Rules and Regulations of the State of Georgia
 

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  • 1. In the address bar, type about:config and press Enter.
  • 2. Click "I'll be careful, I promise" if a warning message appears.
  • 3. In the search box, search for javascript.enabled
  • 4. Toggle the "javascript.enabled" preference (right-click and select "Toggle" or double-click the preference) to change the value from "false" to "true".
  • 5. Click on the "Reload current page" button of the web browser to refresh the page.




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  1. On web browser menu click "Tools" icon and select "Internet Options".
  2. In the "Internet Options" window select the "Security" tab.
  3. On the "Security" tab click on the "Custom level..." button.
  4. When the "Security Settings - Internet Zone" dialog window opens, look for the "Scripting" section.
  5. In the "Active Scripting" item select "Enable".
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  7. In the "Internet Options" window click on the "OK" button to close it.
  8. Click on the "Refresh" button of the web browser to refresh the page.
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 Internet Explorer < 9
  1. On web browser menu click "Tools" and select "Internet Options"
  2. In the "Internet Options" window select the "Security" tab.
  3. On the "Security" tab click on the "Custom level..." button.
  4. When the "Security Settings - Internet Zone" dialog window opens, look for the "Scripting" section.
  5. In the "Active Scripting" item select "Enable".
  6. When the "Warning!" window pops out asking "Are you sure you want to change the settings for this zone?" select "Yes".
  7. In the "Internet Options" window click on the "OK" button to close it.
  8. Click on the "Refresh" button of the web browser to refresh the page.
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chrome Google Chrome

  1. On the web browser menu click on the "Customize and control Google Chrome" and select "Settings".
  2. In the "Settings" section click on the "Show advanced settings..."
  3. Under the the "Privacy" click on the "Content settings...".
  4. When the dialog window opens, look for the "JavaScript" section and select "Allow all sites to run JavaScript (recommended)".
  5. Click on the "OK" button to close it.
  6. Close the "Settings" tab.
  7. Click on the "Reload this page" button of the web browser to refresh the page.
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opera Opera

  • 1. a) Click on "Menu", hover mouse on the "Settings" then hover mouse on the "Quick preferences" and mark the "Enable Javascript" checkbox.
  • 1. b) If "Menu bar" is shown click on the "Tools", hover mouse on the "Quick preferences" and mark the "Enable Javascript" checkbox.
1. a) opera10 a 1. b) opera10 b




safari Apple Safari

  1. On the web browser menu click on the "Edit" and select "Preferences".
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  3. In the "Security" tab section "Web content" mark the "Enable JavaScript" checkbox.
  4. Click on the "Reload the current page" button of the web browser to refresh the page.
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<xmp>.</xmp> <form name="form1" method="post" action="480-50?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-50" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQIGFgJmD2QWAgIFDw8WAh4EVGV4dAUFMiArIDRkZGSFQHSxdIgAcaKiYKFTmTzXv8TwBQ==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCALP3fyoBwLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MdUlkYqIYeIhbM91OlUO/7kD2iBo=" /> <div class='popup'> <div class='cnt223'> <div style="margin-bottom:6px;"> <img alt="Rules and Regulations of the State of Georgia" src="/images/new.gif"/> </div> <div class="header"> Terms and Conditions of Agreement for Access to Rules and Regulations of the State of Georgia Website </div> <div class="scroll"> <p>(Note: certain features of this site have been disabled for the general public to prevent digital piracy. If you are an entitled government entity pursuant the Georgia Administrative Procedures Act, <a target="_new" href="http://links.casemakerlegal.com/states/GA/books/Code_of_Georgia/browse?ci=25id=gasos&amp;codesec=50-13-7&amp;title=50&amp;#50-13-7(d)">O.C.G.A.§ 50-13-7(d)</a> contact the State of Georgia's Administrative Procedures Division at 678-364-3785 to enable these features for your location.)</p> <p>To access this website, you must agree to the following: </p> <p> These terms of use are a contract between you and/or your employer (if any), and Lawriter, LLC. </p> <p> You agree that you will not copy, print, or download anything from this website for any commercial use. </p> <p> You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website.</p> <p> You agree that you will not sell, will not license, and will not otherwise make available in exchange for anything of value, anything that you download, print, or copy from this site.</p> <p> You agree that you will not copy, print, or download any portion of the regulations posted on this site exceeding a single chapter of regulations for sale, license, or other transfer to a third party, except that you may quote a reasonable portion of the regulations in the course of rendering professional advice.</p> <p> If you violate this agreement, or if you access or use this website in violation of this agreement, you agree that Lawriter will suffer damages of at least $20,000. </p> <p> THIS WEBSITE AND ITS CONTENT ARE PROVIDED "AS IS." 