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MPJE Study Set - Federal Law (ProntoPass Cards) questions and answers
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MPJE Study Set - Federal Law (ProntoPass Cards) questions and answers
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MPJE Study Set - Federal Law(ProntoPass Cards)
FDA - correct answer ✔✔Pure Food & Drug Act, 1906
FDCA - correct answer ✔✔Federal Food, Drug and Cosmetic Act, 1938
PPPA - correct answer ✔✔Poison Prevention Packaging Act, 1970
CSA - correct answer ✔✔Controlled Substance Act, 1970
DEA - correct answer ✔✔Drug Enforcement Administration, 1973
PDMA - correct answer ✔✔Prescription Drug Marketing Act, 1987
OBRA - correct answer ✔✔Omnibus Budget Reconciliation Act, 1990
Drug - correct answer ✔✔Intended for use in diagnosis, cure, mitigation, treatment or prevention of
disease in man or animal
Intended to affect the structure or function of body (other than food)
In USP or NF or Homeopathic P
Device - correct answer ✔✔Intended for use in diagnosis, cure, mitigation, treatment or prevention of
disease in man or animal
Intended to affect the structure or function of body - not through chemical actions
Class 1 Device - correct answer ✔✔Have low to moderate risk to patient and/or user
Subject to general controls and with reasonable assurance of safety & effectiveness
, Class 2 Device - correct answer ✔✔Have moderate to high risk to patient and/or user
Insufficient info for reasonable assurance of safety & effectiveness
Class 3 Device - correct answer ✔✔Have high risk to patient and/or user
Usually used to sustain or support life, are implanted, or present potential unreasonable risk of illness or
injury
Cosmetic - correct answer ✔✔Something applied to body for cleansing, beautifying, and altering
appearance
Package Insert Requirements - correct answer ✔✔Description (essential scientific info, clinical
pharmacology), indications & use, contraindications, warnings, precautions, ADRs (drug abuse, overdose,
dosage & administration, how it's supplied, pregnancy, pediatric, and geriatric use)
GRAS - correct answer ✔✔Generally recognized as safe
GRAE - correct answer ✔✔Generally recognized as effective
Adulterated - correct answer ✔✔To corrupt, debase, or made impure by the addition of a foreign or
inferior substance or element
Misbranding - correct answer ✔✔Label is false or misleading
Federal Legend - correct answer ✔✔"Rx only"
Class 1 Recall - correct answer ✔✔Threat to life
Class 2 Recall - correct answer ✔✔Temporary or reversible adverse health consequences
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