MPJE ILLINOIS | 359 Questions with
100% Correct Answers
Form to send to DEA for destroying controls Correct Answer: DEA Form 41
Controlled substance theft/loss form? Correct Answer: DEA Form 106. Must also be sent to DPR.
Doesn't define what you have to report; err on the side of caution!
How long to send in theft/loss form? Correct Answer: 1 business day
Do you need to report pseudophedrine as stolen? Correct Answer: No, it is a C5 under state law but not
controlled under federal law
Difference between detox and maintenance treatment with methadone/LAAM Correct Answer: Detox =
<21 days, Maintenance >21 days.
How do you know if a physician is allowed to treat addictions on an outpatient basis with buprenorphine
(subutex/suboxone)? Correct Answer: If they have a separate DEA # that starts with the letter X
Anytime you dispense a schedule II-V.....tell who and after how long? Correct Answer: Report to Illinois
Prescription Monitoring Program not more than 7 days after. (Fine is $100/day). Hospitals exempt. Also
from narcotic tx program and infusions in house.
Prescriptions from the ER are exempt from reporting to PMP if? Correct Answer: They are for a 72 h or
less supply
All drug manufacturers and repackagers are required to register with FDA. If they fail to do so, their
products are deemed...... Correct Answer: Misbranded
Required licensing of biologics establishments, inspections of vaccine manufacturers and premarket
approval of vaccines Correct Answer: Virus-Toxin law of 1902
Prohibited the marketing of adulterated and misbranded food and drugs Correct Answer: Food and
Drug Act of 1906
Required demonstration to FDA of the safety of drugs prior to marketing, allowed FDA to inspect
facilities, allowed FDA to seek injunctions from courts, provided legal definitions of drugs, devices,
cosmetics and labeling Correct Answer: Federal Food, Drug and cosmetic Act of 1938
Distinguishes between prescription and OTC drugs Correct Answer: Durham-Humphrey Amendment of
1951
Requires drug manufacturers to show the effectiveness of their products as well as safety, to report
adverse events to the FDA, and to ensure that they disclose the risks and benefits. Informed consent
,required for studies. FDA was given jurisdiction over rx drug advertising. Need to submit an NDA!
Correct Answer: Kefauver-Harris Amendment of 1962 (Thalidomide)
Clarified the definition of device and categorized medical devices based on risk Correct Answer: Medical
Device Amendments of 1976
Anti-tampering regulations Correct Answer: Cosmetic liquid oral hygeine products, vaginal products,
contact lens solutions and most OTC drugs need to be tamper resistant. Packaging must be distinctive by
design and must indicate to consumers. Ex) flister packs, film wrappers, aerosols, tape seals, break away
caps, foil.
Drugs intended for the tx of rare diseases and conditions Correct Answer: Orphan Drug Act of 1983
Concerns of drugs being sold that were counterfeit. Requires states to license wholesale distributors of
rx drugs, ban the reimportation of rx drugs, except by the manufacturer. Mandate record keeping for
drug samples. Ban counterfeiting of drug coupons. Prohibit resale of rx drugs. Correct Answer:
Prescription Drug Marketing Act (PDMA) of 1987 and Prescription Drug Amendments of 1992
Allows FDA to accept user fees from drug and biologic companies in return for committing to review
new drug and biologic products within certain time frames Correct Answer: Prescription Drug User Fee
Act (PDUFA) of 1992
Allowed the use of FDA approved health claims of food labels and required a uniform format for the
nutrition info Correct Answer: Nutrition Labeling and Education Act (NLEA) of 1990
Established labeling requirements, allowed "nutritional support statements" describing the effect of the
supplement. Correct Answer: Dietary Supplement Health and Education Act (DSHEA) of 1994. FDA must
prove supplements are UNSAFE as opposed to manufacturers having to prove SAFE.
