Hand Sanitizer from GNS

[Classick]

Ok i did some due diligence on it and everything seems legit now... The guys from Gr Buffalo are just handling the bulk spirits side of things for Chrome, which purposefully decided not to include the ethanol side of their business on that website. I just spoke on the phone with the head guy.

Sorry to cause any concern

[Patio29Dadio]

9 hours ago, DrDistillation said:

Well I was just asking a question.  The difference between 80% and 70% is quite a bit and many more bottles could be produced from the same alcohol. (edit, I was looking at other products beside Purell when I wrote 65% before.  It appears Purell is produced at 70%.)

Purell and many other similar sanitizers have been the standard for a long time and don't get anywhere near the 80% ABV mark.

The Centers for Disease Control and prevention recommends using a hand sanitizer with at least 60 percent alcohol.  The FDA put out a publication https://www.fda.gov/media/136118/download using the formula many have repeated here but fail to see the footnote #6.

"Consistent with the 1994 TFM, alcohol should be used in a final product concentration between 60-95% (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; isopropyl alcohol should be used in a concentration between 70-91.3% (v/v). This guidance is consistent with WHO’s recommended formulation specifications of 80% alcohol and 75% isopropyl alcohol."

So is the WHO being overly high on the ABV needed or is the mass market of commercial sanitizers not really doing a proper job?  I think this is a common sense thing to question and talk about.

It also appears that a solution of 70% final ABV is fine to use as well according to WHO, FDA & CDC.  A target of 70% vs 80% allows a lot more product to be made from the same base spirit. 

Talking to an epidemiologist in my college town they say that 65% - 75% is more ideal because the alcohol evaporates too quickly if higher proof.  However, the glycerin helps, and so does the H202.  But I had the same question about the FDA standards... seems higher than it needs to be.

I am using medical grade ultrasonic gel for the gel-type.  Not too expensive.  I can find it and it is really awesome how it emulsifies and blends well with the ethanol.  Our little bottle filler pumps it fine. 

Today was our first day selling and delivering and we are all exhausted with the flood of people and businesses we provided sanitizer to.  The challenge is getting supplies.  

[twowheels]

Further guidance from TTB:

https://www.ttb.gov/public-guidance/ttb-pg-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.

Guidance regarding transfers in bond:
...TTB is exempting DSPs from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits from another DSP and to obtain additional bond coverage..."

[Thatch]

This is crazy.  If you read the FDA doc they are only allowing State licensed pharmacies to make hand sanitizer or they threaten prosecution.  https://www.fda.gov/media/136118/download  This is no longer about denaturing, we are NOT allowed to do make hand sanitizer.  

4 Specifically, FDA does not intend to take action against pharmacists in State-licensed pharmacies or Federal facilities, for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, for violations of sections 501(a)(2)(B), 502(f)(1), and 505 of the FD&C Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and 355), or against outsourcing facilities for violations of sections 502(f)(1), 505, or 582 of the FD&C Act (21 U.S.C. 352(f)(1), 355, and 360eee-1).

[DrDistillation]

@Thatch it says pharmacies or Federal facilities.  You are a federally bonded DSP with bond correct?

This might make it easier to understand: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a

"Permit guidance for alcohol fuel plants (AFPs) and beverage DSPs: 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 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."

Read that whole bulletin to make sure you understand it before producing.  Feel free to ask any questions here.

Keep an eye on this page for any updates:

https://www.ttb.gov/public-guidance/other-public-guidance-documents

[Thatch]

Dr D, I like your reading a whole lot better than mine.  The key phrase is  "pharmacists in State-licensed pharmacies or Federal facilities"  To me this means only pharmacists can make the formula.  That pharmacists can be in a Drug store or a Federal facility like a penitentiary and the FDA will not prosecute them.  However, the rest of us are not allowed. 

It seems that the TTB is completely deferring to the FDA in this matter. 

I'll stay tuned for updates.  I want to be wrong.

 

[Thatch]

Okay, the new FDA guidance just posted a few minutes ago by the forum moderator is allowing distillers to make hand sanitizer and the FDA says they will not prosecute us for making it.  BUT, it has to be DENATURED.

Here's the new doc

Ethanol-for-Hand-Sanitizer-FINAL-3_24.20 (1).pdf

[EZdrinking]

1 hour ago, Thatch said:

Okay, the new FDA guidance just posted a few minutes ago by the forum moderator is allowing distillers to make hand sanitizer and the FDA says they will not prosecute us for making it.  BUT, it has to be DENATURED.

Here's the new doc

Ethanol-for-Hand-Sanitizer-FINAL-3_24.20 (1).pdf 142.5 kB · 5 downloads

This update was also added to the other discussion thread.

[Classick]

I know its been brought up here previously, but has anyone heard of any movement on the discrepancy between the commercially available sanitizer at 71% vs what we're being required to produce at 80%.

Obviously stretching our scarce materials is of utmost importance.. but in addition to that... we've been in discussion with our EMS guys, Fire marshal, safety coordinator and various doctors, and all have been specifically requesting 70% vs 80%.. to save their hands the additional desiccation from higher proof product. Especially considering we cant ad anything but glycerin to our products as an emollient.