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If you are an entitled government entity pursuant the Georgia Administrative Procedures Act, <a target="_new" href="http://links.casemakerlegal.com/states/GA/books/Code_of_Georgia/browse?ci=25id=gasos&amp;codesec=50-13-7&amp;title=50&amp;#50-13-7(d)">O.C.G.A.§ 50-13-7(d)</a> contact the State of Georgia's Administrative Procedures Division at 678-364-3785 to enable these features for your location.)</p> <p>To access this website, you must agree to the following: </p> <p> These terms of use are a contract between you and/or your employer (if any), and Lawriter, LLC. </p> <p> You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. </p> <p> You agree that you will not sell or license anything that you download, print, or copy from this website.</p> <p> THIS WEBSITE AND ITS CONTENT ARE PROVIDED "AS IS." 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charset=UTF-16"> </HEAD> <div id="infobar"><a href="javascript:;" accesskey="r" Name="Route" title="Route" class="quickkey"><em class="mnemonic">R</em>oute </a>:<div class="searchtips" style="float:right;margin-right:10px;color: rgb(47, 79, 79);"> <a style="text-decoration:none;color: rgb(47, 79, 79);" title="search tips" name="searchtip" href="../help.aspx#searching" target="_blank"><em class="mnemonic">S</em>earch tips</a></div><ul class="breadcrumb"> <li><a href="/GAC" name="GAC" title="GAC">GA R&amp;R</a></li> <li>&raquo; <a href="/GAC/480" title="480">Department 480</a></li> <li>&raquo; Chapter 480-50</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-50 DRUG DISPOSAL AND AUTHORIZED COLLECTORS</nllchapter></h1> <h2><a href="/GAC/480-50-.01" name="480-50-.01" title="480-50-.01">Rule 480-50-.01 Definitions</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Authorized Collectors" or "Collectors" means retail pharmacies, hospitals/clinics with an on-site pharmacy, narcotic treatment programs, manufacturers, distributors, and reverse distributors which have registered with the DEA to become authorized collectors of drugs for disposal, are authorized to handle controlled substances, and are currently licensed by the Georgia Board of Pharmacy.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Authorized Employees" means employees of authorized collectors that have met the DEA employment standards and are pharmacists licensed by the Georgia Board of Pharmacy.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Collection Receptacle" means a lockable and sturdy container with a permanent outer container and a removable numbered inner-liner with a small opening that allows contents to be added but not removed and which container is securely fastened to a permanent structure in a secure area.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Drugs" means controlled substances and dangerous drugs (non-controlled substances) as those terms are defined in O.C.G.A. Title 16, Chapter 13.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Mail-back Packages" means pre-paid postage packages provided by authorized collectors at a price or at no cost to the patient or patient's family</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Mail-back Programs" means programs that utilize mail-back packages provided by authorized collectors in which the packages are mailed directly to a reverse distributor and can never be mailed back to the authorized collector.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Numbered Inner-liner" means a removable, tamper-evident, and tear-resistant liner that bears a unique identification number that is used inside a collection receptacle and which can be securely sealed for transfer to a reverse distributor for transportation to a drug destruction site.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Ultimate user" means a person who has lawfully obtained and who possesses a drug for his/her own use or for the use of a member of his/her household or for an animal owned by him/her or a member of his/her household.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.01(9)">(9)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Unique Identification Number" means a number traceable to a specific authorized collector.</td> </tr> </table> <h2><a href="/GAC/480-50-.02" name="480-50-.02" title="480-50-.02">Rule 480-50-.02 Collection Receptacles Located at Authorized Collectors</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Authorized collectors may place, utilize, and maintain collection receptacles at their DEA registered location. Receptacles can only be available to receive drugs when the collector is open for business and only when an authorized employee is present. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> An authorized collector may only begin receiving drugs for disposal at the facility after providing thirty (30) days of advance notification to the Board and the Georgia Drugs and Narcotics Agency of its qualification for and intention to serve as an authorized collector.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Collection receptacles must be lockable, sturdy, securely fixed within the collector's location. If the authorized collector is in a pharmacy, then the collection receptacle must be in the immediate vicinity of and can be observed from the prescription department areas where controlled substances are stored by registrants and where an authorized employee is present, and display a sign stating that non-controlled and controlled drugs in Schedule II, III, IV, or V can be accepted and placed in the receptacle. If the collection receptacle is in a hospital/clinic, it must be in an area monitored by employees, but shall not be in an area where emergency or urgent care is provided. If the collection receptacle is in an opioid treatment facility, it must be located in a room that does not contain other controlled substances and is securely locked with controlled access.