After Years of Silence, New York Proposes New Rule Addressing Central Fill Arrangements
On June 28, 2023, the New York Education Department, which oversees the Office of Professions and Board of Pharmacy in the state, published long-awaited proposed regulations governing central fill arrangements in the state.
The proposed rule signals a pivot in the state to expressly permit central fill arrangements. Prior to 2018, the New York Board of Pharmacy (“the Board”) took the position that, because shared services and central fill arrangements are not addressed in statute or regulation, such arrangements were not prohibited. As such, multiple pharmacies in the state implemented central fill models under best practice and reasonable care standards. However, in 2018, the Board changed its position, stating that because such arrangements are not addressed in statute or rule, they are not permitted. This change of interpretation caught many pharmacies utilizing central fill arrangements off guard. In response, the Board informally “grandfathered” in many pharmacies operating central fill models and has generally been exercising enforcement discretion on this topic.
While the proposed rule is a welcome sign that central fill models may soon be expressly permitted in the state, stakeholders should be aware that the proposed rule is narrower and more limited than central fill rules in other states. The proposed rule would do the following:
- Create a new central fill pharmacy registration class;
- Prohibit central fill pharmacies from being open to the public;
- Require that central fill pharmacies only prepare and fill prescriptions sent from an originating pharmacy;
- Prohibit direct-to-patient central fill models;
- Require the originating pharmacy to obtain consent from the patient in writing before a prescription may be prepared by a central fill pharmacy;
- Requires an originating pharmacy to be able to prepare and dispense a prescription to a patient should the prescription not be received from the central fill pharmacy or the patient seeks to pick-up the prescription from the originating pharmacy before it has been prepared by a central fill pharmacy; and
- Requires nonresident pharmacies engaged in central fill models to comply with select provisions of the rule.
Notably, pharmacies already operating under a central fill model will have 12 months to comply with the new requirements of the regulation. Any pharmacy that does not comply after 12 months will be denied license renewal.
Stakeholders have until August 27, 2023 to submit comments on the proposed rule. Comments may be submitted to: Sarah S. Benson, Deputy Commissioner, Education Department, Office of the Professions, 89 Washington Avenue, 2nd Floor EB, West Wing, Albany, NY 12234, (518) 486-1727, email: REGCOMMENTS@nysed.gov. Public comments will be received until August 27th, 2023 (60 days after initial publication).
Quarles will continue to monitor developments with respect to New York’s proposed central fill rule. If you are seeking further guidance or if you have any specific inquiries, please contact your local Quarles attorney, or:
- Nicholas Meza: (602) 229-5439 / nicholas.meza@quarles.com
- Monica Wright: (317) 399-2836 / monica.wright@quarles.com