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Hi Folks, 

Does anyone have advice for making sanitizer out of the fores?   A local clinic expects to run out of sanitizing agent and has asked for help, which I'm more than happy to donate.   Just straight though, the fores are still quite whiskeyish in nature and I wouldn't want anyone to be tempted to try to take a swig.  If there are known ways to modify to make a more appropriate sanitizer, I'd appreciate any help.

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The short answer us unless you're bonded to do , your spirits can't be used, period.

This was just talked about here: 

 

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Thank you for the link Dr, and to all those who contributed.  I have been asked, NUMEROUS times, on this topic.  Good info.

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I've got gallons of 5-star santizer, and of glass sanitizer. Why not just make santizer out of sanitizer? Just add water.

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Seems everyone is jumping on the sanitized band wagon around here , so we contacted our lawyer for advice . After looking into the legal implication he has advised us to not get involved , the simple answer is we are not licenced to make pharmaceuticals.  We are also not qualified or trained to make such products , one simple mistake and were wide open for a law suit . We are invested in this distillery with years of work and close to 2 million dollars , were not risking that to start making home made hand sanitizer . Thats our take on situation .

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If I am not mistaken, the COVID -19 call today with the ACDA mentioned that Discus and the ACDA are in contact with the FDA and TTB on the matter.  I could have misheard that, but that was what it sounded like. 

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On 3/17/2020 at 5:22 PM, Hudson bay distillers said:

Seems everyone is jumping on the sanitized band wagon around here , so we contacted our lawyer for advice . After looking into the legal implication he has advised us to not get involved , the simple answer is we are not licenced to make pharmaceuticals.  We are also not qualified or trained to make such products , one simple mistake and were wide open for a law suit . We are invested in this distillery with years of work and close to 2 million dollars , were not risking that to start making home made hand sanitizer . Thats our take on situation .

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 manufactured. This is largely for public safety.

As a healthcare professional I am obligated to “do no harm” and ensure the proper steps and procedures are being followed when it comes to patient safety.

Going rogue, abandoning guidelines, and having total disregard for the law is reckless and puts consumers and employees at unnecessary risk. But hey, I’m sure it’s a great marketing opportunity during a global crisis :eye roll:

 

That being said, if the feds give us the direction and approval to start making a sanitizing product, they have the full support of our entire production facility and all available staff. Until that happens though, we will follow the law.

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New guidance for DSPs producing hand sanitizer is coming from TTB. In the meantime here is some information from DISCUS and WHO.

@Hudson bay distillers & @Skaalvenn it looks like TTB and FDA are going to waive some of the legal requirements during this current shortage.

Hand Sanitizer WHO Formula.xlsx DISCUS Guidance_Hand Sanitizer_20.3.17.pdf

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Special Edition - COVID-19

Production of Hand Sanitizer by Distilled Spirits Permittees

Greetings! This special edition contains guidance for DSPs and Industrial Alcohol User permittees on producing ethanol-based hand sanitizers.

Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary.

Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption.

Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division.

Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.

Guidance for industrial alcohol users: Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer consistent with World Health Organization (WHO) guidance without first obtaining formula approval. During the period of this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure (see 27 CFR 20.42(a)(3) and 20.56). TTB is authorizing these exemptions under its authority in 27 CFR 20.22(b) to approve emergency variations from regulatory requirements.

This information is available on our Public Guidance page.

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16 minutes ago, EZdrinking said:

Special Edition - COVID-19

Production of Hand Sanitizer by Distilled Spirits Permittees

Greetings! This special edition contains guidance for DSPs and Industrial Alcohol User permittees on producing ethanol-based hand sanitizers.

Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary.

Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption.

Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division.

Formula guidance for the manufacture of hand sanitizer: TTB is authorizing the manufacture of hand sanitizer products consistent with World Health Organization (WHO) guidance. All TTB-permitted DSPs (including AFPs and beverage DSPs) may manufacture hand sanitizer products that are comprised of denatured or undenatured ethanol, glycerol (not less than 1.45% of the finished hand sanitizer product on a volume basis), and hydrogen peroxide (not less than 0.125% of the finished hand sanitizer product on a volume basis), without first obtaining formula approval from TTB.

Guidance for industrial alcohol users: Industrial alcohol user permittees may also use denatured ethanol to manufacture hand sanitizer consistent with World Health Organization (WHO) guidance without first obtaining formula approval. During the period of this guidance, TTB is also exempting industrial alcohol user permittees from the requirement to request approval from TTB to increase the quantities of denatured ethanol that they may procure (see 27 CFR 20.42(a)(3) and 20.56). TTB is authorizing these exemptions under its authority in 27 CFR 20.22(b) to approve emergency variations from regulatory requirements.

This information is available on our Public Guidance page.

YES Thanks this is what we all needed!

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The guidance put out by the TTB specifically states that if undenatured alcohol is used, it is still subject to excise tax. My question is there an easy way to change it to denatured alcohol to save the excise tax? Not a huge expense, but as we will be donating the product to our local first responders, every bit of savings on the bottom line helps.

Also, any ideas how to account for this on the monthly TTB reports?

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9 hours ago, Airman700 said:

The guidance put out by the TTB specifically states that if undenatured alcohol is used, it is still subject to excise tax. My question is there an easy way to change it to denatured alcohol to save the excise tax? Not a huge expense, but as we will be donating the product to our local first responders, every bit of savings on the bottom line helps.

Also, any ideas how to account for this on the monthly TTB reports?

Amen to this. Also, having a difficult time finding h2o2 / hydrogen peroxide from a reputable supplier - consumers are buying it out, everywhere, and there appear to be a whole new crop of sudden scammy offers trying to take advantage of things. Even amazon sources appear to be out of stock for 10 days or so, or price gouging is in full swing on in-stock items. 

