药物和药物用具

重要: 如果您在亚马逊上销售商品,则必须遵守适用于这些商品和商品信息的所有联邦、州和地方法律以及亚马逊政策

本页介绍了药物、管制物质和药物用具。药物是用于诊断、治愈、治疗或预防人类或动物疾病的物质。药物也可用于改变人体的结构或功能,例如治疗某些类型的痤疮。有些药物需要提供处方才可出售,例如大多数抗生素,而其他药物可在没有提供处方的情况下出售,因为其经 FDA 批准可进行非处方销售。

“管制物质”是非法药物,如可卡因或海洛因。与管制物质一起使用的商品可被视为药物用具。药物用具包括主要用于或设计用于制造、制备或使用管制物质的商品。

请参照下面的清单,确保您的商品可在亚马逊上销售。

药物和药物用具的合规性清单

包装

  1. 药物必须采用制造商原始包装密封

  2. 药物必须为新品且未使用

  3. 药物必须明确显示制造商或分销商在包装上贴示的识别码,比如矩阵码、批号或序列号

贴标

  1. 药物必须采用英语贴标,并包含以下信息:

    1. 药物名称

    2. “药物成分”表

    3. 活性成分

    4. 药物用途

    5. 药理作用

    6. 所有必需的警告

    7. 药物使用说明

    8. 特定商品所需的任何其他信息

    9. 非活性成分

  2. 药物必须适当使用“经 FDA 批准”的声明

  3. 药物标签不得使用 FDA 徽标

有关更多信息,请参阅美国食品和药物管理局的贴标指南和是否确实“经 FDA 批准?”

详情页面

  1. 详情页面必须包含以下信息:

    1. 药物名称

    2. 活性成分

    3. 商品标签上的“药物成分”表(以及任何“药物成分 [续]”表,如适用)图片

  2. 详情页面必须符合药物的批准贴标要求

  3. 药物必须适当使用“经 FDA 批准”的声明

  4. 药物标签不得使用 FDA 徽标

药物商品和成分

  1. 药物商品必须获得 FDA 批准方可进行非处方 (OTC) 销售

  2. 药物商品不得要求开具处方或在医学专业人士监督或指导下使用,例如:

    1. 处方药物及其活性成分

    2. 抗生素(包括非处方和处方“鱼类”抗生素)

    3. 处方兽药商品及其活性成分

    4. 疫苗(包括人类和动物疫苗)

  3. 药物商品不得出现在 FDA 召回或安全警告中(有关更多信息,请参阅: 召回、市场撤回和安全警告)

  4. 药物商品不得进入美国禁毒署 (DEA) 紧急列管清单(有关更多信息,请参阅: DEA 新闻稿)

  5. 药物商品不得被美国联邦贸易委员会 (FTC) 认定为不真实的营销宣传(有关更多信息,请参阅: 联邦贸易委员会新闻稿)

  6. 药物商品不得在 FDA 警告信中被认定为掺入次级品(如不安全或缺少安全证据)或贴错商标(如标签包含虚假或误导性信息)(有关更多信息,请参阅: FDA 警告信)

  7. 药物商品不得用于管制物质或含有管制物质的商品,例如:

    1. 麻黄碱

    2. 麻黄素类商品

    3. 伪麻黄碱

    4. 麦角胺

    5. 古柯叶,包括各类树叶、茶叶和古柯叶萃取物

    6. 致幻蕈类

    7. 罂粟豆荚、罂粟秆和罂粟秆浓缩液

    8. 含有树脂或四氢大麻酚 (THC) 的大麻商品

    9. 可以发芽的大麻籽(或其他任何大麻品种植物的种子)

    10. 列入《管制物质法》的附录 I、II、III、IV 或 V 的任何物质(有关更多信息,请参阅: 管制物质附录),例如:

    11. 美国禁毒署 (DEA) 指定的“I 类”化学品或其衍生物(有关更多信息,请参阅: I 类和 II 类化学品),例如:

      注意: 亚马逊禁止销售含碘量超过 2.2% 的 Lugol 溶液

  8. 药物商品不得用于被美国禁毒署 (DEA) 确定为毒品或危险化学品的物质,例如:

    1. 曼陀罗

    2. 克腊托姆

    3. 鼠尾草

  9. 药物商品必须符合亚马逊政策

    1. 全光谱大麻油

    2. 含量极高的大麻油

    3. 已被 LegitScript 认定为含有 CBD 的商品

    4. 某些洛派丁胺药品会受到限制以符合针对高药丸计数商品和大剂量洛派丁胺液体的使用限制

    5. 禁止销售宣称具有某些功效的罂粟种子商品,包括可制成罂粟茶的罂粟种子、“未经过清洗”的罂粟种子、包含生物碱含量的罂粟种子,以及可制成麻醉剂的罂粟种子

    6. 禁止销售宣称具有精神作用或致幻效果的商品,包括“人造毒品”,如 methoxetamine

    7. 禁止销售宣称可产生与合成代谢类固醇(如“合法类固醇”)具有类似功效的商品

    8. 禁止销售宣称模仿管制物质、处方药或经 FDA 认定为未经批准的新药或受污染补充剂物质功效的商品,包括合成大麻素和吸食毒品浴盐

    9. 禁止销售顺势疗法磨牙商品

    10. 禁止销售只有处方类药物中才含有的活性成分商品

    11. 禁止销售可注射的药物商品

    12. 禁止销售含有大麻二酚 (CBD) 的商品,包括但不限于:


 亚马逊官网原文详情:

Drugs & drug paraphernalia

Important: If you supply products for sale on Amazon, you must comply with all federal, state, and local laws and Amazon policies applicable to those products and product listings.

