A practical checklist to help pharmacies prepare, document, and show what happened.
DSCSA compliance can feel complicated because it touches several parts of pharmacy operations.
Supplier setup.
Transaction data.
Authorized Trading Partners.
Missing records.
Reconciliation.
Suspect product.
Staff training.
Six-year retention.
Record retrieval.
That is a lot to manage, especially for a busy pharmacy team.
But the practical question is simple:
Can your pharmacy show what it received, where the records are, what happened when something was missing or questionable, and how the team responded?
As Jim Shaver, Managing Director at Advasur, developer behind PRS DSCSA 360, puts it: “A good DSCSA checklist should not just help a pharmacy say the work was done. It should help the pharmacy show the work was done.”
Use this checklist as a practical starting point.
1. Confirm your pharmacy’s DSCSA status
Start by knowing which requirements apply to your pharmacy and when.
If your pharmacy may qualify as a small dispenser, confirm whether the company that owns the dispenser had 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians as of the applicable FDA reference date.
If there is any uncertainty, involve your compliance team or legal counsel.
Do not assume the exemption applies.
And do not assume the exemption removes all DSCSA responsibilities.
2. Know your suppliers
Your pharmacy should know where prescription drug product is coming from.
That includes reviewing whether suppliers are Authorized Trading Partners and maintaining a process for supplier oversight.
Ask:
- Who are our active suppliers?
- Are they properly licensed or registered?
- Do we know which locations or accounts are connected to each supplier?
- Do we have a process when a new supplier or account is added?
This is one of the foundations of DSCSA readiness.
3. Know where your transaction data is stored
Your pharmacy should know where DSCSA transaction records are located.
That may include EPCIS files, EDI 856 records, ASN records, supplier portal records, or other transaction documentation.
The problem is not only whether records exist.
The problem is whether your pharmacy can find them when needed.
Ask:
- Where is our transaction data stored?
- Who can access it?
- Can more than one trained person retrieve it?
- Can we connect records to the right supplier, shipment, and product?
- Can we produce records when someone asks?
“We think it is somewhere in email” is not a compliance strategy.
4. Confirm receipt of transaction information and transaction statements
Pharmacies should have a process to confirm that required transaction information and transaction statements are being received and retained.
Ask:
- Are we receiving expected DSCSA transaction records?
- Are records coming electronically where applicable?
- Are we receiving EPCIS, EDI 856, ASN, portal-based, or other records?
- Are any suppliers missing data?
- Are delays documented?
- Are exceptions tracked?
The goal is to avoid discovering missing records only after someone asks for them.
5. Review supplier connections before the deadline
Supplier setup takes time.
Some suppliers respond quickly.
Others require follow-up.
Some send EPCIS.
Some may use EDI 856, portals, email, or another method.
Your pharmacy should not wait until the final weeks before the deadline to find out which suppliers are connected and which ones still need attention.
Ask:
- Are all active suppliers accounted for?
- Are supplier connections working?
- Are records being received for regular and 340B accounts, if applicable?
- Are new accounts being added to the DSCSA process when created?
- Is someone responsible for keeping supplier information current?
6. Establish a missing-data workflow
Missing or delayed data should not live in someone’s memory.
Your pharmacy should have a clear process for what happens when expected DSCSA transaction data is missing, incomplete, delayed, or difficult to match.
Ask:
- Who reviews missing-data issues?
- How are suppliers contacted?
- Where is the follow-up documented?
- How is the issue escalated?
- How does the pharmacy show what it did?
A missing-data issue is easier to defend when the pharmacy can show the steps it took.
7. Document reconciliation activity
Reconciliation helps compare the product received against the related shipment or transaction data.
That does not mean every pharmacy must scan every package every time.
But the pharmacy should have a practical process for reconciliation activity where appropriate, especially as enhanced DSCSA expectations continue to advance.
Ask:
- Are staff trained on reconciliation workflows?
- Is the scanner setup tested where scanning is used?
- Can the pharmacy document what was checked?
- Can mismatches or exceptions be reviewed?
- Can the record be retrieved later?
Reconciliation should create clarity, not confusion.
