LAWRENCE J. HOGAN, JR., Governor Ch. 224
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Chapter 224
(Senate Bill 200)
AN ACT concerning
Public Health – Prescription Drug Monitoring Program – Naloxone Medication
Data
FOR the purpose of altering the requirements of the Prescription Drug Monitoring Program
to require the Program to monitor the dispensing of naloxone medication by all
prescribers and dispensers in the State and to require dispensers to report naloxone
medication data to the Program; and generally relating to the Prescription Drug
Monitoring Program and naloxone medication data.
BY repealing and reenacting, with amendments,
Article – Health – General
Section 21–2A–01 through 21–2A–04, 21–2A–08, and 21–2A–09
Annotated Code of Maryland
(2019 Replacement Volume and 2021 Supplement)
BY adding to
Article – Health – General
Section 21–2A–06.1
Annotated Code of Maryland
(2019 Replacement Volume and 2021 Supplement)
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Health – General
21–2A–01.
(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. Ch. 224 2022 LAWS OF MARYLAND
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(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 PRESCRIPTIO N DRUG” DOES NOT INCLUDE
NALOXONE MEDICATION .
(G) “NALOXONE MEDICATION ” MEANS AN OPIOID ANTA GONIST APPROVED
BY THE FEDERAL FOOD AND DRUG ADMINISTRATION FOR TH E REVERSAL OF AN
OPIOID OVERDOSE .
(H) “NALOXONE MEDICATION D ATA” MEANS THE INFORMATIO N SUBMITTED
TO THE PROGRAM FOR NALOXONE MEDICATION .
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[(g)] (I) “Office” means the Office of Controlled Substances Administration in
the Department.
[(h)] (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.
[(i)] (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.
[(j)] (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.
[(k)] (M) “Prescriber” means a licensed health care professional authorized by
law to prescribe a monitored prescription drug.
[(l)] (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.
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[(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title.
[(n)] (P) “Prescription monitoring data” means the information submitted to the
Program for a monitored prescription drug.
[(o)] (Q) “Program” means the Prescription Drug Monitoring Program
established under this subtitle.
[(p)] (R) “Registered” means registered with the Program to request or access
prescription monitoring data for clinical use.
[(q)] (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.
21–2A–02.
(a) There is a Prescription Drug Monitoring Program in the Department.
(b) The mission of the Program is to:
(1) Assist prescribers, pharmacists, and public health professionals in:
(i) The identification and prevention of prescription drug abuse; and
(ii) The identification and investigation of unlawful prescription
drug diversion; and
(2) Promote a balanced use of prescription monitoring data to assist
appropriate law enforcement activities while preserving the professional practice of health
care providers and the access of patients to optimal pharmaceutical care.
(c) To carry out its mission, the Program shall monitor the prescribing and
dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled
dangerous substances AND THE DISPENSING O F NALOXONE MEDICATIO N by all
prescribers and dispensers in the State.
21–2A–03.
(a) The Department shall implement the Program, subject to the availability of
funds.
(b) The Secretary may:
(1) Assign responsibility for the operation of the Program to any unit in the
Department; LAWRENCE J. HOGAN, JR., Governor Ch. 224
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(2) Contract with any qualified person for the efficient and economical
operation of the Program; and
(3) Identify and publish a list of monitored prescription drugs that have a
low potential for abuse by individuals.
(c) Except as provided in subsection (d) of this section, each dispenser shall
submit prescription monitoring data AND NALOXONE MEDICATION DATA to the Program
by electronic means, in accordance with regulations adopted by the Secretary.
(d) The Secretary, for good cause shown, may authorize a dispenser to submit
prescription monitoring data OR NALOXONE MEDICATION DATA by an alternative form
of submission.
(e) The Secretary, in consultation with the Maryland Health Care Commission
and the Board, shall:
(1) Determine the appropriate technology to support the operation of the
Program; and
(2) Educate dispensers, prescribers, pharmacists, prescriber delegates,
pharmacist delegates, and consumers about the purpose and operation of the Program.
(f) (1) The Secretary shall grant a waiver to a pharmacy that dispenses
medications to an inpatient hospice from reporting to the Program prescription monitoring
data for hospice inpatients if:
(i) The pharmacy demonstrates how it will distinguish hospice
inpatients from other consumers receiving medications from the pharmacy; and
(ii) The pharmacy agrees that i t will be subject to onsite,
unannounced inspections by the Department to verify its reporting of the prescription data
of consumers who are not hospice inpatients.
(2) A waiver granted under this subsection may remain in effect for up to
2 years.
(3) The Secretary may establish an application process for a pharmacy to
apply for a waiver under this subsection.
21–2A–04.
(a) The Secretary, in consultation with the Board, shall adopt regulations to carry
out this subtitle.
