Georgia Administrative Code

GDNA agents shall have the authority to conduct inspections or audits of all records of drugs received and/or disposed of by any person dispensing drugs in accordance with a dispensing procedure and under authority of a job description or nurse protocol. GDNA agents shall have th…

All licensed pharmacists who sign a dispensing procedure must submit such document to the Georgia State Board of Pharmacy for review. Any such dispensing procedure must be in conformity with this Chapter and O.C.G.A. § 43-34-26.1, and shall include the names of all persons dispen…

Purpose: The purpose of the regulations issued in this part is to comply with the requirements of the Omnibus Budget Reconciliation Act of 1990 and to enhance the public health and welfare by providing that pharmacists shall offer consultation to patients regarding their medicati…

(1) Outpatient Clinic. An outpatient clinic shall be defined as a health care facility or location, other than a medical practitioner's office, providing outpatient treatment or care such as, but not limited to, an outpatient surgery center, outpatient urgent care center, infusio…

(1) All outpatient clinic 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 to outpatient clinic pharmacies which meet the requirements for licensure and which comply wit…

The Personnel shall be as follows: (a) Pharmacist-in-charge. Each outpatient clinic pharmacy shall be directed by a pharmacist, hereinafter referred to as the pharmacist- in-charge, who is licensed to engage in the practice of pharmacy in this State, and who is knowledgeable in a…

The following regulations shall be followed in the absence of a pharmacist: (a) General. When a licensed pharmacist is not physically present in the clinic pharmacy, written policies and procedures shall be prepared in advance by the pharmacist-in-charge for the provision of drug…

(1) Area. An outpatient 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 places, and which meet the other requirements of this section and the Georgia Phar…

(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, in writing, or electronically to an authorized health professional to the time the ordered d…

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 committee of the fac…

The pharmacist-in-charge shall establish procedures relating to medications brought into the clinic. Such drugs shall not be administered unless they can be precisely identified. Administration shall be pursuant to an authorized practitioner's prescription drug order only. If suc…

Investigational drugs shall be properly labeled. Investigational drugs shall be dispensed and administered by the pharmacist in accordance with an approved protocol that includes any requirements for a patient's appropriate informed consent. Nurses may administer such drugs only …

(1) Monthly. The pharmacist-in-charge 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 …

This rule was adopted to protect the health, safety, and welfare of the public. This rule places Carisoprodol (known as Soma) under Schedule IV, of the Georgia Controlled Substances Act, Code Section 16-13-28(a)(2-25). The Board finds that: (a) Carisoprodol has a high potential f…

This rule was adopted to protect the health, safety, and welfare of the public. This rule places Ketamine under Schedule III of the Georgia Controlled Substances Act, Code Section 16-13-27(8). The Board finds: (a) that Ketamine has an extremely high potential for abuse; (b) that …

This Chapter was adopted to protect the health, safety, and welfare of the public. This Chapter places Sodium Oxybate (known as Xyrem) that is contained in a drug product for which an application has been approved under Section 505 of the Federal Food, Drug and Cosmetic Act under…

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including any material, compound, mixture, or preparation which contains these substances or their derivatives, salts, isomers, or salts of isomers, ha…

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places an additional newly identified compound, including any material, compound, mixture, or preparation which contains these substances or their derivatives, salts, isomers, or salts o…

(1) Effective October 6, 2014, Official Code of Georgia Annotated (O.C.G.A.) §§ 16-13-27(4)(C), 16-13-27(4)(D) are hereby removed from Schedule III of the Georgia Controlled Substances Act, O.C.G.A. 16-13-25, et. seq. The following language shall be deleted from O.C.G.A. §§ 16-13…

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places additional newly identified compounds, including any material, compound, mixture, or preparation which contains any quantity of the following substances, their salts, isomers (whe…

(1) This rule was adopted to protect the health, safety, and welfare of the public. Lidocaine topical, 40 mg/gm. or less (4.0%) is deleted from Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(520). (2) This rule is based on the following findings of the Board: (a) tha…

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places additional newly identified compounds, including any material, compound, mixture, or preparation which contains any quantity of the following substances, their salts, isomers and …

This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including their isomers, esters, ethers, salts and salts of isomers, esters, and ethers, whenever the existence of these isomers, esters, ethers, or salts …

(1) This rule was adopted to protect the health, safety, and welfare of the public. Levocetirizine dihydrochloride in 5 mg tablets or an oral solution of 2.5 mg per 5 mL (.05 mg per mL), as identified in Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(516.75), is here…

(a) This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including any derivatives, their salts, isomers, or salts of isomers, unless specifically utilized as part of the manufacturing process by a commercial…

