Chapter 480-48-0.37-.04 Delivery by Mail

(1) As a response to the current state of emergency as declared by the Governor, the Georgia State Board of Pharmacy finds the potential for imminent peril to the public health, safety, or welfare of Georgia citizens. This emergency rule shall go into effect based on O.C.G.A. 50-13-4(b) and shall be effective for the duration of the emergency or a period of not more than 120 days, whichever is shorter. During the time this rule is effective, it shall replace Georgia State Board of Pharmacy Rule 480-48.

(2) Definitions. For purposes of this chapter of the Rules and Regulations, the following definitions apply:

(a) "Board" shall mean the Georgia Board of Pharmacy.

(b) "Delivery by Mail" or "delivered by mail" or "delivery by mail" shall mean delivery to a patient or the patient's designee by the United States Postal Service or by a commercial common carrier from the pharmacy which fills the prescription.

(c) "Delivery by Pharmacy" shall mean delivery directly to a patient or patient's designee from the pharmacy by contract or private carrier or by an employee of the pharmacy.

(d) "Mail order pharmacy" shall mean a pharmacy that uses delivery by mail as a means of delivery of a prescription drug to a patient or the patient's designee.

(e) "Pharmacy" means a pharmacy holding a current Board issued license to operate a pharmacy in Georgia, including pharmacy benefit managers required to be licensed pursuant under O.C.G.A. § 26-4-110.1, and nonresident pharmacy permit holders.

(3) Conditions for Use of Delivery by Mail.

(a) Any pharmacy can regularly employ the U.S. Postal Service or a common commercial carrier to deliver a drug which requires a prescription to a patient only after the patient has requested that a pharmacy deliver by mail his/her filled prescription drugs. Any pharmacy providing delivery by mail to its patients is required to follow applicable Georgia laws and rules.

(b) A mail order pharmacy located outside this state is required to follow all applicable pharmacy and drug rules and laws of the state in which the pharmacy is physically located.

(c) A mail order pharmacy shall ensure that all prescription medications are delivered to the patient in accordance with standards of the manufacturer, United States Pharmacopeia, Federal Food and Drug Administration and other recognized standards. A pharmacy shall ensure integrity of any drug requiring temperature control other than "room temperature storage" that is delivered by mail order and provide a notification to the patient of the timeliness in addressing the proper storage of the medication.

1. The shipping method may include the use of temperature tags, time temperature strips, insulated packaging, or a combination of these.

2. The notification method may be by verbal, written, electronic, or other technological means. If verbal, then the pharmacy must document the notification and maintain such documentation.

(d) Any pharmacy using delivery by mail to deliver dispensed prescription drugs shall comply with the following conditions:

1. Any pharmacy that uses delivery by mail is accountable to the Board to arrange for the appropriate mailing/shipping process.

2. A mail order pharmacy shall provide a method by which a patient or patient's caregiver can notify the mail order pharmacy as to any irregularity in the delivery of their medication to include but not be limited to:

(i) Timeliness of delivery;

(ii) Condition on the prescription drug upon delivery; and

(iii) Failure to receive the proper prescription drug.

(e) A mail order pharmacy shall provide a process by which, if the delivery of a prescription medication is in any way compromised, the pharmacy will replace the patient's medication, to be delivered by next-day delivery or the mail order pharmacy will immediately contact the patient's prescriber to arrange for a prescription for a minimum seven (7) day supply of the medication to be dispensed to the patient by a licensed pharmacy of the patient's choice.

(f) A pharmacy that employs delivery by mail must provide written information, set forth in Board Rule 480-31-.01, for each drug that is delivered, and a method of electronic or telephonic communications for a pharmacist or a Georgia-licensed pharmacy intern under direct supervision of the pharmacist to provide consultation or counseling in accordance with the obligations of O.C.G.A. § 26-4-85. All such counseling will be documented in the pharmacy's patient records. It is sufficient proof to show counseling was refused if a patient or patient's caregiver does not contact the pharmacy.

(g) The pharmacy shall provide information to the patient on the procedure that the patient should follow if any prescription drug does not arrive in a timely manner, or if the integrity of the packaging or medication has been compromised during shipment and delivery by mail.

(h) A pharmacy using delivery by mail shall document in its records when the prescription drug was sent to the patient.

(i) A pharmacy using delivery by mail shall document the instances when prescription drugs have been compromised during shipment and delivery by mail or when drugs do not arrive in a timely manner, and shall maintain such documentation for two (2) years. In addition, the mail order pharmacy shall maintain reports of patient complaints and internal/external audits about timeliness of deliveries, condition of the medication when received by patient including medication that was compromised in delivery, misfills of prescriptions, and the failure of a patient to receive medication. Such records shall be provided to the Board, upon request.

(j) A pharmacy or a pharmacist shall refuse to deliver by mail a prescription drug which, in the professional opinion of the pharmacy or pharmacist may be clinically compromised by delivery by mail.

(k) A mail order pharmacy shall make available to the patient or the patient's caregiver contact information of the Board of Pharmacy.

(4) Delivery by Pharmacy. Any pharmacy may provide for delivery by pharmacy upon the request of the patient or the patient's designee. The Board will hold the pharmacy responsible for any problems in the service of delivery by pharmacy. In order for a delivery to be considered delivery by pharmacy, the delivery must be on a continuous route from the pharmacy to the patient or the patient's designee. All medications shall be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed.

Authority O.C.G.A. § 50-13-4(b)