What is the law as far as selling nicotine?

[Mac]

But I don't think that'll happen anytime soon.

Knock on Smokey's door, Jim, to see why.....

Ask HIM what I'm showing him personally and you'll begin to SEE what's really going on.

Oh and thanks for MOCKING ME, Mac!!

I knew you would.

You got alot of nerve buddy. You come on here insulting people and then and then when one of them responds you play the wounded dove? save it. I wasn't mocking you. I was responding to your nastiness. You reap what you sew. To avoid further confusion I will ignore you from here on out. So insult away. tell me not to drop the soap all you want. You won't hear another peep out of me regarding your nasty derisive comments.

 

[chad]

Good grief, has this thread been derailed!

Take it to the religion thread lesser YHVH!

 

[dperino]

i agree with dedmonwakin. when whatever it is happens, one of the first things the feds are going to do is send some type of cease and desist "request" to the supply side, and in this case it would be to the companies in china via whatever authorities. i posted something along these lines in another thread but i'm thinking this would be included in whatever comes down. also, suppliers over here would most likely receive the same order, handed to them personally by whatever "goon" squad arriving to confiscate.

on the local level something similar occurred a few years back here in colorado. before introducing legalized gambling, the state and local authorities, allowed (very) small-stakes card games in bars and private clubs. but, when the movement began to bring legalized gambling into the state, even before voters approved, local authorities began shutting down the games. they first hit the bars, and then the private clubs.

this is kind of the scenario i see happening. not trying to spread anything negative. i hope this at least takes a couple of more years because there are some very fine people here who are taking the cause to another level through their mods and such. the big kahuna though is ejuice, that is a sure fire , and very safe, method on how to make one's own supply. thanks.

 

[HighTech]

The ONLY US company selling Juices is Johnson Creek, they have just done a re-vamp on the formulas, in anticipation of FDS regs, I suspect, but they do have FDA Approval. The only one I know of at this time. They also have "partners" who sell their product on e-cig websites. I do not know if they could sell bulk pure nicotine, I seriously doubt that they would. Am sure you would need clearance to buy it.

First, Johnson Creek is not the only US company manufacturing juice. There are others, that are way less expensive than JC. Look around...

Second, they do not have FDA approval for anything. They are simply registered with the FDA that any company can do for free, or in the case of Johnson Creek, they paid someone a fee to register for them. They simply use the FDA logo on their website as a deceptive marketing practice, to give the appearance that they are somehow "FDA Approved"... Quite a disgusting practice IMO...

 

[SharonLM]

Incredibly interesting thread, thanks for bringing up this topic. It never fails to amaze me how interesting this forum is. Well, I'm off to read what a pharmist thinks

 

[chad]

There are others, that are way less expensive than JC.

Do you have links? I've looked and not found any. Then again, I'm probably not very good at looking.

They simply use the FDA logo on their website as a deceptive marketing practice, to give the appearance that they are somehow "FDA Approved"... Quite a disgusting practice IMO...

By being FDA "registered" I do believe they allow FDA inspections of the "manufacturing" facilities. That is, the FDA checks out the kitchen table (or whatever they use) and their manufacturing and filling processes for food handling safety and cleanliness. Guidelines documents are at the FDA website. That is better than what many of the Chinese manufacturers do (which is most likely nothing) so I don't think they're entirely deceptive. Buyer beware, after all.

 

[Kate51]

First, Johnson Creek is not the only US company manufacturing juice. There are others, that are way less expensive than JC. Look around...

Second, they do not have FDA approval for anything. They are simply registered with the FDA that any company can do for free, or in the case of Johnson Creek, they paid someone a fee to register for them. They simply use the FDA logo on their website as a deceptive marketing practice, to give the appearance that they are somehow "FDA Approved"... Quite a disgusting practice IMO...

Please refer to Post #26, I stand corrected as to JC's rating, they are FDA REGISTERED, and yes, that means their manufacturing is subject to inspection. But I do think JC is still the only manufacturer in USA, Will check further, so far I stand by my statements.

 

[Territoo]

If you're refering to Bromptom's cocktail, that is a compounded drug. The laws pertaining to compounding are different for marketed Branded or Generic drugs. As long as the compound is made by a licensed pharmacist and contains otherwise approved ingredients, and(here's the real legality issue) as long as that pharmacy does less then 20% of it's gross business by compounding, it IS legal(according to FDA). If the Pharmacy does MORE then 20% of it's gross business via compounding, the pharmacy has to apply for registration as a manufacturer.

