10.19.03.09

.09 Controlled Substances Listed in Schedules III, IV, and V.

A. Requirement of Prescriptions Listed in Schedules III, IV, and V (21 CFR §1306.21).

(1) A pharmacist may dispense directly a controlled dangerous substance listed in Schedules III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, or State Law, only pursuant to either a written prescription signed by a prescribing individual practitioner or a facsimile received by facsimile equipment of a written, signed prescription transmitted by the practitioner or the practitioner's agent to the pharmacy or pursuant to an oral prescription made by a prescribing individual practitioner and immediately reduced to writing by the pharmacist containing all information required in Regulation .07 of this chapter, except the signature of the prescribing individual practitioner.

(2) An individual practitioner may administer or dispense directly a controlled dangerous substance listed in Schedules III, IV, or V in the course of the individual practitioner's professional practice without a prescription, subject to Regulation .07 of this chapter.

(3) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled dangerous substance listed in Schedule III, IV, or V only pursuant to:

(a) A written prescription signed by a prescribing individual practitioner;

(b) A facsimile received by facsimile equipment of a written prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist;

(c) An oral prescription made by a prescribing individual practitioner and immediately reduced to writing by the pharmacist (containing all information required in Regulation .07 of this chapter, except for the signature of the prescribing individual practitioner); or

(d) An order for medication made by an individual practitioner, which is dispensed for immediate administration to the ultimate user, subject to Regulation .07 of this chapter.

B. Refilling of Prescriptions (21 CFR §1306.22).

(1) Unless otherwise instructed by the prescribing individual practitioner, a prescription for a controlled dangerous substance listed in Schedule III, IV, or V, may not be initially filled more than 120 days after the date on which the prescription was issued. If the prescribing individual practitioner instructs that the prescription be filled more than 120 days after the prescription was issued, a prescription for a controlled dangerous substance listed in Schedule III, IV, or V may not be initially filled more than 6 months after the date on which the prescription was issued. A prescription for a controlled dangerous substance listed in Schedule III, IV, or V may not be refilled more than 6 months after the date on which the prescription was issued. A prescription authorized to be refilled may not be refilled more than five times. 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 medication records (prior approval of the Department required), which indicates by the number of the prescription the name and dosage form of the controlled dangerous substance, the date of each refilling, the quantity dispensed, the identity or initials of the dispensing pharmacist in each refilling, and the total number of refills for that prescription, initialed, and dated by the pharmacist as of the date of dispensing. Each refilling of a prescription shall state the amount dispensed. If the pharmacist merely initials and dates the back of the prescription, the pharmacist shall be deemed to have dispensed a refill for the full face amount of the prescription. Additional quantities of controlled dangerous substances listed in Schedule III, IV, or V, beyond the five refill 6-month limitation, may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in §A of this regulation, which shall be a new and separate prescription.

(2) Instead of the procedures in §B(1) of this regulation, and subject to the requirements in 21 CFR §1306.22, an automated data process system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V.

C. Partial Filling of Prescriptions (21 CFR §1306.23). The partial filling of a prescription for a controlled dangerous substance listed in Schedule III, IV, or V is permissible, provided that:

(1) Each partial filling is recorded in the same manner as a refilling;

(2) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(3) No dispensing occurs after 6 months after the date on which the prescription was issued.

D. Labeling of Substances (21 CFR §1306.24).

(1) The pharmacist filling a prescription for a controlled dangerous substance listed in Schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in this prescription or as required by law.

(2) The requirements of §D(1) of this regulation do not apply when a controlled dangerous substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized, if:

(a) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled dangerous substance listed in Schedule III, IV, or V is dispensed at one time;

(b) The controlled dangerous substance listed in Schedule III, IV, or V is not in the possession of the ultimate user before administration;

(c) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled dangerous substance listed in Schedule III, IV, or V; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

E. Filing Prescription (21 CFR §1306.24). All prescriptions for controlled dangerous substances listed in Schedules III, IV, and V shall be kept in accordance with Regulation .05A of this chapter.

F. Dispensing without Prescription (21 CFR §1306.26). Unless prohibited by local or federal law, a controlled dangerous substance listed in Schedule V (Criminal Law Article, §5-406, Annotated Code of Maryland), which is not a prescription drug as determined by federal or State law, may be dispensed by a pharmacist without a prescription to a purchaser at retail according to the requirements stated in Criminal Law Article, §5-505, Annotated Code of Maryland.