Md. Code Regs. 10.47.07.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.47.07.02 - Definitions

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.

Md. Code Regs. 10.47.07.02

Regulation .02 amended effective 45:20 Md. R. 918, eff. 10/8/2018; amended effective 47:10 Md. R. 519, eff. 5/18/2020; amended effective 50:8 Md. R. 338, eff. 7/20/2023