IL MPJE EXAM 2026 COMPREHENSIVE STUDY
GUIDE COMPLETE ANSWERS
◉ Controlled substance theft/loss form?. 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?. Answer: 1 business day
◉ Do you need to report pseudophedrine as stolen?. Answer: No, it is a
C5 under state law but not controlled under federal law
◉ Difference between detox and maintenance treatment with
methadone/LAAM. 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)?. 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?.
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?.
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....... Answer:
Misbranded
◉ Required licensing of biologics establishments, inspections of vaccine
manufacturers and premarket approval of vaccines. Answer: Virus-Toxin
law of 1902
◉ Prohibited the marketing of adulterated and misbranded food and
drugs. 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. Answer: Federal Food, Drug and cosmetic Act
of 1938
◉ Distinguishes between prescription and OTC drugs. 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!. Answer: Kefauver-Harris
Amendment of 1962 (Thalidomide)
◉ Clarified the definition of device and categorized medical devices
based on risk. Answer: Medical Device Amendments of 1976
◉ Anti-tampering regulations. 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. 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.. 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. 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. Answer: Nutrition
Labeling and Education Act (NLEA) of 1990
◉ Established labeling requirements, allowed "nutritional support
statements" describing the effect of the supplement.. 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.. Answer: Food and Drug
Modernization Act (FDAMA) of 1997
◉ Form to register with DEA to dispense controls. Answer: Form 224
(224a for renewal)
◉ When does a pharmacy's license expire?. Answer: March 31 on even
years
GUIDE COMPLETE ANSWERS
◉ Controlled substance theft/loss form?. 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?. Answer: 1 business day
◉ Do you need to report pseudophedrine as stolen?. Answer: No, it is a
C5 under state law but not controlled under federal law
◉ Difference between detox and maintenance treatment with
methadone/LAAM. 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)?. 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?.
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?.
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....... Answer:
Misbranded
◉ Required licensing of biologics establishments, inspections of vaccine
manufacturers and premarket approval of vaccines. Answer: Virus-Toxin
law of 1902
◉ Prohibited the marketing of adulterated and misbranded food and
drugs. 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. Answer: Federal Food, Drug and cosmetic Act
of 1938
◉ Distinguishes between prescription and OTC drugs. 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!. Answer: Kefauver-Harris
Amendment of 1962 (Thalidomide)
◉ Clarified the definition of device and categorized medical devices
based on risk. Answer: Medical Device Amendments of 1976
◉ Anti-tampering regulations. 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. 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.. 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. 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. Answer: Nutrition
Labeling and Education Act (NLEA) of 1990
◉ Established labeling requirements, allowed "nutritional support
statements" describing the effect of the supplement.. 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.. Answer: Food and Drug
Modernization Act (FDAMA) of 1997
◉ Form to register with DEA to dispense controls. Answer: Form 224
(224a for renewal)
◉ When does a pharmacy's license expire?. Answer: March 31 on even
years
