Well, hello, hello, guys.
You're listening to Beauty Bites with Dr. K, Secrets of a Plastic
Surgeon, and we have a great podcast planned for you today.
This year, I really want to focus on making sure people in aesthetics are doing
things within the boundaries of the law, because aesthetics is getting so exciting.
There's new advances, there's molecular techniques coming, and Some of these
are not FDA approved for use in different manners that we're using them.
So today on the podcast, we're talking to Sarah Schickman.
She is a distinguished attorney, a healthcare attorney, and an entrepreneur
with over 16 years of experience.
She's one of the managing partners at Langeia Law, and she's guided
more than a thousand patients with these complex healthcare issues.
And I think we really need to dive in because, um, People are doing
crazy stuff out there, Sarah.
Welcome to the podcast.
And let's talk about how to stay out of jail as an aesthetic injector.
Yeah.
I think the number one way to stay out of jail is probably not to do
things that cause one to go to jail.
Right.
That seems simple, but I think with a lot of the gray areas in
our space, it's kind of hard to figure out, okay, well, what is it?
That would cause someone to go to jail or lose their license or pay a huge fine.
Um, so we're going to talk about all those things.
And we're saying it kind of jokingly, but I will say for sure that there have been
legal cases in the media this year where not only were there patient deaths, but
also, you know, health care providers did get licenses lost and go to jail.
And so it's really, truly serious territory.
Um, but for example, like some of the things that are trending in
aesthetics right now are using products that are labeled for topical use.
Um, and micro needling and then I think injectors are innovating the
use of those and switching them over to injectable use in their practice.
So can you tell me a little bit about, you know, when the FDA approves a product
for injectable use versus when people start using it as cosmeceutical, how do
we, how do we play in that playground?
Yeah.
And that's a great question.
Um, when the FDA approved the product for injectable use.
It goes through lots of process and lots of study and, um, it's a
very, very big investment from the pharmaceutical company doing it.
And it's a very long process with the FDA and the goal of that process to ensure
patient safety as much as possible.
And then their products that are considered topical that
are basically skin care.
The word cosmeceuticals is not really like a legal term.
So there isn't like, okay, as long as this is a cosmeceutical, you can do that.
It's basically things that are approved by the FDA to be
injected and then everything else.
Right so, we have all these new products.
That today have not been approved by the FDA for injecting,
but people are injecting.
Um, so what happens to those people?
What kind of liability do they have and how do they check?
So, the first thing is.
In the patient consents that you have patient sign, make sure that you disclose
the risk of what you're injecting and the fact that it's not FDA approved.
So that and make that as clear as possible and work with your attorneys to.
Create those consents, not, you know, chat GPT or, or, um.
Some getting something off the Internet, so that's the
1st thing to protect yourself.
The 2nd thing is.
Make sure that you personally feel comfortable injecting this thing that
hasn't really been studied for injecting.
Try to find things that if you're going to inject them, maybe there was a study.
About this thing being injected, but not in, let's say the
face, maybe the study was.
That being injected into joints or something else, so something would
be theoretically safer to inject.
If it had a study for injection anywhere in the body.
But if you're going to inject something that has absolutely no
studies of getting injected anywhere, you're taking on a big liability.
And you, as a medical provider can take on that liability.
But a consent will not fully from that liability.
So, um, we've had situations where, for example, somebody injected.
Some platelet product, and then the patient got some adverse reaction.
Relatively minor, but.
You know, on someone's face, everything, nothing is really that minor, right?
If someone's face becomes like, a little bit red or puffy, the
patient was extremely upset.
They, they wanted a refund plus a lot more money than that.
So, the liability will really be on you if you inject something and,
and there aren't any FDA approved indications for injecting it anywhere.
Yeah, so you need to have kind of evidence based guidelines to say
that it's been used in humans before and that these humans turned out
fine and same area of use, roughly.
Yeah, and I think as a physician, someone has a lot more room to, to, um, do
these kind of things than, let's say, someone is a registered nurse doing it.
