Pharmacy Law MPJE Exam: Controlled Substances Act The Controlled Substances Act (CSA) is separated into 3 titles. What is the purpose of each title? - ✔✔Title I - Rehab Programs for Drug Abus ers 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? - ✔✔The federal government has the authority to regulate INTERSTATE commerce. The states have authority to regulate INTRASTATE commerce. However, federal regulation of th e 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 - ✔✔States may regulate controlled substances under its police powers as l ong as the state law does not conflict with the federal law 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 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 Describe Schedule III Controlled Substance s - ✔✔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 Describe Schedule IV Controlled Substances - ✔✔Have a low pote ntial 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 - ✔✔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 What schedule are benzodiazepi nes? - ✔✔C IV Schedule V Codeine may not be higher than what concentration? - ✔✔200 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 ? - ✔✔This 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? - ✔✔Yes What manufacturer labeling does the CSA require? - ✔✔The schedule must be placed on the label
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