21 CFR 600.15 - Temperatures during shipment.

Code of Federal Regulations - Title 21: Food and Drugs (2011)

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER F: BIOLOGICS

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 VaccineDo.
Measles, Mumps, and Rubella Virus Vaccine LiveDo.
Measles and Mumps Virus Vaccine LiveDo.
Measles Virus Vaccine LiveDo.
Mumps Virus Vaccine LiveDo.
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 IDo.
Poliovirus Vaccine Live Oral Type IIDo.
Poliovirus Vaccine Live Oral Type IIIDo.
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 LiveDo.
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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