[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.15]

[Page 13-14]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 600--BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                   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 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.
------------------------------------------------------------------------


[[Page 14]]

    (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]