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January 28, 2025 25 mins

Dive into the complex world of controlled substances in this episode of Deep Dive. From the meticulous schedules of the Controlled Substances Act to the balancing act between regulation, research, and public safety, we explore how powerful drugs are developed, monitored, and controlled. Learn about the roles of the FDA and DEA, the challenges of manufacturing and distribution, and the growing interest in cannabinoids and psychedelics. We also tackle the vital topics of addiction, harm reduction, and equity, emphasizing the need for compassionate, evidence-based approaches. A thought-provoking look at an ever-evolving landscape!

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Episode Transcript

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(00:00):
All right, so get ready to dive deep into a world

(00:02):
where one tiny molecule can heal you or really hurt you.
We're talking controlled substances.
We've had a ton of requests from you guys
to really break down how these powerful drugs
are actually regulated.
From the moment they're made
to when a patient actually gets them,
we're gonna unpack it all.
Yeah, it's a fascinating world
and it never stops changing, right?
Science is always moving forward

(00:23):
and how we see these things as a society is changing too.
The really interesting thing is
there's always this back and forth.
We need to make sure people who need life-saving meds
can get them, but we also need to be really careful
about misuse and people getting addicted, right?
Exactly, and you guys wanna know
how that careful part actually works,
like the nitty-gritty of how you make, handle,

(00:43):
and store controlled substances.
I mean, the FDA and the DEA are watching everything.
We're going deep on all of that.
We're gonna untangle this whole web of regulations
that control this whole field.
We're gonna break down the Controlled Substances Act
and how it affects everything
from how drugs are developed
to the very real problem of addiction.
And we'll take a peek at what's coming next,
especially about how regulations are dealing

(01:04):
with the exploding interest in cannabinoids and psychedelics.
This is a hot topic.
So let's start with the foundation,
the Controlled Substances Act, or CSA.
This act is all about sorting drugs
based on how likely they are to be abused
and what medical uses they have.
It's like a big risk assessment tool.
So kind of like a ranking system.
Exactly.
The CSA takes all these drugs

(01:25):
and puts them into five schedules.
Schedule one is the strictest and schedule V is the least.
Understanding what makes each category different
helps us understand how everything is regulated.
Okay, let's break it down then.
Schedule drugs, these are the most tightly controlled.
So what makes them so different?
Well, schedule A drugs are considered
really likely to be abused and super important,

(01:47):
they're not currently accepted for medical use in the US.
This is where you find stuff like heroin, LSD and ecstasy.
These are drugs that right now
are just seen as too risky to use medically.
These are the drugs that are always in the news
when people talk about the war on drugs, right?
Yeah, often.
Now, moving on to schedule two,
these are also really likely to be abused,

(02:09):
but they do have accepted medical uses
just under very, very tight control.
I'm thinking like really strong painkillers, morphine,
fentanyl, essential in some medical situations,
but also super easy to misuse and get addicted to.
Exactly.
Then we go down a step to schedule three,
where the chance of abuse is lower than schedule two.

(02:29):
Here you'll find things like some anabolic steroids
and products with lower amounts of codeine in them.
So wait, the same drug, like codeine,
can be in different schedules?
Like it depends on how it's made and what it's for.
You got it, that's a little detail we'll dig into more.
It shows how even tiny changes to a drug
can totally change how risky it is.
That makes sense.
Okay, what about schedule four?
Where do they fit in?

(02:49):
Schedule four drugs have a lower chance of abuse
than schedule three.
This is where you find meds like Xanax, Valium, and Ambien.
They're still controlled,
but they're thought to have a lower risk of addiction
compared to the higher schedules.
Ah, okay.
So these are the drugs you hear about
for people with anxiety or sleep problems.
Exactly.
And last but not least, we have schedule V.
This is the least restrictive category.

(03:11):
They usually have very small amounts
of certain narcotics in them,
like cough syrups with a little bit of codeine.
Gotcha.
So the further down the list of schedules you go,
the less risky it is and the fewer rules there are.
That's the general idea.
Now that we have a basic handle on the schedules,
let's talk about the big players
who make sure everyone follows these rules,
the FDA and DEA.

