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  1. https://www.ttb.gov/public-guidance/ttb-pg-2020-1a TTB Public Guidance Production of Hand Sanitizer to Address the COVID-19 Pandemic March 26, 2020 TTB G 2020-1A Summary Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance. Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying ed
  2. I think this site covers this really well. http://melniklegal.com/weblog/1380663946_Mobile-Apps-FDA.html Guidance Documents After a regulation is issued, the FDA may determine that it needs to provide stakeholders with more information on how the FDA intends to exert (or decline to exercise, as the case may be) its regulatory authority. The FDA does this through issuing Guidance documents. The FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance
  3. Update, courtesy of the Virginia Distillers Association: as always, please check with your state's regs! Some of this info looks like a repeat but there is indeed updated guidance. Also, as with @InsuranceMan 2.0's mention, please keep any potential insurance liability in mind and proceed at your own risk. I personally have been in touch with state representatives that have assured me their support in our production of this - for whatever it's worth lol! Apologies in advance for any link issues - let me know if you have a problem accessing and I'll re-work them. FDA:
  4. Does anyone know anything more about the tax relief mentioned by DISCUS in this news release? News Statement by Distilled Spirits Council of the United States President Chris Swonger on House Passage of COVID-19 Relief Package Which Includes Critical Tax Waiver for Distillers’ Production of Hand Sanitizer: March 27, 2020 1:36 pm “We are grateful that Congress recognizes the significant contributions of the nation’s distillers in producing hand sanitizer to help fight COVID-19, and for waiving the federal excise tax on these mu
  5. This is confusing but I think we (DSPs) actually have to use USP. The "Technical grade" footnote you mentioned appears in an FDA document titled: "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry" @ https://www.fda.gov/media/136118/download I believe that guidance is for compounders (i.e. pharmacist-controlled) production facilities that do not normally make sanitizer, allowing them to make it with technical grade peroxide: There is a similar but sepa
  6. Here's my guesses - If you use 5% Isopropanol as your denaturant you will have a hard time proofing accurately using normal methods because Iso has a much lower density than ethyl and you've made a mixture. This renders traditionally-calibrated instruments like hydrometers and density meters pretty much useless without a fudge factor of some kind. - If you use formula 40A/40B with denatonium benzoate the application rate is so low (1.7 grams per 100 gallons) that its effect on proof can be ignored safely - Glycerine being much denser than ethyl will have an obscuring effect on the
  7. Bluestar, I will copy paste an email I have with Discus attorney below. I don't think you have to use a notation on a. finished package of sanitizer. Only if your selling alcohol to someone else to make sanitizer. Convoluted and not my interpretation, but see from Discus below. My message: Subject: Re: COVID-19 Hand Sanitizer: Updated FDA Guidance Documents Date: April 18, 2020 at 10:46:32 AM CDT Joe, We are blasting away at sanitizer, thanks for all the guidance. I do have a question about labeling when we use less than 189.8 p
  8. Personal Comments I want to say a few personal things before saying anything more on this thread. i think the observations are germane to the issues. I post here in sterile terms. This, I say, is what I think the regulations say. It seems officious. Bureaucratic. Uncaring. It is "i" dotting and "t" crossing in a time of public need and social upheaval. Where is the perspective? So, I want to offer a little personal, hopefully humane, perspective before getting back to the officious. It begins with some observations on which I will not elaborate. Bureaucracies do not
  9. Here we go again. from TTB's newsletter today:: EXTENSION OF HAND SANITIZER GUIDANCE On March 26, 2020, TTB issued guidance providing certain exemptions and waivers to distilled spirits permittees to facilitate the production of alcohol-based hand sanitizers, see TTB G 2020-1A, Production of Hand Sanitizer to Address the COVID 19 Pandemic. On March 27, 2020, the CARES Act was signed into law, providing for additional flexibility with regard to removals of distilled spirits free of tax for use in or contained in hand sanitizer that is produced and distributed in a manner c
  10. I reached out to the DISCUS email Covid-19 hotline regarding the sales of hand sanitizer and their response to me was "there is no specific guidance that would prevent you from selling the hand sanitizer." I know their word is far from the final word on the topic so take however you feel necessary.
