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This regulation would amend the reporting requirements found at 21 CFR 1310.05(b)(2) mandating notification to DEA of domestic transactions involving tableting and encapsulating machines 15-days before the seller ships the machine. The draft regulation also would amend the definitions of a tableting machine and an encapsulating machine to include parts thereof. Finally, the draft regulation seeks to modernize customer verification requirements for transactions and proposes modifications to DEA Form 452 to improve tracking of transactions of tableting and encapsulating machines.

Statement of Need:

In order to combat the opioid epidemic currently fueled by counterfeit pills, it is necessary for DEA to amend the reporting requirements for all imports, exports and domestic transactions involving tableting and encapsulating machines and their parts. The proposed amendments to Form 452 are intended to capture more details about all transactions to allow DEA to closely monitor these machines and parts as they move throughout the United States. Additionally, this amended rule proposes to modify the verification methods for regulated persons transacting tableting and encapsulating machines, to reflect modern technological methods (e.g., internet search). The proposed rule amendments will minimize the diversion of tableting and encapsulating machines which will reduce the illegal manufacturing of illicit drugs.

Summary of the Legal Basis:

DEA implements and enforces the CSA and the Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes.

As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822. The CSA further authorizes the Administrator to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA. 21 U.S.C. 871(b), 958(f).

Alternatives:

There are no appropriate alternatives to issuing this NPRM. This NPRM is being issued in accordance with statutory requirements.

Anticipated Costs and Benefits:

DEA anticipates this rule will not be economically significant (that is, that the rule will not have an annual effect on the economy of $200 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities). DEA believes the rule will reduce the time necessary to properly complete and process the required forms for import and export of tabulation and encapsulation machines, reducing delays, while increasing the number of submissions. Any change to cost is expected to be de minimis.

Risks:

If this rule is not amended, tableting and encapsulating machines that enter U.S. ports have a greater chance of being diverted and used to illegally manufacture illicit drugs.