STATE OF NEW YORK ________________________________________________________________________ 228 2021-2022 Regular Sessions IN ASSEMBLY (Prefiled) January 6, 2021 ___________ Introduced by M. of A. GOTTFRIED, ABINANTI, McDONOUGH, THIELE -- read once and referred to the Committee on Health AN ACT to amend the public health law, in relation to source plasma donation centers The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Section 571 of the public health law is amended by adding 2 two new subdivisions 2-a and 2-b to read as follows: 3 2-a. "Source plasma donation center" means a facility where source 4 plasma is collected by plasmapheresis. "Source plasma" means the fluid 5 portion of human blood collected by plasmapheresis and intended as 6 source material for plasma protein therapies. "Source plasma donation 7 center" shall not include single donor plasma products intended for 8 intravenous use. 9 2-b. "Plasmapheresis" means a procedure in which, during a single 10 visit to the facility, blood is removed from an individual, the source 11 plasma separated from the formed elements, and at least the red blood 12 cells are returned to the donor. 13 § 2. The public health law is amended by adding a new section 575-a to 14 read as follows: 15 § 575-a. Source plasma donation centers. 1. A source plasma donation 16 center may collect source plasma through plasmapheresis, and may employ 17 a person to perform total protein tests using digital refractometers, if 18 the source plasma donation center and such person comply with all the 19 requirements of federal law and regulations governing the collection of 20 source plasma, including, but not limited to, laws governing staff 21 supervision, training, and duties, including requirements for performing 22 total protein tests using digital refractometers in a source plasma 23 donation center. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD00571-01-1

A. 228 2 1 2. The commissioner may make reasonable additional regulations govern- 2 ing source plasma donation centers, including requirements for registra- 3 tion as a source plasma donation center and payment of a reasonable 4 registration fee. Rules and regulations applicable to source plasma 5 donation centers shall be consistent with this section. 6 § 3. This act shall take effect on the one hundred eightieth day after 7 it shall have become a law. Effective immediately, the addition, amend- 8 ment and/or repeal of any rule or regulation necessary for the implemen- 9 tation of this act on its effective date are authorized to be made and 10 completed on or before such effective date.

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