Because the, the.
Licensing boards give you a lot more deference as a physician than, let's
say, if you were a registered nurse, even if you're a registered nurse who
did thousands of treatments, that's just how they view it in their way.
So, I would say, you know, if you're a physician, you have a lot more room.
But at the same time, you also have a lot more dilutes.
Because it's your license, and a lot of times, um, you know, once you
have something on your license, it follows you for the rest of your life.
Yeah, it's, it's an interesting scenario because I guess we are using
products off label all the time.
Um, and as a doctor, you can do that as a, I'm not sure, and you'll have to teach
me that for PAs and nurse practitioners and RNs and things like that.
But as a physician, you can take an FDA approved product
and use it off label, correct?
Correct.
Definitely.
Um, so that if I'm using a product like sculpture for the face and I decide to put
it in the butt, that's an off label use.
Yep.
And that's totally
right.
No problem.
As long as I would say you have it in your consent that you're
doing it as an off label use.
And then also, I would recommend checking with your insurance and having it
specifically added that you're doing, let's say sculpture BBL, you would
put that on your insurance policy.
To make sure that they cover you up for that.
Interesting.
I was at a meeting, the Genesis meeting with you, and you had some
really interesting thoughts about polynucleotides, and then you did mention
also reaching out to your malpractice carrier to make sure you add, um, what
was that specific to polynucleotides?
I'm trying to remember what you were saying.
Yeah, I was saying that, you know, sometimes, um, We may be doing like 50
different treatments in the office, or in your case, your office is very innovative.
You guys are probably doing lots of 100 different treatments.
Yeah, right.
So adding every single treatment to your insurance policy,
um, would be very cumbersome.
So, uh, what people can do is just send an email to your insurance
company and say, hey, these are the products that we're using.
And these are all the treatments.
Look at our website.
That's better than nothing.
Um, so I would recommend at least doing that at least putting the onus
on the insurance company to then come back and say, wait, wait, wait.
Uh, you need to do this and that to get this approved, but at least you have a
record of an email that you send to them asking for approval or notifying them.
Um, but we have seen situations where insurance companies have said,
well, we told you we have this line here that this is not FDA approved.
So we're not covering.
This, or we've even had a situation where an insurance company said.
These are our approved consent forms that you have to use and if you didn't use
our consent form, we're not covering you.
That was for a laser situation, so I think this may be a little different.
But I think people have this misunderstanding that.
Uh, let's say you're using sculpture, right?
Um, if you're using sculpture, and even if you're using it 100 percent on label.
It doesn't mean that the manufacturer of sculpture is going to protect you in
case there's some kind of, like, lawsuit.
It's really going to be on you and your offices and your legal procedures.
So, the legal protection you have from the manufacturer is pretty small.
Even if you're doing something on label.
So, um, we've got to redo all our consent forms, make sure we're adding instances
where we may use the product in an off label manner, and then we really have
to inform our malpractice companies, because that's, that's a big thing.
Every year there's like five new products launching now, um, with molecular science,
we have You know, growth factors, we have polynucleotides, we have exosomes,
and the science is all super new, so I'm very sure that they're not used to these
ideas as a conventional treatment yet.
Definitely, so I think those two action steps are really good.
Updating your consents, um, calling your insurance company, and number three,
Updating your in office procedures, so I think sometimes people may feel
like they can do whatever they want.
Like, after the, you know, the person, somebody in the office goes home
and there's 1 provider left and that provider says, well, okay, in our office.
No, 1 ever told me that not to do, you know.
This particular procedure, let me try it on my friend, you
know, or let me try it on myself
and
then things go wrong.
And all of a sudden that friend is not your friend.
And so it's really important to have written procedures
in your office that say.
What every type of person is allowed to do, meaning your are allowed to do this.
Your are allowed to do this.
Like, down to the body part, so if someone feels.
Board and their best friend comes, they don't just start injecting.
You know, filler into someone's butt, which actually happens at a practice like.
