Ga. Comp. R. & Regs. R. 480-21-.05 - Drug Distribution and Control

Regulations are:

(a) General. A drug distribution system is the entirety of that mechanism by which a physician's prescription drug order is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient.

(b) Purchasing. All drugs and pharmaceutical products purchased and dispensed by a retail pharmacy providing home health care services shall meet national standards of quality (USP-NF standards) and shall be clearly and accurately labeled by the manufacturer or distributor as to contents.

(c) Policy and Procedure Manual. A policy and procedure manual shall be prepared and maintained at each retail pharmacy providing home health care services and be available for inspection by agents of the Georgia Drugs and Narcotics Agency. The policy and procedure manual shall set forth in detail the objectives and operational guidelines of the pharmacy. The manual shall be reviewed and revised at a minimum on an annual basis. A copy shall be provided to the Board of Pharmacy when applying for a permit or engaging in this specialized area of practice.

(d) Prescription Drug Order. The pharmacist or pharmacy intern/extern acting under the direct supervision of a licensed pharmacist must receive a written or verbal prescription drug order from a physician before dispensing any compounded, sterile parenteral product or other drug. Prescriptions drug orders may be filed by patient, assigned consecutive numbers, or any other system that assures a complete, retrievable and accurate record. A new prescription drug order is required every six (6) months if the physician does not specify a course of therapy. These prescriptions drug orders shall, at a minimum, contain the following:

1. Patient's full name;

2. Patient address for a controlled substance;

3. Drug name, strength, and dispensing quantity;

4. Patient directions for use;

5. Date of issuance;

6. Prescriber's signature;

7. Prescriber's address and drug enforcement administration identification code, if applicable;

8. Refill instructions.

(e) Patient Profile. A pharmacy generated patient profile that may be separate from the prescription file must be maintained for each patient. The patient profile shall be maintained under the control of the pharmacist-in-charge for a period of two years after the last dispensing activity. The patient profile shall contain, at a minimum:

1. Patient's full name;

2. Age;

3. Weight;

4. Sex;

5. Compounded, sterile parenteral products dispensed;

6. Date dispensed;

7. Drug content and quantity;

8. Patient directions;

9. Prescription serial number;

10. Identification of dispensing pharmacist(s);

11. Other drugs patient is receiving;

12. Patient's drug sensitivities and allergies to drugs and foods;

13. Primary diagnosis of the patient.

(f) Labeling. Each compounded, sterile parenteral product dispensed to outpatients shall be labeled with the following information with a permanent, non-removable label:

1. Name, address, and telephone number of the retail pharmacy providing home health care services;

2. Date and identifying prescription number;

3. Patient's full name;

4. Name of each drug (brand or generic), strength, and amount;

5. Directions for use to the patient, including infusion rate;

6. Prescriber's name;

7. Required precautionary information regarding controlled substances;

8. Date and time of compounding;

9. Expiration date and expiration time of the product; and

10. Identity of pharmacist compounding and dispensing the product.

(g) Records and Reports. The pharmacist-in-charge shall maintain appropriate records and reports as are required to ensure patient's health, safety, and welfare. Such records shall be readily available, maintained for two years, and subject to inspections by the Board of Pharmacy or its agents. These records shall include, as a minimum, the following:

1. Patient profile;

2. Prescription record;

3. Inventories of the pharmacy;

4. Biennial controlled substances inventories;

5. Policy and procedures manual;

6. Training manuals;

7. Policies and procedures for cytotoxic waste, if applicable;

8. Such other records and reports as may be required by law and rules and regulations of the Board of Pharmacy.

9. Delivery Service. The pharmacist-in-charge is responsible for the environmental control of all products shipped or delivered, and must ensure that all drug products are shipped in compliance with O.C.G.A. 26-4-60(a)(11). Therefore, any compounded, sterile parenteral product that is frozen, or requires refrigeration, must be shipped or delivered to a patient in appropriate coolers and stored appropriately in the patient's home.

Notes

Ga. Comp. R. & Regs. R. 480-21-.05

O.C.G.A. Secs. 16-13-34, 16-13-35, 16-13-39, 16-13-41, 16-13-72, 16-13-73, 26-4-27, 26-4-28, 26-4-29, 26-4-60, 26-4-83, 26-4-85, 26-4-87, 26-4-110, 26-4-110.

Original Rule entitled "Drug Distribution and Control" was filed on August 30, 1985; effective September 19, 1985. Repealed: New Rule of same title adopted. F. Feb. 20, 2002; eff. Mar. 12, 2002.