WEBVTT

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Well, welcome back to another episode of Your

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Mom on Drugs. We are so happy to have you here.

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My name is Josh, the son. and i'm jennifer the

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mom yes the mom on drugs professor of pharmacy

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or former professor of pharmacy now retired and

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i have roped her into doing many podcast episodes

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to keep her and my mind sharp uh so this is number

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15 that we're doing today and it's an interesting

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topic it's one that came to my radar um, via

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a friend of mine, we're going to do it on pharmaceutical

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manufacturing, which I promise is more interesting

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than it sounds because it's essentially where

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do drugs come from? Um, I had a friend who went

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to a party one time and this was around the buzz

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when, um, things like semaglutides or semaglutides,

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um, things like Wegovi, um, Ozempic were really

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in the buzz. They probably still are. Um, and

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She was talking about it, and this guy that she

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was talking to was like, oh, I know a guy who

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can get you some, almost like a drug dealer.

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And she said yes. And so she got these drugs

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from this guy, and she took them in a way that

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is not recommended by the mechanism that is laid

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out by the companies. And if you could go back

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in our catalog and look at our episode on GLP

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-1 agonists, and you'll understand why. taking

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it all at once is not a good idea. But I was

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so amazed at one, that you could get these things

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just at a party. And then two, the willingness

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to take them because they were cheaper. And three,

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it just made me think, man, where do drugs come

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from? And why is it so important to really know

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where your drugs are coming from and how they're

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being manufactured? So I turned to my mom on

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drugs and I said, We should do this episode and

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I would really love for you to educate me and

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our listeners on the drug manufacturing process.

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So Dr. Seltzer, would you like to go into an

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overview of where drugs come from? Okay. Yes,

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I'd love to. I by no means am an expert on the

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topic, but I definitely have known about it by

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being a pharmacist and then diving into this

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gave me a lot more information. And we're going

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to compare. pharmaceutical manufacturing versus

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compound pharmacies, which is a little bit, they're

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two different entities. So let me start out with

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pharmaceutical manufacturing. So the pharmaceutical

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industry is referring to the area of business

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that's devoted to the design and development

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and manufacture of chemical products that are

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used in diagnosing and treating disease, disability,

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or some other dysfunction, or they can improve

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function. And pharmaceutical manufacturing is

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incorporated into that pharmaceutical industry.

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Pharmaceutical companies can be public or private.

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And one of the key differences between pharmaceutical

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companies is that they may create either basic

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pharmaceuticals or they can create biopharmaceuticals.

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Regular pharmaceuticals are products that come

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from chemicals and synthetic compounds, whereas

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bio... biopharmaceuticals are biologics that

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are derived from living material and they can

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be a whole host of things such as the vaccines,

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therapeutic proteins, blood and blood components,

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tissues, and they are larger molecules and more

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complex to make. And the regular pharmaceutical

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products are more, are easier to chemically synthesize.

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We're not going to spend, we're not going to,

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go through a whole host of like the differences

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between pharmaceuticals and biopharmaceuticals

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but i just wanted the our audience to know that

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that that the pharmaceutical manufacturing industry

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is is large yeah so if you're making something

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like um ibuprofen versus you're making something

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like you know plasma you know or i guess you

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can't make plasma but you can definitely process

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it in a way then you have different areas and

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what you're doing that That makes a lot of sense.

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Some of the monoclonal antibody type medications

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that are available, like Prolia, I have to take

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it for osteoporosis. So it's going to be a little

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bit more of a complicated medication and obviously

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more expensive because of that mechanism. Okay.

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That makes a lot of sense. Pharmaceutical manufacturing

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is part, like I said, of the pharmaceutical industry,

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and it's responsible for manufacturing medicinal

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drugs in both small quantities as well as in

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larger quantities. One of the key... focuses

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of the pharmaceutical manufacturing industry

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is stringent safety and quality regulatory standards.

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So that really sets them apart from compounding

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pharmacies, which we'll get to in just a few

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moments. A pharmaceutical manufacturing plant

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makes active pharmaceutical ingredients, and

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it also can assemble active ingredients into

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a final product. So that all encompasses pharmaceutical

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manufacturing. Yeah. For our listeners, can you

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let them know what an active ingredient is? Active

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ingredients are going to be the thing in a medication

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that's going to do the work. So the ibuprofen

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in your Advil, the active ingredient in Eliquis,

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which is a blood thinner. Rosuvastatin and Crestor,

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those active ingredients are the ones that are

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going to cause your cholesterol to lower or your

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blood pressure to lower or your blood to be thin.

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There are inactive ingredients in those agents

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as well too that may help to bind them together

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or to solubilize them. But those are not the

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ones that are going to, those parts of the tablet

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or the capsule are not the... part of that agent

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that causes the actual activity. That makes sense.

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It's like when I drink a cup of coffee, there's

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a lot of things in a cup of coffee that could

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help make it the color brown, maybe promote its

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acidity, but the active ingredient caffeine is

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what's giving me that sense of being alert and

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lack of being tired. Yes. Okay. Yes. We're going

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to talk about this a little bit more. This will

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become a little clearer once we get into compounding

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pharmacies, but pharmaceutical manufacturing

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companies are typically what we call a 503b outsourcing

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facility. So they are manufacturing medications.

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They can be sterile medications or intravenous

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products and subcutaneous products, as well as

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oral, topical. sublingual, all of those types

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of products, they make them in larger amounts.

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And the pharmaceutical manufacturing companies

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are registered with the Food and Drug Administration,

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our United States Food and Drug Administration.

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Interestingly, when you think about it, they

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make these large bulk supplies of medications.

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There's no specific patient prescription that

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is assigned to that order. They distribute these

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medications to pharmacies, warehouses, physician's

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offices, and then the prescription comes so that

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the agent can be dispensed at that point. Interesting.

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So the provider, either the doctor or medical

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professional, will essentially be the go -between

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between the pharmaceutical manufacturer who sends

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that drug out, and then you have the patient

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who then will need a prescription for that drug,

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and then based on the evidence or the... expertise

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of that medical practitioner, then they will

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be given that drug. That's correct. Okay. That's

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correct. The pharmaceutical manufacturing process

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is very involved. There are really five key stages

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to it, but they're Each one of them is involved.

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They're broken down into research and development.

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And in research and development, the nickname

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of it is R &D. People may have heard R &D. That's

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where the scientists are going to develop new

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drugs. They're going to contest. conduct testing.

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Maybe they develop a new dosage form. And they

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are also going to be performing clinical trials,

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animal studies on these agents to make sure they're

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safe and effective. So that can take a number

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of months, years, depending on what the agent

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is. The formulation step is the next stage in

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the pharmaceutical manufacturing process. And

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so this is where investigators are or employees

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of the pharmaceutical company are trying to figure

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out how to combine the drug's active ingredients

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with other raw materials to make it an effective

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product as well as a stable one. In the third

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step or the third stage, we have production.

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So you've got the medications being manufactured

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in bulk and you are following specific guidelines

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and quality assurance, quality control measures.

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to make sure that these agents are manufactured

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consistently and that they will all be very comparable.

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Quality control is the fourth stage in the pharmaceutical

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manufacturing process. Again, you're looking

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that every single stage goes into rigorous testing

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to ensure that it is... quality and has efficacy

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and safety. So you can't bypass those steps.

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They are all steps to make sure that then the

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FDA can put their stamp of approval on that particular

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medication when it gets approved. And then the

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fifth stage is packaging and distribution. So

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you've got research and development, formulation,

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production, quality control, and packaging and

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distribution. Okay. Yeah. I mean, I think it's

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amazing how you said all those steps in like

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a minute or two, but like you said, this can

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be a decade long process depending on the drug.

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I think especially let's gloss over stage, like

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the step one, which is just making sure that

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it's safe. We've talked about clinical trials

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a lot on this podcast, but phase one, phase two,

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phase three, like phase one is just making sure

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that it's safe in animals and just making sure

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that when you give it. to an organism that there's

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no adverse effects. And then obviously you work

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yourself up to humans to make sure there's an

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appropriate dose. And then you make sure it does

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what you say it's going to do. And that can take

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time. I mean, it can take years sometimes. Scientists

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aren't cheap. You know, like you have to hire

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them for multiple years and then you have to

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get the patient population to be able to test

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them. So this is a very involved process in every

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step of the way. And again, this is all to get

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FDA approval, correct? Right. Because obviously

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there are drugs out there. We call them supplements.

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Essentially, they can be sold into the market

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and they can make claims, but they're not backed

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up by the FDA. So there's obviously a lot of

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people making claims. But this whole process

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to make sure, are you actually backing up what

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you're really saying? And this is a relatively

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new concept, especially in the 20th century,

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which is kind of crazy to me. And we're going

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to talk about some of those examples. But the

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idea that you actually have to show what you

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actually mean is actually it is it's such a new

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and actually a wonderful thing that we do. And

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it obviously means that these drugs can be very

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expensive. But by all these steps, not just the

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safety in the clinical trials, but also making

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sure that. Your manufacturing processes are super

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controlled. When you say that you're getting

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10 milligrams of acetaminophen, you really know

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that you're getting 10 milligrams of acetaminophen

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rather than this huge ballpark figure. So just

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want to let people know, even though these steps

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kind of seem like a cookbook, this can literally

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take years. Each step, yes. Because I worked

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for a college of pharmacy, I don't know if our

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audience realizes that Schools of pharmacy, schools

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of medicine have researchers that work on developing

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new medications or new dosage forms. And so there

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were scientists that worked within the College

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of Pharmacy that had relationships with pharmaceutical

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manufacturers to help them with that process.

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And you have that all over the country and stuff.

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I mean, they've got their own internal scientists,

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but they do work with colleges as well, too,

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universities as well, too. Pharmaceutical development

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process, as Josh mentioned, is very involved.

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So the purpose of pharmaceutical development

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is to design a quality drug product that uses

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a manufacturing process that provides consistent

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drug process performance. And the environment

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in where it's being processed is stable. And

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the therapeutic objective is also stable. So

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each step. there are quality assurance and quality

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control measures. And so you want to make sure

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that you've got scientific, sound scientific

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principles used throughout the process, that

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you have studies that you're depending on that

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are showing relevant and positive results. That

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means not only does the active ingredient work,

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but... Is the product stable in the dosage form

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that you've decided to create as well too? So

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that's also part of the study process. Is it

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safe? Can you replicate this medication without

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a lot of variability between the different individual

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tablets or capsules or intravenous solutions?

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That's all part of this quality assurance, quality

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control. pharmaceutical development process which

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can take like josh said a long time so yeah you

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might have seen on one of your drug bottles like

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expired by and they have a date in which the

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drug it's not technically despires but it loses

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its potency and its ability to actually you know

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to guarantee to do what it's meant to do um and

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they actually you know stress test it they'll

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put it under conditions quote unquote like you

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know increased temperature increased pressure

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and like, because you have to think about it.

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These drugs are going everywhere. They're not

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just going to be in the laboratory. They're going

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to be here in Texas where it's hot and muggy.

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They're going to your mailbox, your mailbox.

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So like you want a drug that if it's getting

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shipped to you or to your pharmacy, that it'll

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survive that plane or truck ride across the country,

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you know, to your place. And then it can be guaranteed

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to work. So they have to do these tests there

00:15:34.100 --> 00:15:37.379
too. So there's a lot of like guarantees that

00:15:37.379 --> 00:15:40.019
a lot of these. drugs are trying to deliver and

00:15:40.019 --> 00:15:43.120
they have to go through, like my mom said, stringent

00:15:43.120 --> 00:15:44.899
testing to make sure that they're actually done.

00:15:45.059 --> 00:15:53.820
Right. So in order to get a medication approved

00:15:53.820 --> 00:15:56.320
by the United States Food and Drug Administration.

00:15:56.940 --> 00:16:00.960
A pharmaceutical company or an individual, but

00:16:00.960 --> 00:16:04.500
most likely a pharmaceutical company, needs to

00:16:04.500 --> 00:16:08.679
submit what we call a new drug application. They're

00:16:08.679 --> 00:16:12.379
very involved applications. They include clinical

00:16:12.379 --> 00:16:18.919
trial data, animal data, stability data. It is

00:16:18.919 --> 00:16:24.259
the document that needs to be submitted. to propose

00:16:24.259 --> 00:16:26.720
to the FDA that you have a medication that you

00:16:26.720 --> 00:16:31.779
think that they should approve. And the goals

00:16:31.779 --> 00:16:34.299
of the new drug application are to determine

00:16:34.299 --> 00:16:37.100
whether a drug is safe and effective in its proposed

00:16:37.100 --> 00:16:40.379
use. So you will notice that on the package insert

00:16:40.379 --> 00:16:43.759
that there may be like one or two indications.

00:16:43.860 --> 00:16:46.639
That's because they've gone through this rigorous

00:16:46.639 --> 00:16:50.259
assessment process. Now, I know you'll come back

00:16:50.259 --> 00:16:54.250
at me and say, well, my doctor is giving me this

00:16:54.250 --> 00:17:01.990
drug for X. How about this? I'm getting an antidepressant

00:17:01.990 --> 00:17:05.410
to treat my migraine headaches and it's not listed

00:17:05.410 --> 00:17:08.670
on the package insert as an indication, but after

00:17:08.670 --> 00:17:11.250
drugs are approved, there can be some clinical

00:17:11.250 --> 00:17:13.490
trials and there's some off -label uses as well

00:17:13.490 --> 00:17:15.089
too, but we're really not talking about that

00:17:15.089 --> 00:17:17.150
right now. I mean, we could even talk about,

00:17:17.230 --> 00:17:21.349
I mean, that's essentially how things like. ozembek

00:17:21.349 --> 00:17:24.089
and way govi were that's true for me right it's

00:17:24.089 --> 00:17:26.599
like they were they were a type two diabetes

00:17:26.599 --> 00:17:29.220
drug. Right. And then they figured out, oh, we

00:17:29.220 --> 00:17:30.799
can actually use this for weight loss. Right.

00:17:30.900 --> 00:17:32.819
And so you could, they're prescribed under different

00:17:32.819 --> 00:17:35.440
names. I'm trying to remember the name for. Ozempic

00:17:35.440 --> 00:17:38.759
is the diabetes medication and Wagovi is the

00:17:38.759 --> 00:17:41.200
weight loss. Exact same drug, but they just have

00:17:41.200 --> 00:17:42.240
a different name. They're a little bit different

00:17:42.240 --> 00:17:44.539
dosages, but yeah, they're, yeah. So it's the

00:17:44.539 --> 00:17:47.000
same chemical compound. Yes. Yes. We find out,

00:17:47.019 --> 00:17:49.299
I mean, Viagra is the same as well, you know.

