02/25/2025

OFA files reply brief in challenge to tirzepatide drug shortage resolution

02/24/2025

OFA files lawsuit against the U.S. Food and Drug Administration (FDA) challenging the agency’s decision to remove semaglutide, a vital treatment for type 2 diabetes, obesity and cardiovascular disease, from its drug shortage list

02/13/2025

OFA Response in Opposition to Novo Nordisk’s Citizen Petition, requesting that FDA take certain actions with respect to the Outsourcing Facilities Association (“OFA”) nomination of semaglutide to the list of bulk drug substances that may be used by outsourcing facilities in compounding

11/15/2024

OFA Comment to FDA on semaglutide shortage

10/31/2024

OFA urges the FDA to take stakeholder feedback into account to develop a comprehensive understanding of outsourcing facilities 

10/24/2024

OFA Comments on Citizen Petition from Covington & Burling LLP on Behalf of Novo Nordisk Inc. to highlight that the FDA Commissioner and the American public have an interest to know the effects on cost and price that Novo’s requested action would have on consumers.

06/18/2024

OFA Comment to FDA on Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding

01/08/2024

OFA Comment to FDA on Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B

08/28/2023

OFA Comment to FDA on Prohibition on Wholesaling 

01/23/2023

OFA Comment to FDA urging the FDA to define "clinical need"

01/05/2022

OFA Comments on Citizen Petition from Nexus Pharmaceuticals Inc

12/06/2021

OFA Comments on FDA’s revised draft guidance on Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act