DrDistillation

You could probably get volunteers if you ask. Use the volunteers to fill bottles, pack boxes, load pallets, move grains/sugars, etc. What ever they can do to assist with little to no training. Let the departments and first responders know you have staffing issues trying to keep up with orders and filling oddball size bottles/containers you aren't normally equipped to fill. Let the hospitals and other emergency contacts know you are short on supplies (ie Hydrogen Peroxide, Glycerol, denaturing agents) and see if they can contribute/trade for finished product. Put the word out!

They don't know what they are talking about! They are looking at things from ONE or TWO perspective and not all the different ways that WHO looks at things. WHO relies on the top agencies and universities around the globe. This formula is nothing new but has been studied and published in 1994 (and many new studies). From the US Army to CDC, FDA & leading medical academics. Same with many other country's experts. Each component is there for a reason in a specific quantity. These people study everything including how much glyserol it takes to keep skin from scaling and how this affects the spread of bacteria vs drying of hands. How the Hydrogen Peroxide bonds with the Ethanol and changes it (for the better), how each component changes evaporation and skin contact time which affects it's effectiveness. How it affects a 1 year old or 90 year old and everything in between including temperature, humidity and climate on skin and spread of virus/bacteria. This WHO formula wasn't just recently put together, but is based on 25+ years of extensive experience from around the globe costing millions upon millions of dollars of testing. Everything is there for a reason regardless of what "one" other test says. It's the accumulation of thousands of independent tests studying multiple different things. Don't mess with the formulation, neither you, your doctor or any one agency knows better. Regardless, you are NOT authorized to produce it any other way then as specified by your federal government, so it's a mute point.

Good tip on the trade name RevolutionSpirits. Maybe another tip for anyone going this route. If you aren't doing large batches like 100 gallons at a time it's going to be harder to measure 1/16 of an ounce (weight, not volume). You could use a gram scale but that's only marginally better since there is 28.3495 grams per ounce. Get a grain scale (like what's used for hand loading bullets and measuring gun powder). There are 437.5 grains per ounce so 27.34 grains per 100 gallons. If mixing up 20 gallons batches of Ethanol to denature you would use 5.47 grains for example. As Bluestar said above, this is the absolute simplest and cheapest method to denature your Ethanol.

I read it as 40A or B without the tert-butanol. "Formula 40A or 40B with or without the tert-butyl alcohol"

Maybe a lot of people are working from home and bored, been thinking of getting into home distilling and now are taking the plunge? Maybe some people are thinking like preppers and don't want to be without alcohol in the future? Maybe it's just the change of seasons... Regardless, glad to hear your sales are strong. That's a good outlook for the economy.

https://www.fda.gov/media/136118/download Dated March 27 1. The hand sanitizer is compounded using only the following ingredients in the preparation of the product: a. (Select one of two options) (1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume ; OR (2) Isopropyl Alcohol

Got ya, reading your post again make sense. Sorry about that.

If the TTB/FDA gives you a waiver to make a SPECIFIC product a SPECIFIC way, what gives you authority to change it? Do you know more than the doctors and scientist? Do you know more then the FDA whom you must register with to produce the product? Do you want to take on full responsibility of the product if it does harm to someone and is produced out of spec? Do you know more then those who have tested it for other safety reasons, like what happens when a 1 year old ingests the product, how it's treated from a poison control standpoint, etc... This is where "common sense" goes out the window. You have no control what/how the product is used after it leaves you. But regulatory bodies study and try to take these things into consideration. If the TTB tells you that you can't produce a product a specific way, do you do it anyway and bottle it? The TTB & FDA are allowing you to produce a new product per an approved recipe without seeking approval. How is it any different? You make the product per the approved cola. You have been given a cola for how to make this product, follow it OR seek out an approved alternative from them. But you can't go rouge and you don't have permission to deviate from it as a DSP standpoint.

It risks people's health when you are producing a santizer from feints which isn't Ethanol but contain other poisons. It matters when you don't use the correct components as they have been tested a specific way for effectiveness. These formulas didn't just pop up out of the blue, but a lot of time was spent back in 93/94 developing them to find out what is minimally needed to be effective. When you agree to make a product per a specification you do just that and don't improvise when people's health and lives are at stake. A lot of consideration goes into things like this, not just effectiveness of killing bacteria/virus but also things like what happens if a 1 year old ingests the product. These any many other things have been thought through by doctors and chemists over the years that many people don't think of. Don't make an inferior product or something that could be dangerous. Do it right or don't do it at all.

