What is FDA Drug Establishment Registration?
Every chemical component used as a medicine is considered as a drug under US FDA regulation. This could be used for local application or for oral consumption, or for intravenous usage. It could be for human use or animal use. FDA Drug Facility is any establishment that manufactures, repackages, or re-labels drug products in the United States or foreign location
Who needs to register?
Any company that manufactures, repackages, or re-labels drug products in the United States must register with FDA. The company could be of domestic or foreign origin. Both domestic and foreign establishments must register with FDA. These drug products could be for animal use or human use.
Unless Exempted by law all drug manufactures (Like OTC Drug , Prescription Drugs, Generic Drugs, API, Compounding Drug, Sterilization Facilities, Testing Labs ) must complete FDA Establishment registration within 5 days of beginning of operations.
In Addition to Establishment Registration facilities are required to list their drugs with FDA and this listing needs to be renewed every year before 31st December
How to Register?
The minimum information needed while registering will be:
- Name of establishment(s) manufacturing or processing the listed drug and the type of operation(s) performed.
- DEA schedule.
- Route(s) of administration.
- Inactive ingredients.
- Marketing information
- Information related to the application or OTC monograph citation number Package size and type.
- Flavor, Color, Active Ingredients.
Electronic Drug Listing (EDL) in the FDA database will also need SPLs
The Structured Product Labelling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
In addition to this, the application needs:
- Unique Ingredient Identifiers (UNII)
- Data Universal Numbering System (D-U-N-S®) Number
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