UT Arlington BIOL 3303 - OTC Drugs (2 pages)

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OTC Drugs

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OTC Drugs


Focus on over the counter drug

Lecture number:
Lecture Note
University of Texas at Arlington
Biol 3303 - Drugs and Behavior

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BIOL 3303 1st Edition Lecture 5 Outline of Last Lecture I Sections of the Brain a Hindbrain i Medulla Oblongata ii Pons iii Cerebellum b Midbrain c Forebrain i Cerebral Cortex 1 Temporal Lobe 2 Occipital Lobe 3 Parietal Lobe 4 Frontal Lobe ii Hypothalamus iii Limbic System II Drug Development a Procedure Outline of Current Lecture A Over the Counter Drugs a Kefauver Harris Amendment 1962 i GRAS ii GRAE iii GRAHL b Major OTC Drugs i Analgesics 1 Aspirin 2 Acetaminophen 3 Ibuprofen 4 Naproxen ii Dietary Supplements Current Lecture Before the 1900s there were no regulations concerning the use of over the counter drugs So in 1962 the congress passed the Kefauver Harris Amendment for the purpose to regulate all drugs for their safety and efficacy There are three categories that the Federal Drug Administration looked for GRAS GRAE and GRAHL GRAS meant the safety of the drug if the person followed the direction there would be a low probability of These notes represent a detailed interpretation of the professor s lecture GradeBuddy is best used as a supplement to your own notes not as a substitute side effects An example of a OTC drug would be like Tylenol or Advil GRAE was used for the effectiveness of the drug we want it safe but also we want the drug to work for the purpose taken such as to relieve pain GRAHL was the host labeling of the drug because before then there was no labeling on the OTC drugs stating the dangers and effects of the drug Over the course of time the FDA has been involved in simplifying the labels and ensuring safe packaging An example of safe packaging would be the seals that need to be open after opening the lid and labels are now organized in a way the consumer can understand There was a story of the TYLENOL Poising in 1980 involved a person replacing a drug with another causing severe damages to several people Until this day they have not found the person responsible for this crime and there are times were people confess but they are not the ones

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