Pharmacology Notes - Chapter 1 Drug Standardization ensures consumer is receiving safe quality drugs with expected therapeutic properties ensures

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Chapter 1 Drug Standardization: ensures consumer is receiving safe, quality drugs with expected therapeutic properties ensures that drug’s active ingredients have exact concentration or strength with each dosage 1906 - Pure Food and Drug Act First federal attempt to protect consumers by requiring standards of strength, purity, and quality “Dangerous” drugs labeled on container Dangerous drugs include those that cause injury or death, addiction, or inconsistency of the medication 1912 - Shirley Amendment Prevented fraudulent claims by drug manufacturers Harrison Narcotic Act or Federal Narcotic Drug Act of 1914 Established the word narcotic and required the use of narcotic stamp on these medications Regulated the importation, manufacture, sales, and use of opium, codeine and the related medications\ 1938 - Food, Drug, and Cosmetic Act established FDA to supervise and regulate drug safety all new drugs tested for toxicity test results reviewed before FDA approves for marketing unsafe drugs removed from market 1951 Durham-Humphrey Amendment specified how prescription drugs could be ordered and dispensed specified that all legend drugs be labeled “Caution: Federal law prohibits dispensing without a prescription”
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required warning labels for drowsiness, nervousness, habit-forming potential recognized OTC drugs not requiring a prescription Poisoning Prevention Packaging Act of 1970 o Child-resistant packaging Drug Listing Act of 1972 o Required the use of the National Drug Code on packaging 1978 - Drug Regulation and Reform Act o Briefer investigation of new drugs to allow faster access 1970 - Comprehensive Drug Abuse Prevention and Control Act Drugs with abuse potential identified as controlled substances Controlled substances placed into Schedules I through V All prescribers, dispensers, drug manufacturers must have DEA number Creation of BNDD and DEA – (Result of the 1970 Controlled Substances Act) o Bureau of Narcotics and Dangerous Drugs (BNDD) o Drug Enforcement Administration (DEA) Provided for prevention of drug abuse and drug dependence Required security of controlled substances Required the proven effectiveness of drugs before marketing 1983 - Orphan Drug Amendment Law was enacted to fund research of drugs for rare conditions. Historically, this research has not been profitable for pharmaceutical companies.
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Helps find new applications for old drugs as well as discovering new drugs. Use of Generic Drugs: Generic medication formulations sold under non-trademarked name: Tylenol (brand name) acetaminophen (generic name) Generic medication or formulation is cheaper. Pharmacists may substitute generic or bioequivalent drugs if brand name not
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This note was uploaded on 01/28/2011 for the course HSC 3147 taught by Professor Rahim during the Spring '08 term at University of Central Florida.

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Pharmacology Notes - Chapter 1 Drug Standardization ensures consumer is receiving safe quality drugs with expected therapeutic properties ensures

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