Hi markarich,

First of all I would like to thank you for you imput in this thread and also "A pharmacist's view".

Are you a compounding pharmacist? I am a [vaping] physician who is liscened in my state to prescribe. From a practical, not legal, stand point, if I were to write this script, could it be filled?

Nicotine base in propylene glycol to a concentration of 18mg/ml
Use 3-5 gtts (drops) in vaporizor q 3 hours prn (as needed) for withdrawal symptoms. Max 2 ml/day.
Dispense 15 ml

Could a liscensed compounding pharmacist obtain nicotine?

I'm glad to see another health care professional on this forum.l

 

[Zben504]

Hi markarich,

First of all I would like to thank you for you imput in this thread and also "A pharmacist's view".

Are you a compounding pharmacist? I am a [vaping] physician who is liscened in my state to prescribe. From a practical, not legal, stand point, if I were to write this script, could it be filled?

Nicotine base in propylene glycol to a concentration of 18mg/ml
Use 3-5 gtts (drops) in vaporizor q 3 hours prn (as needed) for withdrawal symptoms. Max 2 ml/day.
Dispense 15 ml

Could a liscensed compounding pharmacist obtain nicotine?

I'm glad to see another health care professional on this forum.l

Whenever my pharmacist saw my 26mg bottle she said she can't get anything near that strength. I'm sure the pharmacist on here can give you insight on what specific strength she can get, but I get the feeling it's going to be a very weak solution.

 

[markarich159]

Hi markarich,

First of all I would like to thank you for you imput in this thread and also "A pharmacist's view".

Are you a compounding pharmacist? I am a [vaping] physician who is liscened in my state to prescribe. From a practical, not legal, stand point, if I were to write this script, could it be filled?

Nicotine base in propylene glycol to a concentration of 18mg/ml
Use 3-5 gtts (drops) in vaporizor q 3 hours prn (as needed) for withdrawal symptoms. Max 2 ml/day.
Dispense 15 ml

Could a liscensed compounding pharmacist obtain nicotine?

I'm glad to see another health care professional on this forum.l

Great Question, however, I am not a "compounding pharmacist"(although all pharmacists can technically compound-and I do on occasion compound very simple ointments and creams). However, an acquaintance of mine Tom owns Dorneyville Pharmacy, which is a Compounding specialty pharmacy(it's literally ALL they do) He sold his regular non-compounding script business to a local Rite Aid. Looking at my jobber catalogue, I don't even see an option for me to order Nicotine,USP in any percentage. However, my jobber catalogue, as I said, is not a specialty compounding catalogue. So the only nicotine I see that I would be able to order comes in the regular NRT marketed products. However I know compounding pharmacists can obtain nicotine, as there was an article in a journal I was reading a few years ago about a compounding pharmacist who made Nicotine lollipops. With the FDA now regulating nicotine as a drug, however, I question if that is even legal anymore. But I know that the answer to your question already is, most likely , NO. The reason being your writing a script saying specifically every 3 hours for VAPORIZATION. There is no approved medical device to vaporize(except and this is a stretch , a nebulizer which is not approved for nicotine use) and therefore LEGALLY it could not be compounded. You asked practically, well practically as long as you can get the ingredients from a supplier(which I will contact Tom about the nicotine to make sure) you could physical make the compound. I mean PG is easily obtained. Another legal issue that pops up is that you are clearly stating "for withdrawal symptoms". This reminds me of the methadone federal law that states a physician can only write a methadone Rx if it specifically states "for severe pain" on the Rx. Otherwise, it must be dispensed by a registered methadone clinic for maintenance or withdrawal of addiction. Since the only Nicotine products approved for "withdrawal" are the marketed NRT's the Rx you describe is illegal in that respect as well. So I guess the ultimate answer to your question is , if the Nicotine is available to a pharmacy from a supplier, YES, practically you could compound the script. But since it would be illegal for the pharmacist to dispense it, I don't think the Pharamacist would. I certainly could do it easily if I could order the Nicotine, but I wouldn't do it because I know it would be illegal to dispense. At this point, to my knowledge, the only Nicotine that is legal to market is Tobacco products(to adults over the age of 18) and approved NRT's. And as I mentioned I am a vaping pharmacist as well and I feel this will change dramatically in the next few months to years.

