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.