FDA Drug Establishment Registration and National Drug Code (NDC)

Before a drug can be legally manufactured or distributed in the United States, the facility that makes it must be registered with FDA — and every finished drug product must carry a unique National Drug Code (NDC) that identifies the product, manufacturer, and package size. These twin requirements, implemented through 21 CFR Part 207, give FDA a continuously updated inventory of every drug facility and every drug product in U.S. commerce. Registration and listing are prerequisites to entering the U.S. drug market; failure to register is a prohibited act under the Federal Food, Drug, and Cosmetic Act (FDCA), and unregistered facilities are subject to import alerts and regulatory action.

Legal Authority

• 21 U.S.C. § 360 et seq. — Federal Food, Drug, and Cosmetic Act § 510: requires domestic and foreign drug manufacturers, packers, and distributors to register their establishments with FDA and list all drugs in commercial distribution; failure to register is a prohibited act under FDCA
• 21 CFR Part 207 — FDA regulations implementing drug establishment registration and drug listing requirements; establishes who must register, when, what information is required, the National Drug Code (NDC) system, and electronic submission requirements

Key Mechanics

Registration and listing under Part 207 operate on an annual cycle: establishments must register initially when they begin manufacturing, then renew annually during October 1–December 31. Drug listing must occur at initial marketing and be updated annually; labels submitted with drug listings become FDA's official label record for adverse event tracking, import screening, and inspection targeting. The National Drug Code (NDC) — the unique 10- or 11-digit identifier assigned through listing — encodes labeler (manufacturer), product, and package size; the NDC is used in all automated drug dispensing, insurance billing (CMS, PBMs), and FDA tracking systems. Electronic submission through FDA's Structured Product Labeling (SPL) system is mandatory.

Current Rule (2026)

What This Rule Does

Part 207 operates as the foundational visibility layer for the U.S. drug supply: FDA cannot inspect, audit, or regulate what it cannot find. Registration tells FDA where every drug is made; drug listing tells FDA what those facilities are producing. Together, these two databases — the Drug Establishment Registration database and the Drug Listing database — support FDA's inspection scheduling, import screening, supply chain monitoring, drug shortage tracking, and public transparency through the FDA's Drug Shortages and NDC databases.

Registration and listing are not drug approval. A facility can register and list its drugs without those drugs being FDA-approved for marketing. Registration means FDA knows you exist and what you claim to make — it does not authorize you to legally sell drugs that require premarket approval (prescription drugs, biologics, new drugs). The rule expressly states this: registration "does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed" (§ 207.77). Foreign establishments registering to export to the U.S. should understand this distinction clearly — registration is necessary but not sufficient for legal U.S. marketing of regulated drugs.

Who Must Register (§ 207.9 and § 207.17)

Required to register: all domestic and foreign manufacturers, repackers, relabelers, and salvagers of drugs intended for distribution in the United States — including:

• Domestic facilities that manufacture, repack, relabel, or salvage any drug regardless of whether it enters interstate commerce
• Foreign facilities that manufacture, repack, relabel, or salvage drugs that are imported or offered for import into the United States
• Facilities that manufacture animal feed articles bearing or containing a new animal drug

Exemptions (§ 207.13): certain classes are exempt from registration requirements under FDCA § 510(g), including:

• Pharmacies licensed by state law that dispense or sell drugs at retail on prescription; compounding pharmacies operating under specific exemptions
• Practitioners (physicians, veterinarians) who manufacture, repack, or relabel drugs solely for use in their own practice
• Manufacturers of drugs solely for use in clinical investigations that haven't been introduced into interstate commerce
• Blood banks and related establishments whose drug activities consist solely of preparing blood and blood components

When to Register (§ 207.21)

• New domestic establishments: must register no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug
• New foreign establishments: must register no later than 5 calendar days after beginning to manufacture drugs intended for U.S. import
• Annual registration renewal: all registrations must be reviewed and updated annually between October 1 and December 31 each year
• Expedited updates (§ 207.29): certain changes require updating within 30 calendar days — including closing or selling an establishment, changing the establishment's name or physical address, or beginning or ceasing manufacture of any previously listed drug; this 30-day update requirement ensures FDA's databases remain accurate between annual renewals

What Registration Covers (§ 207.25)

Each registered establishment must provide:

• Name, address, and physical location of the establishment
• Owner or operator name; corporate officers and directors for corporations
• Type of operations performed (manufacturing, repacking, relabeling, salvaging)
• Official contact person responsible for FDA communications
• For foreign establishments: a United States agent (§ 207.69) — a person residing in the U.S. who serves as FDA's point of contact for the foreign facility; the US agent accepts import alerts, warning letters, and inspection notices on the foreign facility's behalf; designation of a US agent is mandatory and cannot be waived

Drug Listing (§§ 207.41–207.57)

In addition to registering the establishment, each registrant must list every drug it manufactures, repacks, relabels, or salvages for commercial distribution at the time of initial registration and update the list annually. Drug listing information includes:

• The NDC (see below) for every package configuration
• Proprietary name (brand name) and non-proprietary name (generic/established name)
• Labeler name — the entity whose name appears on the drug label
• Active ingredients, including strength and concentration
• Dosage form (tablet, capsule, solution, etc.)
• Route of administration (oral, injectable, topical, inhaled, etc.)
• Whether the drug is prescription, over-the-counter (OTC), or non-retail (hospital bulk)
• Drug application number (NDA, ANDA, BLA) if the drug is the subject of an approved application

National Drug Code (NDC) (§§ 207.33–207.37)

The National Drug Code (NDC) is a unique numeric identifier assigned to every finished drug product or unit of use package marketed in the United States. The NDC format is XX-XXXX-XX (10 digits across three segments):

NDC assignment process: the labeler code is assigned by FDA upon registration. The product and package codes are assigned by the registrant (manufacturer or labeler) within the labeler's code space. A manufacturer with a labeler code of 12345 could assign 12345-0001-01 to a 100-tablet bottle of Drug A (10 mg) and 12345-0001-02 to a 30-tablet bottle of the same Drug A (10 mg) — same product, different package, different NDC.

