USA: when is a product suspicious, when is it illegitimate?

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18 June 2024
Barcelona, Spain

QP pre-course Session: Interpersonal and Soft Skills for the QP

In March 2018, the FDA published their draft guidance "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act".

The terms "suspect product" and "illegitimate product" are both defined within the US law for the safety of the drug supply chain. The FDA now published this guideline to further define and illustrate the two terms. The goal is to make sure that all partners involved in the trade in pharmaceutical products know these terms so that they can meet the obligations of verification and notification.

Trade partners in the distribution of medicines must prepare for the threat of suspicious or illegitimate medicinal products. The guideline is supposed to help the industry in identifying those products. All trade partners are asked to initiate specific actions if such products turn up.

The FDA assumes that trade partners will be faced with the four following situations:

a. Counterfeits
b. Diverted products
c. Fraudulent transactions
d. Products unfit for distribution

Fore more information please also see the complete FDA draft guidance "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act".