§830. Regulation of listed chemicals and certain machines — Inbound Citations

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 4 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1316.21 — Definitions.

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• 21 C.F.R. § 1316.22 — Exemption.

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• 21 C.F.R. § 1316.23 — Confidentiality of identity of research subjects.

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• 21 C.F.R. § 1316.24 — Exemption from prosecution for researchers.

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Code of Federal Regulations Citations

Cited by 5 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1310.06(l) — Content of records and reports.

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  (l) Information provided in reports required by § 1310.05(e) which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(6) of title 5, will be provided the same protections from disclosure as are provided in section 310(c) of the Act (21 U.S.C. 830(c)) for confidential business information.

• 21 C.F.R. § 1310.11(a) — Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

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  (a) The Administrator has reinstated the exemption for the drug products listed in paragraph (e) of this section from application of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823, 830, and 957-958), to the extent described in paragraphs (b), (c), and (d) of this section.

• 21 C.F.R. § 1310.12(a) — Exempt chemical mixtures.

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  (a) The chemical mixtures meeting the criteria in paragraphs (c) or (d) of this section are exempted by the Administrator from application of sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971) to the extent described in paragraphs (b) and (c) of this section.

• 21 C.F.R. § 1310.13(i) — Exemption of chemical mixtures; application.

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  (i) The following chemical mixtures, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as exempt chemical mixtures for the purposes set forth in this section and are exempted by the Administrator from application of Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971):

• 21 C.F.R. § 1316.22(a) — Exemption.

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  (a) Any person who is aggrieved by a disclosure of information in violation of subsection (c)(1) of Section 310 of the Controlled Substances Act (21 U.S.C. 830) may bring a civil action against the violator for appropriate relief.

Citations to 21 U.S.C. § 830 as a whole

• 21 U.S.C. § 802(39)(A)(ii)

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  (ii) a delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this clause does not relieve a distributor, importer, or exporter from compliance with section 830 of this title;

• 21 U.S.C. § 841(c)(3)

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  (3) with the intent of causing the evasion of the recordkeeping or reporting requirements of section 830 of this title, or the regulations issued under that section, receives or distributes a reportable amount of any listed chemical in units small enough so that the making of records or filing of reports under that section is not required;

• 21 U.S.C. § 841(f)(1)

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  (1) Whoever knowingly distributes a listed chemical in violation of this subchapter (other than in violation of a recordkeeping or reporting requirement of section 830 of this title) shall, except to the extent that paragraph (12), (13), or (14) of section 842(a) of this title applies, be fined under title 18 or imprisoned not more than 5 years, or both.

• 21 U.S.C. § 841(f)(2)

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  (2) Whoever possesses any listed chemical, with knowledge that the recordkeeping or reporting requirements of section 830 of this title have not been adhered to, if, after such knowledge is acquired, such person does not take immediate steps to remedy the violation shall be fined under title 18 or imprisoned not more than one year, or both.

• 21 U.S.C. § 842(a)(8)

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  (8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section;

• 21 U.S.C. § 842(a)(10)

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  (10) negligently to fail to keep a record or make a report under section 830 of this title or negligently to fail to self-certify as required under section 830 of this title;

• 21 U.S.C. § 842(a)(12)

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  (12) who is a regulated seller, or a distributor required to submit reports under subsection (b)(3) of section 830 of this title—

  (A) to sell at retail a scheduled listed chemical product in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or

  (B) to knowingly or recklessly sell at retail such a product in violation of paragraph (2) of such subsection (d);

• 21 U.S.C. § 843(a)(8)

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  (8) to create a chemical mixture for the purpose of evading a requirement of section 830 of this title or to receive a chemical mixture created for that purpose; or

• 21 U.S.C. § 958(e)

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  (e) No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, sections 822(f), 825, 827, and 830 of this title shall apply to persons registered under this section to the same extent such sections apply to persons registered under section 823 of this title.

Citations to §830(a)

• 21 U.S.C. § 843(a)(4)(A)

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  (A) to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed under this subchapter or subchapter II, or (B) to present false or fraudulent identification where the person is receiving or purchasing a listed chemical and the person is required to present identification under section 830(a) of this title;

Citations to §830(b)(3)

• 21 U.S.C. § 802(39)(A)(v)

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  (v) any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under section 830(b)(3) of this title; or

• 21 U.S.C. § 827(i)(6)

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  (6) That section 830(b)(3) of this title (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the same extent and in the same manner as such section applies with respect to the chemicals and drug products specified in subparagraph (A)(i) of such section.

