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Overseas Pharmaceutical Compliance Guidelines

According to applicable laws, regulations and supervisory policies, any overseas products that can be regulated as drugs (including prescription drugs and OTC drugs) under Chinese laws are prohibited from being sold on Amazon.cn. In view of the complexity in recognizing drugs in different jurisdictions, this document, starting from the source country’s regulatory perspective, serves to provide for a set of practical indicators and examples to preliminarily conclude if a product may be regulated as drug under Chinese laws. 

Drugs from the United States

Any overseas products meeting one of the following criteria will be preliminarily recognized as drugs under Chinese laws and therefore will be prohibited to be sold on Amazon.cn.
1. See if there is an “NDC” (short for National Drug Code) on the package. Any product that bears an NDC is drug registered with US FDA. E.g.: see picture below NDC 0220-1109-63
2. See if there is “Drug Facts”on the general display panel of the package.  “Drug Facts”is an important indication of OTC drug according to US FDA’s OTC drug product labeling requirements. Please be aware that any of aforementioned OTC drugs will be prohibited to be sold on Amazon.cn despite needlessness of prescriptions.

OTC drugs are easily mistaken for dietary supplements. Under current Chinese laws and Amazon policies, we oversee dietary supplements by benchmarking our policy in overseeing food products, which is, food products are allowed to be sold under certain conditions.

Difference between OTC drugs and dietary supplements on the package: all nonprescription, OTC medicine labels are required to bear a principle display panel that have detailed usage and warning information so consumers can properly use the product. Additionally, there are general labeling requirements that must appear on an OTC product or product packaging within the principle display panel, including Active Ingredient, Uses, Warning, Inactive Ingredients, Purpose, Directions for use, and Other Information. The Drug Facts labeling requirements do not apply to dietary supplements, which are regulated as food products, and are labeled with a Supplement Facts panel (see picture below).

3. Please note that certain cosmetics may be classified as/or regulated as drugs in the U.S. if, on the product packaging or product detail page, the product is marketed to affect the structure or function of the body. For example, soaps and cleansers marketed as “antibacterial” are drugs. Lotions intended to make people more attractive are cosmetics, however, lotions intended to affect the structure or function of the body, or for therapeutic purposes, such as treating or preventing disease, are drugs (e.g. Eucerin Eczema Relief is marketed to treat Eczema, which is a disease). Various “diseases” include: acne, eczema, or rosacea. Cosmetics with such marketing claims are classified or regulated as drugs in the U.S. and are therefore prohibited to be sold on Amazon.cn.

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