Thawed Plasma Expiration Joint Commission Standards

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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
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