{"data":{"id":"us/21-cfr-600.15","jurisdiction":"us","citation":"21 CFR 600.15","heading":"Temperatures during shipment.","body":"The following products shall be maintained during shipment at the specified temperatures:\n(a) Products.\nProduct Temperature\nCryoprecipitated AHF −18 °C or colder.\nMeasles and Rubella Virus Vaccine Live 10 °C or colder.\nMeasles Live and Smallpox Vaccine Do.\nMeasles, Mumps, and Rubella Virus Vaccine Live Do.\nMeasles and Mumps Virus Vaccine Live Do.\nMeasles Virus Vaccine Live Do.\nMumps Virus Vaccine Live Do.\nFresh Frozen Plasma −18 °C or colder.\nLiquid Plasma 1 to 10 °C.\nPlasma −18 °C or colder.\nPlatelet 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.\nPlatelets 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.\nPoliovirus Vaccine Live Oral Trivalent 0 °C or colder.\nPoliovirus Vaccine Live Oral Type I Do.\nPoliovirus Vaccine Live Oral Type II Do.\nPoliovirus Vaccine Live Oral Type III Do.\nRed Blood Cells (liquid product) Between 1 and 10 °C.\nRed Blood Cells Frozen −65 °C or colder.\nRubella and Mumps Virus Vaccine Live 10 °C or colder.\nRubella Virus Vaccine Live Do.\nSmallpox Vaccine (Liquid Product) 0 °C or colder.\nSource Plasma −5 °C or colder.\nSource Plasma Liquid 10 °C or colder.\nWhole 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.\nYellow Fever Vaccine 0 °C or colder.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 600—BIOLOGICAL PRODUCTS: GENERAL","Subpart B—Establishment Standards"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"da51ce8b90c91aeda1db2891f5b95af0e133136416555fa4fe33a69440652d68","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-600.14","next":"us/21-cfr-600.20"},"notice":"GroundRules: Original legal text. Not legal advice."}