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Bill

Bill

S 4338

Establishes licensure requirement for source plasma donation centers.

2024-2025 Regular Session Introduced by Vin Gopal

New Jersey requires state licensure for source plasma donation centers, establishing state regulatory oversight of facilities currently regulated only at the federal level.

Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee
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Bill Summary · S 4338

Legislative bill overview

S 4338 establishes a mandatory licensure system for source plasma donation centers operating in New Jersey. Currently, these facilities operate under federal FDA regulations but without state-level licensing requirements. The bill would create a state regulatory framework requiring centers to obtain licenses before operating.

Why is this important

Source plasma donation centers have faced increased scrutiny nationally over safety concerns, donor health protections, and facility standards. This bill would give New Jersey state authority to oversee these centers directly, potentially strengthening inspection protocols, sanitation standards, and donor screening procedures beyond federal minimums. It affects both the plasma donation industry and the estimated tens of thousands of New Jersey residents who donate plasma for income.

Potential points of contention

  • Industry compliance costs: Licensing requirements increase operational expenses for centers, which may be passed to donors through reduced compensation or to patients through higher plasma product prices
  • Donor access and income: Stricter regulations could reduce the number of operating centers or donation slots, affecting individuals who rely on plasma donation income (often low-income populations)
  • Regulatory overlap: Questions about whether state licensing duplicates existing FDA oversight or creates unnecessary bureaucratic burden without meaningful additional safety improvements

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

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