The pharmacy industry is constantly changing. Most changes are gradual and subtle. Others are sudden and not so subtle. The DSCSA compliance deadline is very much a game-changing evolution of the industry.
Though independent pharmacies across the country have had ample time to get their DSCSA-compliant affairs in order, growing pains are always inevitable.
Change can be tough to adjust to, especially when they directly affect your pharmacy’s workflow. When it comes to DSCSA compliance, however, it’s not a matter of “if” but “when” your pharmacy becomes DSCSA compliance.
Let’s clear the compliance air. Here’s what you need to know about DSCSA Compliance.
Let’s start with the basics.
The Drug Quality and Security Act (DQSA) was passed on November 27, 2013. Title 2 of the DQSA, the Drug Supply Chain Security Act (DSCSA) presents steps to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”
The DSCSA helps protect patients from exposure to counterfeit, contaminated, stolen, or harmful medications.
Some DSCSA compliance requirements are already put in place. The November 27, 2023 (which is also the 10th anniversary of the DQSA’s passing) deadline is the second phase of DSCSA, which launches the Track and Trace serialization law.
InfiniTrak President Mark Tate goes over the basics of DSCSA compliance on the Catalyst Pharmacy Podcast. Tune in here:
But as we mentioned before, parts of the DSCSA are already put in place. Let’s see if your independent pharmacy is up to snuff.
At the time of writing, here’s what your independent pharmacy needs to already be doing concerning DSCSA compliance.
The main focus of DSCSA compliance is between your pharmacy and your drug suppliers. Licensure verification is required for all drug suppliers, no matter how often or rarely you use them.
Likewise, do not rely on drug suppliers or manufacturers to cover your DSCSA-related bases. This is all about making sure your pharmacy stays DSCSA compliant. When it comes to compliance between your pharmacy and drug suppliers, you can’t have one without the other.
A common practice in independent pharmacies, selling or lending products to another pharmacy now has to be done within DSCSA guidelines.
If your pharmacy is the one selling or lending products to another pharmacy, you must provide complete and accurate transaction data with the drug. It might seem tedious at first but will make DSCSA compliance easier in the long run.
Continuing with your relationship with drug suppliers, make sure their electronic data is complete, accurate, and stored for six years.
DSCSA compliance is ensuring your pharmacy can detect any counterfeit or harmful medications before they reach your patient.
Your pharmacy must have Standard Operating Procedures (SOPs) to identify suspect or illegitimate products. Make sure you document the process, which should always consist of notifying the FDA and drug supplier of the counterfeit product.
This is a brief rundown of what your pharmacy should already be doing within DSCSA compliance. Now let’s see what you need to do by the November 27, 2023 deadline.
Between now and the November 27th, deadline, make sure your pharmacy is DSCSA compliant in the following ways:
Chances are your pharmacy receives data through an EDI (electronic data interchange) format. DSCSA compliance requires you to move over to the EPCIS (Electronic Product Code Information Services) format.
As a result of this requirement, EDI data will no longer be a part of DSCSA compliance.
Per the FDA, “EPCIS is an appropriate globally recognized standard, and [...] there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.
DSCSA compliance requires you to manually enter and scan products at intake
Most pharmacists already receive their shipments this way, but things might look different for fill facilities or larger pharmacies.
DSCSA compliance requires you to manually enter and scan products at intake. You also must confirm all products have a product identifier, such as a 2D Barcode.
PioneerRx’s 2D Barcode scanning feature makes this part of DSCSA compliance a breeze.
RedSail Technologies’ Director of Education and Training Erin Dalton talks about the importance of this aspect of DSCSA compliance:
“2D barcode scanning allows pharmacies to capture product information and identify any inconsistencies from any electronic files sent by trading partners. This lets pharmacists quickly remove said products from the supply chain for suspected counterfeiting.”
Once DSCSA is in effect, a dispenser can request the status of a certain drug, requiring the manufacturer to respond electronically on the status of the product in question within 24 hours.
As with nearly all aspects of DSCSA compliance, have a plan in place to handle product verification requests. It could affect your pharmacy’s workflow when you or a manufacturer have to present the product information within a tight time window.
DSCSA compliance is shaping the future of pharmacy in the United States. Chains and independent pharmacies alike must adjust their workflow accordingly to ensure they are DSCSA compliant.
Just like pharmacy work, staying compliant is a continuous process. There’s always something new to learn.
Sam Pizzo and Mark Tate of InfiniTrak came on the Catalyst Pharmacy Podcast to discuss the ins and outs of DSCSA compliance. Tune in to learn more about what you need to know about DSCSA compliance.
Erin Dalton and Mark Tate held a webinar regarding DSCSA compliance and InfiniTrak’s role in helping your pharmacy stay compliant. Go to PioneerRx University to catch recordings of both the webinar and Q&A.
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