Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 19 - DANGEROUS DEVICES AND SUBSTANCES
Chapter 10.19.03 - Controlled Dangerous Substances
Section 10.19.03.09 - Controlled Substances Listed in Schedules III, IV, and V

(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:

(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.

(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.

(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: