The final HRSA manufacturer 340B program audit conducted in fiscal year 2023 had no adverse findings for Teva Pharmaceuticals.

News Alert

Teva Is the 23rd Drug Maker to Impose Limits on 340B Contract Pharmacies

Drug manufacturer Teva today became the 23rd drug manufacturer to impose conditions on 340B pricing involving delivery to contract pharmacies.

Covered entities reported getting Teva’s notice by email around 1:00 p.m. Eastern. It said effective July 5:

  • Any covered entity enrolled in 340B as a hospital that has an in-house pharmacy outpatient pharmacy will no longer be eligible to have 340B-discounted product shipped to contract pharmacies, including contract pharmacies that are wholly owned by a 340B hospital. 340B-discounted products will only be shipped to the in-house outpatient pharmacy.
  • Any covered entity hospital that does not have an in-house pharmacy capable of dispensing 340B-discounted Teva product to its eligible patients may designate a single contract pharmacy location. Covered entity hospitals that qualify to designate a single contract pharmacy location may do so under two conditions:
    • The contract pharmacy is physically located within 40 miles of the covered entity hospital’s parent site, and
    • The covered entity submits 340B claims data for the designated contract pharmacy location.

Teva is using 340B ESP for the contract pharmacy designations and claims data submissions. Hospitals must make their designations by June 18 in order for them to take effect on July 5. Claims data must be submitted within 45 days of the dispensing date.

“All federal grantee covered entities are exempt from this policy and may continue to obtain 340B pricing through an unlimited number of contract pharmacies and are not required to submit claims data,” the letter said.

The policy applies to a list of 36 medicines, including its best-selling multiple sclerosis drug Copaxone, its injectable migraine prevention drug Ajovy, and its leukemia and lymphoma treatment Treanda.