MPJE ILLINOIS LATEST UPDATE
GRADED A
Form to send to DEA for destroying controls ✔✔DEA Form 41
Controlled substance theft/loss form? ✔✔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? ✔✔1 business day
Do you need to report pseudophedrine as stolen? ✔✔No, it is a C5 under state law but not
controlled under federal law
Difference between detox and maintenance treatment with methadone/LAAM ✔✔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)? ✔✔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? ✔✔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? ✔✔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…… ✔✔Misbranded
Required licensing of biologics establishments, inspections of vaccine manufacturers and
premarket approval of vaccines ✔✔Virus-Toxin law of 1902
Prohibited the marketing of adulterated and misbranded food and drugs ✔✔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 ✔✔Federal Food, Drug and cosmetic Act of 1938
Distinguishes between prescription and OTC drugs ✔✔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! ✔✔Kefauver-Harris Amendment of 1962 (Thalidomide)
Clarified the definition of device and categorized medical devices based on risk ✔✔Medical
Device Amendments of 1976
Anti-tampering regulations ✔✔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 ✔✔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.
✔✔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 ✔✔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 ✔✔Nutrition Labeling and Education Act (NLEA) of 1990
Established labeling requirements, allowed “nutritional support statements” describing the effect
of the supplement. ✔✔Dietary Supplement Health and Education Act (DSHEA) of 1994. FDA
must prove supplements are UNSAFE as opposed to manufacturers having to prove SAFE.
Illinois MPJE 2022/2023 Already Passed
Exceptions as to when a controlled substance can be returned to the pharmacy (3) ✔✔1.
Dispensing error
- Recall
- Pharmacy is an authorized collector of controlled substances
Places that can be authorized collectors (6) ✔✔1. manufacturers - Distributors
- reverse distributors
- Narcotic treatment programs
- Hospitals/clinics with an on-site pharmacy
- Retail pharmacies
Two methods for authorized collectors to take back controlled substances ✔✔1. Collection
receptacles - mail-back programs
*can also maintain collection receptacles at long-term care facilities
What is the method of destruction for controlled substances? ✔✔No specific instructions, but
must be “non-retrievable” (permanently altering the controlled substance’s physical or chemical
condition by irreversible means)
Two ways patients can dispose of controlled substances ✔✔1. Law enforcement
- DEA take back programs
What are 5 categories of entities that must register with the DEA when it comes to controlled
substance distribution, manufacturing, etc? ✔✔1. Manufacturers - Distributor
- Dispenser
- Narcotic treatment programs
- Detox compounder
What kind of DEA registration is needed for physicians or NPs/PAs in order to prescribe CS?
✔✔dispenser registration
What is a narcotic? ✔✔produced directly or indirectly by extraction from substances of
vegetable origin or via chemical synthesis or by a combination
When an entity applies for DEA registration, the registration form is signed by the “owner”, who
is: ✔✔1. The “sole proprietor” if the entity is a sole proprietorship
- Partnership: any partner is the owner, and can complete the form
- Corporation: any officer or director of the corporation can complete the form
What is a POA? ✔✔Power of attorney: allows someone other than the registrant to issue orders
for C1 or C2 substances via DEA Form 222
The POA form for DEA form 222: who must execute and sign? ✔✔Executed by the person who
signed the most recent application for DEA registration or reregistration, the person to whom the
POA is being granted and two witnesses
Who can revoke a POA? ✔✔the person who signed the most recent application for DEA
registration and two witnesses
Who can be a POA? Who is preferred to be a POA? ✔✔Can be anyone: non-pharmacist owners,
techs, interns, and unlicensed persons. BUT it is always preferable (even if not legally required)
that only pharmacists order controlled substances
Pharmacies register as a _ of controlled substances. One registration covers dispensing of all C2-C5 substances. ✔✔dispenser Pharmacies and other dispensers register with DEA Form for initial registration, and DEA