00:17:49.339 --> 00:17:54.279
Or, yeah. Or finasteride. Finasteride is a great

00:17:54.279 --> 00:17:57.819
example as well, too. It's FDA, although I think

00:17:57.819 --> 00:18:01.299
it carries the both indications, but it was originally

00:18:01.299 --> 00:18:06.500
created for enlarged prostate in men. And then

00:18:06.500 --> 00:18:08.299
it was determined that it can also help with

00:18:08.299 --> 00:18:11.500
hair growth. Yeah, amazing. So, yeah. So you

00:18:11.500 --> 00:18:13.359
were looking for it to be safe and effective

00:18:13.359 --> 00:18:16.859
as well as whether the benefits outweigh the

00:18:16.859 --> 00:18:18.799
risks. Now, most medications are going to have

00:18:18.799 --> 00:18:20.819
an adverse effect associated with it, but can

00:18:20.819 --> 00:18:24.019
we tolerate them for the most part? You want

00:18:24.019 --> 00:18:26.119
to make sure too, when you're going through this

00:18:26.119 --> 00:18:28.980
new drug application process, that the drug's

00:18:28.980 --> 00:18:32.000
proposed labeling is appropriate, that it's not

00:18:32.000 --> 00:18:36.000
labeled in a way that's misleading or false.

00:18:36.720 --> 00:18:40.539
And then also the labeling has to tell you what's

00:18:40.539 --> 00:18:44.700
in the medication. So that's important as well.

00:18:44.900 --> 00:18:48.000
I read that 25 % of all drug recalls were due

00:18:48.000 --> 00:18:51.150
to mislabeling. So essentially they didn't. claim

00:18:51.150 --> 00:18:53.369
to have what they said that they did on the label

00:18:53.369 --> 00:18:55.990
yeah so yeah labels can foods can be that way

00:18:55.990 --> 00:18:58.190
as well too so yeah and then you want to make

00:18:58.190 --> 00:19:02.039
sure also the this is the third uh The third

00:19:02.039 --> 00:19:05.119
purpose of the new drug application is to make

00:19:05.119 --> 00:19:07.180
sure that the methods that were used in drug

00:19:07.180 --> 00:19:10.059
manufacturing and the controls that were used

00:19:10.059 --> 00:19:12.880
to maintain the drug's quality are adequate and

00:19:12.880 --> 00:19:16.000
they preserve the drug's identity, its strength,

00:19:16.019 --> 00:19:18.660
and its quality as well as its purity. So it's

00:19:18.660 --> 00:19:22.140
a very involved process. So when you get a medication

00:19:22.140 --> 00:19:25.400
that is approved by the FDA, it has been through

00:19:25.400 --> 00:19:29.180
a lot of rigorous testing. So you can have some

00:19:29.180 --> 00:19:33.049
assurance that what they say the medication is

00:19:33.049 --> 00:19:37.750
going to do, it's actually going to do. Other

00:19:37.750 --> 00:19:40.009
things that are incorporated into the new drug

00:19:40.009 --> 00:19:43.650
application are United States laws and regulations,

00:19:44.009 --> 00:19:46.390
as well as policies and procedures. It's all

00:19:46.390 --> 00:19:53.450
part of making sure that the drug is safe, effective,

00:19:53.769 --> 00:19:56.329
and therapeutic. It's going to do what it says

00:19:56.329 --> 00:20:00.230
it's going to do. Someone might say, why on earth

00:20:00.230 --> 00:20:02.890
would you need to do this? And, you know, Josh

00:20:02.890 --> 00:20:06.410
mentioned that this process of determining safety

00:20:06.410 --> 00:20:08.910
and efficacy of medications is not that old.

00:20:08.990 --> 00:20:11.329
It's really not. It's not even 100 years old.

00:20:12.049 --> 00:20:17.869
In 1938, before 1938, we had what was called,

00:20:18.069 --> 00:20:29.390
pardon me. Before 1938, we had what was called

00:20:29.390 --> 00:20:33.750
the Pure Food and Drug Act, and it was created

00:20:33.750 --> 00:20:37.910
in 1906, and it was approved by and signed into

00:20:37.910 --> 00:20:41.730
effect by President Theodore Roosevelt. And the

00:20:41.730 --> 00:20:45.400
target for that... That Pure Food and Drug Act

00:20:45.400 --> 00:20:49.059
was primarily misbranding and adulteration, which

00:20:49.059 --> 00:20:52.299
means that it could either be labeled incorrectly

00:20:52.299 --> 00:20:55.539
for its use or it contains something that it

00:20:55.539 --> 00:20:58.640
shouldn't contain for the efficacy that it was

00:20:58.640 --> 00:21:03.420
proposed to have. Can I do an anecdote on that?

00:21:03.420 --> 00:21:05.619
Of course you can. I can't remember the book

00:21:05.619 --> 00:21:07.559
off the top of my head, but there was an author

00:21:07.559 --> 00:21:12.099
who wrote this book basically. thanking everybody

00:21:12.099 --> 00:21:15.480
in the supply chain for his cup of coffee and

00:21:15.480 --> 00:21:18.319
it ended up being hundreds of people long because

00:21:18.319 --> 00:21:20.000
there's just so many people involved with your

00:21:20.000 --> 00:21:21.680
cup of coffee when you purchase it from a store

00:21:21.680 --> 00:21:24.339
but one of the stories that he told was like

00:21:24.339 --> 00:21:27.619
when coffee was just getting popular and it was

00:21:27.619 --> 00:21:29.720
getting this huge demand i think in the 19th

00:21:29.720 --> 00:21:33.160
century um people would be selling these coffee

00:21:33.160 --> 00:21:35.609
beans But they would like fill them with other

00:21:35.609 --> 00:21:37.769
things to basically bulk up the bean. Like it

00:21:37.769 --> 00:21:39.829
would be like sawdust and sometimes even like

00:21:39.829 --> 00:21:42.109
animal droppings to make it look like the color.

00:21:42.710 --> 00:21:46.029
And like if you give people an inch, they'll

00:21:46.029 --> 00:21:48.250
take a mile to make a buck because, you know,

00:21:48.250 --> 00:21:49.990
we're all trying to make money out here. But

00:21:49.990 --> 00:21:53.230
it's amazing what people will do just to trick

00:21:53.230 --> 00:21:55.130
people into thinking they have this product and

00:21:55.130 --> 00:21:58.420
obviously to sell it for cheaper. And so I'm

00:21:58.420 --> 00:22:00.720
sure that this act was in response to things

00:22:00.720 --> 00:22:03.200
like that. It was like, if I'm going to buy a

00:22:03.200 --> 00:22:05.500
coffee bean, I want to make sure that it's an

00:22:05.500 --> 00:22:08.720
actual full, robust coffee bean rather than coffee

00:22:08.720 --> 00:22:11.119
being mixed with these other things that I don't

00:22:11.119 --> 00:22:16.799
want. Absolutely. Absolutely. So in 1938, we

00:22:16.799 --> 00:22:22.799
developed an updated version of that Pure Food

00:22:22.799 --> 00:22:24.940
and Drug Act. And the reason that that happened

00:22:24.940 --> 00:22:29.380
was Again, this Federal Food, Drug, and Cosmetic

00:22:29.380 --> 00:22:33.599
Act of 1938, it's a series of laws that authorize

00:22:33.599 --> 00:22:36.099
the FDA to oversee and regulate the production,

00:22:36.240 --> 00:22:40.359
sale, and distribution of food, drugs, medical

00:22:40.359 --> 00:22:43.160
devices, and cosmetics. So it goes over all of

00:22:43.160 --> 00:22:45.920
those agents. And it protects the general population,

00:22:45.960 --> 00:22:49.420
again, from adulteration and misbranding. So

00:22:49.420 --> 00:22:51.900
you're wanting to make sure that what you get

00:22:51.900 --> 00:22:55.509
in your medication is what's really there. that

00:22:55.509 --> 00:22:58.450
this happened was that there was a mass poisoning

00:22:58.450 --> 00:23:03.250
event in 1937. So there was an antibiotic called

00:23:03.250 --> 00:23:06.309
sulfanilamide, and it was in tablet and powder

00:23:06.309 --> 00:23:14.190
form, and it was used largely for pediatric infections

00:23:14.190 --> 00:23:17.809
childhood you know ear infections maybe sinusitis

00:23:17.809 --> 00:23:20.650
or whatever and stuff so stress and they treated

00:23:20.650 --> 00:23:24.710
streptococcal infections a strep throat and things

00:23:24.710 --> 00:23:29.779
like that so In June of that year, 1937, there

00:23:29.779 --> 00:23:32.700
was a salesperson from the company that was making

00:23:32.700 --> 00:23:35.299
the sulfanilamide that said that there had had

00:23:35.299 --> 00:23:38.640
a greater demand for a liquid formulation of

00:23:38.640 --> 00:23:40.799
sulfanilamide. If you've ever had a child and

00:23:40.799 --> 00:23:42.859
trying to get the drug down them, the liquid

00:23:42.859 --> 00:23:44.819
formulation is going to be better because they

00:23:44.819 --> 00:23:48.299
can't swallow tablets early on. So they had a

00:23:48.299 --> 00:23:54.190
researcher in their company figure out that the

00:23:54.190 --> 00:23:57.670
sulfanilamide would dissolve in ethylene glycol.

00:23:57.890 --> 00:24:00.630
And so they tested it for flavor, appearance,

00:24:00.750 --> 00:24:04.009
and fragrance, and it all passed all of their

00:24:04.009 --> 00:24:07.069
tests. They neglected, though, to test it for

00:24:07.069 --> 00:24:12.150
toxicity. And so 100 people, I believe it was

00:24:12.150 --> 00:24:16.150
over 100 people died in, I think it was 15 states,

00:24:16.250 --> 00:24:22.089
because what... What diethylene glycol is, is

00:24:22.089 --> 00:24:27.430
antifreeze. And it ends up having significant

00:24:27.430 --> 00:24:30.430
damage to a person's body. It can cause kidney

00:24:30.430 --> 00:24:34.069
failure. It can cause some brain effects. It

00:24:34.069 --> 00:24:39.680
can cause coma. It can cause... you know, things

00:24:39.680 --> 00:24:42.759
less serious than a coma, drowsiness, headaches,

00:24:43.019 --> 00:24:45.920
but it can ultimately lead to death. So they

00:24:45.920 --> 00:24:49.740
have over 600 bottles of this stuff that's been

00:24:49.740 --> 00:24:52.180
distributed out into the United States. And so

00:24:52.180 --> 00:24:54.359
they didn't have cell phones, computers back

00:24:54.359 --> 00:24:57.319
then. So they have the Food and Drug Administration

00:24:57.319 --> 00:25:01.509
as well as the employees of this company. going

00:25:01.509 --> 00:25:04.150
out and seizing these bottles that they created

00:25:04.150 --> 00:25:05.789
so no other people would die they had to go to

00:25:05.789 --> 00:25:10.450
hotel rooms um mountain cabins because it was

00:25:10.450 --> 00:25:13.289
just it was everywhere and stuff so this this

00:25:13.289 --> 00:25:17.009
caused this act to start to this this federal

00:25:17.009 --> 00:25:19.869
food drug and cosmetic act to be developed um

00:25:19.869 --> 00:25:23.069
so that was an important thing um to to note

00:25:23.069 --> 00:25:26.089
and stuff so but that that doesn't that doesn't

00:25:26.589 --> 00:25:31.430
That wasn't necessarily enough. And as time went

00:25:31.430 --> 00:25:37.329
on, so we've got more of a safety kind of aspect

00:25:37.329 --> 00:25:41.230
of. drug inspection going on with this federal

00:25:41.230 --> 00:25:45.950
food drug and cosmetic act but in 1962 we had

00:25:45.950 --> 00:25:49.089
an additional amendment created called the kefauver

00:25:49.089 --> 00:25:53.569
harris amendment and this was created in response

00:25:53.569 --> 00:25:56.349
to there was a well i'm sure a lot of people

00:25:56.349 --> 00:25:59.470
have heard of the thalidomide disaster thalidomide

00:25:59.470 --> 00:26:03.670
was an agent it was actually created in germany

00:26:03.670 --> 00:26:08.089
if i'm not mistaken and it was created the The

00:26:08.089 --> 00:26:10.809
key indication was for insomnia, so I believe

00:26:10.809 --> 00:26:13.650
it helped with sleep, but it also helped with

00:26:13.650 --> 00:26:19.269
morning sickness in pregnant women. So it was

00:26:19.269 --> 00:26:23.650
given to a lot of women in other countries, and

00:26:23.650 --> 00:26:26.150
I believe that there were physicians in our...

00:26:26.329 --> 00:26:28.910
in our country that did get some samples of it.

00:26:28.930 --> 00:26:33.869
But we had a woman who was a researcher, a clinical

00:26:33.869 --> 00:26:36.589
scientist who was not willing to put the stamp

00:26:36.589 --> 00:26:39.430
of approval on this medication in the United

00:26:39.430 --> 00:26:41.309
States because she didn't feel like there were

00:26:41.309 --> 00:26:44.390
enough data. And she blocked it from coming into

00:26:44.390 --> 00:26:46.650
the United States because this medication caused

00:26:46.650 --> 00:26:49.670
significant birth defects and deaths in babies.

00:26:49.930 --> 00:26:53.529
So it was not safe to use in pregnant women and

00:26:53.529 --> 00:26:57.509
stuff. So with that came the development of this

00:26:57.509 --> 00:27:00.769
Kefauver -Harris Amendment, which then made drugs

00:27:00.769 --> 00:27:03.650
not only had to be proven safe, but they also

00:27:03.650 --> 00:27:07.349
had to be proven effective. So we do see that

00:27:07.349 --> 00:27:13.690
nowadays in our research process for new medications

00:27:13.690 --> 00:27:17.170
as well. What a concept to actually prove that

00:27:17.170 --> 00:27:20.190
something is safe and effective. I know. And

00:27:20.190 --> 00:27:23.150
as we outlined earlier, like all the mechanisms

00:27:23.150 --> 00:27:26.460
to do so and to think that, a company could just

00:27:26.460 --> 00:27:29.119
be like, does it taste good? Does it smell good?

00:27:29.319 --> 00:27:32.619
Can people tolerate it? And to not have to jump

00:27:32.619 --> 00:27:34.380
to the hoops. And I would like to remind people,

00:27:34.400 --> 00:27:37.259
we're going to get into compounding in a minute,

00:27:37.339 --> 00:27:39.559
but also to talk about in the supplement space,

00:27:39.700 --> 00:27:41.579
which we've talked about a lot. That's essentially

00:27:41.579 --> 00:27:44.480
where we are. We're actually stuck in 1937 in

00:27:44.480 --> 00:27:46.160
the supplement space where you can essentially

00:27:46.160 --> 00:27:48.759
say, does it taste good? Does it claim to do

00:27:48.759 --> 00:27:51.160
the same to do? No, but you can believe me if

00:27:51.160 --> 00:27:53.220
you want to. So you essentially in the supplement

00:27:53.220 --> 00:27:57.259
space, you have pre -1937 regulations. And then

00:27:57.259 --> 00:28:00.279
with things that are regulated by the FDA, they're

00:28:00.279 --> 00:28:02.380
more modern. I'm not saying that the FDA is perfect.