Bad advise! Make product per the TTB and FDA or don't make product at all if in the USA. You have a waiver to make a product PER SPEC if you wish, but are not being forced to make it. If you make it, best do it by the book or you risk your bond, DSP license and people's health or death. You are agreeing to the FDA spec when you register with them which is mandated per your bond/license. How anyone can deal with all the normal paper work of running a DSP, but then make this out to be a big deal is beyond me. A half hour of reading two documents and following the proper instructions is not rocket science. It's far easier than bringing any distilled product to market for sure. This is not hard to do if you can follow directions as they give you the formulas to use! If you don't have the proper ingredients or can't follow the directions, then don't make the product, simple as that. But don't encourage people to go rouge. What we don't want or need is people making a product and distributing it that isn't going to work effectively as it could or be dangerous and giving people a false sense of security using a product not designed correctly. Shit, there are well known people on this forum saying they are making sanitizer using feints which isn't 96% Ethanol. It matters! This is an incredible opportunity for DSPs long term, but a few bad apples can ruin this for everyone. Just follow the directions as given (not hard) and be risk free and know you are doing it correct and helping people. There are reasons the formulas are the way they are and why denaturing is required in the USA and many other countries.

Same thought I had. Of course for me in my parts it's Un-Obtainium LOL

Odin someone pointed your thread to me and asked me to comment on your hand sanitizer. I hesitate but people's health are at risk so no disrespect meant but this is not close to the WHO recommended formula. It requires 96% ETHANOL as a base, not alcohols derived from feints. It needs to be as close to pure ethanol as possible and not include other toxic components that could be harmful. I don't know how much Ethanol you can recover from your feints especially if this was already refluxed but it's probably not worth the time to do so unless maybe they were from pot still runs. But what you should be using is a GNS like product of that purity. You NEED as pure Ethanol as possible for the base. WHO calls for 96% Ethanol not other alcohols or by-products which are likely harmful on their own. It requires specific amounts of Hydrogen Peroxide and Glycerol as well to work effectively and it needs to be 80% not 65%. It also requires a 72 hour quarantine before use to allow the Hydrogen Peroxide time to work properly. Please make sure to follow the steps exactly as outlines per https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf or other federal documents your country may impose as well. Many countries for example require the use of denatured alcohol. The blog post: https://istillblog.com/2020/03/24/istill-distilleries-produce-hand-sanitizer/ and recipe for Sanitizer is non compliant as well as what's written above. PLEASE, PLEASE, PLEASE make sure you and other distillers using your equipment produce a product worthy of use by following WHO formula or specific country regulations exactly as written. In these world wide times it's important to produce a product that will be as effective as possible.

You can't do this. As a DSP without bond to make anything but drinking spirits you don't make the rules. Essentially, DSP live but what the TTB allow/authorizes them to do. In this case you have been given a waiver to make sanitize by following strict rules and LABELING per the FDA. https://www.fda.gov/media/136118/download Look at step 6 (labeling). Front of package is required to say: Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution [Insert Volume of Product in mL] The back is required to have the DRUG FACTS LABEL info as shown. Don't forget the TTB waiver specifies you must register with the FDA as a producer of sanitizer. BTW, a "wash" infers it's a cleanser not a sanitizer which is alcohol based. For example take a look at Dove Hand Wash and it's many lists of ingredients. I'm sure the FDA has requirements for that type of thing but is way beyond the scope here. In our case the TTB has mandated what goes on the label and it's "Hand Sanitizer".

TTB says §21.37 Formula No. 3-C. (a) Formula. To every 100 gallons of alcohol add: Five gallons of isopropyl alcohol. ---- Thus if you start with 100 gallons of 96% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 95.76% Thus if you start with 100 gallons of 95.1% Ethanol and add 5 gallons of 91% isopropyl you will have 105 gallons of denatured Ethanol at 94.9% Note if you can only get 71% isopropyl you could use 100 gallons of 96.1% Ethanol and 5 Gallons of 71% isopropyl and you'll have 105 gallons at 94.9%. you might get a slight bit of contraction due to the water in the alcohols so you may need to adjust ever so slightly with sterile water to top back up to 105 gallons but use your alcoholmeter to test ABV. Without adjusting you are clearly in the margin of error and good to go. FDA uses the following formula: The hand sanitizer is compounded using only the following ingredients in the preparation of the product: a. Alcohol (ethanol) that is not less than 94.9% ethanol by volume (denatured from above) b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”) c. Hydrogen peroxide d. Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified. If anyone is having trouble with the math just post what you have, what % your Hydrogen peroxide is as well as your isopropyl %, your ethanol % and what size batches you wish to make. State if you want to work in gallons or liters and I'll give you the ingredient list and how much of each to use. Liter/mL are far easier to work with and measure in my opinion.

Got ya, that makes sense. Good link as well. CA did a good job on that making it pretty clear how transaction can be done including the money exchange during delivery away from the business property!

