20 CSR 2220-2.013 - Prescription Delivery Requirements
(1) Every
pharmacy delivering, mailing, or shipping a filled prescription or medication
order shall develop and implement written policies and procedures to ensure the
safe and appropriate delivery, mailing, and shipment of
prescriptions/medication orders within the temperature requirements recommended
by the manufacturer or the United States Pharmacopeia (USP). Except as
otherwise provided herein, prescriptions/ medication orders filled by a
Missouri licensed pharmacy may not be left at, accepted by, or delivered to a
location, place of business or entity not licensed as a pharmacy.
(2) At the request of the patient or the
patient's authorized designee, licensees may deliver a filled prescription/
medication order for an individual patient directly to the patient or the
patient's authorized designee or to -
(3) At the request of a customer, legally
filled prescriptions/ medication orders for veterinary use may be delivered,
mailed, or shipped to a residence, business, or clinic designated by the
customer.
(4) Licensees shall
comply with all applicable controlled substance laws and regulations,
including, but not limited to, all applicable security requirements.
(5) Unless otherwise exempted by this rule or
other law, all pharmacies delivering prescriptions/medication orders by mail or
common commercial carrier to a patient, the patient's authorized designee, or a
delivery location authorized by this rule pursuant to a patient's request must
comply with the following:
(A) A reasonable
attempt must be made to notify the patient verbally, electronically, or by
other written means that a prescription/medication order will be shipped or
mailed to the patient or the patient's authorized delivery location identified
in section (2) prior to shipment/mailing. Proof of patient notification, or
documentation of the date and method of notification, must be maintained in the
pharmacy's records and readily retrievable if requested by the board or the
board's authorized designee;
(B)
Patients must be provided the following written instructions notifications with
each prescription/medication order mailing or shipment in a manner that is
clear, conspicuous, and easily visible by the patient or the patient's
authorized designee:
1. Notification that the
pharmacy is licensed and regulated by the Missouri Board of Pharmacy along with
the board's current address, telephone number, and primary email
address;
2. Instructions on how to
detect if the integrity of a prescription or medication order has been
compromised due to improper storage or temperature variations; and
3. Instructions and a mechanism for notifying
the pharmacy verbally or electronically of any suspected or confirmed
irregularity in the delivery of their medication, including but not limited to
-
A. Timeliness of delivery;
B. Integrity of the prescription/medication
order on delivery; and
C. Failure
to receive the proper prescription/medication order;
(C) In addition to the
requirements of section (1), pharmacies offering to mail or ship
prescription/medication orders or regularly engaged in mailing or shipping
prescriptions/ medication orders must maintain current written policies and
procedures that include policies/procedures for-
1. Mailing and shipping
prescriptions/medication orders, including but not limited to notifying
patients of shipments/ deliveries as required in this rule and using/selecting
proper packaging containers and materials to maintain physical integrity and
stability of package contents per manufacturer product labeling or manufacturer
specifications;
2. Handling reports
or complaints that the integrity of a prescription/medication order was or may
have been compromised or adulterated during mailing or shipment; and
3. Actions to be taken in the event of a
suspected or confirmed temperature excursion, including but not limited to
policies/procedures for notifying appropriate pharmacy staff. For purposes of
the rule, a "temperature excursion" means any deviation from the manufacturer's
temperature specifications or allowed excursion range or, in the absence of
manufacturer specifications, applicable USP temperature standards;
(D) For purposes of this rule, a
common commercial carrier means any person or entity who undertakes directly or
indirectly to transport property for compensation for or on behalf of the
pharmacy, including prescription drugs or devices. A common commercial carrier
does not include pharmacy staff or employees delivering
prescriptions/medication orders as part of their pharmacy job responsibilities,
or transportation of a prescription/medication order from the pharmacy by a
healthcare provider or an individual designee of the healthcare provider for
administration to the patient by the healthcare provider or the healthcare
provider's authorized designee.
(E)
The provisions of subsections (5)(A) and (B) are not applicable to
radiopharmaceuticals mailed/shipped to a medical facility for administration to
the patient by an authorized healthcare provider, prescriptions/medication
orders shipped or mailed from one pharmacy to another for subsequent dispensing
to the patient as authorized by law, or prescriptions/medication orders mailed
or shipped to a longterm care facility.
(6) Returns of medication delivered pursuant
to this section shall be governed by, and handled in accordance with, Chapter
338, RSMo, and the rules of the board.
(7) Records required by this rule must be
maintained in compliance with
20 CSR
2220-2.010.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.