(1) 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.
(2) 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.
(3) 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.
(a) The
shipping method may include the use of temperature tags, time temperature
strips, insulated packaging, or a combination of these.
(b) 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.
(4) Any pharmacy using delivery by
mail to deliver dispensed prescription drugs shall comply with the following
conditions:
(a) Any pharmacy that uses
delivery by mail is accountable to the Board to arrange for the appropriate
mailing/shipping process.
(b) 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:
1. Timeliness of delivery;
2. Condition on the prescription drug upon
delivery; and
3. Failure to receive
the proper prescription drug.
(c) Medications designated as requiring
special handling by this rule must be signed for upon delivery by the patient
or patient's designee. In the event that the medication cannot be delivered,
the package will not be left behind and shall be returned to the mailing or
shipping service to be held for pickup until signed for by the patient or the
patient's designee, or redelivered to the patient if so requested by the
patient or the patient's caregiver. The Board has designated the following
drugs as requiring special handling:
1. All
Schedule II, III, IV, and V controlled substances
(d) 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.
(e) 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.
(f) 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.
(g) A pharmacy using delivery
by mail shall document in its records when the prescription drug was sent to
the patient.
(h) 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.
(i) 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.
(j) A mail order pharmacy shall make
available to the patient or the patient's caregiver contact information of the
Board of Pharmacy.