Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability 
2019-965 CDER Guidance for Industry Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research OPEN
2020-09-23 2020-07-24 2020-07-23 2020-07-31 2020-08-26 2020-10-19 2020-09-21 2023-01-26 2020-08-24 2020-07-24
FDA-2020-D-1079-0046 FDA-2020-D-1079-0008 FDA-2020-D-1079-0007 FDA-2020-D-1079-0013 FDA-2020-D-1079-0022 FDA-2020-D-1079-0061 FDA-2020-D-1079-0034 FDA-2020-D-1079-0065 FDA-2020-D-1079-0020 FDA-2020-D-1079-0009
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https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0046 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0008 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0007 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0013 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0022 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0061 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0034 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0065 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0020 https://api.regulations.gov/v4/comments/FDA-2020-D-1079-0009
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Cannabis Varieties and Sources Hemp or Cannabis Sativa has been used for generations to provide relief for a variety of reasons. The cannabinoids found in the plant are now available for more research with the prohibition lifted. Many natural products have been found to be beneficial. Cannabis in particular has never been found to be harmful to consume. Where the trouble comes is with additives. The big vape problem was caused by the cheap vitamin E oil being used. We do need fair and reasonable regulation for the production and sale of cannabis products to keep consumers safe. What we dont need is the misinformation and false statements that lead people to believe that cannabis can be harmful.Please treat cannabis as you would any natural plant.This is a great resource for fiber, food, and relief. The uncertainty and fear is limiting the growth of this emerging industry.Lets get on with it and provide clear guidance for the health and safety of our consumers and the economy! https://patents.google.com/patent/US6630507B1/enHHS shall keep that patent ownership, and license the right (so long as the products are compliant) to make the claims of those specific benefits.The plant itself (in my opinion) needs to remain schedule 1 and ONLY the Products developed from shall be approved for therapies/supplements.But cannabis products are the best first step towards transitioning into Botanical Medicine. Next Catha Edulis Psilocybin  As stated, calculating the amount of a substance in a botanical raw material by dry weight is a standard procedure. However, the calculation of dry weight for an extract or solid oral dosage form is less familiar to many stakeholders than the standard calculation for botanical raw materials. Therefore, the draft guidance recommends calculating delta-9 THC by dry weight in intermediates and drug products by removing the water content, including water contained in excipients. We invite comment from the public on this recommended approach. In addition, FDA invites public comment on the appropriate manufacturing controls over materials that cross under the 0.3 percent delta-9 THC by dry weight threshold during the production of a drug that contains cannabis or cannabis derived compounds.  With respect to the manufacturing controls being contemplated, are contingencies being considered should the federal classification of these substances change? Just one more way for the government to say gotcha. One more reason to arrest and murder people over a damn plant.  I agree with DEAs ruling that CBD Production Process needs to be regulated. Most of the CBD hemp Extraction Processes generate a crude extract which may contain as high as 5% THC. Some of the producers conduct a molecular distillation followed by crystallization/precipitation to make CBD Isolate. Then they are left with a mother liquor which has as much 10-15% THC. Currently these products are instead of being destroyed are being sold in the market under the label Legal Hemp Extract. This should not happen and DEA should not let it happen. There are existing technologies which isolate THC from hemp extracts at an early stage and destroy the THC or make it unusable. ...similar to making alcohol denatured. DEA and the entire Hemp Industry should seriously consider implementing these technologies across the hemp landscape in USA. This will obviate the need to monitor regulatory compliance. It will be built into teh process.If DEA wants more information please reach out to me. I have worked in the chemical processing industry for over 40 years. and have around 100 Patents on various innovative processs. Thanks and Kind Regards....Anil Oroskar I am an American cannabis researcher contributing to cannabis education, and it would truly be a dream to be able to start taking American cannabis research seriously. As of now, I have to look to other countries for reliable cannabis information.Without proper cannabis samples, how are current American scientists expected to produce quality studies, much less medicine to help anyone? Does the US ever want to contribute to cannabis medicine and help its people, or just sit on the sidelines while other countries reap all the benefits?We are already very far behind, and it is time to start catching up. Just deschedule it. CBD  THC have been life saving medicines that has allowed me to work full time  regain my independence without having to live off welfare even tho I totally qualify. Why dont you guys spend time cracking down on fentanyl and pharmaceutical companies? Leave hemp and CBD alone you buttholes. You are trash and wasting tax payer money on bullshit. Before the FDA rules on this matter, the FDA should redefine how patients obtain medical marijuana prescriptions.  At present, it is easy for any adult to obtain the papers necessary to allow them to buy marijuana for medicinal purposes.  The patients should be required to have a written prescription from a physician with a brick-and-mortar office address, and the prescription should contain the physicians name, office address, and his medical license number.  Additionally, the prescription should say what condition the marijuana is treating.  The prescription should have an end date by which the patient would need a new prescription.  The FDA may wish to limit the types of conditions that can be treated with marijuana.  Otherwise, many adults who do not have a medical need for marijuana will be able to buy it, as they currently are able to do.  Not only is this situation skirting the law, but it is also denying tax revenue to the cities and counties that have legalized marijuana for added revenue, since there is no sales tax collected from sales of medical marijuana.