U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Industry Affairs Staff Booklet
April 1999

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

21 CFR Part 110

This is a compilation of the Food and Drug Administration (FDA) Current Good Manufacturing Practice (CGMP) regulations for foods. The regulations are current through April, 1999. The CGMP regulations are printed in Title 21 Code of Federal Regulations, Part 110 (21 CFR 110). The FDA publishes amendments to this and all final rules in the Federal Register. It is the responsibility of the user of this booklet to stay current with any changes. Ordering/subscription information to the FR appears below.

This booklet includes the preamble to the final rule document originally published in 1986. The preamble contains valuable background information about the CGMP regulations.

Related Subjects

The CGMP regulations are general regulations that apply to all foods. In addition, there are specific CGMP regulations that apply to specific food categories. These regulations are printed in Title 21, Code of Federal Regulations, Parts 100-169 (21 CFR 100-169).

1. Quality control procedures for assuring the nutrient content of infant formulas (21 CFR 106).
2. CGMP regulations for thermally processed low-acid foods in hermetically-sealed (air-tight) containers (21 CFR 113), and for acidified foods (21 CFR 114).
3. CGMP regulations for bottled water (21 CFR 129).
4. Title 21 CFR, Part 110.110 allows the FDA to set maximum levels of natural/unavoidable defects in food for human use that present no inherent health hazard.

How to order the Federal Register and the CFR

The Federal Register is published Monday through Friday by the U.S. Government Printing Office (GPO) in paper and microfiche editions, and as on-line database available through Internet. The GPO mails individual copies of the paper edition. Annual subscriptions are also available. Contact the Superintendent of Documents (202-512-1803) for current prices.

To subscribe to the FR and to order the CFR, make check or money order payable to SUPERINTENDENT OF DOCUMENTS and mail to New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh , PA 15250-7954. Purchases may also be made (using Visa, Master Card or a deposit account with the Superintendent of Documents) by calling 202-512-1800.

You may subscribe to the Federal Register online data base by sending e-mail to the GPO Acces User Support Team at "gpoaccess@gpo.gov". For more information, contact Electronic Information Dissemination Services, U.S. Government Printing Office at 202-512-1530, or 888-293-6498 (toll-free)

Full text of 21 CFR 110

Hypertext updated by ear/cjm 2000-NOV-20