SteraMist iHP Expansion into Compounding 503A and 503B Pharmacies
FREDERICK, Md., April 06, 2026 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global leader in disinfection and decontamination solutions, today reported strong momentum in the compounding pharmacy sector, with approximately a dozen client partnerships. This growth is driven by a heightened demand for validated decontamination technologies as pharmacies face increasingly stringent regulatory oversight and rigorous FDA audits.
The compounding pharmacy industry is currently undergoing a period of intense regulatory transformation, with facilities categorized under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act facing higher stakes than ever before. Traditional 503A pharmacies, which provide patient-specific medications, and 503B outsourcing facilities, which manufacture larger batches for hospital and clinic use, must both adhere to rigorous standards such as USP <797> for sterile compounding and USP <800> for the handling of hazardous drugs. For 503B facilities specifically, the requirement to maintain current Good Manufacturing Practice (cGMP) standards creates a manufacturing-level burden of proof for cleanliness and environmental control that many traditional cleaning methods simply cannot meet.
“The compounding pharmacy industry is at a crossroads where manual cleaning is no longer sufficient to meet modern FDA expectations,” said Elissa J. (E.J.) Shane, COO of TOMI Environmental Solutions. “Our growth in this sector, particularly among 503B outsourcers, reflects a shift toward automated, validated technology. The increasing volume of ongoing solution orders proves that our customers view SteraMist not just as a one-time purchase, but as an essential, everyday partner in maintaining the highest standards of patient safety and regulatory standing.
A single failed FDA audit or contamination event can be catastrophic for a compounding facility, often leading to product recalls and operational shutdowns that can cost a company millions of dollars in lost revenue and remediation fees. By utilizing SteraMist routinely, pharmacies proactively mitigate the risk of a failed inspection and avoid the devastating financial and reputational damage associated with regulatory non-compliance.
About TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®
TOMI™ Environmental Solutions, Inc. (NASDAQ:TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for indoor surface disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage Hydrogen Peroxide as its only active ingredient to produce a fog of ionized Hydrogen Peroxide (iHP™). Represented by the SteraMist® brand of products, iHP™ produces a germ-killing aerosol that works like a visual non-caustic gas.
TOMI products are designed to service a broad spectrum of commercial structures, including, but not limited to, hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, meat and produce processing facilities, military barracks, police and fire departments, and athletic facilities. TOMI products and services have also been used in single-family homes and multi-unit residences.
TOMI develops training programs and application protocols for its clients and is a member in good standing with The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America, America Seed Trade Association, and The Restoration Industry Association.
For additional information, please visit https://www.steramist.com or contact us at [email protected].
Forward-Looking Statements
This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to TOMI’s products and services to serve the life sciences sector. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors include, but are not limited to, our ability to acquire new customers and expands sales; our ability to maintain and manage growth and generate sales, our reliance on a single or a few products for a majority of revenues; the general business and economic conditions; and other risks as described in our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by us with the SEC and other periodic reports we filed with the SEC. The information provided in this document is based upon the facts and circumstances known at this time. Other unknown or unpredictable factors or underlying assumptions subsequently proving to be incorrect could cause actual results to differ materially from those in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.
INVESTOR RELATIONS CONTACT:
John Nesbett/Zach Nevas
IMS Investor Relations
[email protected]
