Alkermes and Viatris have become the 36th and 37th manufacturers, respectively, to impose restrictions on contract pharmacy arrangements. These restrictions are effective July 22 and August 1, respectively, but please remember that action must be taken before designating contract pharmacies. A link to each new policy is provided below, and the policies are available on the 340B ESP Resources Page.

Alkermes
In a letter dated June 7, Alkermes announced that it would limit the distribution of 340B drugs to “locations registered as a 340B covered entity (including its child sites)”. It would no longer ship 340B drugs to contract pharmacies of covered entities with an in-house pharmacy. Covered entities without an in-house pharmacy may designate a single-contract pharmacy. The policy will apply to all Alkermes products. Covered entities in Arkansas, Louisiana, and West Virginia are exempt. Covered entities must have designated their single contract pharmacy by June 21, 2024, for the designation to become effective by July 22, 2024. Designations submitted after June 21, 2024, should take effect within ten business days of July 22 or 10 business days after the submission date, whichever is later.

Viatris

On July 1, 2024, Viatris announced that its Mylan Specialty and Viatris Specialty components would limit the distribution of 340B drugs to “locations registered in the 340B OPAIS database as a covered entity [or] a child site location”. They will no longer ship 340B drugs to contract hospital-covered entities and community health centers (CHCs) pharmacies with an in-house pharmacy. The policy exempts non-CHC grantees. Covered entities without an in-house pharmacy may designate a single-contract pharmacy. The policy will apply to commonly used products like Celebrex ®, Effexor®, Lipitor®, Lyrica®, Xanax®, EpiPen®, EpiPen Jr. ®, and Zoloft®. Covered entities in Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, and West Virginia are exempt. Covered entities must designate their single contract pharmacy by July 19, 2024, for the designation to become effective by August 1, 2024.

Neither policy indicates whether the drugmaker will continue to allow 340B drug shipments to “shipping addresses,” locations identified by a covered entity as locations to which 340B products can be shipped but not registered covered entity sites.