CFR

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.

Code of Federal Regulations

[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]

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