Pharmaceutical supply chain : Drug Quality and Security Act

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We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website. Image courtesy of National Institutes of Health. Pharmatech Associates president and chief science officer Bikash Chatterjee.

U.S. Food and Drug Administration

Image courtesy of Pharmatech Associates. Manufacturers and other players in the supply chain will have to keep records of the pharma products they handle, among other requirements. Image: Boehringer Ingelheim GmbH. In November , President Obama signed the Drug Quality and Security Act DQSA into law and its requirements, which include new licensing, record keeping and product identification provisions designed to standardise and thereby further secure the US supply chain, are already starting to come into effect.

So is everything possible being done to ensure the implementation process goes smoothly for all supply chain stakeholders and, when fully in force, will the new regulations have the wide-reaching impact the government is hoping for?

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Conceived to protect consumers from contaminated, counterfeit and stolen pharmaceutical products, the DQSA will gradually standardise the US pharmaceutical supply chain over the next decade, resulting in a single, uniform, national solution, governed by one law and set of regulations. As the Pharmaceutical Distribution Security Alliance PDSA summarises on its website, "a patchwork quilt of state laws, rules, and regulations [currently] leaves patients vulnerable because bad actors can shop around for venues with relaxed rules to introduce counterfeit or adulterated products into the system.

Pharmaceutical Supply Chain Managment

What we do to Comply. Outbound distribution and ASN data for full shipment pedigrees.

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Humanitarian Software LLC. Humanitarian Software has invested following the FDA regulations for many years.

This aids in protecting both traders and consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Additionally, the DSCSC oversees the FDA in establishing national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA every year.

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  • Pharmaceutical Supply Chain: Drug Quality and Security Act.
  • Working towards a uniform national supply chain!