Food and Drug Administration

Examples of Food and Drug Administration in the following topics:

• Regulatory Commissions

  • The Food and Drug Administration (FDA) is an independent regulatory agency intended to promote public health by overseeing food and drug safety.
  • Food and Drug Administration (FDA).
  • The FDA's mission is to promote public health by regulating the production, distribution, and consumption of food and drugs.
  • The FDA employs experts in pharmaceuticals and drug safety, who evaluate the potential benefits and consequences of the drug.
  • The FDA sets regulations governing which drugs can be distributed over the counter and which require a prescription based on an expert evaluation of the drug's effects.

• Filtration

  • Fluids that would be damaged by heat (such as fluids containing proteins like large molecule drug products, but also wine and beer), irradiation, or chemical sterilization can only be sterilized by microfiltration using membrane filters.
  • The typical microfiltration membrane pore size range is 0.1-10 µm, with the most commonly used being 0.2 µm ; and 0.45 µm is sufficient to eliminate bacteria and fungi.
  • It effectively removes major pathogens and contaminants such as Giardia lamblia cysts, Cryptosporidium oocysts, and large bacteria.
  • A non-destructive integrity test assures the filter is undamaged, and is also a regulatory requirement enforced by agencies like the Food and Drug Administration, the European Medicines Agency, and others.
  • A syringe filter with a pore size of 0.22 micrometers, small enough to capture and retain bacterial and fungal cells.

• Radiation from Food

  • Food irradiation is currently permitted by over 50 countries, and the volume of food treated is estimated to exceed 500,000 metric tons annually worldwide.
  • By irradiating food, depending on the dose, some or all of the microorganisms, bacteria, viruses, and insects present are killed.
  • Some foods, e.g., herbs and spices, are irradiated at sufficient doses (five kilograys or more) to reduce the microbial counts by several orders of magnitude.
  • Food and Drug Administration regulations to show a food has been treated with ionizing radiation
  • Explain how food irradiation is performed, commenting on its purpose and safety

• Transdermal Drug Administration

  • Transdermal drug delivery can be acheived by a medicated adhesive patch to deliver a dose of drug through the skin and into the bloodstream.
  • Single-layer, drug-in-adhesive: The adhesive layer of this system also contains the drug.
  • One of the layers is for immediate release of the drug and the other layer is for controlled release of the drug from the reservoir.
  • Food and Drug Administration in December 1979.
  • Transdermal patches are also used to deliver pain relief, hormones, and anti-depressants, among many other uses.

• Consumer Products

  • It then goes on to list eight additional specific exclusions and some further miscellaneous details.
  • The CPSC has jurisdiction over more than 15,000 different products; however, the CPSA excludes from the CPSC's jurisdiction those products that expressly lie in another federal agency's jurisdiction, for example food, drugs, cosmetics, medical devices, tobacco products, firearms and ammunition, motor vehicles, pesticides, aircraft, and boats.
  • These products may fall under the purview of agencies such as the US Food and Drug Administration, the US Bureau of Alcohol, Tobacco, Firearms and Explosives, the US Department of Agriculture, the US Department of Transportation, the US Environment Protection Agency, the US Federal Aviation Administration, and the US Coast Guard.
  • Following WWI, America went into a recession after manufacturing many war products and having to pay off all of its debts to factories and the common people.
  • The production and sale of consumer goods is an important sector of US GDP and creating employment.

• Strategic versus tactical operations decisions

  • Hospital administrators must evaluate the performance and cost of a wide variety of health equipment.
  • Administrators must also assess and purchase information technologies to keep patient records, fulfill government regulations, provide accurate and timely communications, and track financial performance.
  • Doctors, nurses, and staff must be hired and various departments (x-ray, lab, pharmacy, physical therapy, etc. ) must be arranged to maximize both efficiency and effectiveness in patient care.
  • Selecting a food service vendor is important to serving both employees and patients.
  • Ensuring that the right drugs and supplies are on hand is achieved by working closely with vendors in the supply chain.

• Antifungal Drugs

  • These classes include hypersensitivity—allergic reactions based on the presence of mold and spores; mycotoxicoses—diseases based on the presence of fungi that produce toxins in animal feed and human food products; mycetismus—mushroom poisoning; and lastly, mycoses—characterized by infection.
  • Disease-causing fungi are targeted and then drug classes are classified based on drug structure or mechanism.
  • The various types of azole classified drugs include imidazole, triazole and thiazole antifungals.
  • Azole drugs are broad-spectrum drugs and treat fungal infections of the skin or mouth.
  • The discovery process for effective and fungi-specific drugs is enduring and laborious, as the drugs must be specific for fungi cells.

• Allergic Responses to Drugs

  • Virtually any substance, when exposed internally or externally to the body, can act as an allergen and illicit an immune system response, such is the case with antimicrobial drugs.
  • The IgE binds directly to the drug and sets off a cascade of events, including the activation of receptors on immune system cells.
  • The exposure to a drug may not elicit an allergic reaction during the first exposure, but after the first exposure, the body creates antibodies and memory lymphocyte cells against the drug, therefore later exposures to the drug will illicit an immune response.
  • Some factors include genetics and past exposures to other allergens, typically a person who has allergies to other things, such as various foods, is more prone to have or develop drug allergies.
  • Additionally the allergic reaction may not even be due to the penicillin, as dyes and other chemicals added to antimicrobial drugs may in fact cause the allergic response instead.

• Antiprotozoan and Antihelminthic Drugs

  • Antiprotozoan and antihelminthic drugs are characterized based on structure and the mechanism of action by which they target the organism.
  • Parasites are organisms that live on or in a host organism to obtain food.
  • The development of antimalarial drugs are based on the life cycle of Plasmodiain both the mosquito and human host .
  • The drugs utilized to target helminths are characterized based on chemical structure and mechanism of action.
  • The development of antimalarial drugs focuses on the life cycle in both the mosquito and human hosts.

• Drug Screening

  • Explaining why drug testing is necessary and following proven process guidelines will go a long way toward appeasing workers.
  • There are two kinds of employment drug testing: pre-employment drug screening and publish-employment drug testing.
  • In accordance with the most recent reports (2009) released by Compound Abuse and Mental Health Expert services Administration (SAMHSA), out of 19.3 million illicit drug abusers aged 18 many years or older, 12.9 million had been employed full time or part time in United States.
  • This knowledge signifies that many illicit drug users are finding employment and that they may well impact the organizational lifestyle.
  • Most employees feel the purpose of drug screening is to identify people doing something illegal off duty and then punish them.