You can also use isopropyl alchohol. (a) Formula. To every 100 gallons of alcohol add: Five gallons of isopropyl alcohol If you are making sanitizer for a local hospital they may already have it in stock and could contribute it to you for production. It's 20:1 ratio so for every gallon they have you match them 20 for a 25 gallon batch. LOL

Can I get a bottle of rye, vodka and one gin delivered with a complimentary 8 oz bottle of sanitizer? LOL In many states you couldn't do something like this because spirit transaction must take place inside the premises. I don't think you could deliver either without seeing/checking an ID to make sure they are 21. I know deliveries require a signature in my state. I don't know if paying online first would qualify or not but these are the types of things that need to change in state laws moving forward (hard lesson is being learned right now). Glad to hear of your success in this! Surprised you can do this in California!

I think the explanation is much simpler. Normally most of us here would not be able to produce alcohol used for sanitizer. We do not have the proper license or BOND to do so. We would also be paying tax on the alcohol produced. So when I read about the "waiver" I'm reading this as the waiver we have already received not something else. We were given permission to make sanitizer (normally not allowed), we are exempt from taxes on it (normally not) if denatured, we are allowed to remove from bond and give to another party for making sanitizer without tax (normally not allowed), etc. These are the waivers they are talking about AS I READ IT.

Just the same tax waiver that has been talked about in this thread. So we don't pay taxes on the denatured alcohol used for making sanitizer.

Just curious, but what size batches are you guys making that are donating to the public? What size containers are you distributing in?

§21.37 Formula No. 3-C. (a) Formula. To every 100 gallons of alcohol add: Five gallons of isopropyl alcohol. Only downside to this is the amount needed 20:1 ratio which is a lot higher then the other 2 methods. If you can source it locally it's probably the easiest and cheapest way otherwise shipping can be a killer compared to other ingredients. The good side is you have 105 gallons vs 100.x gallons. @Bluestar what strength isopropyl alcohol are you using?

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 documents must not set new legal standards or impose new requirements. Unlike regulations, guidance documents do not contain amendments to the Code of Federal Regulations and are not subject to the notice and comment process. Are FDA Guidance Document Law? No. As the FDA makes clear, the FDA guidance documents are not legally binding on the public or the FDA. BUT, the FDA has come to rely on guidance documents as a means of informal policy making. By telling industries when it does and does not plan to act, the FDA is giving industry stakeholders notice of its position on certain issues (e.g., how the FDA intends to treat mobile medical apps). As a result, impacted industries would be wise to take heed and pay attention to the guidance documents. So, for practical purposes, FDA guidance documents are laws. =============== So the take away is that if you follow the directions outlined in their guidance docs, they won't be coming after you. The thing to keep in mind is that this is TEMP authority to make a new product that we are not normally BONDED to make. Keep in mind this is a temporary solution with an easier way to make sanitizer than usually done as required by the FDA. =============== On another note. The Covid-19 virus and the TTB/FDA allowing DSPs to make sanitizer is going to be a great feather in the cap of DSP in the USA (and other places) if we don't screw it up. In months/years to come this could affect laws in ways that make it easier to open smaller micro distilleries or expansions of existing facilities and maybe even home distillation (like beer and wine). Where at present some city/towns and counties try hard to keep DSPs out or make it very hard, we might be seen in a different light and be more welcomed knowing that we are there if needed in times like Covid-19 or similar. Anyone trying to open or expand facilities should take advantage of this and build it into their business plans from stocking of key ingredients and distribution bottles to having partnered with other local business to help with fermentables & packaging to having a plan for distribution including city/town employees including rescue, police, fire, first responders and health care providers. This could even be a partnering with the city/town to have stock of certain items for just such an emergency that you could use to turn out a product. Showing how you would try to put community first in time of need will go along way in some areas.

Have you looked into the legalities of doing this? I have no idea, but wouldn't be surprised if you had to hold the money in escrow until they take possession of the bottles and you move the spirits out of bond. You might be able to issue them a "gift certificate" that they could later redeem. IE a $50 gift card to a fine restaurant. Typically the funds are placed in a liability account (on the books) until the service is rendered then transfers as a sale when the person dines or purchases. I'd definitely talk to a lawyer versed in TTB regulations to see the proper way to set this up. You could also think outside the box and have investors purchase the barrels, then you rent the barrels from them at a pre-agreed price plus bonus (based on quality) only to be paid at time of bottling. That's a type of investment that would keep you out of trouble as your just renting equipment. You could set the "rental fee" to the low end of the expected amount of bottles and give a bonus based on quality to match the content of additional bottles you get from that barrel. Again run anything like this past a lawyer. What I see as a potential problem is what happens when you have 10 people doing this and 5 barrels turn out great but 5 are a bit lack luster in taste? If blended you likely have a good product but individually might have 5 happy people and 5 not so happy people depending on which barrel they were assigned. The bigger companies like Jack Daniels select known good barrels they sell this way and give the customer a choice of 3 to 5 barrels to sample and decide which barrel to purchase. The customer always gets to pick a barrel they like this way. Don't know how much experience you have with barrel aging but 6 barrels produced right after each other filled with the same spirit may come out a lot different then you might imagine after being in a barrel for 4 years. Master blenders mix many barrels together to "fix" these types of problems while setting extraordinary barrels aside for special releases or single barrel releases. This is something you'd not have the ability to do unless you got an agreement from all parties to blend their barrels. Just something to think about.

