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Based on the given context, it is not clear whether a specific organization can implement a new DSCSA solution provider before the November deadline. It is recommended to consult with a DSCSA solution provider or regulatory authority for more information on implementation timelines.

It is not clear from the given context whether the EPCIS file will generate an error in this specific scenario. It is recommended to consult with service providers involved or refer to the documentation of the EPCIS system to determine the expected behavior in this situation.

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.

It depends on the specific arrangement and responsibilities outlined in the drop ship scenario. If the private label distributor is the one actually selling the product, but the third-party logistics provider (3PL) is handling everything else and has a turnkey solution, then it is likely that the 3PL would be responsible for creating the EPCIS file under DSCSA regulations. However, it is important to note that all authorized trading partners must be able to exchange transaction information securely and electronically, and manufacturers and repackagers have their own unique requirements as well.

It is not explicitly stated in the given context whether all products need to be scanned daily with a 2D scanner or only suspected illegitimate or counterfeit products. However, it is mentioned that a system for verification needs to be in place that includes identifying, quarantining, and investigating suspect products, as well as notifying the FDA and trading partners if a suspect product turns out to be illegitimate. It is also mentioned that all covered drug products should have unique identifiers on them, and trading partners need to have verification systems for suspect and illegitimate products. Therefore, it is recommended to have a system in place for scanning all products with a 2D scanner to ensure compliance with DSCSA regulations.

It depends on the specific circumstances of the return. If the customer is returning the product to the same entity that sold it to them (e.g. a pharmacy returning a product to a manufacturer), it would not be considered a change of ownership or possession under DSCSA regulations. However, if the product is being returned to a different entity (e.g. a pharmacy returning a product to a wholesale distributor), it would be considered a change of ownership or possession and would require transaction data to be provided. In either case, a new EPCIS document may need to be created depending on the specific details of the return.

The first suggestion would be to thoroughly understand the DSCSA requirements and to review all the guidance documents issued by the FDA. It is essential to have a clear understanding of the requirements to implement an effective compliance strategy.

The second suggestion would be to leverage technology to automate processes and reduce the burden of compliance. Dispensers can use software solutions that can help them manage serialized data, verify product identifiers, and maintain transaction records.

Thirdly, it is essential to establish a strong relationship with trading partners and service providers. Communication with trading partners and service providers can help to streamline the exchange of information, reduce errors, and minimize disruptions in the supply chain.

Lastly, it is crucial to conduct regular training and education on DSCSA requirements for all employees involved in the handling and distribution of prescription drugs. This will help to ensure that everyone understands their role in maintaining compliance and reducing the risk of diversion or counterfeit products.

The panel recommends following a framework of Identify, Understand, and Respond to exceptions. This includes having systems in place to identify exceptions, understanding how to investigate and solve them, and having processes for exception handling. Additionally, they suggest participating in the exceptions pilot program and staying informed about automated notification and case organization solutions as they become available. Different trading partners will go through a process to harmonize exception processing, and the guidance document published by HD outlines five error categories and provides a framework for thinking about exceptions. However, the panel did not provide specific steps being put in place for various groups to accommodate exceptions.

The FDA is the licensing authority for the states, and the states cannot establish their own licensure requirements for distributors unless they are the same as federal requirements. So, if a state attempts to modify the federal DSCSA requirements, it would be in violation of the preemption clause in the law. However, states are fully authorized to enforce their own requirements or the same requirements as the Food, Drug, and Cosmetic Act, and any reputational hit that a company might take should also be considered.

The standard operating procedures (SOP) for DSCSA should discuss procedures for requesting the product from downstream trading partners, internal QA, and cobra security. There needs to be a company policy that describes how to deal with serialized data once it is received from a trading partner. The FDA has issued a guidance called Enhanced Drug Distribution Security Requirements Under 582 G 1, which provides requirements for drug distribution security. The guidance also includes detailed guidance on verification systems for suspect and illegitimate products, identification, investigation, quarantine, disposition, and record-keeping. Additionally, the FDA has created a proposed rule that includes a review of existing state standards for licensure, including storage, handling, and holding of prescription drugs. Therefore, companies should refer to these guidelines and regulations to create their own SOPs for DSCSA compliance.