Error 100328: Authorization Required for Prescription and Medical Product Listings
Error 100328 blocks any prescription or regulated medical listing lacking approved credentials. Amazon requires a valid pharmacy license, distributor certificate, or FDA device registration and reviews submissions in 7‑10 business days.
Overview
Amazon blocks sellers with Error 100328 when they attempt to list prescription drugs or regulated medical items without the required authorization. The error appears during creation or editing of such listings and signals that Amazon’s compliance system has detected missing or invalid healthcare credentials. Sellers must address the gap to avoid listing removal and potential account penalties.
Key Points
- Authorization required — Only sellers who have received explicit approval from Amazon can publish prescription or medical product listings; a pharmacy license or equivalent credential is mandatory.
- Multiple trigger points — The error shows up when adding a new prescription item, updating an existing drug listing, or when previously submitted credentials have expired or were never uploaded.
- Specific documentation needed — Amazon expects a current medical or pharmacist license, a valid pharmaceutical distributor certificate, or a certified medical device manufacturer’s accreditation on file.
- Unauthorized listings are removed — Any active listing for a prescription medication that lacks proper approval will be automatically deactivated and may be flagged for removal from the seller’s inventory.
- Compliance enforcement is strict — Repeated attempts to list restricted products without authorization can lead to warnings, suspension of the health‑related categories, or broader account actions.
How to Resolve Error 100328
- Confirm eligibility — Review Amazon’s Restricted Products policy to verify that your business type (e.g., licensed pharmacy, authorized distributor, certified medical device maker) matches one of the approved entity categories. Example: A seller operating a wholesale pharmacy checks the policy and sees that only entities with a state pharmacy license are permitted to list prescription antibiotics.
- Gather required credentials — Collect all relevant documents, such as a state‑issued medical license, pharmacist registration number, FDA registration for devices, or a distributor’s wholesale drug license. Ensure each document is current and matches the name and address on your seller account.
Analysis & Recommendations
Why This Matters
Without the required authorization, listings are automatically deactivated, causing lost sales and potential suspension of health‑related categories. The verification window of 7‑10 business days means delays directly impact revenue and inventory availability.
Key Takeaways
- Error 100328 appears when adding or editing prescription items without a pharmacy license, distributor certificate, or FDA registration.
- Amazon reviews uploaded credentials within 7‑10 business days; listings must remain inactive during this period.
- Repeated unauthorized attempts can lead to warnings, suspension of health categories, or broader account actions.
- All documentation must match the seller account name and address and be kept current to avoid automatic removal.
Recommended Actions
- →In Seller Central, go to Health & Personal Care > Compliance Portal, upload the current pharmacy license or FDA certificate, and complete the quest...
- →Check Seller Central > Account Health for any compliance notices related to Error 100328 and address them within 24 hours.
- →Set calendar reminders 30 days before any health‑related license expires and re‑upload renewed documents via the same compliance portal.
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