• 21 U.S.C. § 842(c)(4)(A)

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  (A) If a regulated seller, or a distributor required to submit reports under section 830(b)(3) of this title, violates paragraph (12) of subsection (a) of this section, or if a regulated seller violates paragraph (13) of such subsection, the Attorney General may by order prohibit such seller or distributor (as the case may be) from selling any scheduled listed chemical product. Any sale of such a product in violation of such an order is subject to the same penalties as apply under paragraph (2).

Citations to §830(b)(3)(A)(i)

• 21 U.S.C. § 827(i)(6)

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  (6) That section 830(b)(3) of this title (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the same extent and in the same manner as such section applies with respect to the chemicals and drug products specified in subparagraph (A)(i) of such section.

Citations to §830(b)(3)(B)

• 21 U.S.C. § 842(a)(15)

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  (15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in section 830(b)(3)(B) of this title, unless such regulated seller or regulated person is, at the time of such distribution, currently registered with the Drug Enforcement Administration, or on the list of persons referred to under section 830(e)(1)(B)(v) of this title;

Citations to §830(e)(1)

• 21 U.S.C. § 842(a)(14)

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  (14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of section 830(e)(1) of this title, information in logbooks under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement authorities;

Citations to §830(e)(1)(A)(iii)

• 21 U.S.C. § 842(a)(14)

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  (14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of section 830(e)(1) of this title, information in logbooks under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement authorities;

Citations to §830(e)(1)(B)(v)

• 21 U.S.C. § 842(a)

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  (a) It shall be unlawful for any person—

  (1) who is subject to the requirements of part C to distribute or dispense a controlled substance in violation of section 829 of this title;

  (2) who is a registrant to distribute or dispense a controlled substance not authorized by his registration to another registrant or other authorized person or to manufacture a controlled substance not authorized by his registration;

  (3) who is a registrant to distribute a controlled substance in violation of section 825 of this title;

  (4) to remove, alter, or obliterate a symbol or label required by section 825 of this title;

  (5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II;

  (6) to refuse any entry into any premises or inspection authorized by this subchapter or subchapter II;

  (7) to remove, break, injure, or deface a seal placed upon controlled substances pursuant to section 824(f) or 881 of this title or to remove or dispose of substances so placed under seal;

  (8) to use, to his own advantage, or to reveal, other than to duly authorized officers or employees of the United States, or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection authorized by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as authorized by section 830 of this title) any information that is confidential under such section;

  (9) who is a regulated person to engage in a regulated transaction without obtaining the identification required by 830(a)(3) of this title.¹

  (10) negligently to fail to keep a record or make a report under section 830 of this title or negligently to fail to self-certify as required under section 830 of this title;

  (11) to distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of this subchapter or subchapter II, with reckless disregard for the illegal uses to which such a laboratory supply will be put;

  (12) who is a regulated seller, or a distributor required to submit reports under subsection (b)(3) of section 830 of this title—

  (A) to sell at retail a scheduled listed chemical product in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or

  (B) to knowingly or recklessly sell at retail such a product in violation of paragraph (2) of such subsection (d);

  (13) who is a regulated seller to knowingly or recklessly sell at retail a scheduled listed chemical product in violation of subsection (e) of such section;

  (14) who is a regulated seller or an employee or agent of such seller to disclose, in violation of regulations under subparagraph (C) of section 830(e)(1) of this title, information in logbooks under subparagraph (A)(iii) of such section, or to refuse to provide such a logbook to Federal, State, or local law enforcement authorities;

  (15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in section 830(b)(3)(B) of this title, unless such regulated seller or regulated person is, at the time of such distribution, currently registered with the Drug Enforcement Administration, or on the list of persons referred to under section 830(e)(1)(B)(v) of this title;

  (16) to violate subsection (e) of section 825 of this title;² or

  (17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 827(f) of this title.

  As used in paragraph (11), the term “laboratory supply” means a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. For purposes of paragraph (11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer. For purposes of paragraph (15), if the distributor is temporarily unable to access the list of persons referred to under section 830(e)(1)(B)(v) of this title, the distributor may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the regulated seller or regulated person, provided the distributor confirms within 7 business days of the distribution that such regulated seller or regulated person is on the list referred to under section 830(e)(1)(B)(v) of this title.

• 21 U.S.C. § 842(a)(15)

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  (15) to distribute a scheduled listed chemical product to a regulated seller, or to a regulated person referred to in section 830(b)(3)(B) of this title, unless such regulated seller or regulated person is, at the time of such distribution, currently registered with the Drug Enforcement Administration, or on the list of persons referred to under section 830(e)(1)(B)(v) of this title;