Title 06 · CRS Title 06

Acquisition of 340B drugs - prohibited acts - use of savings - enforcement - penalties - nonpreemption - data exclusions

Citation: C.R.S. § 6-29-105

Section: 6-29-105

6-29-105. Acquisition of 340B drugs - prohibited acts - use of savings - enforcement - penalties - nonpreemption - data exclusions. (1) Prohibited acts. On and after August 6, 2025: (a) Unless the receipt of the 340B drugs is prohibited by the federal department of health and human services, a manufacturer, third-party logistics provider, or repackager, or an agent, contractor, or affiliate of a manufacturer, third-party logistics provider, or repackager, including an entity that collects or processes health information, shall 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 340B covered entity, a pharmacy contracted with a 340B covered entity, or a location otherwise authorized by a 340B covered entity to receive and dispense 340B drugs; and (b) A manufacturer shall not directly or indirectly require, including as a condition, a 340B covered entity, a pharmacy contracted with a 340B covered entity, or any other location authorized to receive 340B drugs by a 340B covered entity to submit any health information, claims or utilization data, purchasing data, payment data, or other data that does not relate to a claim submitted to a federal health-care program, unless such data is voluntarily furnished by such covered entity or otherwise required to be furnished under applicable federal law. (2) A covered entity that is a reporting hospital, as defined in section 25.5-1-701, shall not use 340B savings for the following purposes: (a) More than thirty-five percent of total annual compensation or expense reimbursement for the hospital's board of directors; (b) Tax penalties or fines issued against the hospital; (c) Expenses related to advertising and public relations that promote the hospital's image, services, or proposals, not including communications required by law or that are essential for patient safety and patient information; (d) Lobbying expenses and other costs intended to influence legislation or ballot measures at the local, state, or federal level; (e) Travel, lodging, food, or beverage expenses for the hospital's board of directors and officers; and (f) Gifts or entertainment expenses. (3) Enforcement - penalties. (a) The attorney general may investigate a complaint concerning a violation of this article 29. A person that violates this article 29 risks the public's health and engages in an unfair or deceptive trade practice pursuant to section 6-1-105 (1)(oooo) and is subject to the enforcement provisions, civil penalties, and damages set forth in article 1 of this title 6. (b) Each package of a 340B drug that constitutes a prohibited act under this article 29 constitutes a separate violation of subsection (1) of this section. (c) Limited distribution of a drug required under 21 U.S.C. sec. 355-1 does not constitute a violation of this article 29. (d) A person regulated by the state board of pharmacy created in section 12-280-104 may be subject to discipline pursuant to section 12-280-108 (1)(c), (1)(d), or (1)(i) for violating this article 29. (4) Nonpreemption. Nothing in this article 29 shall be construed or applied to be less restrictive than any federal law applying to persons regulated by this section. Nothing in this section shall be construed or applied to be in conflict with any of the following: (a) Applicable federal law and related regulations; or (b) Other laws of this state, if the laws are compatible with applicable federal law. (5) Data exclusions. Subsection (1) of this section does not prohibit a manufacturer from requiring health information or other data that a covered entity is required to furnish to the manufacturer under applicable federal law, including data relating to an audit in accordance with procedures established by the federal department of health and human services under 42 U.S.C. sec. 256b (a)(5)(C). Source: L. 2025: Entire article added, (SB 25-071), ch. 313, p. 1640, � 2, effective August 6.