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Cite this Code CFR thus: 21 CFR 100.1


The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.


Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16.........

............ as of January 1 Title 17 through Title 27.........

................. as of April 1 Title 28 through Title 41.........

.......................................................... as of July 1 Title 42 through Title 50......

................ as of October 1 The appropriate revision date is printed on the cover of each volume.


The contents of the Federal Register are required to be judicially noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text of the original documents (44 U.S.C. 1510).


The Code of Federal Regulations is kept up to date by the individual issues of the Federal Register. These two publications must be used together to determine the latest version of any given rule.

To determine whether there have been any amendments since the revision date of the Code volume in which the user is interested (in this case, April 2, 1979) the following two lists must be consulted: the “List of CFR Sections Affected (LSA)" issued monthly and the “Cumulative List of Parts Affected" which appears daily in the Federal Register. These two lists will refer the user to the Federal Register page where he may find the latest amendment of any given rule.


Each volume of the Code contains amendments published in the Federal Reg. ister since the last revision of that volume of the Code. Source citations for the regulations are referred to by volume number and page number of the Federal Register and date of publication. Publication dates and effective dates are usually not the same and care must be exercised by the user in determining the actual effective date. In instances where the effective date is beyond the cut-off date for the Code a note has been inserted to reflect the future effective date. Provisions that become obsolete before the revision date stated on the cover of each volume are not carried. Code users may find the text of provisions in effect on a given date in the past by using the appropriate numerical list of sections affected. For the period before January 1, 1964, the user should consult the “List of Sections Affected, 1949-1963" published in a separate volume. For the period beginning January 1, 1964, a “List of CFR Sections Affected” is published at the end of each CFR volume. CFR INDEXES AND TABULAR GUIDES

A subject index to the Code of Federal Regulations which is revised annually as of July 1, is contained in a separate volume entitled CFR INDEX AND FINDING AIDS. This volume contains the Parallel Table of Statutory Authorities and Agency Rules (Table I), and Acts Requiring Publication in the Federal Register (Table III). A list of CFR Titles, Chapters, and Parts, an alphabetical list of CFR subtitles and chapters, and lists of current and superseded CFR volumes are also included in this volume.

An index to the text of Presidential documents appears at the end of each compilation of Title 3, The President.

The Federal Register Index is issued monthly, quarterly, and annually. This index is based on a consolidation of the “Contents" entries in the daily Federal Register.

A List of CFR Sections Affected (LSA) is published monthly, keyed to the revision dates of the 50 CFR titles.


Inquiries concerning technical aspects of the Code should be addressed to the Director, Office of the Federal Register, National Archives and Records Service, General Services Administration, Washington, D.C. 20408 (telephone 202-5235240). Sales are handled exclusively by the Superintendent of Documents, Gov. ernment Printing Office, Washington, D.C. 20402.


Acting Director, Office of the Federal Register.

April 2, 1979.


Title 21-FOOD AND DRUGS is composed of eight volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-199, 200-299, 300499, 500-599, 600-1299, 1300-end, and the Table of Excepted Prescription Drugs to Part 1308. The first six volumes containing Parts 1-1299 comprise Chapter IFood and Drug Administration, Department of Health, Education, and Welfare. The seventh volume containing Part 1300 to end includes Chapter II–Drug Enforcement Administration, Department of Justice. The eighth volume contains the Table of Excepted Prescription Drugs to Part 1308. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 1979.

Redesignation tables for Chapter I-Food and Drug Administration appear in the Finding Aids section of the first six volumes.

The Code of Federal Regulations is published under the editorial direction of Martha B. Girard, assisted by Pearl Einhorn. For this volume, Kathryn McGrant-English was Chief Editor and Dean L. Smith, Associate Editor.

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