IL MPJE Rickert Study Guide Exam
Questions 100% Well Answered.
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.
How does hospitals register for controlled substances? - 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.
When do you need multiple registrations for controlled substances? - Answer (1) Location: A
registration is required for each site with different street address
Example: A chain pharmacy may have thousands of pharmacies, all owned by the same corporation.
Each pharmacy location has its own DEA number, even though all locations share the same owner.
(2) Activity: For each activity, even if all activity is occurring at a single site.
• Example: single pharmacy could be required to have multiple DEA numbers, depending on its activities
(i.e., it needs a dispenser's registration to dispense, but would need a separate detox compounder
registration if it compounded and provided product to a narcotic treatment program.
What are two activities that trigger multiple registrations? - Answer Pharmacy as a distributor or
manufacturer
Pharmacy as a detox compounder
