2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2A - Prescription Drug Monitoring Program › Section 21-2A-01 - Definitions

(a)    In this subtitle the following words have the meanings indicated.
(b)    “Board” means the Advisory Board on Prescription Drug Monitoring.
(c)    (1)    “Dispense” has the meaning stated in § 12–101 of the Health Occupations Article.
(2)    “Dispense” does not include:
(i)    Directly administering a monitored prescription drug to a patient; or
(ii)    Giving out prescription drug samples.
(d)    (1)    “Dispenser” means a person authorized by law to dispense a monitored prescription drug to a patient or the patient’s agent in the State.
(2)    “Dispenser” includes a nonresident pharmacy.
(3)    “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 Title 2, Subtitle 3 of the Agriculture Article when prescribing controlled substances for animals in the usual course of providing professional services;
(iv)    A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and
(v)    A pharmacy that:
1.    Dispenses medications to an inpatient hospice; and
2.    Has been granted a waiver under § 21–2A–03(f) of this subtitle.
(e)    “Licensing entity” means an entity authorized under the Health Occupations Article to license, regulate, or discipline a prescriber or dispenser.
(f)    (1)    “Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Title 5, Subtitle 4 of the Criminal Law Article.
(2)    “Monitored prescription drug” does not include naloxone medication.
(g)    “Naloxone medication” means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose.
(h)    “Naloxone medication data” means the information submitted to the Program for naloxone medication.
(i)    “Office” means the Office of Controlled Substances Administration in the Department.
(j)    “Opioid treatment services program” means a program that:
(1)    Is certified in accordance with § 8–401 of this article or licensed by the State under § 7.5–401 of this article;
(2)    Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;
(3)    Complies with:
(i)    The Code of Federal Regulations 42, Part 8;
(ii)    COMAR 10.47.02.11; and
(iii)    Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the Office; and
(4)    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.
(k)    “Pharmacist” means an individual who is licensed under Title 12 of the Health Occupations Article, or by another state, to dispense a monitored prescription drug.
(l)    “Pharmacist delegate” means an individual who is:
(1)    Authorized by a registered pharmacist to request or access prescription monitoring data; and
(2)    Employed by or under contract with the same professional practice as the registered pharmacist.
(m)    “Prescriber” means a licensed health care professional authorized by law to prescribe a monitored prescription drug.
(n)    “Prescriber delegate” means an individual who is:
(1)    Authorized by a registered prescriber to request or access prescription monitoring data; and
(2)    Employed by or under contract with the same professional practice as the prescriber.
(o)    “Prescription drug” has the meaning stated in § 21–201 of this title.
(p)    “Prescription monitoring data” means the information submitted to the Program for a monitored prescription drug.
(q)    “Program” means the Prescription Drug Monitoring Program established under this subtitle.
(r)    “Registered” means registered with the Program to request or access prescription monitoring data for clinical use.
(s)    “Terminal illness” means a medical condition that, within reasonable medical judgment, involves a prognosis for a patient that likely will result in the patient’s death within 6 months.