Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES
Rule 480-19-.03 - Over-thecounter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine
Current through Rules and Regulations filed through March 20, 2024
(a) 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.
(b) 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:
Tablets/capsules - Number of tablets/capsules that equal 3.6 grams
Ingredients | Number of tablets = 3.6 grams |
30 mg Pseudoephedrine HCl |
146 Tablets |
60 mg Pseudoephedrine HCl |
73 Tablets |
120 mg Pseudoephedrine HCl |
36 Tablets |
30 mg Pseudoephedrine Sulfate |
155 Tablets |
60 mg Pseudoephedrine Sulfate |
77 Tablets |
120 mg Pseudoephedrine Sulfate |
38 Tablets |
240 mg Pseudoephedrine Sulfate |
19 Tablets |
Liquids -Number of milliliters that equal 3.6 grams
Ingredients |
Number of milliliters (ml) = 3.6 grams |
6.25 mg Ephedrine HCl/ 5 ml Liquid |
3515 ml |
15 mg Pseudoephedrine HCl / 1.6 ml Liquid |
468 ml |
7.5 mg Pseudoephedrine HCl / 5 ml Liquid |
2929 ml |
15 mg Pseudoephedrine HCl / 5 ml Liquid |
1464 ml |
15 mg Pseudoephedrine HCl / 2.5 ml Liquid |
732 ml |
30 mg Pseudoephedrine HCl / 5 ml Liquid |
732 ml |
30 mg Pseudoephedrine HCl / 2.5 ml Liquid |
366 ml |
60 mg Pseudoephedrine HCl / 5 ml Liquid |
366 ml |
(c) 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.
Tablets/capsules - Number of tablets/capsules that equal 9 grams
Ingredients |
Number of tablets = 9 grams |
30 mg Pseudoephedrine HCl |
366 Tablets |
60 mg Pseudoephedrine HCl |
183 Tablets |
120 mg Pseudoephedrine HCl |
91 Tablets |
30 mg Pseudoephedrine Sulfate |
389 Tablets |
60 mg Pseudoephedrine Sulfate |
194Tablets |
120 mg Pseudoephedrine Sulfate |
97 Tablets |
240 mg Pseudoephedrine Sulfate |
48 Tablets |
Liquids -Number of milliliters in 9 grams
Ingredients |
Number of milliliters (ml) = 9 grams |
6.25 mg Ephedrine HCl / 5 ml Liquid |
8788 ml |
15 mg Pseudoephedrine HCl / 1.6 ml Liquid |
1171 ml |
7.5 mg Pseudoephedrine HCl / 5 ml Liquid |
7323 ml |
15 mg Pseudoephedrine HCl / 5 ml Liquid |
3661 ml |
15 mg Pseudoephedrine HCl / 2.5 ml Liquid |
1830 ml |
30 mg Pseudoephedrine HCl / 5 ml Liquid |
1830 ml |
30 mg Pseudoephedrine HCl / 2.5 ml Liquid |
915 ml |
60 mg Pseudoephedrine HCl / 5 ml Liquid |
915 ml |
(d) All logbooks must be retained for a minimum period of 2 years from the date of the last recorded sale.
(e) Logbooks must be kept in a secure location in the pharmacy and information contained in a logbook can be shared:
(f) 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.
(g) 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, 21 U.S.C 830 and 844, 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.
O.C.G.A. §§ 16-13-22, 16-13-29, 16-13-29.2, 16-13-34, 26-4-27, 26-4-28.