5/11/2026 – Gilead and Amphastar Start Using Truzo to Implement Contract Pharmacy Restrictions

Gilead and Amphastar recently became the fourth and fifth manufacturers to announce use of the Truzo platform operated by Kalderos to administer their 340B restrictions for select drugs for covered entities using contract pharmacies. Amphastar is implementing its contract pharmacy restrictions for the first time. Gilead has not substantively changed its contract pharmacy policy. Covered entities are not legally required to submit claims data, but they lose 340B discounts if they do not and HRSA has not taken any action since 2022 to contest these manufacturer policies.

Since January 2024, Gilead has required covered entities seeking to purchase certain branded hepatitis C products – including Epclusa, Harvoni, Sovaldi, and Vosevi – at 340B pricing through contract pharmacies  to submit claims data through ESP. Gilead refuses to provide 340B discounts through contract pharmacies to covered entities that elect not to provide claims data, except that covered entities without an in-house pharmacy may designate a single contract pharmacy location for 340B purchases.  Gilead’s policy states that claims data should be submitted through ESP until June 14, 2026 and to Truzo beginning June 15, 2025.

Amphastar is applying its restrictions to all covered entity types and is requiring claims data to be submitted within 45 days of each dispense.  Amphastar’s restrictions apply only to the drug Baqsimi, a nasal powder used to treat emergency low blood sugar.

Manufacturer-aligned technology company Kalderos officially launched Truzo in September 2024 as a platform to facilitate manufacturers’ administration of upfront discount and rebate models across the 340B program and other government pricing programs. Truzo gained attention when Eli Lilly identified it as the platform Eli Lilly would use in its proposed rebate model submitted to HRSA for approval in 2024.

In November and December of 2025, respectively, Alkermes and Puma transitioned from ESP to Truzo to administer their contract pharmacy policies. Organon then announced in an April 2026 notice that it would move its 340B contract pharmacy claims review and policy oversight functions from ESP to Truzo effective May 1.

Following Organon’s transition to Truzo, Kalderos began sending emails to covered entities’ Authorizing Officials stating that Truzo registration is required to access Organon and Gilead products through contract pharmacies. The emails urge covered entities to register by a specified deadline or “as soon as possible.”

Registration with Truzo is a multi-step process requiring a covered entity’s Authorizing Official to: (1) validate the organization’s profile; (2) designate a primary administrator and additional users; (3) complete attestations regarding the entity’s pharmacies and child sites; and (4) designate the entity-owned and/or contract pharmacies eligible to receive 340B pricing under each participating manufacturer’s policy. Covered entities using the platform must also agree to Truzo’s applicable Terms of Use.

Several Powers clients have asked Powers to analyze the Truzo platform and the legal and operational implications of its Terms of Use. Please contact Powers’ drug pricing team or your lead Powers attorney if you are interested in receiving this analysis or have any questions about Truzo.