Worry-Free Compliance, from the Industry Leading DSCSA Compliance Provider
2024 DSCSA Requirement Deadline:
Frequently Asked Questions:
Barcode scanning is not a DSCSA requirement. DSCSA requires that all human prescription drugs are verified, and its transaction data stored, but it does not mandate the use of a barcode scanner to satisfy that requirement. Barcode scanning is considered industry best practice.
Yes. DSCSA requires all that all transacted product be verified as being legitimate, along with its required transaction data. Even without DSCSA, it is in your best interest to verify all wholesaler orders – to identify any exceptions.
Barcode scanning is not a requirement, but if you do not scan you must complete all of the verification requirements manually. This can be labor intensive and also leaves room for human error. Barcode Scanning is a proven technology in healthcare, for a reason.
ConsortiEX introduced ScanCast™ to address the problem of abundant scanning in the pharmacy. ScanCast removes redundant scans from your receiving process.
DSCSA requires all product that you take ownership is verified. Partial verification or tote level scanning is not compliant with DSCSA. Scanning and verifying 100% of product provides the highest level of supply chain security, and possible cash savings in the form of exception identification.
ConsortiEX works with all vendors to ensure accuracy of EPCIS data; we do not enable EPCIS accounts for our customers until that vendor has proven an ability to provide accurate data. Many vendors are still working towards EPCIS readiness today.
No; Drugs that are under an Emergency Use Authorization are considered exempt from DSCSA.
Below is a list of DSCSA product exemptions:
- Compounded Drugs (from Registered Outsourcing Facilities)
- Imaging Agents
- OTC Products
- Drug Samples
- Solutions for replenishment of fluids or electrolytes
- Emergency Medical Situations
A T3 is required for transfers of product to EMS Providers. However, the EMS Provider is not legally obligated to receive the T3. In other words, the sending party must provide the T3 documentation.
A T3 is a document that is made up of the Transaction Information, Transaction Summary, and Transaction Statement.
Track and Trace is a common industry term that is used to refer to DSCSA.
Tracking refers to a dispensers ability to receive and capture relevant transaction information upon receipt of a product; tracing refers to the collective ability of trading partners to provide product information on its journey through the supply chain, from manufacturer to dispenser.
A T3 is a document containing the Transaction Information, Transaction Summary, and Transaction Statement. This can be a physical, paper, document, or an electronic file.
As defined in the law, the term “suspect product” means is a product for which there is reason to believe the product:
- is potentially counterfeit, diverted, or stolen
- is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans
- is potentially the subject of a fraudulent transaction; or
- appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
As defined in the law, the term “illegitimate product” means a product for which credible evidence shows that the product:
- is counterfeit, diverted, or stolen;
- is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
- is the subject of a fraudulent transaction; or
- appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.
A 3911 is a form that is filled out by Trading Partners to notify the FDA about illegitimate product they have received and, for manufacturers, notifying others of products that are at high risk of being illegitimate.
FDA 3911 FAQ: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions/
The term ‘verification’ or ‘verify’ means “determining whether the product identifier affixed to, or imprinted upon, a package
or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned
to the product by the manufacturer or the repackager, as applicable in accordance with section 582.”Starting in November 2024, received products must be verified against the corresponding EPCIS data provided by the manufacturer/wholesaler.
In 2017, the FDA issued a guidance for industry outlining requirements for manufacturers to include a unique product identifier on prescription drug packages. DSCSA Adopted the GS1 2D Data Matrix Barcode to serve as the product identifier. This identifier serves two purposes:
- A unique identity for individual prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
- Includes the product’s lot number, expiration date, national drug code (or NDC), and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain.
EPCIS, which stands for Electronic Product Code Information Services, is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain.
Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with DSCSA requirements and is compatible with a range of different technological approaches.ConsortiEX works with all vendors to ensure accuracy of EPCIS data; we do not enable EPCIS accounts for our customers until that vendor has proven an ability to provide accurate data. Many vendors are still working towards EPCIS readiness today.
Because the enhanced drug distribution security requirements in section 582(g)(1) of the FD&C Act, FDA recommends using EPCIS data to enable secure, interoperable, electronic data exchange among the pharmaceutical distribution chain.
You may need to obtain GLNs for your organization. GLNs are a data element of EPCIS, and a requirement to facilitate data exchange using EPCIS
DSCSA requires all product that you take ownership is verified. Partial verification or tote level scanning is not compliant with DSCSA. Scanning and verifying 100% of product provides the highest level of supply chain security, and possible cash savings in the form of exception identification.
Yes. DSCSA requires all that all transacted product be verified as being legitimate, along with its required transaction data. Even without DSCSA, it is in your best interest to verify all wholesaler orders – to identify any exceptions.
Barcode scanning is not a DSCSA requirement. DSCSA requires that all human prescription drugs are verified, and its transaction data stored, but it does not mandate the use of a barcode scanner to satisfy that requirement. Barcode scanning is considered industry best practice.
Barcode scanning is not a requirement, but if you do not scan you must complete all of the verification requirements manually. This can be labor intensive and also leaves room for human error. Barcode Scanning is a proven technology in healthcare, for a reason.
Barcode scanning is not a DSCSA requirement. DSCSA requires all product be verified, barcode scanning is the easiest method of product verification.
Although not a DSCSA Requirement, barcode verification offers many benefits. ConsortiEX introduced ScanCast™ to address the problem of abundant scanning in the pharmacy. ScanCast removes redundant scans from your receiving process.
A T3 is required for transfers of product to EMS Providers. However, the EMS Provider is not legally obligated to receive the T3. In other words, the sending party must provide the T3 documentation.
No; Drugs that are under an Emergency Use Authorization are considered exempt from DSCSA.
Below is a list of DSCSA product exemptions:
- Compounded Drugs (from Registered Outsourcing Facilities)
- Imaging Agents
- OTC Products
- Drug Samples
- Solutions for replenishment of fluids or electrolytes
- Emergency Medical Situations
ATP stands for Authorized Trading Partner; within the scope DSCSA restricts access to the distribution system for prescription drug products by requiring trading partners of manufacturers, wholesale distributors, dispensers, and repackagers meet the applicable requirements for being authorized trading partners.
Check out our ATP Requirement Guide, here.SOP stands for Standard Operating Procedure. It’s a document that outlines the step-by-step instructions on how to perform a particular task or process within an organization.
Within the scope of DSCSA, the SOP is the first thing you will be audited on. You should have an SOP documenting how you plan to satisfy each of the DSCSA requirements.
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