Consistent with Section 340B(a)(1) of the Public Health Service Act, manufacturers must provide the same opportunity for 340B covered entities and non-340B purchasers to purchase covered outpatient drugs when such drugs are sold through limited distributors or specialty pharmacies. This extends to the way 340B drugs are made available to covered entities (e.g., direct sales versus through wholesalers, specialty pharmacies, or limited distributors.) Additional information can be found in the following Policy Release (Clarification of Non-Discrimination Policy. Release No. 2011-1.1 (May 23, 2012)).
Manufacturers should notify HRSA of their intent to implement a specialty distribution channel to ensure compliance and ensure that entities are aware of it to promote transparency and limit disputes.