Ga. Comp. R. & Regs. R. 480-18-.05 - Physical Requirements and Equipment

(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.
(2) 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 for.
(c) 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.
(d) Equipment:
1. Sink in working condition with both hot and cold running water;
2. Two spatulas;
3. One oral solid counting tray;
4. Typewriter, word processor or computer with label printer;
5. A refrigerator in working order with a thermometer.
6. Any other equipment the Board may deem necessary for a specialized practice setting where such a specialized practice takes place.
(e) Weighing and labeling:
1. Appropriate prescription labels consistent with the requirements of O.C.G.A. §§ 16-13, 26-3 and 26-4; and
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.
(g) Assorted sizes and types of appropriate dispensing containers.
(3) 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.

Notes

Ga. Comp. R. & Regs. R. 480-18-.05
O.C.G.A. §§ 16-13-34, 26-4-27, 26-4-28, 26-4-110, 26-4-111.
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.

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