also be reviewed as they may be more stringent.



Related Resources: 
Description: 
This webinar, presented by Cathy A. Gallagher, Associate Chief, Liaison and Policy Section of the DEA, explains rules and regulations regarding DEA requirements for buprenorphine treatment providers.
Source: 
PCSS-Buprenorphine
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Description: 
This is the full text of Title 21, Chapter 13 of the US Code, which deals with drug abuse prevention and control.
Source: 
Drug Enforcement Administration (DEA)
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Description: 
Manual written by the DEA to assist physicians in understanding and complying with the Federal Controlled Substances Act. Topics covered include recordkeeping requirements, rules regarding prescription, and security requirements.
Source: 
US Drug Enforcement Administration (DEA)
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