Georgia Administrative Code

The personnel shall be as follows: (a) Director of Pharmacy Services. Each OTP clinic pharmacy shall be under the direction of a Director of Pharmacy Services, hereafter referred to as the Director. The Director shall: 1. Direct, oversee and be responsible for all activities rela…

The following regulations shall be followed in the absence of a pharmacist: (1) General. Access to drugs in the absence of a licensed pharmacist shall be limited to specifically authorized licensed medical personnel consistent with policies and procedures of the Director. Such ar…

(1) Physical Area. An OTP clinic pharmacy shall have within the clinic which it serves, sufficient floor space allocated to it to insure that drugs are prepared in sanitary, well-lighted and enclosed space, and which meet the other requirements of this section, the Georgia Pharma…

(1) General. A drug distribution system is the entirety of that mechanism by which a physician's drug order is executed, from the time the practitioner transmits the order either orally, in writing, or electronically to a licensed health care professional to the time the ordered …

(1) No drug shall be dispensed or administered except upon receipt of a medication drug order written by a licensed medical practitioner granted rights to prescribe in an OTP. (a) A licensed medical practitioner must write an initial dosing medication order for each patient prior…

(1) The Director shall establish policies and procedures relating to drugs brought into the OTP clinic by outside sources. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant only to an authorized practitioner's prescript…

(1) Board Inspection. The Board, through either the GDNA or by its qualified designee, shall, at a minimum, inspect each OTP clinic pharmacy once every two (2) years to verify compliance with the laws and these rules and regulations. (a) The Director shall maintain a copy of the …

Whenever the DHR central registry determines that a patient is improperly utilizing more than one OTP at the same time, and notifies the Director, the Director shall notify the Board and the GDNA.

Excepted Sales of Non-Pseudoephedrine Schedule V Controlled Substances. 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…

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…

(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 applicab…

(1) 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 phar…

(a) 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 d…

Applicants for licensure by examination must complete an application on a form approved by the Georgia State Board of Pharmacy ("Board"), have attained the age of majority, be of good moral character, have graduated and received a professional degree from a college or school appr…

Applicants applying for a license to practice pharmacy by examination must be a graduate of: (1) A generally recognized school or college of pharmacy located in the United States, being one who has obtained candidate status or is approved by the American Council on Pharmaceutical…

Applicants applying for licensure by examination must complete 1500 hours of pharmacy internship or its equivalent as provided by the Board. An applicant for licensure by examination shall submit to the Board a certification that states that the applicant has satisfied the requir…

(1) For licensure, an individual must successfully pass the NAPLEX, and a jurisprudence examination approved by the Board. (a) An individual is not eligible to take the examinations for licensure until such individual has graduated from an approved college or school of pharmacy a…

(1) In order for a pharmacist currently licensed in another jurisdiction to obtain a license as a pharmacist from the Board, an applicant shall: (a) Complete an applicant form supplied by the National Association of Boards of Pharmacy (NABP) to apply for licensure with the Georgi…

(1) As used in this rule: (a) "Military" means the United States armed forces, including the National Guard; (b) "Military spouse" means a spouse of a service member or transitioning service member; (c) "Pharmacy resident" means a graduate who received a professional degree from …

A person or firm issued a license or a permit by the Georgia Board of Pharmacy as a pharmacist, pharmacy intern, retail pharmacy, hospital pharmacy, opioid treatment program clinic pharmacy, clinic pharmacy, nuclear pharmacy, prison clinic pharmacy, manufacturer, drug wholesale d…

(1) Each registrant shall maintain records of unusual orders of controlled substances received by the registrant and s hall inform the Off ice of the Director of the Georgia Drugs and Narcotics Agency (GDNA) of unusual orders when discovered by the registrant. For purposes of thi…

For the purpose of these rules and regulations, the following definitions apply: (a) Retail Pharmacy Providing Home Health Care Services. A retail pharmacy providing home health care services is defined as a licensed retail pharmacy that routinely prepares and dispenses compounde…

All retail pharmacies providing home health care services must have a current retail pharmacy permit. Therefore, they must comply with all retail pharmacy laws and regulations as well as the special regulations contained in these rules.

(1) Pharmacist-in-Charge. The pharmacist-in-charge at each retail pharmacy providing home health care services shall be knowledgeable in the specialized functions of preparing and dispensing compounded, sterile parenteral products, including the principles of aseptic technique an…

The physical requirements are: (a) Space. Each retail pharmacy providing home health care services shall have a designated area for preparing compounded, sterile parenteral products. This area shall be physically separate from other areas and should be designed to avoid unnecessa…

Regulations are: (a) General. A drug distribution system is the entirety of that mechanism by which a physician's prescription drug order is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient. (b) …

The following additional requirements are necessary for those retail pharmacies providing home health care services that routinely prepare chemotherapy agents to insure the protection of the personnel involved: (a) All chemotherapy agents should be compounded in a vertical flow, …

(1) Primary Provider. There shall be a designated practitioner responsible for the patient's medical care. There shall be a clear understanding between the practitioner, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of care, the moni…

There shall be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product shall be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications. (a) Hood C…

Except as noted herein, any term contained in this chapter shall have the same meaning as set forth in O.C.G.A. §§ 16-13-21, 26-3-2, 26-4-5, and Title 43, Chapter 34.

