Since 2010, Regulation 4G of the Customs (Prohibited Imports) Regulations 1956 prohibits the importation of tablet presses into Australia unless permission has been granted. Tablet presses are defined as manual, semi-automatic or fully automatic equipment that can be used to compact or mould powdered or granular solids, or semi-solid material, to produce coherent solid tablets. Regulation 4G does not explicitly state whether the import control for tablet presses includes parts, components or incomplete machines. The import control at the federal level complemented state and territory controls that prohibited the possession of tablet presses without a legitimate reason.

Source: Discussion Paper: Tablet Press Import Control

The Code of Practice for Supply Diversion into Illicit Drug Manufacture (2008) offers best practice principles to assist chemical manufacturers, importers and distributors and scientific equipment and instrument suppliers in the prevention of diversion of chemicals and scientific equipment into illicit drug manufacture, and to co-operate with government and law enforcement to that end. Industry obligations include sales monitoring, record keeping (through end user declaration) and notification of 'suspicious' inquiries or orders. When suspicious circumstances are noted, they are to be reported as soon as practicable and in any case prior to dispatch/collection of the substances.

Source: Code of Practice for Supply Diversion into Illicit Drug Manufacture

Bill C-37 An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts (2017) prevent the uncontrolled import into Canada of devices that can be used to manufacture illicit drugs, such as pill presses and encapsulators. Specifically, Bill C-37 requires every pill press ('manual, semi-automatic or fully automatic device that may be used to compact or mould powdered, granular or semi-solid material to produce coherent solid tablets') or encapsulator ('manual, semi-automatic or fully automatic device that may be used to fill capsules with any powdered, granular, semi-solid or liquid material') imported into Canada to be registered with Health Canada.

Source: Royal Assent of Bill C-37 - An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts

Source: Bill C-37 (Royal Assent)

The provincial government of British Columbia, which has experienced a high number of opioid-related deaths, has introduced legislation that limits the ownership, possession, use, and sale of manufacturing equipment for tablets and capsules to those with a legitimate business or professional purpose. The Pill Press and Related Equipment Control Act and the associated Pill Press and Related Equipment Control Regulation came into force on January 15, 2019. The regulation sets out the information that authorized owners, including registered sellers, must provide in events such as the acquisition, sale, loss or theft of controlled equipment and that will be used to update a database of equipment possessed by legitimate owners and businesses. People selling controlled equipment are required to register and agree to a criminal record check, and they are prohibited from receiving payment in the form of cash, prepaid purchase cards, cash cards or virtual currencies such as bitcoin.

Controlled Equipment under the Pill Press and Related Equipment Control Act includes the following:

• Pill presses or tablet presses ('machines, whether semi-automatic, automated or capable of being automated, that may be used to compact or mould powdered, granular or semi-solid material to produce cohesive solid tablets');
• Encapsulators or gel press machines ('machines, whether semi-automatic, automated or capable of being automated, that can be used to fill capsules with powdered, granular, semi-solid or liquid material');
• Dies, moulds or punches ordinarily used with a pill press, or encapsulator machine; and
• Pharmaceutical mixers or blenders, except if it is used by a person authorized to do so under the Health Professions Act or the Pharmacy Operations and Drug Scheduling Act, or by an individual for personal use.

Source: Pill press regulations tackle manufacturing of illicit drugs

In Germany, there are no specific regulations or restrictions related to the trade in equipment, such as pill / tablet presses, encapsulators, heating mantles or glassware. Nevertheless, if a person sells or provides such equipment with the knowledge and intent that it is used for the illicit production of drugs, the person could be punished for aiding and abetting the illicit production of drugs, based on the national penal code and the national narcotics act.

Additionally, based on article 13 of the 1988 United Nations Convention, European Union regulations and the National Program on Drug Abuse Control, Germany has pursued the concept of voluntary cooperation between authorities and selected companies since the end of the 1990ies. The measures conducted mainly by the Federal Criminal Police Office (Synthetic Drugs Unit) cover especially companies who produce or trade in tableting machines/pill presses, punches/dies, heating mantles and large round bottom glass flasks. A special focus is on second-hand traders of such equipment.

The representatives of the companies are informed and sensitized about the fact that the equipment which they produce or sell could also be used in an illegal manner. The companies are requested to cooperate with the police and give hints on suspicious orders of such equipment. To assist the companies in identifying suspicious orders, examples (suspicion criteria) of behavioural patterns of people who intend to use such equipment illicitly were shared with them. Companies also cooperate in backtracking investigations into seized equipment.

Equipment for processing solid, semi-solid or liquid materials into capsules or tablets is regulated by the Federal law for the control of chemical precursors, essential chemicals and machines to prepare capsules and tablets of 26 December 1997. Accordingly, details of such equipment when produced, disposed of, acquired, imported, exported and stored must be reported annually to the Ministry of Economy. Known or attempted diversions of equipment must be reported to the Attorney General of the Republic.

Source: LEY Federal para el Control de Precursores Químicos, Productos Químicos Esenciales y Máquinas para Elaborar Cápsulas, Tabletas y/o Comprimidos

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).

Source: Advisory to the Chemical Manufacturing Industry on Illicit Activity and Methods Related to the Manufacturing of Fentanyl and Synthetic Opioids

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