...The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter. When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the drug proves to be effective and safe, the FDA will approve it. However, the FDA requires some drugs to be furthered studied and require additional clinical trials. When the drug is officially approved, the FDA sends an approval letter to the company- this process may take many years. Some important steps taken for an approval are (2008 Internet Drug News Inc.): Synthesis & Purification - FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects. Animal Testing (short term) - Generally, two or more species (one rodent, one non-rodent) are tested...
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...CVS Health Summary of Industry Characteristics December 31, 2014 Summary The Food and Drug Store industry consists of stores that primarily focus on the sale of food, drugs (nonprescription and prescription), or a combination of both. Typically smaller than General Merchandisers, such as Wal-Mart, the companies in the Food and Drug Store industry provide grocery products such as cold and hot foods, pharmaceuticals, general pet care, and typical household products meant for everyday living. Stores that fall within the industry may specialize in one aspect over the other, such as CVS Health in pharmacy and health care. Even though the major products of the industry are food and drugs, there are several other minor products like health clinics and fuel centers that play an important role in the industry. Industry Sales The industry revenues can range from $139,367 Million to $14,194 Million and profits range from $4,644 Million to $113 Million, just within the companies within the Fortune 500. Their revenue is mostly derived from their sales of their inventory, no matter which side of the industry they sell from. Since most companies will use FIFO inventory methods, this helps decrease their product waste due to expiration dates and will increase their total sales and revenue. Their highest costs tend to be for plant, property, and equipment. Kroger, for example, owns a majority of the buildings where their retail stores are located and they are slowly disposing of their...
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...The Pure Food and Drug Act provided the U.S. with truthful information about what their food and drugs contained. This prevented untruthful labeling and poisoning. Prior to The Pure Food and Drug Act, people had the ability to lie about what their product contained and what it did. This could potentially cause harm or death to the individuals who consumed it. Overall, The Pure Food and Drug Act saved many Americans from consuming harmful substances, and therefore, is the most significant reform of the Progressive Era. The next most important reform would have to be the Meat Inspection Act of 1906. The Meat Inspection Act made it illegal to contaminate or misbrand meat, and ensured that meat is slaughtered and processed under sanitary conditions....
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...Federal Food, Drug, and Cosmetic Act of 1938 According to, http://www.toxicology.org/gp/fda.asp, the Society of Toxicology website, in 1937 the Massengill pharmaceutical company dispersed Elixir Sulfanilamide. This drug was prescribed generally to anyone who had symptoms of strep throat. Elixir Sulfanilamide contains diethylene glycol, which is a chemical equivalent of antifreeze. There were 107 documented deaths, involving many children, because of the lack in regulations. The Pure Food and Drug Act was deemed to insufficient to protect the public. This tragedy was the critical motivation for the creation of the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act (FFDC) can be found in chapter 9 of title 21 in the United States Code. Congress passed the act in 1938, in effort to protect the well being of the country by controlling the food and medical supply at a federal level. The act permitted the Food and Drug Administration (FDA) to have the authority to carry out legislative obligations. Specifically, the FDA enforced standards that limited the maximum amount of residue levels for unavoidable poisonous substances on food due to pesticides. The FDA website claims to have established laws that provided three types of food standards. These standards include: standard of identity, standard of quality, and standard of regulating the fill of container. Any food that did not meet these FDA standards would be, “misbranded.” The Act also regulates the...
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...Professor Lodge UNIV 200 14 April 2011 Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturing, process of approval, marketing, and post marketing stages. When a drug or medical device is granted approval by the FDA, it will shortly become marketed in the United States and available for public use. The FDA responsibility during this post marketing stage consists of ensuring product safety and efficacy through continued research and testing of the product. If the FDA discovers safety or efficacy problems with the medical device or drug, they are also responsible for removing the product off the market and informing the public of their findings. The FDA is a very powerful United States government agency, who plays a crucial role in American citizen’s health and well-being. Through their legal authority established by the United States government, the FDA is chiefly responsible for ensuring the American public’s health and safety in the foods we eat, to the medicines we take to cure a common cold, to the treatment choices we use to help...
