Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 47 - ALCOHOL AND DRUG ABUSE ADMINISTRATION › Chapter 10.47.07 - Prescription Drug Monitoring Program › Section 10.47.07.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this
				  chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Authorized user" means a licensed
				  prescriber, a prescriber delegate, a licensed pharmacist, a pharmacist
				  delegate, or a licensed health care practitioner registered with another
				  state's prescription drug monitoring program.
(2) "Business day" means any day except
				  Saturday, Sunday, or a holiday on which State offices are closed.
(3) "Dispense" has the meaning stated in
				  Health Occupations Article, §12 "101, Annotated Code of Maryland, but does
				  not include:
(a) Directly administering a
				  monitored prescription drug to a patient; or
(b) Giving a patient prescription drug
				  samples in accordance with Health Occupations Article, §
												12-102(d),
				  Annotated Code of Maryland.
(4) Dispenser.
(a) "Dispenser" means person authorized by
				  law to dispense a monitored prescription drug to a patient or a patient's agent
				  in the State, including a nonresident pharmacy so authorized.
(b) "Dispenser" does not include:
(i) A licensed hospital pharmacy that only
				  dispenses a monitored prescription drug for direct administration to an
				  inpatient of the hospital;
(ii) An
				  opioid treatment services program;
(iii) A veterinarian licensed under
				  Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when
				  prescribing controlled substances for animals in the usual course of providing
				  professional services;
(iv) A
				  pharmacy issued a waiver permit under COMAR
				  10.34.17.03A that
				  provides pharmaceutical specialty services exclusively to persons living in
				  assisted living facilities, comprehensive care facilities, and developmental
				  disabilities facilities; or
(v) A
				  pharmacy issued a waiver from reporting dispensing of monitored prescription
				  drugs to hospice inpatients under Regulation .03G of this chapter.
(5) "Existing bona fide
				  individual investigation" means an active and good faith investigation of an
				  identified prescriber, dispenser, or patient for possible violations falling
				  under the jurisdiction of the requesting governmental unit or agency.
(6) "Existing bona fide investigation" means
				  an active and good faith investigation of identified prescribers, dispensers,
				  or patients for possible violations falling under the jurisdiction of the
				  requesting governmental unit or agency.
(7) "Licensed health care practitioner" means an
				  individual who is:
(a) Licensed, certified,
				  or registered under Health Occupations Article, Annotated Code of Maryland, or
				  the laws of the practitioner's respective state, as appropriate, to provide
				  health care services; and
(b)
				  Authorized by a prescriber or pharmacist to access prescription monitoring data
				  in connection with the medical care of a patient to whom the prescriber
				  prescribes or the pharmacist dispenses a monitored prescription drug.
(8) "Licensing entity" means an
				  entity authorized under Health Occupations Article, Annotated Code of Maryland,
				  to license, regulate, or discipline a prescriber or pharmacist.
(9) "Medical director" means an individual
				  who is:
(a) A prescriber; and
(b) Employed by or under contract with a
				  health care facility and serves as that facility's chief medical officer or in
				  an equivalent role.
(10)
				  Monitored Prescription Drug.
(a) "Monitored
				  prescription drug" means a prescription drug that contains a Schedule II,
				  Schedule III, Schedule IV, or Schedule V controlled dangerous substance
				  designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of
				  Maryland.
(b) "Monitored
				  prescription drug" does not include naloxone medication.
(11) "Naloxone medication" means an opioid
				  antagonist approved by the federal Food and Drug Administration for the
				  reversal of an opioid overdose.
(12) "Naloxone medication data" means the
				  information required to be submitted to the Program when dispensing naloxone
				  medication.
(13) "Office" means the
				  Office of Controlled Substances Administration in the Department.
(14) "Opioid treatment services program"
				  means a program that:
(a) Is certified by the
				  State under Health-General Article, §8-401, Annotated Code of Maryland or
				  licensed by the State under Health-General Article, §7.5-401, Annotated
				  Code of Maryland;
(b) Is authorized
				  to treat patients with opioid dependence with a medication approved by the
				  federal Food and Drug Administration for opioid dependence;
(c) Complies with:
(i) The Code of Federal Regulations 42, Part
				  8;
(ii) COMAR
				  10.47.02.11A;
				  and
(iii) Requirements for the
				  secure storage and accounting of opioid medication imposed by the federal Drug
				  Enforcement Administration and the State Division of Drug Control;
				  and
(d) Has been granted
				  a certification for operation by the Department, the federal Substance Abuse
				  and Mental Health Services Administration, and the Federal Center for Substance
				  Abuse Treatment.
(15)
				  "Patient" means:
(a) An individual for whom a
				  prescriber has prescribed or is considering prescribing a monitored
				  prescription drug; or
(b) An
				  individual for whom a pharmacist has dispensed or is considering dispensing a
				  monitored prescription drug.
(16) "Pharmacist" means an individual who is
				  licensed under Health-Occupations Article, Title 12, Annotated Code of
				  Maryland, to dispense a monitored prescription drug.
(17) "Pharmacist delegate " means an
				  individual who is:
(a) Authorized by a
				  registered pharmacist to request or access prescription monitoring data;
				  and
(b) Employed by or under
				  contract with the same professional practice as the registered
				  pharmacist.
(18)
				  "Prescriber" means a practitioner:
(a)
				  Lawfully authorized to prescribe a monitored prescription drug; or
(b) Legally authorized to prescribe a
				  monitored prescription drug under an institutional DEA registration;
(19) "Prescriber delegate " means
				  an individual who is:
(a) Authorized by a
				  registered prescriber to request or access prescription monitoring data;
				  and
(b) Employed by or under
				  contract with the same professional practice as the registered
				  prescriber.
(20)
				  "Prescription drug" has the meaning stated in Health-General Article, §21
				  "201, Annotated Code of Maryland.
(21) "Prescription monitoring data" means the
				  information submitted to the program for a monitored prescription
				  drug.
(22) "Program" means the
				  Prescription Drug Monitoring Program established under Health-General Article,
				  Title 21, Subtitle 2A, Annotated Code of Maryland.
(23) "Registered" means a person registered
				  with the Program to request or access prescription monitoring data for clinical
				  use.
(24) "Rehabilitation program
				  under a health occupations board" means a group, committee, or program
				  recognized by a licensing entity that provides assistance to a licensed health
				  care practitioner in need of treatment and rehabilitation for alcoholism, drug
				  abuse, chemical dependency, or other physical, emotional, or mental
				  condition.
(25) "Technical Advisory
				  Committee" means the Technical Advisory Committee established by Health-General
				  Article, §21-2 A-07, Annotated Code of Maryland.
(26) "Zero report" means an electronic report
				  submitted by a dispenser to the Program to confirm that no monitored
				  prescription drugs were dispensed during the reporting time
				  frame.