Title 21: Food and Drugs
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/ PART 600 - BIOLOGICAL PRODUCTS: GENERAL
/ Subpart B - Establishment Standards / § 600.15 Temperatures during shipment.
§ 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.