[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.13]

[Page 11-12]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, 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

[[Page 12]]

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]