Current through Register Vol. 51, No. 19, September 20, 2024
A. Provisions
governing the issuance, filling, and filing of prescriptions pursuant to
Criminal Law Article, §§5-501 -5-505, Annotated
Code of Maryland, are set forth generally in those sections and specifically by
the sections of this regulation.
B.
Persons Entitled to Issue Prescriptions (21 CFR § 1306.03).
(1) A prescription for a controlled dangerous
substance may be issued only by an individual practitioner who is:
(a) Authorized to prescribe controlled
dangerous substances in the State of Maryland, in which the practitioner is
licensed to practice the practitioner's profession; and
(b) Either registered or exempted from
registration pursuant to 21
CFR § 1301.22(c) and
21 CFR § 1301.23.
(2) A prescription issued by an individual
practitioner may be communicated to a pharmacist by an employee or agent of the
individual practitioner.
C. Purpose of Issue of Prescription
(21 CFR § 1306.04).
(1) A prescription for a controlled dangerous
substance to be effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of the individual
practitioner's professional practice. The responsibility for the proper
prescribing and dispensing of controlled dangerous substances is upon the
prescribing practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription. An order purporting to be a prescription
issued not in the usual course of professional treatment or in legitimate and
authorized research is not a prescription within the meaning and intent of the
Maryland Controlled Dangerous Substances Act Criminal Law Article, §§5-501 -5-505, Annotated
Code of Maryland, and the person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled dangerous substances.
(2) A prescription may not be issued in order
for an individual practitioner to obtain controlled dangerous substances for
supplying the individual practitioner for the purpose of general dispensing to
patients.
(3) A prescription may
not be issued for the dispensing of narcotic drugs listed in any schedule for
detoxification treatment or maintenance treatment.
D. Manner of Issuance of Prescriptions
(21 CFR § 1306.05).
(1) All prescriptions for controlled
dangerous substances shall be dated as of, and signed on, the day when issued
and shall bear the full name and address of the patient, the drug name,
strength, dosage form, quantity prescribed, directions for use, and the name,
address, and registration number of the practitioner. A practitioner may sign a
prescription in the same manner as the practitioner would sign a check or legal
document (for example, J.H. Smith or John H. Smith). When an oral order is not
permitted, prescriptions shall be written with ink, indelible pencil,
typewriter, or computer and shall be manually signed by the practitioner. The
prescriptions may be prepared by a secretary or agent for the signature of a
practitioner, but the prescribing practitioner is responsible in case the
prescription does not conform in all essential respects to the law and
regulations. A corresponding liability rests upon the pharmacist who fills a
prescription not prepared in the form prescribed by these
regulations.
(2) An individual
practitioner exempted from registration under
21 CFR § 1301.22(c) shall include on
all prescriptions issued by the individual practitioner the registration number
of the hospital or other institution and the special internal code number
assigned to the individual practitioner by the hospital or other institution,
as provided in 21 CFR § 1301.22(c), instead of the
registration number of the practitioner required by this regulation. Each
written prescription shall have the name of the individual practitioner
stamped, typed, or handprinted on it, as well as the signature of the
individual practitioner.
(3) An
official exempted from registration under
21 CFR § 1301.23 shall include on all prescriptions
issued by the practitioner the branch of service or agency (for example-"U.S.
Army" or "Public Health Service") and the practitioner's service identification
number, instead of the registration number of the practitioner required by this
section. The service identification number for a Public Health Service employee
is the practitioner's Social Security identification number. Each prescription
shall have the name of the officer stamped, typed, or handprinted on it, as
well as the signature of the officer.
E. Persons Entitled to Fill Prescriptions. A
prescription for controlled dangerous substances may only be filled by a
pharmacist acting in the usual course of the pharmacist's professional practice
and either registered individually or employed in a registered pharmacy or
registered institutional practitioner.
F. Administering or Dispensing of Narcotic
Drugs (21 CFR § 1306.07).
(1) The administering or dispensing directly,
but not prescribing, of narcotic drugs listed in any schedule to a narcotic
drug dependent individual for "detoxification treatment" or "maintenance
treatment" as defined in 21
U.S.C. § 802 shall be deemed to be
within the meaning of the term "in the course of his professional practice of
research" as provided in 21
U.S.C. § 828(e) and
21 U.S.C. § 802(21), if the practitioner
is separately registered with the United States Attorney General as required by
21 U.S.C. § 823(g) and complies with the
regulatory standards for treatment qualification, security, records, and
unsupervised use of drugs pursuant to the federal Act.
(2) A physician who is not specifically
registered to conduct a narcotic treatment program may administer, but may not
prescribe, narcotic drugs to an individual for the purpose of relieving acute
withdrawal symptoms if necessary while arrangements are being made for referral
for treatment. More than one day's medication may not be administered to the
individual, or for the individual's use, at one time. This emergency treatment
may not be carried out for more than 3 days and may not be renewed or
extended.
(3) A physician or
authorized hospital staff may administer or dispense narcotic drugs:
(a) In a hospital to maintain or detoxify an
individual as an incidental adjunct to medical or surgical treatment of
conditions other than addiction; or
(b) To an individual with intractable pain in
which no relief or cure is possible or none has been found after reasonable
efforts.