DSCSA compliance: Here’s what your supply chain should have at the end of Nov 2023 deadline
DSCSA compliance has been a blessing for the drug supply chain in the USA because the country is the largest consumer of prescription drugs in the world. According to a survey by the Centers for Disease Control and Prevention, in the year 2015–2016, 45.8% of the US population used prescription drugs. The counterfeit market functions mainly in the domain of prescription drugs, having a wide access to people of all age groups and health conditions, sealing the fate of millions with its intake.
In the year 2013, the DSCSA outlined ways to keep the integrity of drugs intact. Considering the safety of the end-users, it was important that the latest equipment and processes were brought in place to reduce the effects of counterfeit medicine. Almost close to the final milestone of DSCSA compliance, Nov 2023, it still remains to be seen how effective the guidelines have been.
But before that, it must be checked whether the requirements of the timeline have been met and whether companies have all that is required to be audit-ready.
So, what did DSCSA want?
The DSCSA outlined steps to build an interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Interoperability is achieved when sources of information within the health ecosystem find, exchange, use and share product data across the supply chain.
Having said that, it is noteworthy here that not all drugs in the pharmaceutical supply chain do not need to follow the DSCSA guidelines.
-Products that are covered and not-covered from the DSCSA guideline
Not covered: Blood or blood components that are intended for transfusions, such as radioactive drugs or biologics, certain IV products, imaging drugs, homoeopathic drugs, medical gas, lawfully compounded drugs, and more.
Covered: Prescription drugs in finished dosage form for administration to a patient without further manufacturing. Few of the examples are capsules, tablets, lyophilized products before reconstitution, etc.
-Exemptions in DSCSA
It is a wrong perception that the DSCSA secures every component of the end-to-end drug supply chain. The pharma industry is a highly complicated domain that requires the involvement of multiple stakeholders. While the bigger entities have to be compliant, the smaller ones can still be exempted from the guidelines because of the way they function. Some such process exemptions are:
· Intracompany distributions
· Distribution among hospitals under common control
· Dispensed pursuant to a prescription
· Product sample distribution
· Blood and blood components for transfusion
· Public health emergencies
· Minimal quantities by a licensed pharmacy to a licensed practitioner
· Certain activities by charitable organizations
· Certain combination of products
· Distributions pursuant to a merger or sale
· Approved animal drugs
· Certain medical kits
· Certain IV products
· Medical gas distribution
Traceability requirements: In details
1. Lot traceability: All pharma manufacturers are required to print lot numbers on the packaging for all prescription drugs. This helps in enhancing the product visibility in the supply chain, making instant data available to all the stakeholders on demand. Lot tracking is essential for inventory management and supply chain integrity. On an overall, lot tracking can avoid poor drug management and secure the integrity of the medicines till the time it reaches end-users. The targeted group for this requirement comprises of manufacturers, repackagers, distributors and dispensers.
2. Serialization: All pharma manufacturers and repackagers are required to include unique serial numbers and expiration dates on prescription drugs packaging, making data for each of them easily available. Earlier this process was conducted manually, but existing generations of pharmaceutical supply chain stakeholders are preferring to use AR-enabled multiscanners that make gathering data time and investment-worthy. The target group here comprises of manufacturers and repackagers.
3. Serial verification: One of the most crucial processes in the pharmaceutical supply chain, it is also understood by the name of Verified Returns Saleables or VRS. In this process, all wholesale distributors must verify the product identifier when a product is returned and redistributed thereon. The process is complicated and requires multi-layered platforms like Traceability Suite that manages information effectively, thus enhancing the visibility of the drug in the supply chain. These platforms, coupled with advanced equipment, help in connecting the VRS provider with the look-up directory when a “suspected” drug case is returned to the warehouse. The most important benefit of the traceability suite is it makes the warehouse VRS-audit-ready. The target group for the process comprises of distributors.
4. Serial verification: Although scheduled for November 2020 deadline, the requirement for this process was delayed by a year because of the pandemic situation. All pharmaceutical dispensers are required to authenticate and verify the medicines they buy before selling them to the consumers. The main target group comprises of dispensers.
5. Interoperability: The last and the most important requirement oversees the overall functioning of the drug supply chain. It is required for the entire supply chain to be DSCSA compliant. Complete unit-level traceability, including aggregation, will be mandatory. The target group for this requirement comprise of manufacturers, repackagers, distributors and dispensers.
What’s holding you back?
DSCSA compliance is not as easy and as time-bound as it sounds. Stakeholders require a lot of preparation and investments to ensure that their sup[ply chain does not deviate from the guidelines. So, at this stage if you are still facing trouble with compliance, you might have been challenged by two of the below-mentioned probabilities:
Lack of equipment: We have already discussed what deploying advanced technology would mean for the effective functioning of the pharmaceutical supply chain. VR-enabled multiscanners at the serialization stage can not only reduce the man-hour investment in the process, but can also double revenues at the end of the year, owing to error-free processes and on-time deliveries. For details, you can read:
[Dealing with Negative Returns: How to be responsibly VRS-compliant?]
[Mere traceability is not enough for VRS compliance; Here’s what you need]
Incompetent service provider: Service providers are probably the most crucial links that connect the dots between each stakeholder in the pharma supply chain. For instance, during the VRS process, their contribution in making operations smoother and faster is inevitable; however, only if they are experienced and have in-depth knowledge of the various aspects of the VRS process. So, here’s a checklist we have already talked about in one of our previous articles that will help you decide if you have to rethink on your new vendor.
[Things that you should look for in your VRS provider]
Penalties for not complying
Once you have checked out the above-mentioned bottlenecks, it is important to ensure that you are following the DSCSA guidelines without fail, otherwise, it may lead to fines, suspension or revocation of licenses and even civil penalties or imprisonment.
Last word:
Building an error-free pharmaceutical supply chain is in your hands. But, it must be remembered that staying by the conventional and the traditional is easier than taking the next bend toward change, a change that roots in the greater good of the healthcare industry, saving lives. DSCSA compliance is just an excuse to test your own instincts- how you wish to utilize the power to make lives better and even save them. It’s time that we stood up against the counterfeit drug supply and take the issue seriously, not merely because we would be penalized by the government health regulatory bodies, but because we have a greater responsibility of delivering medicines that are safe and effective.
