There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates to maintain an accurate and current status:
Establishment registration
Labeler code
Drug product listing(s)
FDA has adopted extensible markup language (XML) files in the structured product labeling (SPL) format for users to submit registration and listing data. Users may transmit the SPL-formatted submission through FDA’s electronic submission gateway (ESG).
Tools for registration and listing submissions
Any SPL authoring software may be used to create registration and listing SPL files including CDER Direct and Xforms. Xforms and other third-party tools used to create SPL files require the creation of a FDA WebTrader account in order to submit the files. All registration and listing submissions, regardless of the source and tool used to create and submit, must pass the same rigorous set of validation rules.
Do I need to register?
Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drug products for U.S. distribution is required to register with FDA. Some exemptions include:
Pharmacies that:
Operate in conformance with local laws regulating the practice of pharmacy and medicine
Regularly engage in dispensing prescription drugs to fill patients’ prescriptions
Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their business of dispensing or selling drugs at retail
Hospitals, clinics, other health care entities and public health agencies that:
Operate establishments in conformance with all applicable local laws regulating the practice of pharmacy and medicine
Regularly engage in dispensing prescription drugs upon a valid order or prescription
Do not manufacture, repack, relabel or salvage drugs other than in the regular course of their practice of pharmacy, including dispensing
Licensed practitioners who prescribe or administer drugs and who manufacture, repack, relabel or salvage drugs for use only in their professional practice
Companies or individuals that manufacture, repack, relabel or salvage drugs solely for use in research, teaching or chemical analysis and not for sale
Manufacturers, repackers and relabelers of certain inactive ingredients such as excipients, colorings, flavorings, emulsifiers, lubricants, preservatives or solvents that become components of drugs
Carriers in their receipt, carriage, holding or delivery of drugs in their usual course of business
Storage facilities that do not perform any manufacturing function
When to register?
Registration is required within five days of introducing drugs into commercial distribution. Annual registration renewal must occur between October 1 and December 31 each year.
Registration process
Create and submit an establishment registration SPL document to register with FDA. Be sure to save a copy of your submission. Remember to include:
The name and Dun and Bradstreet verification, or Data Universal Numbering System (DUNS) number of the establishment (not one linked to the corporate headquarters)
Contact information of someone responsible for receiving FDA communications related to that establishment
All applicable business operations that establishment performs
For foreign establishments, the name and DUNS of a U.S. ...
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