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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.
The Drug Enforcement Administration is pleased to provide you with the 2010 edition of the Pharmacist's Manual to assist you in understanding the provisions of the Controlled Substances Act (CSA) and its implementing regulations. This manual will answer questions you may encounter in the practice of pharmacy and provide guidance in complying with the CSA regulations. This edition has been updated to include information on the provisions of the Combat Methamphetamine Epidemic Act of 2005, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, and the Interim Final Rule entitled Electronic Prescriptions for Controlled Substances. Your role in the proper dispensing of controlled substances is critical to the health of patients and helps protect society against drug abuse and diversion. Your adherence to the CSA, together with its objectives and your compliance, is a powerful resource for protecting the public health, assuring patient safety, and preventing the diversion of controlled substances and...
This report highlights certain non-criminal regulatory requirements of the Controlled Substances Act (CSA). The CSA and its implementing regulations establish a framework through which the federal government regulates the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and prevents these substances from being diverted for illegal purposes. The CSA assigns various plants, drugs, and chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic steroids) to one of five schedules based on the substance's medical use, potential for abuse, and safety or dependence liability. Schedule I contains substances that have no currently accepted medical use and cannot safely be made available to the public under a prescription, while Schedules II, III, IV, and V include substances that have recognized medical uses and may be manufactured, distributed, and used in accordance with the CSA. The order of the schedules reflects substances that are progressively less dangerous and addictive. To restrict access to chemicals used in the illicit manufacture of certain controlled substances, the CSA also regulates 40 “listed chemicals.†Furthermore, the CSA regulates controlled substance “analogues,†which are substances that are not controlled but are structurally or pharmacologically similar to substances found in Schedule I or II and have no accepted medical use. This is a print on demand report.
Get your highest score possible on the MPJE® with detailed state-specific guidance! Complete coverage of 20 states, plus federal regulations! Pharmacy Law is the perfect way to prepare for the MPJE Exam. It delivers a rigorous review of pharmacy-related statutes, rules, and regulations that impact pharmacy practice in twenty states as well as a summary of federal regulations that pertain to pharmacy law. Federal coverage includes summaries of must-know legislation such as the Federal Controlled Substances Act, the Federal Food, Drug & Cosmetics Act, and other relevant federal guidelines. State-specific chapters discuss important topics such as renewal of pharmacists’ licenses, qualifications, prescription transfers, inventory requirements, record-keeping, and prescriptive authority. Each chapter concludes with practice scenarios and questions with appropriate explanations. The Review You Need to Excel in These States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Texas & Wisconsin. Watch for future supplements with additional states.
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.