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Chapter 480-28 PRACTITIONER DISPENSING OF DRUGS

Rule 480-28-.01 Definitions

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.

Rule 480-28-.02 General Requirements

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.

Rule 480-28-.03 Notification of Intent to Dispense

(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:
(a) The name and address of the practitioner;
(b) The state professional license number of the practitioner;
(c) The practitioner's Drug Enforcement Administration license number; and
(d) The complete name and address of the office or facility from which drugs shall be dispensed and the complete address where all records pertaining to such drugs shall be maintained.

Rule 480-28-.04 Record-keeping and Filing

(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, quantity, and strength of such drug;
(c) The directions for taking or giving;
(d) The signature of the practitioner and the date the prescription was written; and
(e) For controlled substance drugs, the name, address, and Drug Enforcement Administration number of the dispensing practitioner.
(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.
(a) Invoices. A record of all controlled substance drugs received and disposed of by a dispensing practitioner must be maintained. All invoices of Schedule II controlled substances must be kept or maintained in a separate file. All invoices for Schedule III, IV or V controlled substances must be kept in or maintained in a separate file, provided that these invoices may be filed with other invoices only if the letter "C" in red ink is stamped on each invoice of Schedule III, IV or V controlled substances so that such invoice shall be easily accessible and retrievable.
(b) Inventory. An inventory of all controlled substances must be maintained separately and taken biennially on May 1st, or two (2) years from the day of the last inventory, of every odd-numbered year.
(c) Files. A prescription drug order for a controlled substance must be filed in one of the following ways:
1. A practitioner can maintain three separate files; one for all Schedule II controlled substances dispensed, one for all Schedule III, IV and V controlled substances dispensed, and one for all dangerous drugs dispensed, or
2. A practitioner can maintain two files, one for Schedule II controlled substances dispensed and one for all other drugs dispensed. If this method is utilized, the prescriptions for Schedule III, IV and V controlled substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner, so that such records are easily accessible and retrievable, or
3. A practitioner can maintain two files; one for all controlled substance drugs dispensed and one for all dangerous drugs dispensed. If this method is utilized, the prescriptions for Schedule III, IV and V controlled substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner so that such records are easily accessible and retrievable.

Rule 480-28-.05 Labeling

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.

Rule 480-28-.06 Packaging

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.

Rule 480-28-.07 Storage

(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.

Rule 480-28-.08 Practitioner's Assistants

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.

Rule 480-28-.09 Practitioner in Charge of Common Inventory

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.

Rule 480-28-.10 Loss or Theft of Controlled Substances

(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:
(a) Full name and address of practitioner;
(b) The practitioner's DEA registration number;
(c) The date of theft;
(d) The type of theft;
(e) A list of cost codes, or identification symbols on package(s) stolen; and
(f) A list of controlled substances missing.

Rule 480-28-.11 Inspection of Records

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.