Certificates of Free Sale Availability

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Wednesday, January 23, 2013

Several countries are requiring excipient suppliers to supply Certificates before they will allow the excipients to be imported into the country.  Certificates typically requested are  Certificates of Free Sale, Certificates of Export, Health Certificates, and GMP Certificates to name a few.  The certificates all require a government agency (e.g. U.S. Food & Drug Administration or U.S. Department of Agriculture) to certify that the excipient manufacturer and/or the excipient product meets pharmaceutical regulatory requirements or the provisions with respect to these types of certification.  In the U.S., neither the U.S. FDA nor the USDA routinely conduct regulatory inspections, registration or certification of excipient facilities, and therefore, will not issue certificates which meet these types of regulatory or trade requirements.

The US FDA issues a "Certificate of Free Sale" for food materials including dietary supplements, and for cosmetics products.  They also issue "Certificate of a Pharmaceutical Product" for Active Pharmaceutical Ingredients, and finished drug products.  However, excipients are not covered by the “Certificate of Free Sale” or by the "Certificate of a Pharmaceutical Product" program.  The US FDA does not offer any type of certificate for excipient products. The FDA clearly answers the question about issuing Certificate of Pharmaceutical Product (CPP) for excipients in:

“CDER Export Certificate Program Frequently Asked Questions (FAQs)” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/UCM318409.pdf

Q. Does FDA issue CPPs for excipients?
A. No. CCPs are not issued for excipients.

The US government and most states do not offer Certification for excipients, therefore the excipient industry provides self-affirmation that they meet the required regulatory requirements for sale of excipients into drug applications.  

Click to access a representative template for the Free Sale and GMP certification for companies to use. Click here to access this information in one PDF file on IPEC-Americas letterhead.