CFR Title 21 Section 600.15 provides a table that lists the required shipping temperatures for biological products. This is not the same as the storage temperatures. Table 3 below includes those sections that apply specifically to blood and blood products.15 Note that exemptions can be made, but only with written approval by the Director of the Center for Biologics Evaluation and Research (CBER).
Table 3. Shipping Temperatures for Blood and Blood Products.15| Product | Temperature |
| Cryoprecipitate AHF | ≤ -18°C |
| Fresh Frozen Plasma (FFP) | ≤ -18°C |
| Liquid Plasma | 1–10°C |
| Plasma | ≤ -18°C |
| Platelet Rich Plasma | 1–10°C if the label indicates storage between 1 and 6°C, or all reasonable methods to maintain the temperature as close as possible to a range between 20–24°C if the label indicates storage between 20 and 24°C |
| Platelets | 1–10°C if the label indicates storage between 1 and 6°C, or all reasonable methods to maintain the temperature as close as possible to a range between 20–24°C if the label indicates storage between 20 and 24°C |
| Red Blood Cells (liquid product) | 1–10°C |
| Red Blood Cells Frozen | ≤ -65°C |
| Source Plasma | ≤ -5°C |
| Source Plasma Liquid | ≤ 10°C |
| Whole Blood | Blood that is transported from the collecting facility to the processing facility shall be transported in an environment capable of continuously cooling the blood toward a temperature range of 1–10°C, or at a temperature as close as possible to 20–24°C for a period not to exceed 6 hours. Blood transported from the storage facility shall be placed in an appropriate environment to maintain a temperature range of 1–10°C during shipment. |
15. Code of Federal Regulations. Part 600-Biological Products: General, Subpart B, Section 600.15 "Temperatures during shipment." Food and Drug Administration, Updated 09 Apr 2024. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-600/subpart-B/section-600.15.
