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Tips: Pharmacy Law

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<ul style="text-align: justify;">
<li>Manufacturers of generic drugs can market their drugs at lower prices than their brand name counterparts because they don't have new drug development and research costs that the brand name companies have.</li>
</ul>
<ul style="text-align: justify;">
<li>Pharmacy technicians must maintain the privacy and confidentiality of patients' personal health information. This requires appropriate safeguards for pharmacy patient records, discarding patient information in a secure manner, and taking reasonable precautions to maintain privacy of pharmacy conversations about patients.  </li>
</ul>

Tips: Pharmacy Law

Manufacturers of generic drugs can market their drugs at lower prices than their brand name counterparts because they don't have new...

5:12 PM

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%;"><br>
<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><b> </b><br />
<b>Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research</b><br />
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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

Pharmacy Law

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<b>Ethical Principles</b><br />
Ethical Principles guide the performance of tasks and responsibilities so they fall within a moral framework.<br />
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Ethical principles include complying with laws and regulations, maintaining competency and respecting patient privacy and confidentiality.<br />
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<b>State Pharmacy Laws and Regulations</b><br />
State pharmacy laws establish the legal requirements, restrictions and prohibitions for the practice of pharmacy.<br />
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State pharmacy laws and regulations distinguish between the tasks and responsibilities that pharmacists perform and those that the technicians are permitted to perform.<br />
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<b>State Boards of Pharmacy</b><br />
State boards of pharmacy are responsible for regulating the practice of pharmacy including pharmacies, pharmacists, pharmacy interns, and pharmacy technicians.<br />
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The state board regulates:<br />
<ol>
<li>Licensing pharmacies and pharmacists</li>
<li>Registering or Licensing technicians</li>
<li>Inspecting pharmacies</li>
<li>Issuing rules and regulations</li>
<li>Investigating complaints</li>
<li>Disciplinary actions</li>
</ol>
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Information on the various state boards is available through the <a href="https://www.nabp.net/" target="_blank">National Association of Boards of Pharmacy (NABP) </a><br />
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<b>Pharmacy Licensure</b><br />
Every state requires pharmacies to have a valid current license or permit in order to operate the facility. Requirements include:<br />
<ol>
<li>Record keeping</li>
<li>Security</li>
<li>A pharmacists in charge</li>
<li>A Licensed pharmacists on duty during operational hours</li>
</ol>
The categories for pharmacy licenses include:<br />
<ol>
<li>Retail</li>
<li>Community</li>
<li>Institutional</li>
<li>Hospital</li>
<li>Nuclear</li>
<li>Mail-order</li>
<li>Long-term</li>
<li>Sterile compounding</li>
<li>nonresident</li>
</ol>
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Most states require pharmacies that are located in a other state (i.e, nonresident pharmacies) to be licensed in the state if they mail, ship, dispense, or deliver prescriptions drugs to residents of the state.<br />
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<b>Pharmacy Technicians</b><br />
The requirements for technicians vary from state to state. Common requirements include:<br />
<ol>
<li>Registration or license</li>
<li>Permitted tasks</li>
<li>Prohibited conduct</li>
<li>Qualifications for registration or license include:</li>
<li>Minimum age</li>
<li>High school diploma or equivalent</li>
<li>Completion of a training program</li>
<li>An examination </li>
</ol>
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The State Board of Pharmacy in each state is the best resource for obtaining the current requirements.<br />
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<b>Patient Counseling</b><br />
State laws and regulations set the requirements for patient counseling by pharmacists regarding their prescription medications.<br />
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The offer to council differs from patient counseling. <br />
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The offer to counsel occurs when patient is asked if he/she would like to receive information from the pharmacists.<br />
<br />
Whereas counseling is providing information to the patient.

Pharmacy Law

Ethical Principles Ethical Principles guide the performance of tasks and responsibilities so they fall within a moral framework. Ethic...

