Oklahoma Board of Pharmacy Proposes Temperature Control Rule for Shipping Drugs

Oklahoma may be the first state in the Union to require temperature-controlled shipping containers when mailing prescription medications, that is if the state adopts the Board of Pharmacy's proposed regulation.

The proposed rule will require pharmacies to maintain "qualified packaging systems and/or devices" to ensure drug stability and potency. Such qualified packaging systems must be tested to ensure they can maintain a specific temperature range for the duration of the shipping process. The temperatures that must be maintained are those temperatures included on the drug manufacturer's labeled storage requirements. Additionally, patients will have to be notified of the incoming shipment, and if the vehicles used for shipping have the same environmental controls in the cargo portion of the vehicle as the driver, the driver will be required to maintain the proper temperature in the vehicle to ensure the drugs are kept within the allowed temperature range.

Oklahoma's proposed rule differs from the current standards included in the United States Pharmacopeia ("USP"). The USP only states manufacturers and pharmacies should have temperature risk and mitigation strategies for the storage and transportation of finished drug products. The Oklahoma provisions go further by creating actual delivery standards pharmacies must follow.

For example, the proposed rule has specific requirements for delivery vehicles, requiring environmental moderation to ensure that drugs are kept within the temperature requirements recommended by the manufacturer or USP, and the use of temperature moderating devices to deal with weather extremes, if anticipated. This is not included in the USP, and thus creates additional requirements for mail order pharmacies shipping product into Oklahoma. If vehicles do not have environmental moderation, Qualified Packaging Systems must be used to maintain "Appropriate Temperatures" (the manufacturer's labeled storage requirements with the USP definitions for controlled cold and controlled temperature outlining temperature allowances during shipping and how to address temperature excursions).

The Board has voted to approve the proposed draft regulation, which has been submitted to the state's governor and legislature for their review. Quarles will continue to monitor the progress of this regulation and will send an alert when we have more information about the timeline for implementation.

If you have any questions regarding the Oklahoma Board of Pharmacy's proposed temperature regulation, please contact your Quarles attorney or:

• Susan Trujillo: (602) 229-5318 / susan.trujillo@quarles.com

• Christopher Dang: (602) 230-5530 / christopher.dang@quarles.com
• Benjamin Lockwood: (414) 277-5661 / ben.lockwood@quarles.com