Run a DSCSA Fire Drill Before There’s Smoke
The best time to find a weak spot in your pharmacy’s DSCSA process is before someone else finds it for you.
Nobody waits for smoke in the building before figuring out where the exits are. That is why businesses run fire drills. Not because they expect a fire every Tuesday, but because people need to know what to do before there is panic, confusion, or pressure.
DSCSA compliance works the same way.
A pharmacy should not wait for an inspection, an audit request, a supplier issue, a product investigation, or a missing data problem to find out whether its process works.
The question is simple:
If someone asked your pharmacy to show its DSCSA records today, could your team do it?
Not eventually.
Not after calling the one person who handles it.
Not after digging through emails, portals, downloads, screenshots, and old notes.
Could your pharmacy show what happened?
That is what a DSCSA fire drill is built to test.
As Jim Shaver, Managing Director at Advasur, developer behind PRS DSCSA 360, puts it: “The best time to test your DSCSA process is before the pressure shows up wearing a badge and carrying a clipboard.”
Why should your pharmacy run a DSCSA fire drill?
Most DSCSA gaps are not dramatic at first.
They start small.
A file is missing. A supplier setup is unclear. A shipment arrives before the expected data. An exception is handled but not documented. A staff member knows the process, but no one else does. Records exist, but nobody is sure where.
On a normal day, these issues may seem manageable.
During a real request, they get much harder to explain.
A fire drill helps your pharmacy find those gaps before someone else does. It does not have to be complicated. Pick a shipment, ask a few practical questions, and see whether your team can produce answers and records without scrambling.
Here is how to run one.
Drill #1: Find the transaction data.
Pick a shipment your pharmacy received within the last few weeks.
Now ask: can we locate the transaction information connected to that shipment?
Depending on the supplier, timing, product, and method, it may have arrived through EPCIS, EDI 856, a supplier portal, email, or another accepted method.
The drill is not about whether the data might exist somewhere.
It is about whether your pharmacy can find it, connect it to the shipment, and show that the record is being retained properly.
Pass: Your team knows where the transaction data is stored and can retrieve it.
Warning sign: Your team starts searching emails, asking one specific person, or logging into several places with no clear process.
Drill #2: Explain what happens when data is missing.
Now test a more realistic scenario.
A shipment arrives, but the expected data is missing, delayed, incomplete, or hard to match.
Ask your team: what happens next?
Do they know whether to hold product, quarantine product, contact the supplier, open a support ticket, document the issue, or escalate internally?
This is where many pharmacies discover a gap.
Missing data is not always the pharmacy’s fault. It can happen for reasons outside its control. The bigger issue is whether the pharmacy has a documented process for what it did next.
Pass: Your team can explain the missing-data workflow, including follow-up and documentation.
Warning sign: The answer is, “We usually figure it out when it happens.”
Drill #3: Show supplier authorization support.
DSCSA requires pharmacies to work with authorized trading partners.
That means your pharmacy should have a way to know who its suppliers are, whether their status has been reviewed, and where the supporting information is kept.
Ask: can we show which suppliers we receive product from and how we support authorized trading partner review?
The process does not need to be fancy.
It does need to be organized.
Your pharmacy should not lean only on “we have always bought from them” or “the wholesaler must be fine.”
Pass: Your pharmacy can identify suppliers and show how supplier information is maintained or reviewed.
Warning sign: Supplier information is scattered, outdated, or based mostly on assumption.
Drill #4: Walk through a past exception.
Think about a shipment issue your pharmacy has already experienced.
Maybe product arrived before the data. Maybe a file was missing. Maybe a supplier connection was incomplete. Maybe something did not match. Maybe a staff member had to call or email for clarification.
Now ask: can we show what happened?
A strong record shows the issue, the follow-up, the response, the resolution, and where the record was retained.
This is one of the most important parts of readiness because exceptions are where compliance gets real.
A pharmacy does not need a perfect world.
It needs a documented response when the world is not perfect.
Pass: Your team can show the exception history and resolution.
Warning sign: The explanation depends on memory, old emails, or “I think we handled that.”
Drill #5: Test the suspect product process.
Now run a more serious scenario.
A product appears suspicious, damaged, altered, mismatched, unsupported by the expected transaction information, or otherwise concerning.
Ask your team: what do we do?
Staff should understand the basics:
- When product should be quarantined
- Who should be notified?
- How the issue is investigated
- What information should be reviewed?
