Pharmacy Controlled Substances Act (Correct Answers)
The Controlled Substances Act (CSA) is separated into 3 titles. What is the purpose of
each title? Correct AnswersTitle I - Rehab Programs for Drug Abusers
Title II - Registration and Distribution of Controlled Substances
Title III - Importation and Exportation of Controlled Substances
Why does the federal government have the authority to regulate controlled substances?
Correct AnswersThe federal government has the authority to regulate INTERSTATE
commerce. The states have authority to regulate INTRASTATE commerce. However,
federal regulation of the intrastate traffic of controlled substances is essential to the
effective regulation of the interstate traffic.
Do the states have any authority to regulate controlled substances Correct
AnswersStates may regulate controlled substances under its police powers as long as
the state law does not conflict with the federal law
Describe Schedule I Controlled Substances Correct AnswersHigh potential for abuse
No currently approved medical use
Lack accepted information on the safety of their use, even under medical supervision
Describe Schedule II Controlled Substances Correct AnswersHigh potential for abuse
Have a currently accepted medical use or accepted use with severe restrictions
Abuse may lead to SEVERE physical or psychological dependence
Describe Schedule III Controlled Substances Correct AnswersHave less potential for
abuse than C I and C II drugs
Have a currently accepted medical use
When abused may lead to MODERATE or LOW physical dependence or HIGH
psychological dependence
Describe Schedule IV Controlled Substances Correct AnswersHave a low potential for
abuse relative to C III drugs
Have a currently accepted medical use
When abused may lead to limited physical dependence or psychological dependence
relative to C III drugs
Describe Schedule V Controlled Substance Correct AnswersHave a low potential for
abuse relative to C IV
Have a currently accepted medical use
, When abused may lead to limited physical or psychological dependence relative to C IV
drugs
What schedule are benzodiazepines? Correct AnswersC IV
Schedule V Codeine may not be higher than what concentration? Correct Answers200
mg codeine / 100 mL
Who has the authority to place an unscheduled drug into a schedule, place a scheduled
drug into a different schedule, or remove a drug from scheduling? Correct AnswersThis
is a joint job of the Attorney General and Secretary of the DHHS
If the Secretary of the DHHS makes a recommendation to the Attorney General, does
the Attorney General have to comply? Correct AnswersYes
What manufacturer labeling does the CSA require? Correct AnswersThe schedule must
be placed on the label
Per the CSA, who must register with the attorney general? Correct AnswersThose who
manufacture, distribute, or dispense a controlled substance, or who purpose to engage
in any of these activities must register with the attorney general
Per the CSA what is the definition of "dispense" Correct AnswersTo deliver a controlled
drug to an ultimate user pursuant to the lawful order of a practitioner, including the
PRESCRIBING and ADMINISTERING of a controlled drug and the packaging, labeling
or compounding necessary to prepare the substance for such delivery.
In the CSA who are dispensers? Correct AnswersPhysicians
Pharmacists/Pharmacies
What is the definition of "distributing" Correct AnswersTo deliver a controlled substance
other than by administering or dispensing.
What is the definition of "manufacturing" Correct AnswersProduction, preparation,
propagation, compounding or processing of a drug with directly or indirectly, either by
extraction from the natural origin or by chemical synthesis.
How often do manufacturers have to register with the attorney general? Distributors?
Correct AnswersManufacturers - annually
Distributors - annually
How often do dispensers have to register with with the attorney general? Correct
AnswersDispensers - every 3 years
What must practitioners have in order to prescribe controlled substances? Correct
AnswersDEA Number
In what instance would a practitioner not need a DEA number? Correct AnswersIf they
are prescribing under an institutions DEA number. However, the practitioner must have
an ID suffix in addition to the institution DEA number.
Does a provider need a DEA number for each office he/she works at? Correct
AnswersNo, a provider may prescribe from any location with their own DEA number
A physician works for the hospital but has a clinic that he works at periodically. He
writes a prescription in the clinic and uses the hospital's DEA number with his ID suffix.
Is this legal? Correct AnswersIf the physician is prescribing out of their office suite and
not the hospital, it's not in the normal course of business and they cannot prescribe
under the hospitals DEA number.
Besides individual practitioners, who else needs a DEA number? Correct AnswersEach
principal place of business or professional practice where controlled substances are
manufactured, distributed or dispensed requires a separate registration.
