Amazon Verification Services for OTCs

Amazon requires certain oral OTC medications sold in the U.S. store to undergo third-party verification through an approved Testing, Inspection and Certification (TIC) provider.

When SGS is selected, verification may include:

• GMP documentation review
• Product label review
• FDA National Drug Code (NDC) verification
• Active Pharmaceutical Ingredient (API) testing
• Heavy metals testing
• Microbiological testing
• Ethylene glycol (EG) and diethylene glycol (DEG) testing for applicable liquid products
• Dosage-form performance testing, including dissolution where applicable

Once the required documentation review and testing are complete, SGS prepares and submits the verification result through Amazon’s required compliance process.

If Amazon requires third-party verification for your ASIN, the compliance request will appear in Seller Central. Follow Amazon’s instructions and select SGS as your approved Testing, Inspection and Certification (TIC) provider. Once your request is submitted to SGS, our team will contact you regarding the documentation, finished-product samples, and other information required to begin the verification.

Testing requirements depend on the product, dosage form, active ingredient, and applicable regulatory standard. Amazon’s policy may require:

• API testing according to the applicable monograph or approved New Drug Application (NDA)
• Heavy metals testing for cadmium, lead, arsenic, and mercury
• Microbiological testing
• EG/DEG testing for applicable liquid products
• Dissolution or other dosage-form performance testing where applicable

SGS will confirm the specific testing requirements for your product during the review.

Amazon requires acceptable evidence that oral OTC medications are manufactured in accordance with applicable current Good Manufacturing Practice requirements. Depending on the facility, acceptable evidence may include qualifying third-party GMP certification, Health Canada Drug Establishment licensing, EudraLex Volume 4 or PIC/S GMP documentation, or qualifying FDA inspection history.

If FDA inspection history shows a Voluntary Action Indicated (VAI) status or an outstanding FDA Form 483, additional documentation may be required. An unresolved Official Action Indicated (OAI) status is not sufficient evidence of compliance under the policy.

Yes. Amazon’s policy requires verification that the product is listed in the FDA National Drug Code Directory. SGS will review the NDC information and confirm that it corresponds to the product being evaluated.

Potentially. Amazon permits SGS to review certain existing third-party test documentation when the laboratory, methods, timing, and documentation meet the applicable program requirements. Testing generally must have been completed within six months before submission to SGS, and SGS must be able to authenticate the documentation.

If existing testing does not meet Amazon’s requirements, additional testing may be necessary.

Amazon’s policy provides that product-compliance status is valid for one calendar year from the verification pass date. If the compliance status expires before new valid verification is provided to Amazon, the ASIN may be suppressed until valid compliance status is restored.

When Amazon issues a new verification request, SGS will evaluate the product against the requirements applicable at that time. Amazon’s program also includes surveillance testing, so additional testing may occur during the verification period.

Sample quantities depend on the dosage form, active ingredients, and testing required. SGS will confirm the required quantity of representative finished-product samples before shipment.

For typical oral OTC analytical testing, SGS’s expected laboratory turnaround time is approximately 5-7 business days from receipt of the required samples at the laboratory. The overall verification timeline can vary depending on documentation completeness, testing scope, number of active ingredients, manufacturer or laboratory follow-up, and any Out-of-Specification investigation or remediation.

Verification costs depend on the product, dosage form, number of active ingredients, required testing, and documentation available for review. SGS will provide a quotation based on the verification requirements for the specific ASIN.

If a product does not meet one or more applicable requirements, SGS will identify the noncompliant parameter and advise whether Amazon’s policy provides an available resolution pathway. Depending on the finding, resolution may involve additional documentation, corrective action, reformulation, retesting, additional product lots, product recall, or other remediation.

Not every failure is remediable, and SGS will explain the applicable next steps based on the specific result.

Potentially. Amazon permits product-family consideration when products are sufficiently similar in formulation and manufacturing procedures. For oral OTC medications, multiple ASINs may potentially be represented by a single test sample when they are manufactured at the same address and are the same product form. The seller must identify the ASINs proposed for product-family consideration, and SGS must determine whether they qualify.

Amazon requires SGS to confirm that external testing and certification documentation is authentic and meets the applicable program requirements. SGS may authenticate documentation through an official issuing-body database or website or obtain confirmation directly from the issuing laboratory, certification body, manufacturer, or other organization when public verification is not available. Providing accurate contact information for the relevant third parties can help avoid delays.