Form for renewal. Renewal is every _ years. ✔✔224; 224a; 3 Neither federal or IL law require the applicant or the person with POA to be a pharmacist. However, under state law, the ordering, securing and dispensing of CS is the responsibility of the , regardless whether they are the registrant, or has POA ✔✔PIC Hospitals register “ _“. This registration is issued to the entire hospital, allowing CS to be
stored anywhere in the registered location, and to give employee practitioners, nurses,
pharmacists the authority to possess, prescribe, dispense, and administer CS. ✔✔institutional
practitioners
T/F: pharmacies in a hospital have to have their own registration and are not allowed to use the
institutional practitioner registration. ✔✔False
Illinois MPJE Latest 2023 Already
Passed
which agencies are in charge of enforcing the Illinois controlled substance act ✔✔department of
human services
offices of alcoholism and substance abuse
Department of financial and professional regulation
are controlled substances regulated by federal or state laws ✔✔both
this law gave the FDA authority to determine schedule of controlled substances ✔✔controlled
substance act
can a controlled substance be returned to the pharmacy if the patient decides they no longer need
it ✔✔NO unless there are the following exceptions
there was a dispensing error
there was a recall of the drug
in either case the pharmacy can take the drug back but cannot redispense it
what schedule are barbituates ✔✔2
what schedule are the barbituate combinations ✔✔3
what schedule are amphetamines ✔✔2
what schedule are anabolic steroids ✔✔3
what schedule are the long acting barbituates like phenobarbital ✔✔4
this schedule has a high potential for abuse with no currently accepted medical use and lack of
accepted safety data ✔✔1
when can schedule 1 products be used ✔✔medically under an investigational protocol
this schedule has currently accepted medical use and a high abuse potential with SEVERE
psychological or physical dependence ✔✔2
narcotic analgesics are in this scedule ✔✔2
what schedule is tapentadol (nucynta) and lisdexamphetamine (vyvanse) ✔✔2
what schedule is pentazocine (talwin) ✔✔2 in illinois but 4 federally
this schedule has currently accepted medical use but may lead to moderate or low physical
dependence or high psychological dependence ✔✔3
fioricet is what schedule under illinois law ✔✔3
examples of schedule 3 ✔✔acetaminophen with codeine
anabolic steroids
apropbarbital
butalbital
ketamine
paregoric
pentobarbital rectal suppository
this is a required warning on pain products that contain acetaminophen ✔✔risk of liver toxicity
this schedule has acceptable medical use and may lead to limited physical or psychological
dependence ✔✔4
what schedule are anxiolytics and sedatives like alprazolam ✔✔4
what schedule is soma ✔✔4
limited quantities of this schedule can be purchased without a prescription ✔✔5
products containing 10 milligrams of dihydrocodeine or any of its salts per 100 milliliters or 100
grams are considered to be schedule ✔✔5
ephedrine and pseudoephedrine are which schedule ✔✔5 under Illinois law
Illinois MPJE (2022/2023) Already
Passed
What are the three exceptions where a patient can return a controlled substance to the pharmacy?
✔✔1. Dispensing error
- Recall of the drug
- Pharmacy is registered as an authorized collector of CS’s
If a patient has extra Norco at home, what are they legally allowed to do with the extras?
✔✔Permanently and irreversibly destroy of them at home OR bring to an authorized collector
Under which classification do pharmacies register with the DEA? ✔✔Dispenser
When may a pharmacy require another DEA registration? ✔✔1) Another dispensing registration:
more than one street address
2.) Distributor license – more than 5% of total CS dispenses are to another pharmacy or
practitioner OR if using the location for storage/shipment of controls to other pharmacies
3.) Manufacturer – if repackaging controls for sale
4.) Detox Compounder – compounds controls for a narcotic treatment program for purposes of
addiction treatment
Who can apply for a pharmacy’s DEA registration? ✔✔The sole proprietor, a partner (i.e. if it’s
Joe and Amy’s pharmacy, joe or amy can apply), or an officer or director of the overarching
corporation
Under federal law, who can act as a pharmacy’s power of attorney? ✔✔1 or more individuals to
issue orders for schedule I and II controls via 222 forms. DOES NOT have to be a pharmacist
but is strongly preferred!!
What DEA form is required for pharmacy to register? How often is renewal? ✔✔Form 224,
renewal every three years with form 224a
Per Illinois state law, if a technician is the pharmacy’s power of attorney, whose responsibility is
it to order controlled substances? ✔✔The PIC!
