Code of Federal Regulations Title 21, Volume 2, April 1, 2015


Book Description

21 CFR Parts 100 to 169 covers an assortment of foods for human consumption, food labeling and packaging, and more. Code of Federal Regulations Title 21, Volume 2, April 1, 2015 Containing parts Parts 100 to 169 Part 100; GENERAL Part 101; FOOD LABELING Part 102; COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS Part 104; NUTRITIONAL QUALITY GUIDELINES FOR FOODS Part 105; FOODS FOR SPECIAL DIETARY USE Part 106; INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS Part 107; INFANT FORMULA Part 108; EMERGENCY PERMIT CONTROL Part 109; UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL Part 110; CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Part 111; CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Part 113; THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS Part 114; ACIDIFIED FOODS Part 115; SHELL EGGS Part 118; PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS Part 119; DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK Part 120; HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS Part 123; FISH AND FISHERY PRODUCTS Part 129; PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER Part 130; FOOD STANDARDS: GENERAL Part 131; MILK AND CREAM Part 133; CHEESES AND RELATED CHEESE PRODUCTS Part 135; FROZEN DESSERTS Part 136; BAKERY PRODUCTS Part 137; CEREAL FLOURS AND RELATED PRODUCTS Part 139; MACARONI AND NOODLE PRODUCTS Part 145; CANNED FRUITS Part 146; CANNED FRUIT JUICES Part 150; FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS Part 152; FRUIT PIES Part 155; CANNED VEGETABLES Part 156; VEGETABLE JUICES Part 158; FROZEN VEGETABLES Part 160; EGGS AND EGG PRODUCTS Part 161; FISH AND SHELLFISH Part 163; CACAO PRODUCTS Part 164; TREE NUT AND PEANUT PRODUCTS Part 165; BEVERAGES Part 166; MARGARINE Part 168; SWEETENERS AND TABLE SIRUPS Part 169; FOOD DRESSINGS AND FLAVORINGS




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


Book 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




United States Code


Book Description

"The United States Code is the official codification of the general and permanent laws of the United States of America. The Code was first published in 1926, and a new edition of the code has been published every six years since 1934. The 2012 edition of the Code incorporates laws enacted through the One Hundred Twelfth Congress, Second Session, the last of which was signed by the President on January 15, 2013. It does not include laws of the One Hundred Thirteenth Congress, First Session, enacted between January 2, 2013, the date it convened, and January 15, 2013. By statutory authority this edition may be cited "U.S.C. 2012 ed." As adopted in 1926, the Code established prima facie the general and permanent laws of the United States. The underlying statutes reprinted in the Code remained in effect and controlled over the Code in case of any discrepancy. In 1947, Congress began enacting individual titles of the Code into positive law. When a title is enacted into positive law, the underlying statutes are repealed and the title then becomes legal evidence of the law. Currently, 26 of the 51 titles in the Code have been so enacted. These are identified in the table of titles near the beginning of each volume. The Law Revision Counsel of the House of Representatives continues to prepare legislation pursuant to 2 U.S.C. 285b to enact the remainder of the Code, on a title-by-title basis, into positive law. The 2012 edition of the Code was prepared and published under the supervision of Ralph V. Seep, Law Revision Counsel. Grateful acknowledgment is made of the contributions by all who helped in this work, particularly the staffs of the Office of the Law Revision Counsel and the Government Printing Office"--Preface.




Code of Federal Regulations, Title 21, Food and Drugs, PT. 170-199, Revised as of April 1, 2017


Book Description

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 United States Federal Government. This print ISBN is the Official U.S. Federal Government edition. Title 21 CFR, Parts 170-199, includes rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and Department of Health and Human Services (food for human consumption), food additives, indirect food additives, indirect food additives (adhesives and components of coatings, paper and paperboard components, polymers, adjuvants, production aids, and sanitizers), irradiation in the production/processing/handling of food, substances generally recognized as safe and those prohibited, dietary supplements, and more. Other related products: United States Code, 2012 Edition, V. 15, Title 21, Food and Drugs to Title 22, Foreign Relations and Intercourse, Sections 1-2141F is available here: https://bookstore.gpo.gov/products/sku/052-001-00632-1 Running a Food Hub: A Business Operations Guide, V. 2 is available here: https://bookstore.gpo.gov/products/sku/001-000-04766-3 Dietary Guidelines for Americans 2015-2020 can be found here: https://bookstore.gpo.gov/products/dietary-guidelines-americans-2015-2020-1 Food Safety: A Need to Know Guide for Those at Risk is available here: https://bookstore.gpo.gov/products/food-safety-need-know-guide-those-risk Food Safe Families Activity Book for Kids is available here: https://bookstore.gpo.gov/products/food-safe-families-activity-book-kids




Model Rules of Professional Conduct


Book Description

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.




Code of Federal Regulations


Book Description

Special edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...




Food and Drug Regulation


Book Description




Pain Management and the Opioid Epidemic


Book Description

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.




Parks and Wildlife Code


Book Description




Water Code


Book Description