Authorized Trading Partner verification
Every supplier's license is verified against FDA and state databases on an ongoing basis. Any unverified partner triggers an immediate alert and blocks further processing.
The most rigorous DSCSA compliance service an independent pharmacy can buy.
The DSCSA Pharmacy Traceability Compliance Engine holds your DSCSA obligation — AI verifies every supplier as an Authorized Trading Partner, reconciles T3/EPCIS data, triages exceptions, drafts suspect/illegitimate investigation files and Form FDA 3911, answers verification requests inside the 24-hour clock, and keeps an audit-ready records vault for six years. A licensed-pharmacist compliance reviewer signs every suspect/illegitimate determination. You pass any board or FDA inspection.
Every subsection of 21 U.S.C. § 360eee-1Authorized Trading Partner verification, ongoingT3/EPCIS ingestion & exception triageLicensed-pharmacist reviewer on every determination24-hour verification-response SLA
Why compliance fails
A single missing record can trigger an FDA action.
The Drug Supply Chain Security Act (DSCSA) requires independent pharmacies to buy only from Authorized Trading Partners, hold and store transaction records, respond to verification requests, quarantine and investigate suspect product, notify FDA of illegitimate product within 24 hours, and keep records for six years. The small-dispenser exemption expires November 27, 2026 — a hard, dated compliance cliff for ~19,000 pharmacies.
Most independents have no compliance staff and rely on a single wholesaler portal, ad-hoc PDFs, and unwritten procedures. There is no system to verify supplier licensure on an ongoing basis, no defined suspect/illegitimate-product workflow, no 24-hour verification-response capability, and no six-year records vault. That is exactly where compliance gaps hide.
The DSCSA Pharmacy Traceability Compliance Engine exists to close that gap with a single, exhaustive standard applied identically to every pharmacy.
1 of 6
DSCSA obligations is enough to fail an inspection
The benchmark
Measured against the letter of the statute — subsection by subsection.
We do not summarize the law and hope. Every file is scored against a versioned rule pack tied to the exact text of 21 U.S.C. § 360eee-1 and related regulations. These are the provisions each file is held to.
Transaction data (T3/EPCIS) reconciliation
Transaction history, information, and statement are ingested, parsed, and reconciled against the shipment. Missing or mismatched data is flagged and triaged.
Suspect product investigation
Any product that fails verification or appears in an alert is quarantined, investigated, and documented. The investigation file is drafted and reviewed by a licensed pharmacist.
Illegitimate product notification (Form FDA 3911)
If a product is deemed illegitimate, Form FDA 3911 is drafted and submitted within 24 hours. The determination is signed by a licensed pharmacist.
Verification request response
Verification requests from trading partners or FDA are answered within 24 hours, with the required product identifier and transaction data.
Record retention (6 years)
All transaction records, investigation files, and correspondence are retained in an audit-ready vault for the mandatory six years, with automated backup and access logs.
How compliance is built
Intake to pharmacist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A licensed-pharmacist compliance reviewer signs every suspect/illegitimate determination. That order is never reversed.
01
Compliance Gap Scan
Upload your current supplier list and transaction records. We return a free completeness read: which DSCSA obligations you already meet, and which are missing.
02
Trading Partner verification
As your authorized clerical agent, we verify every supplier's license against FDA and state databases and build an ongoing monitoring schedule.
03
Data ingestion & reconciliation
T3/EPCIS files are ingested, parsed, and reconciled against shipments. Exceptions are flagged and triaged automatically.
04
Deterministic compliance gates
Every supplier is verified; every transaction is reconciled; every suspect product is investigated; every verification request is answered within 24 hours. Any failure blocks release.
05
Pharmacist review & sign-off
A licensed-pharmacist compliance reviewer reviews the suspect/illegitimate determination and signs the investigation file and Form FDA 3911.
06
Audit-ready vault
You receive a secure, searchable vault with all records, investigation files, and correspondence, retained for six years and ready for any board or FDA inspection.
The bar we hold
Rigor you can measure.
100%
Pharmacist-reviewed
Every suspect/illegitimate determination is signed by a licensed pharmacist.
24 hrs
Verification-response SLA
Every verification request is answered within 24 hours.
<1%
Critical-defect target
Tracked against a gold-standard compliance library.
6 years
Record retention
All records retained in an audit-ready vault for the mandatory six years.
Why DSCSA Pharmacy Traceability Compliance Engine
Built to be the most thorough option a pharmacy has.
Outcome, not software
You buy 'you will pass any board or FDA inspection and you will never distribute an illegitimate product' — not software you have to run.
Deterministic, not vibes
The gates that decide compliance are code, not a model's opinion. A drafting error cannot slip past a statutory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never give legal advice or represent you in any legal matter.
Engagement
Flat annual subscription, per location. No hourly billing, ever.
Simple, predictable, and aligned with a compliance standard — not a cut of any recovery.
- A free Compliance Gap Scan before you commit — see exactly what is missing.
- One flat annual fee per location; disclosed pass-through verification costs.
- Optional per-investigation prep fee for suspect/illegitimate product investigations beyond the included threshold.
- No contingency and no percentage of any recovered amount or sale proceeds.
FAQ
Questions, answered precisely.
Is DSCSA Pharmacy Traceability Compliance Engine a law firm?
No. DSCSA Pharmacy Traceability Compliance Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Pharmacist review is available and recommended for suspect/illegitimate determinations.
Do you contact the FDA or trading partners on my behalf?
Only as your authorized clerical agent for the limited purpose of submitting Form FDA 3911 and responding to verification requests. You remain the responsible party for all DSCSA obligations.
What makes a file 'complete'?
Completeness is defined by the statute: every supplier verified as an Authorized Trading Partner, every transaction reconciled, every suspect product investigated, every verification request answered within 24 hours, and all records retained for six years. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is 24 hours for verification requests and 5 business days for suspect/illegitimate investigation files from complete intake. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat annual fee per location, plus disclosed pass-through verification costs. No hourly billing and no percentage of any recovered amount or sale proceeds.
See what's missing before the November 27, 2026 deadline.
Start with a free Compliance Gap Scan. Send your supplier list and transaction records and we'll return a completeness read against every subsection of 21 U.S.C. § 360eee-1.
Documentation-completeness service · not legal advice · the pharmacy remains the responsible party.