21 C.F.R. § 600.15 Temperatures during shipment.
Title 21 - Food and Drugs
The following products shall be maintained during shipment at the specified temperatures: (a) Products. (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]
Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL
Subpart B—Establishment Standards
§ 600.15 Temperatures during shipment.
------------------------------------------------------------------------ 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 Do. Live.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.------------------------------------------------------------------------