00:28:02.500 --> 00:28:03.980
I'm not saying that pharmaceutical companies

00:28:03.980 --> 00:28:06.880
are perfect. But when you compare the two alternatives,

00:28:07.279 --> 00:28:10.200
one is clearly superior than the other. And it

00:28:10.200 --> 00:28:11.880
would be much better if there was more tightly

00:28:11.880 --> 00:28:14.259
regulated stuff so that we always knew what we

00:28:14.259 --> 00:28:16.359
were getting so that some of these, you know,

00:28:16.359 --> 00:28:19.339
side effects are not hidden by pharmaceutical

00:28:19.339 --> 00:28:22.059
companies. And we should just all know what we're

00:28:22.059 --> 00:28:23.980
taking and that it's safe and effective. And

00:28:23.980 --> 00:28:25.940
the risks associated with it. Correct. Yeah.

00:28:26.000 --> 00:28:29.000
And interestingly, too, when I was in pharmacy

00:28:29.000 --> 00:28:33.180
school back in the late 70s, early 80s, and in

00:28:33.180 --> 00:28:36.880
that time period, and maybe it was, oh, maybe

00:28:36.880 --> 00:28:40.680
it was 2000 or so. where pharmaceutical manufacturing

00:28:40.680 --> 00:28:42.880
companies ramped up the number of medications

00:28:42.880 --> 00:28:45.059
that were created per year. Maybe it was before

00:28:45.059 --> 00:28:49.000
that, but when I was in the late 70s, early 80s,

00:28:49.000 --> 00:28:52.660
you may have gotten one new medication a month.

00:28:52.799 --> 00:28:56.839
So as a pharmacist, you could know a lot about

00:28:56.839 --> 00:28:59.420
all of the new medications that were created

00:28:59.420 --> 00:29:02.900
per year. Well, now, I mean, you can have...

00:29:03.130 --> 00:29:06.069
50, 100 new medications per year. And it's very

00:29:06.069 --> 00:29:09.150
hard to keep up with the new ones. Plus, you

00:29:09.150 --> 00:29:11.589
know, you've got more regulations and you're

00:29:11.589 --> 00:29:14.630
trying to regulate more medications, more new

00:29:14.630 --> 00:29:17.009
drug applications and all the paperwork as well,

00:29:17.009 --> 00:29:21.150
too. So one of the things, again, this goes along

00:29:21.150 --> 00:29:24.910
with pharmaceutical development. This is standard

00:29:24.910 --> 00:29:27.990
for the manufacturing process in pharmaceutical

00:29:27.990 --> 00:29:33.240
companies. It may also be standard in other businesses

00:29:33.240 --> 00:29:35.220
that have to manufacture things as well too.

00:29:35.299 --> 00:29:37.200
And they're called good manufacturing practices.

00:29:37.940 --> 00:29:40.839
So complex pharmaceutical dosage forms, they

00:29:40.839 --> 00:29:42.900
have many steps in the production of them. And

00:29:42.900 --> 00:29:45.099
we've talked about those. And so every step has

00:29:45.099 --> 00:29:47.559
to be done correctly. And you've got appropriate

00:29:47.559 --> 00:29:50.779
testing after each step because you're ensuring

00:29:50.779 --> 00:29:53.480
the quality of the final product. The quality

00:29:53.480 --> 00:29:57.740
is built into every single step in the... process

00:29:57.740 --> 00:30:00.839
of creating this product. You can't develop the

00:30:00.839 --> 00:30:04.859
quality at the end in post -testing after the

00:30:04.859 --> 00:30:07.220
product is already put together, because then

00:30:07.220 --> 00:30:10.880
all you can do is say, this one's not doing great,

00:30:10.960 --> 00:30:13.740
or you just have to reject the whole batch after

00:30:13.740 --> 00:30:17.019
you've spent a lot of money creating this agent.

00:30:17.119 --> 00:30:21.140
So it's very important to have these steps in

00:30:21.140 --> 00:30:23.359
place. And I'm not going to go through all the

00:30:23.359 --> 00:30:26.380
steps, but it does involve having the right people

00:30:26.380 --> 00:30:29.599
working for you, having the right facility to

00:30:29.599 --> 00:30:32.980
develop these medications and produce these medications,

00:30:33.180 --> 00:30:36.119
having the right documents filed and available

00:30:36.119 --> 00:30:38.460
to you to make sure that you've got the right.

00:30:40.329 --> 00:30:42.490
You've got the right temperature to cook this

00:30:42.490 --> 00:30:44.970
particular medication or the right temperature

00:30:44.970 --> 00:30:47.549
in which to store it, all that kind of data.

00:30:47.910 --> 00:30:50.029
Also that their lab surfaces are clean, that

00:30:50.029 --> 00:30:53.450
things are properly ventilated. Yes. Their glassware

00:30:53.450 --> 00:30:55.829
is heated to a certain degree so that it becomes

00:30:55.829 --> 00:30:58.769
aseptic. I think a great analogy to all this

00:30:58.769 --> 00:31:01.369
is like if you were eating at a restaurant, what

00:31:01.369 --> 00:31:04.230
would you want the kitchen to look like? And

00:31:04.230 --> 00:31:06.750
would you want it to look like your kitchen at

00:31:06.750 --> 00:31:08.829
home? Then maybe you don't clean as much. Well,

00:31:08.910 --> 00:31:10.690
with my mom, you definitely want her kitchen.

00:31:10.829 --> 00:31:13.549
She's definitely an FDA approved kitchen. But

00:31:13.549 --> 00:31:17.230
if you go to the back and you see ingredients

00:31:17.230 --> 00:31:19.869
mixing with each other, you see people not washing

00:31:19.869 --> 00:31:22.569
their hands in between meals, like you're going

00:31:22.569 --> 00:31:24.410
to be a little skeptical about the meal that

00:31:24.410 --> 00:31:26.490
you're about to eat. And I think the same thing

00:31:26.490 --> 00:31:27.970
should be applied when you're thinking about

00:31:27.970 --> 00:31:31.890
taking drugs is that I'll talk a little bit in

00:31:31.890 --> 00:31:34.809
a minute about generic drugs versus brand name

00:31:34.809 --> 00:31:38.680
drugs. At the end of the day, yeah, the place

00:31:38.680 --> 00:31:41.220
where the thing is made can make or break everything,

00:31:41.339 --> 00:31:43.519
even if you've done all the clinical trials and

00:31:43.519 --> 00:31:45.539
you've proven that this thing works. But if then

00:31:45.539 --> 00:31:48.319
your manufacturing processes are sloppy, then

00:31:48.319 --> 00:31:52.059
all that work is gone and done in vain. Right.

00:31:52.700 --> 00:31:58.920
And drugs are continued to be assessed even after

00:31:58.920 --> 00:32:04.170
they're approved when they initially get. approved

00:32:04.170 --> 00:32:08.349
and prescribed for the patient population. Data

00:32:08.349 --> 00:32:12.690
are still collected about those medications looking

00:32:12.690 --> 00:32:16.450
primarily for any weird adverse effects that

00:32:16.450 --> 00:32:18.569
did not show up in the clinical trials because

00:32:18.569 --> 00:32:20.750
you didn't have enough of a patient population

00:32:20.750 --> 00:32:23.970
to find them. So yeah, there's still assessment

00:32:23.970 --> 00:32:26.490
being done after it even goes onto the marketplace.

00:32:27.170 --> 00:32:31.559
Yeah, that's a really good point. A lot of people

00:32:31.559 --> 00:32:34.200
have issues with how much their medications cost.

00:32:35.400 --> 00:32:40.779
But it is very expensive to make a brand name

00:32:40.779 --> 00:32:46.680
medication. In 2019, the pharmaceutical industry

00:32:46.680 --> 00:32:51.740
spent $83 billion just on research and development.

00:32:52.299 --> 00:32:54.819
83 billion on research and development. And that

00:32:54.819 --> 00:32:58.700
was up from 38 billion in 2000, and it was only

00:32:58.700 --> 00:33:03.640
5 billion in 1980. So we have ramped up our ability

00:33:03.640 --> 00:33:07.240
to assess and evaluate medications, but it comes

00:33:07.240 --> 00:33:11.519
at a cost. 59 new drugs were developed in 2018,

00:33:11.720 --> 00:33:15.279
and that was an increase of 60 % compared to

00:33:15.279 --> 00:33:22.069
the decade of 2000. The cost estimates... are

00:33:22.069 --> 00:33:25.269
going to include not only the laboratory research

00:33:25.269 --> 00:33:29.349
and the clinical trials on the successful agents,

00:33:29.589 --> 00:33:32.990
but they also include the laboratory research

00:33:32.990 --> 00:33:35.470
and clinical trials on non -successful agents.

00:33:35.549 --> 00:33:37.809
And I know people might think, that's so unfair.

00:33:39.740 --> 00:33:42.819
The pharmaceutical manufacturer is taking their

00:33:42.819 --> 00:33:45.859
time and their resources that they don't get

00:33:45.859 --> 00:33:50.980
paid for with their flops to make those agents

00:33:50.980 --> 00:33:54.420
that work. And they have to recoup their costs

00:33:54.420 --> 00:33:56.619
for that some way or they just couldn't stay

00:33:56.619 --> 00:34:01.319
in business. The third area in which costs are

00:34:01.319 --> 00:34:03.599
included in an estimate of how much a drug is

00:34:03.599 --> 00:34:06.819
made is what we call capital costs. And those

00:34:06.819 --> 00:34:09.380
are the costs for the pharmaceutical company.

00:34:09.639 --> 00:34:14.239
pharmaceutical company that if they could have

00:34:14.239 --> 00:34:16.659
been doing something else instead of making this

00:34:16.659 --> 00:34:18.739
particular medication and getting some revenue

00:34:18.739 --> 00:34:21.639
from it, that gets factored into that as well

00:34:21.639 --> 00:34:24.280
too. They call that a foregone investment. So

00:34:24.280 --> 00:34:26.599
you've got these three estimates, these three

00:34:26.599 --> 00:34:28.639
estimates that are built into the cost of a medication.

00:34:30.110 --> 00:34:32.349
There was an economic evaluation study that was

00:34:32.349 --> 00:34:34.710
done. They looked at both public and proprietary

00:34:34.710 --> 00:34:38.010
sources, and it showed that the mean cost to

00:34:38.010 --> 00:34:43.090
develop a new drug from 2000 to 2018, this is

00:34:43.090 --> 00:34:47.110
the cost to develop the drug, was $173 million.

00:34:47.809 --> 00:34:53.150
But that cost increased to $516 million if you

00:34:53.150 --> 00:34:56.510
added in the cost of failures, and it increased

00:34:56.510 --> 00:34:59.940
to $800 million. $80 million if you included

00:34:59.940 --> 00:35:02.099
the cost of failures as well as those capital

00:35:02.099 --> 00:35:05.639
costs. It's almost a billion dollars per drug.

00:35:06.099 --> 00:35:10.039
And so if there are 59 new drugs developed, that's

00:35:10.039 --> 00:35:14.679
around $59 billion that you're spending, hoping

00:35:14.679 --> 00:35:18.659
to recoup your cost. But it seems like the juice

00:35:18.659 --> 00:35:21.679
is worth the squeeze, depending on the pharmaceutical

00:35:21.679 --> 00:35:25.440
company. Right. And so you're like thinking,

00:35:25.519 --> 00:35:28.280
well, you know, Those pharmaceutical companies

00:35:28.280 --> 00:35:32.380
make a lot of money, and they do. In 2023, the

00:35:32.380 --> 00:35:34.880
United States pharmaceutical companies generated

00:35:34.880 --> 00:35:41.440
$318 billion in domestic revenue. That's not

00:35:41.440 --> 00:35:45.199
net revenue. That's total revenue. So they have

00:35:45.199 --> 00:35:47.780
got to subtract out the cost of those medications,

00:35:48.260 --> 00:35:52.539
the employee salaries, the rent on their facility.

00:35:52.980 --> 00:35:55.239
They're still going to obviously generate a profit.

00:35:56.349 --> 00:35:59.510
That's that's what capitalism is, you know, and

00:35:59.510 --> 00:36:02.949
stuff. So we need that. But it's like but there's

00:36:02.949 --> 00:36:06.590
a cost to getting a good medication that there

00:36:06.590 --> 00:36:09.610
is an estimate that we will that these pharmaceutical

00:36:09.610 --> 00:36:11.630
companies in the United States will generate

00:36:11.630 --> 00:36:15.010
a revenue of over one trillion dollars by the

00:36:15.010 --> 00:36:19.110
year 2030. Drugs, everything costs more and they're

00:36:19.110 --> 00:36:21.809
just they're investigating more new medications

00:36:21.809 --> 00:36:24.570
to make as well, too. Yeah. Also, I mean, I know

00:36:24.570 --> 00:36:26.670
we're hitting a lot on these GLP -1 agonists,

00:36:26.750 --> 00:36:31.130
but those obviously took off between 2022 to

00:36:31.130 --> 00:36:34.829
now. And a lot of the revenue from places like

00:36:34.829 --> 00:36:38.050
Novo Nordisk and Eli Lilly, that's a lot of the

00:36:38.050 --> 00:36:41.150
profits from their R &D department. And I think

00:36:41.150 --> 00:36:43.250
it's very similar to like a record label for

00:36:43.250 --> 00:36:47.630
musicians or for any venture capital firm. 95

00:36:47.630 --> 00:36:50.389
% of the individuals or companies that you invest

00:36:50.389 --> 00:36:53.050
in are going to flop. you just you if anybody

00:36:53.050 --> 00:36:55.550
could predict the future you know please be my

00:36:55.550 --> 00:36:58.690
guest but investment is a risky business because

00:36:58.690 --> 00:37:00.909
you're just trying to predict the marketplace

00:37:00.909 --> 00:37:03.909
and what the marketplace wants um and so record

00:37:03.909 --> 00:37:07.449
label 95 of artists do not yield a return on

00:37:07.449 --> 00:37:09.889
the record labels but then you have your sabrina

00:37:09.889 --> 00:37:12.590
carpenters you have your perry styles you have

00:37:12.590 --> 00:37:15.730
you have your dochis and these are artists who

00:37:15.730 --> 00:37:19.349
obviously blow up and you then continue to invest

00:37:19.349 --> 00:37:21.269
in those artists But you always kind of have

00:37:21.269 --> 00:37:24.309
a quote -unquote R &D department at your label,

00:37:24.389 --> 00:37:26.690
and you're figuring out what's going on. So a

00:37:26.690 --> 00:37:28.710
lot of these companies, even though they make

00:37:28.710 --> 00:37:32.150
a lot of money, there's a lot of risk associated.