8. Prepare for exceptions
Not every shipment will be perfect.
Records may be missing.
Product may not match.
Supplier information may be incomplete.
Data may arrive late.
A barcode may not scan.
A shipment may raise questions.
Your pharmacy should have a process for documenting exceptions and showing how they were handled.
Ask:
- What counts as an exception?
- Who reviews it?
- Where is it documented?
- How is supplier follow-up tracked?
- How is the issue resolved?
- Can the pharmacy show the history later?
A quiet exception process is usually a risky one.
9. Maintain suspect and illegitimate product procedures
Your pharmacy should know what to do if product appears suspect or potentially illegitimate.
That includes processes for identifying, quarantining, investigating, documenting, escalating, and reporting when appropriate.
Ask:
- Do staff know when to stop and escalate?
- Is there a quarantine process?
- Are suspect product concerns documented?
- Is supplier or manufacturer follow-up tracked?
- Does the pharmacy know when Form FDA 3911 may be involved?
- Are final actions and resolution documented?
The middle of a product concern is the wrong time to invent the process.
10. Train staff before the deadline
DSCSA cannot depend on one person.
Receiving staff, technicians, pharmacists, managers, and owners may all need to understand their role.
Ask:
- Who needs DSCSA training?
- Who can retrieve records?
- Who handles supplier questions?
- Who reviews missing data?
- Who performs the reconciliation activity?
- Who escalates suspect product concerns?
- Is backup coverage in place?
Training should happen before the deadline, not during a scramble.
11. Confirm six-year record retention
DSCSA records generally need to be retained for six years.
That means the pharmacy’s process must survive staff turnover, supplier changes, software changes, email cleanup, computer replacement, and time.
Ask:
- Are records retained for the required period?
- Are records organized by supplier, shipment, location, and date?
- Can records still be found years later?
- Is access limited to appropriate users?
- Can the pharmacy retrieve records without rebuilding the story manually?
Retention is not just saving files.
Retention means being able to find and explain them later.
12. Practice record retrieval
The best way to test readiness is to practice.
Pick a shipment.
Find the transaction record.
Confirm the supplier.
Review whether product information is available.
Check whether any issue was documented.
Confirm the record can be retrieved by someone other than the one person who usually handles DSCSA.
Ask:
- Can we find the record quickly?
- Can we explain what it shows?
- Can we show related documentation?
- Can trained staff repeat the process?
If the answer is no, the process needs attention.
13. Review your process before November 27, 2026
The small dispenser deadline is coming.
Pharmacies still have time to get ready, but supplier setup, staff training, reconciliation testing, missing-data cleanup, and record retrieval all take runway.
Do not wait until the final weeks to discover gaps.
Use the time now.
How PRS DSCSA 360 helps
PRS DSCSA 360 helps pharmacies turn this checklist into a practical DSCSA process.
The platform supports:
- Transaction data receipt and retention
- EPCIS and EDI 856 record management
- Supplier and shipment visibility
- Authorized Trading Partner support
- Reconciliation activity
- Missing-data workflows
- Exception documentation
- Suspect product procedures
- Staff training support
- Six-year record retention
- Record retrieval when someone asks.
PRS DSCSA 360 was built by pharmacists, for pharmacists, and shaped by more than a decade of focused DSCSA experience.
The goal is simple.
Help pharmacies move from “we think we are ready” to “we can show what we did.”
Schedule your PRS DSCSA 360 readiness review
If your pharmacy is using a checklist to prepare for DSCSA, the next step is making sure the checklist turns into a working process.
In a 30-minute PRS DSCSA 360 DSCSA Readiness Review, we can walk through your current process and show how PRS DSCSA 360 helps with supplier setup, transaction data, reconciliation readiness, missing-data workflows, exception documentation, staff training, six-year retention, and record retrieval.
No pressure.
No scare tactics.
Just a practical look at where your pharmacy stands and what needs to happen next.
Schedule your 30-minute PRS DSCSA 360 DSCSA Readiness Review today.
A checklist is a good start. PRS DSCSA 360 helps pharmacies turn the checklist into proof.
