Orphan Drug

Summarized by Plex Health
Last Updated: 04 May 2022

For rural referral centers, sole community hospitals, critical access medical facilities, and free-standing cancer medical facilities taking part in the 340B Program, the term "protected outpatient drug" does not consist of a drug marked by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for unusual disease or condition. The Orphan Drug Designation List was updated and established making use of the approach referenced in About the Orphan Drug List. Orphan Drug Designation List Governing April 1 to June 30, 2022 Orphan Drug Designation List Governing January 1 to March 31, 2022 Orphan Drug Designation List Governing October 1 to December 31, 2021 Orphan Drug Designation List Governing July 1 to September 30, 2021 Orphan Drug Designation List Governing April 1 to June 30, 2021 Orphan Drug Designation List Governing January 1 to March 31, 2021 HRSA develops this list and updates it quarterly. It is based on specific fields recorded from the listing of orphan drug designations given by the U. S. Food and Drug Administration Office of Orphan Products Development. Covered entities might require to carry out extra evaluations of the drugs offered on this list to determine the appropriate orphan drugs to omit from the 340B Program. HRSA recognizes that orphan drug designation sponsors listed on the FDA orphan drug checklist might not be the existing maker for an orphan drug. HRSA will proceed to boost the listing that is posted on a quarterly basis to ensure protected entities have the info they need to abide by the orphan drug exemption. HRSA uses the complying with method to develop the listing: Source: FDA OOPD list of orphan drugs; Search Results: All classifications; Output Format: Download Excel File; HRSA only consisted of orphan drugs with a status of Designated and Designated/Approved.

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