Code of Federal Regulations Title 21. Food and Drugs § 21.610.53 Dating periods for Whole Blood and blood components

Whole Blood

ACD, CPD, CP2D․․․․․․․․․․․․․․․․․․․

Between 1 and 6 °C․․․․․․․․․․․․․․․

21 days from date of collection.

CPDA-1․․․․․․․․․․․․․․․․․․․․․․․․․․․

do ¹․․․․․․․․․․․․․․․․․․․․․․․․

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․․․․․․․․․․․․․․․․․․․․․․

do ․․․․․․․․․․․․․․․․․․․․․․․․․․․․․․

24 hours after entering bag.

(e.g., deglycerolized, washed)

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.