(03:32):
Right, the FDA and the DEA.
You always hear about them.
Yeah.
But it's hard to keep track of who does what.
I get it.
They're both involved in making sure drugs are used safely,
but they focus on different things.
Think of the FDA, the Food and Drug Administration,
like the gatekeepers.
They make sure drugs are safe and they work.
So they're the ones who decide if a new drug

(03:52):
is okay to sell.
Exactly.
They go over everything from the clinical trial results
to how the drug is made.
They wanna make sure it actually does
what it's supposed to do without hurting people.
What about labels on the bottles and stuff?
That's them too, right?
Totally.
The FDA checks to make sure those labels
tell the truth about the risks and benefits.
It's super important information for doctors and patients.

(04:13):
Okay, that makes sense.
So the FDA is like the watchdog,
making sure drugs are safe and effective.
So what does the DEA do?
The DEA, the Drug Enforcement Administration,
steps in after the FDA says a drug is okay.
They're all about stopping diversion,
which means making sure controlled substances
don't end up in the wrong hands.

(04:33):
So they're the ones busting people
who are selling illegal drugs and all that.
That's a big part of what they do, yeah.
They enforce the law and make sure these powerful drugs
are handled and given out responsibly.
It's crazy how these two agencies work together.
It's like some perfectly timed dance routine,
and each one has a really important part
to keep it all running smoothly.
It really is.
And you know what's interesting?

(04:54):
Even some over-the-counter drugs,
the kind you can buy without a prescription,
they can still be watched by these agencies.
Really?
Even stuff you can just grab off the shelf at the drugstore.
Yep.
Think about acetaminophen.
It's a really common pain reliever.
It's in tons of over-the-counter products.
Right, like Tylenol.
Exactly.
But it can also be used to make illegal drugs.

(05:15):
So even though you can buy it easily,
how it's made and sold is still controlled.
Wow, so the rules cover way more than I thought.
It has to.
We're talking about stuff that can have huge effects,
and the whole point is to keep things balanced.
People need access to these drugs,
but we also need to control them.
Okay, so we've covered the Controlled Substances Act
and what the FDA and DEA do.

(05:35):
Now, let's get to what you guys really wanna know about.
How controlled substances are made, handled, and stored.
This is the core of it.
This is where it gets real.
Imagine a place where they're working
with these powerful compounds.
The rules are unbelievably strict and for good reason.
Right, it's not like some regular factory-making aspirin.
Nope.
These places are super secure.

(05:57):
Every single gram, every little bit of liquid
has to be accounted for.
So they're doing everything they can
to prevent anything from going wrong.
Like contamination, mixing things up,
and especially stopping drugs
from being stolen or sold illegally.
Absolutely.
Every single step from when they make the drug
to when it's sent out is recorded
and watched super tight security like Fort Knox

(06:19):
and attention to detail like some forensic accountant.
Wow, that sounds intense.
So if you were working in one of these places,
what kind of stuff would you have to deal with every day?
Okay, picture this.
You're walking into this building
with like reinforced walls, alarms are everywhere,
cameras everywhere.
You go through tons of checkpoints
and each one you need special ID.
Sounds a little scary.

(06:39):
It is.
Once you're in, every time a controlled substance moves,
it's tracked and written down.
Who touched it, when, why, and how much was used.
Everything is recorded perfectly.
So there's no room for mistakes at all.
Basically.
Even a tiny mistake can cause a big investigation
and have serious consequences.
And storing the drugs,
that's gotta be a big deal too, right?
Oh, for sure.
Controlled substances are kept in locked up areas,

(07:02):
super secure.
They often need to be at specific temperatures
and humidity levels.
It's all about keeping the drug safe
and making sure no one can get to them who shouldn't.
So it's like this high stakes chess game
where every move is planned to avoid any risk.
I like that analogy.
The point is to create a system where every bottle,

(07:22):
every pill is tracked from the moment it's made
to the moment someone gets it.
It's a chain of custody that's meant to be unbreakable.
That's wild and a little intimidating.
You're dealing with things that can really help people,
but they can also be super dangerous
if they get into the wrong hands.
Exactly.
That's why these rules are so strict.
It's all about finding that balance between helping people

