Drug Establishment Registration For US FDA
Unless exempted by law, all drug manufacturers must complete the US FDA Drug Establishment Registration before they can be marketed in the USA. This is applicable for Generic, Prescription, and OTC drugs, both domestic and foreign import.
US FDA Drug Establishment Registration Types
- New or pioneer drugs (NDAs),
- Generic copies of the new pioneer drugs (ANDAs),
- OTC drugs
- Homeopathic drugs
- Drug testing labs
- Sterilization facilities etc.
To obtain product DRUG approval, a firm must submit a New Drug Application (NDA), or an Abbreviated New Drug Application (ANDA) to the FDA. For OTC drugs, direct registration and listing are possible.
Drugs sold over the counter without prescription are called Over-the-counter (OTC) drugs. OTC drugs are classified under ‘Generally Recognized as Safe and Effective’ (GRASE) and are exempted from pre-market approval such as ANDA or NDA.
OTC monograph details about what active ingredients may be used, at what level, and for what intended uses in the drug formulation.
Homeopathic drugs covered in HPUSP that comply with the FDA’s homeopathic drug Compliance Policy Guide (CPG) also do not require FDA approval before they are marketed. Homeopathic drugs must also be registered and listed.
US FDA Drug Establishment Registration Online
If you are planning to market drugs in the USA, it is mandatory to complete US FDA drug establishment registration. It can be completed online, but FDA won’t help you complete the registration, and it will not tell you what went wrong or where you have filled incorrect details.
US FDA Drug Establishment Registration Process
1. Identify the drug and route of approval.
2. How Important is DUNS number?
3. Appoint US FDA Agent
4. NDC number request with FDA
5. SPL Preparation & Submission.
6. Update SPL, NDC Number and complete US FDA Drug Establishment Registration
7. Complete Drug Listing
National Drug Code (NDC Code)
The National Drug Code (NDC) is universal product identifier for human drugs in the United States by unique 10-digit, 3-segment numbering system. This is also called as NDC labeler code which is present on all non prescription (OTC) and prescription drugs.
The 3 segments of the NDC number identify the
- Labeler / Manufacturer
- Drug ,
- Commercial package size.
Frequently Asked Questions
What is FDA FEI Number Application?
FDA FEI number is an unique identification number issued by the FDA to track inspections of the registered drug facilities. FEI numbers are also used to track GDUFA facility fee payments. FEI number is not for registrants, it is for FDA’s official purpose, therefore all facilities registered with the FDA are not eligible for FEI number immediately after registration. In case if any of the registered firm need, they need to request the FDA Application. Contact Us for guidance and support on this topic.
What is the role of Agent in US FDA Drug Establishment Registration & Listing?
- Act as representative on-behalf of the foreign facility
- Communicate with the FDA & Owner/Operator of the foreign facility
What is Electronic Drug Registration and Listing (E-DRLS)
Section 510 of the Act and 21 CFR part 207, requires establishment owner/operator in the manufacture of any formulation for use in human or veterinary drugs, to register their drug establishments and submit listing information for all drugs in commercial distribution.
Every year before December 31, the owner/operator should re-submit registration and listing information with the FDA even if no marketing activities are continued.
Who is required to SELF IDENTIFY?
- Human generic drug and active pharmaceutical ingredient manufacturers
- Finished Dosage manufacturers
- Facilities involved in packaging and labeling of drugs
- Bioequivalence study centers
What is Drug Listing? Is it necessary for all Drug Facilities to be registered with the FDA?
Listing NOT mandatory for API, Laboratories etc.