MPJE ILLINOIS STUDY GUIDE EXAM
AND ACTUAL ANSWERS.
Form to send to DEA for destroying controls - Answer DEA Form 41
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
When does a pharmacy need to register as a distributor? - 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? - 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? - 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 - 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 - Answer IV
Heroin - Answer Schedule 1
, LSD - Answer 1
Mescaline - Answer 1
Marijuana (even medical) - Answer 1
Marinol - Answer 3
Methaqualone - Answer 1
Peyote - Answer 1
Amphetamine - Answer 2
Cocaine - Answer 2
Codeine sulphate/phosphate - Answer 2
Fentanyl - Answer 2
Hydromorphone - Answer 2
Meperidine - Answer 2
Methylphenidate - Answer 2
Methadone - Answer 2
AND ACTUAL ANSWERS.
Form to send to DEA for destroying controls - Answer DEA Form 41
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
When does a pharmacy need to register as a distributor? - 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? - 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? - 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 - 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 - Answer IV
Heroin - Answer Schedule 1
, LSD - Answer 1
Mescaline - Answer 1
Marijuana (even medical) - Answer 1
Marinol - Answer 3
Methaqualone - Answer 1
Peyote - Answer 1
Amphetamine - Answer 2
Cocaine - Answer 2
Codeine sulphate/phosphate - Answer 2
Fentanyl - Answer 2
Hydromorphone - Answer 2
Meperidine - Answer 2
Methylphenidate - Answer 2
Methadone - Answer 2