(07:44):
and keeping things under control.
This has really got me thinking about all of the challenges
these drug companies must face.
I mean, keeping that level of control can't be easy, right?
You're not wrong.
It's really hard and complicated
and we're gonna dig into all those details
in the next part of our deep dive.
All right, so we know that making these controlled substances
is like a super serious operation with crazy security,

(08:06):
but what are some of the real world problems
these companies run into
when they're trying to keep everything locked down?
Well, just think about it for a second.
You have this whole complicated chain of stuff
from the raw materials to the actual finished drug
and every single step along the way could be a weak spot.
Right, so it's not just about

(08:26):
the building itself being secure.
No.
They have to make sure that everyone involved
is doing things by the book.
You got it.
You've got suppliers bringing stuff in,
people transporting it, places where it's distributed.
Everyone has to follow these crazy strict rules.
Keeping track of all that is a huge job.
I bet they're also always worried
about people trying to cheat the system, right?

(08:47):
Oh, absolutely.
We're not just talking about small time stuff.
We're talking organized crime people
who are really good at finding ways
to break the rules and get what they want.
So it's like a never ending race
between the good guys and the bad guys.
The regulators trying to stay ahead of the criminals.
Yeah, kinda.
The DEA is always changing up
how they do things to fight new threats
and the drug companies have to keep up too.

(09:08):
They're investing in all this new technology
and security stuff to stay one step ahead.
It makes you wonder if there have been any times
when security's been breached or things went wrong.
You know, big mistakes.
Well, there have been some pretty big cases
that show just how easy it is for the system to break down.
Like what?
Give me an example.
One that comes to mind is this huge drug distributor, right?

(09:31):
They got hit with millions in fines
because they didn't report suspicious orders
for controlled substances.
So they were basically ignoring signs
that drugs might be going to the wrong people.
Yeah, pretty much.
They weren't watching their network
of distributor closely enough
and tons of opioids ended up on the black market.
That's scary.
It really shows how important it is to keep an eye on things

(09:52):
and make sure everyone's doing what they're supposed to.
Absolutely.
And it's not just about stopping drugs
from getting to the wrong people.
Sometimes mistakes happen when the drugs are being made
and bad stuff gets into the final product.
Oh, no, like what kind of bad stuff?
Give me an example.
Well, a few years back,
a whole bunch of injectable painkillers
was contaminated with bacteria.

(10:13):
That's terrifying.
What happened?
They had to pull it all back from the market
and some people got really sick.
It just goes to show that even with all these rules,
things can still go wrong.
Yeah, and that's why the FDA is so strict
about quality control and testing everything
throughout the whole manufacturing process.
Okay, so we've talked about the problems
with security and contamination,

(10:33):
but all this control has to be super expensive, right?
Totally.
It costs a lot of money to follow all the rules.
Drug companies have to spend a ton on secure buildings,
fancy tracking systems, and all these tests they have to do.
And those costs are probably passed on to us, right?
Higher drug prices.
A lot of times, yeah.
It's part of this complicated balancing act.

(10:53):
They wanna make sure people can get the meds they need,
but they also have to make sure everything's safe
and controlled, and that costs money.
Makes you think, is there a way to make it all work better
without making it less safe?
Well, people are definitely arguing about that.
Some people think the rules are too much
and that new technology could make it cheaper
to keep track of everything.

(11:14):
Like that blockchain technology.
I've heard people talking about using that to track drugs.
Exactly.
Blockchain could make it so every step of the process
is recorded in a way that can't be changed.
From the moment a drug is made
to when someone picks it up at the pharmacy,
it could really simplify things
and reduce the risk of people cheating the system.
That sounds pretty cool.