I've read and understood that FET relief only comes from producing according to FDA/WHO recipe... but that doesnt seem to be what "the people" want

 

[Classick]

I might have just answered my own question... footnote #9 on the most recent FDA guidance says

 

WE have specifically been told that DSP's are free to use undenatured alcohol... which Im choosing to use to negate the part in that footnote that says "in an aqueous solution denatured according to TTB"

Any thoughts?

[DrDistillation]

 

37 minutes ago, Classick said:

I might have just answered my own question... footnote #9 on the most recent FDA guidance says

 

WE have specifically been told that DSP's are free to use undenatured alcohol... which Im choosing to use to negate the part in that footnote that says "in an aqueous solution denatured according to TTB"

Any thoughts?

I had the same question about ABV % but think the answer is here:

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

"Hygienic handrub

The microbicidal activity of the two WHO-recommended formulations was tested by WHO reference laboratories according to EN standards (EN 1500). Their activity was found to be equivalent to the reference substance (isopropanol 60% v/v) for hygienic hand antisepsis."

Seems like they are trying to say that this "quick/easy formula" requires higher ABV to equal their reference substance therefore it must be made at 80%.

 

But more importantly please make sure you understand that you can not produce sanitizer that is undenatured in the USA.

Here is yesterday's bulletin: https://www.ttb.gov/public-guidance/ttb-pg-2020-1a

"TTB’s March 18 authorization referred to both denatured and undenatured ethanol. However, on March 23, 2020, the FDA issued guidance which specifies the use of denaturants when compounding ethanol-based hand sanitizers."

"TTB is therefore providing this guidance to (1) supersede its prior guidance with regard to the authorized formula to be consistent with FDA guidance; (2) exempt distilled spirits plants (DSPs) from the requirements to request approval from TTB to receive denatured or undenatured distilled spirits in bond from another DSP and to obtain additional bond coverage, through June 30, 2020; (3) provide guidance and certain exemptions from requirements for state and local governments wishing to obtain tax-free alcohol, and (4) offer hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions the same streamlined application process."

This CLEARLY states you must denature the alcohol to make and distribute sanitizer.  You can however purchase undenatured distilled spirit from a DSP but you MUST then denature it for production.  The FDA doesn't want undenatured sanitizer being produced!

 

[Thatch]

That's what it says on the ttb doc for sure.  But, the ttb have deferred to the FDA who basically have said it must be denatured or we may pursue you.  

[twowheels]

FDA guidance relevant to hand sanitizer production at DSPs (all documents found here:

3/14/20 FDA-2020-D-1106 Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

3/19/20 FDA-2020-D-1106 Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

3/24/20 FDA-2020-D-1106 Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry

TTB guidance relevant to hand sanitizer production at DSPs:

3/26/20 TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic (supersedes prior guidance). 

Note:

The TTB guidance above (TTB G 2020-1A) has a reference to a March 23 FDA guidance document but the hypertext link appears to download a copy of the 3/19/20 FDA-2020-D-1106 version linked above.  It's difficult to tell which is which when you're clicking around (I haven't seen any document revision tracking system beyond stating the month of publication).

Also linked above is the 3/24/20 version of FDA-2020-D-1106, which has direct instructions about denaturing ethanol:

."..FDA does not intend to take action against alcohol production firms that manufacture alcohol [for use in] alcohol-based hand sanitizers ... provided the following circumstances are present:

...

3.The alcohol is denatured ... using the formulas in Appendix C of this
document.

...
Beyond alcohol, water, and denaturants (if added at the point of production), the
alcohol production firm does not add other ingredients. Different or additional
ingredients in the API may impact the quality and potency of the finished hand
sanitizer product.

...

[Classick]

SIGHHHHHH.

Thanks all for your inputs and efforts in wading through all this stuff

[DrDistillation]

And you need to make sure to purchase USP grade ingredients for denaturing as well.

[StonesRyan]

It's unfathomable to me that TTB and FDA are so concerned with denaturing (so some folks don't ingest the sanitizer?) while people are dying because of the global pandemic and a nationwide shortage of hand sanitizer. But it's ok to skip the denaturing as long as we give it away and absorb the costs to produce? None of it makes any sense to me but that's bureaucracy, I suppose.

[twowheels]

TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic

This guidance appears to promote two paths to getting ethanol products from DSPs to consumers. 

One path allows ethanol (denatured or undenatured) to be removed tax-free for non-beverage use at government or health facilities.  Correct me if I'm wrong, but this path does not seem to require ~95% neutral spirit.

Another path allows tax-free production of hand sanitizer products per FDA interpretation of WHO rules.  This either requires denaturing in house or purchase of bulk denatured product.

Transfer in bond applications are waived.  With appropriate record keeping, bulk product can move around between DSPs more efficiently. 

[twowheels]

The relaxing of TIB restrictions allows large orders of GNS or denatured spirit to be split among several DSPs. 

Is anyone taking advantage of this?

