FDA Registration Process
In our continuing efforts to keep our distributors up to date and in compliance with all regulatory issues currently affecting our industry, we have added this FDA section to our web site to assist you in understanding the requirements of the Food and Drug Administration.
ABC Compounding is an authorized
FDA establishment. This means that all of our formulas and labels which fall under the auspices of the FDA, such as antibacterial hand soaps and sanitizers, are in compliance with current FDA regulations (21 CFR Parts 201, 207, and 211).
All FDA regulated products require that the company depicted on the label as the manufacturer and/or distributor must have a labeler code (FDA #). Once this code has been obtained it identifies that company on all of its FDA products regardless of the particular product or the particular vendor. As a service to our private labeling distributors, ABC has always obtained this number for our distributors if they did not already have one. Once obtained, this number is the distributor’s and can be used with any vendor the distributor chooses.
Effective in June 2009, per the FDA Amendments Act of 2007, labeler codes can no longer be obtained without the company supplying its Dun and Bradstreet number (DUNS). If you are applying for a labeler code for the first time or are applying for a new FDA product, even if you have an existing labeler code, your DUNS number must be supplied to the FDA to obtain authorization.
If you currently have a DUNS number then we will simply ask you to supply this to us when private labeling an FDA product for the first time. If you do not have a DUNS number we have supplied below the necessary link to Dun and Bradstreet to assist you in obtaining your company's DUNS number. There is no charge to obtain this number, and the application is simple and brief. DUNS Numbers can be obtained through D&B using the basic service (no cost) http://www.dnbgov.com/federal_compliance/
fda/DUNSrequest/requestGuide.html or using the expedited service (nominal fee) at http://www.dnbgov.com/federal_compliance/fda/DUNSrequest/
Some things to look for to assure that your competitor's FDA products as well as your own comply with FDA regulations are:
- Look for a "Drug Facts" box on the label with an active ingredient statement.
- Make sure the manufacturer of the product has a Drug Establishment Registration number identifying the establishment as an FDA-approved facility.
- Make sure each product has a Drug Listing number identifying the product as an FDA-listed product.
- Ask the manufacturer for the product efficacy data.
If you have any questions regarding this process please contact our customer service department for clarification.