Chapter 480-28 PRACTITIONER DISPENSING OF DRUGS
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, physician, podiatrist or veterinarian under Chapters 11, 34, 35 or 50, respectively of Title 43 of the Official Code of Georgia Annotated.|
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 prohibit veterinarians from meeting the prescription drug order record keeping requirements of this Chapter by utilizing a record keeping system in which a patient's prescription drug order is maintained in the patient's chart. However, nothing in such a system shall relieve a veterinarian from meeting the other requirements of this Chapter.|
|(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 notify the Georgia State Board of Pharmacy regarding each practitioner
whom that Board has received a notification of intention to dispense drugs. The
licensing board's notification shall include the following information:
|(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:
|(2)||Documentation required for filling or refilling a prescription drug order. A practitioner who fills or refills a prescription drug order shall write on the prescription itself the date it was filled or refilled and the signature of the practitioner who fills or refills the prescription drug order.|
|(3)||Prescription drug orders dispensed by a practitioner cannot be transferred to another practitioner or pharmacist for subsequent filling.|
|(4)||Retention of records. Prescription drug orders shall be maintained on file by a practitioner for a period of two years from the date the prescription is filled and shall be accessible for inspection by the Board and/or its agents from the Georgia Drugs and Narcotics Agency and its inspectors.|
|(5)|| Special requirements for record-keeping
and filing of controlled substance prescription drug orders.
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 strength;|
|(f)||Directions for use to the patient;|
|(g)||The expiration date of the drug; and|
|(h)||Any other information required by the Drug Enforcement Administration or the Food and Drug Administration.|
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, keeping, handling, and security of such controlled substances and records. When not in actual use, all controlled substance drugs shall be maintained in a place which is secured.|
|(2)||All drugs which bear, or are required to bear, upon the package, the words "Caution, Federal Law Prohibits Dispensing Without Prescription", or "RX only" or words of like import, shall be stored in a secured area by a practitioner possessing such drugs. All drugs shall be stored beyond the normal reach of small children.|
|(3)||There shall be provided within each practitioner's office sufficient space for the neat and orderly storage of all drugs. In addition, there shall be clear floor space within such office to permit a practitioner and his/her assistant employed therein to adequately, safely, and accurately fulfill his/her duties related to prescriptions and drugs.|
|(4)||There shall be provided within each dispensing practitioner's office adequate facilities for the proper storage of drugs which require refrigeration, and such drugs shall be stored therein in such manner as to preserve their therapeutic activity.|
|(5)||No dispensing practitioner shall operate in any manner or dispense any drugs under unclean, unsanitary, overcrowded, or unhealthy conditions, or under any condition which endangers the health, safety, or welfare of the public.|
|(6)||A practitioner shall cause to be removed from stock all outdated and deteriorated drugs, at regular intervals of not more than six months duration, and under no circumstances will any practitioner permit any drug to be dispensed which bears a date of expiration which has been reached, or which is in a deteriorated condition.|
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 physically present and personally supervising the actions of such person in doing such measuring and typing, and provided, further, that no prescription shall be given to the person requesting the same unless the contents and the label thereof shall have been verified by a licensed practitioner. No practitioner shall be assisted by more than one such person at any one time.
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, received, manufactured, sold, dispensed, or otherwise disposed of has been kept in accordance with the record-keeping requirements of federal law, state law, and the rules of the Board.
|(1)|| A loss or theft of any controlled
substance drugs must, within 48 hours of discovery, be reported to the Board,
Drug Enforcement Administration and the GDNA. A written report on DEA Form 106
must be made regarding any theft or loss of any controlled substances. The
original and one copy of the report must be sent to the Board, Drug Enforcement
Administration and one copy must be sent to the GDNA (40 Pryor Street, #2000,
Atlanta, GA 30303) within ten (10) days of the initial receipt of DEA Form 106.
The report shall include the following information:
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 and inventory all controlled substances. It shall be the responsibility of all practitioners possessing such drugs or records to make the same available for such inspection, copying, examination, or inventorying by said Board or GDNA representatives. Any practitioner possessing controlled substances or records may request that such an inspection be made, and upon receipt of such written request, the GDNA Director shall make, or cause to be made, without unreasonable delay, an inspection in compliance with said request.
|(a)||Every dispensing practitioner shall ensure that all controlled substances and/or dangerous drugs are purchased from and returned to firms that have a current permit issued by the Georgia State Board of Pharmacy. The practitioner shall obtain and maintain a copy of each such firm's current Georgia State Board of Pharmacy permit which shall be made available during any GDNA inspection.|