Cite this Code: CFR To cite the regulations in this volume use title, part and section number. Thus, 21 CFR 1301.01 refers to title 21, part 1301, section 01. Explanation The Code of Federal Regulations is a codification of the general and permanent les published in the Federal Register by the Executive departments and agens of the Federal Government. The Code is divided into 50 titles which represent ad areas subject to Federal regulation. Each title is divided into chapters ich usually bear the name of the issuing agency. Each chapter is further subided into parts covering specific regulatory areas. Each volume of the Code is revised at least once each calendar year and issued a quarterly basis approximately as follows: Title 1 through Title 16......... Title 17 through Title 27 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. he contents of the Federal Register are required to be judicially noticed (44 .C. 1507). The Code of Federal Regulations is prima facie evidence of the text he original documents (44 U.S.C. 1510). W TO USE THE CODE OF FEDERAL REGULATIONS he Code of Federal Regulations is kept up to date by the individual issues he Federal Register. These two publications must be used together to detere the latest version of any given rule. o determine whether a Code volume has been amended since its revision date this case, April 1, 1995), consult the "List of CFR Sections Affected (LSA),” ch is issued monthly, and the "Cumulative List of Parts Affected," which ears in the Reader Aids section of the daily Federal Register. These two lists identify the Federal Register page number of the latest amendment of any n rule. ECTIVE AND EXPIRATION DATES ach volume of the Code contains amendments published in the Federal Regsince the last revision of that volume of the Code. Source citations for egulations are referred to by volume number and page number of the Federal ster and date of publication. Publication dates and effective dates are usunot the same and care must be exercised by the user in determining the al effective date. In instances where the effective date is beyond the cutate for the Code a note has been inserted to reflect the future effective In those instances where a regulation published in the Federal Register s a date certain for expiration, an appropriate note will be inserted following ext. CONTROL NUMBERS e Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal agencies splay an OMB control number with their information collection request. agencies have begun publishing numerous OMB control numbers as amend ments to existing regulations in the CFR. These OMB numbers are placed as close as possible to the applicable recordkeeping or reporting requirements. OBSOLETE PROVISIONS 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, 1986, consult either the List of CFR Sections Affected, 1949–1963, 1964-1972, or 1973-1985, published in seven separate volumes. For the period beginning January 1, 1986, 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 is contained in a separate volume, revised annually as of January 1, 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 II). A list of CFR titles, chapters, and parts and an alphabetical list of agencies publishing in the CFR are also included in this volume. An index to the text of "Title 3-The President" is carried within that volume. The Federal Register Index is issued monthly in cumulative form. 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. REPUBLICATION OF MATERIAL There are no restrictions on the republication of material appearing in the Code of Federal Regulations. 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 Administration, Washington, DC 20408 (telephone 202-523–3517). All mail order sales are handled exclusively by the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Charge orders may be telephoned to the Government Printing Office order desk at 202-512-1800. THIS TITLE Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The first eight volumes, containing parts 1-1299, comprise Chapter I-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to End, includes Chapter ПI-Drug Enforcement Administration, Department of Justice and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 1995. The Table of Exempt Prescription Products to part 1308 appears in the volume containing part 1300-End. Redesignation tables for Chapter I-Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170-199 and 500-599. For this volume, Ruth Reedy Green was Chief Editor. The Code of Federal Regulations publication program is under the direction of Richard L. Claypoole, assisted by Alomha S. Morris. |