Md. Code, Health Occ. § 12-6C-09.1

Current through 2024 Legislative Session

Section 12-6C-09.1 - [Effective 7/1/2024] 340B Drugs

(a)

(1) In this section the following words have the meanings indicated.

(2) "Covered entity" has the meaning stated in 42 U.S.C. § 256b(a)(4).

(3) "Package" has the meaning stated in 21 U.S.C. § 360eee (11).

(4)

(i) "340B drug" means a drug that:

1. Is a covered outpatient drug under 42 U.S.C. § 256b;

2. Has been subject to an offer for reduced prices by a 340B manufacturer under 42 U.S.C. § 256b(a)(1); and

3. Is purchased by a covered entity.

(ii) "340B drug" includes a drug that would have been purchased but for the limitation under subsection (c) of this section.

(5) "340B manufacturer" means a manufacturer, as defined in 42 U.S.C. § 1396r-8(k)(5), of covered outpatient drugs that has signed a pharmaceutical pricing agreement under 42 U.S.C. § 256b(a)(1).

(b) This section may not be construed to be:

(1) Less restrictive than any federal law that is applicable to a person regulated by this section; or

(2) In conflict with applicable federal and State laws and regulations.

(c)

(1) Except as provided in paragraph (2) of this subsection, a 340B manufacturer may not directly or indirectly deny, restrict, prohibit, discriminate against, or otherwise limit the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract with or otherwise authorized by a covered entity to receive 340B drugs on behalf of the covered entity unless the receipt of 340B drugs is prohibited by the U.S. Department of Health and Human Services.

(2) A 340B manufacturer may limit the distribution of a 340B drug if the limitation is required under 21 U.S.C. § 355-1.

(d)

(1)

(i) A violation of subsection (c) of this section:

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 subject to the enforcement and penalty provisions contained in Title 13 of the Commercial Law Article; and

2.

A . If the alleged violation was committed by a person that is licensed or permitted by the Board, shall be investigated by the Board or the Consumer Protection Division of the Office of the Attorney General; or

B. If the alleged violation was committed by a person that is not licensed or permitted by the Board, shall be investigated by the Consumer Protection Division of the Office of the Attorney General.

(ii) As part of an investigation conducted under subparagraph (1)(i)2 of this paragraph, the Board or the Consumer Protection Division of the Office of the Attorney General may investigate an affiliate or a contractor of the 340B manufacturer, including a wholesaler or third-party logistics provider.

(2)

(i) In addition to the penalties under Title 13 of the Commercial Law Article, a civil fine may be assessed in the amount of $5,000 per violation of subsection (c) of this section.

(ii) A violation of this section does not create a private right of action under § 13-408 of the Commercial Law Article.

(3) If a violation of subsection (c) of this section is committed by a person licensed or permitted by the Board, the Board may impose discipline, suspension, or revocation of the person's license or permit.

(4) Each package of 340B drugs subject to a violation of subsection (c) of this section shall constitute a separate violation.

Md. Code, HO § 12-6C-09.1

Added by 2024 Md. Laws, Ch. 962,Sec. 1, eff. 7/1/2024.