2.2 FDA Registration & Trading-Partner Reporting

FDA Establishment Registration

Under FDA regulations, "drug establishments" — manufacturers, repackagers, relabelers, and wholesale distributors — must register with the FDA and list each drug they commercially distribute. This is the National Drug Code (NDC) system. Registration gives the FDA a current directory of who is making and handling drugs in the U.S. market — the backbone of supply-chain visibility and the foundation on which DSCSA trading-partner verification rests.

NDC Structure

The National Drug Code (NDC) is a unique, three-segment number that identifies each listed drug product:

• Labeler code (4–5 digits) — identifies the firm that manufactures, repackages, relabels, or distributes the drug
• Product code (3–4 digits) — identifies the specific strength, dosage form, and formulation from that labeler
• Package code (1–2 digits) — identifies the package size and type

The full NDC appears as Labeler-Product-Package (for example, 12345-001-01). For supply-chain work the NDC is the backbone of receiving, ordering, recalls, and DSCSA tracing — every product must be verified by NDC against the invoice, the shelf, and any recall notice.

Drug Listing

Registered establishments must submit drug listing information to FDA for each drug — including the NDC, active ingredients, strength, dosage form, route, and packaging — and keep it current. Updates are required when a product changes (new strength, new package) and must be made electronically through the FDA's electronic drug registration and listing system using Structured Product Labeling (SPL). A supply-chain technician who spots a mismatch between the labeler code on a received product and the FDA's listing record has identified a potential traceability defect worth investigating.

Foreign Establishments and the US Agent

A foreign drug manufacturer that ships product into the U.S. must also register and list its drugs. A key requirement: a foreign establishment must designate a U.S. agent — a person or entity physically located in the United States who serves as the FDA's contact for communications, inspections coordination, and, where needed, service of process. The U.S. agent is part of the registration record and must be kept current. For a supply-chain technician, a foreign source with no U.S. agent on file — or a foreign establishment whose registration cannot be verified — is a red flag under DSCSA trading-partner verification.

Trading-Partner Definitions Under DSCSA

DSCSA defines a trading partner in two halves. The first half is ownership-based: a manufacturer, repackager, wholesale distributor, or dispenser from whom one of those entities accepts direct ownership of a product, or to whom one of them transfers direct ownership. The second half is possession-based: a third-party logistics provider (3PL) from whom one of those entities accepts direct possession, or to whom one of them transfers direct possession. The core categories:

• Manufacturer — the entity that manufactures the drug (holds the NDA/ANDA/BLA or is the listed manufacturer)

• Repackager — an entity that repackages the drug from a bulk container into a different package or changes the label

• Wholesale distributor — an entity (other than the manufacturer) that distributes prescription drugs to persons other than the consumer or patient (for example, sells to pharmacies, hospitals, other distributors)

• Dispenser — a pharmacy or other entity that dispenses prescription drugs to patients — including retail pharmacies, hospital pharmacies, and some health systems

• Third-party logistics provider (3PL) — an entity that provides or coordinates warehousing or other logistics services for a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser, but does not take ownership of the product and has no responsibility to direct its sale or disposition

A 3PL is often confused with a wholesale distributor. The difference is title, not trading-partner status: a wholesale distributor buys and sells the product; a 3PL holds and moves it for someone else. Both are trading partners under DSCSA — the wholesaler through direct ownership, the 3PL through direct possession — and both must be authorized, which for a 3PL means holding a valid license under State law or the federal 3PL licensure provision.

FDA Form 3911: Suspect and Illegitimate Product Reporting

When a trading partner has reason to believe a product is suspect (may be counterfeit, diverted, stolen, or otherwise potentially illegitimate) or illegitimate (confirmed to be so), the DSCSA process kicks in:

1. Investigate — the trading partner must promptly investigate and determine whether the product is suspect or illegitimate.
2. Quarantine — suspect or illegitimate product must be quarantined and not distributed pending the investigation.
3. Notify FDA — if the product is confirmed illegitimate (or if there is a reasonable probability it is illegitimate), the trading partner must notify FDA using FDA Form 3911 (the Suspect and Illegitimate Product Notification form) — generally within 24 hours of making the determination.
4. Notify immediate trading partners — the entity must also notify the immediate trading partners from whom the product was purchased or to whom it was sold, so the product can be contained.

For the PTCB Supply Chain exam, Form 3911 is the federal reporting mechanism — memorize the number and the trigger: suspect/illegitimate product notification to the FDA. This is distinct from DEA theft/loss reporting (Form 106) and from state board complaints.

Trading-Partner Reporting Under DSCSA (T3 Documents)

In addition to suspect-product reporting, trading partners must exchange T3 transaction documentation with each sale:

• Transaction Information (TI) — product name, strength, dosage form, NDC, container size, number of containers, lot number, date of transaction, and shipment date
• Transaction History (TH) — the chain of transactions going back to the manufacturer (or last authorized trading partner)
• Transaction Statement (TS) — a statement attesting that the seller is an authorized trading partner and obtained the product from an authorized trading partner

Under EDDS — phased in from May 27, 2025 for manufacturers and repackagers through November 27, 2026 for small dispensers — these paper or paper/electronic documents are replaced by interoperable electronic product tracing at the package level. The technician's role is to receive, verify, and retain these records — and to make them available to FDA or to subsequent trading partners when requested.