Illinois MPJE - Controlled Substances Act
part 2 UPDATED ACTUAL Exam
Questions and CORRECT Answers
What department is the DEA a part of - CORRECT ANSWER - department of Justice
What did Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA)
do - CORRECT ANSWER - it gave the FDA authority to determine scheduling of
controlled substances and repealed earlier laws and created a comprehensive approach to
preventing drug abuse.
When was the DEA created and what was the impact - CORRECT ANSWER - 1973 - it
removed scheduling responsibility from the FDA and provided the DEA with the following
functions associated with the controlled substances act: interpretation, implementation,
enforcement, development of regulations
what is the "closed system of distribution" - CORRECT ANSWER - the CSA and feds
have created laws and regulations intended to create a closed system of distribution such that
only substances are scheduled and persons with lawful access are registered. access to controls is
restricted through registration and scheduling
what happens if a scheduled substance leaves the closed system of distribution - CORRECT
ANSWER - it may only re-enter under limited circumstances
what is scheduling in regards to "closed system of distribution"? How many schedules are there?
- CORRECT ANSWER - substances with potential for abuse or addiction are scheduled
into 1-5 - Illinois follows this
what is registration in regards to "closed system of distribution"? How many schedules are there?
- CORRECT ANSWER - all those who come in contact with controls must be registered
(or employed by a registered entity) with the exception of the patient who has a legitimate need
for the med and gets it through a REAL prescription
,What are the exceptions for how a scheduled substances may re-enter the closed system of
distribution? - CORRECT ANSWER - CS may be returned if:
- dispensing error and the improperly dispensed drug is brought back to the pharmacy
- drug recall
- the pharmacy is registered as an authorized collector of controls by amending its existing
registration
obviously the pharmacy cannot re-dispense these
who can be authorized collectors of controls - CORRECT ANSWER - manufacturers,
distributors, reverse distributors, narcotic treatment programs, hospitals/clinics WITH an on-site
pharmacy, and retail pharmacies
what is required to qualify for registration as an authorized collector - CORRECT
ANSWER - registrant MUST be registered to handle CII CS
what are the two permissible methods for authorized collectors to take back controlled
substances? - CORRECT ANSWER - - maintaining collection receptacles
- administering mail-back programs
in addition authorized hospitals/clinics and retail pharmacies can voluntarily maintain collection
receptacles at long term care facilities
Once a CS is received by an authorized collector, how is it destroyed - CORRECT
ANSWER - a particular method is not required as long as the desired result is achieved.
CS must be rendered *"non-retrievable"* (permanently alters) in compliance with all applicable
federal, state, tribal and local laws.
This is done to allow public and private entities to develop a variety of destruction methods that
are *secure, convenient, responsible, and consistent* with prevention diversion of such
substances
,what does it mean for an authorized collector to render a CS as "non-retrievable" - CORRECT
ANSWER - the condition or state of the CS shall be rendered following a process that
*permanently* alters the CS physical or chemical condition or state through irreversible means
rendering it unavailable and unusable for all practical purposes.
it needs to be in a state that cannot be transformed to a physical or chemical condition as CS or
CS analogue.
who can take back controls besides authorized collectors? What do they require? - CORRECT
ANSWER - law enforcement agencies. no registration is required
i.e DEA take back programs
patients may also destroy substances themselves
what are the 11, yes 11, classifications for registration of CS - CORRECT ANSWER -
manufacturers, distributor, dispenser, research, instructional activities, narcotic treatment
programs, research with C-I substances, chemical analysis, importer, exporter (CI-CIV),
compoundin by mixing, preparing, packaging, or changing dosage form of CII-V narcotics for
use in maintenance or detoxiciation by another narcotic treatment program
since there is no prescriber registration, where do they fall? - CORRECT ANSWER - they
are issued dispenser registration
can registration be limited by schedule? If yes, Who can limit it? - CORRECT ANSWER -
Yes, pracitioners can have registration for only III, IV and V. they may also be limited by drug
class
the person can voluntarily limit their own registration OR the DEA may limit especially if they
believe continued registration in all categories is inconsistent with public interest
, what are the categories for application for a controlled substance registration - CORRECT
ANSWER - II narcotic, II non-narcotic, III narcotic, III non-narcotic, IV and V
are all CIIs narcotics - CORRECT ANSWER - No. narcotics are a limited subgroup of CS
what does narcotic mean under federal law (and illinois law) - CORRECT ANSWER - any
of the following whether produced directly or indirectly by extraction from substances of
vegetable origin or independently by chemical syntehsis or by a combination of both:
- opium, opiates, derivatives of either, including isomers, esters, ethers, salts, whenever the
existence of these is possible within specific chemical designation.
- poppy straw and concentrate of poppy straw
- coca leaves, except those from which cocaine, ecgonine and derivatives of ecgonine or their
salts have been removed
- cocaine, its salts, optical and geometric isomers and salts of isomers
- ecgonine, its derivatives, their salts, isomers and salts of isomers
- any compound, mixture, or prep which contains any quantity of the substances referred to in the
above
what opium or opiate derivative does not count as a narcotic - CORRECT ANSWER -
isoquinoline alkaloids of opium
who can apply for CS registration? - CORRECT ANSWER - must be an owner, active
partner, or corporate officer or someone assigned by POA to sign for orders for purchases
Who is considered the "owner"? What is the person who completes the form referred to as? -
CORRECT ANSWER - the owner is:
- the "sole proprietor" if the entity is a sole proprietorship - (Joe's Pharmacy means Joe
completes)
- partnership - any partner is the owner and can complete (Joe and Flos pharmacy. both may
complete)
part 2 UPDATED ACTUAL Exam
Questions and CORRECT Answers
What department is the DEA a part of - CORRECT ANSWER - department of Justice
What did Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA)
do - CORRECT ANSWER - it gave the FDA authority to determine scheduling of
controlled substances and repealed earlier laws and created a comprehensive approach to
preventing drug abuse.