(11:34):
But I guess there are also worries about privacy
and keeping people's information safe, right?
For sure.
Any new technology has its own set of problems,
and those would have to be thought about really carefully
before everyone starts using it.
It's wild to see how technology's changing this whole field.
But let's not forget about the people involved.
We talked about the drug companies

(11:54):
and the regulators,
but what about the people actually working in these places?
You're right.
They're the ones on the front lines
making sure everything's done exactly right.
They're super important in keeping the whole system
from falling apart.
What kind of training do they have to go through?
They have to learn everything
about handling controlled substances.
How to store them, how to keep records,
how to spot signs that someone might be trying to steal

(12:17):
or sell the drugs illegally.
And they're working with stuff
that could be dangerous too, right?
Safety must be a big deal.
Absolutely.
They have to be trained on how to handle these drugs safely
so they don't get hurt,
and so there aren't any accidents.
I bet that job is super stressful.
Knowing that one tiny mistake could cause huge problems.
Yeah, definitely.

(12:37):
It takes a lot of focus and attention to detail,
but it's also a really important job.
They're making sure these important medications are made
and handled the right way.
It's obvious that everyone involved,
the scientists who make the drugs,
the people in the factories, the pharmacists who give them out,
they all have a huge responsibility.
Totally.
And that brings us to another super important part
of this discussion.

(12:58):
How does all of this affect how new medications are developed?
Right, we've talked about how drugs are regulated
after they're already out there,
but what about when a drug is brand new?
How does that Controlled Substances Act come into play?
Well, imagine you're a scientist
who's discovered this amazing new compound, right?
You think it could be a great medicine,

(13:18):
but before you can even start testing it on people,
you have to figure out what schedule it belongs in.
So you have to decide where it fits on that scale of I2V
based on how likely it is to be abused.
Exactly, and that decision is going to have a huge impact
on the whole process of developing the drug.
How so?
The higher up on the schedule it is,
the stricter the rules are, especially for doing research.

(13:39):
So a schedule I drug, like LSD,
is going to be way harder to research
than a schedule III drug.
Exactly.
Researchers have to jump through all these hoops.
They need special licenses,
they have to have crazy security,
and they have to deal with tons of paperwork.
It sounds like it would discourage people
from doing research, especially on drugs
that already have a bad reputation.

(13:59):
It definitely can, and a lot of scientists
and people who support these substances
are worried about that.
They think these rules are stopping research
on how these drugs could be helpful.
Right, like how people are looking into using psychedelics
to treat mental health problems.
If those drugs are stuck in schedule I,
it's going to be super hard to do the research.
Exactly, and it's not just about research.

(14:20):
It also affects whether a new drug will be approved.
So even if a schedule I drug looks promising in the trials,
it's still going to be hard to get it approved
for people to use.
You got it.
The FDA is going to be extra careful
about approving a drug that's likely to be abused,
even if it seems to work well.
I get it, they have to think about public safety,
but it's kind of a catch-22, right?

(14:41):
If research is restricted, it's harder to get the proof
you need to show a drug is safe and effective,
and that makes it less likely to be approved.
It's a tricky situation, and it's one of the biggest things
people argue about when it comes to drug policy.
Seems like we need to find a way to be careful,
but also not block scientific progress.
Absolutely, finding that balance is super important.

(15:01):
And speaking of balance, let's talk about something
that's a big challenge with controlled substances,
addiction.
Yeah, the big one.
You can't talk about these drugs
without talking about addiction.
Definitely, addiction is a serious disease
with awful consequences, and it's totally tied
to this whole world of controlled substances.
And how addictive a drug is is one of the main things

(15:23):
they look at when they're deciding
what schedule it goes in, right?
Exactly.
The more likely it is to be abused and get people addicted,
the higher up on the schedule it goes.
So a schedule two drug, like fentanyl,
is way more addictive than a schedule four drug,
like Xanax.
You got it.
And this is where being ethical is super important.

(15:43):
What do you mean?
Well, when you're dealing with drugs that can mess
with how your brain feels pleasure,
you have to be incredibly careful about how you research
them, who you give them to, and how you make sure
they're used safely.
You have to protect people from getting hooked, right?
Totally.
And that's where doctors, nurses, and pharmacists
have such a big role.
So it's not just about the drugs themselves.
It's about making sure the people who are prescribing

(16:05):
and giving out these meds are making good decisions.
For sure.
They need to know how to spot the signs of addiction,
understand the risks and benefits of different meds,
and talk honestly with their patients about any concerns
they might have.
Sounds like a tightrope walk, trying to help people
without causing more problems.
It is.
And it takes a lot of different things, education, awareness,
and compassion.

