Dallas-based Guardian Pharmacy Services — the manufacturer of a compounded solution at the center of 60 lawsuits — reached a settlement with the federal government, according to a press release from the Department of Justice.
Five details:
1. In the dozens of lawsuits filed, patients allege Guardian's solution caused vision damage within weeks after it was injected during procedures at Medical City Surgery Park Central, formerly Park Central Surgical Center, and Key-Whitman Eye Center. Both facilities are located in the Dallas area.
2. On March 11, a federal court in Texas ordered Guardian to halt production of compounded sterile drugs until it can satisfy specific requirements, BuzzFeed News reports. Guardian must stop producing sterile drugs until the company:
- Establishes compliant manufacturing processes
- Implements safeguards against contamination
- Hires an independent expert to confirm the problems are solved as well as conducts periodic audits
3. Guardian was also ordered to cover the FDA's expenses for compliance check-ins. The FDA can charge Guardian roughly $100 per hour, but the total cost to the compounding company wasn't stated.
4. Guardian agreed to the DOJ settlement without admitting or denying wrongdoing. The settlement will be in effect for a minimum of five years.
5. The settlement comes after authorities found Guardian had unclean lab environments, mislabeled drugs and failed to require patient prescriptions, according to a March 6 complaint from the DOJ. Guardian allegedly continued committing safety violations after promising to correct them multiple times.
Note: There are two separate, unaffiliated companies named Guardian Pharmacy Services. This article refers exclusively to the one headquartered in Dallas. The other is based in Atlanta and recently acquired Guardian Pharmacy of Dallas-Fort Worth in Arlington, also not affiliated with the pharmacy referenced in this article.
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