340B
Manufacturer updates
AbbVie
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 July 1, 2024, AbbVie will exempt Minnesota hospital covered entities from its 340B contract pharmacy policy.
Contact:
support@340besp.com
Effective May 1st, 2024, AbbVie will allow Arkansas hospital covered entities to order 340B products and/or place “Bill to/Ship to” replenishment orders at the 340B ceiling price for its contract pharmacies.
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
Effective April 17th, 2023, AbbVie will only provide 340B priced product 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. *Updated policy now includes 90 drugs from original 25 added to exclusion list
Contact:
support@340BESP.com
Effective February 1st, 2022, AbbVie will only provide 340B priced product to a single Contract Pharmacy if Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations.
*Imbruvica effective April 1st, 2022
Contact:
support@340BESP.com
Alkermes
Effective August 1, 2024, Alkermes will exempt Minnesota covered entities from its 340B contract pharmacy policy, in addition to Missouri covered entities from its 340B contract pharmacy policy effective 08.28.2024.
support@340besp.com
Effective July 22, 2024, Alkermes will exempt Arkansas, Louisiana, West Virginia, Mississippi, Maryland and Kansas covered entities from its 340B contract pharmacy policy.
Contact:
support@340besp.com
Effective July 22nd, 2024, Alkermes will only provide 340B priced products to a single Contract Pharmacy of the Covered Entity does not have an in-house or wholly owned pharmacy. Covered entities located in Arkansas and Louisiana may use any contract pharmacies located in the respective states. Covered entities located in West Virginia are not subject to these restrictions.
Contact:
support@340besp.com
Amgen
Effective August 28, 2024, Amgen will exempt Missouri hospital covered entities from its 340B contract pharmacy policy
Contact:
support@340besp.com
Effective July 1, 2024, contract pharmacy arrangements between 340B covered entities located in Mississippi and Maryland and contract pharmacies located in each respective state are exempt from Amgen’s 340B contract pharmacy policy.
Contact:
support@340besp.com
Effective April 2nd, 2024, contract pharmacy arrangements between 340B covered entities located in Arkansas and contract pharmacies located in Arkansas are exempt from Amgen’s 340B contract pharmacy policy.
Contact:
support@340besp.com
Effective March 19th, 2024, Federal Grantees are no longer exempt from Amgen’s 340B contract pharmacy policy. Amgen will only provide 340B priced product to a single Contract Pharmacy located within 40 miles of the parent site if the covered entity doesn’t have an in-house pharmacy. If the covered entity does have an in-house pharmacy, they may designate a single contract pharmacy within 40 miles of the parent site with the provision of claims data.
Contact:
support@340besp.com
Effective April 11th, 2023, Amgen will only provide 340B priced product to a single Contract Pharmacy located within 40 miles of the parent site if the non-grantee doesn’t have an in-house pharmacy. Federal Grantees not subject to limitations.
Contact:
support@340BESP.com
Effective January 3rd, 2022, Amgen will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Policy is limited to four drugs and doesn’t include Federal Grantees.
Contact:
support@340Besp.com
Effective January 1st, 2021, Amgen will no longer provide voluntary, “340B like” discounts, on orphan designated drugs to participating Covered Entities.
Contact:
340Brelations@amgen.com
Astellas
Effective May 1st, 2024, Astellas will include Myrbetriq products in its 340B contract pharmacy policy and only provide 340B pricing for Xtandi® and Myrbetriq ® products to a single contract pharmacy if a hospital covered entity doesn’t have an in-house pharmacy.
Federal Grantees and covered entities in the state of Alabama* and Louisiana* are not subject to limitations.
*For contract pharmacies within the respective states
Contact:
support@340besp.com
Effective October 17th, 2023, Astellas will provide 340B pricing for Xtandi® to an unlimited number of contract pharmacies located in Arkansas for covered entities in the state of Arkansas and an unlimited number of contract pharmacies located in Louisiana for covered entities in the state of Louisiana.
Contact:
support@340besp.com
Effective September 1st, 2023, Astellas will only provide 340B pricing for Xtandi® to a single contract pharmacy if a hospital covered entity doesn’t have an in-house pharmacy. Federal Grantees not subject to limitations.
