DSCSA Compliance Checklist for Pharmacies
A practical checklist to help pharmacies prepare, document, and show what happened.
DSCSA compliance can feel complicated because it touches supplier setup, transaction data, Authorized Trading Partners, missing records, reconciliation, suspect product, staff training, six-year retention, and record retrieval.
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?
DSCSA readiness is not just about checking a box.
It is about having a repeatable process that helps the pharmacy show what happened when someone asks.
“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.”Jim Shaver, Managing Director of Advasur 360
Thirteen practical steps to prepare before the deadline.
Use this checklist to evaluate supplier setup, transaction data, workflows, training, retention, and record retrieval before DSCSA gaps become urgent.
Confirm your pharmacy’s DSCSA status
Start by knowing which requirements apply to your pharmacy and when.
- Confirm small dispenser status when applicable
- Do not assume an exemption applies
- Involve compliance or legal counsel if uncertain
Know your suppliers
Your pharmacy should know where prescription drug product is coming from.
- Review active suppliers
- Check Authorized Trading Partner status
- Maintain supplier oversight
Know where transaction data is stored
The issue is not only whether records exist. The issue is whether you can find them.
- Know where EPCIS, EDI 856, ASN, and portal records live
- Confirm access for trained staff
- Connect records to supplier, shipment, and product
Confirm receipt of TI and TS
Required transaction information and transaction statements should be received and retained.
- Confirm expected records are arriving
- Identify missing supplier data
- Track delays and exceptions
Review supplier connections
Supplier setup takes time. Do not wait until the final weeks before the deadline.
- Account for all active suppliers
- Test supplier connections
- Include regular and 340B accounts if applicable
Establish a missing-data workflow
Missing or delayed data should not live in someone’s memory.
- Assign review responsibility
- Document supplier follow-up
- Show the steps the pharmacy took
Document reconciliation activity
Reconciliation helps compare product received against related shipment or transaction data.
- Train staff on reconciliation workflows
- Test scanner setup where scanning is used
- Document what was checked and what matched
Prepare for exceptions
Not every shipment will be perfect. Exceptions should be documented and resolved.
- Define what counts as an exception
- Track supplier follow-up
- Show the history later
Maintain suspect product procedures
Your pharmacy should know what to do if product appears suspect or potentially illegitimate.
- Identify, quarantine, investigate, and document
- Escalate and report when appropriate
- Know when Form FDA 3911 may be involved
Train staff before the deadline
DSCSA cannot depend on one person.
- Train receiving staff, technicians, pharmacists, managers, and owners as needed
- Assign backup coverage
- Make sure staff know when to escalate
Confirm six-year retention
Retention is not just saving files. It means being able to find and explain them later.
- Retain records for the required period
- Organize by supplier, shipment, location, and date
- Control access for appropriate users
Practice record retrieval
The best way to test readiness is to practice.
- Pick a shipment and find the record
- Confirm supplier and product information
- Make sure trained staff can repeat the process
Review your process before November 27, 2026
The small dispenser deadline is coming. Use the time now.
- Review supplier setup
- Test reconciliation and retrieval
- Clean up missing-data gaps before the final weeks
A checklist only helps if it becomes a working pharmacy process.
A busy pharmacy needs a practical way to connect suppliers, records, receiving activity, missing data, exceptions, reconciliation, suspect product concerns, training, and retrieval.
“We think it is somewhere in email” is not a compliance strategy. The pharmacy needs a process that can survive staff turnover, supplier changes, software changes, email cleanup, computer replacement, and time.
A missing-data issue is easier to defend when the pharmacy can show the steps it took.
Workflow questions to answer:
Record retrieval is where readiness becomes visible.
Pick a shipment. Find the transaction record. Confirm the supplier. Review product information. Check whether any issue was documented.
If someone other than the one person who usually handles DSCSA cannot repeat the process, the workflow needs attention.
Your team should be able to find and explain the record.
- ✓Can we find the record quickly?
- ✓Can we explain what it shows?
- ✓Can we show related documentation?
- ✓Can trained staff repeat the process?
Do not wait until the final weeks to discover what is missing.
Supplier setup, staff training, reconciliation testing, missing-data cleanup, and record retrieval all take runway.
Turn the checklist into proof.
Advasur 360 helps pharmacies turn this checklist into a practical DSCSA process.
Transaction data receipt and retention
Support for receiving, retaining, and retrieving required DSCSA transaction records.
EPCIS and EDI 856 record management
Help organizing electronic records so they can be connected to supplier and shipment activity.
Supplier and shipment visibility
A practical way to understand supplier setup, shipment activity, and related records.
Authorized Trading Partner support
Support for organizing supplier information and reviewing trading partner readiness.
Reconciliation activity
Workflow support for comparing product received against shipment or transaction data.
Missing-data workflows
A clear process for identifying, following up on, and documenting missing or delayed records.
Exception documentation
Tools to help show what happened when product, records, or supplier information did not match expectations.
Suspect product procedures
Support for procedures that help staff identify, quarantine, investigate, document, escalate, and report when appropriate.
Staff training support
Practical support so DSCSA work does not depend on one person.
Six-year record retention
Support for long-term record retention that remains organized and explainable over time.
Record retrieval when someone asks
Help pharmacies move from “we think we are ready” to “we can show what we did.”
Built by pharmacists, for pharmacists
Advasur 360 is shaped by more than a decade of focused DSCSA experience.
A checklist is a good start. Proof is better.
If your pharmacy is using a checklist to prepare for DSCSA, the next step is making sure the checklist turns into a working process.
Advasur 360 helps pharmacies move from “we think we are ready” to “we can show what we did.”
Turn your DSCSA checklist into a working process.
In a 30-minute Advasur 360 DSCSA Readiness Review, we can walk through your current process and show how Advasur 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.
A checklist is a good start. Advasur 360 helps pharmacies turn the checklist into proof.