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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter FPart 610 → Subpart F


Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS


Subpart F—Dating Period Limitations


Contents
§610.50   Date of manufacture for biological products.
§610.53   Dating periods for Whole Blood and blood components.

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§610.50   Date of manufacture for biological products.

(a) When the dating period begins. The dating period for a product must begin on the date of manufacture as described in paragraphs (b) and (c) of this section. The dating period for a combination of two or more products must be no longer than the dating period of the component with the shortest dating period.

(b) Determining the date of manufacture for biological products other than Whole Blood and blood components. The date of manufacture for biological products, other than Whole Blood and blood components, must be identified in the approved biologics license application as one of the following, whichever is applicable: The date of:

(1) Potency test or other specific test as described in a biologics license application or supplement to the application;

(2) Removal from animals or humans;

(3) Extraction;

(4) Solution;

(5) Cessation of growth;

(6) Final sterile filtration of a bulk solution;

(7) Manufacture as described in part 660 of this chapter; or

(8) Other specific manufacturing activity described in a biologics license application or supplement to the biologics license application.

(c) Determining the date of manufacture for Whole Blood and blood components. (1) The date of manufacture for Whole Blood and blood components must be one of the following, whichever is applicable:

(i) Collection date and/or time;

(ii) Irradiation date;

(iii) The time the red blood cell product was removed from frozen storage for deglycerolization;

(iv) The time the additive or rejuvenation solution was added;

(v) The time the product was entered for washing or removing plasma (if prepared in an open system);

(vi) As specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or

(vii) As approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.

(2) For licensed Whole Blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application.

[81 FR 26691, May 4, 2016]

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§610.53   Dating periods for Whole Blood and blood components.

(a) General. Dating periods for Whole Blood and blood components are specified in the table in paragraph (b) of this section.

(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.

Whole Blood and Blood Components Storage Temperatures and Dating Periods

ABC
ProductStorage temperatureDating period
Whole Blood
ACD, CPD, CP2DBetween 1 and 6 °C21 days from date of collection.
CPDA-1do135 days from date of collection.
Red Blood Cells
ACD, CPD, CP2DBetween 1 and 6 °C21 days from date of collection.
CPDA-1do35 days from date of collection.
Additive solutionsdo42 days from date of collection.
Open system
(e.g., deglycerolized, washed)
do24 hours after entering bag.
Deglycerolized in closed system with additive solution addeddo14 days after entering bag.
Irradiateddo28 days from date of irradiation or original dating, whichever is shorter.
Frozen−65 °C or colder10 years from date of collection.
Platelets
PlateletsBetween 20 and 24 °C5 days from date of collection.
PlateletsOther temperatures according to storage bag instructionsAs specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA.
Plasma
Fresh Frozen Plasma−18 °C or colder1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomydo1 year from date of collection.
Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up To 24 Hours After Phlebotomydo1 year from date of collection.
Plasma Cryoprecipitate Reduceddo1 year from date of collection.
Plasmado5 years from date of collection.
Liquid PlasmaBetween 1 and 6 °C5 days from end of Whole Blood dating period.
Source Plasma (frozen injectable)−20 °C or colder10 years from date of collection.
Source Plasma Liquid (injectable)10 °C or colderAccording to approved biologics license application.
Source Plasma (noninjectable)Temperature appropriate for final product10 years from date of collection.
Therapeutic Exchange Plasma−20 °C or colder10 years from date of collection.
Cryoprecipitated AHF
Cryoprecipitated AHF−18 °C or colder1 year from date of collection of source blood or from date of collection of oldest source blood in pre-storage pool.
Source Leukocytes
Source LeukocytesTemperature appropriate for final productIn lieu of expiration date, the collection date must appear on the label.

1The abbreviation “do.” for ditto is used in the table to indicate that the previous line is being repeated.

[81 FR 26691, May 4, 2016]

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