§ 640.31 - Eligibility of donors. Subpart B - Red Blood Cells § 640.14 - Testing the blood. § 640.73 - Reporting of fatal donor reactions. Please review the following FDA and PlasmaLab (PLI) plasma donation requirements to determine if any of the exclusions apply to you. Convalescent refers to anyone recovering from a disease.    § 640.1 - Whole Blood. FDA Relaxes Blood Donation Restrictions On Gay And Bisexual Men During Shortage Curbs on the donations were previously extended to trials on plasma from people who have recovered from COVID-19. One blood donation can save up to three lives. As such, Cohen put FDA … § 640.11 - General requirements. Donors can go through a regular blood donation, where red blood cells and plasma is collected, or opt for a plasma only donation. The information on this page is current as of April 1 2020. 36. “The machine for taking plasma specifically takes about 40 minutes,” says Dr. Karp. Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. § 640.13 - Collection of the blood. § 640.56 - Quality control test for potency.    § 640.60 - Source Plasma. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. Hemarus is managed by a team of experts who have decades of experience in the specialized field of plasma collection, and provides a safe, professional and pleasant donation environment. ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. § 640.69 - General requirements. To learn more and find the site nearest you: You can consider donating blood! Giving this convalescent plasma to hospitalized people currently fighting COVID-19 may help them recover. At PlasmaLab, we strictly adhere to Food and Drug Administration (FDA) regulations. Subpart L - Alternative Procedures § 640.92 - Tests on final product. Donation frequency: Every 112 days, up to 3 times/year* You must be in good health and feeling well** Male donors + must be at least 17 years old in most states, at least 5'1" tall and weigh at least 130 lbs; Female donors + must be at least 19 years old, at least 5'5" tall and weigh at least 150 lbs; See additional requirements for student donors >> § 640.65 - Plasmapheresis. Source plasma collection centers are also certified by the International Quality Plasma Program (IQPP), a rigorous, voluntary program that goes beyond regulatory requirements to help ensure donor safety and further improve the quality of source plasma used for fractionation.. Subpart C - Platelets People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which may help save the lives of other patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Before sharing sensitive information, make sure you're on a federal government site. The requirements to donate plasma have been put in place to protect every component of the blood donation system--the donor, patient and the many therapies developed from the plasma supplies 1. According to FDA regulations, you can donate plasma up to twice per week -- but not 2 days in a row. Their antibodies could help fight the virus. Registered nurse Abbey Baronia takes a blood donation at the Blood Centers of the Pacific, Monday, Dec. 21, 2015, in San Francisco, Calif. § 640.21 - Eligibility of donors. § 640.84 - Labeling. § 640.54 - Processing. Because you fought the infection, your plasma now contains COVID-19 antibodies. ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS, Subpart I - Plasma Protein Fraction (Human), Subpart M - Definitions and Medical Supervision, Instructions for Downloading Viewers and Players. Subpart M - Definitions and Medical Supervision For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Here we review the regulations and standards of the United States Food and Drug Administration (FDA) and the voluntary standards of the Plasma Protein Therapeutic Association (PPTA) which ensure the safety and quality of PF, and the safety and health of the donor relative to the donation … Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product in hospitalized COVID-19 patients.
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