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.




Drugs and Drug Policy


Book Description

While there have always been norms and customs around the use of drugs, explicit public policies--regulations, taxes, and prohibitions--designed to control drug abuse are a more recent phenomenon. Those policies sometimes have terrible side-effects: most prominently the development of criminal enterprises dealing in forbidden (or untaxed) drugs and the use of the profits of drug-dealing to finance insurgency and terrorism. Neither a drug-free world nor a world of free drugs seems to be on offer, leaving citizens and officials to face the age-old problem: What are we going to do about drugs? In Drugs and Drug Policy, three noted authorities survey the subject with exceptional clarity, in this addition to the acclaimed series, What Everyone Needs to Know®. They begin, by defining "drugs," examining how they work in the brain, discussing the nature of addiction, and exploring the damage they do to users. The book moves on to policy, answering questions about legalization, the role of criminal prohibitions, and the relative legal tolerance for alcohol and tobacco. The authors then dissect the illicit trade, from street dealers to the flow of money to the effect of catching kingpins, and show the precise nature of the relationship between drugs and crime. They examine treatment, both its effectiveness and the role of public policy, and discuss the beneficial effects of some abusable substances. Finally they move outward to look at the role of drugs in our foreign policy, their relationship to terrorism, and the ugly politics that surround the issue. Crisp, clear, and comprehensive, this is a handy and up-to-date overview of one of the most pressing topics in today's world. What Everyone Needs to Know® is a registered trademark of Oxford University Press.




Handbook of Drug Abuse Prevention


Book Description

This wide-ranging handbook brings together experts in the sociology of drug abuse prevention. Providing a comprehensive overview of the accumulated knowledge on prevention theory, intervention design, and development and prevention research methodology, this work also promotes prevention science as an evolving field in the practice and policy of drug abuse prevention.







Handbook of Forensic Drug Analysis


Book Description

The Handbook of Forensic Drug Analysis is a comprehensive chemical and analytic reference for the forensic analysis of illicit drugs. With chapters written by leading researchers in the field, the book provides in-depth, up-to-date methods and results of forensic drug analyses. This Handbook discusses various forms of the drug as well as the origin and nature of samples. It explains how to perform various tests, the use of best practices, and the analysis of results. Numerous forensic and chemical analytic techniques are covered including immunoassay, gas chromatography, and mass spectrometry. Topics range from the use of immunoassay technologies for drugs-of-abuse testing, to methods of forensic analysis for cannabis, hallucinogens, cocaine, opioids, and amphetamine. The book also looks at synthetic methods and law enforcement concerns regarding the manufacture of illicit drugs, with an emphasis on clandestine methamphetamine production. This Handbook should serve as a widely used reference for forensic scientists, toxicologists, pharmacologists, drug companies, and professionals working in toxicology testing labs, libraries, and poison control centers. It may also be used by chemists, physicians and those in legal and regulatory professions, and students of graduate courses in forensic science. - Contributed to by leading scientists from around the world - The only analysis book dedicated to illicit drugs of abuse - Comprehensive coverage of sampling methods and various forms of analysis




Physician's Drug Handbook


Book Description

Physician's Drug Handbook features alphabetically organized monographs on over 900 generic and 2,000 trade name drugs. Each entry includes generic name, U.S. and Canadian trade names, pharmacologic and therapeutic classes, pregnancy risk category, controlled substance schedule, drug forms and strengths, indications, dosages, pharmacodynamics, pharmacokinetics, contraindications and cautions, interactions, adverse reactions, prescriber and patient information, and subsections for pregnant, breast-feeding, pediatric, and geriatric patients. The Eleventh Edition has added more than 50 new drugs, dozens of new indications, herb-drug interactions, Alerts to highlight important information, off-label indications, dosage adjustments, and drug effects on laboratory tests. Readers receive drug updates by e-mail on eDrugInfo.com.




The Drug Expert


Book Description

The Drug Expert: A Practical Guide to the Impact of Drug Use in Legal Proceedings targets academic and industry pharmacologists, pharmacology graduate students, and professionals and students of affiliated disciplines, such as pharmacy and toxicology. Users will find it to be an invaluable reference for those involved in the field. In addition, pharmacists and others who increasingly serve as expert witnesses and toxicologists will find an array of very useful information. - Focuses on important topics for the consulting pharmacologist, including prescription, over-the-counter and illegal drugs and their effects on criminal and civil proceedings - Details the "how-to aspects of being an expert witness in pharmacology by presenting real-life cases and effective tips and experiences - Includes several appendices, such as a sample letter of engagement and fee schedule, a litigation report, a consulting invoice and valuable resources




Facing Addiction in America


Book Description

All across the United States, individuals, families, communities, and health care systems are struggling to cope with substance use, misuse, and substance use disorders. Substance misuse and substance use disorders have devastating effects, disrupt the future plans of too many young people, and all too often, end lives prematurely and tragically. Substance misuse is a major public health challenge and a priority for our nation to address. The effects of substance use are cumulative and costly for our society, placing burdens on workplaces, the health care system, families, states, and communities. The Report discusses opportunities to bring substance use disorder treatment and mainstream health care systems into alignment so that they can address a person's overall health, rather than a substance misuse or a physical health condition alone or in isolation. It also provides suggestions and recommendations for action that everyone-individuals, families, community leaders, law enforcement, health care professionals, policymakers, and researchers-can take to prevent substance misuse and reduce its consequences.




Handbook of Substance Misuse and Addictions


Book Description

Substance misuse and addictions are a public health issue. They affect the well-being of each community and nation as a whole. It is, therefore, necessary to identify, educate, and treat individuals who are addicted to substances. Policies and procedures go hand-in-hand with public health education and safety. The science behind the public health issues of one drug may be applicable to other drugs as well. However, marshalling all of the aforementioned information into a single source is somewhat difficult due to the wide array of material. The Editors address this by compiling the research in this single reference work that serves as a "one-stop-shopping" approach to everything readers need to know about the scientific basis of public health and addictions and agents of misuse. Apart from active agents that have a plant or chemical basis, there is a need to consider that there are other forms of addiction which may have common modes of causality or prevention. These include food addiction, gaming, gambling, and other non-drug addictions. These types of addiction may be related to the addiction of drugs. Overall, the Handbook of Substance Misuse and Addictions: From Biology to Public Health offers a holistic understanding of the relationship between public health and substance misuse. The text provides a common platform upon which other forms of addiction or substance misuse can be understood and treated. Addiction processes involve understanding the biological processes as well as behavior, psychology, sociology, and public health, all of which are interlinked. This Handbook is a useful reference for lecturers, students, researchers, practitioners, and other professionals in public health, addiction science, epidemiology, health education, health promotion, and health sciences.




Drug Abuse Handbook


Book Description

Following the well-received first edition, the Drug Abuse Handbook, Second Edition is a thorough compendium of the knowledge of the pharmacological, medical, and legal aspects of drugs. The book examines criminalistics, pathology, pharmacokinetics, neurochemistry, treatment, as well as drugs and drug testing in the workplace and in sports, and the