Contact:
support@340BESP.com
AstraZeneca
Effective October 1, 2024 AstraZeneca requires data submission (within 45 date of dispense) through 340B ESP as a mandatory process for covered entities without an in-house pharmacy to enable a designated contract pharmacy. AirSupra® was added to their list of impacted products.
Contact: support@340BESP.com
Effective August 1st, 2023, AstraZeneca will transition the administration of their 340B contract pharmacy program to a third-party vendor.
Contact: support@340BESP.com
Effective June 1st, 2022, AstraZeneca will no longer provide voluntary, “340B like” discounts, on orphan designated drugs to participating Covered Entities.
*Calquence & Lynparza (October 1st, 2022) and Fasenra (January 1st, 2023) voluntary contracts restored.
Contact:
Effective October 1st, 2020, AstraZeneca will only provide 340B priced product to a single Contract Pharmacy.
Contact:
Bausch Health
Effective March 12th, 2024, contract pharmacy arrangements between 340B covered entities located in Arkansas and contract pharmacies located in Arkansas are exempt from Bausch Health’s 340B contract pharmacy policy.
Contact:
support@340besp.com
Effective June 26th, 2023, Bausch Health will only provide 340B priced products to a single contract pharmacy located within 40 miles of the parent site if the entity does not have an in-house pharmacy.
Contact:
support@340BESP.com
Effective August 1st, 2022, Bausch Health will only provide 340B priced product to a single Contract Pharmacy if Covered Entity doesn’t have an in-house pharmacy. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP.
Contact:
support@340Besp.com
Bausch & Lomb
Effective July 1st, 2024, Bausch & Lomb will only provide 340B pricing on its products to a single contract pharmacy located within 40 miles of the parent site if the entity does not have an in-house pharmacy.
Contact:
support@340Besp.com
Bayer
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
Effective June 24th, 2024, Bayer will include Nubeqa to its 340B Contract Pharmacy Policy.
Contact:
support@340besp.com
Effective May 1st, 2024, Arkansas-based covered entities will be able to place Bill to/Ship to replenishment orders through contract pharmacies located within Arkansas.
Contact:
support@340besp.com
Effective June 1st, 2023, Bayer will only provide 340B priced product 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.
*Updated policy now includes Adempas
Contact:
support@340BESP.com
Effective March 1, 2023, Bayer will only provide 340B priced product to a single Contract Pharmacy location if the hospital Covered Entity does not have an in-house pharmacy. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP. Grantees not subject to limitations.
Contact:
support@340Besp.com
Biogen
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.
Effective December 1st, 2023, Biogen will add Zurzuvae™ to its policy. A 340B hospital covered entity may designate a single contract pharmacy within the limited distribution pharmacy network if the entity does not have an in-house pharmacy capable of dispensing Zurzuvae™. The policy remains the same for Avonex® and Plegridy®.
Federal Grantees not subject to limitations.
Contact:
support@340besp.com
Effective February 1st, 2023, Biogen will only provide 340B priced product to a single Contract Pharmacy location if the Covered Entity does not have an in-house pharmacy. Policy is limited to two drugs and doesn’t include Federal Grantees.
Contact:
support@340BESP.com
Boehringer Ingelheim
Effective June 6th, 2024, Boehringer Ingelheim will provide 340B pricing to an unlimited number of contract pharmacies located in West Virginia for covered entities in the state of West Virginia.
Contact:
support@340Besp.com
Effective May 27th, 2024, Boehringer Ingelheim will provide 340B pricing to an unlimited number of contract pharmacies located in Louisiana for covered entities in the state of Louisiana.
Contact:
support@340Besp.com
Effective May 1st, 2024, Boehringer Ingelheim will provide 340B pricing to an unlimited number of contract pharmacies located in Arkansas for covered entities in the state of Arkansas
Contact:
support@340Besp.com
Effective August 1st, 2023, Boehringer Ingelheim will only provide 340B priced products to a single contract pharmacy located within 40 miles of the parent site if the entity does not have an in-house pharmacy. No central fill pharmacies.
Any covered entity that does not have an in-house pharmacy capable of dispensing specialty products may designate 1 specialty pharmacy from within BI’s limited distribution network for the purpose of dispensing OFEV.