(1) For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing of control…

(1) All controlled substance prescription drug orders issued by the authorized practitioner shall bear the prescribing practitioner's name, address, telephone number and the Drug Enforcement Administration (DEA) permit number assigned to the practitioner for that corresponding ad…

(1) A pharmacist or pharmacy intern/extern shall dispense a schedule II Controlled Substance (C-II), as defined by O.C.G.A. § 16-13-26, only pursuant to a prescription drug order on security paper, except as provided in subparagraphs (1)(a) and (1)(b) and paragraph (3) of this Ru…

The refilling of a prescription for a schedule II (C-II) controlled substance is prohibited.

(1) The partial filling of a schedule II (C-II) prescription drug order is permissible, if the pharmacist is unable to supply the full quantity prescribed in a written or emergency oral prescription drug order, and the pharmacist makes a notation of the quantity dispensed on the …

(1) A pharmacist or pharmacy intern/extern may dispense Schedule III, IV and V Controlled Substances (C-III, IV, V), as defined by O.C.G.A. §§ 16-13-27, 16-13-28, and 16-13-29, pursuant to: (a) A written prescription drug order bearing the signature of a practitioner as permitted…

(1) No prescription drug order for a C-III, IV, or V controlled substance shall be filled or refilled more than six (6) months after the date on which such prescription drug order was issued by the prescribing practitioner and no such prescription drug order may be authorized to …

The partial filling of a C-III, IV, or V prescription drug order is permissible, subject to the following requirements: (a) Each partial filling is recorded in the same manner as a refill; (b) The total quantity dispensed in all partial fillings does not exceed the total quantity…

(1) A pharmacist filling a prescription drug order for a C-II, III, IV or V substance shall affix to the package a label showing the following: (a) The name, address and telephone number of the pharmacy; (b) The prescription drug order serial number; (c) The date the prescription…

(1) The transfer of original prescription drug order information for a C-III, IV, or V substance for the purpose of refill dispensing is permissible between pharmacies one time only. (a) However, pharmacies electronically sharing a real-time, online computerized database may tran…

(1) Physicians Assistants; Prescriptions for Dangerous Drugs and Controlled Substances in Schedule III, IV, or V. Pursuant to O.C.G.A. § 43-34-103(e.1), a physician assistant (PA) licensed by the Georgia Composite Medical Board is permitted to issue a prescription drug order or o…

(1) Any drug scheduled under the Georgia Controlled Substances Act (GCSA), but not scheduled under the Federal Controlled Substances Act (FCSA), must be purchased, stored, inventoried, recorded, distributed, or dispensed in the same manner as any other controlled substance, excep…

(1) For purposes of this rule, a practitioner means: (a) A physician, dentist, podiatrist, veterinarian, or other person licensed, registered, or otherwise authorized under the laws of this state to distribute, dispense, with respect to, or to administer a controlled substance or…

Ophthalmic topical products may be refilled without authorization from a practitioner to prevent unintended interruptions in drug therapy provided that: (1) The original prescription order contains valid refills; (2) Refills occur at 70 percent or greater of the predicted days of…

(1) Proceedings by the Board in the exercise of its authority to cancel, suspend, sanction, or revoke any license issued by the Board shall be conducted in accordance with O.C.G.A. Tit le 50 Chapter 13, the "Georgia Administrative Procedure Act." In all such proceedings, the Boar…

For purposes of these Rules and Regulations, the following definitions apply: (a) Board. Board shall mean the Georgia State Board of Pharmacy. (b) GDNA. GDNA shall mean the Georgia Drugs and Narcotics Agency. (c) Hospice emergency drug kits. A hospice emergency drug kit shall mea…

(1) The responsibilities of the Consulting Pharmacist shall include, at a minimum, review of each patient's drug regimen monthly and report of any irregularities to the Medical Director and Administrator of the nursing facility, written reports of pharmaceutical services, and mon…

The Vendor Pharmacist shall establish standards to ensure that all drugs are stored in a manner sufficient to insure the proper sanitation, temperature, light, ventilation, moisture control, segregation, and security.

(1) Dispensing of all drugs to the facility shall be pursuant to a legal prescription drug order for an individual patients. Standing medication orders shall not be allowed. Policies may be established by the vendor pharmacist in conjunction with the appropriate committee of the …

(1) A pharmacist serving as a consultant to a facility must contract with the facility in writing for those services. Notification must also be made to the Board in writing when a pharmacist becomes a consultant to a facility. The pharmacist must also notify the Board when the co…