NU 578 EXAM 1 PT 5 EXAM QUESTIONS WITH COMPLETE
SOLUTIONS
Food and Drug Act (1906) The federal government (Food and Drug Administration, FDA) may enforce
standards of drug strength and purity as
officially designated by the USP (United States Pharmacopoeia) and NF (National
Formulary).
prohibits mislabeling or adulteration of drugs
This part is still used today
Did NOT say how drug works or what to do if something adverse happens from
drug.
FDA recalls are basis of this law if contamination occurs
Harrison Narcotic Act (1914) . regulated importation, manufacture, sale, and use of opium, cocaine, and
marijuana
2. repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act (1938) enforced by the FDA through registration of all parties involved in the
manufacture, sale, and distribution of drugs
required adequate testing of a compound to prevent marketing of a possibly toxic
substance. New drugs must be safe as well as pure in order to be introduced into
interstate commerce. But this law still did not require proof of effectiveness
Enforced when people engage in manufacturing and distribution of drugs
illegally.
Durham-Humphrey Amendments (1952) separated drugs into legend (prescription) and nonlegend (nonprescription,
over-the-counter) categories. The "legend" must appear on every commercial
container of legend drugs: "Caution: Federal Law Prohibits Dispensing without
Prescription."
2. rules for dispensing legend drugs.
separates who can prescribe from who can dispense.
Kefauver-Harris Amendments (1962) required proof of efficacy as well as safety before any new drug could be placed
in interstate commerce (Thalidomide: A drug approved for morning sickness in
Europe that caused gross birth defects—this drug spurred the passage of these
amendments in the US)
2. guidelines for conducting clinical trials
3. established the Drug Efficacy Study Implementation (DESI)
Risk vs benefit ratio.
Comprehensive Drug Abuse Prevention and Control Act established rehabilitation programs for drug users
of 1970 (Controlled Substances Act) 2. established control (registration) and enforcement (DEA)
3. regulates export and import of controlled substances
1/4
, schedule 1 Which schedule is described? (CS)
- high abuse potential and no accepted medical use in U.S.
investigational drugs
2. opiates: heroin, many synthetic derivatives not for pharmaceutical use
3. hallucinogens: LSD, mescaline, peyote, bath salts
4. marijuana (medical marijuana in 33 states an exception; recreational marijuana
is an exception, too), spice
5. methaqualone (Quaalude)
Note: More complete listings are found for each schedule in many
pharmacology texts
schedule 2 What is the schedule?
currently accepted medical use in U.S. with high abuse potential resulting in
severe physical or psychological dependence
1. Rules for Prescriptions
a. written prescription required with prescriber's actual (legal) signature
Electronic prescriptions are allowed (preferred, required)
b. must be dated the same day as signed
c. no refills allowed
d. in an emergency, a verbal order may be given for a limited quantity of drug
adequate to treat the emergency condition, but must be followed by a written
prescription within 72 hours. Note: This provision of federal law is not recognized in
Alabama since state law may be more stringent than federal law. THERE ARE NO
VERBALORDERS ALLOWED FOR these PRESCRIPTIONS IN ALABAMA.
scheduled 2 list Methylphenidate (Ritalin)
Oxycodone (Oxycontin)
Morphine
Meperidine (Demerol)
Cocaine
Codeine
Fentanyl
Hydrocodone
What schedule are these?
schedule III What schedule CS does this describe?
abuse potential less than Schedule II
1. Rules for Prescriptions
a. written or verbal prescriptions allowed; valid for 6 months from the date written
b. limit of 5 refills
scheduled III list Codeine/Acetaminophen (Tylenol #3)
Anabolic steroids
Sedatives like Secobarbital
2/4
SOLUTIONS
Food and Drug Act (1906) The federal government (Food and Drug Administration, FDA) may enforce
standards of drug strength and purity as
officially designated by the USP (United States Pharmacopoeia) and NF (National
Formulary).
prohibits mislabeling or adulteration of drugs
This part is still used today
Did NOT say how drug works or what to do if something adverse happens from
drug.
FDA recalls are basis of this law if contamination occurs
Harrison Narcotic Act (1914) . regulated importation, manufacture, sale, and use of opium, cocaine, and
marijuana
2. repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act (1938) enforced by the FDA through registration of all parties involved in the
manufacture, sale, and distribution of drugs
required adequate testing of a compound to prevent marketing of a possibly toxic
substance. New drugs must be safe as well as pure in order to be introduced into
interstate commerce. But this law still did not require proof of effectiveness
Enforced when people engage in manufacturing and distribution of drugs
illegally.
Durham-Humphrey Amendments (1952) separated drugs into legend (prescription) and nonlegend (nonprescription,
over-the-counter) categories. The "legend" must appear on every commercial
container of legend drugs: "Caution: Federal Law Prohibits Dispensing without
Prescription."
2. rules for dispensing legend drugs.
separates who can prescribe from who can dispense.
Kefauver-Harris Amendments (1962) required proof of efficacy as well as safety before any new drug could be placed
in interstate commerce (Thalidomide: A drug approved for morning sickness in
Europe that caused gross birth defects—this drug spurred the passage of these
amendments in the US)
2. guidelines for conducting clinical trials
3. established the Drug Efficacy Study Implementation (DESI)
Risk vs benefit ratio.
Comprehensive Drug Abuse Prevention and Control Act established rehabilitation programs for drug users
of 1970 (Controlled Substances Act) 2. established control (registration) and enforcement (DEA)
3. regulates export and import of controlled substances
1/4
, schedule 1 Which schedule is described? (CS)
- high abuse potential and no accepted medical use in U.S.
investigational drugs
2. opiates: heroin, many synthetic derivatives not for pharmaceutical use
3. hallucinogens: LSD, mescaline, peyote, bath salts
4. marijuana (medical marijuana in 33 states an exception; recreational marijuana
is an exception, too), spice
5. methaqualone (Quaalude)
Note: More complete listings are found for each schedule in many
pharmacology texts
schedule 2 What is the schedule?
currently accepted medical use in U.S. with high abuse potential resulting in
severe physical or psychological dependence
1. Rules for Prescriptions
a. written prescription required with prescriber's actual (legal) signature
Electronic prescriptions are allowed (preferred, required)
b. must be dated the same day as signed
c. no refills allowed
d. in an emergency, a verbal order may be given for a limited quantity of drug
adequate to treat the emergency condition, but must be followed by a written
prescription within 72 hours. Note: This provision of federal law is not recognized in
Alabama since state law may be more stringent than federal law. THERE ARE NO
VERBALORDERS ALLOWED FOR these PRESCRIPTIONS IN ALABAMA.
scheduled 2 list Methylphenidate (Ritalin)
Oxycodone (Oxycontin)
Morphine
Meperidine (Demerol)
Cocaine
Codeine
Fentanyl
Hydrocodone
What schedule are these?
schedule III What schedule CS does this describe?
abuse potential less than Schedule II
1. Rules for Prescriptions
a. written or verbal prescriptions allowed; valid for 6 months from the date written
b. limit of 5 refills
scheduled III list Codeine/Acetaminophen (Tylenol #3)
Anabolic steroids
Sedatives like Secobarbital
2/4