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Each receptacle must also be capable of holding a removable, tamper-evident, and tear- resistant inner-liner bearing a unique identification number to receive the drugs. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> To dispose of the contents of a receptacle, the sealed liners may be promptly delivered or transferred to a representative for a licensed reverse distributor for destruction. No on-site disposal of any drug is permitted. Only authorized employees can remove and seal an inner-liner and maintain records required by this rule.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Authorized collectors may store inner-liners that have been sealed upon removal from a collection receptacle in a securely locked, substantially constructed cabinet or a securely locked room with controlled access for up to three business days until the liners can be transferred for destruction, and then transferred to a representative for a licensed reverse distributor for destruction.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Collectors are encouraged to schedule inner-liner removals and installations as frequently as necessary.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drugs placed in the authorized receptacle and stored in secure inner-liners can only be removed from the authorized collector location for destruction by transfer to a reverse distributor with a current permit issued by the Board and authorized by the DEA as a collector.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The date and time that the numbered inner-liners were taken from the collector and the numbers of the inner-liners must be recorded in logs: one maintained by the collector for two years and one maintained by the reverse distributor for each facility for two years.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name, Board permit/license number, address, and telephone number of the reverse distributor removing the drugs must be recorded in logs maintained by the collector and by the reverse distributor for a period of at least two years; and</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.02(3)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name and signature of the responsible person representing the reverse distributor physically removing the inner-liners must be recorded in logs maintained by the collector and by the reverse distributor for a period of at least two years. Nothing in this rule shall prevent a DEA authorized common carrier from serving as the authorized representative of the reverse distributor.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-50-.03" name="480-50-.03" title="480-50-.03">Rule 480-50-.03 Collection Receptacles Located at Long Term Care Facilities (LTCF)</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Collection receptacles in long-term care facilities ("LTCF") must be located in a secured area monitored by long-term care facility employees. Collection receptacles can only be used in facilities where a consultant pharmacist's services are required. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A LTCF may only begin receiving drugs for disposal at the facility after providing thirty (30) days of advance notification to the Board and the Georgia Drugs and Narcotics Agency of its qualification for and intention to set up a collection receptacle.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A LTCF may dispose of drugs on behalf of an ultimate user who resides, or has resided, at such LTCF by transferring those drugs into an authorized collection receptacle located at such LTCF. When using this method of destruction, the drugs must be transferred into the collection receptacle within three (3) business days after discontinuation of use by the ultimate user. This provision applied to drugs that are expired, discontinued from use, or when the patient for whom they were ordered is no longer a patient.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When the drugs are expired, discontinued from use, or the patient for whom they were ordered is no longer a patient, the drugs shall be immediately removed from the active stock and inventoried by two people who shall be licensed either as a pharmacists, a nurses, or a licensed practical nurses. The completed inventory record shall be signed and dated by these two individuals. The original inventory record shall be maintained by the facility for two years by one supervisor-level employee, and a copy shall be kept with the drugs until their final disposition. Once inventoried, these drugs must be placed in a collection receptacle at the facility containing a numbered secure Inner-liner which has been provided by an authorized collector (retail pharmacy). <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If the numbered inner-liner becomes full prior to collection by a reverse distributor, one supervisor-level employee of the LTCF (e.g., charge nurse or supervisor) and one authorized employee designated by the authorized collector or two authorized employees of the authorized collector pharmacy may change the collection receptacle inner-liner. Upon removal, sealed inner-liners may be stored at the LTCF for up to three (3) business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The drugs placed in the authorized receptacle and stored in secure inner-liner and those secured inner-liners stored by the LTCF can only be removed from the LTCF for disposal for destruction by transfer to a representative for a reverse distributor with a current permit issued by the Board and authorized by the DEA as a collector. