Storing Medicinal Products Outdoors? Not a good Idea!

During storage, medicinal products should be protected from the adverse effects of light, temperature, humidity, and other external factors. Outdoor storage generally does not meet these requirements.

That this is not merely a theoretical risk is demonstrated by a recent Warning Letter issued by the U.S. Food and Drug Administration (FDA) on 25 June 2025, to a U.S.-based facility that repackages and manufactures over-the-counter (OTC) drug products, such as hand sanitizers.

During an inspection conducted from 15 to 21 January 2025, the FDA found that large bulk totes of ethanol-based hand sanitizer gel had been stored outdoors since April 2020. This practice clearly violates the declared storage conditions and presents a potential risk to product quality.

The Warning Letter states:

• "Bulk totes of ethanol hand sanitizer gel were stored outdoors, and you informed our investigator that these totes had been stored outdoors since April 2020. Labeling for the bulk ethanol hand sanitizer gel lists a temperature storage range of (b)(4) F. The totes are exposed to temperature excursions that often exceed the specified temperature storage range, which could compromise the quality of the drug product therein."

From the FDA's perspective, the storage practices were incompatible in several respects with the requirements of Current Good Manufacturing Practice (CGMP). According to the FDA, the company has announced that it will cease manufacturing the affected products and will not renew its registration as an OTC manufacturer. Nevertheless, the agency demands a comprehensive evaluation of the distributed batches and expects a formal response.

This case exemplifies the regulatory and quality-related risks associated with inadequate storage practices – even when dealing with “only” bulk material intended for repackaging. Adherence to the specified storage conditions must be consistently and verifiably ensured. Otherwise, not only quality loss but also regulatory action, product recalls, and reputational damage may follow.

The full Warning Letter issued to Nature’s Fusions LLC is available on the FDA’s website.