EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*hb1056*
HOUSE BILL 1056
J2, J5 4lr2443
By: Delegates Guzzone, Bagnall, Hill, Kaiser, R. Lewis, White Holland, and Woods
Introduced and read first time: February 7, 2024
Assigned to: Health and Government Operations
A BILL ENTITLED
AN ACT concerning 1
State Board of Pharmacy – Prohibition on Discrimination Against 340B Drug 2
Distribution 3
FOR the purpose of prohibiting a 340B manufacturer, wholesale drug distributor, or 4
third–party logistics provider, or an agent or affiliate of a 340B manufacturer, 5
wholesale drug distributor, or third–party logistics provider, from taking certain 6
actions to limit or restrict the acquisition or delivery of a 340B drug; making a 7
violation of this Act an unfair, abusive, or deceptive trade practice within the 8
meaning of the Consumer Protection Act; and generally relating to 340B drugs. 9
BY repealing and reenacting, with amendments, 10
Article – Commercial Law 11
Section 13–301(14)(xl) 12
Annotated Code of Maryland 13
(2013 Replacement Volume and 2023 Supplement) 14
BY repealing and reenacting, without amendments, 15
Article – Commercial Law 16
Section 13–301(14)(xli) 17
Annotated Code of Maryland 18
(2013 Replacement Volume and 2023 Supplement) 19
BY adding to 20
Article – Commercial Law 21
Section 13–301(14)(xlii) 22
Annotated Code of Maryland 23
(2013 Replacement Volume and 2023 Supplement) 24
BY repealing and reenacting, without amendments, 25
Article – Health Occupations 26
Section 12–101(a) and (d) 27 2 HOUSE BILL 1056
Annotated Code of Maryland 1
(2021 Replacement Volume and 2023 Supplement) 2
BY adding to 3
Article – Health Occupations 4
Section 12–6C–09.1 5
Annotated Code of Maryland 6
(2021 Replacement Volume and 2023 Supplement) 7
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 8
That the Laws of Maryland read as follows: 9
Article – Commercial Law 10
13–301. 11
Unfair, abusive, or deceptive trade practices include any: 12
(14) Violation of a provision of: 13
(xl) Title 14, Subtitle 13 of the Public Safety Article; [or] 14
(xli) Title 14, Subtitle 45 of this article; or 15
(XLII) SECTION 12–6C–09.1 OF THE HEALTH OCCUPATIONS 16
ARTICLE; OR 17
Article – Health Occupations 18
12–101. 19
(a) In this title the following words have the meanings indicated. 20
(d) “Board” means the State Board of Pharmacy. 21
12–6C–09.1. 22
(A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 23
INDICATED. 24
(2) “COVERED ENTITY ” HAS THE MEANING STAT ED IN 42 U.S.C. § 25
256B(A)(4). 26
(3) “PACKAGE” HAS THE MEANING STATED IN 21 U.S.C. § 27
360EEE(11). 28
HOUSE BILL 1056 3
(4) (I) “340B DRUG” MEANS A DRUG THAT : 1
1. IS A COVERED OUTPATIE NT DRUG UNDER 42 U.S.C. § 2
256B; 3
2. HAS BEEN SUBJECT TO A N OFFER FOR REDUCED 4
PRICES BY A 340B MANUFACTURER UNDER 42 U.S.C. § 256B(A)(1); AND 5
