HB 1426

HOUSE BILL 1426
      J2  6lr0871
  CF SB 778
     By: Delegate Solomon Delegates Solomon, Bagnall, Cullison, Guzzone, Hill,
  Hutchinson, S. Johnson, Kaufman, Kipke, Lopez, Martinez, Reilly,
  Rosenberg, Ross, Taveras, White Holland, and Woorman
     Introduced and read first time: February 13, 2026
     Assigned to: Health
     Committee Report: Favorable with amendments
     House action: Adopted
     Read second time: March 30, 2026
  CHAPTER ______
1 AN ACT concerning
2   Clinical Research Pharmacies and Clinical Trials – Permits, and Ownership,
3and Definition of Practice of Medicine
4 FOR the purpose of establishing a clinical research pharmacy permit; authorizing the State
5      Board of Pharmacy to issue a clinical research pharmacy permit; authorizing a
6      health care provider to hold an ownership interest in a clinical research pharmacy
7      under certain circumstances; exempting the conduct of an investigational or
8      experimental treatment or clinical trial by a corporation or other legal entity from
9      the definition of “practice medicine” for purposes of certain provisions of law
10      requiring that an individual be licensed in the State to practice medicine prohibiting
11      an individual from being required to obtain a license, certification, or authorization
12      to practice under certain provisions of law to own or have an ownership interest in a
13      clinical research pharmacy; authorizing certain health occupations boards to
14      investigate certain allegations, under certain circumstances; and generally relating
15      to clinical research pharmacies and clinical trials.
16 BY repealing and reenacting, without amendments,
17Article – Health Occupations
18Section 12–101(a), (d), (f), (j), (k), (l), (p), and (t) and 14–101(a)
19Annotated Code of Maryland
20(2021 Replacement Volume and 2025 Supplement)
21 BY adding to
     EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW.
  [Brackets] indicate matter deleted from existing law.
  Underlining indicates amendments to bill.
  Strike out indicates matter stricken from the bill by amendment or deleted from the law by
  amendment.
  *hb1426*
2HOUSE BILL 1426
1Article – Health Occupations
2Section 12–101(d–1) and (d–2), 12–102(c)(2)(vii), and 12–401.1
3Annotated Code of Maryland
4(2021 Replacement Volume and 2025 Supplement)
5 BY repealing and reenacting, with amendments,
6Article – Health Occupations
7Section 12–101(d–1), and 12–102(c)(2)(v) and (vi), and 14–101(o)
8Annotated Code of Maryland
9(2021 Replacement Volume and 2025 Supplement)
10SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
11 That the Laws of Maryland read as follows:
12Article – Health Occupations
13 12–101.
14(a)    In this title the following words have the meanings indicated.
15(d)    “Board” means the State Board of Pharmacy.
16      (D–1) “CLINICAL RESEARCH PHARMACY” MEANS A PHARMACY THAT MEETS
17 THE REQUIREMENTS FOR A CLINICAL RESEARCH PHARMACY PERMIT UNDER §
18 12–401.1(C) OF THIS TITLE.
19      (D–2) “CLINICAL RESEARCH PHARMACY PERMIT” MEANS A PERMIT ISSUED BY
20 THE BOARD TO ESTABLISH AND OPERATE A CLINICAL RESEARCH PHARMACY.
21[(d–1)] (D–3)    “Compounded nonsterile  preparations”    means    products
22 compounded in accordance with USP 795.
23(f)    (1)   “Compounding” means the preparation, mixing, assembling, packaging,
24 or labeling of a drug or device:
25(i)   As the result of a practitioner’s prescription drug order or
26 initiative based on the practitioner/patient/pharmacist relationship in the course of
27 professional practice; or
28(ii)   For the purpose of, or incident to, research, teaching, or chemical
29 analysis and not for the sale or dispensing of the drug or device.
