MPJE ILLINOIS EXAM 2025 QUESTIONS
AND ANSWERS
Form to send to DEA for destroying controls - ANS DEA Form 41
Controlled substance theft/loss form? - ANS 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? - ANS 1 business day
Do you need to report pseudophedrine as stolen? - ANS No, it is a C5 under state law but not
controlled under federal law
Difference between detox and maintenance treatment with methadone/LAAM - ANS 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)? - ANS 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? - ANS 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? - ANS They are for a 72 h or
less supply
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,All drug manufacturers and repackagers are required to register with FDA. If they fail to do so,
their products are deemed...... - ANS Misbranded
Required licensing of biologics establishments, inspections of vaccine manufacturers and
premarket approval of vaccines - ANS Virus-Toxin law of 1902
Prohibited the marketing of adulterated and misbranded food and drugs - ANS 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 - ANS Federal Food, Drug and cosmetic Act of 1938
Distinguishes between prescription and OTC drugs - ANS 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! - ANS Kefauver-Harris Amendment of 1962 (Thalidomide)
Clarified the definition of device and categorized medical devices based on risk -
ANS Medical Device Amendments of 1976
Anti-tampering regulations - ANS 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 - ANS Orphan Drug Act of 1983
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,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. - ANS 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 - ANS 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 - ANS Nutrition Labeling and Education Act (NLEA) of 1990
Established labeling requirements, allowed "nutritional support statements" describing the
effect of the supplement. - ANS 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. - ANS Food
and Drug Modernization Act (FDAMA) of 1997
Form to register with DEA to dispense controls - ANS Form 224 (224a for renewal)
When does a pharmacy's license expire? - ANS March 31 on even years
When does a pharmacy need to register as a distributor? - ANS 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.
3 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
, When does a pharmacy register as a manufacturer? - ANS 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? - ANS 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 - ANS 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 - ANS IV
Heroin - ANS Schedule 1
LSD - ANS 1
Mescaline - ANS 1
Marijuana (even medical) - ANS 1
Marinol - ANS 3
Methaqualone - ANS 1
Peyote - ANS 1
4 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
AND ANSWERS
Form to send to DEA for destroying controls - ANS DEA Form 41
Controlled substance theft/loss form? - ANS 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? - ANS 1 business day
Do you need to report pseudophedrine as stolen? - ANS No, it is a C5 under state law but not
controlled under federal law
Difference between detox and maintenance treatment with methadone/LAAM - ANS 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)? - ANS 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? - ANS 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? - ANS They are for a 72 h or
less supply
1 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
,All drug manufacturers and repackagers are required to register with FDA. If they fail to do so,
their products are deemed...... - ANS Misbranded
Required licensing of biologics establishments, inspections of vaccine manufacturers and
premarket approval of vaccines - ANS Virus-Toxin law of 1902
Prohibited the marketing of adulterated and misbranded food and drugs - ANS 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 - ANS Federal Food, Drug and cosmetic Act of 1938
Distinguishes between prescription and OTC drugs - ANS 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! - ANS Kefauver-Harris Amendment of 1962 (Thalidomide)
Clarified the definition of device and categorized medical devices based on risk -
ANS Medical Device Amendments of 1976
Anti-tampering regulations - ANS 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 - ANS Orphan Drug Act of 1983
2 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
,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. - ANS 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 - ANS 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 - ANS Nutrition Labeling and Education Act (NLEA) of 1990
Established labeling requirements, allowed "nutritional support statements" describing the
effect of the supplement. - ANS 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. - ANS Food
and Drug Modernization Act (FDAMA) of 1997
Form to register with DEA to dispense controls - ANS Form 224 (224a for renewal)
When does a pharmacy's license expire? - ANS March 31 on even years
When does a pharmacy need to register as a distributor? - ANS 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.
3 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
, When does a pharmacy register as a manufacturer? - ANS 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? - ANS 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 - ANS 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 - ANS IV
Heroin - ANS Schedule 1
LSD - ANS 1
Mescaline - ANS 1
Marijuana (even medical) - ANS 1
Marinol - ANS 3
Methaqualone - ANS 1
Peyote - ANS 1
4 Copyright ©2025 SIRJOEL ALL RIGHTS RESERVED
