[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.167]

[Page 130-131]
 
                        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 I--Laboratory Controls
 
Sec. 211.167  Special testing requirements.

    (a) For each batch of drug product purporting to be sterile and/or 
pyrogen-free, there shall be appropriate laboratory testing to determine 
conformance to such requirements. The test procedures shall be in 
writing and shall be followed.
    (b) For each batch of ophthalmic ointment, there shall be 
appropriate testing to determine conformance to specifications regarding 
the presence of foreign particles and harsh or abrasive substances. The 
test procedures shall be in writing and shall be followed.

[[Page 131]]

    (c) For each batch of controlled-release dosage form, there shall be 
appropriate laboratory testing to determine conformance to the 
specifications for the rate of release of each active ingredient. The 
test procedures shall be in writing and shall be followed.