Whoa update:
Read this article:

http://www.nutraingredients-usa.com/Regulation/FDA-censures-sale-of-nicotine-lollipops

So apparently, the article and FDA statement concur, a pharmacist can compound a nicotine Rx on the order of a licensed phycician as long as the Nicotine is in it's pure nicotine or Nicotine Polacrilcex form. HOWEVER then read this:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm144843.htm

A Letter received by a pharmacy compounding those lollipops and lip balms April 02, 3/4 of the way down the letter implies that although Nicotine compounding is allowed. Since the Lollipop(and your vaporizing solution) would be consider new drug entities, an NDA(New Drug Application) is in effect for the new formulation. So it sounds like the FDA hasn't really made up it's mind as of yet. On one hand it's saying yes you can compound nicotine Rx's if a licensed physician prescribes. On the other hand they are saying anything other then the pre- approved NRT's would be considered new drug entities and therefore, require NDA approval.

 

[HighTech]

Great Question, however, I am not a "compounding pharmacist"(although all pharmacists can technically compound-and I do on occasion compound very simple ointments and creams). However, an acquaintance of mine Tom owns Dorneyville Pharmacy, which is a Compounding specialty pharmacy(it's literally ALL they do) He sold his regular non-compounding script business to a local Rite Aid. Looking at my jobber catalogue, I don't even see an option for me to order Nicotine,USP in any percentage. However, my jobber catalogue, as I said, is not a specialty compounding catalogue. So the only nicotine I see that I would be able to order comes in the regular NRT marketed products. However I know compounding pharmacists can obtain nicotine, as there was an article in a journal I was reading a few years ago about a compounding pharmacist who made Nicotine lollipops. With the FDA now regulating nicotine as a drug, however, I question if that is even legal anymore. But I know that the answer to your question already is, most likely , NO. The reason being your writing a script saying specifically every 3 hours for VAPORIZATION. There is no approved medical device to vaporize(except and this is a stretch , a nebulizer which is not approved for nicotine use) and therefore LEGALLY it could not be compounded. You asked practically, well practically as long as you can get the ingredients from a supplier(which I will contact Tom about the nicotine to make sure) you could physical make the compound. I mean PG is easily obtained. Another legal issue that pops up is that you are clearly stating "for withdrawal symptoms". This reminds me of the methadone federal law that states a physician can only write a methadone Rx if it specifically states "for severe pain" on the Rx. Otherwise, it must be dispensed by a registered methadone clinic for maintenance or withdrawal of addiction. Since the only Nicotine products approved for "withdrawal" are the marketed NRT's the Rx you describe is illegal in that respect as well. So I guess the ultimate answer to your question is , if the Nicotine is available to a pharmacy from a supplier, YES, practically you could compound the script. But since it would be illegal for the pharmacist to dispense it, I don't think the Pharamacist would. I certainly could do it easily if I could order the Nicotine, but I wouldn't do it because I know it would be illegal to dispense. At this point, to my knowledge, the only Nicotine that is legal to market is Tobacco products(to adults over the age of 18) and approved NRT's. And as I mentioned I am a vaping pharmacist as well and I feel this will change dramatically in the next few months to years.

You feel what will change and in what way in the next few months to years?

 

[markarich159]

You feel what will change and in what way in the next few months to years?

If you read the thread I started called "a Pharmacists point of view" I state my opinion that e-cigs/nicliquid will be placed in it's own category and regulated/taxed more along the lines of recreational tobacco product then a drug/NRT product. If they really wanted to, the FDA would already have stopped e-cig suppliers altogether, at least in the USA. Instead they put out a "report" on the analyses of a lot of seized carts. When the FDA wants something off the shelves, they come into your store/Pharmacy and take it or IMMEDIATELY force the store owner to do likewise. Here's the thread:


http://www.e-cigarette-forum.com/forum/law-e-cigarette/26895-pharmacists-point-view.html

In any case, you will ALWAYS be able to order from China to replenish. The FDA's mandate is regulating the US marketplace, not individual consumers. They are never going to kick your door in and take your e-cig out of your mouth. It would take an act of Congress to do that. The FDA also can do nothing to suppliers OUTSIDE the USA. So, as I said, the most the FDA can/will do is shut down US Suppliers/marketers, but I don't think it will ever even come to that.

