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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2017]
[CITE: 21CFR600.15]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS

PART 600 -- BIOLOGICAL PRODUCTS: GENERAL

Subpart B--Establishment Standards

Sec. 600.15 Temperatures during shipment.

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 Live10 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 Plasma1 to 10 deg. C.
Plasma-18 deg. C or colder.
Platelet Rich PlasmaBetween 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.
PlateletsBetween 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 Trivalent0 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 Live10 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 Liquid10 deg. 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 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 Vaccine0 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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