Physicians who administer, dispense, or prescribe Schedule III substances, including buprenorphine, may be required to submit to random audits as a part of routine surveillance by the Drug Enforcement Agency.
The Drug Enforcement Administration (DEA) has recently sent letters to psychiatrists and other physicians who are registered with the DEA stating that it will be conducting on-site, unannounced inspections under the authority of the Controlled Substances Act (CSA).
The inspections are intended to ensure compliance with recordkeeping, security, and other requirements for administering, dispensing, or prescribing controlled substances under the CSA, according to the government agency.
Jennifer Tassler, J.D., deputy director for regulatory affairs in APA's Department of Government Relations (DGR), said that technically inspections can be conducted for any scheduled narcotic, but that the DEA initiative is focused on buprenorphine.
Tassler told Psychiatric News that DGR has been in contact with the agency and that the DEA has said the inspections are routine and not intended to intimidate or harass physicians or their patients.
DGR provided the following information about what to expect and how to alert APA if there is a problem:
•.
The inspector should present his or her DEA credentials and a “Notice of Inspection” to explain the process of the audit and the physician's rights. Physicians have the right to refuse to consent to the inspection and insist that the DEA obtain an administrative warrant. Members who believe they require legal advice should contact a local attorney.
•.
DEA agents will likely verify physician credentials including DEA registrations and state licensure and will ask to see three months of records. They will verify the number of patients being treated to ensure that it is in line with the limits outlined in the Drug Abuse Treatment Act of 2000.
•.
In the case of physicians who are dispensing or administering buprenorphine, DEA agents will likely take an inventory of the product on hand and reconcile that with the records of what was dispensed or administered. The investigator will also be checking to see that the drugs are properly secured within the facility.
•.
If the DEA investigator finds that there are administrative violations, he or she can issue a “Letter of Admonition” outlining the problems found in the audit. The physician then has 30 days to respond to the DEA with information about how the problem was corrected.
Members who receive an on-site audit and experience any problems should contact APA staff Jennifer Tassler at (703) 907-7842 or Beatrice Eld at (703) 907-8598. ![](/cms/10.1176/pn.45.1.psychnews_45_1_012/asset/images/blacksquare.jpeg)