Personally I'd not do anything until you have your water tested to see what's in it. Then you design the water treatment around your water. Your water might be perfect for mashing but poor for diluting final spirits but you don't know this without having your water tested. If you can use your water as is for mashing then you can get by with a much smaller water treatment system (less ongoing costs as well) as you will need far less of it "pure". Far too many people run everything through water treatment which calls for a bigger/more expensive systems, more ongoing costs for it PLUS then have to add back minerals to the water for fermenting which is another cost. RO system waste water to make water so your water bill will be higher as well with this type of system. So you don't want to use RO water for mashing if you don't have to. An RO system can easily waste 3 gallons of water for every gallon it makes. Depending on your water testing results you might be able to use part of it from the tap and part from the treated water for a nice balance of minerals that won't require additions. You don't know until it's tested. Test your water so you know what you are starting with. Report back your water analysis and we can help you from there. PS you can pick up a cheap TDS meter which will give you a one shot number of total dissolved solids in your water which will give you a mile high view of your water. No substitute for a proper test but you'll want one anyway as it's good to test your water to see when the TDS start to rise (change filters).

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 educational institutions, if not for resale or use in the manufacture of any product for sale. TTB is temporarily waiving certain formula approvals for the manufacture of hand sanitizer using and expediting certain permit requirements. --- It goes on to clarify these items and mention this document dated March 26 supersedes other guidance and refers you to the FDA document "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191) Guidance for Industry" for formulation, registration, denaturing, etc. It is available here: https://www.fda.gov/media/136289/download NOTE: This document was updated on March 27, 2020 (yes after the TTB bulletin). This document lists 8 steps to produce sanitizer including registration with the FDA. You must meet all 8 steps including labeling with their specific label requirements. What you make is considered "non sterile" sanitizer which may be of limited use to hospitals or sterile environments. This product is designed and labeled for consumer and health care personnel only it seems. With the updated wording today step 1 wording changed from something like "USP Alcohol" to now giving a list of ingredients that actually allows Glycerin of USP or Food Grade Index use. Hydrogen Peroxide Concentrate USP or Hydrogen Peroxide Topical Solution USP (see footnote) which probably isn't a big deal either. Step 2 covers denaturing and states Formula 40A or 40B with or without the tert-butyl alcohol from TTB Bureau regulations in 27 CFR part 20 and 21. https://www.ttb.gov/other/regulations §21.75 Formula No. 40-A. (a) Formula. To every 100 gallons of alcohol add: One pound of sucrose octaacetate and 1⁄8 gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). §21.76 Formula No. 40-B. (a) Formula. To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and 1⁄8 gallon of tert-butyl alcohol. (b) Authorized uses. (1) As a solvent: 052. Inks. 111. Hair and scalp preparations. 112. Bay rum. 113. Lotions and creams (hand, face, and body). 114. Deodorants (body). 121. Perfumes and perfume tinctures. 122. Toilet waters and colognes. 141. Shampoos. 142. Soaps and bath preparations. 210. External pharmaceuticals, not U.S.P. or N.F. 410. Disinfectants, insecticides, fungicides, and other biocides. 450. Cleaning solutions (including household detergents). 470. Theater sprays, incense, and room deodorants. 485. Miscellaneous solutions. (2) Miscellaneous uses: 812. Product development and pilot plant uses (own use only). ======================== So I've highlighted/bolded things that stood out to me. We are now clearly making a non sterile product and some rules are more lax. It does not appear we need to use USP grade products to denature now due to the update they just did. I would not sell the product with further clarification as it could change your taxes/bond etc as the new bulletins aren't the clearest on this at least to me. With this new wording I would not be afraid to use "normal" products for denaturing (meaning cheaper) per TTB 40A & 40B above which the FDA is allowing for this CONSUMER product. But with the FDA taking charge of the "rules" of how the product is made, please make sure to read that bulletin and make sure to follow all 8 steps including FDA registration and labeling for sure. Wish I could be more help, but that's it for now from me. What I am curious about is how the TTB/FDA will handle people making products that are not denatured and haven't registered with the FDA since there was a brief period where this was allowed? Hopefully in good faith if product is being given away!