New policy

To better protect our customers, Dry Eye Shop is adopting a new policy to allow us to more effectively screen for potential elevated safety risks.

After a transition period, we will only stock eye drops for which we have the name and location of the manufacturing facility on record. 

Why we insist on knowing where eye drops are manufactured

The reason for this policy is the ongoing manufacturing quality trends that have emerged in recent years at many contract manufacturing facilities in the US and abroad.

Since 2022, 26 manufacturers and 41 distributors have received FDA Warning Letters and 166 products have been recalled. For details, see Recalls and FDA Public Notices on OTC Ophthalmic Drugs, a list maintained by Dry Eye Foundation.

If we know where a product is made, we can conduct some amount of due diligence on product safety, for example:

• We can check FDA inspection findings and enforcement actions
• We can obtain inspection reports (Form 483) to determine if adverse event findings may affect eye drop sterility
• We can consult industry experts to better understand trends and potential risks

We cannot, obviously, ever guarantee the safety of products. But we will do as much as we reasonably can to uphold the highest standard we can.

Why we may have to discontinue some products

Companies that sell eye drops under their own brand are not required to disclose the manufacturing facility.

Many choose to provide this information in their official drug listing submitted to the FDA, where anyone can access it. Others choose not to. 

In cases where this information is not public, and where we have no other way to independently verify the manufacturing source, we are requesting that the companies give us this information unde a confidentiality agreement, which allows us to use the information internally to conduct our risk assessments.

If the company declines, we will not be in a position to stock their products and we apologize to customers for the inconvenience.