October 2020 - Page 3 of 3 - rfxcel.com

DSCSA 2020: November Is Coming & It’s Time to Comply

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

Decoding the Supply Chain Parent-Child Relationship: Complex Connections Unraveled

Over the years, there have been countless instances of counterfeit drugs entering the supply chain. This is problematic, as counterfeit drugs put consumers at risk, even causing injury and death. To help resolve this issue, many stringent compliance regulatory systems have been put in place for the pharmaceutical industry and other industries. One example is traceability and serialization, which includes aggregation.

What is aggregation?

Aggregation creates and maintains a parent-child relationship for the packaging levels and the product owner’s information. It creates the parent-child relationship by associating the aggregated unit, which is the parent, with each carton’s various serial numbers. For example, a basic mapping of aggregation may look like this:

Unit-level pack aggregations (lowest level) → bundle pack aggregation → case aggregation → pallet aggregation (highest level).

Aggregation increases safety and efficiency in the pharmaceutical industry and is an essential part of serialization in the supply chain. Aggregation helps track a package throughout its entire journey – from the time it is packaged to the moment it reaches the consumer.

Why is aggregation necessary in supply chain management?

Increases traceability and transparency

Aggregation makes it much easier to trace products through each step of the supply chain. It also makes it easier to “interpret” what’s in your supply chain. This increases traceability and transparency, which offers a variety of benefits, including:

  • Increased trust from stakeholders
  • Important supply chain data
  • Increased resiliency during a crisis, such as a pandemic, a recall, political unrest, or a natural disaster

Increases efficiency

Because aggregation and parent-child relationships eliminate the need to scan individual units, they create a quicker, more efficient flow in your supply chain. Furthermore, they’ll make your supply chain more accurate because there are fewer opportunities to make mistakes. Last, increased efficiency means saving on costs and time, as less scanning helps companies take care of returns and recalls more quickly.

To further mitigate opportunities for mistakes, you can always consider tools like automated supply chain management systems to stay in sync with capabilities and production needs all the way down the supply chain.

Increases safety

With aggregation and the resulting parent-child relationships, safety is increased in your supply chain. Because aggregation increases accuracy and transparency, the risk of accidentally selling counterfeit products goes down. This means customers can trust that your product is authentic and do not have to fear any harm that can come from these counterfeit products.

Final thoughts

Working with a track and trace company helps improve aggregation within your supply chain, which, in turn, increases efficiency, transparency and safety. By making these improvements to your supply chain, you’ll help prevent counterfeit drugs from entering it. Contact us today to learn how our track and trace system, rfxcel Traceability System (rTS), can simplify and accelerate your processes with aggregation today.

4 Ways Serialization Companies Can Optimize Your Supply Chain

Global compliance regulations are growing increasingly difficult to keep up with. Luckily, companies don’t need to keep up with these regulations on their own. Learn how serialization and track and trace companies can aid this process and help maintain compliance.

Increase risk management

One way that serialization companies can optimize your supply chain is by providing increased risk management. By tracking a product to the unit level, serialization helps prevent the sale of fraudulent products. This is especially important with items such as pharmaceuticals, which if counterfeit, can result in death or injury. Furthermore, with serialization, shortages can be detected, and replacements shipped, more quickly, which increases customer satisfaction.

Increase efficiency

Serialization companies can also help increase your supply chain efficiency. By having the ability to track every product, the returns processing and recall management system becomes simplified and quicker. There will be an increase in marketing efficiency as well, due to punctual information on product sales. For example, if sales are lower than expected, marketing techniques can be adjusted.

Create trust

Working with a serialization company helps create trust among everyone involved in the supply chain. This is because serialization provides complete data for each product and the entire supply chain. Sharing this information fosters transparency, which creates trust among stakeholders, including manufacturers and customers. This trust can increase profitability and decrease the chances of your operations breaking down, especially in times of crisis.

Strengthen supply chain resiliency

With serialization, tracking products becomes easier. This results in more accurate demand management. Therefore, you’ll have a better ability to predict how much supply is needed and you are less likely to end up with excess products, which increases overhead and manufacturing costs. Serialization and traceability also give you a more accurate and detailed view of what is happening in your supply chain and allows you to put it in context of political and economic events. This means you can make a more educated forecast of how events might affect operations and adjust accordingly to create a stronger, more resilient supply chain.

Final thoughts

Global compliance regulations are changing, but that doesn’t mean you need to worry about falling behind. Working with a serialization and track and trace company not only helps you maintain compliance, but will offer all of the benefits mentioned above as well. Contact us to learn how we can help you simplify and accelerate your processes with our rfxcel Traceability System (rTS) and ensure you comply with regulations everywhere you do business.