Outsourcing Facilities Association Sues FDA Over Sudden …
Oct 14, 2024 · The Outsourcing Facilities Association (OFA) filed a lawsuit against the FDA for the sudden removal of tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the federal drug shortage list.
Outsourcing Facilities Association Sues FDA Over Sudden …
Oct 8, 2024 · FORT WORTH, Texas-- (BUSINESS WIRE)--The Outsourcing Facilities Association (OFA) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding the agency’s sudden removal of...
Food & Drug Administration Sued by Outsourcing Facilities Associa
Oct 23, 2024 · OFA’s lawsuit, filed in the U.S. District Court for the Northern District of Texas, seeks a determination that the FDA’s action was contrary to law and to have it vacated immediately.
FDA To Reevaluate Removal of Tirzepatide From Drug Shortage List
Oct 23, 2024 · The FDA is reevaluating tirzepatide's removal from the drug shortages list due to a lawsuit by the Outsourcing Facilities Association. The OFA alleges the FDA acted without proper notice, ignoring evidence of an ongoing tirzepatide shortage.
Compounding group sues FDA for removing Lilly's weight loss …
Oct 7, 2024 · In a lawsuit in Fort Worth, Texas federal court, the Outsourcing Facilities Association claims the FDA removed Lilly's tirzepatide from the list even though it remains in short supply.
FDA’s Removal of Tirzepatide from the Drug Shortage List Sparks …
Oct 8, 2024 · The Outsourcing Facilities Association (OFA) and North American Custom Laboratories, LLC, doing business as Farmakeio Custom Compounding, have filed a lawsuit in Texas federal court challenging the FDA’s decision.
Outsourcing Facilities Association Sues FDA Over Sudden …
Oct 8, 2024 · FORT WORTH, Texas-- (BUSINESS WIRE)-- The Outsourcing Facilities Association (OFA) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding the agency’s sudden removal of Tirzepatide, a GLP-1 medication used to treat diabetes and obesity, from the federal drug shortage list, an action that the suit asserts was taken with...
Outsourcing Facility Association - Drug Shortages - United States
The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities who focus on providing patients and healthcare providers with safe and effective compounded medications. OFA members work with patients, healthcare providers, and facilities on a daily basis to ensure the specific needs ...
Outsourcing Facilities Association’s Settlement Will Expedite …
Oct 11, 2022 · The Outsourcing Facilities Association (OFA) announced that it has reached a settlement agreement with the FDA that spurs the FDA to promptly review long-pending nominations for active pharmaceutical ingredients for use by FDA-registered outsourcing facilities to compound drugs needed by patients.
FDA’s tirzepatide decision creates uncertainty for patients—and …
Oct 10, 2024 · The Outsourcing Facilities Association (OFA), a Texas-based trade association focused on distributing compounded medications throughout the healthcare industry, has sued the U.S. Food and Drug Administration (FDA) for its decision to remove tirzepatide from the federal drug shortage list.