Clinical Research Pharmacies and Clinical Trials - Permits and Ownership

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*

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 ______

AN ACT concerning 1

Clinical Research Pharmacies and Clinical Trials – Permits, and Ownership, 2
and Definition of Practice of Medicine 3

FOR the purpose of establishing a clinical research pharmacy permit; authorizing the State 4
Board of Pharmacy to issue a clinical research pharmacy permit; authorizing a 5
health care provider to hold an ownership interest in a clinical research pharmacy 6
under certain circumstances; exempting the conduct of an investigational or 7
experimental treatment or clinical trial by a corporation or other legal entity from 8
the definition of “practice medicine” for purposes of certain provisions of law 9
requiring that an individual be licensed in the State to practice medicine prohibiting 10
an individual from being required to obtain a license, certification, or authorization 11
to practice under certain provisions of law to own or have an ownership interest in a 12
clinical resear ch pharmacy; authorizing certain health occupations boards to 13
investigate certain allegations, under certain circumstances; and generally relating 14
to clinical research pharmacies and clinical trials. 15

BY repealing and reenacting, without amendments, 16
Article – Health Occupations 17
Section 12–101(a), (d), (f), (j), (k), (l), (p), and (t) and 14–101(a) 18
Annotated Code of Maryland 19
(2021 Replacement Volume and 2025 Supplement) 20

BY adding to 21
2 HOUSE BILL 1426

Article – Health Occupations 1
Section 12–101(d–1) and (d–2), 12–102(c)(2)(vii), and 12–401.1 2
Annotated Code of Maryland 3
(2021 Replacement Volume and 2025 Supplement) 4

BY repealing and reenacting, with amendments, 5
Article – Health Occupations 6
Section 12–101(d–1), and 12–102(c)(2)(v) and (vi), and 14–101(o) 7
Annotated Code of Maryland 8
(2021 Replacement Volume and 2025 Supplement) 9

SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 10
That the Laws of Maryland read as follows: 11

Article – Health Occupations 12

12–101. 13

(a) In this title the following words have the meanings indicated. 14

(d) “Board” means the State Board of Pharmacy. 15

(D–1) “CLINICAL RESEARCH PHA RMACY” MEANS A PHARMACY THA T MEETS 16
THE REQUIREMENTS FOR A CLINICAL RESEARCH PHARMACY PERMIT UNDE R § 17
12–401.1(C) OF THIS TITLE. 18

(D–2) “CLINICAL RESEARCH PHARMACY PERMIT” MEANS A PERMIT ISSUED BY 19
THE BOARD TO ESTABLISH AND OPERATE A CLINICAL RESEARCH PHARMACY. 20

[(d–1)] (D–3) “Compounded nonsterile preparations” means products 21
compounded in accordance with USP 795. 22

(f) (1) “Compounding” means the preparation, mixing, assembling, packaging, 23
or labeling of a drug or device: 24

(i) As the result of a practitioner’s prescription drug order or 25
initiative based on the practitioner/patient/pharmacist relationship in the course of 26
professional practice; or 27

(ii) For the purpose of, or incident to, research, teaching, or chemical 28
analysis and not for the sale or dispensing of the drug or device. 29

(2) “Compounding” includes the preparation of drugs or devices in 30
anticipation of a prescription drug order based on routine, regularly observed prescribing 31
patterns. 32

HOUSE BILL 1426 3

(j) “Dispense” or “dispensing” means the procedure which results in the receipt 1
of a prescription or nonprescription drug or device by a patient or the patient’s agent and 2
which entails the: 3

(1) Interpretation of an authorized prescriber’s prescription for a drug or 4
device; 5

(2) Selection and labeling of the drug or device prescribed pursuant to that 6
prescription; and 7

(3) Measuring and packaging of the prescribed drug or device in accordance 8
with State and federal laws. 9

(k) (1) “Distribute” means the process resulting in the provision of a 10
prescription or nonprescription drug or device to a separate, intervening individual, 11
licensed and practicing under this article, prior to administration of the provided drug or 12
device to the patient pursuant to a prescription issued by an authorized prescriber. 13

(2) “Distribute” does not include the operations of a person who holds a 14
permit issued under § 12–6C–03 of this title. 15

(l) “Drug” has the meaning stated in § 21–101 of the Health – General Article. 16

(p) “Nonprescription drug” means a drug which may be sold without a 17
prescription and which is labeled for use by the consumer in accordance with the 18
requirements of the laws and regulations of this State and the federal government. 19

(t) “Pharmacy” means an establishment in which prescription or nonprescription 20
drugs or devices are compounded, dispensed, or distributed. 21

12–102. 22

(c) (2) This title does not prohibit: 23

(v) A hospital –based clinic fro m dispensing prescriptions to its 24
patients; [or] 25

(vi) An individual licensed or certified under Title 8 of this article 26
from personally preparing and dispensing a drug or device as authorized under Title 8 of 27
this article; OR 28