Established fast-track approval for certain new drugs and accelerated approval for innovative devices by
exempting certain devices from premarket notification requirements. Correct Answer: Food and Drug
Modernization Act (FDAMA) of 1997
Form to register with DEA to dispense controls Correct Answer: Form 224 (224a for renewal)
When does a pharmacy's license expire? Correct Answer: March 31 on even years
When does a pharmacy need to register as a distributor? Correct Answer: If it participates in joint
buying activities and is the location from which drugs are stored and shipped to other pharmacies OR its
annual distribution of controls to other pharmacies/practitioners exceeds 5% of total dosage units
dispensed.
When does a pharmacy register as a manufacturer? Correct Answer: Purchases controls for purposes of
repackaging for sale, Compounds for office use (Not if its aqueous, oleaginous or solids or only up to
20% controls)
, When to register as detox compounder? Correct Answer: Compounds a control for sale to narcotic
treatment program (who must be registered with DEA). Suboxone is allowed to be used on an
outpatient basis! The only other way to treat addiction is to dispense at a narcotic treatment program.
Verification of DEA #s Correct Answer: A, B or F then usually letter of last name. M is mid level.
Manufacturers or distributors = P or R. Add 1+3+5, 2+4+6 x 2 then add totals and should equal last
number.
Entry point for newly scheduled controlled drug Correct Answer: IV
Heroin Correct Answer: Schedule 1
LSD Correct Answer: 1
Mescaline Correct Answer: 1
Marijuana (even medical) Correct Answer: 1
Marinol Correct Answer: 3
Methaqualone Correct Answer: 1
Peyote Correct Answer: 1
Amphetamine Correct Answer: 2
Cocaine Correct Answer: 2
Codeine sulphate/phosphate Correct Answer: 2
Fentanyl Correct Answer: 2
Hydromorphone Correct Answer: 2
Meperidine Correct Answer: 2
Methylphenidate Correct Answer: 2
Methadone Correct Answer: 2
Morphine Correct Answer: 2
Methamphetamine Correct Answer: 2
Pentobarbital Correct Answer: 2
Oxycodone/APAP Correct Answer: 2
100% Correct Answers
Form to send to DEA for destroying controls Correct Answer: DEA Form 41
Controlled substance theft/loss form? Correct Answer: DEA Form 106. Must also be sent to DPR.
Doesn't define what you have to report; err on the side of caution!
How long to send in theft/loss form? Correct Answer: 1 business day
Do you need to report pseudophedrine as stolen? Correct Answer: No, it is a C5 under state law but not
controlled under federal law
Difference between detox and maintenance treatment with methadone/LAAM Correct Answer: Detox =
<21 days, Maintenance >21 days.
How do you know if a physician is allowed to treat addictions on an outpatient basis with buprenorphine
(subutex/suboxone)? Correct Answer: If they have a separate DEA # that starts with the letter X
Anytime you dispense a schedule II-V.....tell who and after how long? Correct Answer: Report to Illinois
Prescription Monitoring Program not more than 7 days after. (Fine is $100/day). Hospitals exempt. Also
from narcotic tx program and infusions in house.
Prescriptions from the ER are exempt from reporting to PMP if? Correct Answer: They are for a 72 h or
less supply
All drug manufacturers and repackagers are required to register with FDA. If they fail to do so, their
products are deemed...... Correct Answer: Misbranded
Required licensing of biologics establishments, inspections of vaccine manufacturers and premarket
approval of vaccines Correct Answer: Virus-Toxin law of 1902
Prohibited the marketing of adulterated and misbranded food and drugs Correct Answer: Food and
Drug Act of 1906
Required demonstration to FDA of the safety of drugs prior to marketing, allowed FDA to inspect
facilities, allowed FDA to seek injunctions from courts, provided legal definitions of drugs, devices,
cosmetics and labeling Correct Answer: Federal Food, Drug and cosmetic Act of 1938
Distinguishes between prescription and OTC drugs Correct Answer: Durham-Humphrey Amendment of
1951
Requires drug manufacturers to show the effectiveness of their products as well as safety, to report
adverse events to the FDA, and to ensure that they disclose the risks and benefits. Informed consent
,required for studies. FDA was given jurisdiction over rx drug advertising. Need to submit an NDA!
