DEA Publishes Policy on Prescribers’ Legitimate Use of Agents
FDA Law Blog: DEA Publishes Policy on Prescribers’ Legitimate Use of Agents
By John A. Gilbert & Peter M. Jaensch
On October 6, 2010, the Drug Enforcement Administration (“DEA”) announced a Statement of Policy -
http://edocket.access.gpo.gov/2010/pdf/2010-25136.pdf - concerning the procedure by which a registrant-prescriber may use an agent, including a nurse in a long term care facility (“LTCF”), to communicate controlled substances prescriptions to a pharmacy.
DEA notes on background that “[w]hile the core responsibilities [of] prescribing controlled substances may not be delegated…an individual practitioner may authorize an agent to…communicat[e] such prescriptions to a pharmacy in order to make the prescription process more efficient.”
The Policy provides a discrete summary of “acts that an agent may take in connection with controlled substance prescriptions.” It enumerates that:
1. An agent may “prepare a written prescription for the signature of the practitioner,” provided the practitioner has “in the usual course of professional practice” made the necessary determinations regarding the legitimate medical need, and has specified the “required elements” of the prescription to the agent.
2. An agent may telephone a pharmacy concerning a prescription for a controlled substance in schedules III through V and convey the practitioner’s otherwise valid oral prescription provided the prescriber has specified all required prescription information.
3. Where otherwise permissible to fax a controlled substance prescription to a pharmacy, the agent may do the actual faxing.
The Notice further states that “[d]ue to the legal responsibilities of practitioners and pharmacists under the CSA and the potential harm to the public from inappropriate and unlawful prescribing and dispensing of controlled substances,” DEA advises practitioners and their agents to commit their agency authorization to writing.
Importantly, DEA states that a nurse in a LTCF may act as practitioner’s agent. The Notice closes with a sample of a written authorization that DEA would consider adequate. This is an area that industry has been seeking clarification on for a long time. DEA’s Notice moves this issue in the right direction.
Notably, the Notice advises that although “not required by DEA,” the agency authorization original should be kept by the practitioner during the life of the agency, and for the two years following. The DEA further notes that a pharmacist’s corresponding duty applies, and even where the pharmacists has a copy of the agency authorization, depending on circumstances, further inquiry may still be necessary to fulfill that duty in connection with a prescription communicated via agent.
The Federal Register Notice advises parties seeking further information to contact Mark W. Caverly, Chief of the Liaison and Policy Section, Office of Diversion Control, DEA, 8701 Morrissette Drive, Springfield, VA 22152, (202) 307-7297. 
opcorn:
Anyway, it will be interesting to see how this all plays out. 
)]
