Drug and DWI Law NJ: TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

day before the date of enactment of this subsection, a prescrip- tion for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a pre- scription to be partially filled.

REGULATION OF LISTED CHEMICALS AND CERTAIN MACHINES

SEC. 310. ø21 U.S.C. 830¿ (a)(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 quan- tity 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 copy- ing 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 trans- action. It is the duty of such other party to present proof of identity to the regulated person. The Attorney General shall specify by reg- ulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph.

(b)(1) Each regulated person shall report to the Attorney Gen- eral, in such form and manner as the Attorney General shall pre- scribe 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 per- son believes may indicate that the listed chemical will be used in violation of this title;

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

(C) any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; and (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 char- acteristic 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 subpara- graph (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 chemi- cals manufactured by the person. The requirement of the preceding

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Sec. 310 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 64

sentence shall not apply to the manufacture of a drug product that is exempted under section 102(39)(A)(iv).

(3) MAIL ORDER REPORTING.—
(A) As used in this paragraph:

(i) The term ‘‘drug product’’ means an active in- gredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act for distribution in the United States.

(ii) The term ‘‘valid prescription’’ means a pre- scription which is issued for a legitimate medical pur- pose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and act- ing in the usual course of the practitioner’s profes- sional practice.

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

(i) involves ephedrine, pseudoephedrine, or phen- ylpropanolamine (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.

(C) The data required for such reports shall include— (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 fol-

lowing distributions to a nonregulated person, and the fol- lowing export transactions, shall not be subject to the re- porting requirement in subparagraph (B):

(i) Distributions of sample packages of drug prod- ucts 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 liq- uid 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 dis- tributors that may not include face-to-face trans- actions to the extent that such distributions are con- sistent with the activities authorized for a retail dis- tributor as specified in section 102(49), except that this clause does not apply to sales of scheduled listed chemical products at retail.

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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

(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 dis- tributions of drug products to a long term care facility for dispensing to or for use by a resident of that facil- ity.

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

(v) Exports which have been reported to the Attor- ney General pursuant to section 1004 or 1018 or which are subject to a waiver granted under section 1018(f)(2).

(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 (in- cluding specific formulations or drug products) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such re- porting is not necessary for the enforcement of this title or title III.
(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 title or title III. 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 1018(c)(1), and shall have the right to an expedited hearing as pro- vided in section 1018(c)(2).

January 16, 2018

(c)(1) Except as provided in paragraph (2), any information ob- tained by the Attorney General under this section which is exempt from disclosure under section 552(a) of title 5, United States Code, 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 title, title III, or the customs laws;

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

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 unau- thorized 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 fea- sible, the disclosure of proprietary business information, in- cluding the names or identities of United States exporters of

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Sec. 310 TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... 66

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 vio- lator for appropriate relief.

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

(d) SCHEDULED LISTED CHEMICALS; RESTRICTIONS ON SALES QUANTITY; REQUIREMENTS REGARDING NONLIQUID FORMS.—With respect to ephedrine base, pseudoephedrine base, or phenyl- propanolamine base in a scheduled listed chemical product—

(1) the quantity of such base sold at retail in such a prod- uct 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 prod- uct 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 AC-

CESS; LOGBOOK REQUIREMENT; TRAINING OF SALES PERSONNEL; PRIVACY PROTECTIONS.—

(1) REQUIREMENTS REGARDING RETAIL TRANSACTIONS.—
(A) IN GENERAL.—Each regulated seller shall ensure that, subject to subparagraph (F), sales by such seller of a scheduled listed chemical product at retail are made in ac-

cordance with the following:
(i) In offering the product for sale, the seller

places the product such that customers do not have di- rect 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 cir- cumstances in which the product is stored in a locked cabinet that is located in an area of the facility in- volved 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 cri- teria issued by the Attorney General, a written or elec- tronic 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 ‘‘log- book’’), except that such requirement does not apply to any purchase by an individual of a single sales pack- age if that package contains not more than 60 milli- grams of pseudoephedrine.

(iv) In the case of a sale to which the requirement of clause (iii) applies, the seller does not sell such a

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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

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 docu- ment 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 ef- fect 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 trans- actions 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 dis- play the notice described in clause (v). Any device used shall preserve each sig- nature 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 pur- chaser, 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 de- scribed 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 docu- ment 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 doc-

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ument 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 infor- mation 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 in- cludes the prospective purchaser’s name, address, and the date and time of the sale, as follows:

(aa) If the purchaser enters the informa- tion, 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 read- er or similar technology.

