OHIO LEGISLATIVE SERVICE COMMISSION
Office of Research Legislative Budget
www.lsc.ohio.gov and Drafting Office
H.B. 588 Bill Analysis
135th General Assembly
Click here for H.B. 588’s Fiscal Note
Version: As Introduced
Primary Sponsors: Reps. Holmes and John
Effective date:
Jason Hoskins, Attorney
Erika Kramer, Attorney
SUMMARY
▪ Prohibits a manufacturer of dangerous drugs, repackager of dangerous drugs, third-party
logistics provider, or wholesale distributor of dangerous drugs from denying, prohibiting,
restricting, discriminating against, or limiting the acquisition of drugs under the 340B Drug
Pricing Program by a covered entity participating in that program.
▪ Prohibits a manufacturer of dangerous drugs, repackager of dangerous drugs, third-party
logistics provider, or wholesale distributor of dangerous drugs from requiring a 340B
covered entity to submit claims or utilization data as a condition for acquiring certain
drugs.
▪ Makes a violation of these provisions a violation of Ohio’s Consumer Sales Practices Act
and authorizes the Attorney General to take actions to enforce compliance with the bill’s
provisions.
▪ Specifies that the bill’s provisions are not to be construed as to conflict with or be less
restrictive than applicable federal or state laws and regulations.
DETAILED ANALYSIS
Acquisition of drugs by 340B covered entities
Generally, the bill prohibits a manufacturer of dangerous drugs, repackager of dangerous
drugs, third-party logistics provider, or wholesale distributor of dangerous drugs from taking
certain actions related to the acquisition of certain drugs by a 340B covered entity. A 340B
covered entity is an entity that under federal law is authorized to participate in the 340B Drug
Pricing Program and includes certain categories of hospitals and certain nonhospital providers
December 6, 2024
Office of Research and Drafting LSC Legislative Budget Office
that are eligible based on receiving federal funding and that generally provide care to the
medically underserved.1
Under the bill, a manufacturer of dangerous drugs, repackager of dangerous drugs, third-
party logistics provider, or wholesale distributor of dangerous drugs may not deny, prohibit,
restrict, discriminate against, or otherwise limit the acquisition or delivery of a drug included in
the 340B Drug Pricing Program (referred to in the bill as a “340B drug”) by or to a 340B covered
entity, unless the purchase or delivery of the drug is prohibited by the U.S. Department of Health
and Human Services (HHS). Similarly, the bill prohibits an entity described above from requiring
a 340B covered entity to submit any claims or utilization data as a condition for the acquisition
or delivery of a 340B drug by a 340B covered entity, unless the claim or utilization data sharing is
required by HHS.2
Enforcement
The bill includes a violation of the above-mentioned provisions as an unfair or deceptive
act or practice in connection with a consumer transaction under Ohio’s Consumer Sales Practices
Act (CSPA).3 The CSPA generally permits the Attorney General to impose a civil penalty of up to
$5,000 or $25,000, depending on the offense. It also grants a private right of action for the
consumer against the alleged violator.4 Instead, the bill specifies that if a manufacturer of
dangerous drugs, repackager of dangerous drugs, third-party logistics provider, or wholesale
distributor of dangerous drugs violates the bill’s provisions, the Attorney General may initiate
criminal proceedings in accordance with existing law or may assess a civil penalty of $50,000 for
each violation.5
The bill specifies that each package of drugs determined to be a violation of the bill’s
prohibitions constitutes a separate violation. In addition to the enforcement mechanisms
described above, the bill permits the Attorney General to refer complaints to the State Board of
Pharmacy for the Board to consider imposing additional sanctions as permitted by existing law.
The Attorney General may adopt rules or delegate rulemaking authority to the State Board of
Pharmacy to implement the bill’s requirements.6
The bill specifies that its provisions are not to be construed to conflict with or be less
restrictive than applicable federal law or regulations, or existing state law or regulations.7
1 R.C. 4729.521(A)(1).
2 R.C. 4729.521(B)(1) and (2).
3 R.C. 1345.02, not in the bill.
4 R.C. 1345.07(A) and (C) and 1345.09, not in the bill.
5 R.C. 4729.521(C).
6 R.C. 4729.521(C) and (D).
7 R.C. 4729.521(E).
P a g e |2 H.B. 588
As Introduced
Office of Research and Drafting LSC Legislative Budget Office
HISTORY
Action Date
Introduced 05-15-24
ANHB0588In-135/ts
P a g e |3 H.B. 588
As Introduced