00:37:32.989 --> 00:37:36.170
But also to hedge their bets against that risk,

00:37:36.309 --> 00:37:39.690
they've negotiated with the United States government

00:37:39.690 --> 00:37:43.230
that they have a 10 -year basically patent on

00:37:43.230 --> 00:37:45.469
any drug that they create because it's such a

00:37:45.469 --> 00:37:47.389
large investment. They're like, hey, we spent

00:37:47.389 --> 00:37:50.400
a lot of money on this drug. We would like to

00:37:50.400 --> 00:37:53.519
be free from competition for at least 10 years.

00:37:53.840 --> 00:37:56.099
And so that's just the deal that we've struck

00:37:56.099 --> 00:37:58.019
up with these large pharmaceutical companies.

00:37:58.119 --> 00:38:00.739
Because if you think about it, let's say you

00:38:00.739 --> 00:38:03.139
put a billion dollars into making a drug and

00:38:03.139 --> 00:38:04.940
then you release it, it becomes wildly successful.

00:38:05.320 --> 00:38:07.099
Another pharmaceutical company can just come

00:38:07.099 --> 00:38:10.139
copy your recipe without doing any of the work

00:38:10.139 --> 00:38:13.239
and then sell it for a lower price. And then

00:38:13.239 --> 00:38:14.820
you would immediately go out of business because

00:38:14.820 --> 00:38:16.780
you have no way to recoup your investment. So

00:38:16.780 --> 00:38:19.739
we've kind of had this wiggle room. of this 10

00:38:19.739 --> 00:38:22.079
-year period. And then after that 10 -year period,

00:38:22.219 --> 00:38:24.940
we've granted this access to quote -unquote generic

00:38:24.940 --> 00:38:27.760
drugs. And actually generic drugs are given like

00:38:27.760 --> 00:38:31.519
a six -month category where they're like, if

00:38:31.519 --> 00:38:33.139
you get approval for that, you can sell your

00:38:33.139 --> 00:38:35.239
generic for six months and then you're open to

00:38:35.239 --> 00:38:37.820
competition as well. Because I didn't know this,

00:38:37.880 --> 00:38:43.920
but when a company releases their information

00:38:43.920 --> 00:38:46.760
on their drug, their patent, all they have to

00:38:46.760 --> 00:38:49.079
do is release the chemical formula. They don't

00:38:49.079 --> 00:38:51.320
have to release any of their way that it's made.

00:38:51.440 --> 00:38:54.000
It's like Coca -Cola. It's like, hey, we'll tell

00:38:54.000 --> 00:38:56.619
you what's in Coca -Cola, but we won't tell you

00:38:56.619 --> 00:38:59.599
the ratios. We won't tell you where we got the

00:38:59.599 --> 00:39:01.719
sugar. We don't tell you all the processes to

00:39:01.719 --> 00:39:04.179
get there. And as anyone has known, we're from

00:39:04.179 --> 00:39:07.039
Texas, and so we go to HEB, and they have their

00:39:07.039 --> 00:39:10.800
simulated Coke there. But it doesn't taste like

00:39:10.800 --> 00:39:15.119
Coca -Cola. It's similar, but it's not the same.

00:39:15.280 --> 00:39:18.070
And generics are the same way. And if anyone

00:39:18.070 --> 00:39:21.110
is interested in generics and understanding where

00:39:21.110 --> 00:39:24.150
they come from, I highly recommend going to listen

00:39:24.150 --> 00:39:27.250
to Peter Attia's The Drive podcast number 71.

00:39:27.389 --> 00:39:30.670
I think her name is Catherine Navarro. And they

00:39:30.670 --> 00:39:33.909
go into a deep dive of why not all generics are

00:39:33.909 --> 00:39:39.730
equivalent to the FDA approved drug for reasons

00:39:39.730 --> 00:39:41.550
that we will kind of skip over because I think

00:39:41.550 --> 00:39:43.289
it would take way too much time and then go into

00:39:43.289 --> 00:39:47.070
a lot more detail. But there's a really interesting

00:39:47.070 --> 00:39:50.070
story that I'll just get into. Like one of our

00:39:50.070 --> 00:39:52.889
former presidents, George W. Bush, felt compelled

00:39:52.889 --> 00:39:55.829
to give cheap medications to Africa because they

00:39:55.829 --> 00:39:58.030
were struggling with the AIDS crisis epidemic

00:39:58.030 --> 00:40:01.530
at the time. But these drugs are really expensive.

00:40:01.750 --> 00:40:05.230
And so he we signed this act called PEPFAR, which

00:40:05.230 --> 00:40:08.219
is essentially it signed this deal of like. If

00:40:08.219 --> 00:40:10.900
we can make pharmaceutical manufacturing companies

00:40:10.900 --> 00:40:13.619
in other countries who can produce drugs for

00:40:13.619 --> 00:40:16.000
cheaper, places like China, places like India,

00:40:16.179 --> 00:40:19.360
then we can essentially buy these drugs for cheaper

00:40:19.360 --> 00:40:21.820
from the American taxpayer and we can fund some

00:40:21.820 --> 00:40:24.719
of this aid to send it over to Africa. And so

00:40:24.719 --> 00:40:28.659
by that logic, we were able to give FDA approval

00:40:28.659 --> 00:40:31.519
to some of these manufacturing plants in places

00:40:31.519 --> 00:40:34.980
like India and China, which opened up generic

00:40:34.980 --> 00:40:38.539
drugs. especially AIDS related drugs to Africa.

00:40:39.059 --> 00:40:41.219
And then we were like, well, wait a minute. If

00:40:41.219 --> 00:40:42.960
we are selling, giving these drugs to Africa,

00:40:43.079 --> 00:40:45.679
why can't we give them to the United States citizens?

00:40:45.980 --> 00:40:48.900
So we then opened up selling these drugs to United

00:40:48.900 --> 00:40:51.039
States citizens, which obviously you can buy

00:40:51.039 --> 00:40:53.619
a brand name drug for cheaper because you can

00:40:53.619 --> 00:40:55.599
manufacture it in a country where manufacturing

00:40:55.599 --> 00:40:58.800
costs are low. That sounds great in theory. And

00:40:58.800 --> 00:41:01.219
this is where I'll stop after this last sentence.

00:41:02.679 --> 00:41:05.949
But the United States does not have. jurisdiction,

00:41:06.030 --> 00:41:07.969
especially the FDA, does not have the ability

00:41:07.969 --> 00:41:10.670
to go over and inspect these facilities. And

00:41:10.670 --> 00:41:13.289
based on some investigative journalists and some

00:41:13.289 --> 00:41:17.349
really intrepid FDA employees who do go over

00:41:17.349 --> 00:41:20.230
to inspect some of these manufacturing, it is

00:41:20.230 --> 00:41:23.349
awful. Like the conditions at which some of these

00:41:23.349 --> 00:41:26.869
generics are made, they do not receive an FDA

00:41:26.869 --> 00:41:28.750
approval for these manufacturing facilities.

00:41:28.969 --> 00:41:31.909
And the mechanisms that my mom talked about earlier,

00:41:32.030 --> 00:41:34.929
the good manufacturing processes are not. in

00:41:34.929 --> 00:41:39.269
place and so i would caution anybody listening

00:41:39.269 --> 00:41:43.110
to this podcast when you buy a generic go to

00:41:43.110 --> 00:41:45.329
your pharmacist or ask somebody who works at

00:41:45.329 --> 00:41:48.710
the pharmacy where is this manufactured and you

00:41:48.710 --> 00:41:50.530
should be able to get the name of that pharmacy

00:41:50.530 --> 00:41:53.929
or the manufacturing facility and go to their

00:41:53.929 --> 00:41:56.750
website and if they have not received an fda

00:41:56.750 --> 00:42:01.210
approval either through a voluntary process or

00:42:01.210 --> 00:42:03.550
via the state working with the federal government

00:42:04.110 --> 00:42:06.550
I would be very hesitant to take that generic

00:42:06.550 --> 00:42:09.789
because it is not getting the same stamp of approval

00:42:09.789 --> 00:42:12.579
as we've alluded to earlier. I don't know if

00:42:12.579 --> 00:42:14.619
you have anything to add about my generic statement,

00:42:14.780 --> 00:42:16.940
but just be cautious. No, I think you covered

00:42:16.940 --> 00:42:20.579
that fairly well. The only thing I might say

00:42:20.579 --> 00:42:23.860
is that you talked about Coca -Cola. Coca -Cola

00:42:23.860 --> 00:42:27.179
is not patented. It is a trade secret, which

00:42:27.179 --> 00:42:30.739
is very different. And so then they don't ever

00:42:30.739 --> 00:42:35.039
have to reveal their way to make Coca -Cola unlike

00:42:35.039 --> 00:42:38.059
a patent. And if I'm not mistaken, patents...

00:42:38.400 --> 00:42:41.460
I think they can be longer than 10 years, but

00:42:41.460 --> 00:42:46.059
they may be 20. But part of that is the development

00:42:46.059 --> 00:42:49.199
process. So by the time they finally get to market

00:42:49.199 --> 00:42:51.340
it, they may have only about 10 years left on

00:42:51.340 --> 00:42:53.159
their patent and stuff, something like that,

00:42:53.199 --> 00:42:56.360
I think. So just a couple of other small points

00:42:56.360 --> 00:42:59.300
I wanted to make about the research and development

00:42:59.300 --> 00:43:03.900
spending, because it is a lot of the money that's

00:43:03.900 --> 00:43:06.559
spent to develop a drug. Things that influence

00:43:06.559 --> 00:43:11.699
that are, The anticipated lifetime global revenues

00:43:11.699 --> 00:43:14.099
from a new drug. So they're thinking about how

00:43:14.099 --> 00:43:18.000
long in the life of this drug are we going to

00:43:18.000 --> 00:43:22.219
make money worldwide? That's one factor. How

00:43:22.219 --> 00:43:24.679
much is it going to cost us to develop this new

00:43:24.679 --> 00:43:27.179
drug? That's another aspect of the research and

00:43:27.179 --> 00:43:30.519
development spending. And then what policies

00:43:30.519 --> 00:43:33.679
and programs? influence the supply and demand

00:43:33.679 --> 00:43:36.599
of prescribing this particular medication. Because

00:43:36.599 --> 00:43:39.659
you think if you spend all this money on a medication

00:43:39.659 --> 00:43:44.199
and you end up with having 50 patients in the

00:43:44.199 --> 00:43:46.699
whole world for it, it is not going to be lucrative.

00:43:46.840 --> 00:43:50.679
So they've got people that think, forward -thinking

00:43:50.679 --> 00:43:53.440
people, that think about that as they're anticipating

00:43:53.440 --> 00:43:56.889
whether or not to market this drug. Again, I

00:43:56.889 --> 00:43:59.550
talked about the fact that I talked about the

00:43:59.550 --> 00:44:03.909
stages of the pharmaceutical manufacturing process.

00:44:03.969 --> 00:44:06.969
The areas that are covered by research and development

00:44:06.969 --> 00:44:09.989
spending include the invention of the medication,

00:44:10.329 --> 00:44:13.230
the development and the clinical trials and the

00:44:13.230 --> 00:44:17.369
FDA applications, something that's called incremental

00:44:17.369 --> 00:44:20.670
innovation. So you may need to tweak your product

00:44:20.670 --> 00:44:23.610
along the way to maintain your patent. product

00:44:23.610 --> 00:44:25.630
differentiation how do you make it different

00:44:25.630 --> 00:44:28.190
than somebody else's as well as safety monitoring

00:44:28.190 --> 00:44:31.429
that's a really good point i think this would

00:44:31.429 --> 00:44:34.469
be a great time to pivot to compounding because

00:44:34.469 --> 00:44:38.650
like essentially this is the downside of capitalism

00:44:38.650 --> 00:44:41.510
is that every company obviously is out there

00:44:41.510 --> 00:44:44.909
to make money and large pharmaceutical companies

00:44:44.909 --> 00:44:47.130
make it by something called the economy of scale

00:44:47.130 --> 00:44:50.880
so like you can make I always think about it

00:44:50.880 --> 00:44:52.980
like cookies in an oven. Like you can turn your

00:44:52.980 --> 00:44:56.000
oven on and you can put one piece of cookie dough

00:44:56.000 --> 00:45:00.000
in that oven. It'll make one cookie. But you

00:45:00.000 --> 00:45:02.900
could also put 30 pieces of cookie dough and

00:45:02.900 --> 00:45:05.760
it'll make 30 cookies. So someone selling 30

00:45:05.760 --> 00:45:07.980
cookies versus one cookie, you can sell 30 cookies

00:45:07.980 --> 00:45:09.940
for cheaper. It took you the same amount of energy

00:45:09.940 --> 00:45:15.599
to make 30 cookies than one cookie. And so pharmaceutical

00:45:15.599 --> 00:45:17.960
companies and any company who makes something

00:45:17.960 --> 00:45:20.780
in large bulk, uses this idea of economy of scale.

00:45:20.940 --> 00:45:23.039
You usually put a certain amount of energy in

00:45:23.039 --> 00:45:25.460
to make more of that product. You can sell that

00:45:25.460 --> 00:45:30.079
product for cheaper to a lot of people. But if

00:45:30.079 --> 00:45:32.920
I was selling a cookie that had peanut butter

00:45:32.920 --> 00:45:34.679
chips in it and somebody had a peanut butter

00:45:34.679 --> 00:45:37.579
allergy or peanut allergy, that person is out

00:45:37.579 --> 00:45:39.139
of cookies. They have no luck. So they're relying

00:45:39.139 --> 00:45:41.679
on somebody coming along to make a batch of cookies

00:45:41.679 --> 00:45:44.159
without peanut butter chips. I only make peanut

00:45:44.159 --> 00:45:45.960
butter chip cookies. So they're relying on a

00:45:45.960 --> 00:45:49.300
compound cookie maker to come along. and make

00:45:49.300 --> 00:45:52.699
a peanut -free cookie. That's going to be more

00:45:52.699 --> 00:45:56.119
expensive for that compound cookie maker, which

00:45:56.119 --> 00:45:57.500
is why I think it would be good to transition

00:45:57.500 --> 00:46:00.599
into talking about the benefits of compound pharmacies,

00:46:00.619 --> 00:46:04.599
but then also why it might not always be the

00:46:04.599 --> 00:46:07.980
best option. Okay, great. So we will transition.

00:46:08.099 --> 00:46:10.179
That's a great transition into compounding pharmacies.

