§ 12–401.1
Statutes in effect as of October 1, 2026.
Md. Code Ann., Health Occ. § 12-401.1 (2026)
Title 12. Pharmacists and Pharmacies
Subtitle 4. Pharmacy Permits
§ 12–401.1LinkCopy Citation
(a)
A person shall hold a clinical research pharmacy permit issued by the Board before the person may establish or operate a clinical research pharmacy in the State.
(b)
A separate clinical research pharmacy permit is required for each clinical research pharmacy that a person establishes or operates.
(c)
The Board may issue a clinical research pharmacy permit to a pharmacy that:
(1)
Exclusively compounds, dispenses, or distributes prescription or nonprescription drugs as part of scientific research conducted under protocols established by an institutional review board that meet U.S. Food and Drug Administration guidelines;
(2)
Compounds, dispenses, or distributes pharmaceuticals solely incident to the research being conducted and consistent with related protocols;
(3)
Is not open to the general public for retail pharmaceutical services and is strictly limited to dispensing to participants in a clinical trial;
(4)
Complies with security and storage protocols established by United States Pharmacopeia and the Board; and
(5)
Satisfies any other requirement established by the Board in regulation.
(d)
(1)
The Board shall adopt regulations to carry out this section.
(2)
The regulations adopted by the Board shall include:
(i)
Required standards for the operation of a clinical research pharmacy;
(ii)
Application procedures;
(iii)
Standards for the suspension and revocation of a clinical research pharmacy permit; and
(iv)
Requirements related to the entry and inspection of clinical research pharmacies.
(e)
Except as otherwise provided in this title, an individual may not be required to obtain a license, certification, or other authorization to practice under this article to own or have an ownership interest in a clinical research pharmacy.
(f)
(1)
The ownership or possession of an ownership interest in a clinical research pharmacy by an individual who is not licensed, certified, or otherwise authorized to practice under this article may not be the sole basis for the Board to initiate a disciplinary action against the individual.
(2)
The applicable health occupations board may investigate an allegation that an individual employed by a clinical research pharmacy:
(i)
Is practicing a profession regulated by the health occupations board under this article without a license, certificate, or other authorization or with an unauthorized person; or
(ii)
Has violated a provision of this article under the jurisdiction of the health occupations board.
(g)
A health care provider with a substantial ownership interest in a clinical research pharmacy may not:
(1)
Serve as a clinical investigator for a scientific research protocol conducted by the clinical research pharmacy; or
(2)
Impede or impair a pharmacist’s ability to fully exercise the pharmacist’s professional judgment.
(h)
This section does not limit:
(1)
The right of an individual to practice a health occupation that the individual is authorized to practice under this article; or
(2)
The right of a person to establish or operate a pharmacy under other provisions of this title.