Someone had a dimple in their butt, they decided that it was a good idea
to inject luma into that dimple.
Unfortunately, there was an infection.
Um, and so.
That even though that person was a friend, it didn't go so well.
Mm hmm.
That's terrible.
What kind, what are kind of the most common claims that you're seeing
that arise out of med spas where, you know, you're seeing problems
where illegal cases develop?
Interestingly, the, the biggest area is lasers because, uh, with a lot of
things like, um, you know, biosimulators, uh, neuromodulators, fillers.
Um, over time, they could either be reversed or they go away on their own,
but with lasers, once someone is burned, it's really hard to get rid of the burn.
You can try creams and surgery and whatever, but so I would say over
70 percent of what I see with claims have to do with lasers, actually,
and a lot of times with hair removal and a lot of times on darker skin.
Um, and is it kind of like these places that are laser mills that do
a whole lot of hair removal and then they're just taking untrained staffing?
Yeah, a lot of the places that, that it's happening to are places that
don't even have a medical director, uh, where there's just, uh, someone
who lacks training operating the laser, you know, they're not familiar with
exactly the settings to use, but even sometimes using all the right settings.
Sometimes things go wrong and the person doesn't know when to stop the
patient said, oh, like, you know, this hurts and that person continues.
So, I think that having a lot of training really helps.
Reduce some of these issues that happen and having properly licensed
medical providers involved.
But, yes, a lot of we have the most.
The biggest majority of cases we've seen have to do with lasers and the
vast majority of them have to do with places where there wasn't a proper
medical provider, even on staff, not even forget about on site, not even on staff.
Yeah, I think the consumer has to be so careful now to.
At least try to understand and vet that because they're walking into
an office where they assume that everyone's credentialed and that
legalities are being followed.
But it's very state specific, but you know, most states and RNs
require supervision by an MD, right?
Nurse practitioners.
Yeah, certain states, nurse practitioners and PAs can practice independently.
Yeah, in
most states, lasers through the practice of medicine.
So, in most states, an esthetician can't just run a laser without anybody else.
So, yeah, it's, um, it's hard, I think, for consumers, right?
Sometimes people, they see someone and they have great marketing and they have
great before and afters and they are tempted by, by a really great price.
Uh, and I, I get that.
I, you know, I've definitely witnessed that myself.
But, you know, I think it's, it's, it's complicated because sometimes the great
price comes with much greater risk.
You know, another thing we've noticed is that with IV hydration, um, a lot
of times, you know, I'm not a doctor, you know, you know, much more about
this than me, but what I have seen is like, uh, patients have some very severe
adverse reaction because the wrong thing was mixed together with something else.
Um, and, you know, it's going into someone's IV, so I.
It seems like it's much stronger than, than if, you know, they were taking it
as a pill and we've seen a lot of, uh, people losing their license because
someone literally had a crazy reaction in their office and died or almost died.
Yeah, buyer beware like intravenous therapies are should not be messed
with and like it scares me when I see the IV hydration rooms that are
popping up all over Vegas and all over LA and different places because like,
I, I think that very often they're staffed by people who are like hourly
rate, um, you know, fill in from an agency type of, RNs and, and, and P's.
And I'm, I'm very hopeful that everyone has great training, but
I also see poor techniques, not, not such sterile techniques.
And like, I think medication errors are super easy to happen.
And this year in Texas, a patient lost their life from a
wrong additive to an IV drip.
And it's not to scare people like IVs are given hundreds of thousands of
IVs are given, you know, daily and monthly in the U S but, um, And very
safely and effectively, but you really have to do your homework and feel
super comfortable with the person.
And it's always nice to know that there's a doctor in the background.
Um, you know, so I think that's really critical.
I can't emphasize that enough.
Um, I think in Vegas.
There was also a situation where PRP was, uh, blood was spun in a centrifuge and,
um, you know, patients contracted HIV to, due to the really crazy, awful, uh,
reusing of test tubes that was done there.
