21 C.F.R. § 610.53
Current through September 30, 2024
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.
21 C.F.R. §610.53