Overview

Amazon maintains strict rules governing the sale of drugs, controlled substances, and drug paraphernalia on its marketplace. Sellers offering any health-related or pharmaceutical products must understand these guidelines to avoid listing removals, account suspensions, or legal consequences. This reference covers everything from over-the-counter (OTC) drug requirements to outright prohibited substances and product categories.

Key Points / What Sellers Need to Know

• OTC drugs must meet full FDA compliance — Products must be FDA-approved for over-the-counter sale, properly labeled, sealed in original manufacturer packaging, and free from any active recalls or safety alerts.
• Prescription drugs are banned — Amazon does not permit the sale of any product requiring a prescription or medical professional supervision, including antibiotics and veterinary prescription products.
• Controlled substances are strictly prohibited — This includes all Schedule I through V substances under the Controlled Substances Act, such as THC-containing products, cannabis seeds capable of germination, coca leaves, psilocybin mushrooms, and poppy pods.
• CBD products cannot be listed — All cannabidiol (CBD) products are prohibited, including full-spectrum hemp oil, broad-spectrum hemp oil, and CBD-infused items.
• Drug paraphernalia is not allowed — Any product primarily designed for making, preparing, or using a controlled substance is banned from the platform.
• Specific listing restrictions apply to certain OTC products — Loperamide is capped at 48 mg per listing, nitrous oxide cannot be marketed for inhalation, and flavored nicotine products are prohibited.

Packaging and Labeling Requirements

Sellers offering OTC drugs on Amazon must ensure their products arrive in the original manufacturer's sealed packaging and are completely new and unused. Each product must display identifying codes from the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers. Labels must be written in English and include the drug name, a "Drug Facts" panel, active ingredients, the drug's purpose, required warnings, usage directions, inactive ingredients, and any other information mandated for that specific product. Importantly, sellers may only use the phrase "FDA approved" when it genuinely applies, and product labels must never feature the FDA logo.