Reading 8 Flashcards
Covers scheduling factors, manufacturer labeling of controlled substances, and the DEA's role.
What is the Controlled Substances Act (CSA) more formally known as?
Comprehensive Drug Abuse Control and Prevention Act of 1970
Why was the Controlled Substances Act enacted?
It was meant to create more control around drugs that had the potential for abuse
What act was used to control the sale and distribution of narcotics prior to the creation of the CSA?
Harrison Anti-Narcotic Act of 1914
How did the Harrison Anti-Narcotic Act of 1914 control the sale and distribution of narcotics?
through taxation
How is the CSA used to control the distribution of controlled substances?
through registration and a closed system
Define “controlled substance”.
a drug with dependence liability or abuse potential
List the 8 factors that are used to determine whether a drug/substance should be added to or removed from one of the five controlled substance schedules.
- its actual/relative potential for abuse
- scientific evidence of its pharmacologic effect (if known)
- the state of current knowledge regarding the drug or other substance
- its history and current pattern of abuse
- the scope, duration, and significance of abuse
- what (if any) risk there is to public health
- its psychic or physiological dependence liability
- whether the substance is an immediate precursor of a substance already controlled
Which controlled substance schedules can be used medically?
II-V
What controlled substance schedules are considered to have “high” abuse potential?
I and II
True or false: the psychological and physical dependencies of C-I drugs are not defined.
true
Which schedule(s) of controlled substances have limited psychological and physical dependency?
IV and V
Which controlled substance schedules can be dispensed from a pharmacy for patient use?
II-V
“schedule I drugs cannot be manufactured, prescribed, or dispensed, except as approved by the DEA for investigation purposes”
The federal government determines the __________ schedule for a substance, and states may place them in a ____________ schedule.
minimum; higher
What is the one exception in which states are not necessarily placing a drug in a higher schedule?
marijuana
Where must the controlled substance symbol be located on a drug’s packaging?
on the label of the commercial container
How large must the controlled substance symbol on a commercial container be?
large enough to easily identify the product’s schedule while on a pharmacy or warehouse shelf
The Controlled Substances Act created a _______ system of distribution for certain substances.
closed
There are _____ schedules of controlled substances, and ______ factors are considered when placing substances in schedules.
five; eight
The federal government determines the ________ schedule of a product.
minimum
The ______ administers all areas of the CSA.
DEA
What must occur in order for a controlled substance (II-V) to be dispensed without a prescription?
- dispensed only by a pharmacist
- not more than 8 ounces of any such controlled substance containing opium, nor more than 4 ounces of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period
- purchaser is 18+
- pharmacist requires every purchaser not known to him to furnish suitable identification
- bound record book for dispensing, maintained by the pharmacist, with the name and address of the purchaser, name and quantity of the substance, date of each purchase, and name/initials of the dispensing pharmacist
- presc
