Georgia Administrative Code

(1) The following methods of destruction of non-controlled substances are approved by the Board for medications dispensed to patients residing in long term care facilities (nursing home or skilled nursing facility) or other facility where a consultant pharmacist's services are re…

Emergency Drug Kits may be placed in licensed hospices by the pharmacy of the consultant or vendor pharmacist provided the following guidelines are met: (1) A record of the drugs to be kept in an emergency drug kit to be kept in the hospice and the provider pharmacy; (2) Drugs sh…

Emergency drug kits may be placed in licensed Crisis Stabilization Units (CSU) by the pharmacy of the consultant or vendor pharmacist provided the following conditions are met: (1) A record of the drugs to be kept in an emergency drug kit must be kept in the CSU and the provider …

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them: (a) "Authentication of product history" means, but is not limited to, identifying the purchasing sou…

(1) All persons who manufacture, possess, transport, or otherwise handle pharmaceuticals or radioactive materials intended for radiopharmaceutical use prior to their arrival at a nuclear pharmacy shall comply with the requirements of the Department's Rules and Regulations for Rad…

(1) Except as provided for in Rule 480-25-.02, all acts of compounding and dispensing radiopharmaceuticals in the State of Georgia shall be performed by persons licensed as nuclear pharmacists; provided, however, that licensed pharmacists and licensed pharmacy interns/externs und…

(1) No nuclear pharmacy shall be operated in the State of Georgia without a valid permit. (2) The governing body of the facility shall submit a completed application with the required fee to the Board for a permit using forms provided by the Board. (3) Separate applications and p…

(1) Any nuclear pharmacy shall be open during all business hours for observation and examination by properly identified representatives of the Board and the Department. (2) All nuclear pharmacies shall be inspected by the Board prior to licensure and may be inspected at the discr…

(1) In addition to complying with these Rules and Regulations, nuclear pharmacies shall comply with the Rules and Regulations of the Board and with all applicable Federal and State laws and regulations pertaining to nonradioactive drugs and pharmaceuticals. (2) The pharmacist in …

(1) Nuclear pharmacies shall have adequate space, commensurate with the scope of service required and provided and meet the minimal space requirements of all pharmacies in the State. (2) Nuclear pharmacies shall have a minimum area, secured from unauthorized personnel, which comp…

(1) In addition to other articles and equipment required by the Board for all pharmacies in the State, the nuclear pharmacy shall have: (a) dose calibrator; (b) vertical laminar flow hood; (c) single or multiple channel scintillation analyzer; (d) microscope and hemocytometer; (e…

All radiopharmaceuticals dispensed from a nuclear pharmacy shall be dispensed in appropriate containers and labeled in accordance with the following: (a) The immediate inner container shall be labeled with: 1. the identifying prescription number; and 2. the name of the radioactiv…

In addition to any reference material required by the Board of all pharmacies in the State, a nuclear pharmacy shall maintain a reference library which shall include the following: (a) Current U.S. Pharmacopoeia/National Formulary with supplements or computer or electronic access…

The nuclear pharmacy shall maintain acquisition and disposition records as required by the Board of all pharmacies in the State.

The enforcement and administration of these Rules and Regulations shall be as prescribed in the Georgia Administrative Procedure Act, O.C.G.A., Title 50, Chapter 13, Title 26, Chapter 4, and Title 43, Chapter 1.

In the event that any rule, sentence, clause or phrase or any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect …

(1) All fees for applications for pharmacist license, examinations, application and examination fee for reciprocity, wall certificates, duplicate wall certificates, renewals, late renewals, reinstatements, and all other fees which may be authorized by law shall be established by …

For purposes of these Rules and Regulations, the following definitions apply: (a) Authentication. Any process by which the identities of the parties sending and receiving electronic prescription data are verified. (b) Automated Electronic Data Processing System. A system utilizin…

(1) Prescription drug orders shall include, but not be limited to, the following information: (a) Date of issue; (b) Name and address of patient (or patient location if in an institution); (c) Name, address, and telephone number of the prescriber; (d) DEA registration number of t…

Records of dispensing for original and refill prescriptions are to be made and kept by pharmacies for two years and shall include, but not be limited to: (a) Quantities dispensed; (b) Date of dispensing; (c) Serial number (or equivalent if an institution); (d) The identification …

(1) All prescription drug orders sent via facsimile or other electronic means must meet the requirements of O.C.G.A. § 26-4-80 and Chapter 480-22 of the Board Rules and the requirements for electronically transmitted prescriptions or drug orders. (2) All persons engaged in the pr…

In order to comply with the record keeping requirements of this Chapter, an automated electronic data processing system may be utilized for the record keeping system if the following conditions have been met: (a) Except as otherwise provided herein, all original prescriptions, th…

The computerized information provided by the system shall be used only by the pharmacy in which the data has been entered or a pharmacy sharing a common database. To maintain the confidentiality of patients' prescriptions, there must exist adequate safeguards or security of the r…

A pharmacy utilizing an automated electronic data processing system must satisfy all the information requirements as that used in a manual mode when transferring an original dangerous drug prescription drug order. The transfer of original prescription drug information for the pur…

Pharmacies utilizing automated data processing systems must satisfy all information requirements of a manual mode for prescription transferal. The transfer of original prescription information for a controlled substance list in Schedules III, IV or V for the purpose of refill dis…

(1) A patient record system shall be maintained by all pharmacies for patients for whom prescription drug orders are dispensed. The patient record system shall provide for the immediate retrieval of information necessary for the dispensing pharmacist to identify previously dispen…

