Georgia Administrative Code

A Prescription Drug Order (defined as a "lawful order of a Practitioner for a Drug or Device for a specific patient") shall include, but not be limited to the following information as well as any information required by Rule 480-22: (1) Full name and address of the patient; (2) N…

As set forth by O.C.G.A. 26-4-110, the Board may provide in its rules and regulations the manner in which the prescription department of a retail pharmacy may be secured. This requirement will be met in the following manner: (1) Any retail pharmacy located in a general merchandis…

(1) "Long-term care facility" means an intermediate care home, skilled nursing home, or intermingled home subject to regulation as such by the Department of Human Resources. (2) "Eligible drugs" means unit dosage drugs which have been paid for or reimbursed through the Department…

If a retail pharmacy has an affiliate as defined by O.C.G.A. § 26-4-119, it shall annually file a disclosure statement identifying all such affiliates no later than June 30 every year.

(a) As used in this rule, the following terms shall mean: (1) "Automated pharmacy systems" (APS) means a mechanical system that perform operations or activities, other than compounding or administration, relative to storage, packaging, and labeling of medication for the purpose o…

(1) For purposes of this rule, the following terms shall means as follow: (a) "Board" shall mean the Georgia Board of Pharmacy; (b) "Immediate notification" shall mean written notification sent within twenty-four hours of the event; (c) "Significant adverse drug reaction" shall m…

All pharmacies are required to purchase or receive dangerous drugs and/or controlled substances from a firm licensed by this state as a drug wholesaler, distributor or manufacturer.

(1) "Administer" or "administration" means the provision of a unit dose and/or doses of medication to an individual patient as a result of the order of an authorized practitioner of the healing arts. (2) "Barrier Isolator" means an isolator specifically designed for compounding p…

(1) Compounded drug preparations - Pharmacist/Patient/Prescriber Relationship. (a) Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order or in anticipation of a prescription drug order based on routine, regu…

(1) The pharmacist has the responsibility and authority to inspect and approve or reject all components, drug preparations containers, closures, in-process materials, and labeling; and the authority to prepare and review all compounding records to assure that no errors have occur…

(1) Facilities. (a) Pharmacies engaging in compounding shall have an adequate area for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile preparations shall be separate and distinct from the area use…

(1) For compounding of drugs in anticipation of prescription drug orders: (a) There shall be written procedures for the compounding of drug preparations to assure that the finished preparations have the identity, strength, quality, and purity they purport or are represented to po…

In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients (components), the preparation date, and the assigned b…

(1) Components, drug preparation containers, closures, and bagged or boxed components of drug preparation containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area (…

(1) Any procedures or other records required to be maintained in compliance with this chapter shall be retained for the same period of time as required in chapter 480-10 of the Board Rules for the retention of prescription files. (2) All records required to be retained under this…

(1) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and facilities. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharm…

The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer's directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical prep…

The Georgia State Board of Pharmacy ("Board") has the authority to approve accreditation or certification programs for specialty pharmacy practice, included, but not limited to: (a) Diabetes; (b) Dyslipidemia; (c) Asthma; and (d) Anticoagulation.

A certification in the management of a specific disease state recognizes that the pharmacist has demonstrated advanced knowledge and skills in the specified disease state necessary to instruct the patient and to assist in the management of the health care of the patient.

(1) In order to qualify for specialty pharmacy practice certification, the applicant must be a pharmacist currently licensed and in good standing with the State of Georgia, and pass an examination approved by the Board in the specific area of speciality practice. A person who has…

For purposes of these Rules and Regulations, the following definitions apply: (a) Hospital. As defined by the Department of Human Resources; (b) Hospital pharmacy. Hospital pharmacy is defined as that portion of a hospital facility which is engaged in the manufacture, production,…

(1) All hospital pharmacies shall renew biennially by June 30th of each odd-numbered year with the Georgia State Board of Pharmacy; certificates of registration shall be issued only to those hospital pharmacies which comply with the provisions of O.C.G.A. § 26-4-110, and with the…

(1) Director of Pharmacy. Each hospital pharmacy shall be directed by a pharmacist, hereinafter referred to as the Director of Pharmacy, who is licensed to engage in the practice of pharmacy in this State, and who is knowledgeable in and thoroughly familiar with the specialized f…

(1) General. When a licensed pharmacist is not physically present in the hospital and the pharmacy is closed, written policies and procedures shall be prepared in advance by the Director of Pharmacy for the provision of drugs to the medical staff and other authorized personnel of…

(1) Area. A hospital pharmacy shall have within the hospital which it serves, sufficient floor space allocated to it to insure that drugs are prepared in sanitary, well-lighted and enclosed places, and which meet the other requirements of this section and the Georgia Pharmacy Law…

(1) General. A drug distribution system is the entirety of that mechanism by which a prescription drug order is executed, from the time the practitioner transmits the order either orally or in writing to an authorized health professional to the time the ordered drug is administer…

(1) General. Drugs shall be administered only upon the orders of those members of the medical staff who have been granted staff privileges. Drugs shall be administered by authorized licensed personnel in accordance with policies and procedures specified by the appropriate committ…

The Director of Pharmacy shall establish policies and procedures relating to drugs brought into the hospital by patients or patients' family members. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant only to an authoriz…

