Mo. Code Regs. tit. 20 § 2220-2.013

Current through Register Vol. 49, No. 24, December 16, 2024

Section 20 CSR 2220-2.013 - [Effective 12/31/2024] Prescription Delivery Requirements

PURPOSE: This rule establishes requirements for authorized prescription/medication order delivery sites.

(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.

20 CSR 2220-2.013

AUTHORITY: section 338.280, RSMo 2000, and sections 338.095, 338.100, 338.140, and 338.240, RSMo Supp. 2011.* Original rule filed May 14, 2012, effective Nov. 30, 2012.

Amended by Missouri Register November 15, 2024/volume 49, Number 22, effective 12/31/2024.

*Original authority: 338.095, RSMo 1993, amended 2007; 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011; 338.240, RSMo 1951, amended 2011; and 338.280, RSMo 1951, amended 1971, 1981.