In a May 2012 letter, the U.S. Drug Enforcement Administration (DEA) attempted to clarify a pharmacy's responsibilities under existing regulations for the proper prescribing and dispensing of controlled substances. Unfortunately, this "clarification" caused significant confusion for pharmacies and physician offices.
Pharmacies have long faxed "reminder letters" or prescription refill requests to notify prescribers that a previously authorized controlled substance prescription is about to expire. The California Medical Association (CMA) has received inquiries from physicians who report that pharmacies are no longer faxing prescription refills for controlled substances and in some cases that physicians are no longer allowed to fax prescriptions for controlled substances "because of a new DEA regulation."
The DEA confirms that there are no new laws or regulations on controlled substance prescription requirements. Rather, the DEA clarified in its letter that "a pharmacy may not initiate a reminder letter to a prescribing practitioner that provides a partially or fully pre-populated [prescription] form" because a controlled substance prescription can only be authorized after the prescriber determines that it is for a legitimate medical purpose.
Although some pharmacies may be misinterpreting the DEA's statement to be more restrictive than intended, pharmacies are not prohibited from contacting physicians by fax or phone to have the physician authorize a refill of a controlled substances prescription. The clarification was intended to emphasize that the reminder letter cannot contain a pre-populated prescription form. Some pharmacies will need to change how they handle prescription refill requests to ensure that they are in full compliance with the law.
For more information on the laws and regulations about prescribing controlled substances, see CMA On-Call document #0509, "Controlled Substances: Prescribing."
This document, as well as the rest of the California Medical Association's online health law library, is available free to members in CMA's online resource library at www.cmanet.org/cma-on-call. Nonmembers can purchase documents for $2 per page.
Contact: CMA Legal Information Line, (800) 786-4262 or email@example.com.