FDA Raises Sterility and Quality Concerns at Mark Cuban’s Dallas Drug Compounding Facility

FDA Inspection:
The FDA conducted a nine-day inspection of Mark Cuban's Cost Plus Drugs compounding facility in Dallas and raised concerns about sterility and quality.

Facility Background:
The 22,000-square-foot, $11 million facility was built to address drug shortages by manufacturing generic medications, starting with sterile injectables like epinephrine and norepinephrine.

Compounding Operations:
Cost Plus Drugs operates as a 503(b) compounding pharmacy, specifically targeting drugs on the FDA shortage list.

Registration:
The facility is registered with the FDA as a human drug compounding outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act.

Quality Concerns:
The FDA's inspection highlighted issues with sterility and other quality concerns, which could impact the facility's operations and drug supply.

Impact:
The facility's goal is to address drug shortages and provide affordable medications, but the FDA's findings could potentially hinder these efforts.