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.
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.
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:
Patient's full name;
address for a controlled substance;
3. Drug name, strength, and dispensing
4. Patient directions for
5. Date of issuance;
6. Prescriber's signature;
7. Prescriber's address and drug enforcement
administration identification code, if applicable;
8. Refill instructions.
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;
5. Compounded, sterile parenteral products
7. Drug content and
9. Prescription serial
10. Identification of
drugs patient is receiving;
Patient's drug sensitivities and allergies to drugs and foods;
13. Primary diagnosis of the
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
3. Patient's full
4. Name of each drug (brand
or generic), strength, and amount;
5. Directions for use to the patient,
including infusion rate;
precautionary information regarding controlled substances;
8. Date and time of compounding;
9. Expiration date and expiration time of the
10. Identity of
pharmacist compounding and dispensing the product.
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
1. Patient profile;
2. Prescription record;
3. Inventories of the pharmacy;
4. Biennial controlled substances
5. Policy and
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
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.
Ga. Comp. R. & Regs.
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.