21 USC 830 - Regulation of listed chemicals and certain machines

§ 830. Regulation of listed chemicals and certain machines

(a) Record of regulated transactions

(1) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction.

(2) A record under this subsection shall be retrievable and shall include the date of the regulated transaction, the identity of each party to the regulated transaction, a statement of the quantity and form of the listed chemical, a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General.

(3) It is the duty of each regulated person who engages in a regulated transaction to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.

(b) Reports to Attorney General

(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation—

(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter;

(B) any proposed regulated transaction with a person whose description or other identifying characteristic the Attorney General furnishes in advance to the regulated person;

(D) any regulated transaction in a tableting machine or an encapsulating machine.

Each report under subparagraph (A) shall be made at the earliest practicable opportunity after the regulated person becomes aware of the circumstance involved. A regulated person may not complete a transaction with a person whose description or identifying characteristic is furnished to the regulated person under subparagraph (B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required under subparagraph (A) and subparagraph (C).

(2) A regulated person that manufactures a listed chemical shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning listed chemicals manufactured by the person. The requirement of the preceding sentence shall not apply to the manufacture of a drug product that is exempted under section 802(39)(A)(iv) of this title.

(3)Mail order reporting.—

(A) As used in this paragraph:

(i) The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act 1

1 See References in Text note below.

[21 U.S.C. 301 et seq.] for distribution in the United States.

(ii) The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.

(B) Each regulated person who engages in a transaction with a nonregulated person or who engages in an export transaction which—

(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and

(ii) uses or attempts to use the Postal Service or any private or commercial carrier;

shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation.

(i) the name of the purchaser;

(ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and

(iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.

(D) Except as provided in subparagraph (E), the following distributions to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in subparagraph (B):

(i) Distributions of sample packages of drug products when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.

(ii) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as specified in section 802(49) of this title, except that this clause does not apply to sales of scheduled listed chemical products at retail.

(iii) Distributions of drug products to a resident of a long term care facility (as that term is defined in regulations prescribed by the Attorney General) or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.

(iv) Distributions of drug products pursuant to a valid prescription.

(v) Exports which have been reported to the Attorney General pursuant to section 954 or 971 of this title or which are subject to a waiver granted under section 971(f)(2) of this title.

(vi) Any quantity, method, or type of distribution or any quantity, method, or type of distribution of a specific listed chemical (including specific formulations or drug products) or of a group of listed chemicals (including specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II.

(E) The Attorney General may revoke any or all of the exemptions listed in subparagraph (D) for an individual regulated person if he finds that drug products distributed by the regulated person are being used in violation of this subchapter or subchapter II. The regulated person shall be notified of the revocation, which will be effective upon receipt by the person of such notice, as provided in section 971(c)(1) of this title, and shall have the right to an expedited hearing as provided in section 971(c)(2) of this title.

(1) Except as provided in paragraph (2), any information obtained by the Attorney General under this section which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(4) of such title, is confidential and may not be disclosed to any person.

(2) Information referred to in paragraph (1) may be disclosed only—

(A) to an officer or employee of the United States engaged in carrying out this subchapter, subchapter II, or the customs laws;

(B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws;

(D) to a State or local official or employee in conjunction with the enforcement of controlled substances laws or chemical control laws.

(3) The Attorney General shall—

(A) take such action as may be necessary to prevent unauthorized disclosure of information by any person to whom such information is disclosed under paragraph (2); and

(B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of United States exporters of listed chemicals, to any person to whom such information is disclosed under paragraph (2).

(4) Any person who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief.

(5) Notwithstanding paragraph (4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the Drug Enforcement Administration.

(d) Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid formsWith respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a scheduled listed chemical product—

(1) the quantity of such base sold at retail in such a product by a regulated seller, or a distributor required to submit reports by subsection (b)(3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and

(2) such a seller or distributor may not sell such a product in nonliquid form (including gel caps) at retail unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches.

