A notice was received from Abbvie, with an effective date of April 9, 2025, announcing the exemption of the state of Nebraska to their Contract Pharmacy Policy. 

A notice was received from AbbVie, effective February 27, 2025, several additions to their Contract Pharmacy Policy including additional NDC additions and Maryland exemption (with restrictions).

Effective January 1, 2025, Grantee covered entities that wish to facilitate bill to/ship to orders must register with 340B ESP and submit limited claims data on the 340B contract pharmacy utilization. There has also been a change to the Abbvie NDCS impacted by this policy. For more information, please visit https://340besp.com/

Effective August 28, 2024, AbbVie will exempt Missouri covered entities from its 340B contract pharmacy policy.

Contact: 
support@340besp.com

Effective August 1, 2024, AbbVie will no longer extend 340B-like voluntary pricing on its orphan-designated drugs to covered entities subject to the orphan drug exclusion. This change will not impact separate agreements with impacted covered entities.  

Contact: 
support@340besp.com

Effective May 1, 2024, AbbVie will include Venclexta products in its 340B contract pharmacy policy. Federal Grantees are not subject to limitations. 

Contact: 
support@340besp.com

A notice was received from Amgen, with an effective date of June 2, 2025, the exemption of the state of Tennessee to their Contract Pharmacy Policy.

A notice was received from Amgen, with varying effective dates, announcing the exemption of the states of Utah, South Dakota, and North Dakota to their Contract Pharmacy Policy.

Effective August 28, 2024, Amgen will exempt Missouri hospital covered entities from its 340B contract pharmacy policy 

Contact: 
support@340besp.com

membership@AstraZeneca.com

Contact:

membership@AstraZeneca.com

Effective October 1, 2024, Bayer will change to their 340B contract pharmacy policy to add federal grantees to their policy and require data submission within 45 days of date of dispense utilizing 340B ESP for all covered entities. 

Contact: 
support@340besp.com

A notice was received from Biogen, with an effective date of May 7, 2025, announcing the exemption of the state of Utah to their Contract Pharmacy Policy.

A notice was received from Biogen, with an effective date of April 10, 2025, the exemption of the state of Nebraska to their Contract Pharmacy Policy

Effective January 20, 2025 Biogen has made changes to their 340B contract pharmacy policy regarding all 340B covered entities (including hospital covered entities, federal grantee covered entities, and all contract pharmacies including wholly owned pharmacies). Data submission is also required via 340B ESP.  Arkansas, Louisiana, Kansas, Maryland, Minnesota, Missouri, Mississippi, and West Virigina are excluded from this policy.  

A notice was received from BMS, with an effective date of July 1, 2025, a change to their Contract Pharmacy Policy, including Augtyro.

A notice was received from BMS, effective immediately, a change to their 340B contract pharmacy policy to require claims-level data to be submitted within 45 days (previously 14 days) and new addition of serialization data point. 

October 22, 2024, Update:  On October 22, 2024, BMS notified HRSA of BMS’ intention to implement a rebate model to carry out their 340B pricing obligations with an effective date of Spring 2025  

November 26, 2024, Update:  BMS sued HRSA over its purported rejection of BMS’ plan to change the way it offers reduced prices on its medicines in the 340B program. 

Contact: 
BMS340B@bms.com

As announced by the BMS third party solution, they have capabilities to accept serialization as of 9/3/2024. Per BMS, they are deferring the requirement for covered entities to submit the product serialization number to allow for additional time for DSCSA compliance stabilization. FDA exemption for serialization requirements for manufacturers through May 27th, 2025.

Contact: 
BMS340B@bms.com

Effective October 1, 2024, BMS will allow for a fourth contract pharmacy for Krazati ®

Contact: 
BMS340B@bms.com

At this time, Clovis won’t be implementing its partnership with Kalderos to effectuate 340B drug discounted prices for 340B Contract Pharmacies. Clovis’ products remain available through all historically available channels.

Contact:
priceadmin@clovisoncology.com

August 2024 Update: In August 2024, Lilly notified HRSA of Lilly’s intention to implement its obligation to offer the 340B ceiling price to covered entities through a rebate via a cash replenishment model, for an effective date of November 1, 2024. 

November 15, 2024 Update: Lilly sued HRSA over its purported rejection of Lilly’s plan to change the way it offers reduced prices on its medicines in the 340B program, through its technology partner Kalderos. 

Effective September 1st, 2020, Lilly restricted access for 340B priced product to Contract Pharmacies, except insulin.

Contact:
340B@lilly.com

A notice was received from GSK, with an effective date of May 7, 2025, the exemption of the state of Utah to their Contract Pharmacy Policy.

