FDA Drug Establishment Registration

FDA Drug Establishment Registration is a mandatory requirement governed by the U.S. Food and Drug Administration (FDA). All entities involved in the manufacturing, repackaging, relabeling, or distribution of pharmaceutical products must register their facilities with the FDA before legally marketing their products in the United States.

This requirement applies to a wide range of drug categories, including:

Prescription Drugs
Generic Drugs
Over-the-Counter (OTC) Medications

By completing the FDA Drug Establishment Registration, companies demonstrate their commitment to regulatory compliance and public health standards. It is essential to work with experienced FDA consultants to ensure that the registration process is completed accurately, efficiently, and in alignment with current regulatory expectations.

Why Is Drug Establishment Registration Important?

Ensures that drug manufacturing and handling facilities are compliant with FDA regulations and Good Manufacturing Practices (GMP).
Enables the FDA to inspect and monitor facilities to ensure product safety, quality, and effectiveness.
Is a prerequisite for legally importing and marketing pharmaceutical products in the U.S. market.
Applies to both domestic and foreign establishments, unless explicitly exempt under FDA regulations.

Types of FDA Drug Establishments

Drug establishments play a critical role in the pharmaceutical supply chain, and the U.S. Food and Drug Administration (FDA) categorizes them based on their operational functions. Below are the primary types of drug establishments regulated by the FDA:

New Drug Application (NDA) Holders – Manufacturers of pioneer or innovator drugs.
Abbreviated New Drug Application (ANDA) Holders – Manufacturers of generic versions of previously approved drugs.
Over-the-Counter (OTC) Drug Manufacturers – Producers of drugs that do not require a prescription and are considered Generally Recognized as Safe and Effective (GRASE).
Homeopathic Drug Manufacturers – Entities producing homeopathic remedies listed in the HPUS (Homeopathic Pharmacopoeia of the United States).
Contract Testing Laboratories – Facilities conducting quality control, stability, or bioequivalence testing.
Sterilization and Packaging Facilities – Establishments responsible for terminal sterilization or final packaging of pharmaceutical products.

Regulatory Pathways for Different Drug Type

NDA/ANDA: For new or generic drug products, firms must file an NDA or ANDA, respectively, to gain market approval from the FDA.
OTC Drugs: Many OTC drugs follow the OTC Monograph system, allowing direct registration and listing without an NDA/ANDA. These drugs must comply with established formulation and labeling standards.
Homeopathic Drugs: Products listed in the HPUS that meet the FDA’s Compliance Policy Guide (CPG) may be marketed without premarket approval, though registration and listing remain mandatory.

FDA Drug Establishment Registration Process

Any company intending to manufacture, repackage, relabel, test, or distribute drugs in the United States must complete FDA drug establishment registration. This process must be completed online via the FDA’s Electronic Submissions Gateway (ESG).

Important Note: The FDA does not provide assistance or troubleshooting for companies completing their own registrations. Incomplete, inaccurate, or improperly formatted submissions may result in delays or rejection.

Due to the complexity of submitting Structured Product Labeling (SPL), managing NDC numbers, completing listings, and maintaining annual renewals, it is strongly recommended that companies work with experienced FDA regulatory consultants or agents. These professionals can streamline the registration process, reduce errors, and ensure compliance with all FDA requirements.

U.S. National Drug Code (NDC Code)

The National Drug Code (NDC) is a unique product identifier used for all human drugs marketed in the United States. It consists of a standardized 10-digit, three-segment number that serves as the official identifier for prescription and over-the-counter (OTC) drug products.

Also known as the NDC labeler code, this number is mandatory on all FDA-registered drug labels and plays a key role in drug listing, distribution, insurance claims, and inventory tracking.

Structure of the NDC Code

The three segments of an NDC number identify:

Labeler Code – Assigned by the FDA to identify the manufacturer, repacker, or distributor.
Product Code – Specifies the particular strength, dosage form, and formulation of the drug.
Package Code – Indicates package size and type (e.g., bottle, blister pack, carton).

Example Format: 12345-6789-01
Note: In some cases, the NDC may be displayed in an 11-digit format for billing and reimbursement.