Prohibitions on the sale of tablet presses and die punches, designed to restrict the reduction of counterfeit medicines, may be undermined by new technologies like 3D printing.
That's the conclusion of a paper published in the journal Science & Justice which suggests that advances in 3D printing and the availability of benchtop milling machines could help criminals producing fake medicines laced with fentanyl and other illicit drugs sidestep the restrictions.
The paper – written by researchers at Ulster University, the University of Central Lancashire, and Liverpool John Moores University in the UK – notes that while pill presses once needed to be made using industrial-level machining processes "low-cost mills and 3D printing systems are already at the stage of producing small format presses within the domestic home."
While controls on drug precursors and pill-making equipment have resulted in some notable successes in the fight against this form of medicine counterfeiting, "the illicit drug trade is counter responsive and clandestine laboratories are quick to adopt new chemicals and synthetic routes and methods of manufacture," according to the authors.
"While once only obtainable from industrial sources, a pill press can now be fabricated in the domestic home and there is an abundance of pill press designs available for download at no cost," they add.
Earlier this year, the US Drug Enforcement Administration (DEA) issued a letter to e-commerce companies, reminding them of their obligations on the sale of tablet presses, after an investigation revealed that some were continuing to list the devices without keeping proper records.
Some online retailers – including Amazon, eBay and Etsy – say they have banned all sales of tabletting and encapsulating machines and pill punches from their platforms, a restriction that could also be got around using 3D-printed machinery.
The authors note that the production of more sophisticated, high-volume presses remains out of reach for now, but with the price and size of printers that can produce metal parts falling and reliability increasing, outputs are likely to rise.
"It is clear that the field is evolving and could render a strategic law enforcement measure redundant," they conclude. While controls on the sale of 3D printers or consumables is likely unworkable, they suggest efforts to restrict access to digital plans may be a way forward.
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