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The date and time that the numbered inner-liners were taken from the facility and the numbers of the inner-liners recorded in logs, one maintained by the facility for two years and one maintained by the reverse distributor for each facility for two years;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name, Board permit/license number, address, and telephone number of the reverse distributor removing the drugs;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(4)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name and signature of the responsible person representing the reverse distributor physically removing the Inner-liners; and</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(4)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name and signature of the persons transferring the drugs Inner-liners to the reverse distributor.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.03(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Authorized collectors may not transfer sealed inner-liners from LTCFs to their primary registered location (i.e., the hospital/clinic or retail pharmacy location). Instead, collectors should deliver sealed inner-liners to a reverse distributor or distributor's registered location by common or contract carrier pick-up or by reverse distributor or distributor pick-up at the LTCF.</td> </tr> </table> <h2><a href="/GAC/480-50-.04" name="480-50-.04" title="480-50-.04">Rule 480-50-.04 Numbered Inner-Liner Requirements</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A numbered inner-liner shall meet the following requirements: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The inner-liner shall be waterproof, tamper-evident, and tear-resistant;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The inner-liner shall be removable and sealable immediately upon removal without emptying or touching the contents;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The contents of the inner-liner shall not be viewable from the outside when sealed;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The size of the inner-liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon, etc.); and</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The inner-liner shall bear a permanent, unique identification number that enables the inner-liner to be tracked.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Access to the inner-liner shall be restricted to authorized employees for the collector.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The inner-liner shall be sealed by two authorized employees immediately upon removal from the permanent outer container, and the sealed inner-liner shall not be opened, x-rayed, analyzed, or otherwise penetrated.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The authorized collector shall maintain a sequential log of all numbered inner-liners. The log shall indicate, at a minimum: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If the Inner-liner has been placed in a receptacle;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If the Inner-liner has been damaged and rendered not usable;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If the Inner-liner has been sealed and removed from the receptacle;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The names of the collector employees sealing and removing the inner-liner from the collector; and</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.04(4)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The date and name of the reverse distributor, and authorized representative, by which the inner-liner was removed from the collector's facility.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-50-.05" name="480-50-.05" title="480-50-.05">Rule 480-50-.05 Mail-back Programs</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.05(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pre-paid mail-back packages may be provided by authorized collectors to patients and their families for a price or at no cost to the patient.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.05(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In Georgia, mail-back packages cannot be returned or mailed back to the authorized collector, unless that collector is a licensed reverse distributor. Collectors that are pharmacies cannot receive or dispose of mail back packages. All such mail-back packages must be shipped directly to a licensed reverse distributor for disposal.</td> </tr> </table> <h2><a href="/GAC/480-50-.06" name="480-50-.06" title="480-50-.06">Rule 480-50-.06 Reverse Distributors</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any person that reverse distributes a controlled substance shall be registered with the United States Drug Enforcement Administration as a reverse distributor and actively licensed by the Georgia Board of Pharmacy as a reverse distributor.