DSCSA & CSA compliance,
wherever you already work.
One compliance platform for serialized drug traceability (DSCSA) and controlled-substance recordkeeping (CSA) — delivered as a free OpenEMR module, Microsoft 365/Teams apps already in production, and a standalone portal on the way.
The Deadline
Large dispensers were already required
to comply. Small dispensers are next.
Large dispensers' DSCSA enhanced drug distribution security deadline passed November 27, 2025. Small dispensers have until November 27, 2026 — and FDA enforcement, including warning letters, is already active.
01
Serialization is manual or missing
Units come in, get shelved, get dispensed — with no system tying a serial number to an EPCIS event, a lot, or a disposition.
02
No verifiable trading-partner exchange
DSCSA requires transaction data exchanged over AS2 with your trading partners. A spreadsheet or a PDF invoice does not satisfy that.
03
Controlled substances need their own trail
A DEA audit doesn't accept a general inventory count — it wants a perpetual ledger, theft/loss records, and PDMP filings tied to a real person's login.
One Platform, Three Ways In
Use it where your pharmacy already lives.
Same compliance engine underneath — one EPCIS/AS2 hub, one controlled-substance ledger — surfaced differently depending on how your practice operates today. We're also extending the same integration pattern to pharmacy management platforms like Pioneer.
OpenEMR Module
Free, open source (GPL-3.0). Installs directly into OpenEMR's custom modules directory — no core-file patches required.
Microsoft 365 & Teams
DSCSA and DSCSA+ (CSA) web parts running in production inside your SharePoint site or as a Teams tab — for practices that live in Microsoft 365, not an EMR.
Compliance Cloud Portal
A standalone, browser-based portal — no EMR or Microsoft 365 required. Secured by Aegis, our identity layer, so every action is tied to a real, individually-accountable login.
DSCSA
Everything drug supply chain traceability requires.
Serialized Inventory
Every unit tracked by GTIN, serial, lot, and expiry from the moment it arrives until it's dispensed or removed — matched against your pharmacy inventory automatically.
EPCIS / AS2 Connectivity
One Endear-operated AS2 hub exchanges EPCIS events with your trading partners the way DSCSA actually requires — or point it at your own AS2 endpoint.
GS1 Scan-and-Trace
Scan GS1 DataMatrix codes on receipt and dispense. Handles real-world scanner quirks (FNC1 placeholder variants) other tools choke on.
Suspect Product & Returns
582(d)(4) investigation workflow — quarantine on scan, verify with the manufacturer, generate FDA Form 3911 — plus recalls, destruction, and saleable-returns tracking.
DSCSA+ / CSA
Purpose-built for controlled substances.
CSA (Controlled Substances Act) compliance layers on top of DSCSA — same platform, added recordkeeping the DEA and state PDMPs actually ask for.
Perpetual Inventory & Audit Trail
A running balance for every controlled-substance lot with a fully searchable transaction log and quantity-on-hand view, shown against the location's DEA registration front and center.
Dispense History & Physical Counts
Dispensing records reconciled against scheduled physical counts, so a shortage surfaces on your dashboard before it surfaces in an audit.
Waste, Adjustments & Theft/Loss
Every waste event, inventory adjustment, or loss logged with a reason code and a name attached — not buried in a spreadsheet nobody reconciles.
PDMP Reporting & Compliance Rules
State PDMP/MassPAT report drafting, a configurable compliance rules engine, and an audit vault built for a DEA records request, not a general-purpose file share.
Open Source
The OpenEMR module is free. GPL-3.0. No lock-in.
If you run OpenEMR, the Endear DSCSA Module installs directly into its custom modules directory — no core-file patches required. Connect it to Endear's hosted EPCIS/AS2 hub, or point it at your own. The subscription tiers below cover the hosted service and support across every delivery surface — the OpenEMR module itself is free to install and inspect.
Pricing
One subscription. Available through OpenEMR, Microsoft 365, or the upcoming Compliance Cloud Portal.
DSCSA+ replaces the base tier's price with a single, all-in price for that tier — never billed on top of it.
Also from Endear AI
Compliance Cloud is one of four platforms. Pair it with private AI and secure agent orchestration for a complete regulated-industry stack.
Ready before your deadline, wherever you work.
Free OpenEMR module, Microsoft 365/Teams apps in production today, and a standalone portal on the way — one compliance platform underneath all of it.