00:46:10.380 --> 00:46:14.559
And I'm sure everybody is aware. Actually, every

00:46:14.559 --> 00:46:18.300
pharmacy can compound. If you go to a pharmacy

00:46:18.300 --> 00:46:24.860
and they add water to the powder and turn it

00:46:24.860 --> 00:46:28.440
into a liquid suspension, that's compounding.

00:46:28.460 --> 00:46:31.340
But anyway, so let me give you a more official

00:46:31.340 --> 00:46:34.739
definition of compounding. It is defined by the

00:46:34.739 --> 00:46:39.440
Drug Quality and Security Act of 2013 as it's

00:46:39.440 --> 00:46:44.969
the combining, admixing, diluting. pooling, reconstituting

00:46:44.969 --> 00:46:47.869
or otherwise altering of a drug or bulk drug

00:46:47.869 --> 00:46:51.030
substance to create a drug. It starts with a

00:46:51.030 --> 00:46:53.829
bulk substance and it is combined with excipients

00:46:53.829 --> 00:46:57.550
to form a final product. Compounding pharmacies,

00:46:57.550 --> 00:47:00.969
this is very different than our pharmaceutical

00:47:00.969 --> 00:47:04.230
manufacturing companies. Compounding pharmacies

00:47:04.230 --> 00:47:06.250
are not regulated by the Food and Drug Administration.

00:47:06.829 --> 00:47:10.030
They are instead regulated by individual state

00:47:10.030 --> 00:47:13.929
boards of pharmacy. And so the compounding regulations

00:47:13.929 --> 00:47:17.349
are going to vary by state. Let me give you a

00:47:17.349 --> 00:47:19.769
little tiny bit of history as far as compounding

00:47:19.769 --> 00:47:22.389
is concerned. Compounding, if you've ever been

00:47:22.389 --> 00:47:26.159
to a... I grew up in Virginia and I loved going

00:47:26.159 --> 00:47:29.119
to Williamsburg. And so they have apothecary

00:47:29.119 --> 00:47:31.500
shops, you know, the little drawers and they

00:47:31.500 --> 00:47:33.599
would have all their little ingredients in the

00:47:33.599 --> 00:47:37.239
drawers, mortars and pestles. You know, the compounding

00:47:37.239 --> 00:47:39.679
was the primary way that medications were produced

00:47:39.679 --> 00:47:42.960
until the early 20th century when large scale

00:47:42.960 --> 00:47:45.280
pharmaceutical manufacturing companies came into

00:47:45.280 --> 00:47:48.139
existence. And we have a decreased reliance on

00:47:48.139 --> 00:47:51.110
compounding now. But there has been a recent

00:47:51.110 --> 00:47:53.849
resurgence in compounding in the last couple

00:47:53.849 --> 00:47:59.650
of decades because people have become more focused

00:47:59.650 --> 00:48:03.050
on personalized medical care. I think about it

00:48:03.050 --> 00:48:07.780
specifically with men and women's health. hormone

00:48:07.780 --> 00:48:10.480
replacement therapy was a big one, pain management,

00:48:10.760 --> 00:48:15.719
hospice care, dermatology, oncology, even veterinary

00:48:15.719 --> 00:48:18.380
care. Almost all veterinary products are, well,

00:48:18.400 --> 00:48:21.400
not all, but a lot of veterinary products are

00:48:21.400 --> 00:48:26.769
compounded. There really is a lack of regulation

00:48:26.769 --> 00:48:30.030
and oversight for the development of compounded

00:48:30.030 --> 00:48:32.230
medications. So when you're in a compounding

00:48:32.230 --> 00:48:35.929
pharmacy, you get a unique prescription for that

00:48:35.929 --> 00:48:38.650
particular patient, but you're not replicating

00:48:38.650 --> 00:48:41.210
it for other patients. Now, you may replicate

00:48:41.210 --> 00:48:44.230
it if that patient comes back for that same prescription,

00:48:44.309 --> 00:48:47.130
or maybe this particular physician uses this.

00:48:47.500 --> 00:48:50.880
recipe, per se, for this compounded medication

00:48:50.880 --> 00:48:54.539
in different patients. But it's not regulated.

00:48:54.739 --> 00:48:57.659
You don't have all those quality control steps

00:48:57.659 --> 00:49:00.840
for a compounding pharmacy. So there sometimes

00:49:00.840 --> 00:49:05.980
can be concerns about whether you could have,

00:49:06.260 --> 00:49:10.699
should there be concerns about patients being

00:49:10.699 --> 00:49:13.840
exposed to medications that are not subject to

00:49:13.840 --> 00:49:17.239
these rigorous uh, quality control standards.

00:49:17.440 --> 00:49:19.400
Yeah. Let's, let's give an example of that. Let's

00:49:19.400 --> 00:49:22.739
say that you like taking Tylenol or acetaminophen

00:49:22.739 --> 00:49:25.920
via pill form. Okay. And I hate it. I hate swallowing.

00:49:25.980 --> 00:49:28.519
It's the worst in the world. So I have, I go

00:49:28.519 --> 00:49:31.000
to a compound pharmacy, I have them crush it

00:49:31.000 --> 00:49:34.780
up and then I have them dissolve it. And let's

00:49:34.780 --> 00:49:37.920
say, what would you say? Diethylene glycol? Yeah.

00:49:37.980 --> 00:49:39.800
Diethylene glycol. Let's say I just really, I

00:49:39.800 --> 00:49:42.320
love the flavor of that for some reason. And

00:49:42.320 --> 00:49:44.239
so I have them dissolve it in that. And then

00:49:44.239 --> 00:49:49.019
I just take it that way. Now, that seems fine.

00:49:49.139 --> 00:49:52.119
But at the end of the day, I don't know how Tylenol

00:49:52.119 --> 00:49:56.019
interacts with diethylene glycol and or the safety

00:49:56.019 --> 00:49:59.179
consideration of consuming that. So the idea

00:49:59.179 --> 00:50:01.840
that you just add it to something else sounds

00:50:01.840 --> 00:50:06.320
quite benign. But then that pharmacy. Can't make

00:50:06.320 --> 00:50:08.820
that and then sell it to my mom. He's like, oh,

00:50:08.860 --> 00:50:10.619
we actually have this liquid version that we

00:50:10.619 --> 00:50:12.500
think would be great. It's like, no, each of

00:50:12.500 --> 00:50:15.039
these has to be tailor -made based on the patient's

00:50:15.039 --> 00:50:17.900
request. Right. You can't compound something

00:50:17.900 --> 00:50:20.480
that is commercially available. And realize,

00:50:20.599 --> 00:50:24.860
too, what's being compounded is being compounded

00:50:24.860 --> 00:50:30.679
with FDA approved. FDA -approved ingredients.

00:50:31.039 --> 00:50:37.679
I mean, the excipients, the active ingredient,

00:50:37.960 --> 00:50:41.179
those parts are regulated, but the actual thing

00:50:41.179 --> 00:50:44.039
coming together doesn't go through those good

00:50:44.039 --> 00:50:46.380
manufacturing processes that a pharmaceutical

00:50:46.380 --> 00:50:50.300
company does. Who can compound, you might say?

00:50:50.679 --> 00:50:52.860
Well, you know, your pharmacist can do it as

00:50:52.860 --> 00:50:55.099
well as anybody that's under the supervision

00:50:55.099 --> 00:50:58.539
of a licensed pharmacist. So they may have technicians

00:50:58.539 --> 00:51:01.280
or they can have pharmacy interns, pharmacy students

00:51:01.280 --> 00:51:03.920
that work with pharmacists can also compound

00:51:03.920 --> 00:51:06.199
and physicians can also compound in their offices

00:51:06.199 --> 00:51:08.559
as well, too, if they've got there. There are

00:51:08.559 --> 00:51:16.519
there are. continuing education processes. You

00:51:16.519 --> 00:51:18.420
need to keep up to date with how to compound.

00:51:18.599 --> 00:51:20.659
So there are definitely classes that need to

00:51:20.659 --> 00:51:23.860
be taken to be able to continue to be compounding

00:51:23.860 --> 00:51:27.699
more complex medications other than adding a

00:51:27.699 --> 00:51:30.119
liquid to a powder that's already inside of a

00:51:30.119 --> 00:51:36.260
bottle. Why on earth do we need a compounded

00:51:36.260 --> 00:51:39.699
medication? Why do we need compounded medications?

00:51:39.760 --> 00:51:42.130
Well, We talked about it. You're going to provide

00:51:42.130 --> 00:51:44.349
a therapeutic agent for something that's not

00:51:44.349 --> 00:51:46.670
commercially available. So it's something that

00:51:46.670 --> 00:51:50.929
you can't get anywhere else. Or it could be that

00:51:50.929 --> 00:51:54.030
you need a particular dosage form. Let's say

00:51:54.030 --> 00:52:00.110
you need Prilosec, which is for ulcers in a suppository

00:52:00.110 --> 00:52:02.329
form. I don't think it comes that way. I don't

00:52:02.329 --> 00:52:06.110
know if it could. It can be. Why not? So something

00:52:06.110 --> 00:52:09.230
that doesn't come. that particular way, you can

00:52:09.230 --> 00:52:13.329
create that. Or the other thing too, that you

00:52:13.329 --> 00:52:16.110
could see a lot of in a pharmacy is as kiddos

00:52:16.110 --> 00:52:18.929
can't swallow pills. So there would be a lot

00:52:18.929 --> 00:52:21.829
of different ways to try to make a medication

00:52:21.829 --> 00:52:25.610
in a liquid form so a kiddo could take it. Or

00:52:25.610 --> 00:52:30.369
like Joshua mentioned, if a particular FDA approved

00:52:30.369 --> 00:52:33.090
medication has an ingredient in it to which a

00:52:33.090 --> 00:52:36.050
patient is allergic, you can recreate it, leaving

00:52:36.050 --> 00:52:39.400
that weird inactive ingredient excipient out

00:52:39.400 --> 00:52:41.519
of it because they happen to be allergic to FDA

00:52:41.519 --> 00:52:44.960
or food, whatever, the FDC dye number three or

00:52:44.960 --> 00:52:48.019
whatever and stuff. And then you can also compound

00:52:48.019 --> 00:52:50.139
medications for which there is either a drug

00:52:50.139 --> 00:52:54.659
shortage or an FDA drug discontinuation. Remember,

00:52:54.880 --> 00:52:59.639
a compounding prescription is originated by a

00:52:59.639 --> 00:53:02.719
prescription. From a physician for a specific

00:53:02.719 --> 00:53:05.239
patient. And then the pharmacist or the person

00:53:05.239 --> 00:53:07.380
who's going to compound it makes it. That's very

00:53:07.380 --> 00:53:09.739
different than the pharmaceutical manufacturer.

00:53:09.739 --> 00:53:12.119
Remember, they were not specific for a particular

00:53:12.119 --> 00:53:18.119
patient. They're a 503B facility. And compounding

00:53:18.119 --> 00:53:22.840
pharmacies are 503A facilities. Yeah. So 503A,

00:53:22.960 --> 00:53:27.699
patient -specific. 503B. much more being able

00:53:27.699 --> 00:53:29.920
to make an economy of scale. It's for the general

00:53:29.920 --> 00:53:33.800
population as long as well as those big giant

00:53:33.800 --> 00:53:36.280
pharmaceutical manufacturing plants. And the

00:53:36.280 --> 00:53:38.900
pharmaceutical manufacturing companies that manufacture

00:53:38.900 --> 00:53:42.760
those agents, they end up in the pharmacy, a

00:53:42.760 --> 00:53:45.659
compounding pharmacy. I'm going to get into this

00:53:45.659 --> 00:53:47.579
right now. Let me just say this and then I'll

00:53:47.579 --> 00:53:49.739
add that thought I was just going to say. So

00:53:49.739 --> 00:53:55.489
how common is it? how common is medication compounding?

00:53:55.550 --> 00:53:58.969
It's really difficult to determine the number

00:53:58.969 --> 00:54:01.050
of drugs that are compounded and the number of

00:54:01.050 --> 00:54:03.429
compounders due to the lack of federal reporting

00:54:03.429 --> 00:54:06.389
requirements. Really, like I said, almost, you

00:54:06.389 --> 00:54:09.829
could say almost 100 % of pharmacies can be compounders

00:54:09.829 --> 00:54:13.929
because they can add liquid to a powder. But

00:54:13.929 --> 00:54:17.949
specifically the more complex compounding pharmacies,

00:54:17.949 --> 00:54:23.269
it's estimated that about 7 ,500 of 56 ,000 US

00:54:23.269 --> 00:54:27.510
pharmacies, so about 13 % specialize in compounding

00:54:27.510 --> 00:54:31.010
services. And it's interesting to note that a

00:54:31.010 --> 00:54:35.010
lot of compounded prescriptions will not be covered

00:54:35.010 --> 00:54:38.929
by your insurance. That's just because they don't

00:54:38.929 --> 00:54:42.050
have the, they haven't been regulated. So insurance

00:54:42.050 --> 00:54:44.909
companies will, and it's not all insurance companies,

00:54:44.989 --> 00:54:47.389
but it may be more difficult to get it paid for

00:54:47.389 --> 00:54:50.869
by an insurance company. About one to 3 % of

00:54:50.869 --> 00:54:52.989
prescriptions written in the United States are

00:54:52.989 --> 00:54:54.809
compounded prescriptions. So there's not that

00:54:54.809 --> 00:54:59.800
many, but there's still a fair number. Although

00:54:59.800 --> 00:55:02.679
we don't have good manufacturing practices in

00:55:02.679 --> 00:55:05.139
place for compounding pharmacies, there are requirements

00:55:05.139 --> 00:55:07.320
that are set by the state boards of pharmacy.