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(b) The regulations adopted by the Secretary shall:
(1) Specify the prescription monitoring data AND NALOXONE
MEDICATION DATA required to be submitted under § 21–2A–03 of this subtitle;
(2) Specify the electronic or other means by which information is to be
submitted:
(i) Without unduly increasing the workload and expense on
dispensers; and
(ii) In a manner as compatible as possible with existing data
submission practices of dispensers;
(3) Specify that the information be submitted by dispensers once every 24
hours;
(4) Specify that the Program:
(i) Shall provide the information technology software to dispensers
necessary to upload prescription drug monitoring data AND NALOXONE MEDICATION
DATA to the Program; and
(ii) May not impose any fees or other assessments on prescribers or
dispensers to support the operation of the Program;
(5) Identify the mechanism by which [prescription]:
(I) PRESCRIPTION monitoring data are disclosed to a person, in
accordance with § 21–2A–06 of this subtitle; AND
(II) NALOXONE MEDICATION DATA ARE DISCLOSED T O A
PERSON, IN ACCORDANCE WITH § 21–2A–06.1 OF THIS SUBTITLE;
(6) Identify the circumstances under which a person may disclose
prescription monitoring data OR NALOXONE MEDICATION DATA received under the
Program;
(7) Specify the process for the Program’s review of prescription monitoring
data AND NALOXONE MEDICAT ION DATA and reporting of:
(i) Possible misuse or abuse of a monitored prescription drug under
§ 21–2A–06(c) of this subtitle; or
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(ii) A possible violation of law or possible breach of professional
standards under § 21–2A–06(d) of this subtitle;
(8) Establish requirements for Program retention of prescription
monitoring data AND NALOXONE MEDICATION DATA for 3 years; and
(9) Require that:
(i) Confidential or privileged patient information be kept
confidential; and
(ii) Records or information protected by a privilege between a health
care provider and a patient, or otherwise required by law to be held confidential, be filed in
a manner that, except as otherwise provided in [§ 21–2A–06] §§ 21–2A–06 AND
21–2A–06.1 of this subtitle, does not disclose the identity of the person protected.
21–2A–06.1.
(A) NALOXONE MEDICATION DATA:
(1) ARE CONFIDENTIAL AND PRIVILEGED, AND NOT SUBJECT TO
DISCOVERY, SUBPOENA, OR OTHER MEANS OF LE GAL COMPULSION IN CI VIL
LITIGATION;
(2) ARE NOT PUBLIC RECORD S; AND
(3) EXCEPT AS PROVIDED IN SUBSECTION (B) OF THIS SECTION OR A S
OTHERWISE BY LAW , MAY NOT BE DISCLOSED TO A NY PERSON.
(B) (1) THE PROGRAM SHALL DISCLOS E NALOXONE MEDICATION DATA,
IN ACCORDANCE WITH R EGULATIONS ADOPTED B Y THE SECRETARY, FOR PUBLIC
HEALTH SURVEILLANCE , RESEARCH, ANALYSIS, PUBLIC REPORTING , AND
EDUCATION AFTER REDACTION OF AL L INFORMATION THAT C OULD IDENTIFY A
PATIENT, PRESCRIBER, DISPENSER, OR ANY OTHER INDIVIDUAL.
(2) THE SECRETARY MAY REQUIRE SUBMISSI ON OF AN ABSTRACT
EXPLAINING THE SCOPE AND PURPOSE OF THE R ESEARCH, ANALYSIS, PUBLIC
REPORTING, OR EDUCATION BEFORE DISC LOSING NALOXONE MEDICATION DATA
UNDER PARAGRAPH (1) OF THIS SUBSECTION .
21–2A–08.
(a) With respect to the administration and operation of the Program, the
Department and its agents and employees are not subject to liability arising from: Ch. 224 2022 LAWS OF MARYLAND
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(1) The inaccuracy of any information submitted to the Program in
accordance with this subtitle; or
(2) The unauthorized use or disclosure of prescription monitoring data OR
NALOXONE MEDICATION DATA by a person to whom the Program was authorized to
provide prescription monitoring data OR NALOXONE MEDICATION DATA under this
subtitle.
(b) Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber
delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability
or disciplinary action arising solely from:
(1) Requesting or receiving, or failing to request or receive, prescription
monitoring data from the Program; or
(2) Acting, or failing to act, on the basis of prescription monitoring data
provided by the Program.
21–2A–09.
(a) A dispenser who knowingly fails to submit prescription monitoring data OR
NALOXONE MEDICATION DATA to the Program as required under this subtitle shall be
subject to a civil penalty not exceeding $500 for each failure to submit required information.
(b) (1) A person who knowingly discloses, uses, obtains, or attempts to obtain
by fraud or deceit, prescription monitoring data OR NALOXONE MEDICATION DATA in
violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to
imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both.
(2) In addition to the penalties under paragraph (1) of this subsection, a
prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly
discloses or uses prescription monitoring data OR NALOXONE MEDICATI ON DATA in
violation of this subtitle shall be subject to disciplinary action by the appropriate licensing
entity.
(3) A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2
of this subtitle shall be subject to disciplinary action by the appropriate licensing entity.
(4) The release of prescription monitoring data by a prescriber, prescriber
delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely
for treatment purposes in a manner otherwise consistent with State and federal law is not
a violation of this subtitle.
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SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
October 1, 2022.
Approved by the Governor, April 21, 2022.