Code of Federal Regulations Title 21. Food and Drugs § 21.600.15 Temperatures during shipment

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.