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]