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40 Cards in this Set

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