Zdrowie i gospodarka · 04/06/2021

FDA Releases Revised Draft Guidance on Definitions of Suspect and Illegitimate Products Under the Drug Supply Chain Security Act

The Food and Drug Administration (FDA) has made available a revised draft guidance to help the industry better comprehend the definitions of 'suspect' and 'illegitimate' products under the Drug Supply Chain Security Act (DSCSA). The guidance clarifies key terms, including 'counterfeit,' 'diverted,' 'stolen,' 'fraudulent transaction,' and 'unfit for distribution,' which are used to define 'suspect' and 'illegitimate' products.