ACU-038 A practical guide and considerations when prescribing herbal supplements to your patients.

In today’s episode I am going to cover…..

• The legal requirements you must follow to prescribe herbs, including state and federal guidelines. 
• What to look for when purchasing herbs from a distributor.
• What you need to know about reselling herbs and other products.
• What you need to know about reselling vs dispensing vs creating products.

Resources

White paper: Good herbal compounding and dispensing practices by AHPA 2017

NCCAOM State Licensure - Does your state require certification?

FDA Labeling Guidelines

NIH-Strengthening Knowledge and Understanding of Dietary Supplements

FDA - Cosmetics Labeling Guide

Jane Electronic Medical Records. Use this link to get your first month free!

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Mentioned in this episode:

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📍 Welcome back to the AcuSprout podcast. We are gonna be talking about how to sell herbs in your clinical practice. I wanna, before I start, I wanna give a special, thanks to Carrie Gian for reaching out to me to ask me to do this episode. Did you guys know that you could do that?

You are fully, fully, fully welcome to contact me and ask me questions or if you have a suggestion for the show, please reach out. You can do that at the AcuSprout. It's AcuSprout dot com and go to the contact me page. And you can fill out a little form and shoot me a question anytime you want.

And I love, love, love hearing from you and giving you specific information that you are truly, truly we're looking for, as opposed to just continually writing the content treadmill. Doom that I do sometimes. So reach out to me, let me know, if there's something else that you want me to really focus on and I will be happy to do so.

Okay. Let's talk herbs. In today's episode, I am going to cover the legal requirements. You must follow to prescribe herbs, including state and federal guidelines. What to look for when you're purchasing herbs from a distributor and what you need to know about reselling versus dispensing versus creating products for your patients,

So before I start, I wanna just sort of give a disclaimer because obviously I'm not an attorney , I don't play one on TV either, but the content that I'm providing is totally for your educational purposes.

So if you are really looking at the legal aspects of this, and you still have questions after this podcast, feel free to reach out to an attorney and ask them those questions. Okay, so starting off, we're going to take a look at the state laws in the United States. So my apologies to my international listeners, we are gonna cover some us stuff first.

So the only states, you know, one of the things that you need to look at when you're prescribing herbs is what is in your scope of practice. According to your state, there are five states, six states. Well, Five states in Washington, DC. That have specific requirements around prescribing herbs. So these are the states that the licenses that you need to practice medicine specifically, herbs are Illinois, Massachusetts, New Jersey, Ohio, and Washington, DC.

These states actually require, Oriental medicine certification or Chinese herbal certification, which you guys know if you pass the herbal board, this is what they're looking for. Basically is the N C a O M herbal board is what you need to pass in order to be certified to practice in Illinois, Massachusetts, New Jersey, Ohio.

In Washington DC. Now there are two other states that are really bizarre of course. So Pennsylvania Actually doesn't require an acupuncture cert certification, but they do require the Chinese herbal ex herbology exam. In order to practice herbs, same thing with Vermont acupuncture certification is not required.

However you do need to pass the herbal board in order to practice in Vermont. So. real slow, real quick. Those are the states, Illinois, Massachusetts, New Jersey, Ohio, Pennsylvania, Vermont, and Washington, D C. So I wanna talk a little bit about insurance this is one of those questions that you should have for your insurance company, whether or not they cover your practice of herbology right of your herbs. I love CMN F cm and F here in the us, and they.

Basically have told me that they cover whatever is in my scope. What that means for us is that you need to go to your state, whatever state you live in and take a look at everything that's written up as far as what is in your scope of practice. So a company like CMN F will, will, no matter what state I'm in, if part of using herbs is a part of the scope of practice, then my insurance company will cover that.

Okay. I'm not sure. if they'll cover it, get this, think about this. If you think that you're gonna do herbs and treat herbs in a telehealth situation across state lines. My guess is you really wanna check with your insurance on that?

Before we get into the details of reselling and dispensing, let's cover some pretty basic elements that you need to be aware of.

In the United States, the us food and drug administration, the FDA has regulations in place that are basically designed to ensure that food, drugs, and cosmetic products are consistently produced and controlled according to quality standards. So these regulations are known as the current good manufacturing practices.

You'll see that as C GMPs and. They can be found in the code of federal regulations, title 21. Anyway, You'll often see the older term GMPs in lieu of CGMP, but this is one of the things that you're gonna need to look for when you're purchasing from a distributor. So when you purchase from an herbal company, you wanna make sure a they follow CGMP.

You also need to take a look at all of the other steps in ethical practices that your favorite companies undertake to ensure the safety of your patients. I use spring wind for bulk herbs because they pretty extensively test their herbs for the proper species, pesticides, heavy metals and organic status. And I love that they also have really amazing customer services, pretty small company, so to speak, like they don't have a million employees, so you can really talk to people which I love. And I, I love bulk herbs, but I would not say if you're a new practitioner, don't go that route because they're not yet, at least because they're, it's an expensive way to do.

