Code of Federal Regulations Title 21, Volume 1, April 1, 2015 (e-book) (used book) | bookbook.eu

Description

21 CFR Parts 0-99 covers a range of topics including general administrative rulings and decisions; to protection of privacy, environmental impact considerations, pharmaceutical manufacturing practices and reports for devices within the United States and European community; color additives in food, drugs, and cosmetics, and more.
This volume would be appropriate for the general public, plus pharmacy and start up health care manufacturers, as well as food, drug, and cosmetic company personnel interested in developing products to be disseminated within the United States of America.

Code of Federal Regulations Title 21, Volume 1, April 1, 2015

Containing parts Parts 1 to 99

Part 1; GENERAL ENFORCEMENT REGULATIONS
Part 2; GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
Part 3; PRODUCT JURISDICTION
Part 4; REGULATION OF COMBINATION PRODUCTS
Part 5; ORGANIZATION
Part 7; ENFORCEMENT POLICY
Part 10; ADMINISTRATIVE PRACTICES AND PROCEDURES
Part 11; ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Part 12; FORMAL EVIDENTIARY PUBLIC HEARING
Part 13; PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
Part 14; PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
Part 15; PUBLIC HEARING BEFORE THE COMMISSIONER
Part 16; REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
Part 17; CIVIL MONEY PENALTIES HEARINGS
Part 19; STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
Part 20; PUBLIC INFORMATION
Part 21; PROTECTION OF PRIVACY
Part 25; ENVIRONMENTAL IMPACT CONSIDERATIONS
Part 26; MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
Part 50; PROTECTION OF HUMAN SUBJECTS
Part 54; FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Part 56; INSTITUTIONAL REVIEW BOARDS
Part 58; GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Part 60; PATENT TERM RESTORATION
Part 70; COLOR ADDITIVES
Part 71; COLOR ADDITIVE PETITIONS
Part 73; LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Part 74; LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
Part 80; COLOR ADDITIVE CERTIFICATION
Part 81; GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
Part 82; LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
Parts 83-98; Reserved
Part 99; DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES