DEA Final Rule on Issuing Multiple Schedule II Prescriptions Goes Into Effect

December 27, 2007

The Drug Enforcement Administration’s (“DEA”) final rule allowing individual practitioners to issue multiple Schedule II prescriptions to individual patients to be filled sequentially went into effect on December 19, 2007.  The rule will allow practitioners to prescribe up to a 90-day supply of a Schedule II controlled substance. 

The federal Controlled Substances Act (“CSA”) and the regulations implementing the CSA prohibit the refilling of Schedule II prescriptions.  DEA’s final rule amends the regulations to allow individual practitioners to issue multiple prescriptions authorizing patients to receive “a total of up to a 90-day supply of a Schedule II substance,” provided:

1.         Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;

2.         The practitioner provides written instructions on each prescription indicating the earliest date on which a pharmacy can fill the prescription;

3.         The practitioner concludes that providing multiple prescriptions to the patient “does not create an undue risk of diversion or abuse;”

4.         Issuing multiple prescriptions is permissible under applicable state law; and

5.         The practitioner fully complies with all other requirements under the CSA and regulations as well as state requirements. 

DEA asserts that nothing in the amended regulation should “be construed as mandating or encouraging” practitioners to issue multiple prescriptions or to see their patients only once every 90 days.  Practitioners “must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients.”  In addition, practitioners must include instructions on each multiple prescription indicating that it shall not be filled until a certain date, and pharmacists cannot fill it before that date. 

The final rule asserts that the amended regulations do not alter the longstanding principle that neither the CSA nor the regulations contain a “specific limit on the number of days worth of a schedule II controlled substance that a physician may authorize per prescription.” 

By John A. Gilbert & Larry K. Houck