Contact:
support@340BESP.com
Boehringer Ingelheim announced effective September 1st, 2022, an expansion to their contract pharmacy policy to include grantees enrolled in the Consolidated Health Center Program (CH/CHC). All other Federal Grantees not subject to limitations.
Contact:
support@340besp.com
Effective December 1st, 2021, BI will add its specialty product, OFEV, to the list of products subject to its 340B Contract Pharmacy policy. BI restrictions from August 1st, 2021, remain effective. Link to both notices below.
Contact:
support@340Besp.com
Bristol Myers Squibb
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
Effective July 1, 2024, BMS will allow Maryland and Mississippi covered entities to order 340B products and/or place “Bill to/Ship to” replenishment orders at the 340B ceiling price for all contract pharmacies located in the respective state.
Contact:
BMS340B@bms.com
Effective July 1st, 2024, BMS will recognize up to three designated 340B contract pharmacy locations per 340B hospital that lacks an entity-owned pharmacy: one for IMiDs, a second for non-IMiDs, and a third for Camzyos. Claims-level data must be submitted.
Contact:
support@340besp.com
Effective immediately, BMS will allow Arkansas covered entities to use any contract pharmacies located in Arkansas to dispense BMS 340B-eligible outpatient drugs.
Contact:
BMS340B@bms.com
Effective March 28th, 2024, BMS will allow Arkansas covered entities to use any contract pharmacies properly licensed by the Arkansas State Board of Pharmacy to dispense all 340B-eligible covered outpatient drugs.
Contact:
BMS340B@bms.com
Effective November 1st, 2023, BMS will recognize up to three designated 340B contract pharmacy locations per 340B hospital that lacks an entity-owned pharmacy: one for IMiDs, a second for non-IMiDs, and a third for Camzyos.
Contact:
BMS340B@bms.com
Effective March 1st, 2022, BMS will recognize up to two designated 340B contract pharmacy
locations per 340B hospital that lacks an entity-owned pharmacy: one for IMiDs and a second for non-IMiDs. Federal Grantees not subject to limitations on non-IMiD products.
*Camzyos effective July 1st, 2022
Contact:
BMS340B@bms.com
Clovis
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
Eisai
Effective November 1, 2023, Eisai will only provide 340B priced products to a single contract pharmacy if the entity does not have an in-house pharmacy.
Federal Grantees not subject to limitations.
*Additional contract pharmacy options may be available to Arkansas and Louisiana hospital covered entities
Contact:
support@340besp.com
EMD Serono
Effective October 1, 2024, EMD Serono will eliminate the exception for wholly owned pharmacies; apply geographic mileage requirements (40 miles) to contract pharmacies under their policy; and apply their policy to all covered entity types other than Ryan White Clinics purchasing Serostim® (somatropin).
Contact:
support@340BESP.com
Effective March 20th, 2024, EMD Serono will allow Arkansas-based covered entities to order 340B products and/or place “Bill to/Ship to” replenishment orders for Arkansas-based contract pharmacies.
Contact:
support@340BESP.com
Effective October 1st, 2023, EMD Serono’s updated contract pharmacy policy will include all EMD Serono marketed Products. EMD Serono will only provide 340B pricing products to a single contract pharmacy if a hospital covered entity doesn’t have an in-house pharmacy.
*Serostim®: covered entities may designate one additional contract pharmacy location in EMDS’s secure distribution network (the “SND”) for the purpose of dispensing Serostim only.
Federal Grantees not subject to limitations.
Contact:
support@340besp.com
Effective March 1, 2023, EMD Serono (EMDS) will only provide 340B pricing for REBIF and GONAL-F to a single Contract Pharmacy if a hospital Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations.
Contact:
support@340Besp.com
Eli Lilly
Received email confirmation that effective February 1, 2025, Kansas is no longer exempt from Lilly’s Contract Pharmacy Policy.
Received email confirmation from Lilly that the following states are exempt from Lilly Contract Pharmacy Policy: Arkansas, Louisiana, Maryland, Minnesota, Mississippi, Missouri , and Kansas.
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.
Contact:
340B@lilly.com
Effective July 1, 2024, Eli Lilly will only provide 340B priced products to a single contract pharmacy if the entity does not have an in-house pharmacy through the provision of claims data. Eli Lilly’s insulin policy remains the same.
