With the start of the New Year, it is important for providers throughout the country to be aware of changes and new rules taking effect in 2025. For example, in Missouri, the State’s Board of Pharmacy has implemented new Rules and Regulations for mail order pharmacies. Specifically, effective December 30, 2024, the Missouri Board of Pharmacy (“the Board”) revised its Prescription Delivery Requirements (20 CSR 2220-2.013) to include added patient safety requirements for pharmacies that mail or ship prescriptions to patients. The Board issued guidance in anticipation of the changes and highlighted various requirements under the new Rules and Regulations, including that pharmacies regularly mailing or shipping prescriptions within or into Missouri must have written policies and procedures for various aspects of mail order delivery including:
- Mailing and shipping medications;
- Notifying patients regarding shipment/deliveries;
- Use of proper materials to safeguard the integrity and stability of medications per manufacturer specifications;
- Fielding reports regarding the possibility that medications either shipped or delivered may have had issues with integrity being compromised; and
- Identifying the steps to be taken if there is a suspected or confirmed temperature excursion.
For patient notifications, pharmacies must make reasonable efforts to notify patients that they will mail or ship the medication prior to sending the prescription. Such notification requirements apply to both original prescriptions and refills. The manner by which such notification is sent, e.g., verbal, electronic, writing, is left to the pharmacies’ discretion but should be reasonable and appropriate for the patients. Pharmacies must also keep proof of notification, notification date, and notification method. Additionally, Missouri pharmacies must also provide patients with:
- A notification that the pharmacy is licensed and regulated by the Board;
- The Board’s current address, phone number, and email address;
- Instructions on detecting if the integrity of the medication has been compromised; and
- Instructions on how to notify the pharmacy of any suspected or confirmed compromised medication.
Of note, these new patient notification requirements do not apply to pharmacies that use pharmacy staff, e.g., delivery drivers, to deliver medications. The patient notification requirements also do not apply in the following situations:
- Medications transported from the pharmacy by a healthcare provider for administration to a patient by the healthcare provider;
- Radiopharmaceuticals mailed or shipped to a medical facility for administration to the patient by an authorized healthcare provider;
- Medications mailed or shipped from one pharmacy to another pharmacy for dispensing to the patient as authorized by law; and
- Medications mailed or shipped to a long-term care facility for delivery or administration to resident patients by authorized long-term care staff.
In its guidance, the Board highlighted the importance of not only developing the written policies and procedures but also training pharmacy staff and personnel on the required policies and procedures. The Board also recommended that pharmacies review the policies and procedures for any third-party delivery or shipping companies, including specifically as it relates to maintaining temperature requirements during normal and customary delivery times, on a periodic basis.
It is vital that pharmacies impacted by these updates review and adjust their practices as needed to ensure compliance with the Board’s regulations.
How Frier Levitt Can Help
Frier Levitt has represented numerous licensees across the country in the pharmacy industry with an emphasis on Board of Pharmacy issues. We have successfully handled and defended a wide range of Board of Pharmacy work, as our attorneys have extensive knowledge of all aspects of Board of Pharmacy proceedings. Additionally, Frier Levitt has worked with pharmacies to ensure compliance when mailing/shipping prescriptions, including when mailing/shipping across state lines. Contact us today for assistance.
