OTC Ophthalmic Drug Products

Amazon’s Ophthalmic Drug Products Program Policy sets out the steps required to verify the safety and quality of eye-care products sold on its platform. The process involves several key stages:

• Product testing and review: you partner with us to conduct the necessary testing for your specific ophthalmic product type. This ensures your product meets Amazon’s safety and quality requirements
• Good Manufacturing Practice (GMP) certification: you provide GMP certificates from your manufacturer to confirm production in facilities that follow recognized quality manufacturing standards.
• Label verification and product testing: we review your product labels, documentation, and testing results to ensure they meet Amazon’s OTC ophthalmic product standards.

The verification itself follows a two-phase structure:

Phase 1: label verification

We verify that your product labels comply with 21 CFR 201 Subpart C and 21 CFR 349, and confirm that your manufacturer meets cGMP 210/211, NSF 455-4, or equivalent standards. Label approval is required before moving on to the next phase.

Phase 2: product sterility testing

Once labels are approved, we perform sterility and tamper-evident packaging testing under cGMP conditions to ensure your products are safe for consumer use.

This two-phase approach helps you avoid unnecessary costs by ensuring products that do not pass label verification are not tested further. Once verification is complete, we report a ‘Pass’ or ‘Fail’ status to you and to Amazon.

Amazon will notify you through your Seller Central account if your product requires compliance verification. Simply select SGS as your testing provider, and our team will contact you to begin the process.

Verification is valid for 12 months from the approval date. After one year, you must renew verification to keep your listing active. If your compliance status expires, Amazon may temporarily remove your product listing until re-verification is complete.

Sample quantities are confirmed during the quotation process. All samples must be unopened, sealed and in their retail packaging.

Once all documentation and samples are received, verification typically takes three to five weeks. Timelines may vary depending on investigations, missing documents or communication delays.

Costs depend on your product type and the testing required. Please contact us for a detailed quotation.

If you disagree with the outcome and we cannot reach a resolution, you may file an appeal directly with Amazon in accordance with its program policy.

If eligible, you can submit a Corrective and Preventive Action (CAPA) plan outlining the steps you will take to address the issues identified. Once the CAPA has been reviewed and corrective actions confirmed, we may retest your product. If successful, your product’s status can be updated to ‘Pass’. Additional testing fees may apply.

To maintain data integrity, Amazon requires us to obtain all supporting documentation – such as Certificates of Analysis (CoAs), GMP certificates and ISO accreditations – directly from your manufacturer or testing laboratory. This ensures authenticity and helps prevent delays in verification.