The Controlled Substances Act (CSA) is separated into 3 titles. What is the purpose of
each title? Correct AnswersTitle I - Rehab Programs for Drug Abusers
Title II - Registration and Distribution of Controlled Substances
Title III - Importation and Exportation of Controlled Substances
Why does the federal government have the authority to regulate controlled substances?
Correct AnswersThe federal government has the authority to regulate INTERSTATE
commerce. The states have authority to regulate INTRASTATE commerce. However,
federal regulation of the intrastate traffic of controlled substances is essential to the
effective regulation of the interstate traffic.
Do the states have any authority to regulate controlled substances Correct
AnswersStates may regulate controlled substances under its police powers as long as
the state law does not conflict with the federal law
Describe Schedule I Controlled Substances Correct AnswersHigh potential for abuse
No currently approved medical use
Lack accepted information on the safety of their use, even under medical supervision
Describe Schedule II Controlled Substances Correct AnswersHigh potential for abuse
Have a currently accepted medical use or accepted use with severe restrictions
Abuse may lead to SEVERE physical or psychological dependence
Describe Schedule III Controlled Substances Correct AnswersHave less potential for
abuse than C I and C II drugs
Have a currently accepted medical use
When abused may lead to MODERATE or LOW physical dependence or HIGH
psychological dependence
Describe Schedule IV Controlled Substances Correct AnswersHave a low potential for
abuse relative to C III drugs
Have a currently accepted medical use
When abused may lead to limited physical dependence or psychological dependence
relative to C III drugs
Describe Schedule V Controlled Substance Correct AnswersHave a low potential for
abuse relative to C IV
Have a currently accepted medical use
, When abused may lead to limited physical or psychological dependence relative to C IV
drugs
What schedule are benzodiazepines? Correct AnswersC IV
Schedule V Codeine may not be higher than what concentration? Correct Answers200
mg codeine / 100 mL
Who has the authority to place an unscheduled drug into a schedule, place a scheduled
drug into a different schedule, or remove a drug from scheduling? Correct AnswersThis
is a joint job of the Attorney General and Secretary of the DHHS
If the Secretary of the DHHS makes a recommendation to the Attorney General, does
the Attorney General have to comply? Correct AnswersYes
What manufacturer labeling does the CSA require? Correct AnswersThe schedule must
be placed on the label
Per the CSA, who must register with the attorney general? Correct AnswersThose who
manufacture, distribute, or dispense a controlled substance, or who purpose to engage
in any of these activities must register with the attorney general
Per the CSA what is the definition of "dispense" Correct AnswersTo deliver a controlled
drug to an ultimate user pursuant to the lawful order of a practitioner, including the
PRESCRIBING and ADMINISTERING of a controlled drug and the packaging, labeling
or compounding necessary to prepare the substance for such delivery.
In the CSA who are dispensers? Correct AnswersPhysicians
Pharmacists/Pharmacies
What is the definition of "distributing" Correct AnswersTo deliver a controlled substance
other than by administering or dispensing.
What is the definition of "manufacturing" Correct AnswersProduction, preparation,
propagation, compounding or processing of a drug with directly or indirectly, either by
extraction from the natural origin or by chemical synthesis.
How often do manufacturers have to register with the attorney general? Distributors?
Correct AnswersManufacturers - annually
Distributors - annually
How often do dispensers have to register with with the attorney general? Correct
AnswersDispensers - every 3 years
What must practitioners have in order to prescribe controlled substances? Correct
AnswersDEA Number
In what instance would a practitioner not need a DEA number? Correct AnswersIf they
are prescribing under an institutions DEA number. However, the practitioner must have
an ID suffix in addition to the institution DEA number.
Does a provider need a DEA number for each office he/she works at? Correct
AnswersNo, a provider may prescribe from any location with their own DEA number
A physician works for the hospital but has a clinic that he works at periodically. He
writes a prescription in the clinic and uses the hospital's DEA number with his ID suffix.
Is this legal? Correct AnswersIf the physician is prescribing out of their office suite and
not the hospital, it's not in the normal course of business and they cannot prescribe
under the hospitals DEA number.
Besides individual practitioners, who else needs a DEA number? Correct AnswersEach
principal place of business or professional practice where controlled substances are
manufactured, distributed or dispensed requires a separate registration.