Effective August 28, 2024, GSK will exempt Missouri hospital covered entities from its 340B contract pharmacy policy 

Effective August 1, 2024, GSK will allow covered entities located in Minnesota to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the state. For specialty/oncology products part of the limited pharmacy network, the contract pharmacies must be a part of GSK’s limited pharmacy network. 

Contact: 
support@340besp.com

Effective August 1, 2024, GSK will allow covered entities located in Minnesota to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the state. For specialty/oncology products part of the limited pharmacy network, the contract pharmacies must be a part of GSK’s limited pharmacy network.

Contact: 
support@340besp.com

Effective July 1, 2024, Johnson & Johnson will allow non-grantee entities located in Maryland and Mississippi to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the respective states through the provision of claims data.

Contact: 
340B_JJHCS@its.jnj.com

Effective January 1st, 2022, Janssen will no longer offer voluntary 340B pricing on orphan drugs to Covered Entities subject to the 340B orphan drug exclusion. This change will not impact separate agreements with impacted Covered Entities.

Contact: 
340B_JJHCS@its.jnj.com

Effective 9/30/2024, Johnson and Johnson will postpone their 340B Rebate Program announced on 8/23/2024.  Additionally, effective 8/20/2024, their contract pharmacy policy will exempt Arkansas covered entities and include claims data submission.

Contact: 
support@340besp.com

An email notice was received from Merck, a change to their 340B contract pharmacy policy for covered entities in Vermont, Tennessee, Hawaii, and Colorado.

A notice was received from Merck, with varying effective dates, the exemption of the states of Utah, Nebraska, South Dakota, and North Dakota to their Contract Pharmacy Policy. 

An email notice was received from Merck, effective April 9, 2025, a change to their 340B contract pharmacy policy for covered entities in Nebraska.

A notice was received from Merck, effective July 1, 2025, a change to their 340B contract pharmacy policy for covered entities in South Dakota, as well as changes to the requirements for mandatory claim submissions. 

Effective 08.01.24, Merck made a change to their 340B contract pharmacy policy for covered entities in Minnesota. Effective August 28, 2024, a change to their 340B contract pharmacy policy for covered entities in Missouri. 

Merck will provide 340B priced products to an unlimited number of contract pharmacies for Minnesota covered entities effective August 1, 2024, and Missouri covered entities effective August 28, 2024, through the provision of claims data. For Winrevair, the specialty contract pharmac(ies) must be within Merck’s limited pharmacy network.

Federal Grantees (except CH grantee entities) are not subject to limitations.

Contact: 
340bdata@merck.com

Effective July 17, 2024, Mallinckrodt will require a single contract pharmacy designation through FFF Enterprises, Inc. for Acthar ® claims for hospital covered entities using their limited distribution network.

Contact:

FFFCustomerCare@fffenterprises.com 

Effective January 1st, 2021, Novo Nordisk will restrict 340B priced product to Contract Pharmacies for hospital Covered Entities. Federal Grantees not subject to limitations.

Contact:
340BInfo@novonordisk.com

Effective August 1, 2024, Novartis will allow hospital covered entities located in Minnesota to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies.

Contact:

Novartis.340B@novartis.com

A notice was received from Pfizer, with an effective date of July 1, 2025, the exemption of the state of South Dakota to their Contract Pharmacy Policy. 

A notice was received from Pfizer, with varying effective dates, a change to their 340B Contract Pharmacy Policy exempting Colorado. 

A notice was received from Pfizer, with varying effective dates, a change to their 340B Contract Pharmacy Policy exempting Hawaii.

A notice was received from Pfizer, with an effective date of August 1, 2025, the exemption of the state of North Dakota to their Contract Pharmacy Policy.

A notice was received from Pfizer, for an effective date of 4/9/25, the exemption of Nebraska to their Contract Pharmacy Policy.

A notice was received from Pfizer, for an effective date of May 7, 2025, a change to their 340B Contract Pharmacy Policy with updates for Utah 340B hospital covered entities.  

Two notices were received from Pfizer, for an effective date of April 1, 2025, a change to their 340B contract pharmacy policy reinstating Kansas and West Virginia to their Contract Pharmacy Policy Restrictions. 
 

A notice was received from Pfizer, for an effective date of April 1, 2025, a change to their 340B contract pharmacy policy for the addition of Paxlovid NDCS to the Contract Pharmacy Policy.

