Bill
Bill > S4338
summary
Introduced
05/12/2025
05/12/2025
In Committee
01/08/2026
01/08/2026
Crossed Over
Passed
Dead
01/12/2026
01/12/2026
Introduced Session
2024-2025 Regular Session
Bill Summary
This bill would require source plasma donation centers to apply annually for a license from the Department of Health (department) in order to operate within the State. The Commissioner of Health (commissioner) would establish a process by which persons operating a source plasma donation center would apply for licensure. The commissioner would establish the initial licensure fee, as well as the fee for renewal, except that the initial licensure fee for a person who has been operating a source plasma donation center prior to the effective date of this bill would be set at $25. The income received from the licensure and renewal fees would be appropriated to the department. The commissioner, to promote the safety and best practices among source plasma donation centers, would promulgate rules and regulations governing the donations of source plasma. The commissioner would also have enforcement powers, including the power to enter and inspect any source plasma donation center to investigate the premises and the books and records. The commissioner would also have the power to suspend, revoke, and refuse to grant a license. Before any such action can be taken, the commissioner must provide notice and an opportunity to be heard to the applicant or licensee, at a time and place as specified in the notice. However, if the commissioner believes that a violation has occurred that is dangerous to the public health, the commissioner may suspend the donation center's license without notice until the correction is completed. If the licensee denies the existence or occurrence of the condition, the licensee would be able to request a hearing and a decision would be rendered within 48 hours of the receipt for the request for a hearing. If the commissioner rules against the licensee, the licensee could then apply for injunctive relief against the commissioner's order. Jurisdiction for the injunctive relief would be in the Superior Court of New Jersey. Any person who violates the provisions of this act or an order of the commissioner issued pursuant to this bill would be liable to a penalty of not less than $100 but not more than $1,000 for the first offense. For the second and each succeeding offense, a penalty of not less than $500 but not more than $5,000, to be established by the commissioner. The penalties are to be enforced pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).
AI Summary
This bill establishes a comprehensive licensing framework for source plasma donation centers in New Jersey, requiring these facilities to obtain an annual license from the Department of Health. The bill defines source plasma as the fluid portion of human blood collected through plasmapheresis (a procedure where blood is drawn, plasma is separated, and red blood cells are returned to the donor) and is intended to support the production of plasma-derived therapies used to treat rare conditions like immune deficiencies and bleeding disorders. The legislation mandates that centers pay an initial licensing fee (with a reduced $25 rate for existing centers) and requires annual renewal by November 10th, with the Commissioner of Health empowered to set and periodically adjust licensing fees. The bill grants the Commissioner broad regulatory authority, including the power to inspect facilities, establish safety and operational standards, and suspend or revoke licenses for violations. Penalties for non-compliance range from $100 to $1,000 for first-time offenders and $500 to $5,000 for subsequent offenses. The bill recognizes the economic importance of source plasma donation centers, noting they provide employment opportunities and contribute significantly to local economies, and aims to create a structured regulatory environment that ensures public health and safety while supporting the critical plasma donation ecosystem.
Committee Categories
Budget and Finance, Health and Social Services
Sponsors (2)
Last Action
Substituted by A5592 (on 01/12/2026)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.njleg.state.nj.us/bill-search/2024/S4338 |
| Analysis - Statement SBA 1/8/26 | https://pub.njleg.gov/Bills/2024/S4500/4338_S2.PDF |
| Fiscal Note - Fiscal Estimate 12/30/25; as introduced | https://pub.njleg.gov/Bills/2024/S4500/4338_E1.PDF |
| Analysis - Statement SHH 12/8/25 | https://pub.njleg.gov/Bills/2024/S4500/4338_S1.PDF |
| BillText | https://pub.njleg.gov/Bills/2024/S4500/4338_I1.HTM |
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