(1) Physical Area. An OTP clinic pharmacy
shall have within the clinic which it serves, sufficient floor space allocated
to it to insure that drugs are prepared in sanitary, well-lighted and enclosed
space, and which meet the other requirements of this section, the Georgia
Pharmacy laws, and other applicable state and federal laws and rules. Such
space shall be at a minimum 150 square feet. Such space shall include all areas
which are assigned and under the direct control of the Director.
Minimum equipment. No OTP clinic pharmacy
licensed in accordance with O.C.G.A. Title 26, Ch. 4 shall engage in the
practice of filling, compounding or dispensing prescription drugs for an OTP
Clinic unless it shall possess the following items:
(a) Copies of and/or electronic access to
current reference materials appropriate to the practice of pharmacy related to
OTP. These reference materials shall be authoritative on at least the topics of
drug interactions; patient counseling; compounding and pharmaceutical
calculations; and generic substitution.
(b) Authoritative, current antidote
information as well as the telephone number of the regional poison control
information center shall be posted or readily available in areas both inside
and outside of the pharmacy where drugs are stored or patients are being cared
Current copies or
electronic or computer access to the following:
1. The Georgia Pharmacy Practice Act/Drug and
Cosmetic Act, O.C.G.A. §§ 26-4 and 26-3;
2. The Georgia Controlled Substances
Act/Dangerous Drug Act, O.C.G.A. § 16-13;
3. The official rules of the Georgia State
Board of Pharmacy.
1. Sink in working condition with
both hot and cold running water;
3. One oral solid
4. Typewriter, word
processor or computer with label printer;
5. A refrigerator in working order with a
6. Any other equipment
the Board may deem necessary for a specialized practice setting where such a
specialized practice takes place.
Weighing and labeling:
1. Appropriate prescription labels consistent
with the requirements of O.C.G.A. §§ 16-13, 26-3 and 26-4;
2. Appropriate auxiliary labels
that should be used in the pharmacist's professional judgement.
3. If compounding onsite using components
which must be weighed, Class A Balance with an assortment of metric weights or
a Class I or II Electronic Balance.
(f) An adequate supply of drugs used in an
OTP Clinic setting.
sizes and types of appropriate dispensing containers.
The Director in an OTP clinic pharmacy
may submit to the Board a typed request for a variance to the provisions
relating to the minimum equipment requirements.
(a) The reason for requesting each variance
must be included in the typed request;
(b) A variance shall be granted by the Board
only when, in the judgement of the Board, there are sound reasons for doing so
which relate to the necessary or efficient delivery of health care.
(c) Any variance granted by the Board shall
be in writing, and the variance must be posted in the pharmacy next to the
current Board issued license certificate.
Ga. Comp. R. & Regs.
Original Rule entitled "Physical Requirements and Equipment"
adopted. F. Feb. 25, 2002; eff.
Mar. 17, 2002.
Amended: F. Apr. 13,
2021; eff. May 3, 2021.