 

[twowheels]

14 minutes ago, StonesRyan said:

But it's ok to skip the denaturing as long as we give it away and absorb the costs to produce? 

Are DSPs being asked to absorb all the costs?

[StonesRyan]

12 minutes ago, twowheels said:

Are DSPs being asked to absorb all the costs?

Yes, as far as I can tell. Someone please correct me if I'm wrong but, if you want to sell it, even just to cover your costs, you must denature it. 

[Thatch]

38 minutes ago, twowheels said:

Are DSPs being asked to absorb all the costs?

Sure, we're all trying to save humanity. 

These new chems are not inexpensive.  We got the last of what they had a one place.  It seems that they are also somewhat controlled according to my distiller.  When purchasing you have to fill out a form and they may or may not ship to you.  It was $68.40 for the Tert-Butyl Alcohol,  2000 ml of Tert-Butyl Alcohol enough for 400 gallons of sanitizer.   50grams of  DENATONIUM BENZOATE enough for 282 gallons was $108

[twowheels]

TTB G 2020-1A requires DSPs to sell to permitted entities in government and medical fields and provides streamlined permitting for these entities.

 I didn’t see anything about restrictions on selling it to these entities to recoup costs. 

Anyone else have a different read on legality of selling these products?

 

 

 

[DrDistillation]

35 minutes ago, twowheels said:

TTB G 2020-1A Production of Hand Sanitizer to Address the COVID-19 Pandemic

This guidance appears to promote two paths to getting ethanol products from DSPs to consumers. 

One path allows ethanol (denatured or undenatured) to be removed tax-free for non-beverage use at government or health facilities.  Correct me if I'm wrong, but this path does not seem to require ~95% neutral spirit.

Another path allows tax-free production of hand sanitizer products per FDA interpretation of WHO rules.  This either requires denaturing in house or purchase of bulk denatured product.

Transfer in bond applications are waived.  With appropriate record keeping, bulk product can move around between DSPs more efficiently. 

That bulletin has been superseded and is no longer valid because people were having trouble understanding it.

You must use denatured alcohol in the sanitizer period.  You do not have to ship/transport denatured alcohol if you aren't producing the finished product.  IE you give/sell  undenatured alcohol that meets USP grade requirements to a local pharmacy or other DSP and they produce the finished product with other USP grade ingredients.  But they (other party) will have to denature it.  You MAY have to prove your spirit is USP grade as that is a requirement.  If you transfer spirits not denatured to another party you MAY have to prove the spirit was used or pay tax on it. To be safe and clear, don't transfer any undenatured alcohol.  You MUST register your company and product with the FDA prior to distributing product, etc...

You must follow the bulletins, requirements and guidelines as specified.  When you register with the FDA, read everything as well. Doing something wrong could cost you long term or cause you to loose your bond/DSP.  Basically don't produce product if you don't fully understand the process.  Neither the TTB or FDA plan on going after anyone making an effort to follow the guidelines and procedures, so make sure to do so.

Be careful what you think are "relaxed regulations".  DSPs are being allowed to register with the FDA and produce a product they are normally not BONDED to make, but that doesn't give you a free ride to change things up or do things your way regardless if you charge for it or donate it.  Your product could be tested at any time. You must produce a USP grade product using ethanol which means you need to be able to produce USP grade ethanol.  You're not recycling heads, etc.  What you need to produce is technically cleaner than what many people produce for GNS use.  Remember you are registering with the FDA to make a pharma class product and you must do this.  Think about it this way.  If you produce a product that has chemicals in it that cause a reaction to a person using your product YOU could be held responsible just as Purell or any other large company.  To make this more clear a spirit like Everclear 190 would not be allowed to be used as it's not USP grade.

Nowhere does anything ask DSP to absorb costs.  There are many DSP contracting with states and cities or hospitals to produce.  Some are partnering with grocery stores to sell products.  Some are donating products as well.

If you don't fully understand exactly what is required of you, don't jeopardize your DSP.  Don't get involved producing sanitizer until you are 100% you meet all requirements and have the proper paper work and tracking in place.  This is a great opportunity for DSP and AFP if done correctly but it only takes a bad apple or two doing things wrong to halt this for everyone.

[DrDistillation]

4 minutes ago, Thatch said:

Sure, we're all trying to save humanity. 

These new chems are not inexpensive.  We got the last of what they had a one place.  It seems that they are also somewhat controlled according to my distiller.  When purchasing you have to fill out a form and they may or may not ship to you.  It was $68.40 for the Tert-Butyl Alcohol,  2000 ml of Tert-Butyl Alcohol enough for 400 gallons of sanitizer.   50grams of  DENATONIUM BENZOATE enough for 282 gallons was $108

Were these USP grade as required?

[Classick]

54 minutes ago, StonesRyan said:

Yes, as far as I can tell. Someone please correct me if I'm wrong but, if you want to sell it, even just to cover your costs, you must denature it. 

We offered to give our first batch  to our local city fire marshal for free, and they're insisting on paying fair market value for it... something about it needing to be like that for their books.

*Shrugs*