This page covers drugs, controlled substances, and drug paraphernalia. A drug is a substance used to diagnose, cure, treat, or prevent diseases in people or animals. Drugs can also be used to change the structure or function of the body, such as to treat some kinds of acne. Some drugs require a prescription for sale, such as most antibiotics, while other drugs may be sold without a prescription because they are approved by the FDA to be sold over the counter.

“Controlled substances” are drugs that are illegal, such as cocaine or heroin. Products used with controlled substances may be considered drug paraphernalia. Drug paraphernalia includes products primarily intended or designed for use in making, preparing, or using a controlled substance.

Please use the checklist below to be sure your product can be sold on Amazon.

Compliance Checklist for Drugs & Drug Paraphernalia

Packaging

  1. Drugs must be sealed in the original manufacturer’s packaging

  2. Drugs must be new and unused

  3. Drugs must clearly display identifying codes placed on the packaging by the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers

Labeling

  1. Drugs must be labeled in English with the following information:

    1. The title of the drug

    2. The “Drug Facts” panel

    3. The active ingredient(s)

    4. The purpose(s) of the drug

    5. The use(s) of the drug

    6. Any required warning(s)

    7. The directions for using the drug

    8. Any other information, as required for the specific product

    9. The inactive ingredients

  2. Drug must use the claim “FDA approved” appropriately

  3. Drug labels must not use the FDA logo

For more information, see the U.S. Food and Drug Administration’s Guidance on Labeling and Is It Really 'FDA Approved?'

Detail page

  1. Detail pages must include the following information:

    1. The name of the drug

    2. The active ingredients

    3. An image of the “Drug Facts” panel (and any “Drug Facts (Continued)” panels, if applicable) from the product label

  2. Detail pages must comply with the approved labeling for the drug

  3. Drug must use the claim “FDA approved” appropriately

  4. Drug labels must not use the FDA logo

Drug products and ingredients

  1. Drug products must be approved by the FDA for over-the-counter (OTC) sale

  2. Drug products must not require a prescription or a medical professional's supervision or direction for their use, such as:

    1. Prescription drugs and their active ingredients

    2. Antibiotics (including "fish" antibiotics, both over-the-counter and prescription)

    3. Prescription veterinary products and their active ingredients

    4. Vaccines (including human and animal vaccines)

  3. Drug products must not be named in an FDA recall or safety alert (for more information, see: Recalls, Market Withdrawals, & Safety Alerts)

  4. Drug products must not have been the subject of a Drug Enforcement Administration (DEA) emergency scheduling (for more information, see: DEA Press Releases)

  5. Drug products must not be named by the Federal Trade Commission (FTC) as making untrue marketing claims (for more information, see: Federal Trade Commission Press Releases)

  6. Drug products must not be identified as adulterated (e.g. unsafe or lacking evidence of safety) or misbranded (e.g. having false or misleading information on the label) in an FDA warning letter (for more information, see: FDA Warning Letters)

  7. Drug listings must not be for controlled substances or products containing controlled substances, such as:

    1. Ephedrine

    2. Phenylpropanalomine

    3. Pseudoephedrine

    4. Ergotamine

    5. Coca Leaves, including all variations of leaves, tea, and coca extract

    6. Hallucinogenic mushrooms

    7. Poppy pods, poppy straw, and poppy straw concentrate

    8. Hemp products containing Resin or tetrahydrocannabinol (THC)

    9. Hemp (or any cannabis Sativa spp. strain) seeds capable of germination

    10. Anything listed in Schedules I, II, III, IV or V of the Controlled Substances Act (for more information, see: Schedules of Controlled Substances), such as:

    11. "List I" chemicals or their derivatives as designated by the Drug Enforcement Administration (DEA) (for more information, see: List I and List II Chemicals), such as:

      Note: Amazon prohibits the sale of Lugol's Solution containing more than 2.2.% iodine

  8. Drugs listings must not be for substances identified by the Drug Enforcement Administration (DEA) as a drug or chemical of concern, such as:

    1. Jimson Weed

    2. Kratom

    3. Salvia Divinorum

  9. Drug listings must comply with Amazon policies:

    1. Full spectrum hemp oil

    2. Rich hemp oil

    3. Products that have been identified as containing CBD by LegitScript

    4. Loperamide listings are restricted to 48 mg of loperamide. Capsule and tablet loperamide must be packaged in blister packs. Images of the “Drug Facts” panel and Heart Alert Warning from the product label must be present on the detail page.

    5. Listings for poppy seeds that make certain claims, including listings for poppy seeds that reference poppy tea, poppy seeds that are “unwashed,” poppy seeds that reference alkaloid content, and poppy seeds that reference opium are prohibited

    6. Listings for products claiming to have psychoactive or hallucinogenic effects are prohibited, including “designer drugs” such as methoxetamine

    7. Listings for products claiming to produce an effect similar to that of an anabolic steroid such as "Legal Steroids" are prohibited

    8. Listings for products claiming to imitate the effects of a controlled substance, prescription drug, or substance identified by the FDA as an unapproved new drug or tainted supplement are prohibited, including synthetic cannabinoids and bath salts

    9. Listings for homeopathic teething tablets, pills, and similar products, and topical creams, gels, and similar products are prohibited

    10. Listings for the active ingredients in prescription-only drugs are prohibited

    11. Listing for injectable drugs are prohibited

    12. Listings for products containing cannabidiol (CBD) are prohibited, including but not limited to:

 文章来源:亚马逊官方网站