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:
| (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. |
|
| (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. |
|
|
All drugs dispensed by a practitioner must be labeled with the
following information:
| (a) |
Date and
identifying serial number; |
| (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:
| (a) |
Full name and address of
practitioner; |
| (b) |
The
practitioner's DEA registration number; |
| (e) |
A list of cost codes, or identification
symbols on package(s) stolen; and |
| (f) |
A list of controlled substances
missing. |
|
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. |
