WES MOORE, Governor Ch. 962
– 1 –
Chapter 962
(House Bill 1056)
AN ACT concerning
State Board of Pharmacy – Prohibition on Discrimination Against 340B Drug
Distribution
FOR the purpose of prohibiting a 340B manufacturer, wholesale drug distributor, or
third–party logistics provider, or an agent or affiliate of a 340B manufacturer,
wholesale drug distributor, or third–party logistics provider, from taking certain
direct or indirect actions to limit or restrict the acquisition or delivery of a 340B drug;
making a violation of this Act an unfair, abusive, or deceptive trade practice within
the meaning of the Consumer Protection Act; requiring the Maryland Prescription
Drug Affordability Board to conduct a study of the 340B Program; and generally
relating to 340B drugs.
BY repealing and reenacting, with amendments,
Article – Commercial Law
Section 13–301(14)(xl)
Annotated Code of Maryland
(2013 Replacement Volume and 2023 Supplement)
BY repealing and reenacting, without amendments,
Article – Commercial Law
Section 13–301(14)(xli)
Annotated Code of Maryland
(2013 Replacement Volume and 2023 Supplement)
BY adding to
Article – Commercial Law
Section 13–301(14)(xlii)
Annotated Code of Maryland
(2013 Replacement Volume and 2023 Supplement)
BY repealing and reenacting, without amendments,
Article – Health Occupations
Section 12–101(a) and (d)
Annotated Code of Maryland
(2021 Replacement Volume and 2023 Supplement)
BY adding to
Article – Health Occupations
Section 12–6C–09.1
Annotated Code of Maryland
(2021 Replacement Volume and 2023 Supplement) Ch. 962 2024 LAWS OF MARYLAND
– 2 –
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND,
That the Laws of Maryland read as follows:
Article – Commercial Law
13–301.
Unfair, abusive, or deceptive trade practices include any:
(14) Violation of a provision of:
(xl) Title 14, Subtitle 13 of the Public Safety Article; [or]
(xli) Title 14, Subtitle 45 of this article; or
(XLII) SECTION 12–6C–09.1 OF THE HEALTH OCCUPATIONS
ARTICLE; OR
Article – Health Occupations
12–101.
(a) In this title the following words have the meanings indicated.
(d) “Board” means the State Board of Pharmacy.
12–6C–09.1.
(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS
INDICATED.
(2) “COVERED ENTITY ” HAS THE MEANING STAT ED IN 42 U.S.C. §
256B(A)(4).
(3) “PACKAGE” HAS THE MEANING STAT ED IN 21 U.S.C. §
360EEE(11).
(4) (I) “340B DRUG” MEANS A DRUG THAT :
1. IS A COVERED OUTPATIE NT DRUG UNDER 42 U.S.C. §
256B;
2. HAS BEEN SUBJECT TO A N OFFER FOR REDUCED
PRICES BY A 340B MANUFACTURER UNDER 42 U.S.C. § 256B(A)(1); AND WES MOORE, Governor Ch. 962
– 3 –
3. IS PURCHASED BY A COV ERED ENTITY.
(II) “340B DRUG” INCLUDES A DRUG THAT WOULD HAVE BEEN
PURCHASED BUT FOR TH E LIMITATION UNDER S UBSECTION (D) (C) OF THIS
SECTION.
(5) “340B MANUFACTURER ” MEANS A MANUFACTURER , AS DEFINED
IN 42 U.S.C. § 1396R–8(K)(5), OF COVERED OUTPATIEN T DRUGS THAT HAS SIG NED
A PHARMACEUTICAL PRI CING AGREEMENT UNDER 42 U.S.C. § 256B(A)(1).
(B) THIS SECTION APPLIES TO:
(1) A 340B MANUFACTURER ;
(2) A WHOLESALE DRUG DISTR IBUTOR;
(3) A THIRD–PARTY LOGISTICS PROV IDER; AND
(4) AN AGENT OR AFFILIATE OF A 340B MANUFACTURER ,
WHOLESALE DRUG DISTR IBUTOR, OR THIRD–PARTY LOGISTICS PROV IDER.
(C) THIS SECTION MAY NOT BE CONSTRUED TO BE :
(1) LESS RESTRICTIVE THAN ANY FEDERAL LAW THAT IS APPLICABLE
TO A PERSON REGULATE D BY THIS SECTION; OR
(2) IN CONFLICT WITH APPL ICABLE FEDERAL AND STATE LAWS AND
REGULATIONS .
