DSCSA for Pharmacies, in Plain English: What to Keep, Check, and Do
Empire Rx Distributors · 7 min read
What DSCSA is for
The Drug Supply Chain Security Act exists to keep counterfeit, diverted, and stolen product out of the U.S. drug supply by making every prescription drug traceable through an unbroken chain of authorized companies. For a pharmacy, it boils down to three habits: buy only from authorized trading partners, receive the tracing data with every purchase, and keep it.
Authorized trading partners
You may only buy prescription drugs from trading partners that are properly licensed or registered — manufacturers, repackagers, and wholesale distributors holding valid state licenses. Verifying a wholesaler's license with the issuing state board takes minutes and is the single highest-value compliance habit a buyer has. If a seller can't tell you their license number, that's the whole answer.
The T3: what must come with every shipment
Each purchase must be accompanied by transaction information (what the product is — name, strength, NDC, lot, quantity), transaction history, and a transaction statement (the seller's attestation of compliance). Today this travels electronically as serialized EPCIS data in most of the chain. Practically: know where your T3 data lives for every supplier, and make sure you can produce it on request.
Keep it six years
DSCSA records must be kept at least six years from the transaction date. Electronic storage is fine — a supplier portal that lets you pull historical transaction documents counts, but confirm you'd still have access if you ever closed the account. Many pharmacies simply download and file T3 PDFs with the invoice.
Suspect and illegitimate product
If product looks wrong — packaging anomalies, prices too good to be true from an unverified seller, missing tracing data — you're required to quarantine it, investigate, and if it proves illegitimate, notify FDA and your trading partners. The cleaner your sourcing, the less you'll ever use this section.
Questions to ask any supplier
Ask three things before the first PO: What's your wholesale license number and in which state? Are you NABP Drug Distributor accredited? How do you deliver T3 data? A legitimate distributor answers all three without friction. Empire Rx publishes its NABP accreditation for verification, sources only from authorized trading partners, and includes DSCSA transaction documentation with every shipment — the standard every supplier should meet. This article is general information, not legal advice; for edge cases, FDA's DSCSA guidance and your state board are the authority.
NABP-accredited wholesale for independent pharmacies.
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