The Food and Drug Administration is a public health agency with law enforcement responsibilities. They regulate products to maximize consumer protection. Types of products regulated include foods, drugs and cosmetics, biological products, medical devices, and electronic products that emit radiation. The FDA also addresses critical public health problems arising from use of FDA-regulated products.

This FDA Manual gives the standard operating procedures in an easy-to-read format:

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  • Administration and Organization – These sections give the organizational breakdown explaining areas of responsibility with office directories.
  • Federal and State Cooperation – This section provides the policy, laws, codes and cooperative agreements for working with other federal and state officials, internationally, and with non-government organizations.
  • Sampling and Establishment Inspections – These sections give preparation and handling techniques for sampling and inspecting establishments.
  • Recall Activities – This section discusses recalls including notification and monitoring procedures.
  • Investigations – This section gives procedures and investigation techniques for complaints, foodborne outbreaks, injury & adverse reaction to regulated products, and disaster procedures.

This manual will be helpful for anyone with regular contact with the FDA, such as state and local regulatory agencies and food and drug researchers.

The FDA Investigation Operations Manual, January 2000 is available from NTIS, call 1-800-553-6847 or 703-605-6000, for $98 plus $5 handling fee, no additional charge for shipping; quote order number PB2000-913399KQR. Most major credit cards accepted. Fax orders to 703-605-6900.

Received the FDA Investigation Operations Manual automatically each year; call NTIS Subscriptions at 1-800-363-2068 or 703-605-6060 for more information.

Access information on more than 400,000 government information products on the NTIS Web site: http://www.ntis.gov.

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