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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 7]
[CITE: 21CFR610.53]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS

PART 610 -- GENERAL BIOLOGICAL PRODUCTS STANDARDS

Subpart F - Dating Period Limitations

Sec. 610.53 Dating periods for Whole Blood and blood components.

(a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.

(b) Table of dating periods. In using the table in this paragraph, when a product in column A is stored at the storage temperature prescribed in column B, storage of a product must not exceed the dating period specified in column C, unless a different dating period is specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA. Container labels for each product must include the recommended storage temperatures.

Whole Blood and Blood Components Storage Temperatures and Dating Periods

A B C
Product Storage temperature Dating period
Whole Blood
ACD, CPD, CP2DBetween 1 and 6 deg.C21 days from date of collection.
CPDA-1do 135 days from date of collection.
Red Blood Cells
ACD, CPD, CP2DBetween 1 and 6 deg.C21 days from date of collection.
CPDA-1do35 days from date of collection.
Additive solutionsdo42 days from date of collection.
Open system
(e.g., deglycerolized, washed)
do24 hours after entering bag.
Deglycerolized in closed system with additive solution addeddo14 days after entering bag.
Irradiateddo28 days from date of irradiation or original dating, whichever is shorter.
Frozenâ??65 deg.C or colder10 years from date of collection.
Platelets
PlateletsBetween 20 and 24 deg.C5 days from date of collection.
PlateletsOther temperatures according to storage bag instructionsAs specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA.
Plasma
Fresh Frozen Plasmaâ??18 deg.C or colder1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomydo1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomydo1 year from date of collection.
Plasma Cryoprecipitate Reduceddo1 year from date of collection.
Plasmado5 years from date of collection.
Liquid PlasmaBetween 1 and 6 deg.C5 days from end of Whole Blood dating period.
Source Plasma (frozen injectable)â??20 deg.C or colder10 years from date of collection.
Source Plasma Liquid (injectable)10 deg.C or colderAccording to approved biologics license application.
Source Plasma (noninjectable)Temperature appropriate for final product10 years from date of collection.
Therapeutic Exchange Plasmaâ??20 deg.C or colder10 years from date of collection.
Cryoprecipitated AHF
Cryoprecipitated AHFâ??18 deg.C or colder1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool.
Source Leukocytes
Source LeukocytesTemperature appropriate for final productIn lieu of expiration date, the collection date must appear on the label.

1 The abbreviation "do." for ditto is used in the table to indicate that the previous line is being repeated.

[81 FR 26691, May 4, 2016]

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