DSCSA, in plain English.

The Drug Supply Chain Security Act is a U.S. federal law enacted in 2013. It established product tracing, identification, authorized trading partner, and verification requirements for certain prescription drugs. Its enhanced system is intended to support secure, interoperable electronic tracing at the package level.

The goal is patient protection. Better identification and tracing can help keep harmful drugs out of the legitimate supply chain, find them when they do enter, and support a faster, more precise response. It also creates a shared evidence trail when a product is recalled or investigated.

The principal trading partner roles are manufacturers, repackagers, wholesale distributors, and dispensers, which are primarily pharmacies. An organization's legal role depends on what it is doing in a transaction, not only what it calls itself. Requirements differ by role and activity.

No. DSCSA product tracing generally concerns certain human, finished prescription drugs. The law excludes some products and some types of transactions. FDA's product tracing FAQ is the better place to check scope for a particular situation.

A pharmacy needs to connect the physical shipment with its electronic tracing information, work only with appropriate trading partners, preserve required records, and have procedures for verification and suspect or illegitimate product. That does not mean the law requires a technician to scan every individual package in every shipment. The right workflow depends on the data, packaging hierarchy, product, transaction, and the pharmacy's procedures.

No single central database is mandated. The required outcome is secure, interoperable electronic exchange. FDA recommends GS1 EPCIS for exchanging tracing information, but trading partners still use many networks, portals, providers, and direct connections. That fragmentation is part of the operational problem OpenDSCSA is exploring.

Planned OpenDSCSA is a planning-stage network and software product for DSCSA receiving and exception work. The idea is a free hosted web app for pharmacies, open interfaces for software providers, and a managed network that connects the systems trading partners already use.

Its purpose is to turn tracing data into a usable operating workflow. When a shipment arrives, staff should be able to see what was expected, record what arrived, release what matches, place only affected product on hold, resolve the difference with the right partner, and preserve the evidence behind every action.

The goal is one open network that any trading partner or software provider can connect to, directly or through a provider it already uses. A pharmacy should not need a different operational process for every supplier, and a developer should not need to rebuild the same receiving behavior for every connection.

Much of the market focuses on moving or storing a file. The difficult last mile is deciding what to do when electronic records meet the physical shipment, especially when something is missing or does not match. OpenDSCSA is focused on that receiving-to-resolution layer while remaining able to connect with existing providers.

It begins with the pharmacy technician receiving a shipment, the pharmacist or operations lead responsible for policy and release decisions, and the developer connecting pharmacy software. It also serves manufacturers, repackagers, wholesalers, and solution providers that need reliable ways to send data and resolve exceptions with pharmacies.

It means open to join, documented interfaces that others can build on, standards-based connections, and complete export in open formats so a customer can leave with its data. OpenDSCSA would operate the hosted network. Open-source licensing is still under review, so “open” is not currently a promise that every part of the system will be open source or self-hostable.

The Lab is a synthetic practice and development environment. It models a shipment, the data around it, the decisions people make, and the evidence those decisions create. It is meant for learning and testing without touching production inventory. Completing a Lab scenario is not certification, regulatory approval, or proof of legal compliance.

OpenDSCSA plans to describe the specific difference, hold only the affected product when appropriate, assign an owner, preserve the evidence, and support communication with the trading partner. An ordinary data mismatch does not automatically mean a product is counterfeit, suspect, or illegitimate. Authorized people make those determinations under their procedures.

No. Software can validate data, show evidence, guide a procedure, track time, and record who approved an action. It cannot replace the trading partner's legal responsibility or turn one technical test into a universal compliance decision. OpenDSCSA will say what was checked and what happened, not claim more than the evidence supports.

The plan is to connect, not replace. A pharmacy could use the planned OpenDSCSA web app, while an existing pharmacy system could embed the same workflow through documented interfaces. Manufacturers, wholesalers, and solution providers could connect the systems and networks they already operate.

Planned Customers should be able to access and completely export their records in open formats. The hosted network is intended to preserve the original data, normalized records, corrections, actions, and evidence without silently rewriting history. Six-year record retention is part of the current plan; final service and security terms have not been published.

Planned The hosted web app for pharmacies is intended to be free. The operated network, including routing, partner connections, credential checks, retention, reliability, and day-to-day operations, is the paid service. Exact pricing and production eligibility have not been set.

As of September 17, 2026, FDA has exempted certain small dispensers, and where applicable their trading partners, from certain enhanced requirements until November 27, 2027. For this exemption, a small dispenser is owned by a company with 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted as of November 27, 2026.

The exemption is limited, does not remove every DSCSA duty, and does not decide whether a particular pharmacy qualifies. FDA urges small dispensers to continue implementation. Review the current FDA exemption page and obtain advice for your situation.

Not yet. OpenDSCSA is a planning-stage product concept, and the public site describes intended behavior. You can join the waitlist, ask to connect your network, or volunteer for a research conversation. Early feedback from people who receive, ship, support, and investigate real shipments will shape what gets built.

Use FDA's DSCSA pages and the law or guidance itself for official regulatory material. Consult qualified counsel or your compliance advisors for advice about your organization, products, transactions, procedures, or exemption status. OpenDSCSA is not affiliated with FDA or any regulator, and this FAQ is not legal advice.