Rules and Regulations of the State of Georgia
 

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  • 1. In the address bar, type about:config and press Enter.
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  • 3. In the search box, search for javascript.enabled
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  1. On web browser menu click "Tools" and select "Internet Options"
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  • 1. a) Click on "Menu", hover mouse on the "Settings" then hover mouse on the "Quick preferences" and mark the "Enable Javascript" checkbox.
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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 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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No person shall obtain or attempt to obtain, sell, dispense or otherwise dispose of any non-pseudoephedrine substance included in Schedule V of the Georgia Controlled Substances Act, except as herein provided, and as in compliance with all other applicable laws, rules and regulations. All terms used in this section shall have the same meaning as in O.C.G.A. T. 16, Ch. 14 and T. 26, Ch. 4, as amended.</P> <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="480-19-.01(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A physician or medical practitioner may dispense Schedule V substances for legitimate medical purposes in the normal course of his/her professional practice.</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="480-19-.01(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A licensed pharmacist, or intern acting under the immediate and direct supervision of a licensed pharmacist, may sell, dispense or otherwise dispose of without prescription not more than 4 oz. or 32 dosage units of an exempted non-pseudoephedrine Schedule V controlled substance within any 48 hour period of time, but only: <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="480-19-.01(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> After applying reasonable means or effort to determine that such is to be used for legitimate medical purpos<B>e</B>s; 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="480-19-.01(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> After the purchaser has written his/her signature, date of birth, address, city, state and zip code upon a register which records and reflects the date of such transaction, the name, kind, quantity and intended use of such Schedule V substance sold, dispensed, or otherwise disposed of, and such records shall be maintained as required by Schedule V records.</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="480-19-.01(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No person shall obtain or attempt to obtain, in any 48-hour period of time, more than 4 oz. or 32 dosage units of a Schedule V controlled substance.</td> </tr> </table> <h2><a href="/GAC/480-19-.02" name="480-19-.02" title="480-19-.02">Rule 480-19-.02 Exempt Non-Pseudoephedrine Schedule V Controlled Substances</a></h2> <P>Before the sale of any non-pseudoephedrine Schedule V Controlled Substance without a prescription, a licensed pharmacist should first determine whether or not the product to be sold is packaged in a container with not more than 4 ounces or 32 dosage units of the drug, and whether the label provided by the product manufacturer contains a Federal Caution or Warning. If such Legend or Warning or Rx Only indication is present on the manufacturer's label, this product cannot be sold without a prescription.</P> <h2><a href="/GAC/480-19-.03" name="480-19-.03" title="480-19-.03">Rule 480-19-.03 Over-thecounter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine</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="480-19-.03(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No person shall obtain or attempt to obtain, sell, dispense or otherwise distribute any exempt Schedule V controlled substance drug product containing pseudoephedrine as listed under O.C.G.A. 16-13-29(5), except as herein provided, and as in compliance with all other applicable state or federal laws, rules and regulations. All terms used in this section shall have the same meaning as in O.C.G.A. T.16, Ch. 13 and T. 26, Ch. 4. <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="480-19-.03(a)1)">1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All exempt Schedule V controlled substance pseudoephedrine containing drug products must be stored in a pharmacy's prescription department.</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="480-19-.03(a)2)">2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All pharmacy personnel who engage in the sale or distribution of exempt Schedule V controlled substance containing drug products must complete the DEA's self-certification training as required by the Combat Methamphetamine Epidemic Act of 2005, <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=830&amp;title=21#" target="_newtab">21 U.S.C. 830</a>.</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="480-19-.03(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may sell, dispense or otherwise dispose of without prescription not more than 3.6 grams every 24 hours, or a maximum of 9 grams every 30 days, to each customer of a pseudoephedrine containing drug product, but only: <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="480-19-.03(b)1)">1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> After applying reasonable means or effort to determine that such is to be used for legitimate medical purposes, following the proper record keeping procedures, and ensuring the required information has been properly recorded in a logbook which contains either a written or electronic list of sales.