- When a Form FDA 3911 may be required
- Where related records are retained
This is not a workflow to invent in the middle of a stressful moment.
A clear suspect product process protects the pharmacy, the patient, and the supply chain.
Pass: Your team can explain how suspect product is identified, quarantined, escalated, investigated, documented, and retained.
Warning sign: The answer is, “We would probably call someone and ask what to do.”
Drill #6: Ask someone other than the owner or lead pharmacist.
This may be the most revealing drill of all.
Ask the person who actually receives product to explain the DSCSA workflow.
Can that person answer the basics?
- What records are expected?
- Where is transaction data stored?
- What happens when data is missing?
- Who follows up with suppliers?
- How are exceptions documented?
- What happens if product appears suspect?
If only one person knows the answers, you have a person-dependent process, not a reliable workflow.
People get busy. People take vacations. People get sick. People leave.
DSCSA readiness should survive normal staffing changes.
Pass: More than one trained person can explain and follow the workflow.
Warning sign: The answer to every DSCSA question is, “Ask the person who usually handles that.”
Drill #7: Produce records without rebuilding the story.
This drill is simple but important.
Pick an older shipment or issue and try to produce the related records.
Can your pharmacy retrieve the information cleanly, or does someone have to rebuild the story from emails, downloads, portals, screenshots, memory, and phone calls?
There is a difference between having information and having usable records.
DSCSA records must be retained for six years. Over that time, employees change, systems change, suppliers change, and access to old information gets harder.
A fire drill shows whether your records are truly retrievable or just theoretically available.
Pass: Your pharmacy can produce records from an organized process.
Warning sign: Someone has to piece together the story after the fact.
What to do after the drill
The point of a DSCSA fire drill is not to embarrass anyone.
It is to find the weak spots while there is still time to fix them.
After the drill, ask:
- Which records were easy to find?
- Which records were hard to find?
- Which steps depended on one person?
- Which answers were based on assumptions?
- Which workflows were unclear?
- Which issues were not documented well enough?
- What should be corrected before a real request arrives?
If your pharmacy finds gaps, that is not failure.
That is useful information.
A fire drill that exposes a weak exit plan is doing exactly what it is supposed to do. A DSCSA fire drill that exposes missing records, unclear workflows, or one-person dependency is doing the same thing.
Better to find the gap now than explain it later.
What a strong DSCSA process should support
A practical DSCSA process should help your pharmacy:
- Receive and retain transaction data.
- Review supplier and shipment information.
- Support authorized trading partner checks.
- Identify missing or delayed data.
- Document exceptions and follow-up.
- Support suspect product workflows.
- Maintain records for six years.
- Train staff on repeatable procedures
- Retrieve records when questions arise.
The goal is not to make pharmacy operations harder.
The goal is to make compliance easier to perform, easier to document, and easier to show.
How PRS DSCSA 360 helps
PRS DSCSA 360 helps pharmacies prepare before the pressure arrives.
The system supports transaction data management, supplier and shipment visibility, reconciliation activity, exception documentation, suspect product workflows, staff training support, and long-term record retention.
Instead of relying on scattered emails, supplier assumptions, one-person memory, or last-minute record searches, PRS DSCSA 360 gives your team an organized way to manage DSCSA activity and show what happened when questions arise.
Our approach is hands-on and practical. We provide white glove support, while recognizing that every sound compliance process still requires some involvement from your pharmacy team.
Through all of it, the goal stays the same: patient safety and the security of the pharmaceutical supply chain.
Most pharmacies do not need another compliance headache.
They need a practical way to receive, review, document, retain, and retrieve the information they may be asked to show.
Run your DSCSA fire drill with us in 30 minutes.
You do not need to wait for an inspection request, supplier problem, missing file, or deadline pressure to learn whether your DSCSA process works.
Bring a recent shipment. Bring a past exception. Bring the warning signs you already suspect may exist.
In one short session, we can walk through your current DSCSA workflow and help identify what is organized, what is unclear, and where PRS DSCSA 360 can help.
We will look at the practical areas that matter most:
- Transaction data access
- Supplier visibility
- Shipment review
- Missing-data workflows
- Exception documentation
- Suspect product procedures
- Staff training
- Six-year record retention
- Record retrieval when someone asks.
If your current process depends on scattered records, one-person memory, supplier assumptions, or a plan to “figure it out later,” now is the time to test it.
Schedule a 30-minute PRS DSCSA 360 DSCSA Readiness Review today.
We will help you move from “we think we are covered” to “we can show what we did.”
