Oklahoma Prescription Shipping Proposed Rules
| by: Deneen Fumich, RPh | Article Posted: January 4, 2023 |
Controlled Temperature of Prescription Drugs Shipped to Residents of Oklahoma
Oklahoma submitted to the Governor and Legislatures proposed rule changes to Title 535, Chapter 15 Pharmacies, OAR.
The proposed Rule change focuses on Prescription Shipping requirements for products shipped to Residents of Oklahoma, to include qualified packaging systems, maintenance of temperature according to the manufacturers labeled storage and provide to the Board evidence upon request that the shipping system meets the definition of a Qualified Packaging system for each category (frozen, refrigerated, room temperature) of medications shipped.
Specialty Pharmacies, Compounding Pharmacies, and Mail Order Pharmacies can you comply? Can you afford the cost to ensure that the medications shipped to customers residing in Oklahoma maintains the proper recommended manufacturer storage requirements and can you provide proof of such?
535:15-3-1.1. Definitions. “Qualified Packaging System” means a container, along with auxiliary materials, that have been tested to ensure the final system can maintain a specific temperature range for the duration of the shipping process.
535:15-3-9. Non-resident pharmacies
(a) Definitions. “Non-resident pharmacy” means a pharmacy, not located in Oklahoma, which transacts or does business in Oklahoma by soliciting, receiving, dispensing, and/or delivering prescription medications and devices to Oklahoma residents.
(j) Prescription shipping. The pharmacy shall maintain and use qualified packaging systems and/or devices to ensure drug stability and potency. Such shipping processes shall include the use of qualified packaging systems and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the shipping process.
(k) Prescription Delivery. Prescription drug delivery/same day delivery (24hrs) containers will be secured in the passenger or cargo portion of the delivery vehicle.
535:15-3-11. Prescription drugs
(f) Prescription shipping.
(1) Any pharmacy which ships medications to residents of Oklahoma must provide evidence to OSBP upon request that the shipping system meets the definition of a Qualified Packaging System for each category (frozen, refrigerated, room temperature) of medications shipped. The Notice of Intent has been published and open comment period started Deccember 15, 2022 with comment submissions through January 23, 2023 at 3:30 p.m. to Marty Hendrick at 2920 N LINCOLN BLVD STE A, OKLAHOMA CITY OK 73105-4212 or by email to pharmacy@pharmacy.ok.gov.
The Board is requesting comments from business entities affected by these proposed rules are requested to provide the Board, within the comment period, in dollar amounts if possible, the increase in the level of direct costs such as fees and indirect costs such as record keeping, equipment, construction, labor, professional services, revenue loss, or other costs expected to be incurred due to compliance with the proposed rule(s).
A public hearing is scheduled for Wednesday, February 1, 2023 at 1:30pm.
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