Regardless if PIC is the DEA registrant or power of attorney, it is still their responsibility to
order, secure, and dispense controls
What license(s) is/are required for an Illinois pharmacy to be able to dispense all prescription
drugs? ✔✔Pharmacy license, DEA federal registration, state controlled substance license or
registration
What is required for Illinois’ state controlled substance registration? When does the license
expire? ✔✔Proof of federal registration and payment of registration fee. Expires on the date
certificate holder’s pharmacy license expires.
Which providers are midlevel providers and would therefore have a DEA license # that starts
with an M? (6) ✔✔NPs, PAs, optometrists, pharmacists, chiropractors, psychologists
What is the way to determine if a DEA # is valid? ✔✔1 + 3 + 5
(2 + 4 + 6) *2
Add together, and last number should equal last number in DEA #
Methamphetamine precursors (ephedrine and psuedoephedrine) are schedule federally
and schedule in IL ✔✔unscheduled federally; schedule 5 in IL
Exempt narcotics are schedule and do not require a Rx in IL for up to _ oz at once.
✔✔V; 4
IL MPJE Questions and Answers 100%
Pass
When can a controlled substance be returned to a pharmacy? (3) ✔✔1. Dispensing error
- Drug recall
- Authorized collector
Who can be authorized collectors of controlled substances? (6) ✔✔1. Manufacturers - Distributors
- Reverse distributors
- Narcotic treatment programs
- Hospitals/clinics with on-site pharmacy
- Retail pharmacies
What are the 2 ways for an authorized collector to take back controlled substances? ✔✔1.
Maintaining collection receptacles - Mail-back programs
What are the functions of the DEA associated with the Controlled Substance Act? (4) ✔✔-
interpretation
- implementation
- enforcement
- development of regulations
T/F: Law enforcement agencies are permitted to take back controlled substances without DEA
registration ✔✔True
What is the method of destruction for controlled substances? ✔✔No specific instructions, but
must be “non-retrievable” (permanently altering the controlled substance’s physical or chemical
condition by irreversible means)
T/F: Patients are required to bring controlled substances to an authorized collector and aren’t
permitted to destroy substances themselves ✔✔False – aren’t required and are permitted to
destroy substances themselves
What are 5 categories must register with the DEA when it comes to controlled substance? ✔✔1.
Manufacturer
- Distributor
- Dispenser
- Narcotic treatment programs
- Detox compounder
What type of registration do physicians and mid-level practitioners obtain in order to prescribe
controlled sustances? ✔✔Dispenser
What is a narcotic? (6) ✔✔Any of the following whether produced directly or indirectly: - Opium, opiates and its derivatives
- Poppy straw
- Coca leaves
- Cocaine
- Ecgonine
- Any compound/mixture/preparation which contains any of 1-5
When an entity applies for DEA registration, the registration form is signed by the “owner”, who
is: (3) ✔✔1. “Sole proprietor” if the entity is a sole proprietorship
- Partnership: any partner is the owner, and can complete the form
- Corporation: any officer or director of the corporation can complete the form
What is a power of attorney? ✔✔Method of delegating responsibility to another person to issue
orders for and obtain schedule I and II controlled substances
Who must the POA for the DEA Form 222 be executed and signed by? ✔✔- the registrant
- person who POA is granted to
- 2 witnesses
If revoking the POA for DEA Form 222, who must revoke the notice of revocation? ✔✔- person
who signed the most recent DEA registration - 2 witnesses
Who can be a POA? Who is preferred to be a POA? ✔✔Can be anyone: non-pharmacist owners,
techs, interns, and unlicensed persons. BUT it is always preferable (even if not legally required)
that only pharmacists order controlled substances
MPJE Illinois Questions and Answers
Rated A
Agency responsible for monitoring and enforcing the Illinois Act ✔✔Department of Human
Services
Office of Alcoholism and Substance Abuse
Department of Financial and Professional Regulation
The DEA is part of which organization? ✔✔DOJ
What is another name for the Comprehensive Drug Abuse Prevention and Control Act of 1970?
