Drug Supply Chain Security Act (DSCSA)
What is DSCSA
Drug Supply Chain Security Act
The U.S. FDA’s Drug Supply Chain Security Act (DSCSA) was enacted in 2013 creating new regulations affecting the sale of prescription drugs to further secure our nation’s drug supply. It creates a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.
DSCSA outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed in the United States. This enhances the FDA’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen or contaminated, and improve detection and removal of potentially dangerous drugs from the drug supply chain.
As of November 27, 2024, an additional phase of requirements will go into effect to further support the secure, interoperable, electronic tracing and data exchange of products at the package level, versus current lot level, with trade partners. Under DSCSA, all trading partners in the supply chain (manufacturers, repackagers, wholesale distributors, and dispensers [excludes dispensers who only dispense human prescription drugs to be used in animals.]) must have the ability to verify the authenticity of a product before accepting it, verify a suspect or illegitimate product identifier upon request from a trading partner, federal agency, or state agency or to submit a request for verification from a trading partner and to retain transaction information.
DSCSA outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed in the United States. This enhances the FDA’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen or contaminated, and improve detection and removal of potentially dangerous drugs from the drug supply chain.
As of November 27, 2024, an additional phase of requirements will go into effect to further support the secure, interoperable, electronic tracing and data exchange of products at the package level, versus current lot level, with trade partners. Under DSCSA, all trading partners in the supply chain (manufacturers, repackagers, wholesale distributors, and dispensers [excludes dispensers who only dispense human prescription drugs to be used in animals.]) must have the ability to verify the authenticity of a product before accepting it, verify a suspect or illegitimate product identifier upon request from a trading partner, federal agency, or state agency or to submit a request for verification from a trading partner and to retain transaction information.
Know your responsibilities under the DSCSA
Following DSCSA, Animal Health International customers will:
- Gain access to DSCSA product tracing documentation for products purchased through Animal Health International. It is encouraged that those affected obtain a standard location identifier called a GLN (Global Location Number). This identifier helps facilitate and simplify the record keeping process and the receipt of serialized product tracing data. See below for more information about GLNs.
- Store or ensure electronic access to the product tracing documentation for six years.
- Create a system and have a process in place for the verification of product at the package level and be able to respond to requests from the U.S. Food and Drug Administration (FDA) or requests from other regulatory bodies in the event of a recall or for investigating suspect or illegitimate product.
How to prepare
To prepare for DSCSA, those affected are encouraged to obtain a Global Location Number (GLN). This identifier helps facilitate and simplify the record keeping process and the receipt of serialized product tracing data. See below for more information about a GLN.
What is a Global Location Number (GLN) and why do I need one?
Driven by global standard drug manufacturers use, the Global Location Number (GLN) identifies unique locations by assigning a unique 13-digit numeric code to each location. By uniquely identifying parties and locations, the GLN helps with tracking products, optimizing processes, and providing greater visibility to shipments moving through the supply chain. It is encouraged that any entity taking part in the supply chain should have a GLN. This includes suppliers, manufacturers and distributors in the supply chain.
How do I obtain a GLN?
Use the link below to go to the GS1 US site. This site will provide you with a unique number licensed by GS1 US that identifies a single location or business entity in the supply chain. There is a small one-time fee as displayed on the site.
Get a GLN
What if I already have a GLN?
If you already have a GLN that you obtained on your own, you can easily provide this to us by completing the secure form. We will add your GLN to your profile.
Provide your GLN to Animal Health International
How do I access product transaction data?
Animal Health International has made DSCSA transaction information and transaction statements and history documents available to customers via RxHub by Patterson.
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