Contact:
340B@lilly.com
Effective November 16th, 2023, Eli Lilly will only provide 340B priced products to a single contract pharmacy if the entity does not have an in-house or wholly-owned pharmacy. Eli Lilly’s insulin policy remains the same.
Contact:
340B@lilly.com
Lilly announced on December 10th, 2021, an expansion to their contract pharmacy policy allowing 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform for dispenses on or after October 29th, 2021.
Contact:
340B@lilly.com
Effective September 1st, 2020, Lilly restricted access for 340B priced product to Contract Pharmacies, except insulin.
Contact:
340B@lilly.com
Exelixis
Effective July 1st, 2024, Exelixis will allow a hospital covered entity to designate a single contract pharmacy within their specialty pharmacy network if the entity does not have an in-house pharmacy or wholly-owned (or common ownership) contract pharmacy. Claims data must be provided for contract pharmacy 340B dispensations. Federal Grantees not subject to limitations
Contact:
340B@exelixis.com
Effective July 6th, 2022, Exelixis will only provide 340B pricing on COMETRIQ and CABOMETYX to a single Contract Pharmacy within the specialty pharmacy network if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations.
Contact:
340B@exelixis.com
Genentech
Effective May 1st, 2024, Genentech will only provide 340B pricing all Genentech products except Hemlibra and Evrysdi to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy capable of dispensing 340B drugs.
Federal Grantees are not subject to limitations.
Contact:
support@340besp.com
Gilead
Effective January 30th, 2024, Gilead will require covered entities to submit claims level data via 340BESP for their branded HCV products purchased at the 340B price for wholly-owned pharmacies.
Contact:
support@340besp.com
Effective May 2nd, 2022, Gilead will only provide a 340B price on branded hepatitis C products to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location.
Contact:
support@340BESP.com
GlaxoSmithKline
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, GSK will allow covered entities located in Mississippi, Maryland, or Kansas to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the respective states. 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 June 6th, 2024, GSK will allow West Virginia-based covered entities to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies. 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 November 1st, 2023, GSK will allow Arkansas-based and Louisiana-based covered entities to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within the respective states. For specialty/oncology products part of the limited pharmacy network, the contract pharmacies must be a part of GSK’s limited pharmacy network.
GSK will honor Arkansas- and Louisiana-based covered entities’ replenishment orders associated with a covered product dispensed within the respective states on or after August 1st, 2023.
Contact:
support@340besp.com
GSK added OJJAARA (Momelotinib) Tablets to its 340B Contract Pharmacy Policy
Contact:
support@340besp.com
Effective May 1, 2023, GSK will only provide 340B priced product to a single Contract Pharmacy if a covered entity doesn’t have an in-house pharmacy. An additional specialty pharmacy part of a limited pharmacy network may be designated.
*Updated policy now includes all GSK drugs
Contact:
support@340BESP.com
Effective July 1st, 2022, GSK will no longer offer voluntary 340B pricing on two orphan drugs (NUCALA and ZEJULA) to Covered Entities subject to the 340B orphan drug exclusion. This change will not impact Covered Entities not subject to the orphan drug exclusion.
Contact:
US.340B@gsk.com
Effective April 1st, 2022, GSK will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations.
Contact
support@340Besp.com
Incyte
Effective October 16th, 2023, Incyte will only provide 340B pricing on Opzelura® to a single contract pharmacy located within 40 miles of the parent site if a hospital entity does not have an in-house pharmacy.
Federal Grantees are not subject to limitations.
Contact:
support@340BESP.com
Jazz
Effective October 9th, 2023, Jazz will only provide 340B pricing for Epidiolex® to a single contract pharmacy if a hospital covered entity doesn’t have an in-house pharmacy.
Federal Grantees not subject to limitations.
Contact:
support@340besp.com
Janssen
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 March 7th, 2023, Janssen will only provide 340B priced product to a single Contract Pharmacy located within 40 miles of the parent site if the non-grantee doesn’t have an in-house pharmacy. An additional specialty pharmacy part of limited distribution system may be designated. Federal Grantees not subject to limitations.
