Missouri’s New Year Resolution: New Prescription Delivery Requirements for Mail Order Pharmacies

Effective December 30, 2024, significant revisions to the Missouri Board of Pharmacy’s Rule 20 CSR 2220-2.013 (Prescription Delivery Requirements) will kick in, introducing new patient safety measures for pharmacies that mail or ship prescriptions. The Missouri Board of Pharmacy issued formal guidance on this new requirement. Pharmacies mailing or shipping prescriptions/medication orders to Missouri patients must comply with the following:

Updated Policies and Procedures

Pharmacies engaged in mailing or shipping prescriptions must implement and adhere to detailed written policies and procedures covering:

• Packaging Integrity: Proper packaging materials must be used to maintain the stability and integrity of medications as per manufacturer specifications.
• Patient Notification: Pharmacies are required to notify patients of shipments before mailing or delivery, maintaining records of notification method and date.
• Temperature Excursions: Clear protocols must address suspected or confirmed deviations from required temperature standards, including notification of pharmacy staff and resolution measures.
• Complaint Handling: Procedures must be in place to address reports of compromised prescription integrity during delivery.

Temperature Control Requirements

The revised rule emphasizes maintaining medications within required temperature ranges during transit. Pharmacies should ensure that:

• Staff are trained to manage temperature deviations.
• Quality assurance processes include periodic reviews of third-party carrier practices.

Mandatory Patient Notifications

Under the new requirements, pharmacies must:

• Provide advance notification to patients for all shipments (new and refill prescriptions).
• Include written instructions with each shipment on identifying compromised medications and reporting issues such as delivery delays or incorrect orders.

Exemptions to the Rule

The revised requirements do not apply to:

• Deliveries made by pharmacy staff.
• Medications transported by health care providers for administration.
• Radiopharmaceuticals or inter-pharmacy shipments under shared service arrangements.

Compliance Timeline and Resources

The rule changes become effective on December 30, 2024. The Missouri Board of Pharmacy will host a free compliance webinar in January 2025 to provide additional guidance. Pharmacies are encouraged to act now to review and update their delivery policies.

If you or your organization have questions or would like to further discuss potential impacts of the new law, please contact your Quarles attorney or:

• Nick Meza: (602)-229-5439 / nicholas.meza@quarles.com
• Susan Brichler Trujillo: (602)-229-5318 / susan.trujillo@quarles.com
• Aaron Sagedahl: (612)-351-5054 / aaron.segedahl@quarles.com