COLORADO MPJE PART 1 LATEST QUESTIONS AND
VERIFIED ANSWERS
Subutex - CORRECT ANSWER✅✅✅buprenorphine SL
Suboxone - CORRECT ANSWER✅✅✅buprenorphine/naloxone
Pseudoephedrine limitation - CORRECT ANSWER✅✅✅3.6 gm/person/day
9 gm/person/30 day period
7.5 gm/person/30 day period - if by mail order
This law prohibited adulteration and misbradning - CORRECT ANSWER✅✅✅1906 pure food and
drug act
Pure food and drug act was amended in 1902 to say what? - CORRECT ANSWER✅✅✅prohibit false
and fraud efficacy claims
This law forces new drugs to be proven to be safe - CORRECT ANSWER✅✅✅1938 federal food, drug,
and cosmetic act (FDCA)
This law established 2 classes of drugs (Rx and OTC) - CORRECT ANSWER✅✅✅1951 Durham-
Humphrey Amendments
This law authorized oral prescriptions and refills - CORRECT ANSWER✅✅✅1951 Durham-Humphrey
Amendments
This law requires drugs to be proven of their efficacy - CORRECT ANSWER✅✅✅1962 Kefauver-Harris
Amendment
(Doesn't apply to drugs before 1938)
, This law established good manufacturing practices (GMP) - CORRECT ANSWER✅✅✅1962 Kefauver-
Harris Amendment
This law required informed consent for research subjects - CORRECT ANSWER✅✅✅1962 Kefauver-
Harris Amendment
This law made sure that prescription labels must contain the symbol RX ONLY - CORRECT
ANSWER✅✅✅1997 FDA modernization Act
According to 2009 FDA guidance, what is the requirement for manufacturer to promote promotion of
drugs for off-label use? - CORRECT ANSWER✅✅✅1. unabridged peer-reviewed articles published in
scientific/medical journals not influenced by drug company
AND ACCOMPANIED BY
2. approved labeling, comprehensive bibliography, contrary publication, any known safety risks, conflict
of interest
Function of FDA - CORRECT ANSWER✅✅✅1. Rulemaking
2. Issue guidance documents
3. Incorporate advice
Structure of FDA - CORRECT ANSWER✅✅✅1. Biologics Evaluation & Research
2. Food Safety and Applied Nutrition
3. Drug Evaluation and Research
4. Veterinary Medicine
5. Devices and radiological health
Contains filthy, putrid or decomposed material or held under unsanitary conditions - CORRECT
ANSWER✅✅✅adulteration
VERIFIED ANSWERS
Subutex - CORRECT ANSWER✅✅✅buprenorphine SL
Suboxone - CORRECT ANSWER✅✅✅buprenorphine/naloxone
Pseudoephedrine limitation - CORRECT ANSWER✅✅✅3.6 gm/person/day
9 gm/person/30 day period
7.5 gm/person/30 day period - if by mail order
This law prohibited adulteration and misbradning - CORRECT ANSWER✅✅✅1906 pure food and
drug act
Pure food and drug act was amended in 1902 to say what? - CORRECT ANSWER✅✅✅prohibit false
and fraud efficacy claims
This law forces new drugs to be proven to be safe - CORRECT ANSWER✅✅✅1938 federal food, drug,
and cosmetic act (FDCA)
This law established 2 classes of drugs (Rx and OTC) - CORRECT ANSWER✅✅✅1951 Durham-
Humphrey Amendments
This law authorized oral prescriptions and refills - CORRECT ANSWER✅✅✅1951 Durham-Humphrey
Amendments
This law requires drugs to be proven of their efficacy - CORRECT ANSWER✅✅✅1962 Kefauver-Harris
Amendment
(Doesn't apply to drugs before 1938)
, This law established good manufacturing practices (GMP) - CORRECT ANSWER✅✅✅1962 Kefauver-
Harris Amendment
This law required informed consent for research subjects - CORRECT ANSWER✅✅✅1962 Kefauver-
Harris Amendment
This law made sure that prescription labels must contain the symbol RX ONLY - CORRECT
ANSWER✅✅✅1997 FDA modernization Act
According to 2009 FDA guidance, what is the requirement for manufacturer to promote promotion of
drugs for off-label use? - CORRECT ANSWER✅✅✅1. unabridged peer-reviewed articles published in
scientific/medical journals not influenced by drug company
AND ACCOMPANIED BY
2. approved labeling, comprehensive bibliography, contrary publication, any known safety risks, conflict
of interest
Function of FDA - CORRECT ANSWER✅✅✅1. Rulemaking
2. Issue guidance documents
3. Incorporate advice
Structure of FDA - CORRECT ANSWER✅✅✅1. Biologics Evaluation & Research
2. Food Safety and Applied Nutrition
3. Drug Evaluation and Research
4. Veterinary Medicine
5. Devices and radiological health
Contains filthy, putrid or decomposed material or held under unsanitary conditions - CORRECT
ANSWER✅✅✅adulteration
