2022 Maryland Statutes
Health - General
Title 21 - Food, Drugs, and Cosmetics
Subtitle 2A - Prescription Drug Monitoring Program
Section 21-2A-04 - Regulations

    (a)    The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle.

    (b)    The regulations adopted by the Secretary shall:

        (1)    Specify the prescription monitoring 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 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 monitoring data are disclosed to a person, in accordance with § 21–2A–06 of this subtitle;

        (6)    Identify the circumstances under which a person may disclose prescription monitoring data received under the Program;

        (7)    Specify the process for the Program’s review of prescription monitoring data and reporting of:

            (i)    Possible misuse or abuse of a monitored prescription drug under § 21–2A–06(c) of this subtitle; or

            (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 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 of this subtitle, does not disclose the identity of the person protected.