DSCSA Readiness: What Each Trading Partner Still Has to Show
Package-level identifiers and electronic tracing now apply to most trading partners. Small dispensers are exempt until 27 November 2027.
In Short
- Serial, lot, expiry and NDC on every package.
- Notify FDA within 24 hours of illegitimate product.
- Keep records at least 6 years.
Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
- Follow a lot both ways.
- Reconcile a trace before acting on it.
- Run a timed trace exercise.
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Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
The Drug Supply Chain Security Act requires package-level product identifiers and secure electronic exchange of transaction data. Most stabilization exemptions have ended; FDA extended small dispensers' exemption to 27 November 2027. Sources checked 3 Oct 2026.
Product Identifier
Manufacturers and repackagers put a product identifier on each package and homogeneous case: the NDC, a unique serial number, lot number and expiry date, in human-readable and 2D barcode form. Aggregation between packages and cases is a business choice, not a separate legal requirement, but it decides how fast you can answer questions.
Enhanced Drug Distribution Security
Section 582(g)(1) of the FD&C Act requires interoperable, electronic tracing at the package level. Trading partners exchange transaction information and transaction statements and must be able to respond to verification and tracing requests.
Exemptions and Current Dates
FDA exempted eligible manufacturers and repackagers until 27 May 2025, wholesale distributors until 27 August 2025 and larger dispensers until 27 November 2025. On 6 August 2026 FDA extended the small dispenser exemption, for owners with 25 or fewer licensed pharmacists and technicians, to 27 November 2027.
FDA Exemption End Dates
| Trading partner | Exempt until |
|---|---|
| Eligible manufacturers and repackagers | 27 May 2025 |
| Eligible wholesale distributors | 27 Aug 2025 |
| Dispensers with 26+ pharmacists and technicians | 27 Nov 2025 |
| Small dispensers (25 or fewer) | 27 Nov 2027 |
- Eligible manufacturers and repackagers
- Exempt until
- 27 May 2025
- Eligible wholesale distributors
- Exempt until
- 27 Aug 2025
- Dispensers with 26+ pharmacists and technicians
- Exempt until
- 27 Nov 2025
- Small dispensers (25 or fewer)
- Exempt until
- 27 Nov 2027
More on exemptions and Current Dates
Check your own status on FDA's exemptions page.
Suspect and Illegitimate Product
Trading partners quarantine and investigate suspect product. If product is found illegitimate, FDA and affected partners are notified within 24 hours of the determination, using Form FDA 3911.
More on suspect and Illegitimate Product
Keep the investigation, decision and disposition with the lots and serials involved.
Records and a Practical Test
Keep transaction information, statements and investigation records for at least 6 years. Test readiness by picking one shipped serial and showing its lot, batch record, shipment and transaction data within your agreed response time.
Trace one serial
Questions
What is in a DSCSA product identifier?
The NDC, serial number, lot number and expiry date, carried in a 2D data matrix barcode and in human-readable form.
Do small dispensers still have an exemption?
Yes. FDA extended it on 6 August 2026 to 27 November 2027 for owners with 25 or fewer licensed pharmacists and pharmacy technicians.
How long are DSCSA records kept?
At least 6 years.
Is V5 a DSCSA verification or EPCIS exchange service?
V5 records lots and serials through production, labeling and shipping and supports GS1 labels. Exchange with trading partners, verification routing and serial commissioning need separate scoping; ask us before relying on them.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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