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Electronic Code of Federal Regulations

e-CFR data is current as of February 24, 2020

Title 21Chapter ISubchapter FPart 600Subpart B → §600.15


Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL
Subpart B—Establishment Standards


§600.15   Temperatures during shipment.

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

(a) Products.

ProductTemperature
Cryoprecipitated AHF−18 °C or colder.
Measles and Rubella Virus Vaccine Live10 °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 Plasma1 to 10 °C.
Plasma−18 °C or colder.
Platelet Rich PlasmaBetween 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.
PlateletsBetween 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 Trivalent0 °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 Live10 °C or colder.
Rubella Virus Vaccine Live      Do.
Smallpox Vaccine (Liquid Product)0 °C or colder.
Source Plasma−5 °C or colder.
Source Plasma Liquid10 °C or colder.
Whole BloodBlood 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 Vaccine0 °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]

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