PTCB Study Guide: DEA

Key Terms: Pharmacy Law

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<b>Controlled Substances - </b>Drugs are chemicals whose possession and use are regulated under the Federal Controlled Substances Act and by state controlled substance laws and regulations. Controlled substances are subject to stricter regulations than other prescription and non-prescription drugs.</div>
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<b>Drug Enforcement Administration (DEA)</b>: The federal agency that administers and enforces federal laws for controlled substances such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the U.S. Department of Justice.</div>
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<b>Legend Drug</b> - A drug that is required by federal law to be dispensed by prescription only. It is the old term for drugs that are now identified as “Rx Only”. </div>
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<b>Prescription Monitoring Programs (PMPs)</b>: or prescription drug monitoring programs (PDMPs) are state-run programs that store and distribute prescriptions for federally controlled substances. These serve physicians, physician assistants, nurse practitioners, dentists and other prescribers, as well as law-enforcement agencies, and support legitimate medical use of controlled substances while limiting drug abuse and diversion. </div>

Key Terms: Pharmacy Law

Controlled Substances - Drugs are chemicals whose possession and use are regulated under the Federal Controlled Substances Act and by s...

12:19 PM

Who regulates Pharmacy in the US?

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<b><br /></b>Pharmacy  is regulated by several agencies. As pharmacy Technicians' it is mandatory to generally know which agency does what to prepare for the PTCB exam.<br />
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These agencies do more than what is listed below. We're just covering the areas that involve pharmacy.  <br />
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<b>FDA</b><br />Food and Drug Administration<br />
<ul>
<li>Approve new drugs to be sold in the US</li>
<li>Process New Drug Applications (NDA)</li>
<li> Regulate package inserts</li>
<li> Regulate advertising of drugs</li>
<li> Issue recalls</li>
<li> Federal agency </li>
</ul>
<br /><b>DEA</b><br />Drug Enforcement Agency<br />
<ul>
<li>Federal Agency (U.S. Dept. of Justice)</li>
<li> Enforce the CSA (controlled substances act)</li>
<li> Track controlled substances manufactured and sold</li>
<li> Investigates all violations involving controlled substances</li>
<li> Set the DEA Sch. Definitions</li>
<li> Issue DEA Numbers</li>
</ul>
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<b>BOP</b><br />
Board of Pharmacy (Individual States)<br />
<ul>
<li>Regulate licensing of Pharmacists</li>
<li> Regulate licensing of Pharmacy Technicians</li>
<li> Set state laws / requirements</li>
<li> Outline the operating guidelines in the pharmacy</li>
<li> Investigate violations of the operating guidelines</li>
<li> Determine state regulated controlled substances*</li>
<li> State agency </li>
</ul>
* States may control drugs not controlled by DEA.<br /> <br /><b>The Joint Commission (Formerly JCAHO)</b><br />
Joint Commission on Accreditation of Healthcare Organizations<br />
<ul>
<li>Watches over Healthcare Organizations<br /> Third Party Auditors / Regulators for insurance Providers </li>
</ul>
<b>How to Remember Who Does What</b><br />
When trying to determine which agency regulates what, first ask, if the question involves a controlled substance. If id does then the DEA will likely be the answer. If the question involved a drug that is not controlled, FDA will likely be the answer. If the question sounds state specific or involves licensing, then the BOP is likely the answer. <b><br /></b><br />

Who regulates Pharmacy in the US?

Pharmacy is regulated by several agencies. As pharmacy Technicians' it is mandatory to generally know which agency does what to prepa...

6:34 PM