WEST VIRGINIA LEGISLATURE
2024 REGULAR SESSION
Introduced House Bill 4892
By Delegate Rohrbach, Hillenbrand, Worrell and Honrbuckle [Introduced January 18, 2024; Referred to the Committee on Prevention and Treatment of
Substance Abuse then Health and Human Resources]
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1 A BILL to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section,
2 designated §60A-8-6a, relating to the distribution of drugs to safety net providers and
3 contract pharmacies; penalties; and preemption.
Be it enacted by the Legislature of West Virginia:
ARTICLE 8. WHOLESALE DRUG DISTRIBUTION LICENSING ACT OF 1991.
§60A-8-6a. Distribution of Safety-Net Drugs to Contract Pharmacies; Penalties; and Preemption.
1 (a) Definitions.
2 (1) As used in this article:
3 (A) "340B drug" means a drug that:
4 (i) Is a covered outpatient drug within the meaning of 42 U.S.C. §256b;
5 (ii) Has been subject to any offer for reduced prices by a manufacturer under 42 U.S.C.
6 §256b(a)(1); and
7 (iii) Is purchased by a covered entity within the meaning of 42 U.S.C. §256b.
8 (B) "340B entity" has the same meaning as that term is defined in §33-51-3 of this code.
9 (C) "Biological product" has the same meaning as that term is defined in 42 U.S.C. § 262.
10 (D) "Board of pharmacy" means the West Virginia Board of Pharmacy, which is the agency
11 of this state authorized to issue and condition licensure and permitting of wholesale drug
12 distributors, third-party logistics providers, and manufacturers.
13 (E) "Commissioner" means the West Virginia insurance commissioner, his or her
14 deputies, or the West Virginia offices of the insurance commissioner, as appropriate.
15 (F) "Manufacturer" has the same meaning as that term is defined in §60A-8-5 of this code,
16 except that the definition shall include manufacturers of biological products.
17 (G) "Package" has the same meaning as that term is defined in 21 U.S.C. §360eee(11)(A).
18 (H) "Pharmacy" has the same meaning as that term is defined in §30-5-4 of this code.
19 (b) Distribution of drugs to safety net providers and contract pharmacies.
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20 (1) A manufacturer, wholesale drug distributor, third-party logistics provider, or an agent or
21 affiliate of such manufacturer, wholesale drug distributor, or third-party logistics provider, may not
22 deny, restrict, or prohibit, either directly or indirectly, the acquisition of a 340B drug by, or delivery
23 of a 340B drug to, a location authorized by a 340B entity to receive such 340B drug unless the
24 receipt of the 340B drug is prohibited by the United States Department of Health and Human
25 Services.
26 (2) A manufacturer, wholesale drug distributor, third-party logistics provider, or an agent or
27 affiliate of such manufacturer, wholesale drug distributor, or third-party logistics provider, may not
28 require a 340B entity to submit any claims or utilization data as a condition for allowing the
29 acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity unless the claims or
30 utilization data sharing is required by the United States Department of Health and Human
31 Services.
32 (c) Penalties and investigations.
33 (1) The commission of any act prohibited by subsection (b) of this section constitutes:
34 (A) A violation of §46A-6-104 of this code and shall subject the violator to a civil penalty of
35 $50,000 for each violation, as well as any and all actions, including investigative demands,
36 remedies, and penalties provided for in §46A-7-1 et seq. of this code, except that there is no right
37 to bring a private cause of action; and
38 (B) A violation of §33-11-1 et seq. of this code and shall subject the violator to all actions,
39 including cease and desist orders, civil penalties, and restitution provided for in §33-11-6 of this
40 code, except that there is no right to bring a private cause of action.
41 (2) Each package of 340B drugs determined to be subject to a prohibited act under
42 subsection (b) of this section constitutes a separate violation under subsection (b) of this section.
43 (3) Upon receipt by the board of pharmacy of a complaint that a person or other entity
44 licensed or permitted by the board of pharmacy has violated subsection (b) of this section, the
45 board of pharmacy:
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46 (A) May investigate the complaint and consider appropriate penalties, including imposing
47 discipline or suspending or revoking the license or permit of any such person or entity; and
48 (B) Shall share the results of the investigation with the attorney general and commissioner
49 if an investigation is conducted.
50 (4) The attorney general, board of pharmacy, and commissioner may promulgate rules to
51 implement the provisions of subsection (b) of this section.
52 (d) Preemption.
53 (1) Nothing in this section is to be construed or applied to be less restrictive than any
54 federal law as to any person or other entity regulated by this section. Nothing in this section is to
55 be construed or applied to be in conflict with any of the following:
56 (A) Applicable federal law and related regulation.
57 (B) Other laws of this state if the state law is compatible with applicable federal law.
58 (2) Limited distribution of a drug required under 21 U.S.C. §355-1 is not to be construed as
59 a violation of this section.
NOTE: The purpose of this bill is to define the distribution of drugs to safety net providers and contract pharmacies, with penalties, and that section not to be less restive than federal law.
Strike-throughs indicate language that would be stricken from a heading or the present law and underscoring indicates new language that would be added.
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Statutes affected:
Introduced Version: 60A-8-6a