[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: 21CFR200.10]

[Page 6]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 200--GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 200.10  Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.

    (a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act 
specifically authorizes inspection of consulting laboratories as well as 
any factory, warehouse, or establishment in which prescription drugs are 
manufactured, processed, packed, or held.
    (b) The Food and Drug Administration is aware that many 
manufacturers of pharmaceutical products utilize extramural independent 
contract facilities, such as testing laboratories, contract packers or 
labelers, and custom grinders, and regards extramural facilities as an 
extension of the manufacturer's own facility.
    (c) The Food and Drug Administration reserves the right to disclose 
to the pharmaceutical manufacturer, or to the applicant of a new drug 
application (NDA) or to the sponsor of an Investigational New Drug (IND) 
Application, any information obtained during the inspection of an 
extramural facility having a specific bearing on the compliance of the 
manufacturer's, applicant's, or sponsor's product with the Federal Food, 
Drug, and Cosmetic Act. The Food and Drug Administration's position is 
that by the acceptance of such contract work, the extramural facility 
authorizes such disclosures.
    (d) The Food and Drug Administration does not consider results of 
validation studies of analytical and assay methods and control 
procedures to be trade secrets that may be withheld from the drug 
manufacturer by the contracted extramural facility.

[40 FR 13996, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990]