Correct Answer: Kefauver-Harris Amendment of 1962 (Thalidomide)
Clarified the definition of device and categorized medical devices based on risk Correct Answer: Medical
Device Amendments of 1976
Anti-tampering regulations Correct Answer: Cosmetic liquid oral hygeine products, vaginal products,
contact lens solutions and most OTC drugs need to be tamper resistant. Packaging must be distinctive by
design and must indicate to consumers. Ex) flister packs, film wrappers, aerosols, tape seals, break away
caps, foil.
Drugs intended for the tx of rare diseases and conditions Correct Answer: Orphan Drug Act of 1983
Concerns of drugs being sold that were counterfeit. Requires states to license wholesale distributors of
rx drugs, ban the reimportation of rx drugs, except by the manufacturer. Mandate record keeping for
drug samples. Ban counterfeiting of drug coupons. Prohibit resale of rx drugs. Correct Answer:
Prescription Drug Marketing Act (PDMA) of 1987 and Prescription Drug Amendments of 1992
Allows FDA to accept user fees from drug and biologic companies in return for committing to review
new drug and biologic products within certain time frames Correct Answer: Prescription Drug User Fee
Act (PDUFA) of 1992
Allowed the use of FDA approved health claims of food labels and required a uniform format for the
nutrition info Correct Answer: Nutrition Labeling and Education Act (NLEA) of 1990
Established labeling requirements, allowed "nutritional support statements" describing the effect of the
supplement. Correct Answer: Dietary Supplement Health and Education Act (DSHEA) of 1994. FDA must
prove supplements are UNSAFE as opposed to manufacturers having to prove SAFE.
Established fast-track approval for certain new drugs and accelerated approval for innovative devices by
exempting certain devices from premarket notification requirements. Correct Answer: Food and Drug
Modernization Act (FDAMA) of 1997
Form to register with DEA to dispense controls Correct Answer: Form 224 (224a for renewal)
When does a pharmacy's license expire? Correct Answer: March 31 on even years
When does a pharmacy need to register as a distributor? Correct Answer: If it participates in joint
buying activities and is the location from which drugs are stored and shipped to other pharmacies OR its
annual distribution of controls to other pharmacies/practitioners exceeds 5% of total dosage units
dispensed.
When does a pharmacy register as a manufacturer? Correct Answer: Purchases controls for purposes of
repackaging for sale, Compounds for office use (Not if its aqueous, oleaginous or solids or only up to
20% controls)
, When to register as detox compounder? Correct Answer: Compounds a control for sale to narcotic
treatment program (who must be registered with DEA). Suboxone is allowed to be used on an
outpatient basis! The only other way to treat addiction is to dispense at a narcotic treatment program.
Verification of DEA #s Correct Answer: A, B or F then usually letter of last name. M is mid level.
Manufacturers or distributors = P or R. Add 1+3+5, 2+4+6 x 2 then add totals and should equal last
number.
Entry point for newly scheduled controlled drug Correct Answer: IV
Heroin Correct Answer: Schedule 1
LSD Correct Answer: 1
Mescaline Correct Answer: 1
Marijuana (even medical) Correct Answer: 1
Marinol Correct Answer: 3
Methaqualone Correct Answer: 1
Peyote Correct Answer: 1
Amphetamine Correct Answer: 2
Cocaine Correct Answer: 2
Codeine sulphate/phosphate Correct Answer: 2
Fentanyl Correct Answer: 2
Hydromorphone Correct Answer: 2
Meperidine Correct Answer: 2
Methylphenidate Correct Answer: 2
Methadone Correct Answer: 2
Morphine Correct Answer: 2
Methamphetamine Correct Answer: 2
Pentobarbital Correct Answer: 2
Oxycodone/APAP Correct Answer: 2