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
Johnson & Johnson
November 12, 2024, Update: JNJ filed a lawsuit against Health Resources and Services Administration (HRSA) due to their letter that was sent September 27, 2024, halting the rebate model.
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.
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
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:
support@340besp.com
Liquidia
Effective April 1st, 2024, Liquidia will only provide 340B priced Yutrepia to a single Accredo or Caremark/CVS Specialty Contract Pharmacy, if the covered entity doesn’t have an in-house pharmacy, with the provision of claims data.
*Effective date subject to FDA’s final approval for Yutrepia
Contact:
support@340besp.com
Merck
An email notice was received from Merck, effective April 9, 2025, a change to their 340B contract pharmacy policy for covered entities in Nebraska.
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 1, 2024, Merck will provide 340B priced products to an unlimited number of contract pharmacies for Maryland, Mississippi and Kansas covered entities 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 June 6th, 2024, Merck will provide 340B pricing to an unlimited number of contract pharmacies for covered entities in the state of West Virginia. Winrevair will only be available through a limited specialty pharmacy network.
Contact:
340bdata@merck.com
Effective April 12th, 2024, Merck will include Winrevair in its 340B Contract Pharmacy Policy for hospitals or consolidated health center program covered entities and will be available through a limited specialty pharmacy network. The designated specialty pharmacy is in addition to the single contract pharmacy designation.
Federal Grantees (except CH grantee entities) are not subject to limitations.
Contact:
340bdata@merck.com
Effective July 31st, 2023, Merck will provide 340B priced products to an unlimited number of contract pharmacies in the state of Louisiana and Arkansas if the hospital or CH covered entity registers and submits 340B claims data. Federal Grantees (except CH grantee entities) not subject to limitations.
Contact:
340bdata@merck.com
Effective June 12, 2023, Merck will only provide 340B priced product to a single contract pharmacy location, within 40 miles of the hospital Covered Entity or Consolidated Health Center, if they don’t have an in-house pharmacy. All other Federal Grantees are not subject to limitations.
Contact:
340Bdata@merck.com
Merck announced on April 28th, 2022, an expansion to their 340B Program integrity initiative to include Consolidated Health Centers. All previous requirements remain effective.
Contact:
340Bdata@merck.com
Effective September 1st, 2021, Merck will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Grantees not subject to limitations.
Contact:
340Bdata@merck.com
Mallinckrodt
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:
Novo Nordisk
Effective July 1st, 2024, Novo Nordisk will allow a maximum of two (2) contract pharmacy designations for all covered entities (e.g. two retail CPs, two specialty CPs, one retail and one specialty CP) regardless of if the covered entity has an in-house pharmacy. Federal Grantees may utilize an unlimited number of contract pharmacies through the provision of claims data via 340B ESP.
There are no changes to wholly-owned pharmacies.
Contact:
support@340besp.com
Effective February 1st, 2024, Novo Nordisk updated its contract pharmacy policy for Arkansas hospital covered entities only. They will allow two contract pharmacy designations for all Arkansas hospital covered entities without the provision of claims data. With the provision of claims data, an unlimited number of contract pharmacies are allowed if they are located within the state of Arkansas.
Federal Grantees not subject to limitations
Contact:
support@340Besp.com340BInfo@novonordisk.com
Effective July 1st, 2023, Novo Nordisk will allow up to two contract pharmacy locations per 340B hospital (one retail, one specialty). Federal Grantees are not subject to limitations.
Contact:
support@340BESP.com
Novo Nordisk announced on December 2nd, 2022, an expansion to their contract pharmacy policy allowing 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform for dispenses on or after January 1st, 2023.
Contact:
340BInfo@novonordisk.com
Novo Nordisk announced effective February 1st, 2022, an expansion to their hospital contract pharmacy policy. 340B hospitals that lack a wholly owned pharmacy can designate two contract pharmacy locations: one retail and one specialty.
Contact:
340BInfo@novonordisk.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
Novartis
On January 14, 2025, HRSA notified Novartis that it rejected Novartis’s proposed rebate model. Novartis then entered litigation against HRSA over its purported rejection of Novartis’s plan to change the way it offers reduced prices on its medicines in the 340B program.