✔✔Controlled Substance Act
What did the Controlled Substance Act do? ✔✔Gave FDA authority to determine scheduling of
controlled substances
Repealed earlier laws
What happened in 1973 federally? ✔✔DEA created as part of DOJ
removed scheduling responsibility from FDA to DEA
DEA allowed for interpretation of the act, implementation, enforcement, and development of
regulations
Controlled substances use a __ system of distribution. What does this mean? ✔✔closed
access is restricted through registration and scheduling
Who must be registered? ✔✔All who come in contact with the controlled substance must be
registered (or employed by registered entity)
exception: patients with valid rx
What happens once a substance leaves the closed system? What are the exceptions? ✔✔It cannot
re-enter
Exceptions:
- dispensing error and CS is brought back to pharmacy
- recall of a drug
During exceptions the CS can be taken back, but not re dispensed
Recently, several entities including retail pharmacies have been allowed to collect controlled
substances from legitimate users. This is _. How is it done? ✔✔Voluntary
using collection receptacles or administering mail-back programs
How can authorized hospitals/clinics and retail pharmacies maintain collection receptacles AT
LONG-TERM CARE FACILITIES? ✔✔1. must be registered for C2 substances - Must apply to DEA to modify registration and obtain authorization to become a collector.
A collector shall not require any person to provide __ ✔✔personally identifying
information
What are the standards for destroying CS by collectors? ✔✔No specifics. Just “non-retrievable”
How many DEA classifications are there for registrants? ✔✔11
DEA classification 1 ✔✔manufacturer
DEA classification 2 ✔✔distributor
DEA classification 3 ✔✔dispenser (C2-5)
DEA classification 4 ✔✔Research; other than narcotic treatment programs (C2-5)
DEA classification 5 ✔✔Instructional activities (C2-C5)
DEA classification 6 ✔✔narcotic treatment programs (C2-C5)
DEA classification 7 ✔✔research with C1 substances
DEA classification 8 ✔✔chemical analysis
Illinois MPJE Questions and Answers
Rated A+
Length of record keeping for purchase records/invoices (controls and non-controls)- IL ✔✔5
years in total, at least one year on site
DEA 222 Forms- IL how long to keep ✔✔IL sees them as invoices, so 5 years
DEA form 106- IL how long to keep ✔✔two years
IL annual inventory of controlled substances: record keeping ✔✔5 years in total, at least 1 year
onsite
Record keeping of disposal of controlled substances-IL ✔✔two years, retain form 41 DEA
Record keeping under federal Law ✔✔2 years
What changes can a pharmacist NEVER permitted to change on Rx ✔✔1. Patients identity
- drug prescribed (other than generic substitution)
- the date on the prescription or add a date (IL specific, federal is silent on this)
- identity of the prescriber or the prescribers signature
Can controlled substances be electronically prescribed by a practitioner? ✔✔yes, as long as
system complies with federal DEA regulations, and Rx is valid under federal law
How does one report theft/loss of CS ✔✔notify DEA within one business day, and do a thorough
investigation/Federal law requires you to fill out a 106 form submit to DEA, IL gets a copy to
submit to DPR. no deadline for completing investigation
Can a pharmacist refill a Rx after prescriber dies, retires, or relocates ✔✔inform patient to get a
new practitioner ASAP, the pharmacist may provide a sufficient amount of maintenance
medications until the patient can get a new practitioner (using professional judgment)
What to do in professional judgment questions on MPJE ✔✔look for answer that allows you to
provide adequate patient care, while being mindful of the need for th patient to follow up with
physician ASAP, answers that set arbitrary deadlines (fill for no more than 30 days) are not
correct.
Good: refill the first time, and counsel the patient it is important to find a new physician
which of the following is not needed in a pharmacy that makes a parenteral product. good
lighting, biological safety cabinet, laminar bench, running water. ✔✔Biological safety cabinet is
not needed.
what should a licensed pharmacy preparing sterile parenteral product have ✔✔1. laminar air flaw
- sink with hot/cold water
- refrigerator with a thermometer or freezer
- temperature controlled container for off site deivereies
- environmental protection agency approved disposal containers for used needles, syringes,
cytotoxic waste for chemo
how often must a laminar air flow hood be certified ✔✔yearly
who can counsel patients ✔✔pharmacist or student pharmacist under the direct supervision of
the pharmacist.
who can make offer to counsel ✔✔RPH, Student RPH, r pharmacy technician.
can cashiers and other unlicensed personnel working in the pharmacy make the offer to counsel
✔✔NO
Can a doctor write prescriptions (controlled) for himself ✔✔NO. Self prescribing or self
dispensing of CS is NO LONGER permitted
can a doctor write prescriptions (Controlled) for family member ✔✔NO. not to an immediate
family member unless there is a bona fide practitioner-patient relationship and appropriate
records are maintained
Which is not a CS (hydrocodone, empirin, fiorinal, or empirin with codeine ✔✔Empirin
Pt brings in a prozac Rx for qty #30, and 3 refills. patient has a history of suicidal behaviors
wants a qty of 90 and the insurance will pay for it.
