Dave Knapp
๐ค PersonAppearances Over Time
Podcast Appearances
I know that you talk about this within your community, many people relying on the compounded versions. Now, compound versions, I don't know how much you want to get into the weeds on this, but essentially pharmacies have been compounding medicines for hundreds of years. That's what they've done, right? But back in 2013, I believe it was, the government wanted to
I know that you talk about this within your community, many people relying on the compounded versions. Now, compound versions, I don't know how much you want to get into the weeds on this, but essentially pharmacies have been compounding medicines for hundreds of years. That's what they've done, right? But back in 2013, I believe it was, the government wanted to
I know that you talk about this within your community, many people relying on the compounded versions. Now, compound versions, I don't know how much you want to get into the weeds on this, but essentially pharmacies have been compounding medicines for hundreds of years. That's what they've done, right? But back in 2013, I believe it was, the government wanted to
realizing that we had some really glaring holes in the way that drug companies were sort of outsourcing active pharmaceutical ingredients and the manufacturing of their drugs. There was this gaping hole that left the United States open to drug shortages. And so it's like, what happens if all of a sudden we can't get antibiotics that are largely made primarily made in China or India.
realizing that we had some really glaring holes in the way that drug companies were sort of outsourcing active pharmaceutical ingredients and the manufacturing of their drugs. There was this gaping hole that left the United States open to drug shortages. And so it's like, what happens if all of a sudden we can't get antibiotics that are largely made primarily made in China or India.
realizing that we had some really glaring holes in the way that drug companies were sort of outsourcing active pharmaceutical ingredients and the manufacturing of their drugs. There was this gaping hole that left the United States open to drug shortages. And so it's like, what happens if all of a sudden we can't get antibiotics that are largely made primarily made in China or India.
What happens if we can't get those, right? And so they basically made a big distinction and they said, you know, we're going to have 503A pharmacies that have always been around. They can make a drug that is commercially available, not in shortage, but maybe a patient can't
What happens if we can't get those, right? And so they basically made a big distinction and they said, you know, we're going to have 503A pharmacies that have always been around. They can make a drug that is commercially available, not in shortage, but maybe a patient can't
What happens if we can't get those, right? And so they basically made a big distinction and they said, you know, we're going to have 503A pharmacies that have always been around. They can make a drug that is commercially available, not in shortage, but maybe a patient can't
stand or is allergic to a certain preservative or a certain dye, or maybe even the doses that are available commercially don't work for that person. So compound 503A pharmacies always have the ability to make a branded medication in a compound form. when there is a medical need that precipitates that.
stand or is allergic to a certain preservative or a certain dye, or maybe even the doses that are available commercially don't work for that person. So compound 503A pharmacies always have the ability to make a branded medication in a compound form. when there is a medical need that precipitates that.
stand or is allergic to a certain preservative or a certain dye, or maybe even the doses that are available commercially don't work for that person. So compound 503A pharmacies always have the ability to make a branded medication in a compound form. when there is a medical need that precipitates that.
But they also, in the Food, Drug, and Cosmetic Act of 2013, established another code that established 503B pharmacies. And basically this was to address that, you know,
But they also, in the Food, Drug, and Cosmetic Act of 2013, established another code that established 503B pharmacies. And basically this was to address that, you know,
But they also, in the Food, Drug, and Cosmetic Act of 2013, established another code that established 503B pharmacies. And basically this was to address that, you know,
What the lawmakers could see happening with the outsourcing of drug manufacturing was if we all of a sudden, let's say there's something that happens on the economic stage of the world and we can't import drugs, we need infrastructure in the United States that can manufacture drugs and make sure people have what they need.
What the lawmakers could see happening with the outsourcing of drug manufacturing was if we all of a sudden, let's say there's something that happens on the economic stage of the world and we can't import drugs, we need infrastructure in the United States that can manufacture drugs and make sure people have what they need.
What the lawmakers could see happening with the outsourcing of drug manufacturing was if we all of a sudden, let's say there's something that happens on the economic stage of the world and we can't import drugs, we need infrastructure in the United States that can manufacture drugs and make sure people have what they need.
And so in establishing 503B pharmacies, they've established basically a pharmacy that's not like a traditional pharmacy. It's a factory. It is a plant that can mass produce medicines. And unlike 503As that have to hold an individual script for a patient, if a drug goes into an FDA shortage, they can mass produce it.
And so in establishing 503B pharmacies, they've established basically a pharmacy that's not like a traditional pharmacy. It's a factory. It is a plant that can mass produce medicines. And unlike 503As that have to hold an individual script for a patient, if a drug goes into an FDA shortage, they can mass produce it.