[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.15]

[Page 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         Do.
 Vaccine 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.
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]