[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.13]

[Page 12]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 600--BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
                   Subpart B--Establishment Standards
 
Sec. 600.13  Retention samples.

    Manufacturers shall retain for a period of at least 6 months after 
the expiration date, unless a different time period is specified in 
additional standards, a quantity of representative material of each lot 
of each product, sufficient for examination and testing for safety and 
potency, except Whole Blood, Cryoprecipitated AHF, Platelets, Red Blood 
Cells, Plasma, and Source Plasma and Allergenic Products prepared to a 
physician's prescription. Samples so retained shall be selected at 
random from either final container material, or from bulk and final 
containers, provided they include at least one final container as a 
final package, or package-equivalent of such filling of each lot of the 
product as intended for distribution. Such sample material shall be 
stored at temperatures and under conditions which will maintain the 
identity and integrity of the product. Samples retained as required in 
this section shall be in addition to samples of specific products 
required to be submitted to the Center for Biologics Evaluation and 
Research. Exceptions may be authorized by the Director, Center for 
Biologics Evaluation and Research, when the lot yields relatively few 
final containers and when such lots are prepared by the same method in 
large number and in close succession.

[41 FR 10428, Mar. 11, 1976, as amended at 49 FR 23833, June 8, 1984; 50 
FR 4133, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990]