21 CFR 600.15 - Temperatures during shipment.

Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER F: BIOLOGICS

PART 600: BIOLOGICAL PRODUCTS: GENERAL

Subpart B: Establishment Standards

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 Live Do.
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.

(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]