30(2)    “Compounding” includes the preparation of drugs or devices in
31 anticipation of a prescription drug order based on routine, regularly observed prescribing
32 patterns.
  HOUSE BILL 1426  3
1(j)    “Dispense” or “dispensing” means the procedure which results in the receipt
2 of a prescription or nonprescription drug or device by a patient or the patient’s agent and
3 which entails the:
4(1)    Interpretation of an authorized prescriber’s prescription for a drug or
5 device;
6(2)   Selection and labeling of the drug or device prescribed pursuant to that
7 prescription; and
8(3)   Measuring and packaging of the prescribed drug or device in accordance
9 with State and federal laws.
10(k)    (1)   “Distribute” means the process resulting in the provision of a
11 prescription or nonprescription drug or device to a separate, intervening individual,
12 licensed and practicing under this article, prior to administration of the provided drug or
13 device to the patient pursuant to a prescription issued by an authorized prescriber.
14(2)   “Distribute” does not include the operations of a person who holds a
15 permit issued under § 12–6C–03 of this title.
16(l)    “Drug” has the meaning stated in § 21–101 of the Health – General Article.
17(p)    “Nonprescription drug” means a drug which may be sold without a
18 prescription and which is labeled for use by the consumer in accordance with the
19 requirements of the laws and regulations of this State and the federal government.
20(t)    “Pharmacy” means an establishment in which prescription or nonprescription
21 drugs or devices are compounded, dispensed, or distributed.
22 12–102.
23(c)    (2)    This title does not prohibit:
24(v)   A hospital–based clinic from dispensing prescriptions to its
25 patients; [or]
26(vi) An individual licensed or certified under Title 8 of this article
27 from personally preparing and dispensing a drug or device as authorized under Title 8 of
28 this article; OR
29(VII) A HEALTH CARE PROVIDER LICENSED UNDER THIS ARTICLE
30 FROM HAVING AN OWNERSHIP INTEREST IN A CLINICAL RESEARCH PHARMACY IF:
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11.   THE OPERATIONS OF THE CLINICAL RESEARCH
2 PHARMACY ARE LIMITED TO THE REQUIREMENTS FOR A CLINICAL RESEARCH
3 PHARMACY PERMIT IN § 12–101 OF THIS SUBTITLE;
42.   A PHARMACIST LICENSED UNDER THIS SUBTITLE:
5A.   IS PRESENT ON–SITE DURING       ALL   HOURS    OF
6 OPERATION OF THE CLINICAL RESEARCH PHARMACY; AND
7B.   IS RESPONSIBLE   FOR    ALL    COMPOUNDING,
8 DISPENSING, AND OVERSIGHT OF PHARMACY SERVICES; AND
93. ANY HEALTH CARE PROVIDER WITH A SUBSTANTIAL
10 OWNERSHIP INTEREST IN THE CLINICAL RESEARCH PHARMACY DOES NOT:
11A.DIRECT PATIENTS TO A SINGLE PHARMACIST OR
12 PHARMACY IN ACCORDANCE WITH § 12–403(C)(8) OF THIS TITLE; OR
13B.   RECEIVE REMUNERATION FOR REFERRING PATIENTS
14 TO A PHARMACIST OR PHARMACY.
15 12–401.1.
