The Export Reform and Enhancement Act of 1996
Specifically authorized FDA (under 801(e)(4):
- To issue certifications for a drug, animal drug or device being exported that meet specifications under section 801 or 802 of FFDCA
- No authority for foods, cosmetics and animal feeds
- Timeframe: - 20 days to issue
- Cost Recovery: Fees can be collected of up to $175 for each certificate issued - credited to FDA