21 CFR § 600.15 - Temperatures during shipment.

---
identifier: "/us/cfr/t21/s600.15"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 600.15 - Temperatures during shipment."
title_number: 21
title_name: "Food and Drugs"
section_number: "600.15"
section_name: "Temperatures during shipment."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "600"
part_name: "BIOLOGICAL PRODUCTS: GENERAL"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264."
cfr_part: "600"
---


# 600.15 Temperatures during shipment.

The following products shall be maintained during shipment at the specified temperatures:

(a) *Products.*

| Product | Temperature |
| --- | --- |
| Cryoprecipitated AHF | −18 °C or colder. |
| Measles and Rubella Virus Vaccine Live | 10 °C or colder. |
| Measles Live and Smallpox Vaccine | Do. |
| Measles, Mumps, and Rubella Virus Vaccine Live | Do. |
| Measles and Mumps Virus Vaccine Live | Do. |
| Measles Virus Vaccine Live | Do. |
| Mumps Virus Vaccine Live | Do. |
| Fresh Frozen Plasma | −18 °C or colder. |
| Liquid Plasma | 1 to 10 °C. |
| Plasma | −18 °C or colder. |
| Platelet Rich Plasma | Between 1 and 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 and 24 °C, if the label indicates storage between 20 and 24 °C. |
| Platelets | Between 1 and 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 to 24 °C, if the label indicates storage between 20 and 24 °C. |
| Poliovirus Vaccine Live Oral Trivalent | 0 °C or colder. |
| Poliovirus Vaccine Live Oral Type I | Do. |
| Poliovirus Vaccine Live Oral Type II | Do. |
| Poliovirus Vaccine Live Oral Type III | Do. |
| Red Blood Cells (liquid product) | Between 1 and 10 °C. |
| Red Blood Cells Frozen | −65 °C or colder. |
| Rubella and Mumps Virus Vaccine Live | 10 °C or colder. |
| Rubella Virus Vaccine Live | Do. |
| Smallpox Vaccine (Liquid Product) | 0 °C or colder. |
| Source Plasma | −5 °C or colder. |
| Source Plasma Liquid | 10 °C or colder. |
| 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 to 10 °C, or at a temperature as close as possible to 20 to 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 between 1 to 10 °C during shipment. |
| Yellow Fever Vaccine | 0 °C or colder. |

(b) *Exemptions.* Exemptions or modifications shall be made only upon written approval, in the form of a supplement to the biologics license application, approved by the Director, Center for Biologics Evaluation and Research.

[39 FR 39872, Nov. 12, 1974, as amended at 49 FR 23833, June 8, 1984; 50 FR 4133, Jan. 29, 1985; 50 FR 9000, Mar. 6, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 56449, Oct. 20, 1999]