(16:25):
Right.
Addiction is a disease, not something people choose.
We have to treat it that way.
Absolutely.
And this leads us to a really interesting part
of this whole conversation.
And it's changing super fast.
I'm talking about cannabinoids and psychedelics.
Ah, yeah.
These are the drugs you see all over the news lately.
People are really interested in how
they could be used in medicine.

(16:46):
Totally.
And they're making us rethink how
we schedule and regulate drugs.
OK, let's start with cannabinoids.
A lot of states have legalized them for medical use
and even recreational use.
But how does that work with the Controlled Substances Act?
Well, that's where it gets kind of messy.
Even though more and more states are saying it's OK,
marijuana is still a schedule-eye drug

(17:06):
at the federal level.
So it's legal in some states, but still illegal
according to the federal government.
How does that even work?
It creates this tangled mess of laws and rules.
Basically, the feds are kind of looking the other way,
and states that have legalized it.
But they could still come in and enforce federal law
if they wanted to.

(17:26):
So it's like a legal gray area.
Exactly.
It's a really uncertain situation for businesses,
researchers, and people who are using marijuana.
Then what about using cannabinoids
for medical reasons?
There's more and more evidence that they
could be helpful for things like chronic pain
and epilepsy.
Is it hard to do research because marijuana
is schedule one?
Absolutely.
All those rules make it almost impossible to do

(17:48):
big, rigorous studies, which you need to prove that a drug is
safe and effective.
So even though tons of people are already
using cannabis for medical reasons,
it's still hard to get solid scientific proof.
Exactly.
That's one of the main reasons people
want to reschedule marijuana.
They say that moving it to a lower schedule
would make it easier to do research,
and more people could get access to its medical benefits.

(18:09):
That makes sense.
But I'm guessing some people don't like that idea.
Of course.
Some people are worried that it could lead to more abuse
and addiction, especially among young people.
And there's also the whole question of how
to regulate something that's been considered
so bad for so long.
It's a complicated issue with no easy answers.
What about psychedelics?

(18:31):
It seems like they're having a comeback.
People are looking at them again as potential treatments
for mental health problems.
Yeah, they really are.
Drugs like psilocybin and LSD that used to be just
counterculture things, they're now being
studied in real clinical trials.
They're looking at whether they can help with depression,
anxiety, and addiction.
So how are those drugs regulated?
There's schedule I right now, which

(18:52):
means all the same restrictions as marijuana.
But there is a growing movement to reschedule them
because the research is looking really promising.
So things are changing for both cannabinoids and psychedelics.
Definitely.
We're seeing a total shift in how
we think about these drugs.
It's being driven by scientific curiosity,
by people's attitudes changing, and by the fact

(19:14):
that we desperately need new ways
to treat all kinds of conditions.
It's exciting, right?
But it also seems like we need to be careful.
Yeah, for sure.
As we learn more about how these drugs could be helpful,
we've got to make sure we're doing it responsibly.
We need to keep safety and ethics in mind,
but also be open to the possibilities.
So it's incredible how much things
are changing when we talk about controlled substances,

(19:36):
especially with all this new interest in cannabinoids
and psychedelics.
But as we learn more, what are some of the big things
we really need to be thinking about?
Well, one of the most important things
is to be level-headed about it.
We can't get carried away.
We need to recognize that these substances might
have real benefits, but there are risks too.
And we need to be smart about how we regulate them.

(19:57):
Right, we can't just jump in without thinking,
but we can't just shut it all down either.
Exactly.
We have to avoid going too far in either direction.
So it's about finding that middle ground,
encouraging new discoveries, but also keeping people safe.
Exactly.
And that means everyone needs to work together, scientists,
people making laws, doctors, and everyday people too.

(20:17):
Right.
This isn't just a conversation for experts.
It affects all of us.
Absolutely.
One of the toughest questions we have to deal with
is how to balance what people want
to do with what's good for society as a whole.
That's a big one.
It's about respecting people's choices
about their own bodies and minds,
but also making sure those choices don't hurt other people

(20:38):
or cause big problems for everyone.
Exactly.
And it's not an easy balance to find.
Especially with drugs that can be addictive and dangerous
if they're misused.
You got it.
If we're going to use these substances for medical reasons,
we have to be really careful about how we control them
and make sure there are safety measures in place.
So it's not just about making these drugs available.
We have to create a system where the good outweighs the bad.

