QUESTIONS AND ANSWERS
Codeine cough and cold products, how old must you be to purchase in IL? - ANS 21 years old
The DEA is part of what department? - ANS Department of Justice
1970 Controlled Substances Act is also known as - ANS Title 2 of the Comprehensive Drug
Abuse Prevention and Control Act of 1970
Title 2 of the Comprehensive Drug Abuse and Prevention Control Act of 1970 (or CSA Act) did
the following: - ANS 1) Gave FDA authority to determine scheduling of controlled substances
2) Repealed earlier laws, creating new approach to prevent drug abuse
3) 1973 - created DEA, removed scheduling responsibility from FDA
4) Provided DEA with the following functions associated with CSA: Interpretation,
Implementation, Enforcement, and development of regulations
What functions was the DEA provided with from the CSA - ANS Interpretation,
Implementation, Enforcement, and development of regulations
Key concept for controlled substances - what type of distribution - ANS Closed System of
Distribution
Describe closed system of distribution for controlled substances - ANS All substances as
SCHEDULED, all those with lawful access are REGISTERED
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,Once a substance leaves the closed system of distribution, it can only re-enter the closed
system under - ANS limited circumstances
All who come in contact with a controlled substance must be - ANS registered or employed
by a registered entity (with exception of patients with a legitimate medical need for the
controlled substance)
Once a controlled substance is purchased/dispensed to a patient, can it be returned to the
pharmacy? - ANS No except under limited circumstances
Under what circumstances can a controlled medication be returned to a pharmacy by a
patient? - ANS 1) Dispensing error
2) Recall of the drug
3) Pharmacy is registered as an authorized collector of CS
*pharmacy cannot redispense CS under any of the conditions*
Who cannot register as a authorized collector of CS? - ANS Individual practitioners (ie a MD),
hospitals without a pharmacy, clinics without a pharmacy
To qualify as an authorized collector of CS, the registrant must: - ANS Be registered to handle
schedule II CS
Two methods for an authorized collector to take back CS: - ANS 1) maintaining collection
receptacles
2) administering mail-back programs
Are collection receptacles allowed at LTCFs? - ANS Yes, if maintained by
hospital/clinic/pharmacy
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, What method of destruction is necessary for CS? - ANS No particular method, as long as the
substance is rendered "non-retrievable" in compliance with all federal, state etc laws
What does making a substance "non-retrievable" mean? - ANS When it cannot be
transformed to a physical or chemical condition or state as a controlled substance or controlled
substance analogue
Besides authorized collectors of CS, who else is permitted to collect CS legally? - ANS Law
enforcement agencies
Classifications of CS registrations: - ANS manufacturer, distributor, dispenser, narcotic
treatment center, detox compounder (makes drugs for detox center)
Dispenser registration does not include prescribers of CS T/F - ANS F, dispensers include
prescribers of controlled substances, including physicians and mid-level prescribers
When registering, a registrant can voluntarily limit the registration, who else can do this? -
ANS the DEA, if it believes that continued registration with categories is inconsistent with
public interest
What is considered a narcotic? - ANS Opium and derivatives of opium, poppy derivatives
(poppy straw and concentrate of poppy straw), coca leaves except coca leaves that has had
salts of ecgonine and cocaine removed, cocaine (and derivatives), ecgonine (and derivatives),
any compound containing any quantity of the above
Who can apply for CS registration? - ANS an owner, active partner, or any corporate officer
(officer or director)
Who is a POA - ANS person authorized by the CS registrant to issue orders for Schedule I and
II CS on registrant's behalf
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