(VII) A HEALTH CARE PROVIDER LICENSED UNDER THIS ARTICLE 29
FROM HAVING AN OWNERSHIP INTEREST IN A CLINICAL RESEARCH PHARMACY IF: 30

4 HOUSE BILL 1426

1. THE OPERATIONS OF THE CLINICAL RESEARCH 1
PHARMACY ARE LIMITED TO THE REQUIREMENTS FOR A CLINICAL RESEA RCH 2
PHARMACY PERMIT IN § 12–101 OF THIS SUBTITLE; 3

2. A PHARMACIST LICENSED UNDER THIS SUBTITLE: 4

A. IS PRESENT ON –SITE DURING ALL HOUR S OF 5
OPERATION OF THE CLINICAL RESEARCH PHARMACY; AND 6

B. IS RESPONSIBLE FOR AL L COMPOUNDING , 7
DISPENSING, AND OVERSIGHT OF PHARMACY SERVICES; AND 8

3. ANY HEALTH CARE PROVI DER WITH A SUBSTANTI AL 9
OWNERSHIP INTEREST IN THE CLINICAL RESEARCH PHARMACY DOES NOT: 10

A. DIRECT PATIENTS TO A SINGLE PHARMACIST OR 11
PHARMACY IN ACCORDANCE WITH § 12–403(C)(8) OF THIS TITLE; OR 12

B. RECEIVE REMUNERATION FOR REFERRING PATIENTS 13
TO A PHARMACIST OR PHARMACY. 14

12–401.1. 15

(A) A PERSON SHALL HOLD A CLINICAL RESEARCH PH ARMACY PERMIT 16
ISSUED BY THE BOARD BEFORE THE PERS ON MAY ESTABLISH OR OPERATE A 17
CLINICAL RESEARCH PHARMACY IN THE STATE. 18

(B) A SEPARATE CLINICAL RE SEARCH PHARMACY PERMI T IS REQUIRED 19
FOR EACH CLINICAL RE SEARCH PHARMACY THAT A PERSON ESTABLISHES OR 20
OPERATES. 21

(C) THE BOARD MAY ISSUE A CLINICAL RESEARCH PHARMACY PERMIT TO A 22
PHARMACY THAT: 23

(1) EXCLUSIVELY COMPOUNDS , DISPENSES, OR DISTRIBUTES 24
PRESCRIPTION OR NONPRESCRIPTI ON DRUGS AS PART OF SCIENTIFIC RESEARCH 25
CONDUCTED UNDER PROT OCOLS ESTABLISHED BY AN INSTITUTIONAL REV IEW 26
BOARD THAT MEET U.S. FOOD AND DRUG ADMINISTRATION GUIDELINES; 27

(2) COMPOUNDS, DISPENSES, OR DISTRIBUTES PHARM ACEUTICALS 28
SOLELY INCIDENT TO T HE RESEARCH BEING CO NDUCTED AND CONSISTE NT WITH 29
RELATED PROTOCOLS; 30

HOUSE BILL 1426 5

(3) IS NOT OPEN TO THE GE NERAL PUBLIC FOR RET AIL 1
PHARMACEUTICAL SERVI CES AND IS STRICTLY LIMITED TO DISPENSIN G T O 2
PARTICIPANTS IN A CLINICAL TRIAL; 3

(4) COMPLIES WITH SECURIT Y AND STORAGE PROTOC OLS 4
ESTABLISHED BY UNITED STATES PHARMACOPEIA AND THE BOARD; AND 5

(5) SATISFIES ANY OTHER R EQUIREMENT ESTABLISH ED BY THE 6
BOARD IN REGULATION. 7

(D) (1) THE BOARD SHALL AD OPT REGULATIONS TO C ARRY OUT THIS 8
SECTION. 9

(2) THE REGULATIONS ADOPTED BY THE BOARD SHALL INCLUDE: 10

(I) REQUIRED STANDARDS FO R THE OPERATION OF A 11
CLINICAL RESEARCH PHARMACY; 12

(II) APPLICATION PROCEDURES; 13

(III) STANDARDS FOR THE SUS PENSION AND REVOCATION OF A 14
CLINICAL RESEARCH PHARMACY PERMIT; AND 15

(IV) REQUIREMENTS RELATED TO THE ENTRY AND INSPECTION 16
OF CLINICAL RESEARCH PHARMACIES. 17

(E) EXCEPT AS OTHERWISE PROVIDED IN THIS TITLE, AN INDIVIDUAL MAY 18
NOT BE REQUIRED TO O BTAIN A LICENSE , CERTIFICATION, OR OTHER 19
AUTHORIZATION TO PRA CTICE UNDER THIS ART ICLE TO OWN OR HAVE AN 20
OWNERSHIP INTEREST IN A CLINICAL RESEARCH PHARMACY. 21