00:55:07.699 --> 00:55:10.659
You need to have a specific area in your pharmacy

00:55:10.659 --> 00:55:13.260
that's dedicated for compounding. It has to be

00:55:13.260 --> 00:55:17.639
clean. It has to have a good counter area, good

00:55:17.639 --> 00:55:21.820
lighting to be able to. to keep it separate from

00:55:21.820 --> 00:55:23.920
the other part of the pharmacy. You have to have

00:55:23.920 --> 00:55:27.059
the right equipment, the right supplies, the

00:55:27.059 --> 00:55:30.840
right ingredients, the right, you need either

00:55:30.840 --> 00:55:33.320
water or alcohol, depending on whether or not

00:55:33.320 --> 00:55:37.539
the particular agent will dissolve in water or

00:55:37.539 --> 00:55:40.739
alcohol. You need to keep records. Even though

00:55:40.739 --> 00:55:43.539
it's not FDA approved, you still need to keep

00:55:43.539 --> 00:55:45.559
records and record keeping for these compounded

00:55:45.559 --> 00:55:48.400
agents. And there are still policies and procedures

00:55:48.400 --> 00:55:52.760
to follow. set by the state to to make sure that

00:55:52.760 --> 00:55:57.059
you do use certain uh safety measures standard

00:55:57.059 --> 00:55:59.320
operating procedures that you do it the same

00:55:59.320 --> 00:56:02.179
way every time and that you have quality assurance

00:56:02.179 --> 00:56:05.900
and control in those as well too um so yeah so

00:56:05.900 --> 00:56:10.780
unlike um so joshua mentioned earlier that with

00:56:10.780 --> 00:56:14.739
a pharmaceutical manufacturing medication, after

00:56:14.739 --> 00:56:16.760
it goes through the whole process, it ends up

00:56:16.760 --> 00:56:19.860
with an expiration date. And an expiration date,

00:56:20.079 --> 00:56:23.420
when you get to that expiration date on a medication,

00:56:23.639 --> 00:56:31.139
it means that 10 % of the efficacy of the medication

00:56:31.139 --> 00:56:34.559
has been lost. Well, we don't set expiration

00:56:34.559 --> 00:56:37.920
dates with compound. pharmacy medications, but

00:56:37.920 --> 00:56:41.019
we set beyond use dates. And these dates are

00:56:41.019 --> 00:56:45.159
assigned to guide the patient for appropriate

00:56:45.159 --> 00:56:49.320
use as well as storage. The beyond use dates

00:56:49.320 --> 00:56:53.599
allow the product enough time to be used appropriately

00:56:53.599 --> 00:56:57.039
without it being able to be stored for long time

00:56:57.039 --> 00:57:01.650
periods and degrade and lose its potency. There

00:57:01.650 --> 00:57:04.510
are actual standards for setting these beyond

00:57:04.510 --> 00:57:07.949
use dates. It depends on the dosage form. If

00:57:07.949 --> 00:57:10.670
it's an oral preparation containing water versus

00:57:10.670 --> 00:57:15.170
a limit liquid or semi -solid, like a topical

00:57:15.170 --> 00:57:18.690
or mucosal agent versus a preparation containing

00:57:18.690 --> 00:57:21.710
no water. Preparations that contain no water

00:57:21.710 --> 00:57:25.090
can have a longer beyond use date up to six months,

00:57:25.210 --> 00:57:29.670
whereas those agents that are Oral preparations

00:57:29.670 --> 00:57:32.670
that contain water, like the reconstituted antibiotic,

00:57:33.130 --> 00:57:37.550
only has a 14 -day beyond use date. Your beyond

00:57:37.550 --> 00:57:40.869
use date cannot be greater than the expiration

00:57:40.869 --> 00:57:44.489
date of the active ingredient that's used to

00:57:44.489 --> 00:57:46.730
make that medication. So if you happen to be

00:57:46.730 --> 00:57:51.489
low on an ampicillin... I don't even know if

00:57:51.489 --> 00:57:55.170
they prescribe impicillin anymore, but suspension

00:57:55.170 --> 00:57:57.949
that needs to be reconstituted. You have to set

00:57:57.949 --> 00:58:00.809
the beyond use date on what the bottle says rather

00:58:00.809 --> 00:58:04.929
than the actual 14 days. You always need to make

00:58:04.929 --> 00:58:07.750
sure that you dispense your medication in a container

00:58:07.750 --> 00:58:11.150
that protects from light and moisture. And typical,

00:58:11.230 --> 00:58:14.469
you can really compound most everything. You

00:58:14.469 --> 00:58:18.139
can compound solutions. You can compound suspensions,

00:58:18.159 --> 00:58:20.659
which are two -phase systems that have finely

00:58:20.659 --> 00:58:23.519
divided solids that are dispersed in the liquid

00:58:23.519 --> 00:58:26.199
vehicle. You can do emulsions, which are two

00:58:26.199 --> 00:58:29.239
-phase systems that have two what they call immiscible

00:58:29.239 --> 00:58:31.019
liquids. Then you shake them up. I think we need

00:58:31.019 --> 00:58:32.639
to slow down because I don't think a lot of people

00:58:32.639 --> 00:58:35.900
know these terms. And we need to give examples.

00:58:36.099 --> 00:58:40.159
Okay. So a solution is going to be just like

00:58:40.159 --> 00:58:47.309
if you add water to a – Well, it may just come

00:58:47.309 --> 00:58:48.730
as a solution. We don't know if you're going

00:58:48.730 --> 00:58:50.250
to make it. Well, just, I mean, think of sugar

00:58:50.250 --> 00:58:52.429
water as a solution. Okay. So you have a solid,

00:58:52.510 --> 00:58:54.449
which is the sugar, and then you have the water,

00:58:54.489 --> 00:58:56.949
which is the liquid. You stir it around. You

00:58:56.949 --> 00:58:59.469
make sure it's nice and evenly mixed. You now

00:58:59.469 --> 00:59:01.610
have a two phase solution where you have solids

00:59:01.610 --> 00:59:04.630
mixed with liquids and you can probably no longer

00:59:04.630 --> 00:59:06.389
see the solid anymore because it's mixed in and

00:59:06.389 --> 00:59:09.730
it tastes delicious. Yes. There you go. A suspension

00:59:09.730 --> 00:59:13.230
is going to be your. uh antibiotic that you've

00:59:13.230 --> 00:59:15.449
got the powder in the bottom of the bottle you

00:59:15.449 --> 00:59:18.670
add the water you shake it up it gets dispensed

00:59:18.670 --> 00:59:21.630
and dispersed within the water you can still

00:59:21.630 --> 00:59:24.230
see it i know i'm like i'm shaking my hand i'm

00:59:24.230 --> 00:59:27.130
just i'm i'm mixing up my suspension right now

00:59:27.130 --> 00:59:29.150
it's like i think orange juice is a great example

00:59:29.150 --> 00:59:32.789
because you you have the pulp with the rest of

00:59:32.789 --> 00:59:36.230
the juice and so you can still see the pulp that's

00:59:36.230 --> 00:59:39.670
inside and it's not mixed evenly like you would

00:59:39.670 --> 00:59:43.920
see in sugar water Okay. Emulsions. Best example

00:59:43.920 --> 00:59:46.340
of an emulsion. Again, we're talking about two

00:59:46.340 --> 00:59:49.260
liquids that don't mix together. Oil and water,

00:59:49.360 --> 00:59:53.440
salad dressing, mayonnaise. Milk actually is

00:59:53.440 --> 00:59:57.340
an emulsion. You've got the milk droplets that,

00:59:57.400 --> 00:59:59.780
and there are drugs that like that as well too.

01:00:00.139 --> 01:00:01.820
We should say that oil and water is not a good

01:00:01.820 --> 01:00:03.800
emulsion because they separate. Right. But you

01:00:03.800 --> 01:00:07.199
can add an emulsifier, which is a thing that

01:00:07.199 --> 01:00:10.900
will bind the water and the oil. together. Help

01:00:10.900 --> 01:00:14.139
them stay clumped together. Yes. So you can make

01:00:14.139 --> 01:00:18.380
capsules. You can make tablet triturates. You're

01:00:18.380 --> 01:00:20.639
like, what on earth is that? They actually have

01:00:20.639 --> 01:00:23.679
little molds that you can add the medication

01:00:23.679 --> 01:00:27.519
to and it will solidify and it can become a sublingual

01:00:27.519 --> 01:00:30.019
tablet. So that's how they make those. What is

01:00:30.019 --> 01:00:31.920
it? What is a sublingual tablet? Sublingual tablets

01:00:31.920 --> 01:00:34.300
are those tablets that you put under your tongue

01:00:34.300 --> 01:00:35.980
and then they melt and you don't have to swallow

01:00:35.980 --> 01:00:39.000
them. Oh, fun. Sometimes I have a medication

01:00:39.000 --> 01:00:41.739
that I take for migraines. So sometimes migraines

01:00:41.739 --> 01:00:43.699
can make you feel nauseated and you don't feel

01:00:43.699 --> 01:00:46.340
like drinking water. So things like that might

01:00:46.340 --> 01:00:48.820
be sublingual. Or if it's a cancer patient, sometimes

01:00:48.820 --> 01:00:51.159
they can't swallow very well. So you can give

01:00:51.159 --> 01:00:53.300
them medications under their tongue. So a sublingual

01:00:53.300 --> 01:00:58.920
tablet. Another thing that can be... made in

01:00:58.920 --> 01:01:01.179
a compounding pharmacy are things that we call

01:01:01.179 --> 01:01:05.019
trochies or lozenges or lollipops. Trochies are,

01:01:05.039 --> 01:01:07.420
again, agents that you can put in your mouth.

01:01:07.440 --> 01:01:15.010
It's kind of like a mint. Yeah, I meant that

01:01:15.010 --> 01:01:17.190
you can suck on that will get the medication

01:01:17.190 --> 01:01:20.929
into your systemic circulation. Same thing with

01:01:20.929 --> 01:01:23.710
the lozenge that you can suck on it and lollipops

01:01:23.710 --> 01:01:25.909
as well too. They do make lollipops for pain

01:01:25.909 --> 01:01:29.329
management and cancer patients. You can get some

01:01:29.329 --> 01:01:32.110
FDA approved and there may be others that you

01:01:32.110 --> 01:01:35.329
can make in a compounding pharmacy. Ointments,

01:01:35.329 --> 01:01:38.070
creams, and paste. They were the bane of my existence

01:01:38.070 --> 01:01:40.469
in pharmacy school. Like making them? Making

01:01:40.469 --> 01:01:43.269
them. Yes, you had to make them. Because you

01:01:43.269 --> 01:01:46.030
needed to make them smooth. And they'd always

01:01:46.030 --> 01:01:47.969
pick these nasty ingredients that you had to

01:01:47.969 --> 01:01:50.750
make. Because it was mainly there for dermatologic

01:01:50.750 --> 01:01:54.630
issues like psoriasis or eczema. You had to mix

01:01:54.630 --> 01:01:56.889
things together. And you had a spatula. You had

01:01:56.889 --> 01:01:59.869
to make them smooth and mixed in completely in

01:01:59.869 --> 01:02:02.010
there. So you didn't see any evidence left of

01:02:02.010 --> 01:02:05.679
the ingredient to which. that was being added

01:02:05.679 --> 01:02:10.880
to the base. And so that was a common thing.

01:02:11.760 --> 01:02:14.460
Gels, suppositories, there's definitely molds

01:02:14.460 --> 01:02:18.559
and you can make suppositories as well too. Powders.

01:02:19.199 --> 01:02:22.119
And then I used to, I made powder papers. You're

01:02:22.119 --> 01:02:24.239
like, what on earth is a powder paper? They were

01:02:24.239 --> 01:02:25.860
really cool, but you had, you have to have the

01:02:25.860 --> 01:02:27.480
writing, you have to have the right equipment.

01:02:27.559 --> 01:02:31.239
You had to have a balance. And so you had to

01:02:31.239 --> 01:02:32.719
have these little powder papers, you put them

01:02:32.719 --> 01:02:35.489
on the balance, you would. either get a supply

01:02:35.489 --> 01:02:39.050
from a manufacturer that was just raw powdered

01:02:39.050 --> 01:02:42.110
medication, or you could grind it up in a mortar

01:02:42.110 --> 01:02:46.050
and pestle. You would then weigh it out on the

01:02:46.050 --> 01:02:48.550
balance and then you put it into the powdered

01:02:48.550 --> 01:02:50.690
paper and then you folded these powder papers

01:02:50.690 --> 01:02:52.690
in a particular way and they went into these

01:02:52.690 --> 01:02:55.269
little boxes and stuff. So for patients that

01:02:55.269 --> 01:02:57.389
can't swallow pills, but they could potentially

01:02:57.389 --> 01:02:59.530
be mixed up in their water or juice, it was another

01:02:59.530 --> 01:03:03.940
way to give medications as well too. So that's

01:03:03.940 --> 01:03:07.860
it as far as, you know, so again, really, I've

01:03:07.860 --> 01:03:11.800
never actually worked in a full -fledged compounding

01:03:11.800 --> 01:03:14.539
pharmacy, so I can't give you a lot of examples

01:03:14.539 --> 01:03:18.219
of what they do. I do know that there was a...

01:03:18.699 --> 01:03:20.739
compounding pharmacy in san antonio that was

01:03:20.739 --> 01:03:23.880
known for making veterinary medications so they

01:03:23.880 --> 01:03:27.760
had all these amazing flavors to add to the medications

01:03:27.760 --> 01:03:30.039
that dogs and cats would like so it was like

01:03:30.039 --> 01:03:32.739
it was really cool so yeah yeah it seems to be

01:03:32.739 --> 01:03:35.840
a really nice addition for the personalized aspect

01:03:35.840 --> 01:03:38.679
of medicine like in just in case you have an

01:03:38.679 --> 01:03:41.280
allergy to a certain type of medicine but you

01:03:41.280 --> 01:03:43.440
still need to take it then somebody can find

01:03:43.440 --> 01:03:47.260
a way to personalize it for you. I know there's

01:03:47.260 --> 01:03:50.079
a difference between non -sterile and sterile

01:03:50.079 --> 01:03:54.400
compound pharmacies where one is needing to be

01:03:54.400 --> 01:03:56.619
a lot more stringent in their safety procedures.

01:03:57.099 --> 01:03:59.659
I believe there was that case with the NECC.

01:03:59.679 --> 01:04:00.960
I don't know if we're going to talk about the

01:04:00.960 --> 01:04:03.400
New England Compounding Center. So this is actually

01:04:03.400 --> 01:04:06.199
the reason that the new compounding law was enacted.

01:04:06.460 --> 01:04:09.199
So in 2012, there was something called the NECC,

01:04:09.219 --> 01:04:11.699
called the New England Compounding Center, and

01:04:11.699 --> 01:04:15.610
they were making steroid injections. And unfortunately,

01:04:15.710 --> 01:04:19.349
they were made in non -sterile conditions and

01:04:19.349 --> 01:04:23.710
they got contaminated with basically a fungus

01:04:23.710 --> 01:04:28.489
that caused fungal meningitis. And we should

01:04:28.489 --> 01:04:31.690
let people know that what fungal meningitis is,

01:04:31.750 --> 01:04:34.489
if you've never heard of meningitis. Itis means

01:04:34.489 --> 01:04:37.610
inflammation. Menin means meninges, which is

01:04:37.610 --> 01:04:39.429
kind of like part of your nervous system. And

01:04:39.429 --> 01:04:42.170
it essentially gets into your brain. So essentially,

01:04:42.269 --> 01:04:45.050
these injections went into the bloodstream, crossed

01:04:45.050 --> 01:04:48.369
the blood -brain barrier, and then infected over

01:04:48.369 --> 01:04:51.869
700 people. And about 60 -something of them died

01:04:51.869 --> 01:04:58.250
from these injections. And this basically propelled

01:04:58.250 --> 01:05:01.840
Congress to say, hey, we need some more. tighter

01:05:01.840 --> 01:05:03.900
regulations on the compound pharmacy, especially

01:05:03.900 --> 01:05:06.519
on the sterile side when you're actually injecting

01:05:06.519 --> 01:05:09.019
things into people's bodies rather than making

01:05:09.019 --> 01:05:15.139
things like mints or lollipops. And so the risk

01:05:15.139 --> 01:05:20.300
of something being compounded is that it can

01:05:20.300 --> 01:05:22.900
be made at a place, like my mom said, in a place

01:05:22.900 --> 01:05:26.920
that's not FDA approved. And we mentioned before

01:05:26.920 --> 01:05:28.960
there are two types of compounding pharmacies.