(v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a no- tice 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, United States Code, 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 pur- chasers or who deal directly with purchasers by ob- taining payments for the products, the seller has sub- mitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under subparagraph (B)(ii), undergone training pro- vided by the seller to ensure that the individuals un- derstand the requirements that apply under this sub- section and subsection (d).

(viii) The seller maintains a copy of such certifi- cation and records demonstrating that individuals re- ferred to in clause (vii) have undergone the training.

(ix) If the seller is a mobile retail vendor:

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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

(I) The seller complies with clause (i) by plac- ing 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 CERTIFI- CATIONS AND TRAINING.—

(i) IN GENERAL.—A regulated seller may not sell any scheduled listed chemical product at retail unless the seller has submitted to the Attorney General the self-certification referred to in subparagraph (A)(vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions re- garding the training of individuals referred to in such subparagraph, the certification includes 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.

(ii) ISSUANCE OF CRITERIA; SELF-CERTIFICATION.— The Attorney General shall by regulation establish cri- teria for certifications under this paragraph. The cri- teria shall—

(I) provide that the certifications are self-cer- tifications provided through the program under clause (iii);

(II) provide that a separate certification is re- quired for each place of business at which a regu- lated seller sells scheduled listed chemical prod- ucts at retail; and

(III) include criteria for training under sub- paragraph (A)(vii).
(iii) PROGRAM FOR REGULATED SELLERS.—The At-

torney General shall establish a program regarding such certifications and training in accordance with the following:

(I) The program shall be carried out through an Internet site of the Department of Justice and such other means as the Attorney General deter- mines to be appropriate.

(II) The program shall inform regulated sell- ers that section 1001 of title 18, United States Code, 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 auto- matically 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

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with staff of the Department (other than the pro- vision of technical assistance, as appropriate).
(iv) AVAILABILITY OF CERTIFICATION TO STATE AND

LOCAL OFFICIALS.—Promptly after receiving a certifi- cation under subparagraph (A)(vii), the Attorney Gen- eral shall make available a copy of the certification to the appropriate State and local officials.

(v) PUBLICATION OF LIST OF SELF-CERTIFIED PER- SONS.—The Attorney General shall develop and make available a list of all persons who are currently self- certified in accordance with this section. This list shall be made publicly available on the website of the Drug Enforcement Administration in an electronically downloadable format.

(C) PRIVACY PROTECTIONS.—In order to protect the pri- vacy of individuals who purchase scheduled listed chemical products, the Attorney General shall by regulation estab- lish 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 informa- tion in the logbooks for any purpose other than to en- sure compliance with this title or to facilitate a prod- uct recall to protect public health and safety.
(D) FALSE STATEMENTS OR MISREPRESENTATIONS BY

PURCHASERS.—For purposes of section 1001 of title 18, United States Code, entering information in the logbook under subparagraph (A)(iii) shall be considered a matter within the jurisdiction of the executive, legislative, or judi- cial branch of the Government of the United States.

(E) GOOD FAITH PROTECTION.—A regulated seller who in good faith releases information in a logbook under sub- paragraph (A)(iii) to Federal, State, or local law enforce- ment authorities is immune from civil liability for such re- lease unless the release constitutes gross negligence or in- tentional, wanton, or willful misconduct.

(F) INAPPLICABILITY OF REQUIREMENTS TO CERTAIN SALES.—Subparagraph (A) does not apply to the sale at re- tail of a scheduled listed chemical product if a report on the sales transaction is required to be submitted to the At- torney General under subsection (b)(3).

(G) CERTAIN MEASURES REGARDING THEFT AND DIVER- SION.—A regulated seller may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of scheduled listed chemical products, which may include, notwith- standing State law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or controlled substances.

(2) MAIL-ORDER REPORTING; VERIFICATION OF IDENTITY OF PURCHASER; 30-DAY RESTRICTION ON QUANTITIES FOR INDI- VIDUAL PURCHASERS.—Each regulated person who makes a sale

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TITLES II AND III OF THE COMPREHENSIVE DRUG ABUSE... Sec. 310

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