Empower Pharmacy's no good, very bad week.

Compounded medicines fill an important niche role in our drug supply, but the NECC scandal and GLP-1 compounding concerns are flashpoints that draw attention to the potential safety risks of compounding and raise questions about whether regulators have the tools to address those risks effectively.

After months of rumors, two articles from Endpoints News by Shelby Livingston and the Houston Chronicle by Julian Gill have finally laid out concerns about Empower Pharmacy, a 503B compounding facility, that have been swirling around for a while now. The allegations include:

Shabbir Imber Safdar is the Executive Director of the Partnership for Safe Medicines.

A version of this post appeared in our executive director Shabbir Safdar's LinkedIn on May 16, 2025

Prohibited ingredients:

  • "[use of] active pharmaceutical ingredients, or APIs, after it had failed quality control tests, including sterility tests";
  • "former supply chain director Samuel Pray, who worked at Empower from 2022 to August 2024, alleged that Noorian instructed employees to order food or animal-grade APIs to cut costs"
  • "FDA inspections of Empower’s facilities from 2022 to 2024 turned up instances in which the company used non-pharmaceutical-grade ingredients for different types of drugs, including the skin treatment azelaic acid, a non-GLP-1 weight loss drug, and the anti-aging drug NAD+, according to two inspection reports. One drug ingredient came from a manufacturer that did not have an active registration with the FDA, the report said."

Sterility and safety issues:

  • “production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.”
  • "one of the FDA’s warning letters from April 2025 mentioned that a 2024 inspection of Empower’s outsourcing facility found that it released a batch of pyridoxine HCL, or vitamin B6, even though microbial contamination was found in the room where it was made. The letter states that Empower recalled the drug after the inspection"

Related:

"Empower Pharmacy says it sells 'quality' compounded drugs. 10 years of FDA violations raise doubts," Julian Gill, The Houston Chronicle, May 12, 2025

"Exclusive: Drug compounder Empower was built on risky shortcuts, ex-employees and inspections allege," Shelby Livingston, Endpoints News, May 15, 2025

FDA Warning Letters: April 2, 2025 (1, 2) | October 15, 2024 | May 25, 2017

California State Board of Pharmacy disciplinary order (factual allegations begin on PDF page 31)

Trouble with regulators:

  • "At least a dozen states have brought actions against Empower within the last decade. They allege that it violated state rules or regulations, and many states accused the compounding pharmacy of making copies of available drugs that weren’t in shortage. Some of their actions are based on violations alleged by other state boards of pharmacy. Several states, including Oklahoma, Idaho, Iowa and Alabama, have together imposed tens of thousands of dollars in fines on Empower for alleged violations. California’s board of pharmacy has gone the farthest, revoking Empower’s permits and then staying the decision and placing Empower on probation for four years starting in 2023."
Empower's very bad week is not an isolated problem when it comes to 503Bs. Compounding facilities have a role in mitigating drug shortages, and at the same time they can't be allowed to operate without oversight of their federal regulator or they will become threat to patient safety. The question everyone should be asking is this: With so many violations, and so many actions at the state and federal level, did our regulators  have sufficient authority to sanction the company and force changes? Judging from these two articles, the answer is no.