01:05:30.039 --> 01:05:33.559
They get 503A designation or 503B designation.

01:05:34.139 --> 01:05:37.920
503A designation means you're making very personalized

01:05:37.920 --> 01:05:43.719
doses for people. The NECC was a 503B compounding

01:05:43.719 --> 01:05:45.559
pharmacy where essentially they were making large

01:05:45.559 --> 01:05:49.219
batches of a substance like this steroid injection.

01:05:50.250 --> 01:05:52.809
And what a 503B is meant to do is kind of be

01:05:52.809 --> 01:05:56.030
a filler anytime there's a supply shortage of

01:05:56.030 --> 01:05:58.030
a certain type of drugs. If there's a larger

01:05:58.030 --> 01:06:00.829
demand for something like a steroid, or in the

01:06:00.829 --> 01:06:03.670
case of COVID, monoclonal antibodies or vaccines,

01:06:03.869 --> 01:06:06.849
you can essentially have these 503B pharmacies

01:06:06.849 --> 01:06:10.369
come in and say, hey, we will fill the gap where

01:06:10.369 --> 01:06:14.110
the supply is being limited at the moment. Because

01:06:14.110 --> 01:06:16.530
maybe they could get a source of the drug from

01:06:16.530 --> 01:06:18.650
somewhere else that's not the main manufacturer.

01:06:19.670 --> 01:06:23.829
So that sounds great in theory. But unfortunately,

01:06:24.010 --> 01:06:26.710
if these pharmacies, very similar to like the

01:06:26.710 --> 01:06:29.269
generic drugs I mentioned, don't have that FDA

01:06:29.269 --> 01:06:32.829
approval or an FDA auditor hasn't come by and

01:06:32.829 --> 01:06:35.190
inspected their facility, you're kind of taking

01:06:35.190 --> 01:06:38.929
their word that they are doing best practices.

01:06:38.989 --> 01:06:41.750
And depending on the state and how often that

01:06:41.750 --> 01:06:44.610
state audits these facilities, you're relying

01:06:44.610 --> 01:06:48.199
on these facilities to be clean. and safe. And

01:06:48.199 --> 01:06:54.179
unfortunately, this place wasn't. And that's

01:06:54.179 --> 01:06:58.400
one of the downsides with having these 503B pharmacies.

01:06:58.559 --> 01:07:01.840
But luckily now, it's not mandatory, but these

01:07:01.840 --> 01:07:04.679
pharmacies can now voluntarily work with the

01:07:04.679 --> 01:07:07.059
FDA. They can go across state lines and say,

01:07:07.139 --> 01:07:09.940
hey, we want you to come and approve us. So,

01:07:09.940 --> 01:07:12.639
which is what I strongly recommend if you are

01:07:12.639 --> 01:07:16.369
getting your drugs from a compounding pharmacy.

01:07:16.949 --> 01:07:19.650
And this can be a lot of different things. We've

01:07:19.650 --> 01:07:22.409
talked a lot about GLP -1 agonists on this episode,

01:07:22.530 --> 01:07:25.250
but there are a lot of wellness companies out

01:07:25.250 --> 01:07:27.030
there. Some of them you might've heard of on

01:07:27.030 --> 01:07:31.929
commercials, things like Noom, HIMS, HERS, and

01:07:31.929 --> 01:07:36.469
they are offering semaglutide or terzepatide

01:07:36.469 --> 01:07:41.150
injections at a lower price than what a company

01:07:41.150 --> 01:07:44.409
like Novo Nordisk or Eli Lilly is offering. And

01:07:44.409 --> 01:07:46.170
the reason they're able to do that is they partner

01:07:46.170 --> 01:07:49.710
with larger compound pharmacies to make these

01:07:49.710 --> 01:07:54.389
at a lower price. Some of these facilities have

01:07:54.389 --> 01:07:56.650
been approved by the FDA. They work with the

01:07:56.650 --> 01:07:58.949
FDA to get that stamp of approval that they're

01:07:58.949 --> 01:08:01.289
doing all the things that a large manufacturing

01:08:01.289 --> 01:08:03.949
facility would do. But a lot of them are not.

01:08:04.289 --> 01:08:08.210
And a lot of them are actually using semaglutide

01:08:08.210 --> 01:08:12.059
mixed with another base. Something like a sodium

01:08:12.059 --> 01:08:15.619
salt that will mix in a solution that's slightly

01:08:15.619 --> 01:08:18.220
different than the original formula. It's almost

01:08:18.220 --> 01:08:22.199
kind of like having Coca -Cola mixed with aspartame

01:08:22.199 --> 01:08:25.359
instead of stevia, for example. They might be

01:08:25.359 --> 01:08:28.399
the same thing, but consuming 12 Diet Cokes a

01:08:28.399 --> 01:08:32.479
day could be different if you have 12 parts aspartame,

01:08:32.500 --> 01:08:34.619
12 parts stevia. You just don't know if you've

01:08:34.619 --> 01:08:38.239
never done the clinical trial. Just a word of

01:08:38.239 --> 01:08:40.539
caution for anybody who is getting any of these

01:08:40.539 --> 01:08:43.840
cheaper alternatives is to really do your due

01:08:43.840 --> 01:08:46.859
diligence and figure out where these things are

01:08:46.859 --> 01:08:49.500
being made, where they're being sourced, just

01:08:49.500 --> 01:08:51.920
like you would do with your food. Because you

01:08:51.920 --> 01:08:53.479
are putting these things in your body and you

01:08:53.479 --> 01:08:55.000
want to make sure that they've gone through the

01:08:55.000 --> 01:08:58.079
same stringent testing as a lot of these other

01:08:58.079 --> 01:09:00.920
FDA approved drugs have done. So just wanted

01:09:00.920 --> 01:09:03.399
to give the delineation between a 503A and a

01:09:03.399 --> 01:09:06.670
503B and the risk. and benefits to either of

01:09:06.670 --> 01:09:11.829
those. You know, as far as, so when we're, what

01:09:11.829 --> 01:09:14.270
I've been talking as far as compounding pharmacies

01:09:14.270 --> 01:09:18.449
this morning is primarily the non -sterile compounding

01:09:18.449 --> 01:09:25.800
dosage forms. You can do sterile compounding

01:09:25.800 --> 01:09:28.000
as well, too, but when you do sterile compounding,

01:09:28.000 --> 01:09:33.199
you need a hood. It's got to be ventilated in

01:09:33.199 --> 01:09:37.680
a particular way. You have to gown, glove. You're

01:09:37.680 --> 01:09:40.579
making a sterile product, so it's a very different

01:09:40.579 --> 01:09:44.880
type. I did an internship in a pharmacy, and

01:09:44.880 --> 01:09:48.340
also hospital pharmacies have sterile hoods to

01:09:48.340 --> 01:09:50.430
make. intravenous preparations and stuff. So

01:09:50.430 --> 01:09:52.270
they've got guidelines around those as well too.

01:09:53.050 --> 01:09:55.770
But when you think about a compounding pharmacy,

01:09:56.189 --> 01:09:59.750
you think maybe more of the non -sterile compounding

01:09:59.750 --> 01:10:02.010
parts rather than the sterile compounding parts.

01:10:02.050 --> 01:10:04.529
But they can be made in a compounding pharmacy

01:10:04.529 --> 01:10:06.649
as well too. So again, they're going to have

01:10:06.649 --> 01:10:09.869
regulations. And again, although they may not

01:10:09.869 --> 01:10:11.930
be regulated by the Food and Drug Administration,

01:10:12.270 --> 01:10:15.189
they are regulated by the state boards of pharmacies.

01:10:15.210 --> 01:10:19.060
So they can't get away with everything. things

01:10:19.060 --> 01:10:21.840
can happen like in that new england compound

01:10:21.840 --> 01:10:23.960
i can only imagine in texas where we live they

01:10:23.960 --> 01:10:26.260
probably check them once and then they just let

01:10:26.260 --> 01:10:28.939
them do whatever they want um because we do not

01:10:28.939 --> 01:10:31.159
like regulating people down here and then but

01:10:31.159 --> 01:10:33.819
in a place like new york or california there

01:10:33.819 --> 01:10:36.579
might be more stringent regulations and i think

01:10:37.220 --> 01:10:39.600
It's not good or bad, but I think the thing that

01:10:39.600 --> 01:10:41.680
I always want to get across on an episode like

01:10:41.680 --> 01:10:44.439
this is that you have a choice between cost versus

01:10:44.439 --> 01:10:47.279
safety. And I think a lot of times, if you think

01:10:47.279 --> 01:10:50.260
about any activity that you do, if you want to

01:10:50.260 --> 01:10:53.520
be more safe, it's going to be more costly, whether

01:10:53.520 --> 01:10:56.859
in terms of your money or your time. If you want

01:10:56.859 --> 01:10:59.699
to walk outside without tripping, you will tie

01:10:59.699 --> 01:11:01.500
your shoes. That's going to take a certain amount

01:11:01.500 --> 01:11:05.439
of time. Or shoes with laces, right? But if you

01:11:05.439 --> 01:11:07.420
don't tie your shoes, It doesn't mean that you

01:11:07.420 --> 01:11:09.739
are going to trip, but there is a higher likelihood

01:11:09.739 --> 01:11:11.659
that you will trip because you will step on your

01:11:11.659 --> 01:11:14.979
shoes. So I think in this episode, we wanted

01:11:14.979 --> 01:11:17.779
to really get across it like there's no evildoers

01:11:17.779 --> 01:11:20.340
here. It's just everyone is responding to incentives.

01:11:20.899 --> 01:11:23.619
And if I was a company and I could get out of

01:11:23.619 --> 01:11:26.260
paying a billion dollars to develop a drug and

01:11:26.260 --> 01:11:29.140
I could just, you know, sell it and compound

01:11:29.140 --> 01:11:31.500
it, heck, I would do that. And if I didn't have

01:11:31.500 --> 01:11:34.279
to be regulated as hard, heck yes, let's do that.

01:11:35.100 --> 01:11:37.239
But at the end of the day, if I was an ethical

01:11:37.239 --> 01:11:39.180
person, I would want to think I'd still want

01:11:39.180 --> 01:11:41.560
to guarantee that my customer is getting the

01:11:41.560 --> 01:11:46.340
same health benefit as a normal drug. And unfortunately,

01:11:46.460 --> 01:11:49.159
I think relying on somebody's goodwill to do

01:11:49.159 --> 01:11:51.899
the right thing sounds very nice. But this is

01:11:51.899 --> 01:11:53.899
why we have government. We have government and

01:11:53.899 --> 01:11:56.920
regulation so that everyone has these best practices.

01:11:57.239 --> 01:11:59.500
Not because we want to chastise people, but we

01:11:59.500 --> 01:12:02.399
want to be guaranteed being given the same thing.

01:12:02.890 --> 01:12:06.409
If I was in Oregon versus I was in Ohio. And

01:12:06.409 --> 01:12:09.289
I think that type of consistency just gives you

01:12:09.289 --> 01:12:11.510
a nice peace of mind. So then whenever you walk

01:12:11.510 --> 01:12:14.109
into a drugstore and you see a generic versus

01:12:14.109 --> 01:12:16.329
a brand name, or if you go to a compound pharmacy,

01:12:16.590 --> 01:12:18.869
that you can have a relative confidence that

01:12:18.869 --> 01:12:20.489
a lot of these things are going to be similar

01:12:20.489 --> 01:12:22.689
rather than think, oh my gosh, what am I getting

01:12:22.689 --> 01:12:26.050
today? Similar to when you buy a piece of meat

01:12:26.050 --> 01:12:29.380
somewhere, you want to make sure that. It's actually

01:12:29.380 --> 01:12:33.539
cow that I'm buying rather than antelope. So

01:12:33.539 --> 01:12:37.039
I think the consistency is what we want for our

01:12:37.039 --> 01:12:39.579
customers. And I know that I want as someone

01:12:39.579 --> 01:12:43.859
who takes pharmaceuticals. I would probably beg

01:12:43.859 --> 01:12:45.779
to differ. I think that the Texas State Board

01:12:45.779 --> 01:12:48.180
of Pharmacy does do some regulation in their

01:12:48.180 --> 01:12:50.399
pharmacies. but there are a lot of pharmacies

01:12:50.399 --> 01:12:52.720
in the state of Texas. So, I mean, they may,

01:12:52.819 --> 01:12:55.859
but they, they were always assessing, you know,

01:12:55.880 --> 01:12:57.800
pharmacists and pharmacies to make sure that

01:12:57.800 --> 01:12:59.479
they're doing appropriate things. Do they go

01:12:59.479 --> 01:13:02.500
out and inspect? They do. We have like officers

01:13:02.500 --> 01:13:05.119
here. There's a board of pharmacy. Yeah, there

01:13:05.119 --> 01:13:09.779
are. So yeah. Now again, and how they, because

01:13:09.779 --> 01:13:12.380
there's paperwork that pharmacies have to submit

01:13:12.380 --> 01:13:17.079
to, to the. board of pharmacy and then they've

01:13:17.079 --> 01:13:19.659
got monitoring systems for narcotics and things

01:13:19.659 --> 01:13:21.680
like that and so things can be flagged i think

01:13:21.680 --> 01:13:24.319
that you know that that that they might find

01:13:24.319 --> 01:13:26.560
uh concerning right and they'll look at things

01:13:26.560 --> 01:13:28.340
i guess i'm just saying people can just lie on

01:13:28.340 --> 01:13:33.920
their paperwork uh they yes but when you're talking

01:13:33.920 --> 01:13:36.800
about actual counts of medications and and stuff

01:13:36.800 --> 01:13:40.819
i you know yeah i mean i'm sure yes they Anybody

01:13:40.819 --> 01:13:43.699
can get by with something. But, you know, they

01:13:43.699 --> 01:13:46.399
do. I'm just saying that they do their best to

01:13:46.399 --> 01:13:47.960
regulate. I'm not saying that they're not doing

01:13:47.960 --> 01:13:49.420
their best. I'm just saying is like sometimes

01:13:49.420 --> 01:13:52.079
you're just hampered by the laws within your

01:13:52.079 --> 01:13:54.479
state. Right. So for example, even the FDA is

01:13:54.479 --> 01:13:56.739
like the FDA is wonderful. They are incredibly

01:13:56.739 --> 01:14:00.359
underfunded for the amount of demand. Like the

01:14:00.359 --> 01:14:03.279
pharmaceutical industry is a multibillion dollar

01:14:03.279 --> 01:14:08.760
industry. And the fact that our FDA. is not funded

01:14:08.760 --> 01:14:10.739
to the degree to be able to regulate an industry

01:14:10.739 --> 01:14:14.039
like that like that seems wrong to me like i

01:14:14.039 --> 01:14:17.060
think at the end of the day we would want a lot

01:14:17.060 --> 01:14:19.779
of these officers the same with the epa is like

01:14:19.779 --> 01:14:22.520
i don't want people dumping their waste into

01:14:22.520 --> 01:14:25.619
rivers and so i want officers out there to be

01:14:25.619 --> 01:14:27.819
able to prevent things like that happening but

01:14:27.819 --> 01:14:30.520
if we're not going to fund the proper law enforcement

01:14:30.520 --> 01:14:33.720
officers to police these things and they can

01:14:33.720 --> 01:14:36.279
only rely on getting paperwork into these offices.