When a new NDC is required (§ 207.35): a registrant must propose a new NDC whenever any of the following change after initial marketing:

• The product's active ingredient(s) or their strengths
• The dosage form or route of administration
• The labeler (name change or company acquisition)
• Any other information that would make the existing NDC misleading

NDC restrictions (§ 207.37): a product is misbranded if its NDC is used to represent a different drug, to imply FDA approval, or on products not otherwise required to carry an NDC. NDC misuse in prescription drug billing (using an NDC for a different drug to avoid formulary restrictions or trigger higher reimbursement) is a federal false claims violation separate from Part 207 itself.

2026 NDC Amendment: FDA amended § 207.33 in March 2026 (91 FR 10770) to update NDC format requirements and clarify listing obligations for new categories of drug products, including certain FDA-regulated digital health applications.

Electronic Submission (§ 207.61)

All registration and drug listing information must be submitted electronically through FDA's Structured Product Labeling (SPL) system via the electronic drug registration and listing (eDRLS) system. Paper submissions are not accepted except by specific FDA waiver (§ 207.65), which is available only when electronic submission is not technically feasible. The electronic submission requirement enables automated processing, real-time database updates, and cross-system linkage between the registration database and FDA's drug approval records.

Public Disclosure (§ 207.81)

FDA makes the following registration and listing information publicly available:

• All establishment registration information (name, address, contact)
• All drug listing information except trade secret manufacturing process details
• NDC database — fully public and searchable at FDA's website

The public NDC database is a critical tool for healthcare operations: insurers, pharmacy benefit managers, hospitals, and dispensing systems use NDC codes as the primary identifier for drug billing, formulary management, automated dispensing, and supply chain tracking. Drug claims submitted to Medicaid and Medicare use NDC codes; insurance coverage determinations are NDC-specific. An unlisted drug cannot be billed by NDC, which creates a practical barrier to distribution even for drugs not otherwise requiring FDA approval.

How It Affects You

If you manufacture, repack, or relabel drugs for the U.S. market: registration is a Day-1 compliance requirement — you must register within 5 days of beginning drug manufacturing. "Drug" under the FDCA is broadly defined and includes OTC products, vitamins making drug claims, certain cosmetics that meet the drug definition, and compounded preparations in some cases. Consult FDA guidance on the drug definition before assuming a product is exempt. Foreign manufacturers must designate a U.S. agent — this is not optional and must be a person physically located in the United States who can receive FDA notices in real time.

If you are a pharmacy or compounding facility: most retail pharmacies are exempt from registration, but compounding pharmacies under FDCA § 503A and outsourcing facilities under § 503B have specific registration obligations. Section 503B outsourcing facilities must register as drug manufacturers — they do not qualify for the retail pharmacy exemption — and must comply with the full registration, listing, and NDC requirements.

If you acquire or sell a drug manufacturing business: the drug establishment registration must be updated within 30 days of the sale; the drug listing must reflect any change in labeler. Failure to update leaves the seller's registration in place and creates regulatory ambiguity about who is responsible for compliance. The due diligence checklist for pharmaceutical M&A should include verification of current FDA registration status and confirmation of the transition plan for registration updates.

If you manage a health information system or pharmacy benefit: the NDC database is the authoritative source for drug product identification. NDC codes can change when a product is reformulated, repackaged, or acquired by a new labeler — a drug that was NDC 12345-0001-01 may become 98765-0001-01 under new ownership with no change to the physical product. Build your systems to handle NDC changes and maintain historical NDC-to-product mapping for retrospective claims analysis.

Statutory Authority

This rule implements:

• 21 U.S.C. § 360 (FDCA § 510) — establishment registration and drug listing requirements; prohibits manufacturing, preparing, propagating, compounding, or processing drugs without registration; authorizes FDA to inspect registered establishments; requires annual drug listing
• 42 U.S.C. § 262 (PHS Act § 351) — biologics licensure; biological products subject to Part 207 registration requirements in addition to BLA licensure requirements
• 21 U.S.C. § 331 (FDCA § 301) — prohibited acts; failure to register is a prohibited act subjecting the facility to import alerts, injunctions, and criminal prosecution

Recent Rulemakings

2016 Final Rule (81 FR 60212, September 2016): major reorganization and modernization of Part 207, converting it from a paper-based to all-electronic submission system; established the current SPL-based electronic drug registration and listing framework; clarified foreign establishment registration requirements; updated exemptions to reflect compounding pharmacy law changes under the Drug Quality and Security Act (DQSA) of 2013.

2021 Amendment (86 FR 17061, March 2021): technical corrections and updates to listing content requirements, particularly around inactive ingredient reporting and labeling cross-references.

2026 NDC Amendment (91 FR 10770, March 5, 2026): updated § 207.33 NDC format requirements; clarified listing obligations for new drug product categories including certain software-regulated products; revised guidance on multi-ingredient product NDC assignment.

Pending Action