[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.82]

[Page 145]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
Subpart E_Control of Components and Drug Product Containers and Closures
 
Sec.  211.82  Receipt and storage of untested components, drug product containers, and closures.

    (a) Upon receipt and before acceptance, each container or grouping 
of containers of components, drug product containers, and closures shall 
be examined visually for appropriate labeling as to contents, container 
damage or broken seals, and contamination.
    (b) Components, drug product containers, and closures shall be 
stored under quarantine until they have been tested or examined, as 
appropriate, and released. Storage within the area shall conform to the 
requirements of Sec.  211.80.

    Effective Date Note: At 72 FR 68069, Dec. 4, 2007, Sec.  211.82 was 
amended by revising paragraph (b), effective Apr. 17, 2008. For the 
convenience of the user, the revised text is set forth as follows:

[[Page 146]]


 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
Subpart E_Control of Components and Drug Product Containers and Closures
 
Sec.  211.82  Receipt and storage of untested components, drug product 
          containers, and closures.

                                * * * * *

    (b) Components, drug product containers, and closures shall be 
stored under quarantine until they have been tested or examined, 
whichever is appropriate, and released. Storage within the area shall 
conform to the requirements of Sec.  211.80.