1310.1 A prescription for a controlled substance listed in Schedule III, IV, or V may not be filled or refilled more than six (6) months after the date on which the prescription was issued.

1310.2 A prescription authorized to be refilled may not be refilled more than five (5) times.

1310.3 Each refilling of a prescription shall be entered on the back of the prescription, or on another appropriate, uniformly maintained, readily retrievable record such as a patient profile. The following information must be retrievable by the prescription number:

1. (a) The name of the controlled substance, or the name and manufacturer of the drug if it is a substitute or generic drug for the drug actually prescribed or filled initially;
2. (b) The strength and dosage form of the controlled substance;
3. (c) The date of each refilling and the quantity dispensed;
4. (d) The identity or initials of the dispensing pharmacist for each refill; and
5. (e) The total number of refills for that prescription.

1310.4 Each refilling of a prescription shall state the amount dispensed.

1310.5 If the pharmacist merely initials and dates the back of the prescription, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.

1310.6 The prescribing practitioner may authorize additional refills of a Schedule III, IV or V prescription controlled substance on the original prescription or through an oral refill authorization transmitted to the pharmacist provided that the following conditions are met:

1. (a) The total quantity authorized, including the amount of the original prescription, does not exceed five (5) refills or extend beyond six (6) months from the date of issue of the original prescription;
2. (b) The pharmacist obtaining the oral authorization shall record the date, quantity of refill, and number of additional refills authorized, on the

reverse of the original prescription and initial the prescription documenting that he or she received the authorization from the prescribing practitioner who issued the original prescription; and

(c) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

1310.7 Additional quantities of prescription controlled substances listed in Schedule III, IV or V, beyond the five (5) refill, six (6) month limitation, shall only be authorized by a prescribing practitioner through the issuance of a new and separate prescription.

1310.8 As an alternative to the procedures provided under § 1310.3 of this chapter, an automated data processing system may be used for the storage and retrieval of refill information for prescription drug orders for controlled substances in Schedule III, IV, or V, subject to the conditions outlined under 21 C.F.R. § 1306.22(b).

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009).