16      (A)  A PERSON SHALL HOLD A CLINICAL RESEARCH PHARMACY PERMIT
17 ISSUED BY THE BOARD BEFORE THE PERSON MAY ESTABLISH OR OPERATE A
18 CLINICAL RESEARCH PHARMACY IN THE STATE.
19      (B)    A SEPARATE CLINICAL RESEARCH PHARMACY PERMIT IS REQUIRED
20 FOR EACH CLINICAL RESEARCH PHARMACY THAT A PERSON ESTABLISHES OR
21 OPERATES.
22      (C) THE BOARD MAY ISSUE A CLINICAL RESEARCH PHARMACY PERMIT TO A
23 PHARMACY THAT:
24(1)   EXCLUSIVELYCOMPOUNDS, DISPENSES, OR DISTRIBUTES
25 PRESCRIPTION OR NONPRESCRIPTION DRUGS AS PART OF SCIENTIFIC RESEARCH
26 CONDUCTED UNDER PROTOCOLS ESTABLISHED BY AN INSTITUTIONAL REVIEW
27 BOARD THAT MEET U.S. FOOD AND DRUG ADMINISTRATION GUIDELINES;
28(2)   COMPOUNDS, DISPENSES, OR DISTRIBUTES PHARMACEUTICALS
29 SOLELY INCIDENT TO THE RESEARCH BEING CONDUCTED AND CONSISTENT WITH
30 RELATED PROTOCOLS;
  HOUSE BILL 1426  5
1(3)   IS NOT OPEN TO THE GENERAL PUBLIC FOR RETAIL
2 PHARMACEUTICAL SERVICES AND IS STRICTLY LIMITED TO DISPENSING TO
3 PARTICIPANTS IN A CLINICAL TRIAL;
4(4) COMPLIES WITH SECURITY AND STORAGE PROTOCOLS
5 ESTABLISHED BY UNITED STATES PHARMACOPEIA AND THE BOARD; AND
6(5)SATISFIES ANY OTHER REQUIREMENT ESTABLISHED BY THE
7 BOARD IN REGULATION.
8      (D)   (1)   THE BOARD SHALL ADOPT REGULATIONS TO CARRY OUT THIS
9 SECTION.
10(2)   THE REGULATIONS ADOPTED BY THE BOARD SHALL INCLUDE:
11(I)REQUIRED STANDARDS FOR THE OPERATION OF A
12 CLINICAL RESEARCH PHARMACY;
13(II)   APPLICATION PROCEDURES;
14(III) STANDARDS FOR THE SUSPENSION AND REVOCATION OF A
15 CLINICAL RESEARCH PHARMACY PERMIT; AND
16(IV)
  REQUIREMENTS RELATED TO THE ENTRY AND INSPECTION
17 OF CLINICAL RESEARCH PHARMACIES.
18      (E)EXCEPT AS OTHERWISE PROVIDED IN THIS TITLE, AN INDIVIDUAL MAY
19 NOT BE REQUIRED TO OBTAIN A LICENSE, CERTIFICATION, OR OTHER
20 AUTHORIZATION TO PRACTICE UNDER THIS ARTICLE TO OWN OR HAVE AN
21 OWNERSHIP INTEREST IN A CLINICAL RESEARCH PHARMACY.
22      (F)   (1)  THE OWNERSHIP OR POSSESSION OF AN OWNERSHIP INTEREST IN
23 A CLINICAL RESEARCH PHARMACY BY AN INDIVIDUAL WHO IS NOT LICENSED,
24 CERTIFIED, OR OTHERWISE AUTHORIZED TO PRACTICE UNDER THIS ARTICLE MAY
25 NOT BE THE SOLE BASIS FOR THE BOARD TO INITIATE A DISCIPLINARY ACTION
26 AGAINST THE INDIVIDUAL.
27(2)   THEAPPLICABLE   HEALTH   OCCUPATIONS  BOARD    MAY
28 INVESTIGATE AN ALLEGATION THAT AN INDIVIDUAL EMPLOYED BY A CLINICAL
29 RESEARCH PHARMACY:
30(I)
  IS PRACTICING A PROFESSION REGULATED BY THE HEALTH
31 OCCUPATIONS BOARD UNDER THIS ARTICLE WITHOUT A LICENSE, CERTIFICATE, OR
32 OTHER AUTHORIZATION OR WITH AN UNAUTHORIZED PERSON; OR
6HOUSE BILL 1426
1(II)
