Hospital and health system compliance

DSCSA for health systems: the scan passed. Was the receipt compliant?

You have a DSCSA system and your technicians scan every tote. But a passing scan doesn't tell you whether the supplier's file was complete or whether the transaction statement arrived with it. Here is where receiving still breaks and how health systems fix it.

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Hospital pharmacy technician on the phone while sorting medication bottles at a crowded receiving counter
Self-test

If FDA walked into your health system tomorrow, could you…

01

Produce the complete transaction history for one serialized drug, within one business day?

YesNoIt depends who's on shift
02

Show how you identify, quarantine, investigate and disposition suspect product?

YesNoIt depends who's on shift

Answer both questions to see your result.

If you answered "no" or "it depends who's on shift" to either question, there is a gap in your process.

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Two yeses. Keep reading: the next sections cover where receiving still breaks even when both answers hold up.

Where the day breaks

A typical receiving day

One pallet, three scan lanes and a quarantine bin nobody planned for.

1
DSCSA scan
Your DSCSA system
2
Inventory or carousel scan
Pharmacy inventory system
3
EHR scan
Your EHR
Technician scanning medication at a receiving table, with red totes and pallets of boxes behind her
Quarantine
Product held pending data · A bad file fails a whole tote or order

Three scans, one product

Your DSCSA system, your inventory or carousel system and your EHR each scan the same product. None of those three systems talk to each other, and the time it costs you scales with your volume.

One bad file, a whole tote on hold

When the DSCSA scan fails, product sits in quarantine pending data. Patients wait for medication that is already in the building.

Why it breaks

What is working against you

01

Three scans, three systems and none of them talking

DSCSA first, then pharmacy inventory, then the EHR. The problem isn't how you're staffed. It's duplicate scans across systems that aren't integrated.

02

The data was supposed to get better on its own. It didn't

At one health system that measured it, 17% of inbound files failed (LSPedia customer audit, April 2026).

03

The files arriving with your product have more errors than you think

Duplicate files, missing transaction statements, data sent to the wrong entity. These errors come from your suppliers, not your team, and you won't see them until an order lands in quarantine.

04

A passing scan can still be a non-compliant receipt

Missing or incomplete transaction records are a documented FDA inspection finding, and findings can lead to a Form 483 and a warning letter.

05

Compliance was bolted onto software built for something else

Ask what your current system was originally built to do. The answer usually explains the rest.

OneScan verification screen showing a green check, Product Identifier Verified, Verified: true

A passing verification confirms the product identifier. It doesn't tell you whether the transaction statement arrived.

Gloved pharmacy technician scanning the barcode label on a red medication tote
Scanning the tote or the item? Here's the trade-off

You don't have to scan every bottle, but tote-level receiving leaves a gap

Most large systems scan at the tote, not the bottle. Tote-level scanning keeps receiving moving, but a mis-pick inside the tote goes unverified. Totes also vary widely: one holds three products, the next holds 150.

✓
What it gives you

Receiving keeps moving.

△
What it leaves open

A mis-pick inside the tote goes unverified.

Your staffing is already stretched

It's not just you

66 hrs

a week managing drug shortages at the top end, before any DSCSA data work

1.5 FTE

the equivalent staff time in large hospitals

88%

of hospitals report shortages of experienced pharmacy technicians

92%

of hospitals report shortages of technicians with sterile compounding experience

64%

of hospitals report entry-level technician shortages

Source: ASHP National Survey of Pharmacy Practice in Hospital Settings, Operations and Technology 2023 and Clinical Services and Workforce 2024, AJHP. Among responding hospitals.

Recall

Recalls are where the hours quietly go

765

recalled drug products listed in FDA's enforcement reports in 2025

FDA's enforcement reports listed 765 recalled drug products in 2025. For each one that reaches your shelves, ASHP's recall guidance calls for running inventory reports, checking every pharmacy, unit, dispensing cabinet and emergency cart, quarantining the product, documenting it and rechecking later. At one health system we work with, a single recall took several days, start to finish.

01
Run inventory reports
02
Check every pharmacy, unit, cabinet and cart
03
Quarantine
04
Document
05
Recheck later
Self-test

How many recalls did your team work last month? How many hours did each one take? And who checked the lot numbers by hand?

Source: FDA Enforcement Reports, 2025 (openFDA, pulled Sep 30, 2026) · ASHP, Guidance on Medication Recalls, May 2023.

OneScan for health systems

How health systems close these gaps with OneScan

01

Scan once, or at most twice

If your cabinet or carousel system integrates with OneScan, a single scan could feed your inventory, your EHR and your DSCSA record. If your system does not integrate with OneScan, you go from three scans to two.

OneScan feeds one scan to three systems: inventory or carousel, EHR and DSCSA
02

Stop bad files before receiving

Investigator sends them back to the supplier with the fix named.

03

Work the exception the same way at every site

Hold, check, decide, record.

Hold
Check
Decide
Record
04

Pull the record for one serial in seconds

The answer an inspector means by "show me."

05

Add Recall Management

This optional OneScan module will help you find recalled lots.

Explore OneScan for health systems →
What inspectors ask

Who audits you and what they ask to see

FDA and state boards of pharmacy can both ask to see your DSCSA records. Here's what they ask and what a good answer looks like.

01
What is your receiving process?
−

A good answer is the same at every site, from whoever is asked, and it lives in an SOP someone can produce.

A good answer is the transaction record for that serial, pulled on request, not a description of how you'd find it.

Hold it, check it against the supplier data, decide against your SOP and record why. Over-quarantining is also a wrong answer because it keeps good product from patients.

A place staff can walk to, at every site that receives.

Support

Support is part of your team, and it's included

Proven at switch

A step-by-step transition, including your historical records. More than 140 organizations have transitioned.

Supported

A dedicated account manager, phone and email support, audit support, open office hours and a knowledge base, at no extra cost.

Certified

ISO 27001, ISO 9001:2015 and GS1 US Elite Partner. SOC 2 Type 2 pending.

Before you sign with anyone, ask what the contractual response time is on a compliance-blocking issue and what support costs when you need it.

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Customers

1B

Serials processed

750K+

Trading-partner connections

120+

Wholesalers and distributors are customers

FAQs

Frequently asked questions

Are health systems exempt from any part of DSCSA?

−

No. FDA's exemption for larger dispensers ended November 27, 2025. Size is counted across every site a health system owns, so even a small outpatient pharmacy inside a large system is no longer exempt.

No. The requirements sit at receipt and in your records: getting complete transaction data from your suppliers, keeping it for six years and investigating suspect product.

Tote-level scanning is technically compliant, but mis-picks inside the tote go unverified.

You can hold the order or authenticate another way under your SOP and release it. Catching the file before receiving avoids the hold entirely.

FDA and your state board of pharmacy.

Because faster receiving and fewer exceptions give your team time back for patient care. If your current system still means three scans and a quarantine bin, that time is going to data instead.

Your technicians should be moving medication, not data

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