- fill for 90
- fill for 30
- call insurance company
- call MD and ask if its ok before dispensing 90 ✔✔Call MD and ask
IL MPJE Rickert Questions and Answers
100% Pass
What is the Drug enforcement administration responsible for? ✔✔Enforcing federal controlled
substances laws
What Illinois organizations are responsible for monitoring and enforcement of the Illinois act?
✔✔The Department of Human Services, Office of Alcoholism and Substance Abuse, and the
Department of Financial and Professional Regulation
What does the Comprehensive Drug Abuse Prevention and Control act of 1970 entail? ✔✔Gave
FDA authority to determine the scheduling of controlled substances
Removed Scheduling responsibility from the FDA
Provided the DEA with the following functions associated with CSA: Interpretation:
Implementation; Enforcement; Development of regulations
What year was the Virus-Toxin Law enacted and what was the effect? ✔✔Enacted in 1902,
AKA Biologics Control Act. Required licensing of biologics establishments, inspections of
vaccine manufacturers, and premarket approval of vaccines and other products
What does it mean when controlled substances is a closed system of distribution? ✔✔Only the
substances themselves are scheduled, and all persons with lawful access are registered. Access to
controlled substances are restricted through REGISTRATION and SCHEDULING. Once a
scheduled substance leaves the closed system of distribution, and can only re-enter the closed
system under limited circumstances.
What are scheduled drugs? ✔✔Substances that have the potential for abuse, or can cause
addiction
Scheduled into one of 5 schedules
Illinois law follows federal law, and has 5 schedules that correspond to the federal schedules.
What does registration of closed system of distribution mean? ✔✔All who come in contact with
controlled substances must be registered (or in some cases employed by a registered entity) with
the exception of the patient that has a legitimate medical need for the medication, and accesses it
through a valid prescription.
What are the exceptions to the closed network? ✔✔(1) There has been dispensing error, and the
improperly dispensed CS is brought back to the pharmacy;
(2) There has been a recall of the drug; or
(3) The pharmacy to register as an authorized collector of controlled substances by amending its
existing registration to add this additional category.
What is an authorized collector? ✔✔Only manufacturers, distributors, reverse distributors,
narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies
are permitted to be an authorized collector. Physicians and other practitioners, hospitals without
a pharmacy, and clinics without a pharmacy cannot be an authorized collector of controlled
substances
What are the two ways for an authorized collector to take back controlled substances? ✔✔(1)
maintaining collection receptacles
(2) administering mail-back programs. In addition, the regulations allow authorized
hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term
care facilities.
What is non-retrievable mean? ✔✔Process that permanently alters that controlled substance’s
physical or chemical condition or state through irreversible means and thereby renders the
controlled substance unavailable and unusable for all practical purposes
What are the regulations of collection by law enforcement agencies? ✔✔Permitted to take back
controlled substances
No DEA registration is required for the law enforcement agency.
What are DEA take back programs? ✔✔From time to time throughout the year, DEA sponsors
“National Prescription Take Back Days”. It partners with local law enforcement to encourage
patients to bring unused controlled substances to law enforcement for proper disposal.
Who must be registered with federal DEA? ✔✔(1) manufacturer
(2) distributor
(3) dispenser (C-II thru C-V)
(4) narcotic treatment program
(5) detox compounder
There are the types of registrations a pharmacy may be required to obtain, depending on its
activities.
What year was the Food and Drug Act enacted and what was the effect? ✔✔Enacted in 1906.
Prohibited the marketing of adulterated (meaning, contaminated) and misbranded food and
drugs. Products were subject to seizure by the government. Did not limit the claims a