Yeah.
I mean, what you, you saved a hundred dollars or something on your PRP,
but you got it, you know, a, a Uh, terminal illness as a result of it.
I mean, uh, or a super serious illness.
I mean, it's, I think it's, it's really a scary world out there and So sometimes
with a lot of these treatments, one small mistake can make a big difference.
For example, we've had instances of lidocaine toxicity.
With a lot of these treatments, a little bit of lidocaine is mixed in to make
the treatment more comfortable, like with sculpture or treatments like that.
A small difference could mean the difference between safe and toxic,
like someone may have a heart attack.
So really, really important, right, to, to Check as a consumer that the
person you're going to understand that as the right credentials.
And we, with that particular situation, we've seen people
lose their license because.
Yeah,
cardiac arrest is a big deal when you're having your scoltra.
I'm sorry, that's like, but I would tell the consumer out there that very
sadly, I would say the vast majority of injectors are not aware of that.
And we teach this in our, my modern aesthetic theory course, and I'm super,
you know, as a surgeon, we calculate your lidocaine dose when you arrive
based on your body weight, and we make very hundred percent sure that
we, underdose lidocaine added to all the vials because it can stack up.
You're getting 20, 30 vials done on your butt or other places.
Like you become very close to like the lethal dose or maximum dose if you're not.
Careful and you don't modulate that.
And like, I don't think the consumer knows that the average nurse or nurse
practitioner or PA, or I mean, average is average and there's always excellence.
You should strive for that.
And maybe you even ask those questions.
It's so, so awful that the consumer has to be put in that position.
You would expect that professionalism everywhere you go.
And yet it's not there.
Many people learn how to do their injectables off of
YouTube or watching Instagram.
Sadly, this is the reality of the world we live in.
Like, they don't read books, they don't take classes, they don't get
certifications, they maybe don't have degrees, and they're out there practicing.
So, like, that's, that's the buyer beware message that, um, you
really have to vet this person.
Are they board certified?
Are they super credentialed?
Do they take a lot of classes, you know?
And I've had situations where on the website, it says the
person is board certified.
And they're actually not, they just actually like, the person actually
wrote that they are and they're not.
Yeah, it's, it's, it's really a weird world out there that that happened.
Yeah,
but enforcement is up in many states, like.
For example, in New York, there's a new task force.
That's, uh, created by the different boards where they have, uh, a lot
more resources and they're literally going door to door to, um, different
meds class starting with actually more in upstate New York, because.
Albany is where, um, like, the headquarters of the
boards are in New York.
And so I guess it's a shorter trip for these investigators, but they're
literally going to multiple people a day and saying, like, do you have.
You know, procedures.
Who is your medical director?
Show us all your paperwork.
So just be ready because a lot of times.
I think in some places, like, people have been in business for 20 years.
They never saw anyone and now it's really, it's really become the focus because
of patient death and because of all the new treatments that have come out.
Well, what do you see as like upcoming regulatory changes that can make it
either easier or harder for practitioners to use the new biologics like exosomes
or even peptides in their practices?
I think the FDA will likely come out with new position statements on these
products this year, especially if, um, adverse events are experienced.
So if there's going to be a patient death or multiple, I think the
FDA will come and say, okay, like.
We are aware of people injecting, let's say, exosomes, and you shouldn't do that.
And if the FDA does that, then right away, you're basically, I noticed that if there
was a complication, uh, the malpractice discerning would say, well, if the FDA
said this is not safe, then you weren't following reasonable standard of care.
So, it's just important to stay abreast of those kind of things.
I think with the new administration, the FDA will be a little bit
more open toward new therapy.
And I think that in general, as long as we continue this trend where.
The new therapies are proven to work through experience through where
people are doing these treatments and.
Um, clients are happy, but also there are very few adverse events.
Um, that'll be great and the FDA is not going to issue any position
statement saying these treatments.
Are not safe, however, that's always subject to change and.
It's a little unfortunate where there are a few practitioners that are doing
things badly and there are adverse events.
