The Drug And Cosmetic Act 1938

Frequently, consumers like you and I buy items everyday not knowing chemicals or harsh byproducts that they are made with. We trust that cosmetic products we buy everyday will be safe, but there are ingredients in our daily products that could or has caused some health or skin conditions. In 1820, the U.S gathered physicians to create, The FDA and regulations on drugs in the United States. The general purpose of The Food and Drug Act was to have a standard on the specific food and drugs that were being imported into the United States. It was not until 1848 the Drug Importation Act was passed by Congress. It required U.S. Customs Service Inspection to stop entry of adulterated drugs from outside our border. In the middle of 1906, fifty-eight years later the food and drugs act was passed. The original Food and Drugs Act was passed by Congress on the 30th of June and signed by President Theodore Roosevelt. The Food and Drug Act prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs (FDA). The Food and Drug establishes standards and regulations ensuring that general public is safe from harmful domestically and internationally produced products.

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.

In the UK, there are more than 1 billion scripts prescribed and dispensed every year (HSCIC, 2013). There are over 12,000 pharmacies in the UK, and approximately 1.6 million people visit a pharmacy every day (HSCIC, 2013). It is therefore natural to assume that between these 1 billion prescriptions, an error or mistake will be made. Current studies suggest that of all the dispensed medicines, there are approximately 0.01-3.32% errors made in community pharmacy and 0.02-2.7% in hospital pharmacy (James et all, 2009).

Pure food and drug Act is a valid and useful Act because it is still felt today. The immediate results of this Act is to stop the unsafety misbranded food and the drugs that don’t have details about the ingredients in it. Also, it made people to become conscious about what they're eating or drinking. It is a good way to become conscious about it because it is our freedom to know about what’s in our food and drug that we usually take everyday. On the other hand, the long term results is that, people would feel safe about what they buy in a store because it benefits them to protect their health and awareness about the unsanitary factories. It is a fundamental piece of the legislation that people should be thankful for, because without this Act

The first Pure Food and Drug Act was put into action by Theodore Roosevelt in 1906. The act was passed to prevent the manufacture, sale, or transportation of misbranded or harmful food, drugs, medicines, and liquors. Due to this act the Food and Drug Administration (FDA) came to be. The FDA is now responsible for the testing of all foods and drugs for human consumption and the label warnings on them as well.

This policy paper is going to analyze and show the strategic use of public policy. The law is called the Pure Food and Drug Act of 1906, which is a law to protect consumers from purchasing adulterated or mislabeled food or drug products. This law also led to the creation of the Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. In my policy paper, I will be providing a comprehensive history of Pure Food and Drug Act of 1906 in the next section to give a general and brief description regarding to the background of this Act, and see why the law is necessary. Next, I will be trace the implementation of Pure Food and Drug Act, and its code and agency to provide an insight of how the law was passed. For decades, this law has made a huge impact on the business and society, and many progressive food, drug manufacturers, and the general public worked actively to support the law. Lastly, I will be conducting a policy analysis of this law to observe the strengths and weaknesses of this policy, and formulate some recommendations for further improvement of this act.

Everyday you consume things may it be food, drinks, or prescription drugs. Most people will just absent mindedly intake these products subconsciously knowing that they are monitored by government organizations ensuring your safety. It has not always been that was and has progressed greatly throughout the years. although all consumer safety organizations may not be reputable, they do much more good than harm. Consumer safety is something that is extremely important to the American family, and has help thousands of people survive. Consumer safety is something that has allowed America to progress to where it is today.

The Act controls supply of the medications. This act states that medicines supplied or sold at a pharmacy under the management of a qualified pharmacist. Then again, a few medications can be sold at different premises, for example, stores, the length of their repackaging and the premises can be shut to bar people in general. It's unlawful to offer medication from business stalls or from vehicles, for example, at auto boot

In 1906, the Pure Food and Drug Act, that was years in the making was finally passed under President Roosevelt. This law reflected a sea change in medicine-- an unprecedented wave of regulations. No longer could drug companies have a secret formula and hide potentially toxic substances such as heroin under their patent. The law required drug companies to specify the ingredients of medications on the label. It also regulated the purity and dosage of substances. Not by mere coincidence was the law passed only about five years after Bayer, a German based drug company began selling the morphine derivative, heroin. Thought to be a safe, non-habit forming alternative to morphine, heroin quickly became the “cure-all drug” that was used to treat

This act, under the direct administration of the Bureau of Chemistry, forbade the interstate transport of illegal food and drugs, and exposed any responsible parties, that dare to violate the law, to penalty of seizure of the questionable products and/or prosecution. In fact, the foundation of the law relies on the regulation of product labeling rather than pre-market approval. The selling of Drugs, which are defined according to the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary, is denied under any other condition except that the specific variations from the applicable standards were clearly stated on the label. However, there were different standards that defined foods, but the law outlawed the addition of any ingredients that would alternate for the food, hide damage, generate a health danger, or constitute a filthy or decomposed substance. The controversial interpretations of the food provisions in the law engendered many, sometimes prolonged, court battles. In case the manufacturer decided to list the weight or measure of a food, this had to be done accurately. Also, the food or drug label could not be false or misleading in any particular, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed (Nash 276-77).

2) The Pure Food and Drug Act said that certain drugs could only be sold on prescription.

The final move was the 1962 Kefuaver- Harris Amendment, which tightened safety requirements and also recquired the manufacturers to provide FDA with evidence that the drug was both safe and effective for its intended clinical purpose. People of the drug industry were outraged because this would delay, often by many years, the time and cost of which a company could market a new product and begin to recoup its investment.2

12. The FDA would not let unsafe replications of drugs onto the market, prescription or over the counter medications

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.