DEA Lab Registration

Hey all,

With the release of the final ruling by USDA I feel in the future it may be necessary for my lab to go ahead and register with the DEA.

Our lab works as an internal QC measure for a manufacturing facility for hemp extraction in CO. Our typical sample load involves mainly testing extracts produced by the facility, and also hemp biomass entering the process. Occasionally we are testing formulations that may be sold to an external client. All samples are always tested third party (ISO-17025) before sale as we cannot have the wolves watching the hen house. We do not accept fee for service external samples.

From the USDA final ruling:

“AMS is retaining the requirement in this final rule that any laboratory testing hemp for purposes of regulatory compliance must be registered with DEA to conduct chemical analysis of controlled substances in accordance with 21 CFR 1301.13. This requirement also applies to any laboratory testing hemp throughout the growing season to informally monitor THC concentration.”

The “any laboratory testing hemp throughout the growing season to informally monitor THC concentration.” part is what I think will end up applying to my lab. I realize this ruling has no specific intention for hemp processors, and even though we are strictly internal I think it may be better to play this safe. The biggest concern from the DEA is that we may end up testing some material with a THC >0.3% which happens on occasion.

I am struggling with whether or this will be necessary for our lab or other laboratories like it. A big part of the DEA registration is reporting results back to the USDA with the license holder information, but this seems to be aimed at growers and not manufactures. Currently all our licenses for hemp extraction/manufacturing are held at a state level and there does not seem to be a clear direction given by the USDA in regards to this aspect of the pipeline.

I realize this requirement is not active until Fall 2022, but I wanted to see how others in the testing space felt about this. Hopefully THC will be rescheduled before the enforcement date rolls around, but if not I do not want to be scrambling at the last minute and flying under the radar is unfortunately not an option for us.

Would love to hear thoughts on this and if anyone has gone through the registration process I would love to know of any hiccups so we can be well prepared.

I think this is gonna be the important part. If your manufacturing facility is using your tests as part of regulatory compliance then yes, you will have to be DEA registeted. However if you’re only testing for internal QC purposes and everything is verified by 3rd party, then as long as your 3rd party is registered, you’re good.

That’s how it reads to me but IANAL so take it for what it’s worth.

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Basically this says since you could possibly be testing a schedule 1 you have to register with the DEA (hot hemp is a controlled substance) this is how the farm bill gives testing labs protection when dealing with a schedule 1 substance derived from hemp

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And that would be okay. Once you are registered with the DEA - even if you had hot stuff, you would be covered. You’d let them and the state know what happened and the normal process for handling “hot” materials would start. Its state specific, but to get the DEA license you’ll have to have already thought through that process, how you are going to handle it, and how you will store it - since everything you store will be Schedule I until proven otherwise.

DEA registration is not easy. I have yet to successfully do this in the cannabis/hemp sphere. I have friends who have been trying to do this for over a year, and still not been successful. Most of the licensed labs were existing drug testing facilities or pharma facilities.

I say this so you are prepared for what you are looking at. I think @mcpikeig may be correct that if you are doing in-house in-process testing you might not need to do anything. However - if you are using these tests to show compliance or to support your case saying you are not “negligently” creating hot hemp - that you’d want to make sure that was a licensed facility.

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Thank you for your response. We do currently have SOPs regarding the disposal of hot material, controlled storage, and handling. I am sure these would need some review before submittal as only the disposal SOP was targeted towards a schedule 1 drug.

We only use the tests for internal controls but I am concerned that we would be working in a grey area. We may as well play it safe.

Thank you for your information regarding timeline as we (naively) thought it would be a more streamlined process.

Are you really destroying your hot products and not further processing them into something of value that is compliant?

Not on a large scale.

We receive samples of biomass before they are allowed to enter the facility. While we require third party testing from the farmers, we also test in house to ensure there is nothing shady going on. If our tests show the hemp is hot, we do not allow the hemp to enter the facility. The only thing destroyed at this point is the sample which is mixed with ground corn leaves.

Hot material coming from the manufacturing side is either being remediated with a further processing step or diluted into a final retail good where the levels go to ND.

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Thanks for clarifying, I was a little concerned for a moment you were throwing away a bunch of money.

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