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Yes, as a wholesale distributor that buys and sells human drugs, you are subject to the DSCSA requirements regardless of whether you sell to human or veterinary clinics. Therefore, it is necessary for you to have a DSCSA solution in place to comply with the regulations.

Yes, product samples are subject to DSCSA regulations as they are considered a type of drug product. The DSCSA requires that all covered drug products, including samples, have a product identifier and be tracked through the supply chain. Additionally, dispensers are required to verify the product identifier of at least three packages or 10% of the suspect product, whichever is greater, in the event of a suspected counterfeit or illegitimate product.

Yes, as a re-packager/re-labeler who receives goods from manufacturers, you need to comply with the DSCSA regulations. You need to be an authorized trading partner in order to exchange transaction information with the manufacturer. You also need to verify the product identifier with the manufacturer and maintain all records for six years. It's important to ensure that you are registered with the FDA and compliant with applicable obligations.