DSCSA compliance, handled in the workflow.
The Drug Supply Chain Security Act traces every prescription drug package through every change of ownership — including a trade between two pharmacies. Here is what the law requires, and what PrimePostRx does about each requirement so you don't carry the paperwork.
What the law requires.
- Authorized trading partners
- Every buyer and seller in a transaction must hold valid licensure — for pharmacies, a state board license in good standing. Trading with an unauthorized partner is a violation for both sides of the trade, not just one.
- Product identifiers
- Every package carries a 2D barcode encoding four data points: the NDC (inside a GTIN), a unique serial number, the lot number, and the expiration date. Since November 2023, tracing happens at this individual-package level.
- Transaction data — TI and TS
- Each change of ownership must pass Transaction Information (product, strength, NDC, lot, quantity, parties, dates) and a Transaction Statement (the seller's attestation of authorized status and clean custody), exchanged electronically and interoperably.
- Records and suspect product
- Both parties keep transaction records for six years. Suspect product must be quarantined and investigated; product confirmed illegitimate must be reported to the FDA and trading partners within 24 hours.
How PrimePostRx covers each duty.
Authorized trading partners
✓ CompliantThe gate is the platform: every account is license-verified against state board records before it can list or buy. You never have to establish a counterparty's status yourself — unverified pharmacies cannot transact here.
Transaction information + statement
✓ CompliantGenerated with every order, automatically. The listing's NDC, lot, expiration, and quantity plus both parties' verified details become the TI; the TS attestation executes at checkout. Nothing to type, nothing to forget.
Six-year recordkeeping
✓ CompliantEvery record stays on your dashboard for the statutory six years — searchable by NDC, lot, counterparty, or date, and exportable as PDF or CSV when an inspector asks.
Suspect and illegitimate product
✓ CompliantFlag an order and it freezes: escrow holds the funds, the listing comes down, and both parties receive the documentation trail needed for the FDA Form 3911 notification.
A decade of phase-ins.
- 2013DSCSA signed into law — Title II of the Drug Quality and Security Act.
- 2015Lot-level tracing begins: TI and TS accompany each change of ownership.
- 2018Manufacturers begin serializing every package with a unique identifier.
- 2023Statutory deadline for electronic, package-level, interoperable tracing.
- 2024FDA stabilization period ends November 27 — enhanced requirements enforceable.
- 2026Small-dispenser exemption (fewer than 26 FTEs) ends November 27.
Asked by pharmacists, answered plainly.
Yes. The law excludes dispenser-to-dispenser sales only when they fill a specific patient need. A general overstock sale is a change of ownership — a transaction — so TI and TS must travel with it and both parties keep records. That is exactly the paperwork PrimePostRx generates automatically.
No. The platform produces and exchanges the transaction data — in the GS1 EPCIS format the industry standardized on — for every trade you make on it. Your obligations for purchases made outside PrimePostRx are unchanged, but trades made here arrive with their records already built.
The FDA exemption running to November 27, 2026 defers the enhanced electronic tracing requirements for small dispensers. It does not remove the authorized-trading-partner, recordkeeping, or suspect-product duties. Trades on PrimePostRx produce full package-level records regardless, so the deadline passing changes nothing about how you work here.
Both parties to a transaction must be able to produce records for six years. PrimePostRx retains every transaction record for the full statutory period and serves it back to you on demand — your copy is always one export away.
Primary sources.
Don't take a marketplace's word for federal law. Read the regulator and the statute directly:
- Drug Supply Chain Security Act — overviewfda.gov
- DSCSA law and policies: guidance documentsfda.gov
- Waivers, exceptions, and exemptionsfda.gov
- For pharmacists: using DSCSA to protect patientsfda.gov
- Notify FDA of illegitimate products (Form FDA 3911)fda.gov
- H.R. 3204 — Drug Quality and Security Act, full textcongress.gov
- EPCIS — the data exchange standardgs1.org
This page is a plain-language summary of the Drug Supply Chain Security Act as it applies to pharmacy-to-pharmacy trades. It is not legal advice — for your pharmacy's specific obligations, consult your compliance counsel or state board of pharmacy.
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