In New York, the Department of Health released emergency regulations that revise requirements for the Collection of Blood Components. These revisions simplify the regulatory landscape for source plasma1 donation in New York by harmonizing New York State requirements with national standards. The changes should enhance plasma availability, while maintaining high blood safety standards.
PPTA is grateful that our discussions with the Department have led to the adoption of many of our goals which are reflected in the revisions to 10 NYCRR 58-2.14 found in the emergency regulations. We look forward to further discussions with Department concerning other remaining hurdles to source plasma donation found in New York regulations. Clearing the remaining hurdles will benefit the individuals in New York that rely on plasma protein therapies.
In California, PPTA would like to thank Assembly Member Adrin Nazarian for his leadership and for authoring Assembly Bill 2199, which was signed into law on September 24, 2020, by Governor Gavin Newsom. The law should improve plasma donation, create jobs, and help patients who rely on plasma protein therapies, including individuals with bleeding disorders, primary immune deficiencies, Alpha-1 Antitrypsin deficiency, and certain neurological disorders. Assembly Bill 2199 continues the pilot in California that allows plasma donation center staff to perform the total protein test using a digital refractometer, as long as they meet the federal standards for performing the test. The pilot will expire on January 1, 2023.
“We are so grateful to committed leaders in New York and California,” remarked Amy Efantis, PPTA’s President and CEO. “Plasma donation is more essential than ever, and the emergency regulations released in New York, coupled with Governor Newsom’s signing of Assembly Bill 2199, show a growing understanding from coast to coast that plasma donors save lives. Particularly now, as we continue to face the impacts of the COVID-19 pandemic, plasma donations are increasingly urgent. While the advancements in New York and California will not result in an overnight increase in plasma donations, we remain hopeful they will increase opportunities for people in these two states to roll up their sleeves and donate lifesaving plasma for patients whose lives depend on the dedication of plasma donors.”
Please visit www.donatingplasma.org to find a donation center near you.
1 21 CFR 640.60 defines Source plasma as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use.
Created on October 01 2020.