NACDS Submits Comments to FDA on Expanding Access to Nonprescription Drugs
Comments emphasize the importance of coordinated policy and operational alignment to support affordable and seamless patient access.
Comments emphasize the importance of coordinated policy and operational alignment to support affordable and seamless patient access.
This delay is an acknowledgement of a much needed delay – advocated by NACDS, along with supply chain and other pharmacy partners – to address technical and operational issues that had the potential to create supply chain disruptions and adversely impact patients’ access to needed medications.
Seventy-two percent who support track and trace, and 70% of those who have experienced a medicine or health product shortage, back an extension of the DSCSA’s final implementation date.
“Specifically, we request FDA use its authority under the law for dispensers to comply with the EDDS requirements no earlier than February 27, 2026.”
A White House ceremony on Tuesday marked the end of the “X-waiver” requirement.
NACDS today welcomed the announcement by the U.S. Food and Drug Administration (FDA) that it revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), “to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.”
Diverse NACDS-backed provisions would enhance patients’ access to OTC hearing aids and to biosimilar and generic medications, and would maintain flexibility in drug disposal options.
Read the complete statement provided to The New York Times in January 2020.