Effective January 1, 2025, Novartis announced changes to its contract pharmacy policy to require data submission for Non-Grantee Covered Entities. Wholly Owned Contract Pharmacies are no longer exempt from Novartis policy, and covered entities located in Maryland are allowed to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies.
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:
Effective July 8, 2024, Novartis will allow covered entities located in Mississippi to place “Bill to/Ship to” replenishment orders to their HRSA designated contract pharmacies located within Mississippi.
Contact: Novartis.340B@novartis.com
Effective March 20th, 2024, Novartis will allow Arkansas hospital covered entities to order 340B products and/or place “Bill to/Ship to” replenishment orders for Arkansas-based contract pharmacies.
Contact: Novartis.340B@novartis.com
Effective May 1st, 2023, Novartis will only provide 340B priced product to a single Contract Pharmacy if the hospital covered entity doesn’t have an in-house pharmacy. Federal Grantees not subject to limitations.
Contact:
Novartis.340B@novartis.com
Effective November 16th, 2020, Novartis will restrict 340B priced product to Contract Pharmacies based on a 40 mile radius for hospital Covered Entities. Federal Grantees not subject to limitations.
Contact: Novartis.340B@novartis.com
Organon
Effective December 1, 2024, Organon has made a change to their 340B contract pharmacy policy for HRSA-Funded Health Center (CH) grantees
Effective 8.01.2024, Organon will exempt Minnesota covered entities from its 340B contract pharmacy policy, in addition to covered entities in Missouri as of 08.28.2024
Effective June 6th, 2024, Organon will allow Kansas, Maryland and Mississippi-based covered entities to place “Bill to/Ship to” replenishment orders to unlimited contract pharmacies if claims level data is submitted via 340B ESP. Organon will allow West Virginia-based covered entities to place “Bill to/Ship to” replenishment orders to unlimited contract pharmacies without requiring claims submission.
Contact:
support@340BESP.com
Effective December 1st, 2023, Organon will allow Arkansas-based and Louisiana-based covered entities to place “Bill to/Ship to” replenishment orders to unlimited contract pharmacies if claims level data is submitted via 340B ESP.
Contact:
support@340BESP.com
Effective July 1st, 2023, Organon will only provide 340B priced product to a single contract pharmacy location if the hospital Covered Entity provides Claims Level Detail via 340B ESP platform. Federal Grantees not subject to limitations.
Contact:
support@340BESP.com
Pfizer
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 Kansas 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 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 Mississippi 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 May 6th, 2024, Pfizer will allow Arkansas hospital covered entities to order 340B products and place “Bill to/Ship to” replenishment orders at 340B ceiling prices for its registered contract pharmacies. For Vyndamax and Vyndaquel, they may engage in multiple VYNDA Network specialty contract pharmacy arrangements without providing limited claims data, and for oral oncology medicines (“DON”), they may engage in multiple DON Network specialty contract pharmacy arrangements without proving limited claims data.
Contact:
support@340besp.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 November 1st, 2023, Pfizer will change its process on acquiring Vyndamax® and Vyndaquel® at the 340B ceiling prices. A 340B covered entity may either apply to have its specialty pharmacy be a VYNDA Network Institution or establish a contract pharmacy relationship with a specialty contract pharmacy in the VYNDA Network.
Federal Grantees not subject to limitations.
Contact:
340BCP@pfizer.com
Effective May 1st, 2023, Pfizer will only provide Xeljanz at a 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 March 1st, 2022, Pfizer will recognize up to two designated contract pharmacy locations per 340B hospital that lacks a wholly owned: one for Xeljanz and a second for oral oncology products. Multiple contract pharmacy access is permissible through provision of claims data via 340B ESP.
Contact:
340BCP@pfizer.com
Sandoz
Effective July 1st, 2024, Sandoz will include Zarxio in its contract pharmacy policy.
Contact:
support@340besp.com
Effective December 1st, 2023, Sandoz will only provide 340B priced products to a single Contract Pharmacy located within 40 miles of the parent site, regardless of if a hospital covered entity has an in-house or wholly owned pharmacy, through provision of claims data via 340B ESP. Federal Grantees and covered entity hospitals located in Arkansas and Louisiana are not subject to limitations.
