Time check - There are five months left before DSCSA enforcement. Do you have a compliance plan?

June 8, 2023

Technically there's a little over five and a half months to the DSCSA enforcement deadline, but let's be real: if you don't use those five months, those last two weeks really won't do you much good. Aside from the fact that onboarding EPCIS with your trading partners is a process that can take weeks to months itself -- those last two weeks are also the run-up to Thanksgiving, with the deadline day itself also being Cyber Monday. So, let's start by looking at the timeline realistically.

It's June now. That means your kids are out of school, and you and your colleagues have begun taking summer vacations. That makes coordination a little harder. That coordination won't get too much easier in September, when you can expect many companies across the pharmaceutical supply chain to attempt to get DSCSA done at once.

Overall, you can expect this to get a bit more difficult with each passing week. This is why we're getting so many questions, often from dispensers, around that deadline itself: namely, whether it’s going to happen as planned, and what sort of preparations to make. Here are some questions you can use to examine the situation as you plan DSCSA support.

1. Are your trading partners ready?

Manufacturers and wholesalers are already putting processes and technologies in place for interoperability, and to meet the Enhanced Supply Chain Security requirement. Due to the phased implementation of DSCSA, they’ve had to go through this decision point sooner, in expectation of the final deadline – and they’re doing their part. Many have, in fact, set their own deadlines for trading partners, with penalties that increase month by month for those who are late to onboard EPCIS.

LSPedia’s Investigator platform tracks the industry EPCIS data exchange volume and exceptions status; at the start of 2023, our team noticed that EPCIS exchanges skyrocketed in the Test Environment. Whereas testing files had been steady at around 1,000 files a month throughout 2022, we processed 15,000 test files in January alone.

So, simply put, the industry’s already moving. The wave is headed toward cooperation on DSCSA, not away from it, and that brings expectations of achieving end-to-end traceability as outlined by the FDA.

2. What has the FDA said about the deadline?

In the past, the FDA granted enforcement discretion when there were serious logistical obstacles that hadn’t been resolved yet. Moving forward on the original timeline would have had negative impacts for the supply chain that couldn’t have been resolved or mitigated quickly.

Now, DSCSA solutions for pharmacies are not only available and complete, but affordable and easy to access. While the law is transformational to how business is conducted in the pharma supply chain by making every product traceable at the item level, its implementation can be carried out via a cloud layer that sits on top of, rather than replacing, any existing systems.

In short, the situation wasn’t similar to the present moment, when businesses across the prescription drug supply chain have had a chance to adapt, to create workable solutions and processes, and have a secure window of time – including the seven months between now and the deadline – to implement DSCSA requirements in full. In 2023, there’s no regulatory rationale to accommodate businesses that don’t take these steps.

This is in line with the FDA’s indications in recent months that it intends to follow through with the enforcement deadline, in line with its previous statements and its summer draft guidance releases. Businesses who have not moved to comply will be facing steep costs and enforcement actions –all when they could have taken simple steps that, in the long term, protect their patients, their partners, and themselves.

3. What are the costs of non-compliance?

If you’re asking whether the deadline will stand, you’re asking what happens if you make the choice not to comply; you’re looking at the pros and cons, costs and benefits, of compliance against noncompliance.

The costs of compliance are rather light, given that not only are there now pharmacy DSCSA solutions affordable enough to weigh against your daily coffee habit, they’re certainly much cheaper than fines from trading partners and regulators; the benefits are stronger and more secure relationships with your trading partners, and the security for patients that DSCSA was put in place to achieve. In fact, the best DSCSA solutions are also an opportunity to save money, given that they can also help streamline and optimize your supply chain operations.

By comparison, noncompliance is essentially all drawbacks. After the DSCSA deadline in November 2023, dispensers who haven’t complied will face operational disruptions that seriously impact or even block their ability to complete everyday exchanges. So, less money coming in, more money going out to resolve disputes and stopped transactions – and yet more going toward the aforementioned fines. There’s also potential for rifts with trading partners who don’t want to have to deal with transaction problems, particularly starting in December, one of the trickiest times of the year for the supply chain.

4. What is the least stressful way forward?

Given the amount of time needed for EPCIS onboarding, and the limited time remaining to the DSCSA deadline, it’s much easier, safer, and less stressful to move forward with implementing DSCSA than to wait. Solutions that go beyond compliance to actually improve supply chain management are now readily available, and trading partners across the industry have easy access to information on DSCSA’s requirements for each business type.

While we’re seeing many businesses getting DSCSA done, there are simply too many left who are going to get to October without taking action, and then try to rush to the finish. We all know how rushed projects go, particularly ones that are meant to serve a long-term goal; you’re more likely to spend far more time and money all told, and take much greater risks, on a last-minute solution than one done with adequate time to communicate with trading partners and find the processes that make DSCSA flow smoothly with your operations.

Outsourcing is a great way to simplify the entire process - you can opt to have experts manage the entire DSCSA implementation for you. Check out Proactive Resource Group to see how this can be done.

5. How can I get a quick view of what to do?

LSPedia hosts a free webinar series! It's an easy way to stay on top on the latest developments with the law -- covering compliance requirements, serialization, product tracing, EPCIS onboarding, Authorized Trading Partners, and more. Register for the free webinar here.

Also, you can boost your compliance game with LSPedia's comprehensive two-day DSCSA training program! This intensive in-person and online training course will give your business everything it needs to achieve DSCSA compliance, stay on top of compliance with SOPs and procedures, and get the most out of your DSCSA implementation. Register for our introductory 101/201 program here, and our advanced 301/401 program here.

6. What if I want to get started now?

There’s no reason to risk a pharmacy business when affordable, convenient help is here. LSPedia's OneScan Pharmacy solutions, including the newly updated OneScan Pharmacy Pro, are the industry's leading DSCSA compliance tools for dispensers. In addition to managing and automating aspects like Authorized Trading Partners, 3911 reporting, verification, and EPCIS exceptions management, OneScan employs serialization data for expiry management and store transfer to get rid of dead stock costs.

With an easy-to-use interface, quick implementation time, and our compliance guarantee, OneScan Pharmacy allows you to focus on what you do best: patient care.

Click here to start using LSPedia’s DSCSA Pharmacy Solution today.  

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