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This book contains the rules and regulations constituting Parts 1 to 119 of Title 21, Revised as of January 1, 1968. It replaces the volume entitled "Title 21-Food and Drugs, Parts 1 to 119, Revised as of January 1, 1967," and becomes an integral part of the Code of Federal Regulations.

The text in this revision is derived from the latest text of the rules and regulations, general and permanent in nature, duly promulgated in the Federal Register on or before December 31, 1967. Source materials from which the text is derived are cited with the text and should be consulted to determine the effective date of any given provision. All dates appearing in the source citations are dates of publication in the Federal Register and should not be construed as effective dates.

Current regulatory material appearing in the daily issues of the Federal Register follows the numbering system used herein and serves as a daily supplement hereto. This book contains the following finding aids: a table of CFR titles and chapters; an alphabetical list of CFR subtitles and chapters; and a list of sections affected which furnishes Federal Register citations to all changes in this book beginning January 1, 1964, including changes which are no longer in effect.

A compilation of the list of sections affected for the entire Code of Federal Regulations from January 1, 1949, through December 31, 1963, is published in a separate volume entitled "List of Sections Affected, 1949–1963."

A General Explanation of the Code of Federal Regulations, a list of current CFR volumes, and a list of superseded CFR volumes appear in the volume containing Titles 1-3, and in the General Index volume. A list of titles, subtitles, chapters, subchapters, and parts of the entire Code of Federal Regulations is also published in the General Index volume.

This volume is published pursuant to Part 30 of the regulations of the Administrative Committee of the Federal Register, as revised December 7, 1965 (30 F.R. 15131; 1 CFR Part 30), under the authority contained in section 11 of the Federal Register Act, as amended (67 Stat. 388 as amended; 44 U.S.C. 311). The contents of the Federal Register and the Code of Federal Regulations are by law prima facie evidence of the text of the original documents and are required to be judicially noticed (49 Stat. 502, 67 Stat. 388; 44 U.S.C. 307, 311). The preferred citation of the Code is "CFR". Thus the citation "21 CFR 1.1" refers to section 1.1

of this Title.

January 2, 1968.


Cite this Code CFR

thus: 21 CFR 1.1

Title 21-Food and Drugs

(This book contains Parts 1 to 119)


CHAPTER I--Food and Drug Administration, Department of Health, Education, and Welfare

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CROSS REFERENCES: Compliance with the Federal Food, Drug, and Cosmetic Act required of the Agricultural Research Service, Department of Agriculture: See Animals and Animal Products, 9 CFR Part 26.

Federal Trade Commission: See Commercial Practices, 16 CFR Chapter I.

Bureau of Customs, Department of the Treasury: See Customs Duties, 19 CFR Chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR Chapter I. Intoxicating Liquors, 27 CFR Chapter I.

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