SUBSTANCES ACT PART 2. EXAM 2025
QUESTIONS AND ANSWERS
What department is the DEA a part of - ANS department of Justice
What did Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA) do
- ANS 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repealed earlier laws and created a comprehensive approach to preventing drug abuse.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 - ANS 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" - ANS 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 - ANS it may
only re-enter under limited circumstances
what is scheduling in regards to "closed system of distribution"? How many schedules are
there? - ANS substances with potential for abuse or addiction are scheduled into 1-5 - Illinois
follows this
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,what is registration in regards to "closed system of distribution"? How many schedules are
there? - ANS 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? - ANS 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 - ANS 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 - ANS registrant MUST
be registered to handle CII CS
what are the two permissible methods for authorized collectors to take back controlled
substances? - ANS - 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 - ANS a particular
method is not required as long as the desired result is achieved. CS must be rendered *"non-
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,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" - ANS 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? - ANS 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 - ANS 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? - ANS they are issued dispenser
registration
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, can registration be limited by schedule? If yes, Who can limit it? - ANS 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 - ANS II
narcotic, II non-narcotic, III narcotic, III non-narcotic, IV and V
are all CIIs narcotics - ANS No. narcotics are a limited subgroup of CS
what does narcotic mean under federal law (and illinois law) - ANS 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 - ANS isoquinoline alkaloids of
opium
who can apply for CS registration? - ANS must be an owner, active partner, or corporate
officer or someone assigned by POA to sign for orders for purchases
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