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The problem is finding containers to put the sanitizer in.  Plastic bottles are out of stock seemingly everywhere.

Regarding hydrogen peroxide, you need to order from a lab supply company, not retail bottles on Amazon for goodness sakes.  Will you be able to use up a few gallons of 35%?  No but it's cheap, so doesn't matter.

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All,

     Not to place a damper on this in any way, there is one other aspect to contemplate aside from the Fed's and the TTB.  That aspect is YOUR INSURANCE.  Please see the post here: 

     Before you jump in full throttle on the sanitizer bandwagon, you may want to make a call to your insurance provider to see if they will cover you for this none-contemplated liability exposure.  If it is not on the policy as a General Liability Hazard Classification Code, you may not have insurance coverage if something were to happen.  Make the call, then make the sanitizer.  I am all for it and as you will see, I have been tirelessly working on this for the majority of the day today.  Call with questions:  307-752-5961.

Stay Vigilant,

Aaron Linden

a.k.a.  InsuranceMan 2.0!!!

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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:

The FDA has issued guidance for its temporary policy for compounding of certain alcohol-based hand sanitizer products. Please CLICK HERE for the presser. The downloadable guidance document entitled " Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191 ) Guidance for Industry" (attached to this post) provides protocol for distilleries to manufacture hand sanitizer. Items 1-6 listed in the document provide the essence of the protocol that will need to be followed. Item 6 states you will need to register with the FDA, but it appears once you register online you will receive immediate approval by FDA.

 

TTB:

Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. Any existing DSP therefore can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer, as described below, without having to obtain authorization first. These measures are generally authorized under authorities that apply in disaster situations, and as a result, are initially approved through June 30, 2020, with the possibility for extension as necessary.

 

Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption.

 

Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division.

 

WHO production: https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf

DistilleryTrail.com map and listings for producers: https://www.distillerytrail.com/blog/breaking-ttb-gives-distillers-green-light-to-produce-ethanol-based-hand-sanitizer/

ADI survey: https://www.surveymonkey.com/r/QMXWY32

FDA_Hand Sanitizers Immediately in Effect Guidance Other Firms FINAL_0.pdf

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On 3/19/2020 at 2:01 AM, Airman700 said:

The guidance put out by the TTB specifically states that if undenatured alcohol is used, it is still subject to excise tax. My question is there an easy way to change it to denatured alcohol to save the excise tax? Not a huge expense, but as we will be donating the product to our local first responders, every bit of savings on the bottom line helps.

Also, any ideas how to account for this on the monthly TTB reports?

Well, I wasn't thinking in terms of using the drinkable whiskey, but rather the fores.  Those don't get reported to the TTB or the state as production of drinkable product.  I suppose if things went south enough and the local hospital really needed it I'd do that, but at present I was more thinking just in terms of helping clinics in my area with what has to this point largely gone to waste. 

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23 hours ago, InsuranceMan 2.0 said:

All,

     Not to place a damper on this in any way, there is one other aspect to contemplate aside from the Fed's and the TTB.  That aspect is YOUR INSURANCE.  Please see the post here: 

     Before you jump in full throttle on the sanitizer bandwagon, you may want to make a call to your insurance provider to see if they will cover you for this none-contemplated liability exposure.  If it is not on the policy as a General Liability Hazard Classification Code, you may not have insurance coverage if something were to happen.  Make the call, then make the sanitizer.  I am all for it and as you will see, I have been tirelessly working on this for the majority of the day today.  Call with questions:  307-752-5961.

Stay Vigilant,

Aaron Linden

a.k.a.  InsuranceMan 2.0!!!

I hear you, and thanks for the reminder.   I don't intend to enter a market for selling sanitizer.    I was merely thinking in terms of donations for the duration of a national emergency.  I dunno, I guess the terms you're thinking in are more the usual concerns that we all have to be careful of.    I'm more thinking of emergency options.    

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On 3/20/2020 at 12:03 PM, Allan said:

Permit guidance for alcohol fuel plants (AFPs) and beverage distilled spirits plants: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under the authority of 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption.

 

Tax guidance for the manufacture of hand sanitizer: Hand sanitizer products are not subject to Federal excise tax if made with denatured ethanol. However, if made with undenatured ethanol, Federal excise tax applies. For information regarding denaturants, please contact TTB’s Scientific Services Division.

FDA_Hand Sanitizers Immediately in Effect Guidance Other Firms FINAL_0.pdf 169.09 kB · 2 downloads

So, what seems NOT to be addressed is that normally a DSP can not denature alcohol for some other use without a permit. The TTB does not seem to have indicated that requirement is waived. And while they indicate you could make sanitizer with un-denatured alcohol if you pay the federal tax, the FDA has issued guidance requiring that the alcohol be denatured according to TTB formulas. I will note, interestingly, that the FDA ingredient list does not list the denaturing agents in the final product. Also, WHO does not require denaturing, which is what the TTB refers to. So, there seems to be a small Catch 22 regarding denaturing for DSPs that want to produce the sanitizer themselves for distribution.

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For those getting into this. (We are on the fence but acquiring materials to be ready)

What size containers are y'all producing in? Wasn't sure if we should be doing 12 oz guys or only in bulk .5 to 1 gallon

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Just heard the NPR story on Cotton and Reed in the DC area making hand sanitizer. They blended everything up in an immersion blender when walking the interviewer through the steps to make the product. 

Can someone please find the article or information on the guy that killed/seriously maimed himself using an immersion blender blending up high-proof alcohol in his distillery.

Just thinking to myself how crazy stupid that is and now it's out in the public for many many more idiots the blow themselves up. 

Ugh!

 

 

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