| (a) Applicability. This section applies to the delivery
of prescription drugs by a pharmacy licensed by the board as a Class
A, Class A-S, Class E, or Class E-S pharmacy.
(b) Delivery by common carrier. A pharmacy may deliver
prescription drugs by use of a common carrier (e.g., U.S. Mail) as
provided in §291.9 of this title (relating to Prescription Pick
Up Locations) on request of the patient or patient's agent. Common
carrier means a person or entity who holds out to the general public
a willingness to provide transportation of property from place to
place for compensation in the normal course of business. A pharmacy
that delivers prescription drugs by use of a common carrier providing
a same-day courier service is not subject to subsection (b) of this
section and shall comply with subsection (c) of this section.
(1) Standards. The pharmacy shall ensure that all prescription
drugs are delivered to the patient or patient's agent in accordance
with nationally recognized standards, such as those of the manufacturer
or the United States Pharmacopeia.
(2) Packaging. The pharmacy shall ensure that prescription
drugs are packaged in commercially available tamper evident packaging.
(3) Temperature. The pharmacy shall ensure that any
prescription drug delivered by common carrier is packaged in a manner
that maintains a temperature range appropriate for the drug. This
may include, without limitation, use of temperature tags, time temperature
strips, insulated packaging, gel ice packs, or a combination of these
as necessary.
(4) Irregularity in delivery. The pharmacy shall provide
a method by which a patient or patient's agent can notify the pharmacy
as to any irregularity in the delivery of the patient's prescription,
to include but not be limited to:
(A) timeliness of delivery;
(B) condition of the prescription drug upon delivery;
and
(C) failure to receive the proper prescription drug.
(5) Refusal to deliver. The pharmacy shall refuse to
deliver by common carrier a prescription drug which in the professional
opinion of the dispensing pharmacist may be clinically compromised
by delivery by common carrier.
(c) Delivery by pharmacy employee or common carrier
providing a same-day courier service. A pharmacy may deliver prescription
drugs by means of its employee or a common carrier providing a same-day
courier service as provided in §291.9 of this title on request
of the patient or patient's agent.
(1) Standards. The pharmacy is responsible for any
problems in the delivery of the prescription drug.
(2) Temperature. The prescription drug shall be maintained
within the temperature range allowed by the United States Pharmacopeia
or recommended by the manufacturer until the delivery has been received
by the patient or patient's agent.
(d) All deliveries. A pharmacy that delivers prescription
drugs by common carrier or by pharmacy employee or by a common carrier
providing a same-day courier service shall also comply with the following:
(1) Counseling information. The pharmacy shall comply
with the requirements of §291.33(c)(1)(F) of this title (relating
to Operational Standards).
(2) Notification of delivery. The pharmacy shall notify
the patient or patient's agent of the delivery of a prescription drug.
(3) Compromised delivery. If a pharmacist determines
a prescription drug is in any way compromised during delivery, the
pharmacy shall replace the drug or arrange for the drug to be replaced,
either by promptly delivering a replacement to the patient or by promptly
contacting the prescriber to arrange for the drug to be dispensed
to the patient by a pharmacy of the patient's or patient's agent's
choice.
(4) Records. The pharmacy shall maintain records for
two years on the following events:
(A) when a prescription drug was sent and delivered
to the patient or patient's agent; and
(B) patient complaints regarding compromised deliveries,
which may be documented in the patient profile.
(5) Controlled substances. A pharmacy shall comply
with all state and federal laws and rules relating to the delivery
of controlled substances.
|
