Requests for Waivers to 21 CFR 1301.76(a)
Questions & Answers - Requests for Waivers to 21 CFR 1301.76(a)
The intent of this regulation is to prevent a registrant from hiring as an agent or employee, an individual who would most likely be denied a DEA registration if he or she applied for one on his or her behalf, or on behalf of a pharmacy owned or operated by that individual.
The purpose of the waiver process is to facilitate the hiring registrant in maintaining adequate safeguards against the diversion of controlled substances by either precluding the individual's employment when such employment would not be in the public interest, or ensuring that the employer is fully informed about the prospective employee's past so that adequate oversight and controls may be provided.
This regulation applies to individuals as follows:
1. Individuals who have been convicted of a drug related felony.
2. Individual who have had DEA registrations revoked or denied.
3. Individuals who have surrendered DEA registrations for cause at any time in the past and who have been hired since the August 1, 1991, effective date or who are currently seeking employment.
A registrant who employs or wishes to employ an individual who meets the criteria defined in 21 CFR 1301.76 (a) must apply for an exception to the application of the above section. The request for a waiver shall be filed with the Deputy Assistant Administrator, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152. The Deputy Assistant Administrator may grant an exception at his/her discretion, but in no case is required to grant an exception unless otherwise required by law or regulation.
The request for waiver should set forth the following:
1. The circumstances of the employee's or prospective employee's conviction or loss/surrender of DEA registration.
2. The status of the individual's state licenses.
3. The circumstances surrounding the individual's access to controlled substances and the degree of oversight the registrant intends to implement to guard against the diversion of controlled substances.**
4. The registrant will provide sufficient detail (copies of court or board actions, and/or operating procedures documenting control measures in place regarding the handling of controlled substances) to enable the DEA to make a fair evaluation of the situation.
**Access to controlled substances includes not only physical access, but also any influence over the handling of controlled substances such as purchases, inventories, issuance of medical orders, etc.
Once received by the DEA, all requests for waivers are sent to the appropriate DEA Field Office for a thorough investigation. Once the field completes a detailed investigative report, the report is then reviewed by the Diversion Control Division for verification of the facts and circumstances set forth, and for a decision. Waiver requests generally take a substantial amount of time to be processed. Following the Diversion Control Division's review, the Deputy Assistant Administrator will render a decision. The decision will be forwarded to the requestor as soon as possible.