PTCB Study Guide: Pharmacy Law

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Guidelines for Filling Prescription Orders

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<b>Prescription Order Expiration Dates:</b> A prescription order must be dated, and have an appropriate expiration date based on the type of drug ordered. If it's not filled in time, the script expires.<br />
<br />
<b>Refills:</b> If refills are allowed by the prescriber, it will be noted on the prescription. However, there are boundaries and limitations.<br />
<br />
<b>Generic Substitutions:</b> Generic drug substitutions may not be used unless the prescriber has authorized it. Generic substitutions may only be used if the prescriber has requested or authorized them.<br />
<br />
<b>DEA Controlled Drug Prescriptions Must contain: </b><br />
<ul>
<li>Date of prescription issue </li>
<li>Patient's name and address</li>
<li>Practitioner's name, address, and phone number</li>
<li>Drug name </li>
<li>Drug strength</li>
<li>Exact quantity prescribed</li>
<li>Have a valid DEA Number</li>
<li>Complete directions for use</li>
<li>Number of refills authorized</li>
<li>Dosage form and instructions</li>
</ul>
<b>In addition Schedule II drug prescriptions:</b><br />
<ul>
<li>Must be manually signed by the practitioner. No exceptions.</li>
<li>May not be Faxed or Called in, except for a valid emergency.</li>
<li>May not have any refills.</li>
</ul>
New York State <a href="http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm" target="_blank">VALID PRESCRIPTION REQUIREMENTS</a><br />
<ul></ul>
<br />
<table style="width: 100%;"><tbody>
<tr>     <th></th>     <th colspan="2">Prescription order expiration dates</th>     <th colspan="2">Refills</th>   </tr>
<tr>     <td></td>     <td>Federal</td>     <td>State Ex. NY</td>     <td>Federal</td>     <td>State Ex. NY</td>   </tr>
<tr>     <td>DEA Sch II </td>     <td>No Expiration</td>     <td>30 days</td>     <td>NO REFILLS ALLOWED</td>     <td>NO REFILLS ALLOWED</td>   </tr>
<tr>     <td>DEA Sch III thru V</td>     <td>6 Months</td>     <td>6 Months</td>     <td>up to 5 times, but only 5 times</td>     <td>up to 5 times within 6 months</td>   </tr>
<tr>     <td>Legend Drugs</td>     <td>12 Months</td>     <td>No Expiration</td>     <td>up to 12 Months worth</td>     <td>up to 3 Months worth</td>   </tr>
</tbody></table>

Guidelines for Filling Prescription Orders

Prescription Order Expiration Dates: A prescription order must be dated, and have an appropriate expiration date based on the type of dru...

5:57 PM

Brand Name Drugs and Generic Drugs

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The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective.<br />
<br />
Before a new drug is approved, the manufacturer must submit a New Drug Application (NDA) to the FDA. The NDA includes:<br />
<ol>
<li>Info about the drug</li>
<li>Results from human clinical trials </li>
<li>Results from animal clinical trials</li>
<li>How drugs acts in the body</li>
<li>How it is manufactured, processed and packaged</li>
</ol>
Most companies market new drugs with a trade or brand name. Lipitor is an example of a brand name for a drug that is produced and distributed by the manufacturer Pfizer.<br />
<ol>
<li>The generic name for Lipitor is atrovastatin</li>
<li>Pfizer developed atrovastatin</li>
<li>Pfizer submitted a NDA to the FDA</li>
<li>FDA approved atrovastatin</li>
<li>Pfizer is granted patents for an average of 11 years.</li>
<li>Once the patent expires other drugs companies may apply for approval of generic or copies of the drug.</li>
</ol>
Generic equivalents contain the same active ingredients and have the same dosage form, strength and formulations as their brand name counterparts.<br />
<br />
Generic drug companies must submit an Abbreviated New Drug application (ANDA). Generic manufactures must meet the same standards for:<br />
<ol>
<li>Manufacturing</li>
<li>Quality</li>
<li>Labeling</li>
<li>They do not need to repeat the original research.</li>
<li>Must show bioequivalence to the brand name drug.</li>
</ol>
<b>Generic Drug Substitution</b><br />
Pharmacists are permitted to substitute the generic equivalent drug for the brand name unless the prescriber prohibits generic substitution.<br />
<br />
Generic substitution is regulated by state laws. These laws and regulations set requirements for when pharmacists may or may not substitute therapeutically equivalent  generic drugs for brand name drugs.<br />
Indications of no substitution include:<br />
<ol>
<li>“Dispense as written”</li>
<li>“DAW”</li>
<li>“no substitution”</li>
<li>“do not substitute” </li>
<li>“DNS”</li>
</ol>
Pharmacists use the “Orange Book” to find the FDA’s decision on whether or not a generic drug is therapeutically equivalent to the brand name.

