[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.15]

[Page 14-15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, 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 [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    Do.
 Live.
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.

[[Page 15]]


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]