{"data":{"id":"us/21-cfr-610.53","jurisdiction":"us","citation":"21 CFR 610.53","heading":"Dating periods for Whole Blood and blood components.","body":"(a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.\n(b) Table of dating periods. In using the table in this paragraph, when a product in column A is stored at the storage temperature prescribed in column B, storage of a product must not exceed the dating period specified in column C, unless a different dating period is specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA. Container labels for each product must include the recommended storage temperatures.\nWhole Blood and Blood Components Storage Temperatures and Dating Periods\nA B C\nProduct Storage temperature Dating period\nWhole Blood\nACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection.\nCPDA-1 do 1 35 days from date of collection.\nRed Blood Cells\nACD, CPD, CP2D Between 1 and 6 °C 21 days from date of collection.\nCPDA-1 do 35 days from date of collection.\nAdditive solutions do 42 days from date of collection.\nOpen system (e.g., deglycerolized, washed) do 24 hours after entering bag.\nDeglycerolized in closed system with additive solution added do 14 days after entering bag.\nIrradiated do 28 days from date of irradiation or original dating, whichever is shorter.\nFrozen −65 °C or colder 10 years from date of collection.\nPlatelets\nPlatelets Between 20 and 24 °C 5 days from date of collection.\nPlatelets Other temperatures according to storage bag instructions As specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA.\nPlasma\nFresh Frozen Plasma −18 °C or colder 1 year from date of collection.\nPlasma Frozen Within 24 Hours After Phlebotomy do 1 year from date of collection.\nPlasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomy do 1 year from date of collection.\nPlasma Cryoprecipitate Reduced do 1 year from date of collection.\nPlasma do 5 years from date of collection.\nLiquid Plasma Between 1 and 6 °C 5 days from end of Whole Blood dating period.\nSource Plasma (frozen injectable) −20 °C or colder 10 years from date of collection.\nSource Plasma Liquid (injectable) 10 °C or colder According to approved biologics license application.\nSource Plasma (noninjectable) Temperature appropriate for final product 10 years from date of collection.\nTherapeutic Exchange Plasma −20 °C or colder 10 years from date of collection.\nCryoprecipitated AHF\nCryoprecipitated AHF −18 °C or colder 1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool.\nSource Leukocytes\nSource Leukocytes Temperature appropriate for final product In lieu of expiration date, the collection date must appear on the label.\n1 The abbreviation “do.” for ditto is used in the table to indicate that the previous line is being repeated.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS","Subpart F—Dating Period Limitations"],"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":"7549b9a8b6729db433dddfffb2016d22d888c9cbd1000f0541df18ab8522ba7e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-610.50","next":"us/21-cfr-610.60"},"notice":"GroundRules: Original legal text. Not legal advice."}