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...Revised Date: Review date: Distribution: P&P References: Food - Drug Interaction D-01 6/97 08/00 Key words: food, drug, nutrient, interaction, patient education Policy: Interactions between medications and foods or nutrients can compromise therapy. Therefore, the Department of Pharmacy Services will be actively involved in detecting these interactions, incorporating information regarding these interactions on the pharmacy-generated medication administration record (MAR), and counseling patients on the potential for these interactions and how to avoid them. Procedures: 1. Identification of clinically significant food-drug interactions: a. The Drug Information Coordinator will notify a pharmacy member of the Nutrition Therapy Committee of any food-drug interactions for drugs newly added to the MUSC hospital formulary. b. The Nutrition Therapy Committee will review additions to and deletions from the MUSC formulary, as the need arises, in order to maintain an updated list of clinically significant food-drug interactions. c. As changes occur to the list of targeted food-drug interactions, a pharmacy member of the Nutrition Therapy Committee will be responsible for: i. updating the patient education brochure ii. notifying all pharmacists via E-mail and/or department staff meetings of changes to the current listing of targeted drugs iii. notifying all nurse manager via E-mail of changes to the current listing of targeted drugs iv. notifying the department=s information resources specialist...
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...Food safety is a growing concern globally. With the innovations in the processing technologies, packaging techniques, agricultural practices, and change in food habits, industry and enforcement authorities are facing new challenges every day. Currently there are more than twenty Indian laws relating to food, which are administered by a number of different Ministries and Departments. Food processors have to comply with these rules. Among the more important food laws are: • Prevention of Food Adulteration Act (PFA) of 1954 and the PFA Rules of 1955. Covers specifications related to food colour, preservatives, pesticide residues, packaging and labelling, and regulation of sales. • The Standards of Weights and Measures Act, 1976, and the Standards of Weights and Measures (Packaged Commodities) Rule, 1977. Designed to establish fair trade practices with respect to packaged commodities. • The Fruit Products Order, 1955. Specifications and quality control requirements regarding the production and marketing of processed fruits and vegetables, sweetened aerated water, vinegar, and synthetic syrups. • Meat Food Products Order, 1992. Administers the permissible quantity of heavy metals, preservatives, and insecticide residues for meat products. • Milk and Milk Products Order, 1992. Regulates the production, distribution, and supply of milk products; establishes sanitary requirements for dairies, machinery, and premises; and sets quality control standards for milk and milk products. ...
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...Food and Drug Administration Almost Everyday grocery stores all around the world are filled with many customers looking to buy goods. Is the FDA administering food unhealthy to humans? The answer to this question varies among so many people, as all of us have different views on how the FDA system works. The FDA is allowing these foods to be sold. In my opinion, the food is very unhealthy. Although, many people like anything they can get their hands on and sometimes that is always not the best choice. People have so many concerns whether food is unhealthy or not, it is always hard to find good and healthy food, but FDA is not one of them. Most of the food is non-organic and has GMO in it. That is why a lot of people get sick more than usual ,because of the chemicals that the individual is putting in their body....
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...he United States Food and Drug Administration (FDA) is a regulatory body vetted by the US Federal Government. It is responsible for securing the safety of its citizens and livestock in the realm of consumables like food, medicines, chemicals and all of their biological delivery methods. The FDA charter, by default, makes it intimately tied to various industrial and economic entities within the United States. Since the United States is the principal world leader in economics, the FDA is often viewed as the most efficient, thorough, and authoritative food and drug organization in the world. While the US FDA oversees the majority of food and medical innovation internationally, it is not the only world class regulatory department actively engaged in the safety of the world’s population. Comparable government committees throughout the industrialized world have matching, if not higher, standards than the US FDA. Without the “red tape” associated with...
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...The Food And Drug Administration has made a rule that requires motor carriers and shippers to make sure that vehicles are cleaned and properly-refrigerated when they are transporting food. Doug Morris is the OOIDA Director Of Safety And Security Operations. He has stated that the changes are something that they have been working on since January 2013. He also stated that these are major changes dealing with the housing, shipping and production of food. The Food And Drug Administration Modernization Act sets requirements for carriers, loaders and shippers who are involved in transporting both human and animal food. People are required to use the proper sanitary practices in order to ensure that food is safely transported. The rule specifically...
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...risks. Here I am about to tell my readers important information that you can share with your family and friends about Dietary Supplements! Dietary supplements refer to vitamins, minerals and other substances available in the form of a pill, gum, lozenge, drops or injections and intended for human consumption. Dietary supplements are available at health food stores, vitamin shops and even in doctor's offices. While their purpose is to provide health benefits, supplements should never be used as a substitute for nutrients found in foods or medication prescribed by your doctor. Dietary Supplements are vitamins, minerals, and other less familiar substances — such as herbals, botanicals, amino acids, and enzymes (see box at right). Dietary supplements are also marketed in forms such as tablets, capsules, soft gels, and gel caps. Some benefits of taking Dietary Supplements are some supplements may help to assure that you get an adequate dietary intake of essential nutrients. However, supplements should not replace the variety of foods that are important to a healthful diet — so, be sure you eat a variety of foods as well. Unlike drugs, supplements are...
