In addition, the API must be used only in the manufacture of such new drug limited to investigational use as provided under the IND regulations. 21 C.F.R. § 201.122(b). The importer must provide information on this intended use to FDA at the time of import and, if the clinical trial is to be conducted under an IND, the IND number must be provided.

The contract manufacturer provided an end-use letter that stated the acetaminophen would be further manufactured into over-the-counter drug products, and identified one of the brands that would be manufactured from the bulk product. The bulk acetaminophen, as proposed for import, had been labeled with the statement, “Caution: For manufacturing, processing, or repacking” in accordance with 21 C.F.R. § 201.122. In addition, the ultimate customer of the contract manufacturer also contacted the FDA prior to the refusal.

This allegation was apparently incorrect, as the Chinese facility was a registered establishment. After FDA was notified of this, the Agency then alleged the product lacked adequate directions for use, notwithstanding the fact that the material was not intended for use in humans, was for laboratory testing purposes only, and even if it were a drug for human use, would be subject to the exemption from adequate directions for use for bulk drugs intended for further processing pursuant to 21 C.F.R. § 201.122(c).The products remain detained despite Amphastar notifying FDA of these issues.