Pharmacy Law MPJE Exam: Controlled Substances Act
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1. The Controlled Substances Act (CSA) is separated into 3 titles. What is the
purpose of each title?: Title I - Rehab Programs for Drug Abusers
Title II - Registration and Distribution of Controlled Substances
Title III - Importation and Exportation of Controlled Substances
2. Why does the federal government have the authority to regulate controlled
substances?: The 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.
3. Do the states have any authority to regulate controlled substances: States may
regulate controlled substances under its police powers as long as the state law does not conflict with the federal law
4. Describe Schedule I Controlled Substances: High potential for abuse
No currently approved medical use
Lack accepted information on the safety of their use, even under medical supervision
5. Describe Schedule II Controlled Substances: High potential for abuse
Have a currently accepted medical use or accepted use with severe restrictions
Abuse may lead to SEVERE physical or psychological dependence
6. Describe Schedule III Controlled Substances: Have 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
7. Describe Schedule IV Controlled Substances: Have a low potential for abuse relative to C III
drugs
Have a currently accepted medical use
, Pharmacy Law MPJE Exam: Controlled Substances Act
Study online at https://quizlet.com/_hui5ra
When abused may lead to limited physical dependence or psychological dependence relative to C III drugs
8. Describe Schedule V Controlled Substance: Have 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
9. What schedule are benzodiazepines?: C IV
10. Schedule V Codeine may not be higher than what concentration?: 200 mg codeine
/ 100 mL
11. 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?-
: This is a joint job of the Attorney General and Secretary of the DHHS
12. If the Secretary of the DHHS makes a recommendation to the Attorney
General, does the Attorney General have to comply?: Yes
13. What manufacturer labeling does the CSA require?: The schedule must be placed on the
label
14. Per the CSA, who must register with the attorney general?: Those who manufacture,
distribute, or dispense a controlled substance, or who purpose to engage in any of these activities must register with
the attorney general
15. Per the CSA what is the definition of "dispense": To 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.
16. In the CSA who are dispensers?: Physicians
Pharmacists/Pharmacies
17. What is the definition of "distributing": To deliver a controlled substance other than by admin-
istering or dispensing.
18. What is the definition of "manufacturing": Production, preparation, propagation, compound-
ing or processing of a drug with directly or indirectly, either by extraction from the natural origin or by chemical
synthesis.
Study online at https://quizlet.com/_hui5ra
1. The Controlled Substances Act (CSA) is separated into 3 titles. What is the
purpose of each title?: Title I - Rehab Programs for Drug Abusers
Title II - Registration and Distribution of Controlled Substances
Title III - Importation and Exportation of Controlled Substances
2. Why does the federal government have the authority to regulate controlled
substances?: The 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.
3. Do the states have any authority to regulate controlled substances: States may
regulate controlled substances under its police powers as long as the state law does not conflict with the federal law
4. Describe Schedule I Controlled Substances: High potential for abuse
No currently approved medical use
Lack accepted information on the safety of their use, even under medical supervision
5. Describe Schedule II Controlled Substances: High potential for abuse
Have a currently accepted medical use or accepted use with severe restrictions
Abuse may lead to SEVERE physical or psychological dependence
6. Describe Schedule III Controlled Substances: Have 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
7. Describe Schedule IV Controlled Substances: Have a low potential for abuse relative to C III
drugs
Have a currently accepted medical use
, Pharmacy Law MPJE Exam: Controlled Substances Act
Study online at https://quizlet.com/_hui5ra
When abused may lead to limited physical dependence or psychological dependence relative to C III drugs
8. Describe Schedule V Controlled Substance: Have 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
9. What schedule are benzodiazepines?: C IV
10. Schedule V Codeine may not be higher than what concentration?: 200 mg codeine
/ 100 mL
11. 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?-
: This is a joint job of the Attorney General and Secretary of the DHHS
12. If the Secretary of the DHHS makes a recommendation to the Attorney
General, does the Attorney General have to comply?: Yes
13. What manufacturer labeling does the CSA require?: The schedule must be placed on the
label
14. Per the CSA, who must register with the attorney general?: Those who manufacture,
distribute, or dispense a controlled substance, or who purpose to engage in any of these activities must register with
the attorney general
15. Per the CSA what is the definition of "dispense": To 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.
16. In the CSA who are dispensers?: Physicians
Pharmacists/Pharmacies
17. What is the definition of "distributing": To deliver a controlled substance other than by admin-
istering or dispensing.
18. What is the definition of "manufacturing": Production, preparation, propagation, compound-
ing or processing of a drug with directly or indirectly, either by extraction from the natural origin or by chemical
synthesis.
