Thawed Plasma Expiration Joint Commission Standards TAC October 2011 Joint Commission Standards • Federal regulation 21 CFR 606.122 (m) – Requires the infusion of thawed plasma within six hours of thawing – Review regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdoc s/cfcfr/CFRSearch.cfm?fr=606.122 TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 606 -- CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Subpart G--Finished Product Control Sec. 606.122 Instruction circular. m) For Plasma, the instruction circular shall contain: (1) A warning against further processing of the frozen product if there is evidence of breakage or thawing. (2) Instructions to thaw the frozen product at a temperature between 30 and 37 deg. C. (3) When applicable, instructions to begin administration of the product within 6 hours after thawing. (4) Instructions to administer to ABO-group-compatible recipients. (5) A statement that this product has the same hepatitis risk as Whole Blood; other plasma volume expanders without this risk are available for treating hypovolemia. Joint Commission Standards • File for variance from FDA for extension of plasma infusion time from 6 hours to 24 hours • Sample variance form included in packet • Joint Commission will recognize the FDA variance as evidence for extending the expiration date