3. IS PURCHASED BY A COV ERED ENTITY. 6
(II) “340B DRUG” INCLUDES A DRUG THAT WOULD HAVE BEEN 7
PURCHASED BUT FOR TH E LIMITATION UNDER S UBSECTION (D) OF THIS SECTION. 8
(5) “340B MANUFACTURER ” MEANS A MANUFACTURER , AS DEFINED 9
IN 42 U.S.C. § 1396R–8(K)(5), OF COVERED OUTPATIEN T DRUGS THAT HAS SIG NED 10
A PHARMACEUTICAL PRI CING AGREEMENT UNDER 42 U.S.C. § 256B(A)(1). 11
(B) THIS SECTION APPLIES TO: 12
(1) A 340B MANUFACTURER ; 13
(2) A WHOLESALE DRUG DISTR IBUTOR; 14
(3) A THIRD–PARTY LOGISTICS PROV IDER; AND 15
(4) AN AGENT OR AFFILIATE OF A 340B MANUFACTURER , 16
WHOLESALE DRUG DISTR IBUTOR, OR THIRD–PARTY LOGISTICS PROV IDER. 17
(C) THIS SECTION MAY NOT BE CONSTRUED TO BE : 18
(1) LESS RESTRICTIVE THAN ANY FEDERAL LAW THAT IS APPLICABLE 19
TO A PERSON REGULATED B Y THIS SECTION; OR 20
(2) IN CONFLICT WITH APPL ICABLE FEDERAL AND STATE LAWS AND 21
REGULATIONS . 22
(D) (1) EXCEPT AS PROVIDED IN PARAGRAPH (2) OF THIS SUBSECTION , 23
AN ENTITY SUBJECT TO THIS SECTION MAY NOT DIRECTLY OR INDIRECT LY DENY, 24
RESTRICT, PROHIBIT, DISCRIMINATE AGAINST, OR OTHERWISE LIMIT T HE 25
ACQUISITION OF A 340B DRUG BY, OR DELIVERY OF A 340B DRUG TO, A PHARMACY 26
THAT IS UNDER CONTRA CT WITH OR OTHERWISE AUTHORIZED BY A COVE RED 27
ENTITY TO RECEIVE 340B DRUGS ON BEHALF OF T HE COVERED ENTITY UN LESS THE 28 4 HOUSE BILL 1056
RECEIPT OF 340B DRUGS IS PROHIBITED BY THE U.S. DEPARTMENT OF HEALTH 1
AND HUMAN SERVICES. 2
(2) AN ENTITY SUBJECT TO THIS SECTION MAY LIM IT THE 3
DISTRIBUTION OF A 340B DRUG IF THE LIMITATI ON IS REQUIRED UNDER 21 U.S.C. 4
§ 355–1. 5
(E) (1) A VIOLATION OF SUBSECT ION (D) OF THIS SECTION: 6
(I) SUBJECT TO PARAGRAPH (2) OF THIS SUBSECTION , IS AN 7
UNFAIR, ABUSIVE, OR DECEPTIVE TRADE P RACTICE WITHIN THE M EANING OF TITLE 8
13 OF THE COMMERCIAL LAW ARTICLE AND IS SUBJEC T TO THE ENFORCEMENT AND 9
PENALTY PROVISIONS C ONTAINED IN TITLE 13 OF THE COMMERCIAL LAW ARTICLE; 10
AND 11
(II) SHALL BE JOINTLY OR SEPARATELY INVESTIGATE D BY THE 12
BOARD OR THE CONSUMER PROTECTION DIVISION OF THE OFFICE OF THE 13
ATTORNEY GENERAL. 14
(2) (I) IN ADDITION TO THE PE NALTIES UNDER TITLE 13 OF THE 15
COMMERCIAL LAW ARTICLE, A CIVIL FINE MAY BE ASSESSED IN THE AMOU NT OF 16
$50,000 PER VIOLATION OF SUB SECTION (D) OF THIS SECTION. 17
(II) A VIOLATION OF THIS SE CTION DOES NOT CREAT E A 18
PRIVATE RIGHT OF ACT ION UNDER § 13–408 OF THE COMMERCIAL LAW ARTICLE. 19
(3) IF A VIOLATION OF SUB SECTION (D) OF THIS SECTION IS 20
COMMITTED BY A PERSO N LICENSED OR PERMIT TED BY THE BOARD, THE BOARD 21
MAY IMPOSE DISCIPLIN E, SUSPENSION, OR REVOCATION OF THE PERSON’S LICENSE 22
OR PERMIT. 23
(4) EACH PACKAGE OF 340B DRUGS SUBJECT TO A VIOLATION OF 24
SUBSECTION (D) OF THIS SECTION SHAL L CONSTITUTE A SEPAR ATE VIOLATION. 25
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 26
1, 2024. 27