Question: We are importing fully released, CBER-approved commercial lots to use in Clinical Trials. Are approved vaccines used in clinical trials considered to be investigation new drugs? Do we need to meet the labeling requirements of 312.6 (“Caution: For clinical trial use only”) even though this is a fully released, CBER-approved commercial lots because the […]
Question: I had submitted a question regarding the FDA Product Code PHN and asked for examples of what this meant. I received a helpful answer – “Diluents, solvents used in manufacturing, flavoring used in medications, preservatives.”I have a follow up question(s): what if the buffer is being imported for lab testing purposes. The buffer does […]
Question: Can anyone tell me the definition of PHN? What is an example of a PHN? Answer 1: Diluents, solvents used in manufacturing, flavoring used in medications, preservatives.
Question: My company occasionally imports non-medical equipment that flags for FDA (laser printers, touch screens, etc). These are not typically purchased directly from the manufacturer, but as part of a bigger package. Is the “manufacturer” information that is reported to Customs the name-brand manufacturer? Or is it expected to be the small, possibly sub-contracted factory […]
Question: We are importing a commercial vaccine to and sending it to another company where it will be used as a comparator in a clinical trial that other company is running. Do we need to import the comparator and declare it to the FDA with the intended as clinical trial and import it under the […]
Question: Three-part question Can anyone explain the difference between FDA Hold and FDA Detained? Is there an FDA Glossary available online somewhere? Is an FDA approved drug or vaccine imported for use as a comparator in a clinical trial sponsored by another party also considered an investigational drug and should it be imported under the […]
Question: I’ve searched the FDA regulations and resources and cannot locate a definition for “further processing” or “further processed”. Looking for a clear definition and also example listing of what meets (i.e. sterilization, manufacture, package/label, etc.). Was hoping someone might be able to provide resource links or details. Thank you! Answer 1: According to Regulatory […]
Question: We import finished pharmaceutical products. Sometimes the API supplier changes for the drug we are importing from lot to lot. Thus, it is possible that there could be 2 lines on the entry for the same product, that have different API suppliers. Our current broker links a single API supplier to our part number […]
Question: I am interested in which FDA Product Code pharma and life sciences importers use for vials of saline placebo to be used in clinical trials of vaccines. I have been on the FDA Product Code Builder site and cannot seem to find it under Industry Codes 57 or 60-66 Answer 1: I would classify […]
Question: In the audit of an entry, it was discovered that an incorrect HTS#6913.90.1000 was transmitted to CBP and the shipment was released from CBP. After the fact and after Customs duty was paid, our compliance department determined the correct HTS#6912.00.4500 ceramic mugs should have been claimed. While we can do a PSC with CBP, […]
Question: Hello, I work for a Biotech company and our finished product is temperature controlled and we are looking at contingency plans for a potential FDA Hold. If the product is not removed from its temp controlled packaging and moved into proper storage it could potentially cause an excursion and product could be invalided. Per […]
Question: For all of you TC people in pharma and life sciences with product regulated by the FDA, who in your company makes the FDA Product Code and FDA Intended Use Code determinations. This is being done by the TC team at my company but no has a science, biology or chemistry background and really […]