</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="480-19-.03(b)2)">2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For hand-written logbooks used to record patient information before the sale of an exempt Schedule V pseudoephedrine containing drug product can take place: <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="480-19-.03(b)2)(A)">(A)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must approve all such sales or transactions. Approval means verifying the patient's identification and ensuring the patient has a valid reason for obtaining the pseudoephedrine. After approval, the registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may direct designated pharmacy personnel, to complete any sales transactions to a patient by writing in the logbook at a minimum the name of the pseudoephedrine containing drug product, strength, and quantity sold along with the name of the patient, their date of birth, address, zip code, data and time of sale; The pharmacy may require additional patient information for the logbook as long as the required information is obtained.</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="480-19-.03(b)2)(B)">(B)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The patient must sign the logbook to acknowledge the sale and receipt of the pseudoephedrine containing drug product.</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="480-19-.03(b)2)(C)">(C)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may personally, or may direct designated pharmacy to, ask the patient to produce a photo identification issued by a state or the federal government to use in verifying that the patient's name on the photo identification matches the name the patient wrote in the logbook; No exempt Schedule V pseudoephedrine containing drug product can be sold to a patient unless they present appropriate identification</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="480-19-.03(b)2)(D)">(D)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist must or may direct designated pharmacy personnel to verify that the date and time of the sale and other information that has been entered in the logbook is correct by use of the patient's photo identification, and initial the logbook verifying the information for the sale as being correct.</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="480-19-.03(b)3)">3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For electronic logbooks used to record patient information for the sale of an exempt Schedule V pseudoephedrine containing drug product: <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="480-19-.03(b)3)(A)">(A)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist, must approve all such sales or transactions. Approval means verifying the patient's identification and ensuring the patient has a valid reason for obtaining the pseudoephedrine. After approval, the registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may direct designated pharmacy personnel, to complete any sales transactions to a patient by entering, at a minimum, the name of the pseudoephedrine containing drug product, strength, and quantity sold; the patient's name, date of birth, address, and zip code, or entering this information may be accomplished through a point of sales system and bar code reader. The pharmacy may require additional patient information for the logbook as long as the required information is obtained.</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="480-19-.03(b)3)(B)">(B)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The computer for the electronic logbook can automatically enter the date and time of the sale,</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="480-19-.03(b)3)(C)">(C)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The patient's signature on the logbook must be captured using an electronic signature system of a type similar to or one used for credit card purchases</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="480-19-.03(b)3)(D)">(D)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist may personally, or may direct designated pharmacy personnel to, must ask the patient to produce a photo identification issued by a state or the federal government to use in verifying that the patient's name on the photo identification matches the name the patient wrote in the logbook; No exempt Schedule V pseudoephedrine containing drug product can be sold to a patient unless they present appropriate photo identification</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="480-19-.03(b)3)(E)">(E)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist must, or may direct designated pharmacy personnel to, enter their name or pharmacist, pharmacy intern license number, or pharmacy personnel's identification in the logbook to indicate the information for the sale is correct. </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="480-19-.03(b)(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The quantities of different strength pseudoephedrine containing drug products that equals 3.6 grams is: <P><B>Tablets/capsules - Number of tablets/capsules that equal 3.6 grams</B></P> <P> <TABLE border="1"> <TR> <TD rowspan="1" colspan="1"><B>Ingredients</B></TD> <TD rowspan="1" colspan="1"><B>Number of tablets = 3.6 grams</B></TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>146 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>60 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>73 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>120 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>36 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>155 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>60 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>77 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>120 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>38 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>240 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>19 Tablets</P> </TD> </TR> </TABLE> </P> <P><B>Liquids -Number of milliliters that equal 3.6 grams</B></P> <P> <TABLE border="1"> <TR> <TD rowspan="1" colspan="1"> <P align="center"><B>Ingredients</B></P> </TD> <TD rowspan="1" colspan="1"> <P align="center"><B>Number of milliliters (ml) = 3.6 