12:40 PM

DEA Schedule Drugs from the Top 200 Drug List

<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDIcuP_ZeyYybRbltMGCV6LEY4v25TD2mtfF7nAqrXasUA4KqPcbkRmCrNikoRpI2NAovLFy24xS8eppGcXFg8NxmWAbO-eLysBUQiwZyIa-xPq45k1PjQsYk9BKwLegrHRd3TJZiSSBcU/s1600/controlledSubstance.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="244" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgDIcuP_ZeyYybRbltMGCV6LEY4v25TD2mtfF7nAqrXasUA4KqPcbkRmCrNikoRpI2NAovLFy24xS8eppGcXFg8NxmWAbO-eLysBUQiwZyIa-xPq45k1PjQsYk9BKwLegrHRd3TJZiSSBcU/s1600/controlledSubstance.jpg" width="640" /></a></div><div class="separator" style="clear: both; text-align: center;"></div><table style="width: 100%;"><tr>     <th>Schedule</th>     <td><b>Brand Name</b></td>     <td><b>Generic Name</b></td>     <td><b>Function</b></td>   </tr>
<tr>     <th rowspan="9">DEA Schedule II</th>     <td>Percocet®</td>     <td>Oxycodone/APAP</td>     <td>Pain Relief</td>   </tr>
<tr>     <td>Concerta®</td>     <td>Methylphenidate</td>     <td>A.D.H.D.</td>   </tr>
<tr>     <td>OxyContin®</td>     <td>Oxycodone</td>     <td>Pain Relief</td>   </tr>
<tr>     <td>Vyvanse®</td>     <td>Lisdexamfetamine</td>     <td>A.D.H.D.</td>   </tr>
<tr>     <td>Duragesic®</td>     <td>Fentanyl</td>     <td>Narcotic Analgesic</td>   </tr>
<tr>     <td>Dolophine®</td>     <td>Methadone</td>     <td>Anti-addictive</td>   </tr>
<tr>     <td>Adderall®</td>     <td>Amphetamine / Dextroamphetamine</td>     <td>ADHD / Narcolepsy</td>   </tr>
<tr>     <td>Demerol®</td>     <td>Meperidine</td>     <td>Narcotic Analgesic</td>   </tr>
<tr>     <td>Vicodin®</td>     <td>Hydrocodone/APAP</td>     <td>Pain Relief</td>   </tr>
<tr>     <th rowspan="3">DEA Schedule III</th>     <td>Suboxone®</td>     <td>Buprenorphine</td>     <td>Opiate Addiction</td>   </tr>
<tr>     <td>Tylenol® #2,3,4</td>     <td>Codeine / APAP</td>     <td>Pain Relief</td>   </tr>
<tr>     <td>AndroGel®</td>     <td>Testosterone</td>     <td>Low T (testosterone)</td>   </tr>
<tr>     <th rowspan="9">DEA Schedule IV</th>     <td>Ambien®</td>     <td>Zolpidem</td>     <td>Insomnia</td>   </tr>
<tr>     <td>Xanax®</td>     <td>Alprazolam/td>     <td>Anti-Anxiety</td>   </td></tr>
<tr>     <td>Klonopin®</td>     <td>Clonazepam</td>     <td>Anti-Anxiety</td>   </tr>
<tr>     <td>Soma®</td>     <td>Carisoprodol</td>     <td>Muscle Relaxer</td>   </tr>
<tr>     <td>Valium®</td>     <td>Diazepam</td>     <td>Anti-Anxiety</td>   </tr>
<tr>     <td>Ativan®</td>     <td>Lorazepam</td>     <td>Anti-Anxiety</td>   </tr>
<tr>     <td>Lunesta®</td>     <td>Eszopiclone</td>     <td>Sleep Aid</td>   </tr>
<tr>     <td>Restoril®</td>     <td>Temazepam</td>     <td>Sleep Aid</td>   </tr>
<tr>     <td>Adipex®</td>     <td>Phentermine</td>     <td>Weight Loss</td>   </tr>
</table><b> </b><br />
<br />
<div class="separator" style="clear: both; text-align: center;"></div><br />
<b>The DEA Sch. Drugs listed above are from the Top 200 list, and this is just a partial list of those Schedule Drugs.  </b><span style="font-size: 16px;"><span style="font-size: 18px;"><span style="font-weight: normal;">View </span><b><span style="font-weight: normal;">full list of controlled substances can be found on the <a href="http://www.deadiversion.usdoj.gov/schedules/" target="_blank">Drug Enforcement Website</a>.</span></b></span></span><br />
<b> </b> <br />
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DEA Schedule Drugs from the Top 200 Drug List

Schedule Brand Name Generic Name Function DEA Schedule II Percocet® Oxycodone/APAP Pain Relief ...

3:37 PM

Definition of Controlled Substance Schedules

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<b>Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules.</b><br />
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Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused. <b><br />
</b><br />
<table style="width: 100%;"><tbody>
<tr>     <td><b>Schedule</b></td>     <td><b>Classification</b></td>     <td><b>Examples</b></td>   </tr>
<tr>     <td><b>Schedule I (CI)</b></td>     <td>Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.</td>     <td>Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("Ecstasy").</td>   </tr>
<tr>     <td><b>Schedule II (CII)</b></td>     <td>Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.</td>     <td>Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®).  Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.<br />
<br />
Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®).  Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.</td>   </tr>
<tr>     <td><b>Schedule III (CIII)</b></td>     <td>Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.</td>     <td>Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®).<br />
<br />
Examples of Schedule IIIN non-narcotics include: benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone. </td>   </tr>
<tr>     <td><b>Schedule IV (CIV)</b></td>     <td>Substances in this schedule have a low potential for abuse relative to substances in Schedule III.</td>     <td>Examples of Schedule IV substances include: alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).</td>   </tr>
<tr>     <td><b>Schedule V (CV)</b></td>     <td>Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.</td>     <td>Examples of Schedule V substances include: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.</td>   </tr>
</tbody></table>
<br />
<a href="http://www.deadiversion.usdoj.gov/schedules/" target="_blank">View Full List of Controlled Substances</a> <br />
<br />
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Definition of Controlled Substance Schedules

Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five sche...

2:59 PM

Key Notes: Pharmacy Law

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<ul style="text-align: justify;">
<li>If the state and federal laws or regulations differ, both laws and regulations must be followed, including the more stringent requirements, whether federal or state. </li>
</ul>
<ul style="text-align: justify;">
<li>The qualifications for pharmacy technician registration or licensure generally include minimum age, high school graduation or the equivalent, completion of training program, including pharmacy employer training programs, and an  examination. </li>
</ul>
<ul style="text-align: justify;">
<li>State pharmacy laws do not permit pharmacy  technicians to perform pharmacy tasks and responsibilities that are limited to pharmacists and require the professional judgement, education, and training of a pharmacist.</li>
</ul>
<ul style="text-align: justify;">
<li>Patient counseling must be provided by the pharmacists. Technicians are not authorized to counsel patients on their medications.</li>
</ul>
<ul style="text-align: justify;">
<li>Prescription monitoring programs require pharmacies to submit information on controlled-substance prescriptions to help states identify potential diversions and abuse. </li>
</ul>
<ul style="text-align: justify;">
<li>Pharmacists use the "<a href="http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm" target="_blank">Orange Book</a>" to find the FDA's determination that a particular manufacturer's generic drug is therapeutically equivalent to the brand name.   </li>
</ul>

Key Notes: Pharmacy Law

If the state and federal laws or regulations differ, both laws and regulations must be followed, including the more stringent requirement...

2:21 PM