The FDA.
Is likely to come out and say, hey, these treatments are not safe.
You shouldn't be.
Injecting them, you shouldn't be using them until they are FDA trials on them.
But in general, I think the FDA's position to be.
A little bit more friendly toward emerging treatments than they were.
In the previous administration.
So currently the, um, legality surrounding exosomes are that they
should only be used for topical microneedling treatments, right?
Have you heard anything other than that?
So we do see people injecting them into hair, injecting them in Place in the body.
I've even seen IV exosomes given to some of my patients, which unless
they're your very own exosomes, I definitely would not do that.
So, um, I think that they have had emergency FDA approvals for people who
are like on death's door with COVID and having pulmonary shutdown and giving
exosomes truly helped those people to recover from their whole acute
respiratory distress, you know, white out lung, um, But other than that,
it's really not approved for anything.
Yeah, I would say exosomes are really not approved for any kind
of injecting anywhere in the body and doing it is dangerous.
So, um, if I was a practitioner, I would say it doesn't really make sense to
inject exosomes right now because it's the liability, the potential liability
is too high, uh, because it's going to be pretty easy for a lawyer to show that you
didn't meet the standard of A reasonable person where you inject something that was
not studied for injection in the body or FDA for injection anywhere in the body.
There are plenty of other things you can inject that are FDA
approved for at least something.
So, I would go for those things 1st.
Um, also speaking to some of these companies, they say that.
Their products are not made to be injected that they get.
They're, they're not formulated for injection.
Or even when they're micro needle, they get, um, destroyed.
So, with some of these exosomes, like, Does it even make sense?
Uh, sense to inject them.
Is it worth the liability?
You know, I don't, I don't think so.
Yeah, I agree.
Um, can you talk a little bit about polynucleotides or the salmon sperm
craze where people are also micro needling that, but they have been used
in Asia and other places as injectable treatments like under eyes and around.
Um, so they're, and they're also sold in the syringe form, even though
they're for topical microneedling.
So I feel like it's so much mixed messaging for the aesthetic injector.
Yeah, uh, in the U. S. the FDA does not care if the product was
approved overseas for anything.
Um, neither does the U. S. law.
So I think that even if salmon sperm or some of these other things were
approved overseas, uh, for injection, that doesn't mean that they're safe.
To use, or you could use that as your reason should something go wrong.
So, um, personally, I don't think that it makes sense to do those
products injecting those products today in the U. S. You're just taking
on too much liability for yourself.
Some people may say to themselves, okay, well, I'm going to treat 1000 people with
this for 1000 dollars each and if I get in trouble, okay, that's going to cost me.
50, 000 and then, you know, I'm just going to fight it.
Um, but it's a pretty short sighted perspective, because once you have
a warning on your license, the next time it's not just a warning.
They're going to send your license or do something else.
So, um, even if you're making a financial decision.
Um, it's not good when it comes to safety to make decisions
that way, because long term.
It's going to lead to some bad consequence, both for
yourself and for your patient.
I think if you have to try these treatments and you want to, you know,
have a logical approach, then you have to come up with a clinical trial and
you have to go through the motions and, you know, talk to the FDA.
Is it an investigational use of a new drug designation?
And you have to have an IRB, like a research board, decide that
you're doing ethical and safe study, and then you go for it.
But nobody, nobody does that.
Yeah, I mean, I think it's very expensive, right?
So, uh, a lot of people find it cost prohibitive, but companies
are, uh, getting investors and are trying to do some of these
studies and they will happen.
Uh, but they just haven't happened yet for things like, uh, salmon sperm or, um.
Exosomes, but I think they are pending.
I think the companies are are.
Trying, but it's going to take time, but there are lots of treatments
available today that are FDA approved.
But also off label, there are, uh, there are lots of treatments there
and I think that then it becomes as a provider, you protect yourself
with paperwork between you and your staff, between you and the clients,
and you and your insurance company.