(1) All prescription drug orders lawfully authorized to be received via facsimile or other electronic means are allowed to serve as the original prescription drug order for the receiving pharmacy. (2) No person or firm licensed under O.C.G.A. Title 26, Chapter 4 (the Georgia Phar…

For purpose of these Rules and Regulations, the following definitions apply: (a) Drugs. Drugs shall mean drugs as defined in O.C.G.A. Section 26-4-5. (b) Practitioner or Dispensing Practitioner. Practitioner or dispensing practitioner means a person licensed as a dentist, physici…

All practitioners who dispense drugs shall comply with all record-keeping, labeling, packaging, and storage requirements imposed upon pharmacists and pharmacies with regard to such drugs and those regulations contained in this Chapter. (a) Nothing in this Rule is meant to prohibi…

(1) Any practitioner who intends for his/her agent to dispense drugs shall notify, at the time of the renewal of that practitioner's license to operate, that practitioner's respective licensing board of that practitioner's intention to dispense drugs. The licensing board shall no…

(1) Requirements of a prescription drug order. A practitioner shall write a prescription drug order for each drug dispensed. The prescription drug order shall contain the following information: (a) The name and address of the person for whom the drug is prescribed; (b) The name, …

All drugs dispensed by a practitioner must be labeled with the following information: (a) Date and identifying serial number; (b) Name of patient; (c) Name of practitioner prescribing; (d) Name, address and telephone number of the dispensing practitioner; (e) Name of drug and str…

All drugs dispensed by a practitioner must be dispensed in containers which meet the requirements of the Food and Drug Administration and the Consumer Protection Agency, including the use of child-proof and moisture-proof containers.

(1) All practitioners shall exercise diligent care in protecting controlled substance drugs and records possessed from loss or theft. Agents of the Board shall have the responsibility of offering to practitioners written recommendations concerning the satisfactory storage, keepin…

Nothing in these rules shall prohibit any person from assisting any duly licensed practitioner in the measuring of quantities of medication and the typing of labels therefore, but excluding the dispensing, compounding, or mixing of drugs, provided that such practitioner shall be …

Whenever more than one practitioner dispenses drugs from a common inventory, one of the practitioners shall be designated "practitioner in charge" of said inventory. All practitioners in charge shall insure that a complete and accurate record of all controlled substances on hand,…

(1) A loss or theft of any controlled substance drugs must, within 48 hours of discovery, be reported to the GDNA. (2) A written report must be made regard any theft of significant loss, as defined under 21 C.F.R. 1301.76, of controlled substances by completing a DEA Form 106 and…

The Board, GDNA and their representatives shall have the authority to conduct inspections or audits of all records of drugs received and/or disposed of by any practitioner. The Board or GDNA personnel shall have the authority to examine and copy all such records, and to examine a…

For purposes of these Rules and Regulations, the following definitions apply: (a) College of Pharmacy. A school or college of pharmacy located in the State of Georgia and accredited by the American Council on Pharmaceutical Education. (b) Pharmacy Permit. A permit which is issued…

(1) A pharmacy located within and owned and operated by a college of pharmacy may apply to the Board for a pharmacy permit in order to purchase, receive, possess, and dispose of drugs utilized solely for educational and research purposes. (2) An applicant for a pharmacy permit fo…

Each pharmacy owned and operated by a college of 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 and thoroughly familiar with the speciali…

(1) Except as provided herein, the holder of a pharmacy permit for a college of pharmacy shall be exempt from requirements otherwise applicable to pharmacies, including but not limited to those contained in Chapter 480-10 of these Rules and Regulations. (2) The holder of a pharma…

(1) Each pharmacist license will expire and must be renewed by December 31st of the even numbered years. Licenses not renewed by December 31st of the even number years may be late renewed by January 31st of the following year by payment of the current renewal fee, plus an additio…

(1) Pharmacists who wish to have their license placed on inactive status may do so by requesting such status in writing, with an explanation of the request, to the Board. Pharmacists requesting inactive status must have an active license in good standing which includes meeting th…

(1) The Georgia State Board of Pharmacy has the statutory responsibility and authority for the requirement of continuing education as prerequisite for a license renewal. (2) The purpose of continuing education for pharmacists is to maintain and enhance the professional competency…

For purpose of these Rules and Regulations, the following definitions apply: (a) "Dispensing procedure" means a written document signed by a licensed pharmacist and a licensed practitioner which document establishes the appropriate manner under which drugs may be dispensed under …

Any person who dispenses drugs in accordance with a dispensing procedure and under the authority of a job description or nurse protocol shall comply with all record keeping, labeling, packaging, and storage requirements imposed upon pharmacists and pharmacies with regard to such …

All drugs dispensed in accordance with a dispensing procedure and under authority of a job description or nurse protocol must be labeled with the following information: (a) Date and identifying serial number; (b) Name of patient; (c) Name of practitioner prescribing; (d) The name…

All drugs dispensed in accordance with a dispensing procedure or under authority of a job description or nurse protocol must be dispensed in containers meeting the requirements of the Food and Drug Administration and the Consumer Protection Agency, including the use of child-proo…

(1) Any person dispensing drugs in accordance with a dispensing procedure and under authority of a job description or nurse protocol shall exercise diligent care in protecting drugs and records possessed from loss or theft. Agents of the Georgia Drugs and Narcotics Agency (GDNA) …