Exam Questions and CORRECT Answers
What is the Drug enforcement administration responsible for? - CORRECT ANSWER -
Enforcing federal controlled substances laws
What Illinois organizations are responsible for monitoring and enforcement of the Illinois act? -
CORRECT ANSWER - 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? -
CORRECT ANSWER - 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? - CORRECT
ANSWER - 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? - CORRECT
ANSWER - 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? - CORRECT ANSWER - 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? - CORRECT ANSWER -
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? - CORRECT ANSWER - (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? - CORRECT ANSWER - 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? -
CORRECT ANSWER - (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? - CORRECT ANSWER - 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? - CORRECT
ANSWER - Permitted to take back controlled substances
No DEA registration is required for the law enforcement agency.
,What are DEA take back programs? - CORRECT ANSWER - 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? - CORRECT ANSWER - (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? - CORRECT
ANSWER - 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 manufacturer can make with respect to their product as
long as the product was correctly identified. Did not require premarket inspections and approval.
Controlled substance registration is divided into what categories? - CORRECT
ANSWER - II narcotic
II non-narcotic
III narcotic
III non-narcotic
IV
V
What is a narcotic? - CORRECT ANSWER - (1) Opium, opiates, derivatives of opium and
opiates, etc.
(2) Poppy straw and concentrate of poppy straw.
(3) Coca leaves
, (4) Cocaine, etc.
(5) Ecgonine, etc.
(6) Any compound of the above
Who can apply for a DEA registration? - CORRECT ANSWER - An owner, active
partner, or any corporate officer. May assign power of attorney
What is an example of an owner for applying for a DEA registration? - CORRECT
ANSWER - Sole proprietor
Partnership
Corporation - Any Officer or Director of the corporation can complete the form.
The person who completes the form is referred to as the "registrant". The entity that receives the
registration is also called the "registrant".
What is a power of attorney? - CORRECT ANSWER - Provide authority to execute
federal order forms to obtain schedule II controlled substances. The POA can be assigned to
anyone - not just pharmacists, including non-pharmacist owners, technicians, pharmacy interns
(students), and even unlicensed persons. However, read exam questions carefully, because it is
always preferable (even if not legally required) that only pharmacists order controlled
substances.
However, under state law, the ordering, securing and dispensing of controlled substances is
responsibility of PIC, regardless of whether the PIC is the registrant, and regardless of whether
the PIC has POA.
How does pharmacy register for controlled substances? - CORRECT ANSWER -
Pharmacies register as a dispenser of controlled substances. One registration covers dispensing
of all C-II thru C-V substances. Employee pharmacist need not obtain separate registration.
How does hospitals register for controlled substances? - CORRECT ANSWER -
"institutional practitioners". This registration is issued to the entire hospital, allowing controlled
substances to be stored anywhere in the registered location, and to give employee practitioners,
nurses, pharmacists the authority to possess, prescribe, dispense, and administer controlled
substances.