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Mail-order pharmacy hit with new licensing board charges

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Mail-order pharmacy hit with new licensing board charges

Apr 02, 2024 | 5:02 pm ET
By Clark Kauffman
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Mail-order pharmacy hit with new licensing board charges
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The Iowa Board of Pharmacy oversees state-licensed pharmacies, pharmacists and pharmacy technicians in Iowa. (Photo by Getty Images; logo courtesy the State of Iowa)

A Texas-based pharmaceuticals company sanctioned for illegally selling hormones to Iowans is facing a new round of charges from state regulators.

Empower Pharmacy of Houston, Texas, is charged by the Iowa Board of Pharmacy with failing to exercise professional judgment regarding the accuracy, validity, and authenticity of a prescription drug order. It is also charged with compounding copies of federally approved drugs that lack any clinically significant difference from the approved drugs; failing to ensure pharmacy personnel and patients are adequately protected from unnecessary exposure to hazardous drugs; failing to follow standards related to nonsterile compounding of drugs; and failing to follow standards related to sterile compounding.

The actions that Empower allegedly took in violating those regulations have not been publicly disclosed by the board. However, the violations appear to be related to requirements the board imposed on the company in 2021.

In that case, the board issued a warning to Empower and ordered it to permanently halt shipments of compounded human chorionic gonadotropin, or HCG, into Iowa.

In addition, the board placed the company’s pharmacy license on probation for three years and imposed a $25,000 civil penalty. It also required the company to submit reports to the board on a quarterly basis and undergo at least one on-site inspection.

That action stemmed from a set of charges the board levied against Empower in 2019 when it accused the company of shipping unregulated, compounded HCG to Iowa patients in 2017 and 2018, rather than sending the commercially available version of the product.

Typically, prescriptions for drugs are filled at pharmacies using commercially available products that have been evaluated for safety and efficacy, approved by the U.S. Food and Drug Administration, and are manufactured at facilities that are registered with the FDA.

When there is not a commercially available drug product that’s suitable for a particular patient, a pharmacy is allowed to compound, or manufacture, a product that has been significantly altered to meet the specific needs of that patient.

Since compounded products of that nature have not undergone the FDA-approval process, they lack the safety and efficacy evaluations required of commercially available drugs. For that reason, pharmacies are required to use commercially available drugs whenever possible.

The Iowa Board of Pharmacy had claimed Empower bypassed that requirement and shipped to Iowans its own compounded version of HCG, which is a hormone that supports the normal development of an egg in a woman’s ovary. It is often used to cause ovulation and to treat infertility in women and to increase sperm count in men.

Empower went to court to challenge the board’s actions and to seek judicial review of the board’s decision. It claimed the board’s investigators chose not to interview any of the company’s pharmacists, any of the prescribing medical providers who coordinated the medications with the company, or any of the Iowa patients who received the compounded HCG.

Polk County District Judge Celene Gogerty sided with board and denied the company’s request for judicial review, noting that the question before the court was whether there was substantial evidence to support the board’s findings, not whether the evidence might support a different finding.

In her ruling, Gogerty indicated the court was bound by the board’s factual findings unless a contrary result is demanded as a matter of law. There was, she ruled, “substantial evidence” to support the board’s findings that Empower violated Iowa law. That decision was upheld by the Iowa Court of Appeals in March 2023.

Compounding pharmacies like Empower are a hybrid of traditional, retail pharmacies and pharmaceutical manufacturing companies in the sense that they custom-produce medications in formulations that are then shipped directly to patients. The custom formulations enable them to forgo royalty payments they’d have to make if they simply stocked and sold FDA-approved products.

In 2019, the FDA notified Empower that the company had violated FDA regulations by failing to have on file any FDA-approved applications for new drug products it was compounding. The agency also alleged Empower violated regulations on misbranded drug products by compounding products intended for conditions that are “not amenable to self-diagnosis and treatment.”