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US FDA offers new supply chain security guidance

By Zachary Brennan+

12-Jun-2014
Last updated on 12-Jun-2014 at 11:23 GMT

As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might enter the supply chain.

Beginning January 1, 2015, trading partners will be required, upon determining that a product in their possession or control is a suspect product, to quarantine the product while they promptly conduct an investigation to determine whether the product is an illegitimate product. Manufacturers also must notify the US FDA and certain immediate trading partners when a suspect product is identified.

But what may cause some issues is that the definition of a suspect product is somewhat loosely defined. According to section 581(21) of the FD&C (Food, Drug and Cosmetics) Act, a suspect product is defined as either a potentially counterfeit, diverted, or stolen product; a potentially intentionally adulterated product such that it would result in serious adverse health consequences or death to humans; a product potentially the subject of a fraudulent transaction; or a product that appears otherwise unfit for distribution such that it would result in serious adverse health consequences or death to humans.

Manufacturers should be especially vigilant in cases, according to the FDA, where they are:

• Purchasing from a source new to the trading partner;

• Receiving an unsolicited sales offer from an unknown source;

• Purchasing on the Internet from an unknown source, especially if they are searching for a better price on the Internet or for a product that they cannot obtain from their usual source;

• Purchasing from a source that a trading partner knows or has reason to believe has transacted business involving suspect products;

Drugmakers should also be weary of trading partners with a history of problematic or potentially false transaction histories or pedigrees, “such as those that contain misspelled words or incomplete information,” as well as partners who are “reluctant to provide a transaction history or pedigree associated with the product being purchased, or does not do so in a timely manner,” the FDA says.

The draft guidance comes as the agency is still debating how to create a track-and-trace system that will help to rid the supply chain of fraudulent or falsified medicines. The DSCSA (Drug Supply Chain Security Act) outlines critical steps to build an electronic, interoperable system over the next 10 years.

The agency also calls on drugmakers to be careful when product is generally in high demand in the US market; with product that has previously been falsified, such as HIV, antipsychotic, or cancer treatments; or product that is or has been involved in a drug shortage.

In addition, the FDA calls for increased discussions among drugmakers on suspect product, noting: “Trading partners should discuss with each other any observations, questions, or concerns they have related to the status of a drug as a suspect product to aid them in determining whether the drug should be considered a suspect product.”

The appearance of drug packages, including the identification codes and numbers, as well as lot identification and expiration dates should also be investigated.

The draft guidance also offers information on the process that must be used when trading partners believe that a notification they made to FDA regarding illegitimate product, or a notification of a high risk of illegitimacy, is no longer necessary.

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