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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