Quality Control Over Drugs And Cosmetics Act 1940 Essay

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.

In 1986 Anti-Drug Abuse Act was passed in effort to stop the drug crisis. The Act was aimed towards accountability and zero-tolerance towards addicts.. Critics accused the government of spending too much on enforcing rather than educating and treatment. Its effects were similar to those of Prohibition so in 1988 the act was redone (Bondi 395).

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.

This act is an Act of Parliament of the United Kingdom and it governs the manufacture and supply of medicine.

As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would eliminate adulterations and poisons sometimes found in foods, sometimes in drugs and often in both. The foundation of food and drug protection came from the development of scientific methods of analysis by the Federal Bureau of Chemistry,

The Medicines Act 1968:- The Medicines Act controls the manufacture and supply of medicines for human and veterinary use. The act defines three categories of the supply of drugs; Prescription only medicines, Pharmacy Medicine, and General sales list medicines the act controls

The Social Work (Scotland) Act 1968 as amended by The Regulations of Care Act 2001

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

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).

CONTROLLED SUBSTANCE ACT: PREFATORY NOTE 1 (UNIF. LAW COMM’N 1994). In 1970, the Act was adopted by the National Conference of Commissioners on Uniform State Laws. Id. This non-profit association “provides states with non-partisan, well-conceived and well-drafted legislation that brings clarity and stability to critical areas of state statutory law.” UNIF. LAW COMM’N, CONTROLLED SUBSTANCE ACT: DRAFTING HISTORY (2016). This organization was established in 1892 and is composed of lawyers, judges, and legislators who have been appointed by state governments to research, draft, and promote enactment of uniform state laws. UNIF. LAW COMM’N: ABOUT THE ULC (2016). After an Act is adopted by this association, each state legislature will vote to adopt the uniform law for it to become effective in the state.

b.)The misuse of Drugs act 1971 and amendments 1985, 2001 -this controls dangerous or otherwise harmful drugs designated as Controlled drugs (CD). The main purpose of this act is to prevent the misuse of controlled drugs. CD’s are prescribed

·The Misuse of Drugs Regulations 2001: Act which intends to prevent the non-medicinal use of certain drugs, particularly those that can lead to

The Controlled Substances Act (CSA) gives certain bodies or individuals such as research scientists, pharmacies, doctors and manufacturers the legal right to access controlled substances.

The history of drug use dates back for thousands of years with diverse purposes throughout humanity. According to Levinthal (2012), the drug-taking behavior gained federal awareness in the early 1900s, due to the lack of drug control regulations. Moreover, Levinthal (2012) mentions four major drug control laws which were established, including: (1) The Harrison Narcotic Act 1914, (2) The Marijuana Tax Act 1937, (3) The Boggs Act 1951, and (4) The Controlled Substance Act 1970. The drug control laws formed help regulate importation, manufacture, selling, or distribution of drugs within the United States (Levinthal, 2012).

: A controlled substance is any drug, prescription or illegal. That has the potential for abuse or addiction. For the public’s protection, controlled substances come under a category of prescription drugs that contain and elevated level of restrictions. In 1970 controlled substances act established the (DEA) Drug Enforcement Administration, under the department of justice, which maintains oversight of the legally prescribed drugs, used narcotics drugs and for containment of illegal drugs. This was put in to effect to implement controls on drugs that are commonly abused by society, controlled prescriptions provided for the drugs, and prescribers are required to be registered with an individual (DEA) numbers.