Contact:
support@340BESP.com
Sanofi
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
Effective August 28, 2024, Missouri Covered Entities may access 340B pricing at an unlimited number of Missouri based contract pharmacies by submitting claims data through the 340B ESP™ platform for each of the Covered Entity’s contract pharmacy
arrangements in Missouri. Covered Entities that currently have a contract pharmacy designation in place through 340B ESP™ will have that designation canceled and must begin submitting claims data to have access to 340B pricing at their contract pharmacies. This policy is effective August 28, 2024. Contact: Sanofi340BOperations@Sanofi.com
Effective September 23, 2024, Sanofi is requiring certain Arkansas-based 340B hospitals (CAH, DSH, RRC and SCH) to provide evidence or attestation that they “retain legal title to Sanofi 340B-priced drugs delivered to [their] contract pharmacies until the contract pharmacies dispense those drugs to 340B-eligible patients.” The 340B Integrity Initiative is for Arkansas based community pharmacies and certain Arkansas-based 340B hospitals only. Consolidated Health Center Program (CH) is exempt from the Arkansas-based policy.
Contact: Sanofi340BOperations@Sanofi.com
Contact:
Sanofi340BOperations@Sanofi.com
Effective September 23, 2024, Sanofi is requiring certain Arkansas-based 340B hospitals (CAH, DSH, RRC and SCH) to provide evidence or attestation that they “retain legal title to Sanofi 340B-priced drugs delivered to [their] contract pharmacies until the contract pharmacies dispense those drugs to 340B-eligible patients.” The 340B Integrity Initiative is for Arkansas based community pharmacies and certain Arkansas-based 340B hospitals only. Consolidated Health Center Program (CH) is exempt from the Arkansas-based policy.
Contact:
Sanofi340BOperations@Sanofi.com
Effective August 28, 2024, Missouri Covered Entities may access 340B pricing at an unlimited number of Missouri
based contract pharmacies by submitting claims data through the 340B ESP™ platform for each of the Covered Entity’s contract pharmacy
arrangements in Missouri. Covered Entities that currently have a contract pharmacy designation in place through 340B ESP™ will have that designation canceled and must begin submitting claims data to have access to 340B pricing at their contract pharmacies.
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 July 1st, 2024, Sanofi will only provide 340B priced product to a single contract pharmacy location if the hospital Covered Entity doesn’t have an in-house pharmacy via the provision of claims data. Wholly owned pharmacies may only access 340B pricing if the covered entity lacks an in-house pharmacy, the wholly owned pharmacy is designated as the single contract pharmacy, and claims data is submitted. Claims data is not required for Consolidated Health Center (CH) entities. All other Federal Grantees, Children’s Hospitals, and Free Standing Cancer Hospitals are not subject to limitations.
Contact:
Sanofi340BOperations@Sanofi.com
Effective June 1, 2023, Sanofi will only provide 340B priced product to a single contract pharmacy location if the hospital Covered Entity doesn’t have an in-house pharmacy. Federal Grantees, Children’s Hospitals, and Free Standing Cancer Hospitals are not subject to limitations.
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:
Sumitomo
Missouri exception to Sumitomo contract pharmacy policies with claims data from 45 days of dispense.
support@340besp.com
On July 3, 2024, Sumitomo announced it will allow covered entities in Kansas, Maryland, Minnesota, and Mississippi to please bill-to/ship-to replenishment orders at the 340B price to all contract pharmacies through the provision of claims data starting July 1, 2024. Sumitomo will also exempt covered entities in West Virginia starting June 6, 2024.
Contact:
support@340besp.com
Kansas, Maryland, Minnesota, Mississippi exception to Sumitomo contract pharmacy policies with claims data from 45 days of dispense.
Contact:
support@340besp.com
Effective May 1st, 2024, Sumitomo will only provide 340B pricing for Aptiom, Gemtesa, and Myfembree to a single specialty Contract Pharmacy located within 40 miles of the parent site if the Covered Entity does not have an in-house pharmacy location. Sumitomo will only provide 340B pricing for Orgovyx to a single specialty Contract Pharmacy within SMPA’s ORGOVYX limited distribution network if the Covered Entity does not have an in-house pharmacy location capable of dispensing specialty products.
Louisiana and Arkansas covered entities are not subject to limitations.
