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DEA Clarifies Requirements for Prescribing Controlled Substances

On January 1, 2005, the U.S. Drug Enforcement Administration (DEA) published a request for comments in response to its withdrawal of guidelines on dispensing of controlled substances that had been released in August 2004.  Many comments, including those of AAPM&R, expressed concern about the DEA’s statement that physician preparation of multiple prescriptions for schedule II controlled substances on the same date with instructions to fill the prescriptions on different dates is tantamount to authorizing refills, a practice not allowed under the Controlled Substances Act (CSA).  In order to address some of the concerns voiced in the comments they received, the DEA issued a clarification in the August 26, 2005 Federal Register.

The clarification states that it is up to physicians to determine whether they should see patients receiving prescriptions for schedule II controlled substances every time a prescription is written or if a less frequent interval is appropriate.  Therefore, patients are not required to see a physician every month when receiving a prescription. However, the DEA reiterates the importance of physicians ensuring that there is a legitimate medical need for the controlled substance being prescribed and the importance of ensuring against diversion and misuse of the substance.

Furthermore, in instances when the physician determines that it is not necessary to see a patient in person, the DEA allows the prescription to be mailed to the patient or pharmacy or sent via fax directly to the pharmacy provided that the original signed prescription be presented before the controlled substance is dispensed to the patient.  Finally, the DEA indicates that current federal policy does not limit the number of days worth of a controlled substance that may be authorized per prescription, even though some states have mandated specific limits.

The clarification indicates the DEA’s intention to issue new guidelines, including the pertinent legal principles, on dispensing of controlled substances for the treatment of pain.

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