When was the DEA created and what was the impact - CORRECT ANSWER - 1973 - it
removed scheduling responsibility from the FDA and provided the DEA with the following
functions associated with the controlled substances act: interpretation, implementation,
enforcement, development of regulations
what is the "closed system of distribution" - CORRECT ANSWER - the CSA and feds
have created laws and regulations intended to create a closed system of distribution such that
only substances are scheduled and persons with lawful access are registered. access to controls is
restricted through registration and scheduling
what happens if a scheduled substance leaves the closed system of distribution - CORRECT
ANSWER - it may only re-enter under limited circumstances
what is scheduling in regards to "closed system of distribution"? How many schedules are there?
- CORRECT ANSWER - substances with potential for abuse or addiction are scheduled
into 1-5 - Illinois follows this
what is registration in regards to "closed system of distribution"? How many schedules are there?
- CORRECT ANSWER - all those who come in contact with controls must be registered
(or employed by a registered entity) with the exception of the patient who has a legitimate need
for the med and gets it through a REAL prescription
,What are the exceptions for how a scheduled substances may re-enter the closed system of
distribution? - CORRECT ANSWER - CS may be returned if:
- dispensing error and the improperly dispensed drug is brought back to the pharmacy
- drug recall
- the pharmacy is registered as an authorized collector of controls by amending its existing
registration
obviously the pharmacy cannot re-dispense these
who can be authorized collectors of controls - CORRECT ANSWER - manufacturers,
distributors, reverse distributors, narcotic treatment programs, hospitals/clinics WITH an on-site
pharmacy, and retail pharmacies
what is required to qualify for registration as an authorized collector - CORRECT
ANSWER - registrant MUST be registered to handle CII CS
what are the two permissible methods for authorized collectors to take back controlled
substances? - CORRECT ANSWER - - maintaining collection receptacles
- administering mail-back programs
in addition authorized hospitals/clinics and retail pharmacies can voluntarily maintain collection
receptacles at long term care facilities
Once a CS is received by an authorized collector, how is it destroyed - CORRECT
ANSWER - a particular method is not required as long as the desired result is achieved.
CS must be rendered *"non-retrievable"* (permanently alters) in compliance with all applicable
federal, state, tribal and local laws.
This is done to allow public and private entities to develop a variety of destruction methods that
are *secure, convenient, responsible, and consistent* with prevention diversion of such
substances
,what does it mean for an authorized collector to render a CS as "non-retrievable" - CORRECT
ANSWER - the condition or state of the CS shall be rendered following a process that
*permanently* alters the CS physical or chemical condition or state through irreversible means
rendering it unavailable and unusable for all practical purposes.
it needs to be in a state that cannot be transformed to a physical or chemical condition as CS or
CS analogue.
who can take back controls besides authorized collectors? What do they require? - CORRECT
ANSWER - law enforcement agencies. no registration is required
i.e DEA take back programs
patients may also destroy substances themselves
what are the 11, yes 11, classifications for registration of CS - CORRECT ANSWER -
manufacturers, distributor, dispenser, research, instructional activities, narcotic treatment
programs, research with C-I substances, chemical analysis, importer, exporter (CI-CIV),
compoundin by mixing, preparing, packaging, or changing dosage form of CII-V narcotics for
use in maintenance or detoxiciation by another narcotic treatment program
since there is no prescriber registration, where do they fall? - CORRECT ANSWER - they
are issued dispenser registration
can registration be limited by schedule? If yes, Who can limit it? - CORRECT ANSWER -
Yes, pracitioners can have registration for only III, IV and V. they may also be limited by drug
class
the person can voluntarily limit their own registration OR the DEA may limit especially if they
believe continued registration in all categories is inconsistent with public interest
, what are the categories for application for a controlled substance registration - CORRECT
ANSWER - II narcotic, II non-narcotic, III narcotic, III non-narcotic, IV and V
are all CIIs narcotics - CORRECT ANSWER - No. narcotics are a limited subgroup of CS
what does narcotic mean under federal law (and illinois law) - CORRECT ANSWER - any
of the following whether produced directly or indirectly by extraction from substances of
vegetable origin or independently by chemical syntehsis or by a combination of both:
- opium, opiates, derivatives of either, including isomers, esters, ethers, salts, whenever the
existence of these is possible within specific chemical designation.
- poppy straw and concentrate of poppy straw
- coca leaves, except those from which cocaine, ecgonine and derivatives of ecgonine or their
salts have been removed
- cocaine, its salts, optical and geometric isomers and salts of isomers
- ecgonine, its derivatives, their salts, isomers and salts of isomers
- any compound, mixture, or prep which contains any quantity of the substances referred to in the
above
what opium or opiate derivative does not count as a narcotic - CORRECT ANSWER -
isoquinoline alkaloids of opium
who can apply for CS registration? - CORRECT ANSWER - must be an owner, active
partner, or corporate officer or someone assigned by POA to sign for orders for purchases
Who is considered the "owner"? What is the person who completes the form referred to as? -
CORRECT ANSWER - the owner is:
- the "sole proprietor" if the entity is a sole proprietorship - (Joe's Pharmacy means Joe
completes)
- partnership - any partner is the owner and can complete (Joe and Flos pharmacy. both may
complete)
