Stop Pills That Kill 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, encapsulating machine, or critical part of a tableting or encapsulating machine; or

(C) acts as a broker or trader for a regulated transaction involving a listed chemical, tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.

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

(B) a distribution, delivery, sale, importation, exportation, or international transaction of a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.

(3) in paragraph (42), by inserting , tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine after listed chemical;

(4) in paragraph (43), in the matter preceding subparagraph (A)—

(A) by striking an international and inserting a regulated; and

(B) by inserting , tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine after listed chemical; and

(5) by adding at the end the following:

(61) The term critical part, when used in reference to a tableting 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.

(D) Any additional parts that the Attorney General has determined to be integral to the operation of a tableting or encapsulating machine, provided that such determination—

(i) is made through rulemaking; and

(ii) does not go into effect until the rulemaking process has been completed.

(62) 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.

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

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

(65) 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—

(A) in paragraph (1), by striking or an encapsulating machine and inserting , encapsulating machine, or critical part of a tableting or encapsulating machine; and

(B) in paragraph (2)—

(i) by striking or encapsulating machine and inserting , encapsulating machine, or critical part of a tableting or encapsulating machine; and

(ii) by inserting before the period at the end the following: and shall identify the tableting machine, encapsulating machine, or critical part of a tableting or 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 or 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 of a tableting or encapsulating machine, including the serial number affixed to the tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine.

(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 paragraphs (1) and (2).

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

(4) Applicability

(A) In general. Except as specified in subparagraph (B), the amendments made by paragraphs (1) and (2) shall apply only to any tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine manufactured, distributed, delivered, sold, imported, exported, or included in an international transaction after the effective date of the regulations promulgated under paragraph (3).

(B) Exception. Beginning on the date that is 180 days after the date of the enactment of this Act, the amendments made by paragraph (1) of this subsection to paragraphs (1) and (2) of section 310(a) of the Controlled Substances Act (21 U.S.C. 830(a)) shall apply with respect to a tableting machine, encapsulating machine, or critical part of a tableting or encapsulating machine manufactured on or before the date of enactment of this Act.

(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, or critical part of a tableting or 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 a tableting machine, encapsulating machine, or critical part of a tableting or 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.