Revised Amendments to Texas Central Fill Rule Address Concerns for Misinterpretation
Health & Life Sciences 05/09/22 Nicholas H. Meza, Roger N. Morris, Edward D. Rickert, Katie E. Lavigne
On May 3, 2022, the Texas Board of Pharmacy reviewed proposed amendments to its Central Fill Rule, 22 Tex. Admin. Code § 291.125, and voted to send the revised language for final adoption in the next Board meeting tentatively scheduled for August 2022. In February, the Board directed staff to redraft the proposed amendments to its Central Fill Rule after receiving public comment. While public comments generally voiced support for the proposed amendment, there were concerns the initial draft had potential for misinterpretation. In the May meeting, the Board noted that the most recent revisions addressed the public's concerns.
The revised language of the proposed amendments adds a Class E pharmacy to the definitions of "centralized prescription dispensing" and "outsourcing pharmacy" in § 291.125. The revised language clarifies that a Class E pharmacy may outsource prescription drug order dispensing to a central fill pharmacy in the state. Finally, the revised amendment addresses published public concerns that a strict reading of the amended rule would impose licensure requirements on nonresident pharmacies receiving centralized prescription dispensing services from a resident Texas pharmacy, regardless of whether the nonresident pharmacy serves patients in Texas. This language now emphasizes that nothing in § 291.125 requires a nonresident pharmacy that outsources drug order dispensing to a resident Texas central fill pharmacy to be licensed as a Class E pharmacy if that pharmacy does not physically ship, mail, or deliver prescription drugs or devices directly to a patient or patient’s agent in Texas.
Quarles & Brady will continue to monitor developments with respect to the Texas Board of Pharmacy’s central fill rules. If you are seeking further guidance or if you have any specific inquiries, please contact your local Quarles & Brady attorney, or: