[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: 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]
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