In yet another escalation of data transparency requirements, AstraZeneca has joined the ranks of Eli Lilly and Novo Nordisk and announced that effective May 1, 2026, covered entities must submit pharmacy and medical claims data for all 340B purchases, including in-house pharmacy dispensations, as a condition of accessing 340B pricing. According to the April 13, 2026 notice issued by the UK-based pharmaceutical giant, any failure to provide complete, timely, and accurate data “may result in suspension of 340B pricing access until such data is submitted and validated.” In similarity to Eli Lilly and Novo Nordisk, AstraZeneca is taking the position that the data is necessary to prevent duplicate discounts and minimize diversion.
A copy of the full notice can be accessed here. Covered entities who have not already done so should promptly assess the operational, legal, and compliance implications of these requirements and coordinate with counsel and internal stakeholders to implement appropriate protocols to ensure the required data is provided in a timely manner so as to avoid disruption to their continued access to 340B pricing and any associated cost savings.
Should you have any questions regarding the above or need help addressing 340B compliance requirements, please contact the author, the Garfunkel Wild attorney with whom you regularly work, or contact us at [email protected].