Brand Name Drugs and Generic Drugs

The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective. Before a new drug...

1:09 PM

Controlled Substances

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Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, abuse, diversion, and addiction.<br />
<br />
The Federal law regulating controlled substances is the Controlled Substance Act.<br />
<br />
The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances.<br />
Pharmacies must comply with both State and Federal controlled substance laws.<br />
<br />
<b>Schedules of Controlled Substances</b><br />
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V.<br />
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A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use.<br />
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Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances.<br />
<br />
<b>Labeling Controlled Substances</b><br />
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol.<br />
<br />
<b>Dispensing Controlled Substances</b><br />
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice. <br />
<br />
The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain:<br />
<ol>
<li>The date issued</li>
<li>The patients full name & address</li>
<li>The practitioners name, address & DEA registration number</li>
<li>The drug name</li>
<li>Strength</li>
<li>Dosage form </li>
<li>Quantity prescribed</li>
<li>Direction of use</li>
<li>Number of authorized refills</li>
<li>Signature of prescriber</li>
</ol>
Federal law allows Schedule III and IV prescriptions to be refilled up to five times within six months after the issuing date.<br />
<br />
Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills.<br />
<br />
Schedule II prescriptions may not be refilled and are not transferable between pharmacies.<br />
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits).<br />
<br />
Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense.<br />
<br />
Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include: <br />
<ol>
<li>Invoices</li>
<li>Receipts of purchases</li>
<li>Inventory of records</li>
<li>Records of transfer</li>
</ol>
State Prescription Monitoring Programs, require pharmacies to report information on controlled substance prescriptions dispensed for drugs in Schedules II, III, IV and V. (varies from state to state.) The programs help states identify potential diversion and abuse. Required information includes:<br />
<ol>
<li>Patient info</li>
<li>Prescriber info</li>
<li>Pharmacy ID</li>
<li>Prescription info</li>
</ol>

Controlled Substances

Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, a...

12:04 PM

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 />
<b> </b>  <iframe height="410" src="https://quizlet.com/81180278/flashcards/embedv2" style="border: 0;" width="100%"></iframe>

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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<br />
<b>Ethical Principles</b><br />
Ethical Principles guide the performance of tasks and responsibilities so they fall within a moral framework.<br />
<br />
Ethical principles include complying with laws and regulations, maintaining competency and respecting patient privacy and confidentiality.<br />
<br />
<b>State Pharmacy Laws and Regulations</b><br />
State pharmacy laws establish the legal requirements, restrictions and prohibitions for the practice of pharmacy.<br />
<br />
State pharmacy laws and regulations distinguish between the tasks and responsibilities that pharmacists perform and those that the technicians are permitted to perform.<br />
<br />
<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 />
<br />
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>
<br />
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 />
<br />
<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>
<br />
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 />
<br />
<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>
<br />
The State Board of Pharmacy in each state is the best resource for obtaining the current requirements.<br />
<br />
<b>Patient Counseling</b><br />
State laws and regulations set the requirements for patient counseling by pharmacists regarding their prescription medications.<br />
<br />
The offer to council differs from patient counseling. <br />
<br />
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 />
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<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 />
<br />
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

Key Terms: Pharmacy Law

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<div style="text-align: justify;">
<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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<br /></div>
<div style="text-align: justify;">
<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>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<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>
<div style="text-align: justify;">
<br /></div>
<div style="text-align: justify;">
<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 />
<br />
These agencies do more than what is listed below. We're just covering the areas that involve pharmacy.  <br />
<br />
<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>
<br />
<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