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Monthly HealthRISC Overview | FDA DSCSA Guidance

With our HealthRISC Report, you'll have access to any and all regulatory updates including: state and federal legislative activity, administrative rule promulgation, and medical and pharmacy board activity. Most recently, the FDA issued a comprehensive Guidance Document to interpret the terms used in the definition of "suspect product," "illegitimate product," "counterfeit," "diverted," and "stolen". As described by the FDA, the Drug Supply Chain Security Act (DSCSA) "amended the FD&C Act to establish requirements for product tracing, verification, and identification for certain drug products that are distributed in the United States." (March 2023).


Intended to be utilized as a resource to those in the industry, this guidance can assist those in identifying suspect and illegitimate products within the pharmaceutical distribution supply chain in the United States. While online or written comments can continue be submitted to FDA at any time, it is worth noting that previously submitted comments were incorporated into this final draft.


November 2023 is just around the corner - don't hesitate to get in touch with an industry expert from the RSG Team regarding the new DSCSA requirements.





Resources:

  • Guidance document: https://www.fda.gov/media/111468/download

  • Comment submissions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply?utm_medium=email&utm_source=govdelivery



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