(21:01):
Exactly.
And that means having good education programs
to prevent problems and making sure people can get treatment
if they need it.
Right.
We have to look at the whole picture.
For sure.
Another super important thing is equity.
What do you mean by that?
We need to make sure that everyone who could benefit
from these treatments, if they turn out
to be safe and effective, can actually get them.

(21:21):
It can't just be for rich people or people with connections.
So everyone deserves a chance, no matter their background
or how much money they have.
Exactly.
We have to be careful that these treatments don't just
make existing inequalities worse.
That's a really good point.
Yeah.
We don't want to repeat the mistakes of the past,
where some groups of people were hurt way more by drug policies

(21:44):
than others.
Exactly.
And this is where social justice and science and regulations
all come together.
It's complicated, right?
All these things are connected.
It is.
And to deal with all this complexity,
we need to be open-minded, willing to question
what we think we know, and always look at the evidence.
And we have to learn from the past, too.
Totally.
We can't ignore the mistakes that have been made with drug

(22:04):
policies.
We have to make sure we're not making those same mistakes
again.
Right.
It's time to stop just punishing people for using drugs
and start focusing on helping them.
Exactly.
And that's where harm reduction comes in.
Can you explain what harm reduction is
for people who might not know?
Harm reduction is a way of thinking about public health.
It's about reducing the bad stuff that
can happen when people use drugs without necessarily making them

(22:27):
stop completely.
So it's about meeting people where they're at
and giving them the tools to stay as safe as possible.
Exactly.
It's recognizing that people use drugs for different reasons.
And just telling them to quit doesn't always work,
or it's not realistic for them.
So things like needle exchange programs,
safe places for people to use drugs, and medications

(22:48):
to reverse overdoses, those are all harm reduction strategies.
Exactly.
Those kinds of things have been proven to save lives
and stop diseases from spreading.
It sounds like a way more practical and compassionate
approach.
It is, and more and more people are starting to see it that way.
We're moving away from just punishing people who use drugs
and starting to focus more on health and well-being.

(23:08):
I'm glad to hear that things are changing in that direction.
Me too.
And as we learn more about the potential of these substances,
we need to make sure that harm reduction is
part of every policy and program.
So it's about creating a system that puts people
in communities first.
Absolutely.
People need access to accurate information, treatment that
works, and support services.

(23:29):
It's about treating everyone with dignity and respect,
whether they use drugs or not.
Exactly.
And it's about recognizing that addiction is a health problem
and needs to be treated with compassion
and with approaches that we know work.
Well said.
As we wrap up this deep dive into controlled substances,
I think the main thing we've learned
is that this whole area is constantly changing.

(23:49):
Absolutely.
We're at a really important point in history.
Scientific discoveries, people's attitudes changing,
and realizing that the old ways of dealing with drugs
don't always work.
It's all happening at the same time.
It's a chance to completely rethink
how we deal with these powerful substances
with a focus on harm reduction, equity,
and making sure people are healthy and well.

(24:10):
You got it.
It's a challenge, but it's also hopeful.
It takes careful thought, open conversation,
and making decisions based on evidence.
Well, thanks so much for walking us through this.
It's fascinating, but it's definitely complicated.
I feel like I have a much better grasp on the rules
the science, and the ethics of all this.
Happy to do it.
I hope this deep dive has given you the knowledge you need

(24:32):
to have informed conversations about this important stuff.
As always, thanks for being here with us.
Yeah.
We encourage you guys to keep learning about this stuff
because it's always changing.
And stay involved in the conversation
about how to create a better, more compassionate system
for dealing with drugs.
And remember, the more you know, the better.
The more we understand about these substances,

(24:54):
the better choices we can make for ourselves
and our communities.
That's a perfect way to end this.
Thanks again for tuning into the deep dive.
We'll see you next time for another fascinating
exploration.
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