Contact:
support@340besp.com
Sobi
Effective July 1st, 2024, Sobi will only provide 340B priced products to a single contract pharmacy located within 40 miles of the parent site if the covered entity doesn’t have an in-house pharmacy. Federal Grantees included in this policy.
Contact:
support@340besp.com
Takeda
Effective March 22nd, 2024, Takeda will include Ninlaro in its 340B Contract Pharmacy Policy. Only pharmacies in Takeda’s limited distribution network may be designated so the 40-mileage restriction does not apply.
Federal Grantees not subject to limitations
Contact:
support@340besp.com
Effective February 16th, 2024, Takeda will include Inclusig, Alunbrig and Fruzaqla in its 340B Contract Pharmacy Policy. Only pharmacies in Takeda’s limited distribution network may be designated so the 40-mileage restriction does not apply.
Federal Grantees not subject to limitations
Contact:
support@340besp.com
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:
Teva
Effective May 20th, 2024, Teva will include Simlandi to its 340B Contract Pharmacy Policy.
Contact:
support@340besp.com
Effective April 8th, 2024, Teva will include Alvaiz in its contract pharmacy policy.
Contact:
support@340besp.com
Effective November 6th, 2023, Teva will include Austedo and Austedo XR product families to its contract pharmacy policy.
Contact:
support@340besp.com
Effective September 26th, 2023, Teva will provide 340B priced products to an unlimited number of contract pharmacies for covered entities in the state of Arkansas.
Contact:
support@340BESP.com
Effective August 1st, 2023, Teva will provide 340B priced products to an unlimited number of contract pharmacies in the state of Louisiana. Federal Grantees not subject to limitations.
Contact:
support@340Besp.com
Effective July 5th, 2023, Teva will only provide 340B priced products to a single contract pharmacy located within 40 miles of the parent site if the non-grantee entity does not have an in-house pharmacy. Federal Grantees not subject to limitations.
Contact:
support@340Besp.com
UCB
Effective November 25, 2024, UCB has made a change to their 340B contract pharmacy policy for addition of claims data requirement for hospital covered entities and inclusion of federal grantees in the policy.
Contact:
340B@ucb.com
Effective June 6th, 2024, UCB will provide 340B pricing for its products to an unlimited number of contract pharmacies located in West Virginia for covered entities in the state of West Virginia.
Contact:
340B@ucb.com
Effective June 3rd, 2024, UCB will provide 340B pricing for its products to an unlimited number of contract pharmacies located in Arkansas for covered entities in the state of Arkansas.
Contact:
340B@ucb.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
Effective December 13th, 2021, UCB will only provide 340B priced product to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Federal Grantees not subject to limitations.
Contact:
340B@ucb.com
United Therapeutics
Effective December 1st, 2021, United Therapeutics will only provide 340B priced product to a Contract Pharmacy if Covered Entity provides Claims Level Detail via 340B ESP platform.
Contact:
340B@unither.com
Vertex
Effective July 2nd, 2024, Vertex will only provide 340B pricing on its Cystic Fibrosis products to a single Contract Pharmacy of the Covered Entity does not have an in-house pharmacy. Covered Entities located in Arkansas, Kansas, Louisiana, Maryland, Mississippi, or West Virginia, as well as Federal Grantees, are not subject to limitations.
Contact:
support@340besp.com
Viatris
Effective August 28, 2024, Viatris will exempt Missouri hospital covered entities from its 340B contract pharmacy policy
Contact:
support@340besp.com
Effective August 1, 2024, Viatris will only provide 340B priced products to a single Contract Pharmacy if the Covered Entity does not have an in-house pharmacy location. Arkansas, Louisiana, West Virginia, Mississippi, Kansas, Maryland, and Minnesota covered entities are exempt from Viatris’ contract pharmacy policy. Federal Grantees, with the exception of Consolidated Health Centers (CH/CHC), not subject to limitations.
Contact:
support@340besp.com
Woodward
Effective April 1, 2023, select Woodward Pharma products will only be available at a 340B ceiling price through direct distribution via DCS and no longer available via full line distributor 340B accounts.
*12 additional NDCs effective March 15th, 2023
Contact:
340b-clientsservices@
directcustomersolutions.com
340B