grams</B></P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>6.25 mg Ephedrine HCl/ 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>3515 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 1.6 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>468 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>7.5 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>2929 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>1464 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 2.5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>732 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>732 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl / 2.5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>366 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>60 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>366 ml</P> </TD> </TR> </TABLE> </P> </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="480-19-.03(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist can knowingly sell more than 9 grams of pseudoephedrine to a patient in a 30 day period of time. <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="480-19-.03(c)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The quantities of different strength pseudoephedrine containing drug products that equals 9 grams is: <P><B>Tablets/capsules - Number of tablets/capsules that equal 9 grams</B></P> <P> <TABLE border="1"> <TR> <TD rowspan="1" colspan="1"> <P align="center"><B>Ingredients</B></P> </TD> <TD rowspan="1" colspan="1"> <P align="center"><B>Number of tablets = 9 grams</B></P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>366 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P> 60 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>183 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>120 mg Pseudoephedrine HCl</P> </TD> <TD rowspan="1" colspan="1"> <P>91 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>389 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>60 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>194Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>120 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>97 Tablets</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>240 mg Pseudoephedrine Sulfate</P> </TD> <TD rowspan="1" colspan="1"> <P>48 Tablets</P> </TD> </TR> </TABLE> </P> <P><B>Liquids -Number of milliliters in 9 grams</B></P> <P> <TABLE border="1"> <TR> <TD rowspan="1" colspan="1"> <P align="center"><B>Ingredients</B></P> </TD> <TD rowspan="1" colspan="1"> <P align="center"><B>Number of milliliters (ml) = 9 grams</B></P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>6.25 mg Ephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>8788 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 1.6 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>1171 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>7.5 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>7323 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>3661 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>15 mg Pseudoephedrine HCl / 2.5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>1830 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>1830 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>30 mg Pseudoephedrine HCl / 2.5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>915 ml</P> </TD> </TR> <TR> <TD rowspan="1" colspan="1"> <P>60 mg Pseudoephedrine HCl / 5 ml Liquid</P> </TD> <TD rowspan="1" colspan="1"> <P>915 ml</P> </TD> </TR> </TABLE> </P> </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="480-19-.03(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All logbooks must be retained for a minimum period of 2 years from the date of the last recorded sale.</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="480-19-.03(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Logbooks must be kept in a secure location in the pharmacy and information contained in a logbook can be shared: <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="480-19-.03(e)(A)">(A)</a></td> <td valign="top" style="text-align:left" class="leftalign"> To comply with state or federal laws and rules;</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="480-19-.03(e)(B)">(B)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For a product recall</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="480-19-.03(e)(C)">(C)</a></td> <td valign="top" style="text-align:left" class="leftalign"> With local, state, and federal law enforcement officers, to allow logbook information to be inspected, copied.</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="480-19-.03(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in this rule would prohibit pharmacies, or 3rd party information technology company acting on behalf of a pharmacy, to report or transmit sales data for exempt Schedule V controlled substance drug products containing pseudoephedrine to the state operated central registry, also known as the Georgia Methamphetamine Information System (GMIS). Without approval from GDNA, such data cannot be reported to any other central record keeping system. These sales may be reported to the registry either electronically, by means of transmitting a faxed copy of a handwritten logbook, or by sending copies of handwritten logbooks to the GDNA designated collection location for the registry via the U.S. mail or other similar means.</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="480-19-.03(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in this rule requires a pharmacy to maintain a logbook that is separate and apart from the logbook required under the U.S. Combat Methamphetamine Epidemic Act of 2005, <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=830&amp;title=21#" target="_newtab">21 U.S.C 830</a> and <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=844&amp;title=21#" target="_newtab">844</a>, other than drug products containing pseudoephedrine must be stored in the prescription department area of a pharmacy and the sales are made by a registered pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist.