Frequently Asked Questions
The time required to become DSCSA compliant varies based on your current processes, technology readiness, and trading partner connectivity. For most pharmacies, implementation typically takes a few weeks to a few months, depending on system setup, data testing, and staff training. Starting early helps reduce disruption and allows time to resolve issues before full enforcement.
No. Four of six core DSCSA compliance requirements are in effect already. Even with an exemption through November 27, 2026, the FDA expects active, good-faith progress toward compliance with the balance. Waiting until the deadline increases the risk of disrupted trading relationships and compliance failures once enforcement resumes.
DSCSA does not provide an official compliance checklist. However, pharmacies commonly use industry-developed checklists to assess readiness.
LSPedia offers a DSCSA pharmacy compliance checklist that helps pharmacies review key requirements such as licensing, product tracing, EPCIS data handling, verification, and exception management to support compliance efforts.
Small dispensers have an FDA-granted exemption extending certain enhanced DSCSA requirements until November 27, 2026. Until that date, the FDA is exercising enforcement discretion for those specific obligations. After November 27, 2026, full DSCSA compliance is expected.
Yes. The DSCSA applies to finished prescription drug products, not active pharmaceutical ingredients (APIs). API manufacturers and distributors that only sell APIs and do not handle finished, labeled prescription drugs are not required to comply with DSCSA.
However, if your partner also manufactures, repackages, distributes, or otherwise handles finished prescription drugs, then DSCSA requirements would apply to those activities.
DSCSA applies only to prescription drugs approved for commercial distribution in the U.S. It does not apply to non-prescription (OTC) drugs.
Most drugs used in clinical trials or research are also excluded from DSCSA, as they are not commercially marketed prescription products. Once a drug is approved and distributed commercially, DSCSA requirements apply.
Generally, no. Products returned solely for destruction are not subject to DSCSA transaction documentation requirements.
However, DSCSA requirements may apply if a returned product is eligible for redistribution. In those cases, standard DSCSA verification and documentation rules would still apply.
DSCSA does not mandate a specific number of GLNs. The number needed depends on how your organization conducts DSCSA transactions.
Typically, each physical location that receives or ships prescription drugs uses its own GLN to accurately identify trading partners and locations. For clinic locations, this often results in a 1:1 relationship of 10 GLNs to sites, though fewer may be used if operations are centralized.
DSCSA applicability is based on whether a product is a prescription drug, not solely how it is listed in the NDC Directory.
If a product is labeled “Rx” or “Rx only” on the package, it is treated as a prescription drug and DSCSA compliance is required, even if it appears as an OTC product in the NDC Directory. A mismatch between labeling and NDC listing may also indicate a labeling or regulatory issue that should be addressed separately.
Not necessarily. EPCIS files can be received but not immediately visible due to processing delays, validation errors, or matching issues (such as missing or incorrect identifiers).
In many cases, the data is successfully transmitted and stored, but only becomes visible once it is processed and linked to the correct product or transaction. Your solution provider can help confirm whether this was a timing or data-quality issue, rather than a transmission failure.
No. The Verification Router Service (VRS) is not a manual call or email to the manufacturer.
VRS is an automated, electronic network that routes verification requests from an authorized trading partner to the appropriate manufacturer or repackager and returns a response in near real time.
A commercial DSCSA compliance platform helps by receiving, validating, storing, and connecting EPCIS data with your products and trading partners, while managing verification, exceptions, and audit readiness.
While it is technically possible to exchange EPCIS data directly with trading partners, most companies use a compliance platform to reduce complexity, ensure interoperability, handle errors, and stay aligned with evolving DSCSA requirements.