Herbs and people probably your compliant patient is in the like 5% range. So literally 5% of the people will actually comply and cook their herbs and take them

so I wanna talk a little bit about reselling versus dispensing versus product development. or As an herbalist, you. Make and give things to your patients to sell them to the general public or to market them is, is a bit different. And I know this just crushes your creative souls because I also got outta school and wanted to like, make all these great products and sell them all over the place.

But there there's really a lot of guidelines that you have to follow to do something like that. However, you can't make things for your patients. With regards to reselling things, some things that you might consider reselling are patent formulas, tinctures, topicals, ma sticks, herbal skin products, SAS, TheraBands, all sorts of things in the, in those categories.

These are items that you purchase from a wholesaler like blue poppy or gold needle or loss of O. That you then adjust the price and resells for profit. So here are some things that you need to consider when reselling, you need to check number one, you need, you need to find out if you need a reseller's permit, that's probably gonna be a state city or county thing.

So you'll need to do some research with that. I have never had to have a resellers permit, to sell herbs two. Does the company that you're purchasing from have specific regulations, with regards to reselling, for example, clinical pearls, which is Hoff's company has very specific reseller rules.

You need to make sure that you have an account set up with your state city and possibly your county to pay excise taxes. So these are the sales taxes that you collect. So usually, , they're paid quarterly

so make sure when you're looking these things up that though I've said this before, cuz this got me. Hung up when I was new, make sure that your, that your URL ends in.gov or whatever your state is, maybe dot a for Washington or ID for Idaho or whatever, make sure that your URL ends there because this is how people will catch you and sell you stuff that you don't need.

Cuz you think you're on an official website. So make sure that they end in.gov or dot. It may even be DOR. I think it's DOR dot wa for us, the department of revenue, Washington. So be sure do your research on this and find out if you actually need to collect state sales tax for supplements.

If your state collects sales tax, you will have to pay sales tax on hard goods. Like if you're selling a GU shot tool, that is something you'll have to collect sales tax because obviously that's not a supplement.

Okay. Number four. So you're gonna set your price. So how do you do this? How do you know how to set your price? So basically you, sometimes there will be like an MSRP, which is, manufactured, suggested retail price, and that's just a suggestion. You can price things, however you want. With my patents personally, . Unfortunately I actually often look on Amazon and then charge a couple dollars under what Amazon is charging, just to encourage my patients, to support me instead of ordering online, because obviously you can find a lot of these products online and you don't want your patients out there undercutting you and they will.

And it's sad when it happens and they just don't understand. So I usually take a Gander at What's on Amazon, specifically the brand that I'm using. So I love blue poppy, but I also know that blue poppy also distributes on Amazon. And so I just check the price. And then charge a 📍 couple dollars under, so number five, you can be audited by the IRS.

So as soon as you purchase an item with the intent to sell it for profit, you are absolutely required to include that income when you file your taxes. So a good way of doing this, if you don't have an EHR as I, I use square, I think I've talked about this before, but I use square and then I set square up to charge the proper amount of sales tax for herbal supplements.

And I have that as a category on square, and that's how I run my report. So I can actually pull up a quarterly or monthly report showing what, how much I sold and how much I collected in sales tax. Only just in that one spot. If you have an electronic health record system, it'll keep track of all of this and you can program it specifically.

Not only that, some of them will also keep track of your inventory, which is nice, but as soon as you're selling products, if you're not registered with your state and filing your taxes, you really are opening yourself up to an audit with the IRS. So be sure to, keep track of the taxes that you collect and then pay them quarter.

number six. So price setting. So in general, honestly, reselling is, is legal. And I had a question around this. Can you purchase something and then resell it? Yes, actually the Supreme court ruled in several cases that if you purchase something, you are the owner and you can sell or resell it as you see fit.

In fact, that's actually the way, you know, our market and commerce systems work kind of throughout the world. Right? So. Nearly every physical business is based on purchasing an item and reselling it for a higher price. So this is exactly what you're gonna do, and you do get to choose the price with which you get to sell it at.

So don't worry about. Purchase resell number seven, record keeping. So we already talked about how to keep records on your taxes, but you also absolutely need to chart what you sold. So be sure to indicate the date you prescribed it, the strength or how much and how often you told the patient to take it.

I also usually make a note about when they should be finishing up. So as I treat, I can go, I can look back and keep track , of what I might prescribe next. I usually do this in, in the beginning, like I'll think of like three different formulas that might really ch treat this particular challenge.

And then I. Prescribe one of them, but note the others just in case I missed something and things need to, to change a little bit. So you might wanna keep track that way anyway. So, and then depending on. on where I think their pattern might change too. In the future. I usually have thoughts in my head about that too.

And I note those in the, in the chart notes so that I don't have to go back and think about all of that all over again. So it's a pretty basic thing that I do, but it is something that has been saves me time and is pretty beneficial. So, the note section is just a part of my soap notes, where I communicate with the future me sometimes.

But something that I want you to truly remember if a patient or another practitioner requests, copies of medical records, they will see that.