And how about, um, mixing products into, let's say we're
using a filler and we're at it.
We want to add nutrients that are normally given in the body like
vitamin B12 or we wanted to, you know, products that are just amino
acids or normal minerals, vitamins.
Can those be mixed in with your injectable or does that change the
whole, uh, approval of that product?
Yeah.
Great question.
So again, that becomes completely off label.
And then you would look at each product separately.
Okay.
Has this formulation of vitamin D been approved for injecting?
And has this formulation of filler been approved for injecting?
Okay, if yes, then you can proceed with the treatment, but it's off label.
Um, but if you're injecting some, you know, vitamin D that that is not
approved or, or it's not supposed to be injected, but you decided you have a vial
and you're going to inject it anyway.
That's not a good idea, but also realize, like, just because something is a
vitamin doesn't mean that it's safe.
So, like, there are lots of vitamins where, if you inject that whole
vial of the vitamin into someone's body, like, they may have, uh.
A huge reaction that you're not prepared for.
So, it's really, there's a reason why there aren't FDA studies of
all these combinations of things.
They're very expensive and they're very particular.
So, it would take a long time to get all these things approved.
Um, you don't want to be the one doing the experiment on your patients.
Yeah, I mean, sometimes the combination can trigger different effects than
the solo products by themselves.
Um, in terms of platelet rich plasma and PRP, people really are using
that liberally and feeling like that, um, because it's your own product
harvested from you as a human, you don't need any special approvals and
you can do anything with it anywhere.
Is that accurate?
Oh, again, it's, it's 1 of those things where, um,
it's not a drug.
It's a human derived product.
Yeah, I think that it's, it's not a drug because it hasn't been approved as a
drug to treat any, any of these things.
But what you're doing with it is not specifically approved.
So you're really on your own.
Something go wrong.
Um, the chance of something going wrong, at least based on what we've
seen through our data and through the malpractice that we've seen.
Is relatively small compared to some of the things that where it's
not made out of your own stuff.
But again, um, you just never know.
Sometimes again, it's next slide again.
Uh, it's mixed to some other things, so just make sure that.
Whatever you're doing, you feel really confident that you a
adequate training and be that.
Uh, legally someone not a Facebook group and not the Internet
told you that it's okay to do.
Yeah.
Yeah, I think that's so true.
And, um, uh, uh, in terms of other products like growth factors, there's
platelet derived growth factor, one of my favorite products area, since that's
FDA approved for use in orthopedics and in surgery and oral maxillofacial
surgery injected into joints.
Um, what's the legalities of taking something that has all those FDA approvals
and injecting it elsewhere in the face?
Yeah, so that would be, uh, an off label injection, which is much more safe than
just injecting something that's not FDA approved for any injection anywhere.
So that's kind of similar to Substra being FDA approved for
here, and you're injecting it here, or wherever people are injecting.
So it's, um, I think it's relatively safer to do that, but just be very clear
in your consents with your patients that this product is not FDA approved.
For this particular use and the special risks for that.
So, um, that shouldn't be like a line buried and at the bottom somewhere
where someone say they didn't see it.
There should be a paragraph explaining.
That is not approved and then there should be a paragraph explaining
what are the possible side effects.
Um, to make it very clear that this product is not
just risk free and also, um.
The, the lack of the approval for injecting.
Got it.
Um, yeah, I think that's so important.
So basically transparency is one of the main things I'm hearing from
you is you have to be so transparent in terms of teaching your patient
what they're about to get done.
Um, yeah.
Can you talk a little bit about peptides and, um, like the new
longevity managements that we're doing in the office, which again,
peptides are Some of them human derived compounds, like your own body makes
BPC 157, the body protective compound.
And so, um, I think people need to be aware of the problems with the
compounding pharmacies that are creating these products, and whether they're
research or animal based products.
So can you dive into any scenarios where you've seen problems with these?
Yeah, I think that, uh, with compounding pharmacies, there's very little oversight
about where the products are coming from.