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A reverse distributor shall acquire controlled substances and non-controlled drugs from a collector in the following manner: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pick-up of sealed inner liner from a collector at the collector's licensed location or authorized receptacle collection site such as a LTCF; or</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Receive a sealed inner-liner delivered by common or contract carrier or delivered directly by a registrant or a LTCF to the reverse distributor. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(2)(b)(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Delivery to the reverse distributor by common or contract carrier may only be made to the reverse distributor at the reverse distributor's registered location. Once <I>en route</I>, such deliveries may not be re-routed to any other location or person, regardless of registration status.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(2)(b)(ii)">(ii)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All controlled substance and non-controlled drug deliveries to a reverse distributor shall be personally received by an employee of the reverse distributor at the registered location.</td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Upon acquisition of a drug by delivery or pick-up, a reverse distributor shall: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Immediately store the controlled substance, in accordance with the security controls in accordance with DEA rules at the reverse distributor's registered location or immediately transfer the drugs to the reverse distributor's registered location for secure storage, in accordance with the security controls in DEA rules, until timely destruction.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.06(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A reverse distributor shall destroy or cause the destruction of any drug received for the purpose of destruction no later than 30 calendar days after receipt.</td> </tr> </table> <h2><a href="/GAC/480-50-.07" name="480-50-.07" title="480-50-.07">Rule 480-50-.07 Inspections</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Georgia Drugs and Narcotics Agency (GDNA) shall have the authority to conduct inspections of any place, premises, or receptacle utilized by any authorized collector in relation to collection, retention, and disposal of drugs.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> GDNA shall have the authority to examine, copy, or remove all records required by this rule, and to examine, remove, or inventory all numbered inner-liners.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> It shall be the responsibility of any authorized collector to make same available for such inspection, copying, examination, or inventorying by said GDNA.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Following any such examination, inventory, or inspection of records or receptacles, GDNA shall provide to the authorized collector a copy of any written inspection report produced on which any deficiencies or violations are made along with any recommendations, if any, concerning the satisfactory storage, record-keeping, handling, and security of drugs for disposal.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Pharmacist-in-Charge of each authorized collector shall obtain a copy of the current Board permit of every reverse distributor to which inner-liners are returned. Such copies shall be made available during the GDNA's inspection.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-50-.07(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Pharmacist-in-Charge of each authorized collector shall respond in a written report addressing any discrepancies or deficiencies noted in a GDNA inspection report within two weeks after receipt of the inspection notice. The deficiencies shall be corrected within ten (10) business days.</td> </tr> </table> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-50-.01" name="480-50-.01" title="480-50-.01">Rule 480-50-.01 Definitions</a></li><li><a href="/GAC/480-50-.02" name="480-50-.02" title="480-50-.02">Rule 480-50-.02 Collection Receptacles Located at Authorized Collectors</a></li><li><a href="/GAC/480-50-.03" name="480-50-.03" title="480-50-.03">Rule 480-50-.03 Collection Receptacles Located at Long Term Care Facilities (LTCF)</a></li><li><a href="/GAC/480-50-.04" name="480-50-.04" title="480-50-.04">Rule 480-50-.04 Numbered Inner-Liner Requirements</a></li><li><a href="/GAC/480-50-.05" name="480-50-.05" title="480-50-.05">Rule 480-50-.05 Mail-back Programs</a></li><li><a href="/GAC/480-50-.06" name="480-50-.06" title="480-50-.06">Rule 480-50-.06 Reverse Distributors</a></li><li><a href="/GAC/480-50-.07" name="480-50-.07" title="480-50-.07">Rule 480-50-.07 Inspections</a></li></ul> </div> </div> <!--content ends here--> <div id="footer" class="noprint"><span class="footer">Copyright &copy; 2019 Lawriter LLC - All rights reserved.</span>| <a href="mailto:support@casemakerlegal.com?subject=Rules and Regulations of the State of Georgia">Email Us</a> | 844-838-0769 | <a href="http://livechat.casemakerlegal.com/client.php?locale=en" target="_blank" onclick="if(navigator.userAgent.toLowerCase().indexOf('opera') != -1 && window.event.preventDefault)window.event.preventDefault();this.newWindow = window.open('http://livechat.casemakerlegal.com/client.php?locale=en&url='+escape(document.location.href)+'&referrer='+escape(document.referrer), 'webim','toolbar=0,scrollbars=0,location=0,status=1,menubar=0,width=640,height=480,resizable=1');this.newWindow.focus();this.newWindow.opener=window;return false;">Live Chat</a> </div> </div> </body> </html>