Okay. So briefly, like again, I said this earlier, but as an Herbst, you can make things to give to your patients so you can make DJA and you can make, any topical you want, you can create all sorts of different products. Because you're distributing them to your patient, then you're working in your scope.

If you make these products and you mass sell them, there's a whole different line of guidelines that goes along with that. So what we're gonna talk about right now is dispensing. Basically dispensing just means that it would include the formulas that you create specifically for a patient and create using like granules or raw herbs.

So the following dispensing suggestions can actually be found on the N C C a O M website. And the link will be in your show notes under references, or if your show notes don't hyperlink and you can't, or you can't find them, you can always look on the AcuSprout website on this particular show notes for this particular episode.

so I'm just gonna give you a little bit of information that is just quick and super helpful. I think. So let's talk about labeling the herbal prescription label should include all of the information required by your state. And federal law as a, as applicable, and then accepted standards of practice, including the presence of any major food allergens.

Now, the companies that you purchase your grand rules from should have the allergen information on their labels. So you can just transfer that in information to your labels. So this is for if you were creating a personalized or if you are. Putting granules in a new bottle, you need to label that new bottle that you're gonna give to your patient with these things.

So the herbal prescription should be labeled at a minimum with the following. Should have the patient's name number one, number two should have the herbal prescription name. Number three would be the dosage form and strength. Number four would be the preparation date. So it's the date that you actually mix those herbs up and put them in that container which often, and then number five is the dispensing date. So if the patient didn't pick it up that day, then you would note on the label the day that they did pick it up.

So dispensing just means.

The date that it was dispensed. You need to put the name and address your name and address. And if you have a control number, you can put a controller number on there.

So in addition, The following has to be on your prescription labels as well. Number one, a complete list of ingredients, including the inactive ingredients. Excuse me, number two, a declaration, if, if there's alcohol in the liquid preparation.

So if you create a tincture, you need to make sure that you note that, that it is an alcohol prepared tincture number three, recommendations for use. So three, three dropper fulls twice a day with meals, whatever. Number four, the possible side effects only is it's applicable.

Right? So here are the records that you need to keep. This is the documentation that you need to keep. You need to keep a, a dispensing record that shows the following information. Number one, the patient's name, date, date of birth comorbidities and TCM pattern.

Number two diagnostic information. So tongue and pulse, if available, and then vital signs, if available and temperature number three there's symptoms. So if they have shortness of breath, if they're hot or cold, if it's a cough, . So you need to keep all of the symptoms you need to document number four, current medications, including prescriptions and over the counter products.

Number five, any known allergies. Number six, the herbal prescription that you dispensed the ingredients, the dosage, the lot number and the date that you prescribed, number seven, the treatment status strategy. So in other words, what are you trying to do? Are you clearing heat, resolving damp fle in the lung?

Cosing the Chi, what is it that you're doing? Number eight. Copy of the, a copy of the recommendations for use provided to the patient. That can look actually just quite literally as taking a picture and putting that in your file. So let's talk about production and I'm only gonna touch on this briefly with very basic guidelines because you could. This could probably be a whole episode of its own. And if this does interest you let me know because I'd be happy to do an episode on this.

So some of us, absolutely. I said this earlier, love making SAVs and tinctures and line and topicals. But the real question is, can you sell these products to mass markets and mass markets can include Etsy guys or taking them to an herbal shop. and selling them that way or the farmer's market, whatever.

So the question is, can you open an online store and sell your products? Well, number one, if you wanna bulk produce herbal products, you have to follow the CGMP. So like I talked about in the very beginning, you have to follow all of the CGMP. and that is gonna take an initial investment of time and money.

Because first you'll have to take a CGMP course, and then you need to develop your templates and procedure and paperwork while making sure that your facility is properly equipped. Or you could just outsource all of that. . So if you're creating number two, if you're creating skincare products, you'll need to follow certain guidelines.

That would be linked in the show notes, but these are, these are guidelines for cosmetics, actually, if it's a skincare product. So you have to be careful because the whole there's a whole other guidelines for cosmetics and skincare. Number three. So I'm gonna link some of those guidelines in the show notes. If you're interested in taking a look at those number three. Here is what you can do. You can sell to your patients. You can make ments, topicals and treat your patients. Remember your insurance covers the scope of practice according to the state.

So you need to keep this in mind as a practitioner. Number four, if you want to sell to the masses, you'll have to jump through a bunch of hoops of getting also extra insurance and following production and labeling instructions. So that again is a whole other episode. Whew. Okay. I think that covers everything.

So quick recap. In this episode, you learned about state requirements. As far as licensure, you need to take a look at whether or not your insurance will cover you practicing herbs. You need to be cognizant that if you practice herbs and cross state lines, like telehealth situation, that you may not be insured.

You also, I told you all about labeling and. What you need to do as far as the patient's label and then what you need to do as far as your own documentation in your soap notes. And lastly, just things to be aware of, if you're going to create products on your own. So.

that's today's episode. Thanks for listening you guys. And thank you again to Carrie Guillen for 📍 inspiring this episode. We'll catch you next time.