PTCB Study Guide: FDA

A History of the FDA & Drug Regulation in the U.S.

<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipqUinyPsfK_8cQVcYk19JdAvB9V4NntCyJ2kGUTYoo9Iwv5-GAXvUs66xHAfCDCsnYy1oT9YgCI4ntiZFS8N80tK7tii55OQTKOfggEG-BKjJAYcX910EcysxexCdynXfK2eKZzddgb96/s1600/2000px-Food_and_Drug_Administration_logo.svg.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="274" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipqUinyPsfK_8cQVcYk19JdAvB9V4NntCyJ2kGUTYoo9Iwv5-GAXvUs66xHAfCDCsnYy1oT9YgCI4ntiZFS8N80tK7tii55OQTKOfggEG-BKjJAYcX910EcysxexCdynXfK2eKZzddgb96/s1600/2000px-Food_and_Drug_Administration_logo.svg.png" width="640" /></a></div><table style="width: 100%;"> 
<tr> <th>Year</th> <th>Act</th> <th>Purpose</th> </tr>
<tr> <td>1906</td> <td>Food and Drug Act</td> <td>Outlaws states from buying and selling food,drinks, and drugs that have been mislabeled and tainted.</td> </tr>
<tr> <td>1912</td> <td>Sherley Amendment</td> <td>Outlaws labeling drugs with fake medical claims meant to trick the buyer.</td> </tr>
<tr> <td>1930</td> <td>FDA</td> <td>Food and Drug Administration is named.</td> </tr>
<tr> <td>1938</td> <td>Federal Food, Drug, and Cosmetic (FDC) Act of 1938</td> <td>Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulations; requires safe limits for unavoidable poisonous substances; and allows for factory inspections. </td> </tr>
<tr> <td>1951</td> <td>Durha-Humphrey Amendment</td> <td>Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.</td> </tr>
<tr> <td>1962</td> <td>Kefauver-Harris Drug Amendments</td> <td>Requires manufacturers to prove that their drug are effective prior to marketing.</td> </tr>
<tr> <td>1972</td> <td>Over-the-Counter Drug Review </td> <td>Nonprescription medications must be safe, effective and appropriately labeled.</td> </tr>
<tr> <td>1982</td> <td>Tamper-Resistant Packaging Regulations</td> <td>Makes it a crime to tamper with packaged products and requires tamper-proof packaging.</td> </tr>
<tr> <td>1984</td> <td>Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)</td> <td>Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs make up for time lost while their products were going through the FDA approval process</td> </tr>
<tr> <td>1988</td> <td>Prescription Drug Marketing Act</td> <td>Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed.</td> </tr>
<tr> <td>1997</td> <td>Food and Drug Administration Modernization Act</td> <td>Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)</td> </tr>
<tr> <td>2003</td> <td>Medicare Prescription Drug Improvement and Modernization Act of 2003</td> <td>Includes Medicare Part D which increases access to medications through private insurers.</td> </tr>
</table>  
Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research 
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A History of the FDA & Drug Regulation in the U.S.

Year Act Purpose 1906 Food and Drug Act Outlaws states from buying and selling food,drinks, and drugs...

2:33 PM

Who regulates Pharmacy in the US?

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 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. 
 
These agencies do more than what is listed below. We're just covering the areas that involve pharmacy.  
 
FDA Food and Drug Administration 
<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>
 DEA Drug Enforcement Agency 
<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>
 
BOP 
Board of Pharmacy (Individual States) 
<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. The Joint Commission (Formerly JCAHO) 
Joint Commission on Accreditation of Healthcare Organizations 
<ul>
<li>Watches over Healthcare Organizations Third Party Auditors / Regulators for insurance Providers </li>
</ul>
How to Remember Who Does What 
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.

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