NY State Senate Bill 2019-S7811

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Feb 24, 2020	referred to health

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2019-S7811 (ACTIVE) - Details

See Assembly Version of this Bill:: A9915
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Amd §571, add §575-a, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S2119, A228

2019-S7811 (ACTIVE) - Summary

Relates to source plasma donation centers.

2019-S7811 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S7811

SPONSOR: RIVERA
 
TITLE OF BILL:

An act to amend the public health law, in relation to source plasma
donation centers

 
PURPOSE:

To authorize collection of source plasma at source plasma donation
centers that comply with federal law

 
SUMMARY OF PROVISIONS:

Section one of the bill amends Public Health Law § 571 to create defi-
nitions of "source plasma donation center," "source plasma," and "plas-
mapheresis."

Section two creates a new Public Health Law § 575-a authorizing source
plasma donation centers to collect source plasma using plasmapheresis,

including employing individuals to perform total protein tests, if the
center and the individual comply with federal law and regulations.
Section two also authorizes the commissioner of health to make reason-
able additional regulations governing source plasma donation centers.

Section three is the effective date.

 
JUSTIFICATION:

Source plasma collection through donation is the first step in manufac-
turing plasma protein therapies to treat diseases, including creation of
clotting factor products for individuals with bleeding disorders, auto-
immune disorders, and other conditions. It is a completely separate
process from blood collection for donation purposes. Source plasma is
not used for transfusion; it is used to manufacture therapeutic
products. It is collected at separate centers.

This bill would authorize plasma donation centers to operate in New York
as long as they meet federal standards. Plasma donation centers are
regulated extensively by the FDA and most states allow plasma donation
centers to operate under these federal standards (CFR title 21, part
640, sub-part G.) Federal rules govern donor screening, blood collection
processes (such as containers), blood sample handling (such as storage
and pooling), and other processes. The bill also allows the Department
of Health to make additional regulations.

New York's regulatory requirements for source plasma collection are
substantially and unnecessarily more restrictive than requirements in
Federal law.  Consequently, there are fewer than 10 source plasma
donation centers operating in New York out of over 800 across the coun-
try.

 
LEGISLATIVE HISTORY:

New bill.

 
FISCAL IMPLICATIONS:

None to the state.

 
EFFECTIVE DATE:
180 days from enactment

2019-S7811 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   7811
 
                             I N  S E N A T E
 
                             February 24, 2020
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed 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:

   Section 1. Section 571 of the public health law is amended  by  adding
 two new subdivisions 2-a and 2-b to read as follows:
   2-A.  "SOURCE  PLASMA  DONATION  CENTER" MEANS A FACILITY WHERE SOURCE
 PLASMA IS COLLECTED BY PLASMAPHERESIS. "SOURCE PLASMA" MEANS  THE  FLUID
 PORTION  OF  HUMAN  BLOOD  COLLECTED  BY  PLASMAPHERESIS AND INTENDED AS
 SOURCE MATERIAL FOR PLASMA PROTEIN THERAPIES.  "SOURCE  PLASMA  DONATION
 CENTER"  SHALL  NOT  INCLUDE  SINGLE  DONOR PLASMA PRODUCTS INTENDED FOR
 INTRAVENOUS USE.
   2-B. "PLASMAPHERESIS" MEANS A PROCEDURE  IN  WHICH,  DURING  A  SINGLE
 VISIT  TO  THE FACILITY, BLOOD IS REMOVED FROM AN INDIVIDUAL, THE SOURCE
 PLASMA SEPARATED FROM THE FORMED ELEMENTS, AND AT LEAST  THE  RED  BLOOD
 CELLS ARE RETURNED TO THE DONOR.
   § 2. The public health law is amended by adding a new section 575-a to
 read as follows:
   §  575-A.  SOURCE PLASMA DONATION CENTERS. 1. A SOURCE PLASMA DONATION
 CENTER MAY COLLECT SOURCE PLASMA THROUGH PLASMAPHERESIS, AND MAY  EMPLOY
 A PERSON TO PERFORM TOTAL PROTEIN TESTS USING DIGITAL REFRACTOMETERS, IF
 THE  SOURCE  PLASMA  DONATION CENTER AND SUCH PERSON COMPLY WITH ALL THE
 REQUIREMENTS OF FEDERAL LAW AND REGULATIONS GOVERNING THE COLLECTION  OF
 SOURCE  PLASMA,  INCLUDING,  BUT  NOT  LIMITED  TO, LAWS GOVERNING STAFF
 SUPERVISION, TRAINING, AND DUTIES, INCLUDING REQUIREMENTS FOR PERFORMING
 TOTAL PROTEIN TESTS USING DIGITAL  REFRACTOMETERS  IN  A  SOURCE  PLASMA
 DONATION CENTER.
   2. THE COMMISSIONER MAY MAKE REASONABLE ADDITIONAL REGULATIONS GOVERN-
 ING SOURCE PLASMA DONATION CENTERS, INCLUDING REQUIREMENTS FOR REGISTRA-
 TION  AS  A  SOURCE  PLASMA  DONATION CENTER AND PAYMENT OF A REASONABLE
 REGISTRATION FEE. RULES AND  REGULATIONS  APPLICABLE  TO  SOURCE  PLASMA
 DONATION CENTERS SHALL BE CONSISTENT WITH THIS SECTION.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                       [ ] is old law to be omitted.
                                                            LBD15433-01-0

 S. 7811                             2
 
   § 3. This act shall take effect on the one hundred eightieth day after
 it  shall have become a law. Effective immediately, the addition, amend-
 ment and/or repeal of any rule or regulation necessary for the implemen-
 tation of this act on its effective date are authorized to be  made  and
 completed on or before such effective date.

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Senate Bill S7811

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

co-Sponsors

2019-S7811 (ACTIVE) - Details

2019-S7811 (ACTIVE) - Summary

2019-S7811 (ACTIVE) - Sponsor Memo

2019-S7811 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S7811

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Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

co-Sponsors

2019-S7811 (ACTIVE) - Details

2019-S7811 (ACTIVE) - Summary

2019-S7811 (ACTIVE) - Sponsor Memo

2019-S7811 (ACTIVE) - Bill Text download pdf

Comments