(F) (1) THE OWNERSHIP OR POSSESSION OF AN OWNERSHIP INTEREST IN 22
A CLINICAL RESEARCH PHARMACY BY AN INDIV IDUAL WHO I S NOT LICENSED , 23
CERTIFIED, OR OTHERWISE AUTHORIZED TO PRACTICE UNDE R THIS ARTICLE MAY 24
NOT BE THE SOLE BASI S FOR THE BOARD TO INITIATE A D ISCIPLINARY ACTION 25
AGAINST THE INDIVIDUAL. 26

(2) THE APPLICABLE HEALTH OCCUPATIONS BOARD MA Y 27
INVESTIGATE AN ALLEG ATION THAT AN INDIVIDUAL E MPLOYED BY A CLINICA L 28
RESEARCH PHARMACY: 29

(I) IS PRACTICING A PROFESSION REGULATED BY THE HEALTH 30
OCCUPATIONS BOARD UNDER THIS ARTICLE WITHOUT A LICENSE, CERTIFICATE, OR 31
OTHER AUTHORIZATION OR WITH AN UNAUTHORIZED PERSON; OR 32
6 HOUSE BILL 1426

(II) HAS VIOLATED A PROVISION OF THIS ARTICLE UNDER THE 1
JURISDICTION OF THE HEALTH OCCUPATIONS BOARD. 2

(G) A HEALTH CARE PROVIDER WITH A SUBSTANTIAL O WNERSHIP 3
INTEREST IN A CLINICAL RESEARCH PHARMACY MAY NOT: 4

(1) SERVE AS A CLINICAL I NVESTIGATOR FOR A SC IENTIFIC 5
RESEARCH PROTOCOL CONDUCTED BY THE CLINICAL RESEARCH PHARMACY; OR 6

(2) IMPEDE OR IMPAIR A PHARMACIST’S ABILITY TO FULLY EXERCISE 7
THE PHARMACIST’S PROFESSIONAL JUDGMENT. 8

(H) THIS SECTION DOES NOT LIMIT: 9

(1) THE RIGHT OF AN INDIV IDUAL TO PRACTICE A HEALTH 10
OCCUPATION THAT THE INDIVIDUAL IS AUTHOR IZED TO PRACTICE UND ER THIS 11
ARTICLE; OR 12

(2) THE RIGHT OF A PERSON TO ESTABLISH OR OPER ATE A 13
PHARMACY UNDER OTHER PROVISIONS OF THIS TITLE. 14

14–101. 15

(a) In this title the following words have the meanings indicated. 16

(o) (1) “Practice medicine” means to engage, with or without compensation, in 17
medical: 18

(i) Diagnosis; 19

(ii) Healing; 20

(iii) Treatment; or 21

(iv) Surgery. 22

(2) “Practice medicine” includes doing, undertaking, professing to do, and 23
attempting any of the following: 24

(i) Diagnosing, healing, treating, preventing, prescribing for, or 25
removing any physical, mental, or emotional ailment or supposed ailment of an individual: 26

1. By physical, mental, emotional, or other p rocess that is 27
exercised or invoked by the practitioner, the patient, or both; or 28

HOUSE BILL 1426 7

2. By appliance, test, drug, operation, or treatment; 1

(ii) Ending of a human pregnancy; and 2

(iii) Performing acupuncture as provided under § 14–504 of this title. 3

(3) “Practice medicine” does not include: 4

(i) Selling any nonprescription drug or medicine; 5

(ii) Practicing as an optician; [or] 6

(iii) Performing a massage or other manipulation by hand, but by no 7
other means; OR 8

(IV) CONDUCTING AN INVESTIGATIONAL OR E XPERIMENTAL 9
TREATMENT OR CLINICAL TRIAL BY A CORPORATION OR OTHER LEGAL ENTITY THAT 10
IS NOT AN INDIVIDUAL LICENSED UNDER THIS TITLE IF: 11

1. THE INVESTIGATIONAL O R EXPERIMENTAL 12
TREATMENT OR CLINICAL TRIAL IS CONDUCTED IN ACCORDANCE WITH PROTOCOLS 13
REGISTERED BY THE U.S. FOOD AND DRUG ADMINISTRATION, THE EUROPEAN 14
MEDICINES AGENCY, OR ANOTHER OFFICIAL INTERNATIONAL BODY A ND IN 15
COMPLIANCE WITH ALL APPLICABLE ETHICAL G UIDELINES AND FEDERA L AND 16
STATE REGULATIONS GOVERNING HUMAN SUBJECTS RESEARCH; 17

2. ALL MEDICAL DECISION MAKING WITHIN THE 18
CLINICAL TRIAL IS CARRIED OUT BY INDIVIDUALS WHO ARE LICENSED UNDER THIS 19
ARTICLE; AND 20

3. THE CORPORATION OR OT HER ENTITY CONDUCTIN G 21
THE TRIAL DOES NOT E NGAGE IN THE GENERAL PRACTICE OF MEDICINE OR 22
PROVIDE CLINICAL PAT IENT CARE OUTSIDE TH E SCOPE OF THE REGIS TERED 23
CLINICAL TRIAL. 24

SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 25
October 1, 2026. 26