Federal Food, Drug, and Cosmetic Act


Book Description

This book is designed to be a unified reference source for the U.S. Federal Food, Drug, and Cosmetic Act and is designed to be used both as a reference for experienced industry representatives and as a training resource for those new to the industry. Federal Food, Drug, and Cosmetic Act: * Introduction to the FDA and the FD&C Act * Part I: Federal Food, Drug, and Cosmetic Act o Section Number Reference: Federal Food, Drug, and Cosmetic Act o FD&C Act Chapters I and II: Short Title and Definitions o FD&C Act Chapter III: Prohibited Acts and Penalties o FD&C Act Chapter IV: FoodFD&C Act Chapter V: Drugs and Devices o FD&C Act Chapter VI: Cosmetics o FD&C Act Chapter VII: General Authority o FD&C Act Chapter VIII: Imports and Exports o FD&C Act Chapter IX: MiscellaneousSignificant Amendments to the FD&C Act Reference Tools * Part II: Combined Glossary and Index for all Regulations




Drug and Cosmetic Catalog


Book Description

A sourcebook listing suppliers to the drug and cosmetic industry. With 92/93, covers raw materials, packaging, and machinery and equipment manufacturers. Also includes a trade name directory and suppliers addresses.




Percutaneous Absorption


Book Description

Since publication of the Second Edition in 1989, numerous innovations have occurred that affect the way scientists look at issues in the field of percutaneous absorption. Focusing on recent advances as well as updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption, Third Edition provides thorough coverage of the skin's role as an important portal of entry for chemicals into the body. Assembles the work of nearly 80 experts-30 more than the Second Edition-into a unified, comprehensive volume that contains the latest ideas and research! Complete with nearly 600 drawings, photographs, equations, and tables and more than 1600 bibliographic citations of pertinent literature, Percutaneous Absorption, Third Edition details the applied biology of percutaneous penetration factors that affect skin permeation, such as age, vehicles, metabolism, hydration of skin, and chemical structure in vivo and in vitro techniques for measuring absorption, examining factors influencing methodology such as animal models, volatility of test compound, multiple dosage, and artificial membranes procedures for use in transdermal delivery, exploring topics such as effects of penetration enhancers on absorption, optimizing absorption, and the topical delivery of drugs to muscle tissue And presents new chapters on mathematical models cutaneous metabolism prediction of percutaneous absorption in vitro absorption methodology dermal decontamination concentration of chemicals in skin transdermal drug delivery mechanisms of absorption safety evaluation of cosmetics absorption of drugs and cosmetic ingredients nail penetration Emphasizes human applications-particularly useful for pharmacists, pharmacologists, dermatologists, cosmetic scientists, biochemists, toxicologists, public health officials, manufacturers of cosmetic and toiletry products, and graduate students in these disciplines! An invaluable reference source for readers who need to keep up with the latest developments in the field, Percutaneous Absorption, Third Edition is also an excellent experimental guide for laboratory personnel.




A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition


Book Description

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.




An Overview of FDA Regulated Products


Book Description

Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations







CRC Handbook of Food, Drug, and Cosmetic Excipients


Book Description

CRC Handbook of Food, Drug, and Cosmetic Excipients provides a comprehensive summary of toxicological issues regarding inactive ingredients in pharmaceutical products, cosmetic products, and food additives. Background information on regulations and labeling requirements for each type of product is provided, and 77 articles critically review human and animal data pertinent to a variety of agents and makes judgments regarding the clinical relevance. The book also identifies at-risk populations, such as neonates, patients with renal failure, and atopic patients. Inactive common pharmaceutical agents and/or foods containing certain ingredients are listed to help physicians counsel hypersensitive patients who must avoid products containing these excipients.




Cosmeceuticals


Book Description

This text defines what constitutes cosmeceuticals and discusses various classes of products, from anti-ageing skin care and repair, anti-acne, and hair-growth compounds to agents for treating skin infections, rashes and irritations.




Coloring of Food, Drugs, and Cosmetics


Book Description

"Provides a wide range of information on the composition, utilization, and evaluation of colorants and pigments in food, pharmaceuticals, and cosmetic products. Tabulates key data for food, drug, and cosmetic colorants by Color Index Numbers. Thoroughly describes the relationships between coloring reactions."