Um, and whether they're being coming from China, whether they're for research
purposes, whether they have additives.
Um, again, these things are not the compounded versions of these
things are not FDA approved.
So, you have to make sure that in your paperwork, you discuss
this and they added with.
So, the compounding pharmacies themselves.
Sometimes are saying things that are not 100 percent legally
accurate, but don't just take a compounding pharmacy's word for it.
Ask your lawyer about it.
Um, and
for in terms of your clients, it's really important to educate
them on, like, no results of these things are really guaranteed.
And these are the, you expect a series of treatments and, and some possible
side effects and, and all that stuff.
So.
Like with anything else, it's about client education and being very
transparent with your clients.
But also, in this case, with your vendors really not taking their word for what
they say, especially when it comes to, um.
Some of the things, like, you may ask them in some states, the, the pharmacy
that you're getting it from has to be registered with the state and has to
have a special permit from your state.
They may not have that permit, they may just ship from out of state.
But they're not allowed to do that.
So always ask your pharmacy, like, do you have the required
permit to operate in our state?
Ask them this Friday and make sure you get an answer.
Can you be a distributor in California, for example?
Exactly.
Like, you've got a
compound here, but can you distribute here?
Or you can ship it in from your Texas facility, but are you authorized
to distribute in California?
That kind of
thing.
Yeah, exactly.
Yeah, and then are there other legal designations that they need to have in
order to be a good compounding pharmacy?
Um, it depends on the state.
So the regulation of compounding pharmacies, a lot of it is,
is really state specific.
Um, the FDA doesn't have a lot of regulations around them.
They may say, oh, the FDA came to, you know, came to visit us or inspect
us and you would ask them or, you know, what exactly does that mean?
Do you have any paperwork from the FDA saying your facility was approved?
Um, so it's, it's a changing industry too.
I think there'll be more regulation coming.
To compounding pharmacies right now, a lot of it is a bit in the gray area.
. Hmm.
And what is, um, the 5 0 1 designation?
Like the, am I, maybe I'm even saying it wrong.
Was it 5 0 3 or 5 0 1
? There are two types of pharmacies.
Um, I think it's 5 0 3 A and 5 0 3 B.
Yes.
Um,
and I'm keeping taxes when I'm thinking 5 0 1, sorry.
Yeah.
Maybe you're thinking of 5 0 1 C3.
Yes.
Nonprofits maybe.
Um, so yeah, so there are two different types of pharmacies.
Uh, 1 is allowed to do more than the other and 1 is subject to
more regulation than the other.
Uh, but right now, a lot of them are 1, they're not really operating within those.
Uh, 2 fields correctly, so ask your pharmacy for their supporting paperwork.
Like, are they.
And a pharmacy or a pharmacy and then.
You know, what paperwork they can show you that meets those standards.
One is allowed to do more bulk shipments and in office use.
One is allowed to do only patient specific, uh, orders.
And there are some other differences between them, but,
um.
So I think 503A is patient specific, like I give you a prescription and you
can, the pharmacy can fill it for that particular compounded patient need.
And then 503B is that more like they can produce bulk amounts of Product and
they compound and then distribute it.
Um, and they, they have to be regulated by the FDA and they have
these good manufacturing practice guidelines that they have to follow.
That's kind of my understanding.
So 503 B is like, they're a big producer.
Yeah.
And I think, but just because one, one of them is, is the B type doesn't mean
that they're actually up to date and all of that stuff, because the FDA has.
There have been a lot more compounding pharmacies, uh, now more than ever,
so a lot of times their, their certifications may not be up to date in
terms of what they're supposed to do, but don't, um, just because they are
saying that's what they are, you can ask them for their supporting paperwork
and see if they actually have it.
Got it.
Um, and in terms of giving a patient peptides or these bioactive compounds,
are there any guidelines that you suggest that, um, longevity clinics will follow?
Paperwork, um, in terms of having really good consents that talk
about the risks, um, benefits and possible alternative things.
