[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.94]

[Page 142]
 
                        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--
 
Subpart E_Control of Components and Drug Product Containers and Closures
 
Sec.  211.94  Drug product containers and closures.

    (a) Drug product containers and closures shall not be reactive, 
additive, or absorptive so as to alter the safety, identity, strength, 
quality, or purity of the drug beyond the official or established 
requirements.
    (b) Container closure systems shall provide adequate protection 
against foreseeable external factors in storage and use that can cause 
deterioration or contamination of the drug product.
    (c) Drug product containers and closures shall be clean and, where 
indicated by the nature of the drug, sterilized and processed to remove 
pyrogenic properties to assure that they are suitable for their intended 
use.
    (d) Standards or specifications, methods of testing, and, where 
indicated, methods of cleaning, sterilizing, and processing to remove 
pyrogenic properties shall be written and followed for drug product 
containers and closures.