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Bill

A 2288

Establishes licensure requirement for source plasma donation centers.

2026-2027 Regular Session Introduced by Rosy Bagolie and 2 co-sponsors

New Jersey will require annual licenses for all source plasma donation centers, with safety standards, inspections, and penalties for noncompliance.

Reported and Referred to Assembly Appropriations Committee
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Bill Summary · A 2288

Bill A 2288 (Session 222, New Jersey): Establishes licensure requirement for source plasma donation centers

Purpose and intent

  • Establishes a dedicated licensure framework for operating source plasma donation centers in New Jersey.
  • Aims to promote safety, standardization, and oversight of plasma collection operations, recognizing the growing demand for plasma-derived therapies and the economic importance of these centers to communities.

Key provisions and changes

Licensing framework

  • Requires anyone operating a source plasma donation center in New Jersey to obtain a license from the New Jersey Department of Health (the Commissioner).
  • Licenses are annual, expiring December 31 each year.
  • Applicants must use forms provided by the Department; renewal applications due by November 10.
  • A license must be prominently displayed at the center.

Initial and renewal fees

  • The Commissioner will establish initial licensure and renewal fees.
  • A special transitional provision sets the initial licensure fee for centers already operating before enactment at $25.
  • Ongoing fees thereafter (initial or renewal) are determined by the Commissioner, and may be adjusted over time per rulemaking.

Scope and exemptions

  • Licensure is in addition to any local licenses or permits required by a municipality, except:
    • Centers that perform only non-diagnostic donor screening tests and conduct plasmapheresis but do not collect source plasma or do not operate as a traditional blood bank/clinical laboratory license are exempt from blood bank or clinical laboratory licensing.

Regulatory authority and compliance

  • The Commissioner is authorized to promulgate rules and regulations to promote safety and best practices in source plasma donation, including requirements for:
    • Staff supervision, training, and duties
    • Plasmapheresis and pre-donation screening tests
    • Alignment with applicable federal and voluntary standards:
    • 42 C.F.R. Part 493
    • 21 C.F.R. Parts 600–640
    • Plasma Protein Therapeutics Association Voluntary Standards Program

Inspections and enforcement

  • The Commissioner may enter and inspect source plasma donation centers and examine premises, books, and records as needed.
  • The Commissioner can issue complaints and enforce licensure provisions, including suspending or revoking licenses for violations.
  • Due-process protections:
    • The Commissioner must provide notice and an opportunity to be heard before denying, suspending, or revoking a license (except in emergencies related to public health, where immediate suspension is permitted).
    • If a violation is deemed an imminent threat, a suspension may be ordered pending correction with a hearing decision to be issued within 48 hours of hearing request. Injunctive relief can be sought in Superior Court.

Violations and penalties

  • Penalties for violations (or orders) range:
    • First offense: $100 to $1,000
    • Second and subsequent offenses: $500 to $5,000
  • Penalties are enforced under the Penalty Enforcement Law of 1999.

Administration and funding

  • Income from licensure and renewal fees is to be appropriated to the Department of Health to support the act’s purposes.

Affected entities and scope

  • Primary: Operators of source plasma donation centers in New Jersey.
  • Indirectly affects:
    • Center staff and management (due to licensing, training, and compliance requirements)
    • Local boards of health and municipal authorities (due to interaction with local licensing where applicable)
    • Plasma-derived therapy supply chains and patients (through potential improvements in safety and oversight)

Timeline and effective date

  • Effective date: November 1 following enactment, with anticipatory administrative action allowed as needed for implementation.
  • Licenses would begin on an annual cycle, expiring December 31 each year.

Summary in plain terms

Bill A 2288 creates a statewide licensing regime for all source plasma donation centers in New Jersey. It requires centers to obtain annual licenses, pay (to-be-determined) fees (with a $25 initial fee for pre-existing centers), meet safety and operational standards, and undergo Department of Health inspections. The bill empowers the Department to inspect facilities, enforce rules, and suspend or revoke licenses for violations, with due-process protections and penalties for noncompliance. Funding from fees supports the program, and the act aligns with federal and industry standards to safeguard the collection of source plasma used to manufacture plasma-derived therapies.

Compiled from official sources — confirm details with the bill’s official record.

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