(D) (C) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS
SUBSECTION, AN ENTITY SUBJECT TO THIS SECTION A 340B MANUFACTURER MAY
NOT DIRECTLY OR INDI RECTLY DENY , RESTRICT, PROHIBIT, DISCRIMINATE
AGAINST, OR OTHERWISE LIMIT T HE ACQUISITION OF A 340B DRUG BY, OR
DELIVERY OF A 340B DRUG TO, A PHARMACY THAT IS U NDER CONTRACT WITH O R
OTHERWISE AUT HORIZED BY A COVERED ENTITY TO RECEIVE 340B DRUGS ON
BEHALF OF THE COVERE D ENTITY UNLESS THE RECEIPT OF 340B DRUGS IS
PROHIBITED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES.
(2) AN ENTITY SUBJECT TO THIS SECTION A 340B MANUFACTURER
MAY LIMIT TH E DISTRIBUTION OF A 340B DRUG IF THE LIMITATI ON IS REQUIRED
UNDER 21 U.S.C. § 355–1.
Ch. 962 2024 LAWS OF MARYLAND
– 4 –
(E) (D) (1) (I) A VIOLATION OF SUBSECT ION (D) (C) OF THIS
SECTION:
(I) 1. SUBJECT TO PARAGRAPH (2) OF THIS SUBSECTION , IS
AN UNFAIR, ABUSIVE, OR DECEPTIVE TRADE PRACTICE WITHIN THE MEANING OF
TITLE 13 OF THE COMMERCIAL LAW ARTICLE AND IS SUBJEC T TO THE
ENFORCEMENT AND PENA LTY PROVISIONS CONTA INED IN TITLE 13 OF THE
COMMERCIAL LAW ARTICLE; AND
(II) 2. A. SHALL IF THE ALLEGED VIOLAT ION WAS
COMMITTED BY A PERSO N THAT IS LICENSED OR PERMITTED BY THE BOARD, SHALL
BE JOINTLY OR SEPARATEL Y INVESTIGATED BY THE BOARD OR THE CONSUMER
PROTECTION DIVISION OF THE OFFICE OF THE ATTORNEY GENERAL; OR
B. IF THE ALLEGED VIOLAT ION WAS COMMITTED BY A
PERSON THAT IS NOT L ICENSED OR PERMITTED BY T HE BOARD, SHALL BE
INVESTIGATED BY THE CONSUMER PROTECTION DIVISION OF THE OFFICE OF THE
ATTORNEY GENERAL.
(II) AS PART OF AN INVESTI GATION CONDUCTED UND ER
SUBPARAGRAPH (1)(I)2 OF THIS PARAGRAPH , THE BOARD OR THE CONSUMER
PROTECTION DIVISION OF THE OFFICE OF THE ATTORNEY GENERAL MAY
INVESTIGATE AN AFFIL IATE OR A CONTRACTOR OF THE 340B MANUFACTURER ,
INCLUDING A WHOLESAL ER OR THIRD–PARTY LOGISTICS PROV IDER.
(2) (I) IN ADDITION TO THE PE NALTIES UNDER TITLE 13 OF THE
COMMERCIAL LAW ARTICLE, A CIVIL FINE MAY BE ASSESSED IN THE AMOU NT OF
$50,000 $5,000 PER VIOLATION OF SUB SECTION (D) (C) OF THIS SECTION.
(II) A VIOLATION OF THIS SE CTION DOES NOT CREAT E A
PRIVATE RIGHT OF ACT ION UNDER § 13–408 OF THE COMMERCIAL LAW ARTICLE.
(3) IF A VIOLATION OF SUB SECTION (D) (C) OF THIS SECTION IS
COMMITTED BY A PERSO N LICENSED OR PERMIT TED BY THE BOARD, THE BOARD
MAY IMPOSE DISCIPLIN E, SUSPENSION, OR REVOCATION OF THE PERSON’S LICENSE
OR PERMIT.
(4) EACH PACKAGE OF 340B DRUGS SUBJECT TO A V IOLATION OF
SUBSECTION (D) (C) OF THIS SECTION SHAL L CONSTITUTE A SEPAR ATE VIOLATION.
SECTION 2. AND BE IT FURTHER ENACTED, That:
WES MOORE, Governor Ch. 962
– 5 –
(a) The Maryland Prescription Drug Affordability Board, in consultation with the
Maryland Department of Health:
(1) shall conduct a study on:
(i) the current implementation and scope of the 340B Program in
the State;
(ii) the implementation and impact of the implementation of Section
1 of this Act; and
(iii) the finances of the Program in the State, including how covered
entities reinvest savings realized from the Program; and
(2) may require covered entities and 340B manufacturers to report
information as necessary to complete the study.
(b) On or before July 1, 2026, the Maryland Prescription Drug Affordability Board
shall report its findings and recommendations from the study to the Senate Finance
Committee and the House Health and Government Operations Committee, in accordance
with § 2–1257 of the State Government Article.
SECTION 2. 3. AND BE IT FURTHER ENACTED, That this Act shall take effect
July 1, 2024.
Approved by the Governor, May 16, 2024.