Question: Would like references/recommendations to online continuing education, for learning more about PGAs, in particular, FDA, EPA? Answer 1: Global Training Center has PGA foundations eLearning course (including FDA and EPA) that will be available starting August 1, 2025. Our website link for OnDemand – https://globaltrainingcenter.com/elearning-classes/. Please take a look at our website and let […]
Question: We have a vaccine with an FDA approved BLA. The documentation approves a specific strain of the vaccine. We are working on two strains. We were importing samples of the vaccine for testing and clinical trials under a USDA Permit. Now that the vaccine is FDA approved, per USDA regs, we can import the […]
Question: Has the trade community that uses the FedEx Memphis Hub noticed a delay in having their shipments examined and released? We have had several shipments on hold for over 2 weeks. No one from Ag is responding to our broker either by phone or email. Answer 1: Yes, I finally found a shipment that […]
Question: Can anyone point me in the direction of USDA regs that pertain to importing into the US? Also need guidance on where to find USDA definitions and explanations for different terms. In the context of USDA Permits, what does “Commercial” mean and what does “Research” mean? Is a vaccine a pharmaceutical drug in the eyes […]
Question: Does anyone have a strong opinion on this decision? I would think the government agencies such as EPA, FDA, etc. could be significantly impacted by this decision. Does anyone foresee turmoil in the future of trade compliance? Answer 1: I think it cuts both ways. I think there are fewer enforcement actions and agreements, […]
Question: Do any members have experience with Project Shield America, an Outreach Program from ICE / Homeland Security Investigations? If so, what has this experience been like? Is there benefit from engaging with the regulators in this program / receiving the visit and presentation materials? Are there downsides or risks? Is this sometimes a precursor […]
Question: We import material that requires a USDA Permit. We have an R&D Permit and we have a Commercial Permit. The material that is imported are samples from production batches that will be sold commercially. These samples are tested for purification, toxicity, quality etc. So, I would not consider them to be R&D because the […]
Question: Does anyone have a USDA decision tree to help trade compliance specialists determine if an imported item needs a USDA Permit or if a GS is sufficient? Answer 1: https://efile.aphis.usda.gov/s/vs-permitting-assistant Hope this helps.
Question: My company imports Reagents and Certified Reference materials which are antibodies developed in Mouse, Rabbit, Human, Alpaca and Llama to detect certain Protein Receptor Binding Domain (RCB). We are importing under HTSUS 3822.90.0000. The OGA flags FD1 & AQ1. It has been suggested that we need to include a USDA Guideline statement (1120 or […]
Question: We are reviewing the requirements for labeling a product as “Made in the USA”. US Customs addresses waste/recovered products in the definitions under 102.1 but I do not see where the FTC addresses this in the regs under title 16 for made in the USA labeling. They specifically address recycling oil but do not […]
Question: We are importing a saline solution placebo composed of .9% sodium chloride, minute amounts of hydrochloric acid and sodium hydroxide in 99.1% water. This is to mimic the experience of an injectable medicine. We are trying to determine the most appropriate HS Code to use. We considered 2106.90.9998 but figured that this is usually […]
Question: Can anyone explain the difference between Customs Release and FDA Release? Can a shipment that has been released by US Customs be moved to the final delivery site or to an interim location until FDA Release has been received? Keep in mind that the goods would be put into a location of the warehouse […]
