Resources for pharmacy DSCSA compliance
DSCSA FAQs
Q:
What is the Drug Supply Chain Security Act (DSCSA)?
A:
The Drug Supply Chain Security Act was enacted in 2013 with full implementation planned for November 2023. DSCSA requires Authorized Trading Partners to have an electronic, interoperable system to trace prescription pharmaceutical products at the package level. The law was created to prevent, detect, and respond to suspect and illegitimate products.
Q:
What is an Authorized Trading Partner and how can I verify that my supplier is an ATP?
A:
Under DSCSA, only Authorized Trading Partners (ATP) can sell or buy prescription pharmaceuticals from other Authorized Trading Partners.
Authorized trading partners must meet criteria as defined by the FDA such as:
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Manufacturers and Repackagers
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Must have a valid registration with the FDA
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Accept and transfer direct product ownership
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Wholesale distributors
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Must have a valid state license and comply with reporting requirements to the FDA
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Accept and transfer direct product ownership
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Dispensers
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Must have a valid state license
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Accept and transfer direct product ownership
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Third Party Logistics Partners (3PLs)
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Must have a valid state license and comply with reporting requirements to the FDA
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Take possession of product but not ownership
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Capital Drug 360 can help you monitor and maintain your Authorized Trading Partners.
Without a compliance solution like Capital Drug 360, you can still validate licenses by using websites such as State Boards of Pharmacy, the FDA, and NABP.
Q:
Which DSCSA regulations apply to dispensers?
A:
Dispensers must only purchase from an Authorized Trading Partner (ATP). They must have processes to identify product, receive and maintain product tracing data, and verify product is legitimate. As of November 27, 2023, dispensers will need a Global location number (GLN), their own standard operating procedures for identifying, quarantining, and investigating suspect product.
Q:
What is a Product Identifier?
A:
A product identifier must be on every saleable unit label and include:
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Serial number
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NDC
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Lot number
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Expiration date
This information can be found in the format of a 2D bar code and human readable label.
Q:
What is on a current traceability statement? Will this still be required in November 2023?
A:
A current traceability statement, or T3, has been required since 2015 and contains transaction history, transaction information, and the transaction statement. This information can be provided in paper format or with an advanced shipping notice (ASN). Beginning in November 2023, the transaction history is no longer required. At that time, Authorized Trading Partners must begin exchanging data including product serial numbers with each transaction.
Q:
What is an ASN?
A:
Advance Ship Notice is an electronic data interchange (EDI) message sent from the shipper to the receiver prior to the departure of the shipment from the shipper’s facility. The message includes complete information about the shipment and its contents. Information contained within the ASN includes a description of the medication being shipped such as NDC, lot number and expiration date.
Q:
What is EPCIS and how does it relate to traceability statements?
A:
Electronic Drug Distribution Security (EDDS) goes into effect November 27, 2023, and will require data be exchanged in a secure, electronic and interoperable format. The FDA recommends using the EPCIS format to achieve this requirement. EPCIS data will be the standard for tracing medications electronically. The data will include product identifiers (serial numbers, name, strength, container size, GLN information) that will follow the medications and track the physical location of the medication throughout the supply chain.
Q:
What is a global location number (GLN) and why is a dispenser required to have one?
A:
A Global Location Number is assigned to a pharmacy based on the United States postal address. The GLN is necessary for track and trace statement requirements as of November 27, 2023.
Q:
How does a pharmacy obtain a GLN?
A:
A global location number is assigned by GS1.com. Go to GS1.com store to purchase a GLN for $30. A dispenser may also contact their primary wholesaler to verify if they were assigned a GLN by their primary. HOME - GS1US Ecommerce
Q:
What is interoperability tracing?
A:
Tracing data must follow the medications throughout the supply chain. Starting with medications shipping from the manufacturers to an Authorized Trading Partner (ATP) to a dispenser or another ATP. The ability to track the medications up and down stream is the interoperability required to meet the DSCSA regulations.
Q:
Third Party solution provider: Capital Drug 360 Compliance Solution?
A:
Third party DSCSA solution providers are companies that will help dispensers manage the DSCSA compliance regulations by monitoring traceability documents. There are a variety of these companies contacting dispensers to sell their solution (scanners, software systems, repositories, etc.). Capital Drug is aligning with Advasur 360 to offer Capital Drug 360 to our customers to help comply with DSCSA regulations for reduced fees or for free. Contact your Capital Drug Account Manager for details.