The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into law by President Richard Nixon. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs, which may be sold only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
Pharmacists, also known as chemists or druggists, are health professionals who practice in pharmacy, the field of chemical sciences and health sciences focusing on safe and effective medication use. Pharmacists undergo university or graduate-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. This is mated to anatomy, physiology, and pathophysiology. Pharmacists interpret and communicate this specialized knowledge to patients, physicians, and other health care providers.
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, and reviewing drugs, aiming to ensure the safe, effective, and affordable use of drugs. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, the pharmacy is classified as a community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies are considered clinical pharmacy.
A prescription, often abbreviated ℞ or Rx, is a health care program implemented by a physician or other qualified health care practitioner in the form of instructions that govern the plan of care for an individual patient. The term often refers to a health care provider's written authorization for a patient to purchase a prescription drug from a pharmacist.
A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
The Pharmaceutical Benefits Scheme (PBS) is a program of the Australian Government that provides subsidised prescription drugs to residents of Australia, as well as certain foreign visitors covered by a Reciprocal Health Care Agreement. The PBS seeks to ensure that Australian residents have affordable and reliable access to a wide range of necessary medicines. The PBS has faced increased scrutiny as its cost has increased. The scheme assumes responsibility for the cost of drugs to patients in the community setting rather than while in hospital which is the responsibility of each state and territory. Together with Medicare the PBS is a key component of health care in Australia.
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
A pharmacy technician is a title-protected, licensed health care provider who performs pharmacy-related functions, working collaboratively with a licensed pharmacist. Pharmacy technicians work in a variety of locations, but can also work for long-term care facilities, pharmaceutical manufacturers, third-party insurance companies, computer software companies, or in government or teaching. Job accountabilities include dispensing prescription drugs and other medical devices to patients and instructing on their use. They may also perform administrative duties in pharmaceutical practice, such as reviewing prescription requests with doctor's offices and insurance companies to ensure correct medications are provided and payment is received. Pharmacy technicians often take on the role of Compounding Supervisor, overseeing day to day sterile and non-sterile dose preparation while meeting standards required by regulatory bodies.
In pharmacology, compounding is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools.
A drug is any substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, or dissolution under the tongue.
A pharmacy is a retail shop which provides prescription drugs, among other products. At the pharmacy, a pharmacist oversees the fulfillment of medical prescriptions and is available to give advice on their offerings of over-the-counter drugs. A typical pharmacy would be in the commercial area of a community.
A drug coupon is a coupon intended to help consumers save money on pharmaceutical drugs. They are offered by drug companies or distributed to consumers via doctors and pharmacists, and most can be obtained online. There are drug coupons for drugs from many categories such as cholesterol, acne, migraine, allergies, etc.
Pharmacy automation involves the mechanical processes of handling and distributing medications. Any pharmacy task may be involved, including counting small objects ; measuring and mixing powders and liquids for compounding; tracking and updating customer information in databases ; and inventory management. This article focuses on the changes that have taken place in the local, or community pharmacy since the 1960s.
The Ohio Automated Rx Reporting System (OARRS) is Ohio's state Prescription Monitoring Program (PMP) and is controlled by the Ohio State Board of Pharmacy. The law permitting the Board of Pharmacy to create the PMP was signed on March 18, 2005, and became effective January 1, 2006. The OARRS program began operation on October 2, 2006. The law is available to read in the Drug Laws of Ohio pages C-50 through C-54. The Ohio State Board of Pharmacy is responsible for collecting and verifying data for prescriptions that the Drug Enforcement Administration (DEA) classifies Schedule II-V as well as carisoprodol and tramadol prescriptions.
This article is about the history of the United States Food and Drug Administration.
Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
