United States of America - National Approach on Materials and Equipment Used in Illicit Drug Manufacture
Federal law requires people who buy or sell pill presses or encapsulating machines to report these transactions to DEA. The notification of any domestic regulated transaction in a tableting machine or an encapsulating machine must be made orally to the Special Agent in Charge (SAC) of the DEA Divisional Office for the area in which the regulated person making the report is located when the order is placed with the seller. The regulated person must also file a report of the transaction to DEA via the DEA Form 452 through the DEA Diversion Control Division's secure network application within 15 calendar days after the order has been shipped by the seller.
Pill presses or encapsulating machines that are imported into the United States without the proper notification are subject to interception, seizure, and destruction by U.S. Customs and Border Protection (CBP). This equipment is also subject to forfeiture by the DEA.
The punches and dies used to produce counterfeit pharmaceutical pills are typically trademarked, and the use of these without permission from the trademark holder violates the law. It is also an offense under the CSA, subject to imprisonment up to four years, to possess, distribute, manufacture, import, or export any tableting or encapsulating machine, chemical, equipment, or material knowing, intending, or having reasonable cause to believe it will be used to manufacture a controlled substance or listed chemical in violation of the provisions of the CSA. 21 U.S.C. § 843(a)(6)-(7).
Federal law also governs the distribution and use of pill press machines and related substances or materials used for manufacturing. On March 31, 2017, a new set of DEA regulations went into effect regarding pill press transactions. Under the regulations, persons or entities that manufacture, distribute, import, or export a pill press, or who broker international transactions, must keep records of transactions for two years and submit electronic reports of transactions to the DEA. Additionally, they "must verify the existence and apparent validity of a business entity" ordering such a machine and must keep identifying information for any "individuals or cash purchasers." The regulations put sellers or distributors of pill press machines on notice that failure to "adequately prove the identity of the other party to the transaction" may result in "specific penalties . . . for violations of law," and that cash transactions "are suspect and should be handled as such."
Source: U.S. Attorney's bulletin: Fentanyl and Related Threats (p.39)
What laws and regulations govern ownership and use of a pill press and counterfeit die molds? (p.14) in Illegal Pill Presses: An overlooked threat to American Patients (2019), a joint project by the National Association of Boards of Pharmacy, National Association of Drug Diversion Investigators, and the Partnership for Safe Medicines
Source: Illegal Pill Presses: An Overlooked Threat to American Patients