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What is the Drug enforcement administration responsible for? - ANSWER Enforcing federal
controlled substances laws
What Illinois organizations are responsible for monitoring and enforcement of the Illinois act? -
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? -
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? - 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? - 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? - 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? - 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? - 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? - 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? -
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? - 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? - ANSWER Permitted to
take back controlled substances
,No DEA registration is required for the law enforcement agency.
What are DEA take back programs? - 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? - 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? - 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? - ANSWER II narcotic
II non-narcotic
III narcotic
III non-narcotic
IV
V
, What is a narcotic? - 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? - 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? - 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? - 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? - 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.