Title 21
SECTION 610.53
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 | 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 (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.