  HAS VIOLATED A PROVISION OF THIS ARTICLE UNDER THE
2 JURISDICTION OF THE HEALTH OCCUPATIONS BOARD.
3(G) A HEALTH CARE PROVIDER WITH A SUBSTANTIAL OWNERSHIP
4 INTEREST IN A CLINICAL RESEARCH PHARMACY MAY NOT:
5(1) SERVE AS A CLINICAL INVESTIGATOR FOR A SCIENTIFIC
6 RESEARCH PROTOCOL CONDUCTED BY THE CLINICAL RESEARCH PHARMACY; OR
7(2)
  IMPEDE OR IMPAIR A PHARMACIST’S ABILITY TO FULLY EXERCISE
8 THE PHARMACIST’S PROFESSIONAL JUDGMENT.
9(H)   THIS SECTION DOES NOT LIMIT:
10(1)    THE RIGHT OF AN INDIVIDUAL TO PRACTICE A HEALTH
11 OCCUPATION THAT THE INDIVIDUAL IS AUTHORIZED TO PRACTICE UNDER THIS
12 ARTICLE; OR
13(2)
  THE RIGHT OF A PERSON TO ESTABLISH OR OPERATE A
14 PHARMACY UNDER OTHER PROVISIONS OF THIS TITLE.
15 14–101.
16(a)   In this title the following words have the meanings indicated.
17(o)   (1)    “Practice medicine” means to engage, with or without compensation, in
18 medical:
19(i)     Diagnosis;
20(ii)    Healing;
21(iii)   Treatment; or
22(iv)    Surgery.
23(2)    “Practice medicine” includes doing, undertaking, professing to do, and
24 attempting any of the following:
25(i)   Diagnosing, healing, treating, preventing, prescribing for, or
26 removing any physical, mental, or emotional ailment or supposed ailment of an individual:
271.    By physical, mental, emotional, or other process that is
28 exercised or invoked by the practitioner, the patient, or both; or
  HOUSE BILL 1426  7
12.    By appliance, test, drug, operation, or treatment;
2(ii)    Ending of a human pregnancy; and
3(iii)   Performing acupuncture as provided under § 14–504 of this title.
4(3)    “Practice medicine” does not include:
5(i)     Selling any nonprescription drug or medicine;
6(ii)    Practicing as an optician; [or]
7(iii)   Performing a massage or other manipulation by hand, but by no
8 other means; OR
9(IV)    CONDUCTING AN INVESTIGATIONAL OR EXPERIMENTAL
10 TREATMENT OR CLINICAL TRIAL BY A CORPORATION OR OTHER LEGAL ENTITY THAT
11 IS NOT AN INDIVIDUAL LICENSED UNDER THIS TITLE IF:
121.    THE
  INVESTIGATIONAL   OR    EXPERIMENTAL
13 TREATMENT OR CLINICAL TRIAL IS CONDUCTED IN ACCORDANCE WITH PROTOCOLS
14 REGISTERED BY THE U.S. FOOD AND DRUG ADMINISTRATION, THE EUROPEAN
15 MEDICINES AGENCY, OR ANOTHER OFFICIAL INTERNATIONAL BODY AND IN
16 COMPLIANCE WITH ALL APPLICABLE ETHICAL GUIDELINES AND FEDERAL AND
17 STATE REGULATIONS GOVERNING HUMAN SUBJECTS RESEARCH;
182.    ALL MEDICAL DECISION MAKING WITHIN THE
19 CLINICAL TRIAL IS CARRIED OUT BY INDIVIDUALS WHO ARE LICENSED UNDER THIS
20 ARTICLE; AND
213.    THE CORPORATION OR OTHER ENTITY CONDUCTING
22 THE TRIAL DOES NOT ENGAGE IN THE GENERAL PRACTICE OF MEDICINE OR
23 PROVIDE CLINICAL PATIENT CARE OUTSIDE THE SCOPE OF THE REGISTERED
24 CLINICAL TRIAL.
25SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect
26 October 1, 2026.