(1) This rule was adopted to protect the health, safety, and welfare of the public. Triamcinolone acetonide nasal spray 55mcg per spray or less, is hereby deleted from the dangerous drug list as referenced in the Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(976). (…

(1) This rule was adopted to protect the health, safety, and welfare of the public. Sodium chloride injection in quantities of 10cc or less, when used as a catheter flush solution to act by physically occupying space within a catheter and exerting pressure on the patient's circul…

(1) This rule was adopted to protect the health, safety, and welfare of the public. Four mg naloxone hydrochloride nasal spray, is hereby deleted from the dangerous drug list as referenced in the Official Code of Georgia Annotated (O.C.G.A.) §§ 16-13-71(b)(635) and 16-13-71(c)(14…

(1) Board. Board means the Georgia State Board of Pharmacy. (2) Drug Therapy Modification. Drug Therapy Modification means the adjustment of dosages, dosage schedules, and/or medications by a pharmacist under authority delegated and supervised by a physician. Such medications nee…

(1) A pharmacist may apply to the Board for a certification which will allow the pharmacist to enter into a protocol or agreement with a physician for drug therapy modification. Each application shall be reviewed by the Board for completeness and authenticity before certification…

In order to renew a certification under this chapter, the continuing education must: (1) Be from a provider approved by the Board pursuant to Rule 480-3-.03 or a provider approved by ACPE. (2) Have been taken and credit received for the continuing education during the 12 months p…

(1) A physician may delegate authority to a pharmacist certified under this chapter to modify drug therapy through a protocol for a patient under the physician's direct medical care and supervision. The protocol shall meet the applicable requirements for the issuance of prescript…

(1) Each pharmacist certified for drug therapy modification, who enters into a drug therapy modification protocol with a physician, shall establish and maintain a separate record system which shall include, but not limited to, the following: (a) A patient medical record for each …

Nothing in this rule shall be construed to prohibit the pharmacist from being remunerated for the professional services rendered.

Nothing in this chapter shall be construed to limit or restrict the authority of a pharmacist to substitute a drug as provided in O.C.G.A. Section 26-4-81.

Nothing in this chapter shall be construed to limit hospital pharmacists from participating in medication therapy management by protocol or other legal authority established or approved by a member of the hospital medical staff for the care and treatment of hospital patients.

As used in this chapter, the following terms: (1) "Board" shall mean the Georgia Board of Pharmacy. (2) "Remote prescription drug order processing" shall mean the processing of prescription or patient information from a location other than the location from which the prescription…

(1) Secondary remote entry pharmacists who perform remote prescription drug order processing shall be licensed by the Board. (2) When a secondary remote entry pharmacist performs remote prescription drug processing from any pharmacy, the pharmacy must be licensed in this State. (…

(1) The primary dispensing pharmacy shall have a licensed pharmacist on site during business hours and his/her duties shall include the verification of the validity of all prescriptions. Such pharmacist shall be responsible for obtaining and recording all information needed. This…

The primary dispensing pharmacy shall have a written policy and procedure that relates to the remote processing of prescriptions and such policy shall be available for inspection by the Board or its representative. The policy shall at a minimum include the following: (a) The resp…

(1) The primary dispensing pharmacy and the secondary remote entry pharmacist shall share a common electronic file or have technology which allows sufficient information necessary to process a non-dispensing function. (2) In addition to any other required records, the primary dis…

(1) It shall be the responsibility of the pharmacist on duty at the primary dispensing pharmacy to perform patient counseling of all prescriptions, as required, including those assisted by remote processing. (2) The secondary remote entry pharmacist shall not perform patient coun…

For purposes of this Chapter, the following words shall mean: (a) "Board" means the Georgia Board of Pharmacy (b) "GDNA" means the Georgia Drugs and Narcotics Agency. (c) "Remote automated medication system" or "RAMS" means an automated mechanical system in which medication is st…

(a) In order to install or operate a RAMS, a Georgia licensed pharmacy must make application for licensure to the Board on a form approved by the Board, and pay a fee. No person other than an approved licensed pharmacy may install or operate a RAMS. Each location having a RAMS mu…

Minimum Requirements. A pharmacy may use a RAMS provided that: (a) The pharmacy has a policy and procedure manual at the skilled nursing facility or hospice that includes: 1. The type or name of each RAMS including a serial number or other identifying nomenclature. 2. A method to…

Drugs shall only be dispensed by the RAMS pursuant to prescription drug orders of practitioners authorized under the laws of this state to prescribe drugs.

(1) The Pharmacist in Charge, personally or by licensed pharmacist designee, shall inspect all RAMS within his/her jurisdiction and responsibility and make appropriate written records of such inspections. Such inspections, at a minimum, shall verify that: (a) All drugs in a RAMS …