Counterfeit Drugs - Questions-and-Answers Paper from FDA

On 2 June 2008, the FDA published the document "Counterfeit Drugs Questions and Answers". It includes general information by the FDA on counterfeit medicinal products and is directed at the American public.

The FDA emphasises in this document that it plays a highly active part in WHO's working group IMPACT (International Medical Products Anti-Counterfeiting Task Force).

The question for the existing technological possibilities to protect medicinal products in general against counterfeiting is answered above all with a reference to RFID (Radio Frequency Identification).

The complete Q&A Document can be found here:

In March 2008, the FDA published two dockets in the Federal Register in which the Agency asked for comments and information on possible standards and technologies regarding track-and-trace systems.

In the meantime the pharmaceutical industry has given feedback on these requests. The July 2008 issue of the Gold Sheet mentions that - at least in the short term - the industry prefers the use of the 2-dimensional bar code technology over that of RFID!

In fact, this 2-D bar code had already been pointed out expressly as the preferred technology in WHO's IMPACT report of March 2007.

In their feedback to the FDA, many companies informed the FDA that in their opinion the standards developed by GS1 should be adopted. GS1 is an international standardisation organisation with 108 member organisations in 150 countries worldwide. The pharmaceutical companies recommended FDA to adopt the Global Trade Item Number (GTIN) for tracing back products in international trade.

The European pharmaceutical association EFPIA also advises to use the GS1 standards in its comments to the FDA. EFPIA has announced that a corresponding pilot project will soon be launched with the 2D datamatrix code using the Data Matrix Code ECC 200.

On the whole, the 2D bar code option is considered as the favourite technology by the pharmaceutical industry, since the costs are significantly lower than for the RFID technology.

The European Compliance is co-sponsoring the conference "Strategies against Counterfeit Medicines" in Würzburg, Germany, from 3-5 November 2008. To find out more about the conference, please visit

Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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