FDA warns Empower Pharmacy over unauthorized weight-loss drugs

FDA Targets Empower Pharmacy Over Weight-Loss Drug Volume

Compounding pharmacies typically customize medications for individual patients, such as mixing liquid solutions for people who struggle to swallow pills. Regulators inspect these facilities but do not formally review the drugs they produce, meaning the FDA cannot offer the same safety guarantees associated with its standard drug approval process. However, federal rules allow compounders to copy brand-name medications when the agency officially declares a drug shortage. When Novo Nordisk and Eli Lilly struggled to meet consumer demand for their appetite-suppressing medications in 2022, numerous compounders began producing alternative versions at lower prices.

The regulatory environment shifted when the FDA declared an end to the shortages in 2025. While federally licensed compounding pharmacies largely halted production of Eli Lilly’s tirzepatide—sold as Zepbound and Mounjaro—and Novo Nordisk’s semaglutide—marketed as Wegovy and Ozempic—smaller, state-licensed facilities continued manufacturing them. These smaller pharmacies relied on a specific policy permitting custom alterations to approved drugs, such as changing dosages or adding vitamins, provided a licensed medical professional deems the adjustment necessary for an individual patient.

Evidence Cited in the Federal Warning Letter

Following an inspection in November 2025, the FDA concluded that Empower used customization rules as a pretext to manufacture large-scale copies of approved drugs. The warning letter highlights three primary violations:

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• Orders processed without any documentation from a prescriber stating that Empower’s formulation would provide a significant clinical difference compared to the FDA-approved medication.
• Prescriptions featuring prescriber rationales that appeared repeatedly word-for-word.
• A massive total volume of production, with exact manufacturing figures redacted in public documents.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, noted that the federal action focused primarily on missing documentation to prove individual patient need rather than sheer production volume alone.

Legal Battles and Industry Impact

Drug manufacturers have pushed back aggressively against these compounding practices through public statements and federal lawsuits. Eli Lilly filed a lawsuit against Empower, accusing the pharmacy of deceptive marketing practices by selling standardized knockoffs disguised as personalized treatments. Empower denied these allegations in court filings, and the litigation remains active.

Darshan Kulkarni, founding partner of the Kulkarni Law Firm and an expert in healthcare and pharmacy law, stated that the federal warning acts as a clear signal to the industry. While the notice is unlikely to halt the production of compounded weight-loss treatments overnight, it will likely force compounding pharmacies to alter how they market and document their products. “That avenue is definitely getting narrower,” Kulkarni said.

In response to the federal action, Empower released a statement confirming it has already addressed many of the concerns raised in the warning letter and pledged to continue working cooperatively with regulators to maintain patient access to compounded products.

Frequently Asked Questions

Why are compounding pharmacies allowed to copy brand-name drugs?

Federal regulations permit compounding pharmacies to produce copies of FDA-approved medications specifically when the agency formally declares a drug shortage.

Are compounding pharmacies still making GLP-1 medications?

While major federal compounders stopped production after the FDA declared the shortages resolved in 2025, some state-licensed pharmacies continue manufacturing them by claiming individual patient modifications.

What did the FDA find during its inspection of Empower Pharmacy?

Inspectors found massive production volumes, orders lacking documentation of required medical differences, and identical prescriber rationales repeated across multiple orders.