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 10.19.03.08 - Controlled Substances Listed in Schedule II

Current through Register Vol. 51, No. 14, July 12, 2024
A. Requirement of Prescription-Schedule II
				  (21 CFR §
											1306.11).
(1) A pharmacist may dispense directly a
				  controlled dangerous substance listed in Schedule II, which is a prescription
				  drug as determined under the Federal Food, Drug, and Cosmetic Act, only
				  pursuant to a written prescription signed by the prescribing individual
				  practitioner, except as provided in §A(4) of this regulation. Except as
				  noted in §A(5)-(7) of this regulation, a prescription for a Schedule II
				  controlled substance may be transmitted by the practitioner or the
				  practitioner's agent to a pharmacy by facsimile equipment, if the original
				  written, signed prescription is presented to the pharmacist for review before
				  the actual dispensing of a controlled substance.
(2) An individual practitioner may administer
				  or dispense directly a controlled dangerous substance listed in Schedule II 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 substance
				  listed in Schedule II only pursuant to a written prescription signed by the
				  prescribing individual practitioner or to an order for medication made by an
				  individual practitioner which is dispensed for immediate administration to the
				  ultimate user.
(4) In the case of
				  an emergency situation, as cited in
				  21 CFR §
												1306.11(d), a pharmacist may
				  dispense a controlled dangerous substance listed in Schedule II upon receiving
				  oral authorization of a prescribing individual practitioner, if all of the
				  following requirements are met:
(a) The
				  quantity prescribed and dispensed is limited to the amount adequate to treat
				  the patient during the emergency period (dispensing beyond the emergency period
				  must be pursuant to a written prescription signed by the prescribing individual
				  practitioner);
(b) The prescription
				  shall be immediately reduced to writing by the pharmacist and shall contain all
				  information required in Regulation .07 of this chapter, except for the
				  signature of the prescribing individual practitioner;
(c) If the prescribing individual
				  practitioner is not known to the pharmacist, the pharmacist shall make a
				  reasonable effort to determine that the oral authorization came from a
				  registered individual practitioner, which may include a call back to the
				  prescribing individual practitioner using the prescribing individual
				  practitioner's telephone number as listed in the telephone directory or other
				  good faith efforts to insure the individual practitioner's identity;
(d) Within 7 days after authorizing an
				  emergency oral prescription, the prescribing individual practitioner shall have
				  a written prescription for the emergency quantity prescribed delivered to the
				  dispensing pharmacist. In addition to conforming to the requirements of
				  Regulation .07 of this chapter, the prescription shall have written on its face
				  "Authorization for Emergency Dispensing", and the date of the oral order. The
				  written prescription may be delivered to the pharmacist in person or by mail,
				  but if it is delivered by mail, it shall be postmarked within the 7-day period.
				  Upon receipt, the dispensing pharmacist shall attach this prescription to the
				  oral emergency prescription which had earlier been reduced to writing. The
				  pharmacist shall notify in writing the Department of Health and Mental Hygiene
				  if the prescribing individual practitioner fails to deliver a written
				  prescription to the pharmacist; failure of the pharmacist to do so shall void
				  the authority conferred by this section to dispense without a written
				  prescription of a prescribing individual practitioner.
(5) A prescription prepared in accordance
				  with 21 CFR §
												1306.05 written for a Schedule II narcotic
				  substance to be compounded for the direct administration to a patient by
				  parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion,
				  may be transmitted by the practitioner or the practitioner's agent to the
				  pharmacy by facsimile equipment. The facsimile received by facsimile equipment
				  serves as the original written prescription for purposes of §A(5) of this
				  regulation and the facsimile received by facsimile equipment shall be
				  maintained in accordance with
				  21 CFR §
												1304.04(h).
(6) A prescription prepared in accordance
				  with 21 CFR §
												1306.05 written for a Schedule II substance
				  for a resident of a long-term care facility may be transmitted by the
				  practitioner or the practitioner's agent to the dispensing pharmacy by
				  facsimile equipment. The facsimile received by facsimile equipment serves as
				  the original written prescription for purposes of §A(6) of this regulation
				  and the facsimile received by facsimile equipment shall be maintained in
				  accordance with 21 CFR
				  §
												1304.04(h).
(7) A prescription prepared in accordance
				  with 21 CFR §
												1306.05 written for a Schedule II narcotic
				  substance for a patient enrolled in a hospice care program certified or paid
				  for by Medicare, or both, under Title XVIII or a hospice program which is
				  licensed by the State, may be transmitted by the practitioner or the
				  practitioner's agent to the dispensing pharmacy by facsimile equipment. The
				  practitioner or the practitioner's agent shall note on the prescription that
				  the patient is a hospice patient. The facsimile received by the facsimile
				  equipment serves as the original written prescription for purposes of
				  §A(7) of this regulation and the facsimile received by facsimile equipment
				  shall be maintained in accordance with
				  21 CFR §
												1304.04(h).
(8) A prescription for a Schedule II
				  controlled dangerous substance shall be dispensed within 120 days of the date
				  of issue.