Fight Illicit Pill Presses Act

This Act may be cited as the “Fight Illicit Pill Presses Act”.

(a) Definitions.— Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended—

(1) by striking paragraph (38) and inserting the following:

“(38) The term regulated person means a person who—

(A) manufactures, distributes, imports, or exports a listed chemical;

(B) manufactures, distributes, delivers, sells, imports, or exports a tableting machine, an encapsulating machine, or a critical part; or

(C) who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, an encapsulating machine, or a critical part.”;

(2) by striking paragraph (39)(B) and inserting the following:

“(B) a distribution, delivery, sale, importation, or exportation of a tableting machine, encapsulating machine, or critical part.”; and

(3) by adding at the end the following:

“(60) The term critical part, when used in reference to a tableting machine or encapsulating machine, means any of the following integral parts of a tableting or encapsulating machine:

(A) An upper punch.

(B) A lower punch.

(C) A die.

(61) The term die means a tool that serves as the mold in which a product is compressed to form the desired size and shape of a tablet or capsule.

(62) The term lower punch means the punch inserted into the turret below the die.

(63) The term punch means a rod-shaped tool used in producing tablets and other products.

(64) The term upper punch means the punch inserted into the turret above the die.”.

(b) Regulation.—

(1) Records of regulated transactions.— Section 310(a) of the Controlled Substances Act (21 U.S.C. 830(a)) is amended by adding at the end the following:

“(4) Each regulated person who manufactures, distributes, delivers, sells, imports, or exports a tableting machine, an encapsulating machine, a critical part of a tableting machine, or a critical part of an encapsulating machine shall, when and as required by regulations of the Attorney General, identify the tableting machine, encapsulating machine, critical part of a tableting machine, or critical part of an encapsulating machine by means of a serial number that is engraved, cast, or otherwise permanently affixed to a nonremovable part of the tableting machine, encapsulating machine, or critical part of a tableting machine, or critical part of an encapsulating machine.”.

(2) Reports to attorney general.— Section 310(b)(1) of the Controlled Substances Act (21 U.S.C. 830(b)(1)) is amended by striking subparagraph (D) and inserting the following:

“(D) any regulated transaction in a tableting machine, encapsulating machine, or critical part, including the serial number affixed to the tableting machine, encapsulating machine, or critical part.”.

(3) Regulations.—

(A) In general.— Not later than 180 days after the date of enactment of this Act, the Attorney General shall promulgate regulations carrying out the amendments made by paragraph (1).

(B) Detailed guidance.— The regulations required under subparagraph (A) shall include detailed guidance on serial numbers affixed to tableting machines, encapsulating machines, or critical parts manufactured on or before the date of enactment of this Act.

(C) Requirement.— Notwithstanding paragraph (4), a serial number affixed to a tableting machine, encapsulating machine, or critical part manufactured on or before the date of enactment of this Act in accordance with the guidance provided under subparagraph (B) shall be deemed required under paragraph (4) of section 310(a) of the Controlled Substances Act, as added by paragraph (1) of this subsection.

(4) Effective date.— The amendments made by paragraph (1) shall apply only to any tableting machine, encapsulating machine, or critical part manufactured, distributed, delivered, sold, imported, or exported after the effective date of the regulations promulgated under paragraph (2).

(c) Prohibited acts.— Section 403(a) of the Controlled Substances Act (21 U.S.C. 843(a)) is amended—

(1) in paragraph (8), by striking “or” at the end;

(2) in paragraph (9), by striking the period at the end and inserting a semicolon; and

(3) by adding at the end the following:

“(10) to remove, alter, or obliterate any serial number affixed to a tableting machine, encapsulating machine, a critical part of a tableting machine, or a critical part of an encapsulating machine, that is required to have a serial number and with reasonable cause to believe the serial number is so required; or

(11) to transport, ship, receive, possess, distribute, deliver, sell, import, or export any tableting machine, encapsulating machine, a critical part of a tableting machine, or a critical part of an encapsulating machine that is required to have a serial number, knowing that the serial number has been removed, altered, or obliterated, and with reasonable cause to believe the serial number is so required.”.