S4338

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 1200 in 2024 to more than 1800 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.).