[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.34]

[Page 117]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                  Subpart B--Organization and Personnel
 
Sec. 211.34  Consultants.

    Consultants advising on the manufacture, processing, packing, or 
holding of drug products shall have sufficient education, training, and 
experience, or any combination thereof, to advise on the subject for 
which they are retained. Records shall be maintained stating the name, 
address, and qualifications of any consultants and the type of service 
they provide.

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