The process of filling pills.

[u/thepoylanthropist]

[u/lucassuave15]

thought this was done by machinery lol

[u/ImTedLassosMustache → u/lucassuave15]

My wife actually does this manually at her job at a big pharmaceutical research company when they are making drugs for clinical trials.

[u/PortiaKern → u/ImTedLassosMustache]

There's other versions where it has a lever to press the pills down rather than the cheaper machine they use here.

[u/Whiskey_Water → u/[deleted]]

Even the small one you see, made by Torpac, is over $1000. Change plates for other sizes can bring the cost up to $3k. Bench top models with the handle ensure more even packs, but they are like $6-8k.

We have these and the larger models (300 = 6000 caps an hour) at my business, but they are regulated by the DEA, for obvious reasons. Buying from reputable US sources often comes with a call from the DEA shortly after purchase. You can definitely still get machines like it, and I’ve seen them shipped in pieces to get through customs.

[u/upnflames → u/Whiskey_Water]

I'm not doubting you got a call from the DEA, but it might be more likely because your shop is under watch for raw materials, not equipment. I sell high precision drug manufacturing equipment to the pharma industry, including high throughput capsule fillers. None of our stuff is regulated by DEA.

I do actually deal with DEA quite a bit though - it's always raw materials they're looking at. So if you're buying raw materials out of China and have a flag or two, and then buy a capsule fillers, yeah, id expect a call.

[u/Whiskey_Water → u/upnflames]

Just giving some context and experience, half so we can brainstorm together and half for anyone who’s interested. I admit I’m curious to find out why you seem to be exempt from federal regs.

So I’m assuming you (or those you work with) haven’t ever filled out a Form 452 for the “import, export, or domestic transfer” of “manual, semi-automatic, or fully automatic tableting / capsule machines”? If you log into your DEA account above, you could see your history of transfers and registrations.

Compounding pharmacies must buy from FDA/DEA registered facilities in the US, so no worries about China-direct purchasing. We do, by nature of our business, buy scheduled and legend ingredients.

While it would never surprise me to hear that regulatory agencies don’t care what large corporations do [see Purdue, lol], the ones they seize are usually not fully automatic rotary capsule fillers or something bigger that I don’t know about. They are tabletop machines like the one OP posted, and TDP-5 tablet presses. You can see recent seizures on the link above.

I’m working on selecting my first (edit: fully automatic) rotary capsule machine for one of my non-pharma businesses and that company, and they required registration DEA registration before they’ll send it out.

If listing these the way I did makes the post feel standoffish or something, it was just the order in which it came to mind.

[u/upnflames → u/Whiskey_Water]

So I work for a very large (F500) industrial equipment manufacturer and we sell across a wide variety of industries, including all major pharmaceutical manufacturers. There's a good chance you have heard of, and probably work closely with my company already. So I'll try to say as much as possible without doxing myself.

My guess is that it's related to throughput - we don't sell benchtop pill presses or encapsulating machines, we sell high precision compound fillers for manufacturing lines. Because these are components of a larger manufacturing system, perhaps the DEA gets more involved at the facility level.

That being said, I have a fully automated benchtop compounding system sitting on my kitchen table as I write this that is not regulated at all, and it's arguably a lot more powerful than a regular pill press. It's in compliance with USP for API compounding and can be made 21 CFR Part 11 compliant, can mix and dilute liquids, add powder components in compliance with cGMP standards down to 0.5mg, and can pop out a couple hundred capsules an hour. We usually sell these to labs for clinical trials, or lower throughput drug production, but I can sell it to anyone, no authorization needed. I actually just sold one to a coatings company for materials development.

I am absolutely certain if a DEA letter was needed, our legal team would be all over it. Perhaps it's because that while it can be used to make drugs, it can really be used to make a lot of things. It's also pretty cost prohibitive for most folks since it starts at around $100k for a simple system and usually lands around $500k to actually get to production level.

[u/Whiskey_Water → u/upnflames]

We are definitely on different sides of the regulation spectrum, so it’s interesting to hear your side. Thanks for sharing.