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2014-06-14 Lachman CONSULTANTS

2015年1月1日起，非法嫌疑产品的FDA通告新规

FDA发布了一项名为《药品供应链安保法案实施：嫌疑产品的鉴别和通告》的指南草案，该指南介绍了贸易伙伴将具有潜在嫌疑的产品告知FDA的适当方法。《药品供应链安保法案（DSCSA）》新规于2015年1月1日起执行，并要求公司鉴别具有嫌疑的直接贸易伙伴。指南将“贸易伙伴”定义为生产商、再包装商、批发商或药剂师，要求公司认定了一种可疑产品后，必须在24小时内告知FDA。

该指南中，依据FD&C法案，可疑产品定义为有理由相信出现以下情形者：（A）可能为伪造、转手或偷窃所得；（B）可能为故意掺杂，致使产品导致严重的不良健康后果或造成人员死亡；（C）可能为欺诈交易产品；（D）可能由于配送不当，致使产品导致严重的不良健康后果或造成人员死亡。

指南中举例说明以下情形：贸易伙伴应注意来自其他贸易伙伴或产品采购部门的可疑产品警告，产品供应记录，产品价值以及产品外观。可以参考以下列出的相关指南章节。

警惕低价销售的产品或那些“好的不真实的”的产品

• 谨慎检查包装及运输容器（如箱子或手提袋）：检查其是否具有破损迹象（例如开封、封口破损、损坏、修复过或更换过的）
• 检查自上次接收之后，其是否由于未明原因发生变化（例如未收到生产商关于变更的通知）。
• 检查产品中附带的说明书等是否遗失或与产品不符。
• 检查配送地址、邮戳以及其他可能指示产品来自非预期境外实体或来源的信息。

如适用，仔细检查包装上的标签，或者单个零售单位上的标签：

• 信息是否遗失，例如批号或者其他批次信息、NDC、规格；
• 产品信息是否更改，例如打印内容是否油污，是否难以辨认；
• 是否有错字；
• 标签表面是否有气泡；
• Rx标志是否缺失；
• 使用外国语言，提供较少英语或不提供；
• 使用外语描述批号
• 使用与FDA批准的药品名称不同
• 使用在其他国家流通所使用的药品名称；
• 在不应使用箱子或手提袋运输时使用。
• 产品批号和有效期与256批号及外容器标识的有效期不符。

指南也介绍了如何将可疑产品报告FDA，指出可疑产品应当隔离检查，直至调查结束。如证明产品没有问题，应如何告知FDA终止通告。

所以请做好准备！ 供应链下一年初必须要为此付出努力，以进一步确保整个供应链安保。确保只有合法、完好的产品最终到达消费者手中是每一个人的责任。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-10
校译：识林-柯 2014-06-13

New Requirements on FDA Notification of Suspected Illegitimate Products To Begin January 1, 2015
Written by Bob Pollock • June 10, 2014

FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of FDA by trading partners of the potential suspect products. The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion. The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.

Under the Guidance a “[S]uspect product is defined in section 581 of the FD&C Act as a product for which there is reason to believe it (A) is potentially counterfeit, diverted, or stolen; (B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (C) is potentially the subject of a fraudulent transaction; or (D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.”

The Guidance provides example of scenarios that trading partners should pay attention to in alerting them to a possible suspect product from other trading partners or product sourcing options; cautions firms to be wary of supply history, value of the product; and appearance of the product. Some passages from the Guidance can be found below.

Be alert for offers of product for sale at a very low price or one that is “too good to be true”

• Closely examine the package and the transport container (such as the case or tote):- To look for signs that it has been compromised (e.g., opened, broken seal, damaged, repaired, or altered).
• To see if it has changed since it was last received for an unexplained reason (e.g., a notification about the change from the manufacturer has not been received)
• To see if product inserts are missing or do not correspond to the product.
• For shipping addresses, postmarks, or other materials indicating that the product came from an unexpected foreign entity or source.

Closely examine the label on the package, or the label on the individual retail unit, if applicable, for:

• Any missing information, such as the lot number or other lot identification, NDC, or strength of the drug
• Any altered product information, such as smudged print or print that is very difficult to read.
• Misspelled words.
• Bubbling in the surface of a label.
• Lack of an Rx symbol.
• Foreign language with little or no English provided.
• Foreign language that is used to describe the lot number
• A product name that differs from the name of the FDA-approved drug.
• A product name that is the product name for a foreign version of the drug.
• A product that is transported in a case or tote, when not expected under the circumstances.
• Lot numbers and expiration dates on product that do not match the lot 256 numbers and expiration dates of its outer container.

The Guidance also describes how to notify FDA of the suspect product, indicated that the product should be quarantined until the investigation is complete and, if the product is found not to actually be a problem product, how to notify the FDA of the termination of the notification.

So get ready – here is something else that the supply chain must being doing on the first of the year to aid in further securing the entire supply chain. It is everyone's business to assure that only legitimate and non-tampered with products ultimately reach the consumer.

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