The Who, What, Why, When and How for Registering New Drugs

In the US, there are registration and listing requirements for new drugs going into clinical trials and the companies that manufacture these drugs.  Do you know if these requirements apply to your company and new investigational drug? To find you, you may look into the Code of Federal Regulations (the CFR) and in the Guidance for Industry that the FDA has made publicly available.  But these on-line resources are very exhaustive, content rich and extremely detailed. 

For a more hands-on approach, we suggest you contact the FDA’s Drug Registration and Listing System Team who are a very helpful resource to help you understand requirements specific to your unique situation and will walk you through the process if deemed necessary.

To this end, we wanted to provide you with the nuts and bolts of the requirements.

Why

  • Drug safety - Electronic listing database include comprehensive information on drug products that can include:
  1. Active pharmaceutical processing
  2. Drugs that requiring further processing
  3. Drugs manufactured exclusively for a private label distributor
  4. Drugs marketed solely as part of a kit or inner layer of a multi-level packaged product not marketed individually.
  • Companies who don’t follow the drug registration and listing process are sent FDA warning letters to resolve the issue. This is a situation you want to avoid.

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Who

  • Business operations who participate in the manufacturing or processing of a human drug.
  • Business operations that have their drug enter into US commercial distribution after being manufactured or processed.

 

What

  • Active pharmaceutical ingredients or other unfinished drugs that require further processing, labeling, or packaging
  • Prescription drugs, whether or not the subject of an approved new drug application
  • Over-the-Counter (OTC) drugs, whether or not the subject of an approved application
  • Homeopathic drugs

 

When

  • Initial submission must be completed within 5 days of beginning to manufacture a drug for commercial distribution
  • All registered firms must renew their registration between Oct 1st and Dec 31st of each year by either updating previously submitted information, or certifying that no changes in registration have occurred.

 

How

  • FDA discontinued the use of paper submission in Jan 2009.
  • Businesses must register and list all products electronically using the Structured Product Labeling 

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