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§ 21-2A-04. Regulations

West's Annotated Code of MarylandHealth--GeneralEffective: October 1, 2022

West's Annotated Code of Maryland
Health--General
Title 21. Food, Drugs, and Cosmetics (Refs & Annos)
Subtitle 2a. Prescription Drug Monitoring Program (Refs & Annos)
Effective: October 1, 2022
MD Code, Health - General, § 21-2A-04
§ 21-2A-04. Regulations
In general
(a) The Secretary, in consultation with the Board, shall adopt regulations to carry out this subtitle.
Scope of regulations
(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:
(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 to 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 medication 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 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 and 21-2A-06.1 of this subtitle, does not disclose the identity of the person protected.

Credits

Added by Acts 2011, c. 166, § 2, eff. Oct. 1, 2011. Amended by Acts 2012, c. 66, § 1, eff. April 10, 2012; Acts 2014, c. 651, § 1, eff. Oct. 1, 2014; Acts 2016, c. 147, § 2, eff. Oct. 1, 2016; Acts 2019, c. 531, § 1, eff. Oct. 1, 2019; Acts 2022, c. 224, § 1, eff. Oct. 1, 2022.
MD Code, Health - General, § 21-2A-04, MD HEALTH GEN § 21-2A-04
Current through legislation effective through April 25, 2024, from the 2024 Regular Session of the General Assembly. Some statute sections may be more current, see credits for details.
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