The DSCSA requires wholesale distributors and 3PL providers to report licensure and other information annually to the FDA. Additionally, to further enhance the security of the drug supply chain, manufacturers, contract packagers, distributors, and dispensers are required to notify the FDA and other trading partners with 24 hours after determining if a product is illegitimate. The DSCSA  has a few major provisions such as product trading, national uniform policy, product ID, enhanced system, penalties, and product verification. A 3PL is an entity that provides or coordinates warehousing, or other logistic services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have the responsibility to direct the sale or disposition of the product. A Wholesale Distributor is a person (other than a manufacturer) engage in wholesale distribution. This contains a number of exceptions, for example, intracompany distribution, transfers to and from third-party logistics providers and common carriers, distribution of certain drugs in medical convenience kits, IV fluid replenishment and dialysis of drugs, medical gases, etc. Licensing and standards for wholesale distributors include FDA shall develop regulations establishing standards for licensing for Wholesale Distributors (WD), WD standards for licensure go into effect 2 years after regulations are finalized, and The federal system for wholesale drug distributor licensing shall be used when the state from which the drug is distributed has not established a licensure requirement. Licensing and standards for 3PLs include not state shall regulate 3PLs as wholesale distributors, FDA shall develop regulations establishing standards for licensing 3PLs, 3PL standards for licensure go into effect 1 year after regulations are finalized, and the federal system for 3PL licensing shall be used when the state from which the drug is distributed has not established a licensure requirement.

 

Source: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandsupplychainsecurity/drugsupplychainsecurityact/UCM464908,pdf

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