Effective August 28, 2024, Pfizer will exempt Missouri hospital covered entities from its 340B contract pharmacy policy 

Contact:
340BCP@pfizer.com

Effective July 1, 2024, Pfizer will allow Maryland 340B covered entities to access 340B ceiling price for Pfizer products affected by their contract pharmacy policy. For Vyndmax and Vyndaquel, the specialty contract pharmacies must be part of the VYNDA Network. For Pfizer’s oral oncology medications, the specialty contract pharmacy must be part of Pfizer’s DON.

Federal Grantees not subject to limitations.

Contact:
340BCP@pfizer.com

Effective July 1, 2024, Pfizer will allow Maryland 340B covered entities to access 340B ceiling price for Pfizer products affected by their contract pharmacy policy. For Vyndmax and Vyndaquel, the specialty contract pharmacies must be part of the VYNDA Network. For Pfizer’s oral oncology medications, the specialty contract pharmacy must be part of Pfizer’s DON.

Federal Grantees not subject to limitations.

Contact:
340BCP@pfizer.com

Effective June 6th, 2024, Pfizer will allow West Virginia and Louisiana 340B covered entities to access 340B ceiling price for Pfizer products affected by their contract pharmacy policy.

Federal Grantees not subject to limitations.
 
Contact:
340BCP@pfizer.com

Effective November 1st, 2023, Pfizer will include additional products to the defined distribution model currently in place for Xeljanz. They will only provide the 340B price to a single Contract Pharmacy if the hospital covered entity doesn’t have an in-house pharmacy. 
Federal Grantees not subject to limitations.

*No modifications to Pfizer’s DON policy

Contact: 
340BCP@pfizer.com

Effective February 1st, Sanofi announced that West Virigina and Kansas are subject to the contract pharmacy and claims data submission policy.  

November 22, 2024, Update: Sanofi announced it is transitioning to a 340B Credit Model for Hospital Covered Entities (CAH, DSH, RRC, SCH) as well as Consolidated Health Centers (CH). The Credit Model effective dates are below: 

January 6, 2025: CAH, DSH, RRC, SCH 

March 1, 2025: CH  

Beacon will be the platform to capture Claim Submission, Validation, and 340B Credit Payment Process.  

Sanofi also announced changes to their Contract Pharmacy Policy effective January 6, 2025, for Hospital Covered Entities and a March 1, 2025, effective date for Consolidated Health Centers.  

Contact: 
Sanofi340BOperations@Sanofi.com

Sanofi340BOperations@Sanofi.com

Effective August 1, 2024, Sanofi will allow covered entities located in Maryland and Mississippi to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the respective states through the provision of claims data.

Contact: 
Sanofi340BOperations@Sanofi.com

Effective March 1st, 2021, Sanofi will only provide 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform. 

Contact:

Sanofi340Boperations@sanofi.com

A notice was received from Sumitomo with varying effective dates, a change to their Contract Pharmacy Policy.

Kansas, Maryland, Minnesota, Mississippi exception to Sumitomo contract pharmacy policies with claims data from 45 days of dispense.

Contact: 
support@340besp.com

West Viriginia exception to Sumitomo contract pharmacy policies.

Contact: 
support@340besp.com

A notice was received from Takeda, with an effective date of May 23, 2025, changes to their Contract Pharmacy Policy

Effective January 22nd, 2024, Takeda will only provide 340B pricing for select products to a single independent contract pharmacy or wholly owned contract pharmacy(ies) within 40 miles* of the parent site through provision of claims data via 340B ESP if a hospital covered entity doesn’t have an in-house pharmacy. If a hospital covered entity  does have an in-house pharmacy, it may also designate its wholly owned contract pharmacy(ies) through provision of claims data via 340B ESP.

Federal Grantees not subject to limitations

*Exception: Entyvio

Contact:

support@340besp.com

Effective October 2nd, 2023, UCB updated its contract pharmacy policy to exclude wholly owned (and common ownership) pharmacy exemption. UCB will only provide 340B pricing to a single contract pharmacy located within 40 miles of the parent site if a hospital covered entity doesn’t have an in-house pharmacy.

Federal Grantees not subject to limitations

Contact: 
340B@ucb.com

A notice was received from United Therapeutics, with an effective date of May 28, 2025, a change to their 340B Contract Pharmacy Policy, which has two components: a grandfathering requirement and a claims data requirement. In order to be permitted to submit contract pharmacy orders, a covered entity must comply with both requirements.

Effective 08.28.2024, Vertex has updated their contract pharmacy policies for Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, West Virginia and Missouri.

A notice was received from Viatris, with varying effective dates, a change to their Contract Pharmacy Policy surrounding state exemptions. 

Effective August 28, 2024, Viatris will exempt Missouri hospital covered entities from its 340B contract pharmacy policy

Contact: 
support@340besp.com