Knowledge Base
DSCSA requirements only apply to finished goods. If your company purchases APIs to create the finished drug, that is the point where it becomes DSCSA traceable.
The FDA has stated that any company can apply for a WEE, however you should not stop your work to be compliant by November, 27, 2024.
DSCSA requirements apply to prescription drugs. Any non-prescription medications are not part of DSCSA requirements.
Any time a change of ownership occurs there shoul dbe a DSCSA transaction. If you are returnng product and receive reimbursement, you will record the event, regardless of whether the medicine is returned or set for destruction.
A specific check list is not available for ensuring compliance with DSCSA regulations. However, there are 4 general pillars of compliance surrounding DSCSA: All trading Partners must be authorizedProduct Identifiers are unique for all covered prescription drugsAll ATPs exchange and maintain the data to enable tracingVerification of products / identifiers is in place and the ability to manage suspect and illegitimate products. It is always best to consult with regulatory experts or legal professionals to ensure compliance with DSCSA regulations.
"Each unique physical location should typically have its own Global Location Number (GLN). GLNs are often assigned by wholesalers like McKesson or Cardinal, but they can also be purchased directly from GS1.
You can buy a GLN for a one-time fee of $30 per location. However, if you manage more than nine locations, it will be more cost-effective to purchase a GLN that can be subdivided into 10 locations for $250.
For additional details about GLNs, you can reach out to LSPedia."
Based on the provided pieces of context, it is unclear how pharma products listed as Human OTC drugs in the National Drug Code Directory will be handled if they have "Rx" or "Rx only" printed on the actual bottle/package label. It is recommended to consult with the FDA or a qualified healthcare professional for further information regarding DSCSA compliance requirements for such products. The manufacturer must ultimately identify what is classified as DSCSA-relevant and follow the appropriate guidelines.
It is possible for EPCIS files to be missing from a DSCSA system despite being transmitted by trading partners if there was a communication issue or a technical error during the transmission process. It may not necessarily be an issue with the solution provider's system, but it is important to investigate the issue thoroughly to determine the root cause and identify any necessary corrective actions.
No, it is not a simple process to use VRS by calling the manufacturer of a drug product. While calling the manufacturer is one way to verify a product identifier, the VRS (Verification Router Service) is a more efficient way to handle it. However, it is important to note that not every manufacturer is required to participate in the VRS, and there are many nuances to the system. It is best to consult with a knowledgeable expert or resource to ensure proper use of the VRS.
A commercial DSCSA compliance platform can assist with compliance by providing serialization, traceability, business intelligence, and supply chain solutions to the pharmaceutical industry. The platform can ensure compliance, secure the supply chain, and improve supply chain efficiencies.
It is possible to receive and process EPCIS information without a middleman, but it can be complex and it requires technical expertise and resources. A solution provider can facilitate the process and make it easier for trading partners to comply with DSCSA requirements.
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