S 3380

SENATE, No. 3380
STATE OF NEW JERSEY
222nd LEGISLATURE
�
INTRODUCED FEBRUARY 5, 2026
Sponsored by:
Senator� VIN GOPAL
District 11 (Monmouth)
Senator� RAJ MUKHERJI
District 32 (Hudson)
SYNOPSIS
���� Establishes licensure requirement for source plasma
donation centers.
CURRENT VERSION OF TEXT
���� As introduced.
��
An Act concerning licensure of source plasma donation centers
and supplementing Title 26 of the Revised Statutes.
���� Be It
Enacted by the Senate and General Assembly of
the State of New Jersey:
���� 1.��� The Legislature finds
and declares that:
���� a.���� The clinical need for
plasma-derived therapies has been steadily increasing for many years.
���� b.��� Plasma-derived therapies
are often the only therapies for many rare and chronic conditions such as
primary immune deficiencies and bleeding disorders.
���� c.���� Plasma-derived
therapies also treat acute blood loss, burns, and sepsis.
���� d.��� Donors at source plasma
donation centers provide the source plasma necessary to manufacture
plasma-derived therapies.
���� e.���� Source plasma donation
centers employ thousands of New Jersey residents and provide millions of
dollars to local economies through wages, taxes, and donor fees.
���� f.���� Source plasma donation
centers provide excellent opportunities for entry-level jobs for high school
graduates.
���� g.��� As recently as 2019, the
federal Food and Drug Administration declared a shortage of immune globulin, a
plasma-derived therapy.
���� h.��� A leading analyst
predicts the number of source plasma donation centers will increase from more
than 1,200 in 2024 to more than 1,800 in 2030.
���� i.���� It is in the best
interest of the State to create a unique licensure for source plasma donation
centers.
���� 2.��� For the purposes of this
act:
���� �Commissioner� means the
Commissioner of Health.
���� �Department� means the
Department of Health.
���� �Licensee� means a person
holding a license under the provisions of this act.
���� �Person� means a natural
person, partnership, association, corporation, cooperative, institution, sole
proprietorship, agency, limited liability partnership or company, or other
similar entity authorized to transact business in this State.
���� �Plasmapheresis� means a
procedure by which, during a single visit to a source plasma donation center,
blood is removed from an individual, the source plasma is separated from the
formed elements, and at least the red blood cells are returned to the donor.
���� �Source plasma� means the
fluid portion of human blood collected by plasmapheresis and intended as source
material for plasma protein therapies.� It does not include single donor plasma
products intended for intravenous use.
���� �Source plasma donation
center� means a facility other than a blood bank where source plasma is
collected by plasmapheresis.
���� 3.��� a. A person shall not operate
or conduct a source plasma donation center in this State unless duly licensed
by the commissioner under the provisions of this act.� A license required by
this act shall be in addition to any other license or permit required by any
local board of health or other body exercising the powers of such a board in
any municipality in this State, except that any source plasma donation center
receiving source plasma donations by plasmapheresis and performing only
non-diagnostic donor screening tests shall not need a blood bank or clinical
laboratory license.
���� b.��� A license issued
pursuant to this act shall expire on December 31 in each calendar year and
application for renewal therefor shall be made on or before November 10 on
forms provided by the department.� The original or a certified copy of the
license shall be conspicuously displayed by the licensee at the premises
occupied as a source plasma donation center.
���� c.���� The commissioner shall
establish the fee necessary to accompany the initial licensure application and
each renewal thereof, except the license fee for any person who has been
operating a source plasma donation center prior to the effective date of this act
and upon submission of a properly completed application form shall pay an
initial application fee of $25.� Upon expiration of the initial license, the
owner of the source plasma donation center shall be subject to the licensure
fees as set by the commissioner.
���� d.��� The commissioner may,
pursuant to the �Administrative Procedure Act,� P.L.1968, c.410 (C.52:14B-1 et
seq.), establish and periodically increase the application and renewal fees to
reflect increased State costs in source plasma donation center licensure operations.
���� e.���� The income received
from licensure and renewal fees pursuant to this section shall be appropriated
to the department to effectuate the purposes of this act.
���� 4.��� a. The commissioner
shall promulgate rules and regulations, to promote the safety and best
practices among source plasma donation centers, pursuant to the �Administrative
Procedure Act,� P.L.1968, c.410 (C.52:14B-1 et seq.), governing the donation of
source plasma, including, but not limited to, rules governing staff
supervision, training, and duties, including requirements for plasmapheresis
and pre-donation screening tests in accordance with:� (1) 42 C.F.R. Part 493;
(2) 21 C.F.R. parts 600 through 640; and (3) the Plasma Protein Therapeutics
Association Voluntary Standards Program.
���� b.��� The commissioner shall
have the power and authority to enter and inspect any source plasma donation
center and to make such investigation of the premises and the books and records
as is reasonably necessary to carry out the provisions of this act.
���� c.���� The commissioner shall
enforce the provisions of this act and may make complaints against persons
violating its provisions or the rules or regulations issued thereunder and
prosecute violations of same.� The commissioner may suspend or revoke any
license issued for a violation of any of the provisions of this act.
���� d.��� The commissioner, before
refusing to grant a license, or before suspending or revoking a license
previously granted, except as hereafter provided in section 5 of this act,
shall give notice to the applicant or licensee personally, or by mail addressed
to the applicant or licensee at the applicant�s or licensee�s last known
address, and afford the applicant or licensee an opportunity to be heard with
respect thereto at a time and place specified in such notice.� The applicant or
licensee shall have the right to be heard in person or by attorney, and to
offer evidence pertinent to the subject of the hearing.� A duly certified copy
of the order of the commissioner issued as a result of such hearing shall be
served on the applicant or licensee by mail personally addressed the applicant
or licensee at the applicant�s or licensee�s last known address, except if such
applicant or licensee is a corporation, then the order shall be served in the
same manner upon any officer of registered agent of the corporation.
���� 5.��� a. It shall be a
violation of this act for any person to obstruct, hinder, delay, or interfere,
by force or otherwise, with the performance by the commissioner of any duty
under the provisions of this act.� If the commissioner shall have reason to
believe that a condition exists or has occurred at a source plasma donation
center, in violation of the provisions of this act, which is dangerous to the
public health, the commissioner may order such source plasma donation center to
correct such violation and may suspend the license of the source plasma
donation center until the correction is completed.� If a licensee denies the
existence or occurrence of a violation, the licensee may apply to the
commissioner for a hearing.� The hearing shall be held and a decision rendered
within 48 hours of the receipt of the request for a hearing.� If the
commissioner rules against the licensee, the licensee shall have the right to
apply for injunctive relief against the commissioner�s order.� Jurisdiction for
such injunctive relief shall be in the Superior Court of New Jersey.
���� b.��� Any person who violates
the provisions of this act or an order of the commissioner issued pursuant to
this act, shall be liable to a penalty of not less than $100 but not more than
$1,000 for the first offense, and 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 herein provided shall be enforced by the
department as plaintiff in a summary proceeding in accordance with the �Penalty
Enforcement Law of 1999,� P.L.1999, c.274 (C.2A:58-10 et seq.).
���� 6.��� This act shall take
effect on November 1 next following the date of enactment except that the
Commissioner of Health may take any anticipatory administrative action in
advance as shall be necessary for the implementation of this act.�
STATEMENT
���� 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.).