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40 Cards in this Set
- Front
- Back
ASHP
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America Society of Health-System Pharmacists
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PTEC
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Pharmacy Technician Educator's Council
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PTCE, PTCB, CPhT
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Pharmacy Technician Certification
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Food and Drug Act of 1906
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adulterated or misbranded
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1914 Harrison Tax Act
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due to cocaine - narcotic folks be licensed & taxed
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1927 Food, Drug and Insecticide Addministration
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became FDA in 1930
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1938 Food, Drug and Cosmetic (FDC) Act
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untested sulfanilamide - drugs must be safe before marketing
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1950 Alberty Food Products v. U.S.
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drug purpose on label
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1951 Durham-Humphrey Amendment
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legend - Rx only
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1962 Kefauver-Harris Amendment
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saftey & effectiveness
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1966 Fair Packaging and Labeling Act
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honestly & informative
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1970 Poison Prevention Packaging Act
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child-proof
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1970 Controlled Substances Act (CSA)
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schedules - DEA (division of Justice)
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1976 Medical Device Amendment
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safety & effectiveness devices
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1983 Orphan Drug Act
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promote - rare diseases
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1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
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extension of drug patent & generics
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1987 Prescription Durg Marketing Act
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state licenses
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1990 Omnibus Budget Reconciliation Act (OBRA)
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pharmacist counseling
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1990 Anabolic Steroid Control Act
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steroid abuse
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1996 Healh Insurance Portability and Accountability Act
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right & privacy
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phase I
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safety, 25% success
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phase II
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effectiveness, safety
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phase III
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doseage, safety, effectiveness
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OTC
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over the counter
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Combat Methamphetamine Epidemic Act (CMEA)
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3.6 g per day per purchaser
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NDC - National Drug Code
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1 - manufacturer [4-5 digits]
2 - medication (strenght,dosage form) [3-4 digits] 3 - package size [2 digits] |
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DEA Formula
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2 letters - 7 digits
(1+3+5) + 2(2+4+6) = number with same last digit as DEA # |
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Schedule I
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high potential for abuse - no accepted medical use
illegal drugs |
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Schedule II
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high potential for abuse - currently accepted medical use - no refills - time & quantity limits
amphetamines, opium, cocaine, methadone, opiates |
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Schedule III
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potential for abuse - currently accepted medical use
anabolic steroids, limited amounts of codeine |
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Schedule IV
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lower potential for abuse - currently accepted medical use
phenobarbital, chloral hydrate, methohexital |
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Schedule V
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lowest potential for abuse - currently accepted medical use
limited amounts of codeine |
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Orange Book
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Theraputic Equivalence
A = yes B = no |
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Form 222
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DEA from to order C-I & C-II
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Class I recall
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likely to cause serious injury or death
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Class II recall
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temporary or reversable adverse effects
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Class III recall
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not like to cause adverse effects
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USP
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United State Pharmacopeia
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JCAHO
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Joint Commission on Accreditation of Health Care Organizations
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ASCP
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American Society for Consultant Pharmacists
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