(e) Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections

(1) Requirements regarding retail transactions

(A) In generalEach regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in accordance with the following:

(i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as “behind-the-counter” placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the facility involved to which customers do have direct access.

(ii) The seller delivers the product directly into the custody of the purchaser.

(iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the “logbook”), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine.

(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following:(I) The prospective purchaser—(aa) presents an identification card that provides a photograph and is issued by a State or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and(bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means:(AA) Signing a device presented by the seller that captures signatures in an electronic format. Such device shall display the notice described in clause (v). Any device used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature.(BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in clause (v).(CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in clause (v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document.(II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.(III) The logbook maintained by the seller includes the prospective purchaser’s name, address, and the date and time of the sale, as follows:(aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.(bb) If the seller enters the information, the prospective purchaser must verify that the information is correct.(cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology.

(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under section 1001 of title 18, which notice specifies the maximum fine and term of imprisonment under such section.

(vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made.

(vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and subsection (d).

(viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in clause (vii) have undergone the training.

(ix) If the seller is a mobile retail vendor:(I) The seller complies with clause (i) by placing the product in a locked cabinet.(II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(B) Additional provisions regarding certifications and training

(i) In general

(ii) Issuance of criteria; self-certificationThe Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall—(I) provide that the certifications are self-certifications provided through the program under clause (iii);(II) provide that a separate certification is required for each place of business at which a regulated seller sells scheduled listed chemical products at retail; and(III) include criteria for training under subparagraph (A)(vii).

(iii) Program for regulated sellers(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General determines to be appropriate.(II) The program shall inform regulated sellers that section 1001 of title 18 applies to such certifications.(III) The program shall make available to such sellers an explanation of the criteria under clause (ii).(IV) The program shall be designed to permit the submission of the certifications through such Internet site.(V) The program shall be designed to automatically provide the explanation referred to in subclause (III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of regulated sellers with staff of the Department (other than the provision of technical assistance, as appropriate).

(iv) Availability of certification to State and local officials

(v) Publication of list of self-certified persons

(C) Privacy protectionsIn order to protect the privacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under subparagraph (A)(iii). Such regulations shall—

(i) provide for the disclosure of the information as appropriate to the Attorney General and to State and local law enforcement agencies; and

(ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety.

(D) False statements or misrepresentations by purchasers

(E) Good faith protection

(F) Inapplicability of requirements to certain sales

(G) Certain measures regarding theft and diversion

(2) Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasersEach regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General is subject to the following:

(A) The person shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures.

(B) The person may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period.

(C) Each regulated person who makes a sale at retail of a scheduled listed chemical product and is required under subsection (b)(3) to submit a report of the sales transaction to the Attorney General may not sell any scheduled listed chemical product at retail unless such regulated person has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under subsection (d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order distributors that are consistent with the criteria established for the certifications of regulated sellers under paragraph (1)(B).

(3) Exemptions for certain products

(Pub. L. 91–513, title II, § 310, as added Pub. L. 95–633, title II, § 202(a), Nov. 10, 1978, 92 Stat. 3774; amended Pub. L. 100–690, title VI, § 6052(a), Nov. 18, 1988, 102 Stat. 4312; Pub. L. 103–200, §§ 2(c), 10, Dec. 17, 1993, 107 Stat. 2336, 2341; Pub. L. 104–237, title II, § 208, title IV, § 402, Oct. 3, 1996, 110 Stat. 3104, 3111; Pub. L. 106–310, div. B, title XXXVI, § 3652, Oct. 17, 2000, 114 Stat. 1239; Pub. L. 109–177, title VII, §§ 711(a)(2)(B), (b)(1), (c)(1), (2), (d), 716(b)(2), Mar. 9, 2006, 120 Stat. 257, 261, 267; Pub. L. 110–415, § 2, Oct. 14, 2008, 122 Stat. 4349; Pub. L. 111–268, §§ 2, 3, Oct. 12, 2010, 124 Stat. 2847.)