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Cite this Code CFR thus: 21 CFR 100.120

Explanation

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.

ISSUE DATES

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.................

Title 17 through Title 27....

Title 28 through Title 41...............

Title 42 through Title 50.......

as of January 1

.as of April 1 as of July 1

as of October 1

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

LEGAL STATUS

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).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

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 a Code volume has been amended since its revision date (in this case, April 1, 1980), consult the "List of CFR Sections Affected (LSA),” which is issued monthly, and the “Cumulative List of Parts Affected," which appears in the Reader Aids section of the daily Federal Register. These two lists will identify the Federal Register page number of the latest amendment of any given rule.

EFFECTIVE DATES

Each volume of the Code contains amendments published in the Federal Register 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 pub-
lished at the end of each CFR volume.

INQUIRIES AND SALES

For a summary, legal interpretation, or other explanation of any regulation in
this volume, contact the issuing agency. Inquiries concerning editing procedures
and reference assistance with respect to the Code of Federal Regulations may be
addressed to the Director, Office of the Federal Register, National Archives and
Records Service, General Services Administration, Washington, D.C. 20408 (tele-
phone 202-523-3517). Sales are handled exclusively by the Superintendent of
Documents, Government Printing Office, Washington, D.C. 20402.

ERNEST J. GALDI,

Acting Director,

Office of the Federal Register.

THIS TITLE

Title 21-Food and Drugs is composed of ten volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200299, 300-499, 500-599, 600-799, 800-1299, 1300-end, and the Table of Excepted Prescription Drugs to Part 1308. The first eight volumes, containing Parts 11299, comprise Chapter I-Food and Drug Administration, Department of Health, Education and Welfare. The ninth volume, containing Part 1300 to end, includes Chapter II-Drug Enforcement Administration, Department of Justice. The tenth 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, 1980.

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

For this volume Dean L. Smith was Chief Editor. The Code of Federal Regulations publication program is under the direction of Martha B. Girard, assisted by Robert E. Jordan.

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