An Index of United States Regulations Pertaining to Labeling of Prescription Drugs
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0092-8615/97 Copyrighr G 1997 Drug Information Associalion Inc.
AN INDEX OF UNITED STATES REGULATIONS PERTAINING TO LABELING OF PRESCRIPTION DRUGS CHARLES F. CURRAN, PHD Associate Director, Regulatory Affairs and Pharrnacovigilance, Fujisawa USA, Inc., Deerfield, Illinois
An index is provided of the contents ofthe sections of Title 21, Code of Federal Regulations 201, and other selected sections of Title 21 which cover the content of prescription drug package inserts and other aspects of labeling requiredof United States drug niunufucturers. Key Words: Package insert: Drug package labeling; United States regulations; Prescription
drugs
INTRODUCTION
well as specific drug labeling requirements for prescription drugs, insulin, and over-thecounter drugs. The specific requirements on labeling content and format for prescription drugs are provided in 21 CFR 201.57. In the section below, each of the primary concepts found in 21 CFR 201.57 is indexed by its formal term and also by its common term where feasible. This index also includes applicable general principles and definitions relevant to prescription drug labeling, but which are covered in portions of part 201 other than 21 CFR 201.57.
THIS IS AN INDEX OF Federal regulations found in Title 2 1, Code of Federal R e p l a tions (CFR) ( 1 ) which govern the labeling of prescription drugs in the United States. It is intended to assist in locating specific sections of the rules and regulations covering drug labeling. These regulations govern the labeling contents and the criteria of labeling acceptability required by the Food and Drug Administration (FDA) and the Drug Enforcement Agency. This index is offered as a general reference and is also intended to be used during training of individuals who need to become familiar with Federal regulations governing labeling. Title 21 CFR contains the United States Federal regulations governing food and drugs. It is a multiple volume series in which one volume contains Parts 200-299. These parts are collectively grouped as Subchapter C (Drugs: General) of 21 CFR. Within Subchapter C, part 201 contains the general as
DISCUSSION The Code of Federal Regulations is a dynamic, constantly changing document, of which Title 21 governs the manufacture, sale, and distribution of prescription drugs and other substances. Almost all of the rules and regulations which govern the labeling of prescription drugs are found in section 201, although labeling rules concerning drugs in specific contexts are found elsewhere in Title 21. The reader is also directed to the proposed rule on prescription drug labeling (2)
Reprint address: Charles F. Curran, PhD, Fujisawa USA, Inc.. Three Parkway North. Deerfield, IL 600152548.
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Charles F . Curran
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TABLE 1 Index Abuse potential ...................................................................... Adequate directions for use exemptions ....... ................ general provisions ................................
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