Current through Rules and Regulations filed through March 20, 2024
(1)
Area. A hospital pharmacy
shall have within the hospital 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 Pharmacy Laws. The hospital pharmacy space requirements should be a
minimum of 10 square feet per hospital bed, which includes all areas assigned
and under the direct control of the Director of Pharmacy.
(a) The pharmacy of substance abuse treatment
or mental health facility shall be exempt from the minimum square footage
requirement provided that the pharmacy receives a satisfactory inspection from
the Georgia Drugs and Narcotics Agency that shows that the pharmacy space is
sufficient to supply the needs of the patients and that all aspect of the
management and operations of the pharmacy comply with the law and the rules of
the Board to ensure that the health, safety, and welfare of the patients served
by the pharmacy are protected. No application for licensure of a pharmacy of a
substance abuse treatment or mental health facility seeking an exemption shall
be approved without a satisfactory inspection.
(b) "Mental health facility" shall mean a
specialized hospital, inpatient unit, or other institution that is licensed to
provide twenty-four (24) hour care and has as its primary function the
diagnosing and treating of patients with psychiatric disorders.
(c) "Substance abuse treatment facility"
shall mean a specialized hospital, inpatient unit, or other institution that is
licensed to provide twenty-four (24) hour care and has as its primary function
the diagnosing and treating of patients with substance use disorders.
(2) Equipment and supplies. Each
hospital pharmacy shall have sufficient equipment and physical facilities for
proper compounding, dispensing, and storage of drugs, including parenteral
preparations. The equipment and physical facilities shall include the
following:
(a) Compounding and dispensing
area:
1. A refrigerator in operating condition
with a thermometer, preferably a biological refrigerator;
2. A sink in operating condition with hot and
cold running water;
3. A Class A
Balance and an assortment of metric weights if utilizing a Class A Balance or a
Class I or II Electronic Balance, if compounding onsite using components which
must be weighed;
4. Graduates of
assorted sizes;
5. Mortar and
pestle;
6. Two (2) spatulas and a
counting tray;
7. Typewriter, word
processor, or computer with a label printer;
8. Pill tile; and
9. Other equipment as deemed necessary by the
Director of Pharmacy.
(b) Parenteral solution additives area as
required in
480-13-.06(2)(a);
1. Laminar flowhood; and
2. Facility for light-dark field
examination.
(c) Storage
and receiving area;
(d)
Manufacturing and packaging area; and
(e) Office space area.
(3)
(a) The
pharmacy of a substance abuse treatment or mental health facility shall be
exempt from (2)(a)(3.), (2)(b)(1.), and (2)(b)(2.) under the following terms
and conditions:
1. The Director of Pharmacy
attests that the pharmacy will purchase only commercially prepared medications
and intravenous preparations;
2.
The Director of Pharmacy attests that no compounding will occur
on-site;
3. The pharmacy includes
the attestations in its application for licensure as a hospital pharmacy;
and
4. The pharmacy receives a
satisfactory inspection from the Georgia Drugs and Narcotics Agency that shows
that in the absence of the equipment, the pharmacy is sufficient to supply the
needs of the patients and that all aspect of the management and operations of
the hospital pharmacy comply with the law and rules of the Board to ensure that
the health, safety, and welfare of the patients served by the pharmacy are
protected.
(b) No
application for licensure of a pharmacy of a substance abuse treatment or
mental health facility seeking an exemption shall be approved without a
satisfactory inspection.
(c)
"Mental health facility" shall mean a specialized hospital, inpatient unit, or
other institution that is licensed to provide twenty-four (24) hour care and
has as its primary function the diagnosing and treating of patients with
psychiatric disorders.
(d)
"Substance abuse treatment facility" shall mean a specialized hospital,
inpatient unit, or other institution that is licensed to provide twenty-four
(24) hour care and has as its primary function the diagnosing and treating of
patients with substance use disorders.
(4) Each hospital pharmacy shall maintain a
reference library which includes, at a minimum, the following:
(a) Copy of and/or electronic or computer
access to the latest edition of the Georgia Pharmacy Practice Act, the Georgia
Controlled Substances Act and the Rules and Regulations of the Georgia State
Board of Pharmacy;
(b) Copies of
and/or electronic or computer access to current reference materials appropriate
to the practice of the hospital pharmacy;
(c) Copy of and/or electronic or computer
access to the latest edition of the American Society of Health-system
Pharmacists Formulary Service;
(d)
Compatibility charts;
(e) Current
drug interaction references;
(f)
Current antidote information;
(g)
Copy of and/or electronic access or computer access to the latest edition of
text and reference works covering theoretical and practical pharmacy, reference
materials on general, organic, pharmaceutical and biological chemistry,
toxicology, pharmacology, sterilization and disinfection.
(5)
Storage. All drugs shall be
stored in the hospital pharmacy within designated areas which are sufficient to
insure proper sanitation, temperature, light, ventilation, moisture control,
segregation, and security. Drug storage cabinets and unit dose carts at the
nursing station shall be locked when the station is not in attendance by
nursing personnel.
(6) Controlled
drug storage for Schedule II drugs. An enclosed controlled room with limited
access capable of showing forced entry is preferable. However, a safe or metal
cabinet adequately locked that is permanently affixed to the structure is
acceptable.
(7) Unattended areas.
Whenever any area of a hospital pharmacy is not under the personal and direct
supervision of authorized personnel, such areas shall be locked.
(8)
Security. All areas occupied
by a hospital pharmacy shall be capable of being locked by key or combination,
so as to prevent access by unauthorized personnel by force. The Director of
Pharmacy shall designate in writing, by name and specific area, those persons
who shall have access to particular areas within the pharmacy. These areas
shall meet the security requirements of Federal and State Laws and Regulations.
Only those persons so authorized shall be permitted to enter these
areas.
(9)
Variances.
(a) The Director of Pharmacy may submit to
the Board a typed request for a variance to the provisions relating to minimum
equipment requirements. The reasons for the request for a variance must be
included. A variance may be granted by the Board only when, in the judgment of
the Board, there are sound reasons for granting the variance which relate to
the necessary or efficient delivery of health care. After consideration by the
Board, the Director of Pharmacy will be notified of the Board's decision in
writing.
(b) If approved, said
letter(s) will serve as proof of the Board's approval for each variance(s)
indicated in the letter, and shall be posted next to the Georgia Drugs and
Narcotics Agency inspection report.
O.C.G.A.
§§
26-4-27, 26-4-28, 26-4-80, 26-4-110.