Talking about, um, that they're not FDA approved and then not
promising any kind of, uh, results.
So, not talking about treating any kind of, uh, conditions.
So, not saying this is going to, you know, I don't know, uh, cure your
X or Y disease, but just saying, you know, maybe it's going to.
Make you make you feel generally better or make your skin appear healthier.
Um, and not promoting any brand names of anything, if you're not
actually selling the brand name.
So a lot of a lot of these fights that we've seen between.
Um, big companies and, uh, meds boss, for example.
Um, someone saying, okay, they're selling, uh, but in really
they're selling semi blue tide.
So these companies are searching the internet for people saying Ozempic, but
not actually selling Ozempic, and then filing actual lawsuits against people,
and these lawsuits are getting settled for hundreds of thousands of dollars.
So, that's their trademark and copyright infringement protections,
right?
Yeah.
Yeah, which they, they should go after people if they're saying
they use Ozempic and they don't.
For sure, I mean, they, they've invested thousands of dollars to, to create
these things, and if someone says, Is saying that they're doing Ozempic and
they're actually selling semi glutide, like they're also not telling the truth.
Yeah.
Um, now the FDA has FDA approved 26 different peptides as drugs.
So would you say if you're giving peptides, you should stick within
that realm as like a good starting before you, you know, advance into
the really complex and different peptides that are not FDA approved?
Yeah, definitely.
I think whenever you're going into something that's not FDA approved.
For anything in terms of injectable, you're going into a
territory of a lot of legal risk.
So first, to the things that are, um,
Yeah.
Um, well, I think this is so fascinating.
I have a bazillion other questions I want to ask.
But before getting to esoteric, um, where can people find you if they
want to reach out and ask all of their legal questions and guidelines?
Our website is lingealaw.
com, which is L E N G E A L A W. com.
Um, we're also on Instagram, Facebook, LinkedIn.
Uh, we do offer free consultations.
Um, and we love hearing from people.
And no question is too small or too large for us.
We've, we've, we've heard it all.
We've seen it all.
Sometimes, uh, we get these interesting questions where, um, let's say,
uh, someone wants to buy this new product, but just We just heard of
a lawsuit with our other client.
That has to do with this new product, so we can kind of tell you, like, hey,
no, this is something to watch out with just because it's a, it's a pretty.
Tight knit industry and everyone, um, I think we all know a little bit about
each other and so, um, it's helpful to just kind of have a sounding board.
Awesome.
I think that's so valuable.
I feel like we need to do another podcast because I have a whole other
section of questions I want to ask you about before and after pictures
and going after people who write terrible fake Yelp reviews and like,
Oh yeah, we should talk about that next time.
Yeah,
that's a good.
Okay.
So part two is coming soon until then don't forget Schickman
on her various handles.
What's your Instagram too?
Tell everybody.
Um, it's Sarah Schickman.
So it's.
My la my name is very complicated.
I'm, I'm sorry, it's from Ukraine.
That's Sarah, SARA, my last name, which is S-H-I-K-H-M-A-N.
And then my law firm's Instagram is at law.com.
Also complicated.
I
mean, I think we should have a rebrand.
Um, if you like, beauty by Dr. K is a much better name.
So maybe that's
because you didn't have to rerun just the last name on my last name is super
and that's why I'm beating by Dr. K or Dr. K, but that's it for now, guys.
Don't forget to find us on Tuesdays for longer, more detailed podcasts, and we'll
do another one with Sarah Schickman soon.
And every Friday at five minute Friday, you can find me on my Instagram.
It's beauty by Dr. K D R K A Y doing amazing things with people's faces.
And our website is the same beauty by Dr. K dot com.
If you're in L. A., come and visit.
You know, we have the most advanced stuff going on for collagen
biostimulators using these products legally and ethically with exosomes,
polynucleotides, um, platelet derived growth factor and all the peptides.
So trying to learn and make sure we keep our patients super safe in this process
of navigating molecular level beauty.
That's it for now, guys.
Stay beautiful.