Interpretation of Federal Controlled Substance Prescription Refill Regulations (Resolution No. 98-8-02)

Topics: Resolutions

Resolution No. 98-8-02
Title: Interpretation of Federal Controlled Substance Prescription Refill Regulations

Whereas, 21 CFR 1306.22(a) provides that no prescription for a controlled substance listed in Schedules III or IV may be refilled more than five times, and 21 CFR 1306.23 allows for the partial filling of such prescriptions; and

Whereas, US Drug Enforcement Administration (DEA) personnel interpret these regulations to mean the five refill limit exists regardless of the quantity dispensed in each refill; and

Whereas, the intent of a prescribing practitioner in ordering a specific quantity of medication with refills is to assure the patient is able to obtain the full amount of the specified quantity; and

Whereas, the five refill limit, if dispensed in lesser quantities, may prevent the patient from obtaining the full amount ordered by the practitioner, which may be detrimental to the patient’s health;

THEREFORE BE IT RESOLVED that NABP encourage the DEA to clarify whether
21 CFR 1306.23 allows for the continued refilling beyond five refills up to six months of prescriptions for controlled substances listed in Schedules III or IV regardless of the number of partial refills dispensed, up to, but not to exceed, the total quantity prescribed by the practitioner on the original prescription.

(Resolution passed at NABP’s 98th Annual Meeting, Phoenix, AZ)