§ 610.53 - Dating periods for Whole Blood and blood components.

§ 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, CP2D	Between 1 and 6 °C	21 days from date of collection.
CPDA-1	do1	35 days from date of collection.
Red Blood Cells
ACD, CPD, CP2D	Between 1 and 6 °C	21 days from date of collection.
CPDA-1	do	35 days from date of collection.
Additive solutions	do	42 days from date of collection.
Open system (e.g., deglycerolized, washed)	do	24 hours after entering bag.
Deglycerolized in closed system with additive solution added	do	14 days after entering bag.
Irradiated	do	28 days from date of irradiation or original dating, whichever is shorter.
Frozen	−65 °C or colder	10 years from date of collection.
Platelets
Platelets	Between 20 and 24 °C	5 days from date of collection.
Platelets	Other temperatures according to storage bag instructions	As 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 Plasma	−18 °C or colder	1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomy	do	1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy	do	1 year from date of collection.
Plasma Cryoprecipitate Reduced	do	1 year from date of collection.
Plasma	do	5 years from date of collection.
Liquid Plasma	Between 1 and 6 °C	5 days from end of Whole Blood dating period.
Source Plasma (frozen injectable)	−20 °C or colder	10 years from date of collection.
Source Plasma Liquid (injectable)	10 °C or colder	According to approved biologics license application.
Source Plasma (noninjectable)	Temperature appropriate for final product	10 years from date of collection.
Therapeutic Exchange Plasma	−20 °C or colder	10 years from date of collection.
Cryoprecipitated AHF
Cryoprecipitated AHF	−18 °C or colder	1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool.
Source Leukocytes
Source Leukocytes	Temperature appropriate for final product	In 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]