Investigational drugs shall be properly labeled and shall be administered only under the personal and direct supervision of the principal practitioner- investigator or his/her authorized clinician(s) with prior approval of the appropriate committee(s) of the hospital. Investigati…

(1) Monthly. The Director of Pharmacy shall no less than once per month, personally or by qualified designee, inspect all matters within his/her jurisdiction and responsibility and make appropriate written records of such inspections. Such inspections shall, at a minimum, verify …

The following shall apply to said personnel of the Drugs and Narcotics Agency: (1) GDNA Special Agent. A GDNA Special Agent shall be a graduate of a recognized school or college of pharmacy and hold a current pharmacist license issued by the Georgia State Board of Pharmacy (Board…

For purposes of this chapter, the following definitions shall apply: (a) "Board" shall mean the Georgia State Board of Pharmacy. (b) "Certified pharmacy technician" shall mean a registered pharmacy technician who has either successfully passed a certification program approved by …

(1) Effective August 1, 2011, a pharmacy may only employ registered pharmacy technicians to perform pharmacy technician duties. (2) In order to be registered as a Pharmacy Technician in this State, an applicant shall: (a) Submit an application to the Board on the form prescribed …

(a) In dispensing drugs, no individual other than a licensed pharmacist, intern or extern working under direct supervision of a licensed pharmacist shall perform or conduct those duties or functions which require professional judgment. It shall be the responsibility of the superv…

(1) The Pharmacist in Charge shall be responsible for: (a) Providing updated information to the Board in accordance with rules and regulations regarding the registered pharmacy technicians employed in the pharmacy for purposes maintaining the registry of registered pharmacy techn…

(a) In dispensing drugs, no individual other than a licensed pharmacist shall perform or conduct those duties or functions which require professional judgment. It shall be the responsibility of the supervising pharmacist to ensure to that no other employee of the pharmacy, exclud…

(1) Effective June 1, 2016, a pharmacy may permit pharmacy observers to shadow licensed pharmacists for the limited and exclusive purpose of education about the practice of pharmacy. (2) Requirements. In order to be pharmacy observer, an individual must: (a) Be at least seventeen…

(1) Report of unlicensed dispensing. No licensed pharmacist of this state shall knowingly allow any unlicensed person to fill prescriptions (except as provided under the direct and personal supervision of a Georgia licensed pharmacist) or practice pharmacy while impaired in any p…

(1) No person or entity other than an establishment licensed under O.C.G.A. 26-4 shall engage in the practice of accepting and receiving prescriptions and forwarding same to a drug store or pharmacy to be filled and returned to the forwarding agency, which, in turn, delivers the …

(1) It shall be unlawful, and a violation of these rules, for any licensed pharmacist or pharmacy licensed under O.C.G.A. 26-4 to accept for refund purposes, or otherwise, any unused portion of a drug which has been previously dispensed via a prescription drug order and delivered…

(1) Any drugs, poisons, narcotics, family remedies, grocers' drugs, flavoring extracts, essences, toilet articles, stock powders, veterinary supplies, proprietary preparations and any and all other and similar items intended for internal or external use of humans or animals which…

(1) No person or entity licensed under O.C.G.A. 26-4 shall engage in fraudulent or deceptive advertising or promotional procedures with respect to drugs, devices, cosmetics, poisons, or other substances subject to the provisions of O.C.G.A. Sections 16-13 or 26-3.

(1) The theft, loss, or the discovery of unaccounted for controlled substances, within three (3) days of its discovery, must be reported to the GDNA. (2) A written report must be made regarding any theft or significant loss, as defined under 21 C.F.R. 1301.76, of controlled subst…

Confidential prescription drug order information means information maintained by the pharmacist in the patient's records or which is communicated to the patient as part of patient counseling which is privileged and may be released only to the patient, to the patient's designee, o…

All pharmacies are required to purchase or receive dangerous drugs and/or controlled substances from a firm licensed by this state as a drug wholesaler, distributor or manufacturer.

According to O.C.G.A. 16-13-72(4.2), a registered professional nurse licensed under O.C.G.A. 43-26-6 who is employed or contracted by a licensed home health agency may possess sterile saline, sterile water and diluted heparin for use as intravenous maintenance for use in a home h…

(1) Home Health Agency. Home Health Agency (HHA) means a public, non-profit, or proprietary organization which is licensed by the Georgia Department of Human Resources (DHR) to engage in providing home health services to individuals who are under a written plan of care of a physi…

As set forth by this rule, pharmacies, hereafter known as Issuing Pharmacies, may issue sealed Sterile Drug IV Maintenance Kits (SDM Kits) to RNs who are employed or contracted by a HHA. The contents of such kits are strictly limited to the following IV maintenance drugs: sterile…

For purposes of this chapter, the following definitions apply: (a) Administer. The term administer means to give one, single dose of a pharmacy prepared narcotic controlled substance. (b) Board. Board means the Georgia State Board of Pharmacy. (c) Compound. The term compound mean…

(1) All opioid treatment program (OTP) clinics must have an on-site pharmacy. All such pharmacies shall obtain a license by registering with the Georgia State Board of Pharmacy (Board). Such license shall be renewed biennially with the Board. Before a Board license can be issued,…