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...fall into two categories: dietary supplements and cosmetics. Dietary supplements are products that are ingested, such as dried herbs, teas, tinctures, capsules, and tablets. These must meet regulatory requirements for processed foods as well as those listed below. Cosmetics are products that are applied to the human body for cleaning or body care. Fresh culinary herbs are exempt from these regulations. Information on selling fresh herbs can be found in the Fresh Fruit and Vegetable Fact Sheet. Washington State law abides by the federal food, drug, and cosmetic act and with the federal trade commission act that expressly outlaws the false advertisement of food, drugs, devices, and cosmetics. For more information, please see the Washington State Food, Drug, and Cosmetic Act (RCW 69.04) which outlines the regulations governing the sale of dietary supplements and cosmetics at http://apps.leg.wa.gov/RCW/default.aspx?cite=69.04. In this fact sheet, we will review the regulations for: • dietary supplements definition; • dietary supplements safety and claims; • labeling dietary supplements; • definition of cosmetics; • federal regulations for cosmetics; and • cosmetics claims. Dietary Supplements Definition The State of Washington follows the Food and Drug Administration (FDA) definition of dietary supplements. These are considered products (other than tobacco) that are: • Intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin...
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...global scope. The FDA, Big Pharmaceuticals, and Governments make trillions of dollars, not caring for the health or welfare of the population of the world. There is massive corruption between these organizations with very strong ties. Big Pharmaceuticals such as Bayer, Mereck, BASF, Monsanto, and Pfizer are just a few of the influential lobbing companies, with strong ties to the FDA government regulators of products Pharmaceutical companies produce and invest heavily in. Keeping the masses sick, controlled, and monopolizing every aspect they can. From food, crops, medicine, natural herbs, and the way any ingredient is introduced or allowed to be used. Our bodies are continually poisoned and polluted every day of our lives, all while being told what to think and lied to. It is a conflict of interest that the very people approving the use of ingredients and drugs in everything, profit financially from the very ingredients and drugs they approve. Not just the FDA but...
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...Well Being Hospital Well Being Hospital Well being hospital is looking to buy drugs from Get Well Drugs Pharmaceutical. As an administrator at Well Being Hospital, it is my job to ensure that we are making the right decision in buying drugs from this company. I have to make sure that this is the right decision for the hospital and the patients we serve. FDA As the administrator I am to find out the details on the drugs that will be purchased from Get Well Drugs. I have to ensure that the drugs that will be bought meet the standards of the Food and Drug Administration. The FDA is responsible for regulating the safety and effectiveness of drugs sold in the United States (Thaul, 2012). The FDA require that drug manufacturers meet the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product (Thaul, 2012).A drug can not be sold in the U.S. legally if it is not FDA approved. Even after approval the FDA still watch the drug to ensure safety and effectiveness and if it fall below standards it will be removed (Thaul, 2012). In order to gain any information on the drugs being bought for the hospital I will have to communicate with Get Well Drugs. I will ask that they release all information gained from the FDA clinical trials. Finding the Facts First I will contact the company by phone. In that conversation I will inform the company that I am...
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...Drug and alcohol control Name Course Institution Tutor Date Drug and alcohol control The pure food and drug act of 1906 The pure food and drugs act of 1906 was an important piece of the progressive Era registration. This act was enacted to safeguard the public against the adulteration of food and also from the products which were identified to be healthful without the scientific support. It was applied to the goods that were shipped in the foreign commerce. The main reason was to safeguard against misbranding or adulteration. The adulteration was as a result of poisonous color or flavor in food or even various ingredients that which would be harmful to the health of humans. The provisions included development of the food and drug administration that was entrusted on with the charge of testing of all drugs and foods that was meant for human consumption (Curtis, 2013). The provisions required that there be prescriptions from the licensed physicians prior to purchasing certain drugs by the patients. There were also requirements for the label caution for drugs that are addictive. In case a distributor or a manufacturer were caught offending this enforcement they were liable for prosecution by the central government. However distributors were not entirely liable to this action if they could show a sufficient guarantee from the vendors (Curtis, 2013). The pure food and drug act also required that certain drugs inclusive of alcohol, heroin, cocaine, cannabis and morphine...
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