Question: I am seeking guidance on the proper procedure for returning a shipment of controlled substances to the United States. The shipment has already been re-exported to a second country and was not refused. However, we need to import the product back into the US for a legitimate reason (return sample for investigation). We are […]
Question: One of the R&D employees shipped the noted substance to USA. The HTS is triggering DEA. If the quantity is 0.05KGS, can we bypass the prior notice process and issuance of form 486 due to limited quantity? Thank you. Answer 1: List chemical regulations are under 21 CFR part 1310. Imports of (MIBK) destined […]
Question: The company I work for acquired a company that has DEA material. We did not have DEA regulated material previously. The person that was handling compliance for the acquired company is no longer there. It seems our product safety team and business units are handling the majority of the responsibilities. I am looking to […]
Question: Has anyone in the membership filed a disclosure with the DEA? Where can we find information on the process and did the disclosure offer any type of protection against fines/penalties? Background: Company imports a DEA List II-regulated chemical and then sells it to a customer in Canada. It was recently discovered some exports […]
QUESTION: I am new to DEA exports and do not seem to be able to find an answer to my question. I am trying to determine what gets filed for a DEA list chemical below threshold? For example, the material below is on list II (21CFR 1310.02(b)(1)). The regulations and other publications are clear for at or […]
