340B Manufacturer Exclusions Summary
Updated January 25, 2024
| Manufacturer | Effective Date | CEs Affected | ESP Submissions |
|---|---|---|---|
| Eli Lilly | 9/1/2020 | All | No starting 11/16/23 – only allows 1 pharmacy designation for CP |
| AstraZeneca | 10/1/2020 | All | No |
| Novartis | 11/16/2020 | Hospitals Only | Yes – but only for 1 CP or WO pharmacy starting 5/1/2023 |
| Novo Nordisk | 1/1/2021 | Hospitals Only | No starting 6/1/2023 – only allows 1 pharmacy designation for CP or WO |
| Sanofi | 3/1/2021 | Hospitals and CHC | No starting 6/1/2023 – only allows 1 pharmacy designation for CP |
| Boehringer Ingelheim | 8/1/2021 | Hospitals and CHC | No – only allows 1 pharmacy designation for CP within 40 miles |
| Merck | 9/1/2021 | Hospitals and CHC | No starting 6/12/2023 – only allows 1 pharmacy designation for CP within 40 miles. Starting 7/31, allow pricing for all CEs in AR and LA only if submit data to ESP |
| United Therapeutics | 12/1/2021 | All | Yes |
| UCB | 12/31/2021 | Hospitals Only | No |
| Amgen | 1/3/2022 | Hospitals Only | Yes – but only for 1 CP starting 4/11/2023 within 40 miles |
| Abbvie | 2/1/2022 | Hospitals Only | Yes – but only for 1 CP within 40 miles or WO pharmacy starting 4/17/2023 |
| Bristol Myers Squibb | 3/1/2022 | All | No |
| Pfizer | 3/1/2022 | Hospitals Only | Yes – but can only pick 1 contract pharmacy starting 5/1/2023 for certain products only |
| GlaxoSmithKline | 4/1/2022 | All | No starting 5/1/23 – only allows 1 pharmacy designation for CP or WO |
| Janssen | 5/2/2022 | Hospital Only | Yes – but only for 1 CP plus WO pharmacy starting 3/7/2023 |
| Gilead | 5/2/2022 | All | Yes for WO pharmacy only. CE without in-house pharmacy can designate one CP |
| Exelixis | 7/6/2022 | Hospitals Only | Yes – but only for 1 CP starting 5/15/2023 and WO pharmacy starting 6/26/23 |
| Bausch Health | 8/1/2022 | All | No starting 6/26/23 – only allows 1 pharmacy designation for 1 CP within 40 miles |
| Biogen | 2/1/2023 | Hospitals Only | No |
| Bayer Health | 3/1/2023 | Hospital Only | No starting 6/1/23 – only allows 1 pharmacy designation for 1 CP within 40 miles |
| EMD Serono | 3/1/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP or WO |
| Organon | 7/1/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP |
| Teva | 7/5/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP within 40 miles. Starting 8/1/2023, allow pricing for all CEs in LA with no data submission requirement |
| Astellas | 9/1/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP |
| Jazz Pharmaceuticals | 10/9/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP |
| Incyte | 10/16/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP within 40 miles |
| Eisai | 11/1/2023 | Hospitals Only | No – only allows 1 pharmacy designation for CP |
| Sandoz | 12/1/2023 | Hospitals Only | Yes but only for 1 CP within 40 miles of parent site. If no CP within 40 miles, may consider 1 exception. WO pharmacy unaffected |
| Takeda | 1/22/2024 | Hospitals Only | Yes but only for 1 CP or WO pharmacy within 40 miles of parent site |