01:14:36.659 --> 01:14:38.579
I'm not saying this is the case. We should probably

01:14:38.579 --> 01:14:43.060
look more into it. But if I can't literally walk

01:14:43.060 --> 01:14:45.380
into somebody's facility and see what they're

01:14:45.380 --> 01:14:48.000
doing at a random day, just like we do with kitchens,

01:14:48.119 --> 01:14:51.579
we'll have the health officer for the city. We'll

01:14:51.579 --> 01:14:54.619
just walk into a restaurant and then give them

01:14:54.619 --> 01:14:57.619
a grade. I don't see why we can't do that for

01:14:57.619 --> 01:15:00.859
a compound pharmacy or even a 503B pharmacy.

01:15:01.550 --> 01:15:03.449
Just walk in. All right. You're getting audited

01:15:03.449 --> 01:15:06.050
today. Right. And that seems very reasonable.

01:15:06.170 --> 01:15:07.789
And I'm not sure that they don't do it that way.

01:15:07.850 --> 01:15:11.069
Okay. Yeah. One last point. Well, two last points

01:15:11.069 --> 01:15:13.489
I wanted to make. So we talked about how much

01:15:13.489 --> 01:15:18.430
money is generated from pharmaceutical manufacturing

01:15:18.430 --> 01:15:23.250
industry. So the 503A compounding pharmacies.

01:15:23.880 --> 01:15:28.619
are projected to grow from $4 .47 billion in

01:15:28.619 --> 01:15:35.520
2024 to $8 billion in 2034. So they make a substantially

01:15:35.520 --> 01:15:38.300
lower amount of money than the pharmaceutical

01:15:38.300 --> 01:15:40.920
manufacturing company, but that's still... A

01:15:40.920 --> 01:15:42.439
chunk of change, you know, when you think about

01:15:42.439 --> 01:15:45.260
it. It's about double. Yeah. In 30 years. 30

01:15:45.260 --> 01:15:48.500
years. So, yeah. Well, no, in 10 years. 2024

01:15:48.500 --> 01:15:50.619
to 2034. For some reason, I thought we were in

01:15:50.619 --> 01:15:55.300
2004. We're in 2025, actually. So, yeah. So,

01:15:55.300 --> 01:15:57.619
let me just remind you again, the differences

01:15:57.619 --> 01:16:02.770
between a pharmacy compounding. institution and

01:16:02.770 --> 01:16:04.649
a manufacturing or pharmaceutical manufacturing

01:16:04.649 --> 01:16:08.390
company. Remember, the compounding pharmacy is

01:16:08.390 --> 01:16:11.250
patient specific. It's regulated by the state

01:16:11.250 --> 01:16:13.890
boards of pharmacy. You don't have to have clinical

01:16:13.890 --> 01:16:18.470
trials to determine the safety and efficacy of

01:16:18.470 --> 01:16:21.029
that particular compound you're making. You don't

01:16:21.029 --> 01:16:24.109
have to submit a new drug application, but you

01:16:24.109 --> 01:16:26.789
do have to use good compounding practices. You

01:16:26.789 --> 01:16:29.649
need to assign a beyond use date. and you are

01:16:29.649 --> 01:16:32.729
exempt from the FDA labeling requirements. Whereas

01:16:32.729 --> 01:16:35.989
a manufacturing company is not patient -specific,

01:16:36.170 --> 01:16:39.689
but they're regulated by the FDA, there are clinical

01:16:39.689 --> 01:16:42.210
trials involved as well as submitting a new drug

01:16:42.210 --> 01:16:44.869
application. They have to follow good manufacturing

01:16:44.869 --> 01:16:48.409
processes. They assign expiration dates, and

01:16:48.409 --> 01:16:50.970
they do follow FDA labeling requirements. So

01:16:50.970 --> 01:16:53.090
I think we can see differences between both.

01:16:53.850 --> 01:16:58.449
We can see utility in both. And I think Josh

01:16:58.449 --> 01:17:01.210
offered just some, just, you know, just have

01:17:01.210 --> 01:17:10.229
some, just be aware, you know, if you sense something

01:17:10.229 --> 01:17:13.649
could be maybe not correct, you know, or maybe

01:17:13.649 --> 01:17:15.750
a little off or whatever, just to ask questions.

01:17:15.970 --> 01:17:21.170
Yeah. If this stuff is not documented, that's

01:17:21.170 --> 01:17:25.170
a bit concerning. I can even see from the compounding

01:17:25.170 --> 01:17:28.930
side, especially on the 503A, why a lot of that

01:17:28.930 --> 01:17:31.789
FDA stuff would not be required because essentially

01:17:31.789 --> 01:17:35.649
it's just your personal relationship with your

01:17:35.649 --> 01:17:38.789
pharmacist. Like there's no company involved.

01:17:39.029 --> 01:17:40.729
I mean, obviously they get the chemical from

01:17:40.729 --> 01:17:44.369
the manufacturer itself. Which has gone through

01:17:44.369 --> 01:17:46.890
all of the rigorous. But at the end of the day,

01:17:46.909 --> 01:17:48.369
if they're going to personalize it, it's like,

01:17:48.430 --> 01:17:50.829
okay, the liability is now on you, the individual,

01:17:51.029 --> 01:17:53.340
because you've gone this route. and then this

01:17:53.340 --> 01:17:56.260
compound pharmacist is now taking this route

01:17:56.260 --> 01:17:59.840
as well so i could see why you know you wouldn't

01:17:59.840 --> 01:18:01.560
want to be too strict around that because at

01:18:01.560 --> 01:18:03.699
the end of the day it's such a small scale um

01:18:03.699 --> 01:18:06.100
especially with developing things like therapeutics

01:18:06.100 --> 01:18:08.539
like you said for cancer patients and maybe even

01:18:08.539 --> 01:18:11.859
novel medications for you know like hey we don't

01:18:11.859 --> 01:18:13.319
know if this drug works we're kind of at the

01:18:13.319 --> 01:18:15.520
end of our rope here we want to try this thing

01:18:15.520 --> 01:18:19.229
so let's compound a new treatment for this hospital,

01:18:19.310 --> 01:18:21.630
for this specific patient so that they can do

01:18:21.630 --> 01:18:25.630
this. And there are definitely rules or regulations

01:18:25.630 --> 01:18:27.510
they have to follow. It's not just like carte

01:18:27.510 --> 01:18:29.949
blanche, do whatever you want. It's just different

01:18:29.949 --> 01:18:37.409
and not as rigorous as the manufacturing practices

01:18:37.409 --> 01:18:41.930
for a pharmaceutical company. That's what I have.

01:18:42.229 --> 01:18:44.710
All right. Well, I think, man, this has been

01:18:44.710 --> 01:18:47.770
such a deep dive into this. And I think... One

01:18:47.770 --> 01:18:52.250
thing that I've really learned a lot is the history

01:18:52.250 --> 01:18:56.710
of drug regulation in this country and just how

01:18:56.710 --> 01:18:59.909
a lot of times we operated on good faith, that

01:18:59.909 --> 01:19:01.670
people were just kind of giving you what they

01:19:01.670 --> 01:19:02.970
said they were going to give you. And it took

01:19:02.970 --> 01:19:05.609
a couple of unfortunately bad historical examples

01:19:05.609 --> 01:19:08.909
to remind us that the grass isn't always that

01:19:08.909 --> 01:19:11.699
green. And even though it can be quite annoying

01:19:11.699 --> 01:19:14.399
and quite frustrating and quite expensive to

01:19:14.399 --> 01:19:16.399
go through the process to make sure that something

01:19:16.399 --> 01:19:19.859
is safe and effective, it might actually be worth

01:19:19.859 --> 01:19:23.439
it in the end. But I would really like to see

01:19:23.439 --> 01:19:28.380
the generic space and the compound space catch

01:19:28.380 --> 01:19:31.899
up to the standards that we set at the FDA. I

01:19:31.899 --> 01:19:34.239
would just love to see the FDA get more funding

01:19:34.239 --> 01:19:37.979
so that it can... actually almost like train

01:19:37.979 --> 01:19:40.420
a lot of these other folks in those practices

01:19:40.420 --> 01:19:43.680
or even supply grants for some of these places

01:19:43.680 --> 01:19:46.420
to have the necessary safety equipment. Because

01:19:46.420 --> 01:19:48.039
I'm sure for a compound pharmacy, it's got to

01:19:48.039 --> 01:19:50.899
be really expensive to have all of these extra

01:19:50.899 --> 01:19:54.159
vent hoods and, you know. If you were compounding

01:19:54.159 --> 01:19:56.760
sterile products, yes. And at the end of the

01:19:56.760 --> 01:19:59.340
day, we want to have a country and a world where

01:19:59.340 --> 01:20:02.899
a lot of these medications are safe and effective.

01:20:03.720 --> 01:20:06.439
And I think another just a last point to make,

01:20:06.439 --> 01:20:09.560
too, is that I know our medications can be expensive

01:20:09.560 --> 01:20:12.220
and, you know, biopharmaceutical medications

01:20:12.220 --> 01:20:14.279
cost a lot more. And it depends on whether or

01:20:14.279 --> 01:20:17.220
not you have health insurance and what kind of

01:20:17.220 --> 01:20:19.640
health insurance you have. But when you look

01:20:19.640 --> 01:20:22.899
and again, pharmaceutical companies, there are

01:20:22.899 --> 01:20:24.699
parts of them, I'm sure, that are not completely

01:20:24.699 --> 01:20:30.319
ethical. But. It takes a long time for one medication

01:20:30.319 --> 01:20:34.520
to get designed all the way from the idea all

01:20:34.520 --> 01:20:37.500
the way through the whole new drug application,

01:20:38.039 --> 01:20:41.880
clinical trials, production, and packaging. And

01:20:41.880 --> 01:20:45.920
it can take a decade. And that pharmaceutical

01:20:45.920 --> 01:20:49.460
company is not making any money on that medication

01:20:49.460 --> 01:20:52.399
at all during that time period. So they have

01:20:52.399 --> 01:20:56.489
to have a way to be able to... generate revenue

01:20:56.489 --> 01:20:58.609
from that effort. And that's why they have all

01:20:58.609 --> 01:21:01.210
those people assigned, assess how well is this

01:21:01.210 --> 01:21:03.550
drug going to be used, how many people are going

01:21:03.550 --> 01:21:06.029
to use it, for how long, to help them figure

01:21:06.029 --> 01:21:09.289
out how to price it, and then how long the patent

01:21:09.289 --> 01:21:11.909
lasts and all that stuff. That's really well

01:21:11.909 --> 01:21:15.289
said. And you can also imagine the perverse incentive,

01:21:15.409 --> 01:21:18.029
which obviously has happened where pharmaceutical

01:21:18.029 --> 01:21:21.569
companies have bribed members of the FDA or they

01:21:21.569 --> 01:21:24.090
fudged the numbers on their data. or they've

01:21:24.090 --> 01:21:28.189
hid side effects because you have this 10 -year

01:21:28.189 --> 01:21:31.270
gamble and you really want it to work. And it's

01:21:31.270 --> 01:21:33.930
your goal as a company, unfortunately, to deliver

01:21:33.930 --> 01:21:36.930
money to your shareholders and things like that

01:21:36.930 --> 01:21:40.949
rather than the public good. But I always want

01:21:40.949 --> 01:21:43.649
to stress too, even though that's bad and we

01:21:43.649 --> 01:21:46.329
try to catch the bad actors, the alternative

01:21:46.329 --> 01:21:49.890
is to not get rid of it. It's to make it better.

01:21:50.029 --> 01:21:51.649
I think a lot of people think like, well, the

01:21:51.649 --> 01:21:54.090
FDA is corrupt. It's done these corrupt things.

01:21:54.310 --> 01:21:56.470
I'm just going to buy supplements from now on.

01:21:56.569 --> 01:21:59.489
It's like, no, it's like they don't have to do

01:21:59.489 --> 01:22:01.909
anything. There's no FDA member to bribe. They

01:22:01.909 --> 01:22:04.930
can just go out and sell it on Amazon and you

01:22:04.930 --> 01:22:07.189
have no idea what you're getting. So I would

01:22:07.189 --> 01:22:09.250
really encourage people, even if you're frustrated

01:22:09.250 --> 01:22:12.310
with the process, is to engage with the process

01:22:12.310 --> 01:22:14.890
and make it better. Because as you've seen from

01:22:14.890 --> 01:22:19.329
1937 to 2025. how much better the process has

01:22:19.329 --> 01:22:21.630
gotten. And even though we do have instances

01:22:21.630 --> 01:22:23.970
where some of this stuff slips through, most

01:22:23.970 --> 01:22:27.130
drugs from the FDA are safe and effective and

01:22:27.130 --> 01:22:30.329
we're getting better as years go along. So we

01:22:30.329 --> 01:22:32.010
hope that you've learned something today. Well

01:22:32.010 --> 01:22:35.170
said. Yeah. Well, this has been a great episode

01:22:35.170 --> 01:22:38.229
and I've learned a lot. And so I hope that you

01:22:38.229 --> 01:22:40.069
have too. And I hope you ask questions at your

01:22:40.069 --> 01:22:42.010
local pharmacy and also give them a high five.

01:22:42.529 --> 01:22:44.850
So this has been another episode of Your Mom

01:22:44.850 --> 01:22:48.729
on Drugs. My name is Josh, the son. And I'm Jennifer

01:22:48.729 --> 01:22:50.869
the Mama. And we'll see you next time. Thank

01:22:50.869 --> 01:22:51.449
you. Bye.