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The following products shall be maintained during shipment at the specified temperatures:
(a) Products.
| Product
| Temperature
|
|---|
| Cryoprecipitated AHF | - 18 deg.C or colder.
| | Measles and Rubella Virus Vaccine Live | 10 deg.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 deg.C or colder.
| | Liquid Plasma | 1 to 10 deg.C.
| | Plasma | - 18 deg.C or colder.
| | Platelet Rich Plasma | Between 1 and 10 deg.C if the label indicates storage between 1 and 6 deg.C, or all reasonable methods to maintain the temperature as close as possible to a range between 20 and 24 deg.C, if the label indicates storage between 20 and 24 deg.C.
| | Platelets | Between 1 and 10 deg.C if the label indicates storage between 1 and 6 deg.C, or all reasonable methods to maintain the temperature as close as possible to a range between 20 to 24 deg.C, if the label indicates storage between 20 and 24 deg.C.
| | Poliovirus Vaccine Live Oral Trivalent | 0 deg.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 deg.C.
| | Red Blood Cells Frozen | - 65 deg.C or colder.
| | Rubella and Mumps Virus Vaccine Live | 10 deg.C or colder.
| | Rubella Virus Vaccine Live | Do.
| | Smallpox Vaccine (Liquid Product) | 0 deg.C or colder.
| | Source Plasma | - 5 deg.C or colder.
| | Source Plasma Liquid | 10 deg.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 deg.C, or at a temperature as close as possible to 20 to 24 deg.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 deg.C during shipment.
| | Yellow Fever Vaccine | 0 deg.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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