New Bill Mandates Serial Numbers and Tracking for Pill Presses and Critical Parts to Fight Illicit Drug Production

If you’ve been following the news about the opioid crisis, you know that a major problem is the proliferation of counterfeit pills—often laced with fentanyl—pressed and sold illegally. The machinery used to make these pills, known as tableting or encapsulating machines (or ‘pill presses’), is currently hard to track once it leaves the factory.

The Fight Illicit Pill Presses Act aims to change that by treating this specialized machinery much like controlled substances themselves. The core of this legislation is simple: it expands the definitions in the Controlled Substances Act to include these machines and their “critical parts”—specifically the upper punch, lower punch, and die—and mandates that they must be traceable through serial numbers and transaction reporting.

The New Rules of the Machine Shop

For the busy professionals who manufacture, distribute, import, or export this equipment, this bill means new paperwork and new compliance costs. Under the amended law, anyone dealing in these machines or their critical parts is now considered a “regulated person.”

Here’s the biggest immediate change: every machine and every critical part must be assigned a unique serial number. This number must be permanently affixed—engraved or cast—onto a nonremovable part of the equipment. Think of it like the Vehicle Identification Number (VIN) on your car, but for industrial-grade pill makers. When a transaction occurs—a sale, delivery, import, or export—that serial number must be included in the report filed with the Attorney General.

This system is designed to create a clear, traceable paper trail from the moment the equipment is made until it reaches its final destination. If a machine is later found in an illegal pill operation, law enforcement can quickly track who bought it and where it came from. This is a huge win for traceability and a direct attack on the supply chain of illicit pill manufacturers.

Tampering is Now a Federal Crime

The bill also closes a critical loophole by making it explicitly illegal to remove, alter, or obliterate the required serial number on a machine or critical part. If you’re caught transporting or possessing equipment knowing the required serial number has been tampered with, and you have “reasonable cause to believe” the number was required, you’re looking at a prohibited act under the Controlled Substances Act.

This provision is key because it anticipates the bad actors trying to file off the numbers and makes that act itself a separate, punishable offense. It’s a clear message that the government is serious about maintaining the integrity of this tracking system.

The Compliance Clock is Ticking

While the goal is to fight the drug crisis, the immediate impact will be felt by legitimate businesses. Manufacturers and distributors of punches and dies—which are common tools used in many industries beyond pharmaceuticals—will need to implement new tracking and reporting systems. The Attorney General has 180 days after the bill’s enactment to issue detailed regulations on how this will all work, including guidance on how to serial-number equipment that was already manufactured before the law takes effect.

For the legitimate pharmaceutical industry or other companies using this equipment, the compliance burden will increase. While the bill’s vagueness level is low—meaning the language is pretty clear about what needs to be done—the “how” will depend entirely on the Attorney General’s regulations. Businesses will need to pay close attention to this guidance to ensure they don't face penalties for non-compliance, especially concerning the proper marking of pre-existing inventory.