 

[HighTech]

If you read the thread I started called "a Pharmacists point of view" I state my opinion that e-cigs/nicliquid will be placed in it's own category and regulated/taxed more along the lines of recreational tobacco product then a drug/NRT product. If they really wanted to, the FDA would already have stopped e-cig suppliers altogether, at least in the USA. Instead they put out a "report" on the analyses of a lot of seized carts. When the FDA wants something off the shelves, they come into your store/Pharmacy and take it or IMMEDIATELY force the store owner to do likewise. Here's the thread:


http://www.e-cigarette-forum.com/forum/law-e-cigarette/26895-pharmacists-point-view.html

In any case, you will ALWAYS be able to order from China to replenish. The FDA's mandate is regulating the US marketplace, not individual consumers. They are never going to kick your door in and take your e-cig out of your mouth. It would take an act of Congress to do that. The FDA also can do nothing to suppliers OUTSIDE the USA. So, as I said, the most the FDA can/will do is shut down US Suppliers/marketers, but I don't think it will ever even come to that.

Yes, I had read the other thread, but your comment about things changing were in this thread. I had no idea that your comment about things changing were about comments in another thread, hence the reason I asked. Please try to keep thoughts together in pertinent threads...

Also, you stated that "the most the FDA can/will do is shut down US Suppliers/marketers, but I don't think it will ever even come to that". Do you think the current seizures are a Sunday picnic for the FDA? They have every intention of stopping the importation, marketing and sale of these products in the US. Once this lawsuit is over, I see them dropping the hammer... The press release the FDA gave a couple of days ago was to sway public opinion for the actions they are about to take. Watch what happens...

 

[quititllc]

As a retailer, I covered my .... by purchasing a Retail Tobacco Permit here in the State of Florida. Whether it does any good or not in regards to the definition of cigarettes is still unclear.

BUT

at least this way I can legally retail cigarettes and tobacco products in the State of Florida. I WON'T be charged with the misdemeanor crime of selling cigarettes without a license.

This license won't matter though if it is found to be a drug and drug/device combo. At least in the meantime I am somewhat covered. It was $50 for the license, and well worth it to protect my company.

 

[SharonLM]

As a retailer, I covered my .... by purchasing a Retail Tobacco Permit here in the State of Florida. Whether it does any good or not in regards to the definition of cigarettes is still unclear.

BUT

at least this way I can legally retail cigarettes and tobacco products in the State of Florida. I WON'T be charged with the misdemeanor crime of selling cigarettes without a license.

This license won't matter though if it is found to be a drug and drug/device combo. At least in the meantime I am somewhat covered. It was $50 for the license, and well worth it to protect my company.

Good for you! Good thinking and foresight.

 

[markarich159]

Yes, I had read the other thread, but your comment about things changing were in this thread. I had no idea that your comment about things changing were about comments in another thread, hence the reason I asked. Please try to keep thoughts together in pertinent threads...

Also, you stated that "the most the FDA can/will do is shut down US Suppliers/marketers, but I don't think it will ever even come to that". Do you think the current seizures are a Sunday picnic for the FDA? They have every intention of stopping the importation, marketing and sale of these products in the US. Once this lawsuit is over, I see them dropping the hammer... The press release the FDA gave a couple of days ago was to sway public opinion for the actions they are about to take. Watch what happens...

That's certainly a possibility. We'll see.

 

[vaportiger]

This is a firm that sells it here 90% pure cost about $350 a kg or 1 liter. They said I just needed to prove I was a copmany by giving them a tax ID# or a copy of a busness liscence. You can get it from Chine for half that price.

 

[twoshadetod]

How many packages did that come in? That price is very very very low.

To the physician - isn't 18mg/ml 18mg's of nic per 18ml's of liquid? If so you are writing them straight nioctine. A drop of it would be over 20x more powerful than a drop of 48mg. I don't think they'd die but it'd definitly keep those WDs away

This is a firm that sells it here 90% pure cost about $350 a kg or 1 liter. They said I just needed to prove I was a copmany by giving them a tax ID# or a copy of a busness liscence. You can get it from Chine for half that price.

 

[markarich159]

To the physician - isn't 18mg/ml 18mg's of nic per 18ml's of liquid? If so you are writing them straight nioctine. A drop of it would be over 20x more powerful than a drop of 48mg. I don't think they'd die but it'd definitly keep those WDs away

No the physician is correct. The strength of liquid expressed w/v(weight/volume) is 18mg per 1 ml of liquid. 18mg per 18ml would reduce to 1mg per 1ml wich would be a much lower strength.

 

[twoshadetod]

Are you sure about that?

Specific Gravity: 1.0097 (Water = 1)

I don't think it's even possible to fit 18mg of nicotine into 1ml of liquid, just because 18ml of pure nicotine weighs *about* 18mg

No the physician is correct. The strength of liquid expressed w/v(weight/volume) is 18mg per 1 ml of liquid. 18mg per 18ml would reduce to 1mg per 1ml wich would be a much lower strength.