</td> </tr> </table> <h2><a href="/GAC/480-19-.04" name="480-19-.04" title="480-19-.04">Rule 480-19-.04 Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine</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="480-19-.04(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A record created this rule must be maintained in the pharmacy at which the transaction occurred, except that records may be kept either at a single, central location for the pharmacy or by a third party information technology company on behalf of the pharmacy only if the pharmacy has notified the GDNA of its intention to do so and received GDNA approval. <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="480-19-.04(a)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Written notification must be submitted by registered or certified mail, return receipt requested, to the Director, Georgia Drugs and Narcotics Agency, 40 Pryor Street, SW, Suite 2000, Atlanta, Georgia 30303.</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="480-19-.04(a)(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> This notification must include telephone and address contact information as well as a telephone number and email address for a point of contact person who is responsible for providing requested record for either the pharmacy's central record keeping location or any third party information technology company.</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="480-19-.04(a)(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Director of the Georgia Drugs and Narcotics Agency shall issue written approval of any central record keeping location or third party information technology company prior to records being maintained in such a manner.</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="480-19-.04(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The records required to be kept under this rule must be readily retrievable and available for inspection and copying by GDNA or other law enforcement officers as requested as provided for under the provisions of <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=880&amp;title=21#" target="_newtab">21 U.S.C. 880</a>, and the U.S. Combat Methamphetamine Epidemic Act of 2005. <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="480-19-.04(b)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A record developed and maintained to comply with federal law may be used to meet the requirements of this rule if the record includes the information specified 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="480-19-.04(b)(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Readily retrievable shall mean records must be produced by the pharmacy or the harmacy's third party information technology company in less than 6 hours for all electronically maintained records or 24 hours for any handwritten records.</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="480-19-.04(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a pharmacy fails to produce records or produce records in the required time is considered a violation of O.C.G.A. Sections <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=16-13-37&amp;title=16#" target="_newtab">16-13-37</a>, <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=16-13-39&amp;title=16#" target="_newtab">16-13-39</a>, and <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=16-13-42&amp;title=16#" target="_newtab">16-13-42</a>.</td> </tr> </table> <h2><a href="/GAC/480-19-.05" name="480-19-.05" title="480-19-.05">Rule 480-19-.05 Exceptions to Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine Sales</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="480-19-.05(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any drug product containing pseudoephedrine which comes in a container packaged by the its manufacturer with and its label contains a Federal Caution or Rx Only indication, this product is not an exempt narcotic under this rule and cannot be sold as an Exempt OTC Schedule V drug product and can only be dispensed by a pharmacist, or pharmacy intern or pharmacy extern acting under the direct supervision of a registered pharmacist upon receipt of a prescription issued by a licensed practitioner. <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="480-19-.05(a)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Such prescriptions should be filed and maintained in the manner set forth for Schedule III, IV or V controlled substance prescriptions.</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="480-19-.05(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any licensed practitioner who is authorized to dispense drugs by O.C.G.A. 26-4-130 may dispense drug products containing pseudoephedrine in accordance to state laws and board of pharmacy rule 480-28. <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="480-19-.05(b)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Such prescriptions dispensed according to board of pharmacy rule 480-28 should be filed and maintained in the manner set forth for Schedule III, IV or V controlled substance prescriptions.</td> </tr> </table> </td> </tr> </table> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-19-.01" name="480-19-.01" title="480-19-.01">Rule 480-19-.01 Excepted Sales of Non-Pseudoephedrine Schedule V Controlled Substances</a></li><li><a href="/GAC/480-19-.02" name="480-19-.02" title="480-19-.02">Rule 480-19-.02 Exempt Non-Pseudoephedrine Schedule V Controlled Substances</a></li><li><a href="/GAC/480-19-.03" name="480-19-.03" title="480-19-.03">Rule 480-19-.03 Over-thecounter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine</a></li><li><a href="/GAC/480-19-.04" name="480-19-.04" title="480-19-.04">Rule 480-19-.04 Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine</a></li><li><a href="/GAC/480-19-.05" name="480-19-.05" title="480-19-.05">Rule 480-19-.05 Exceptions to Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine Sales</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>