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    FDA unveils new drug pedigree requirements

    Mandatory reporting begins January 1, 2015

    Ned MilenkovichNed MilenkovichTitle II of the Drug Quality and Security Act is composed of the Drug Supply Chain Security Act (DSCSA). The DSCSA modified Section 582 of the Federal Food, Drug, and Cosmetic Act to require pharmaceutical manufacturers, repackagers, wholesale distributors, and drug dispensers who are not practitioners to notify FDA and certain trading partners of products that are identified as illegitimate within 24 hours of making such determination. 

    Products that manufacturers, repackagers, wholesale distributors, and dispensers determine are suspect must be quarantined and an investigation must be conducted to determine whether the products are illegitimate. Suspect or illegitimate pharmaceutical products include those that are potentially counterfeit, diverted, or stolen; capable of adversely affecting human beings; possible subjects of fraudulent transactions; or unfit for distribution.

    Verification systems

    It is expected that, in compliance with the modifications to the DSCSA, trading partners will develop secure electronic systems to verify the status of a pharmaceutical product and create processes to ensure that appropriate quarantine, investigation, and reporting requirements are met if a product is determined to be illegitimate or suspect.

    Concerns over improper pharmaceutical products entering commerce are not new. However, it does appear that the new mandates increase the attention required to protect the public and impose requirements on supply-chain stakeholders to assist in identification of improper pharmaceutical products.

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...


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