  11. This sanitizer business sucks. At first I did not expect that flood of demand, so I had not purchased enough supplies. When I went back to reorder, they were out and back-ordered. Then I had to scramble to find containers and parts to meet the demand. That required re-pricing and retooling the process. Then those ran out and I had to use different containers. Now with my distillery stocked and the process of efficient production implemented, the demand seems to have died. I have noted in social networking a flood of offers for hand sanitizer from various sources. My sense is that the f
  12. As I said somewhere a long time ago in this now too long thread, DISCUS and its likes are better able to deal with this by playing above the rim than a pipsqueak like me is. I'm copying, below, two documents from the Distilled Spirits Council's website. https://www.distilledspirits.org/news/discus-statement-on-u-s-reps-yarmuth-barr-letter-to-fda-commissioner-urging-flexibility-for-distilleries-producing-hand-sanitizer/ One is a letter members of congress have sent to the FDA on this issue. The other is the councils statement on the letter.. It's time to let the big boys play. I
  13. If you think the world is over-reacting to COVID-19 you have not understood the problem. Comparing it to normal flu is irrelevant. You need to compare it to the 1918 Spanish Flu. The only good news so far is that the Chinese have proven that it can be beaten - using basically the same techniques that worked in 1918 and against SARS. If you are prepared to invest half an hour into understanding the process and the risks we face, have a read through this article. Our problem in the west is that we rank personal freedoms above those of the group and this makes it more difficult for us to imp
  14. Greetings! I'm an independent spirits bottler in Berkeley, California and am trying to do some research on the best way for craft producers to navigate the hurdles involved in in hand sanitizer production. I spoke to two bulk alcohol suppliers today who were not able to reassure me about current or continued availability of GNS, especially for new customers and at smaller quantities (~1000 liters). From the bulk supplier's point of view, the supply chain supporting large manufacturers is more efficient at distributing this needed resource. This opinion was reiterated by someone who r
  15. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Went over this already. Hand sanitizer is regulated by the FDA as a OTC drug. Unless you are licensed as a drug manufacturer and reseller you are treading in dangerous territory. https://www.fda.gov/drugs/information-drug-class/topical-antiseptic-products-hand-sanitizers-and-antibacterial-
  16. https://www.fda.gov/media/136118/download Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present: It's only 9 pages that are easy to read. I didn't even give thought to selling this when reading the thread and just thought it was for own personal/family use. Interesting they give a recipe using 80% alc
  17. I have the sneaky feeling they are doing this by incorrectly reading this section: Look at page 5 of https://www.fda.gov/media/136289/download Footnote 18 & 19 18 Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured in accordance with this guidance (see also FDA guidance for industry Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19); isopropyl alcohol should be used in a concentration between 7
  18. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Unless i'm reading this wrong, it does not say distillers can make hand sanitizer Disclaimer: I have not finished reading it yet.
  19. Further reading: Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. I am not entirely familiar with USP certification or grade. Is what we make USP grade? I'm guessing not. Ethanol, 80% vv denatured according to TTB. If you do not have the checkbox for denaturing operations, you can not legally do this. Mind "The compounder does not
  20. The form on DISCUS may or may not help distilleries connect with vendors looking to help supply necessary ingredients https://www.distilledspirits.org/distillers-responding-to-covid-19/
  21. We are requesting support of an important Economic Impact Study covering the formulation of Hand Sanitizer by Distilleries, Breweries, Wineries and Cider makers in response to COVID-19. With the outbreak of Covid-19, the demand for hand sanitizers sky-rocketed globally. For the U.S. distillery industry, especially entrepreneurial firms in the small and medium scale sector, this presented a tremendous opportunity. According to anecdotal evidence, some entrepreneurs seized the opportunity, moving into the production of sanitizers, and thus helping the society at large. By su
  22. Edit on 23March2020. The information below is out dated due to new guidance and guidelines that have recently changed. I am leaving this post up as current regulation loosening may be temporary. Best to check with the proper authorities for anyone reading this after the covid-19 outbreak passes. Same with us. Those laws and regulations are there for a reason. You wouldn’t trust a distillery to make Baby Asprin, would you? It’s production is regulated no different. As a PROFESSIONAL distiller I am obligated to follow the rules and laws of what I can manufacture and how it’s to be m
  23. Updated FDA Guidence 3/24/20 This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Download full doc below. Et
  24. DISCUS has put together a resource page for distillers here: https://www.distilledspirits.org/distillers-responding-to-covid-19/ Our COVID-19 Hand Sanitizer Connection Portal is a resource for distillers looking to produce hand sanitizer – providing a list of the necessary ingredients and supplies for making sanitizer and identifying distribution methods.. The portal is available for ALL American distillers to access.
  25. TTB Public Guidance Production of Hand Sanitizer to Address the COVID-19 Pandemic March 26, 2020 TTB G 2020-1A Summary Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance. Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the
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