Texas Board of Pharmacy to Review Central Fill Rules for Potential Change
At its upcoming February 1, 2022 meeting, the Texas Board of Pharmacy will review and discuss a potential rule change that may have serious implications for resident Texas pharmacies providing central fill or prescription fulfillment services in the state.
In late 2021, some resident Texas pharmacies were informed by Texas Board of Pharmacy inspectors that existing rules do not permit resident Texas pharmacies to perform central fill services for nonresident or Class E pharmacies. Note, however, that Class E pharmacies are still permitted to perform central fill services for Texas resident Class A or Class C pharmacies.
After years of permitting cross-state central fill arrangements whereby Texas pharmacies provide central fill services for pharmacies in other states, Board staff have taken a stricter reading of the applicable rule. The Board's position is based on the definitions of "centralized prescription dispensing" and "outsourcing pharmacy" under 22 Tex. Admin. Code § 291.125. The applicable definitions state:
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.
(1) Central fill pharmacy--a Class A, Class A-S, Class C, Class C-S, Class E, or Class E-S pharmacy that prepares prescription drug orders for dispensing pursuant to a valid prescription transmitted to the central fill pharmacy by an outsourcing pharmacy.
(2) Centralized prescription dispensing--the dispensing or refilling of a prescription drug order by a Class A, Class C, or Class E pharmacy at the request of another Class A or Class C pharmacy [No CLASS E Listed] and the return of the dispensed prescriptions to the outsourcing pharmacy for delivery to the patient or patient's agent, or at the request of the outsourcing pharmacy for direct delivery to the patient.
(3) Outsourcing pharmacy--a Class A or Class C pharmacy [No CLASS E Listed] that transmits a prescription drug order via facsimile or communicates prescription information electronically to a central fill pharmacy to be dispensed by the central fill pharmacy.
22 Tex. Admin. Code § 291.125(b)(1) - (3).
Per Board staff, the definitions do not contemplate Class E (or nonresident) pharmacies serving as originating or requesting pharmacies in a central fill arrangement. Thus, under this interpretation, no resident Texas pharmacy may provide central fill services for any out-of-state pharmacy. Despite this new interpretation, the Board is exercising enforcement discretion until it can discuss and potentially implement a modification of the existing rule to permit such arrangements. Absent such a change, non-resident pharmacies involved in central fill arrangements with Texas pharmacies will be required to perform a full legal transfer of prescriptions in order for Texas pharmacies to lawfully fill such prescriptions.
Pharmacies engaged in central fill arrangements in Texas may submit written comment for the Board's consideration by Wednesday, January 26th and are invited to provide comments during open session at the February 1, 2022 meeting.
Quarles & Brady will continue to monitor developments with respect to the Texas Board of Pharmacy potential change in central fill rules. If you are seeking further guidance or if you have any specific inquiries, please contact your local Quarles & Brady attorney, or: