[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Rules and Regulations]
[Pages 74696-74699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30630]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1314

[Docket No. DEA-328]
RIN 1117-AB25


Implementation of the Methamphetamine Production Prevention Act 
of 2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: In October 2008, the President signed the Methamphetamine 
Production Prevention Act of 2008 (MPPA), which clarifies the 
information entry and signature requirements for electronic logbook 
systems permitted for the retail sale of scheduled listed chemical 
products. On March 23, 2010, DEA published a Notice of Proposed 
Rulemaking to implement the provisions of the MPPA and make its 
regulations consistent with the new requirements. This action finalizes 
without change the Notice of Proposed Rulemaking published on March 23, 
2010. The Final Rule will make it easier for regulated sellers to 
maintain electronic logbooks by allowing greater flexibility as to how 
information may be captured.

DATES: Effective Date: January 3, 2012.

FOR FURTHER INFORMATION CONTACT: Rhea D. Moore, Office of Diversion 
Control, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone (202) 307-7165.

SUPPLEMENTARY INFORMATION: 

DEA's Legal Authority

    DEA implements the Comprehensive Drug Abuse Prevention and Control 
Act of 1970, often referred to as the Controlled Substances Act (CSA) 
and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 
801-971), as amended. DEA publishes the implementing regulations for 
these statutes in Title 21 of the Code of Federal Regulations (CFR), 
Parts 1300 to 1321. These regulations are designed to ensure that there 
is a sufficient supply of controlled substances for legitimate medical, 
scientific, research, and industrial purposes and to deter the 
diversion of controlled substances to illegal purposes.
    The CSA mandates that DEA establish a closed system of control for 
manufacturing, distributing, and dispensing controlled substances. Any 
person who manufactures, distributes, dispenses, imports, exports, or 
conducts research or chemical analysis with controlled substances must 
register with DEA (unless exempt) and comply with the applicable 
requirements for the activity. The CSA as amended also requires DEA to 
regulate the manufacture and distribution of chemicals that may be used 
to manufacture controlled substances illegally. Listed chemicals that 
are classified as List I chemicals are important to the manufacture of 
controlled substances. Those classified as List II chemicals may be 
used to manufacture controlled substances.

Background

    On March 9, 2006, the President signed the Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). CMEA 
amended the CSA to regulate the sale of products that contain 
ephedrine, pseudoephedrine, and phenylpropanolamine, their salts, 
optical isomers, and salts of optical isomers, that may be marketed or 
distributed lawfully in the United States under the Federal Food, Drug, 
and Cosmetic Act as nonprescription drugs. CMEA defines these products 
as ``scheduled listed chemical products'' (21 U.S.C. 802(45)). 
Ephedrine, pseudoephedrine, and phenylpropanolamine are List I 
chemicals because they are used in, and important to, the illegal 
manufacture of methamphetamine and amphetamine, both Schedule II 
controlled substances. The Methamphetamine Production Prevention Act of 
2008 (MPPA) (Pub. L. 110-415) was enacted in 2008 to clarify the 
information entry and signature requirements for electronic logbook 
systems permitted for the retail sale of scheduled listed chemical 
products. On March 23, 2010, DEA published a Notice of Proposed 
Rulemaking to implement the provisions of the MPPA and make its 
regulations consistent with the new requirements. 75 FR 13702. This 
finalizes that proposed rulemaking.

Requirements for Retail Sales of Scheduled Listed Chemical Products

    CMEA defines nonprescription drug products marketed or distributed 
lawfully in the United States under the Federal Food, Drug, and 
Cosmetic Act containing ephedrine, pseudoephedrine, or 
phenylpropanolamine as ``scheduled listed chemical products'' (21 
U.S.C. 802(45)). Direct, in-person sales to a customer, whether by a 
regulated seller (e.g., grocery store, general merchandise store, drug 
store) (21 U.S.C. 802(46), (49)) or a mobile retail vendor (e.g., 
kiosk, flea market), (21 U.S.C. 802(47)) are subject to requirements 
for training of employees who either are responsible for delivering 
scheduled listed chemical products into the custody of purchasers or 
who deal directly with purchasers by obtaining payments for the 
products (21 U.S.C. 830(e)(1)(A)(vii)). The regulated seller must 
certify to DEA that the employees have been trained (21 U.S.C. 
830(e)(1)(B)). These regulated sellers must also check identifications 
of purchasers and maintain specific records (the logbook) of each sale 
of scheduled listed chemical products (21 U.S.C. 830(e)(1)(A)). The 
only sales exempt from recordkeeping are sales of single packages where 
the package contains not more than 60 milligrams of pseudoephedrine (21 
U.S.C. 830(e)(1)(A)(iii)).
    On September 26, 2006, DEA published in the Federal Register an 
Interim Final Rule, ``Retail Sales of Scheduled Listed Chemical 
Products; Self-Certification of Regulated Sellers of Scheduled Listed 
Chemical Products'' (71 FR 56008; corrected at 71 FR 60609, October 13, 
2006). That rule incorporated the standards set forth by the CMEA, 
requiring regulated sellers of scheduled listed chemical products to 
maintain logbooks regarding their sales on and after September 30, 
2006. If a regulated seller maintains the logbook on paper, DEA 
requires that the book be bound, as is currently the case for records 
of sales of Schedule V controlled substances that are sold without a 
prescription (21 CFR 1314.30(a)(2)). The records must be readily 
retrievable and available for inspection and copying by DEA or other 
State or local law enforcement agencies (21 U.S.C. 830(e)(1)(C)(i), 21 
CFR 1314.30(i)). Logs must be kept for not fewer than two years from 
the date the entry was made (21 CFR 1314.30(g)). CMEA required the logs 
include the information entered by the purchaser (name, address, 
signature, date and time of sale) and the quantity and form of the 
product sold.

[[Page 74697]]

    DEA permitted by regulation that where the record was entered 
electronically, the computer system may enter the date and time 
automatically. An electronic signature system, such as the ones many 
stores use for credit card purchases, could be employed to capture the 
signature for electronic logs (21 CFR 1314.30(c)). The information that 
the seller must enter could be accomplished through a point-of-sales 
system and bar code reader.

Changes to Sec.  1314.30

    On October 14, 2008, the President signed the MPPA. The Act amended 
the existing language in 21 U.S.C. 830(e)(1)(A) by revising clauses 
(iv) through (vi). The purpose of this Act was to facilitate the 
creation of electronic logbooks. Several options were provided for 
obtaining signatures of purchasers and recording transactions at the 
time of the sale.
    Specifically, the requirements now state that a regulated seller of 
scheduled listed chemical products may not sell such a product unless 
the purchaser:
     Presents a government issued photographic identification; 
and
     Signs the written logbook with his or her name, address, 
time and date of the sale, or signs in one of the following ways:
    [cir] In the case of an electronic logbook, the device must capture 
the signature in an electronic format.
    [cir] In the case of a bound paper book, a printed sticker must be 
affixed to the book at the time of sale adjacent to the signature line. 
The sticker must display the product name, quantity, name of purchaser, 
date and address, or a unique identification that can be linked to that 
information.
    [cir] In the case of a printed document, the document must include 
a clear line for the purchaser's signature and include product name, 
quantity, name and address of purchaser, and date and time of sale.
    The MPPA expressly permits the regulated seller to capture 
information regarding the name of the product and the quantity sold 
through bar code, electronic data capture, or similar technology. The 
regulated seller remains responsible for determining that the name 
entered corresponds to the photographic identification presented by the 
purchaser. The MPPA indicates that if the prospective purchaser enters 
the information into the logbook, the regulated seller must determine 
that the name entered in the logbook corresponds to the name provided 
on the photographic identification and must determine that the date and 
time of the sale as entered by the purchaser are correct. If the 
regulated seller enters the information into the logbook, the 
prospective purchaser must verify that the information is correct.
    In addition, the written or electronic logbook must continue to 
include 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 purchaser to criminal penalties 
under section 1001 of title 18 of the U.S. Code (21 U.S.C. 
830(e)(1)(A)(v)). The logbook must be maintained by the regulated 
seller for not fewer than two years after the date on which the entry 
is made (21 U.S.C. 830(e)(1)(A)(vi)).
    The changes made by the MPPA and implemented in this rulemaking 
will provide greater flexibility for regulated sellers of scheduled 
listed chemical products. These persons may now choose several 
alternative ways in which to capture and maintain required logbook 
information: A fully written logbook, a fully electronic logbook, or a 
logbook where some information is captured electronically and the 
prospective purchaser's signature is captured and linked to that 
information.

Discussion of Comments

    DEA received one comment on its Notice of Proposed Rulemaking. An 
association representing chain drug stores commented that the proposed 
rule allowed for flexibility in complying with Federal and State 
logbook requirements. The commenter also stated that the proposed rule 
was both logical and time-saving. By allowing regulated sellers to scan 
purchaser identifications, the proposed rule makes it possible for 
regulated sellers to simultaneously check purchaser identification and 
electronically capture purchaser information.
    DEA appreciates the support for its Notice of Proposed Rulemaking 
regarding the implementation of the MPPA, and is finalizing the 
Proposed Rule without change.

Regulatory Analyses

Executive Orders 12866 and 13563

    This final rule implementing the MPPA has been developed in 
accordance with the principles of Executive Orders 12866 and 13563. As 
discussed above, this action incorporates statutory provisions into 
existing regulations. This statutory change imposes no new costs on 
regulated sellers of the List I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine. Rather, it provides greater flexibility for 
regulated sellers who may choose to capture required logbook 
information in a written form, in an electronic form, or in a manner 
that combines written and electronic information. While not 
economically significant, this final rule has been reviewed by the 
Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
to eliminate ambiguity, minimize litigation, establish clear legal 
standards, and reduce burden.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of State 
law, impose enforcement responsibilities on any State, or diminish the 
power of any State to enforce its own laws. Accordingly, this 
rulemaking does not have federalism implications warranting the 
application of Executive Order 13132.

Executive Order 13175

    This rule is required by statute, will not have tribal implications 
and will not impose substantial direct compliance costs on Indian 
tribal governments.

Regulatory Flexibility Act

    This rule has been reviewed in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612), and the Deputy Assistant 
Administrator certifies that this rule will not have a significant 
economic impact on a substantial number of small entities. This rule 
simply incorporates the statutory provisions of the MPPA into existing 
regulations. This rule will provide greater flexibility to regulated 
sellers, permitting them to capture required logbook information in a 
variety of ways.

Paperwork Reduction Act of 1995

    Although the requirements of the MPPA revise the ways in which 
logbook information may be captured or presented, these requirements 
are not substantially different than the previously existing 
requirements for documentation of sales in logbooks. DEA believes that 
these revised requirements will have a negligible impact on the time 
estimated to document a sale. Estimates of this time burden are 
included in information collection 1117-0046, ``Certification, 
Training, and Logbooks for Regulated Sellers of Scheduled Listed 
Chemical Products.'' Therefore, as DEA does not believe that the burden 
associated with

[[Page 74698]]

this collection will measurably change, DEA is not revising this 
information collection.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$136,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act). This rule will not result in an annual 
effect on the economy of $100,000,000 or more, a major increase in 
costs or prices, or have significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets.

List of Subjects in 21 CFR Part 1314

    Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR Part 1314 is amended as 
follows:

PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS

0
1. The authority citation for Part 1314 continues to read as follows:

    Authority:  21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.


0
2. Section 1314.30 is revised to read as follows:


Sec.  1314.30  Recordkeeping for retail transactions.

    (a) Except for purchase by an individual of a single sales package 
containing not more than 60 milligrams of pseudoephedrine, the 
regulated seller must maintain, in accordance with criteria issued by 
the Administrator, a written or electronic list of each scheduled 
listed chemical product sale that identifies the products by name, the 
quantity sold, the names and addresses of the purchasers, and the dates 
and times of the sales (referred to as the ``logbook'').
    (b) The regulated seller must not sell a scheduled listed chemical 
product at retail unless the sale is made in accordance with the 
following:
    (1) The purchaser 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 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).
    (2) The purchaser signs the logbook as follows:
    (i) For written logbooks, enters in the logbook his name, address, 
and the date and time of the sale.
    (ii) For electronic logbooks, provides a signature using one of the 
following means:
    (A) Signing a device presented by the seller that captures 
signatures in an electronic format. The device must display the warning 
notice in paragraph (d) of this section. Any device used must 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.
    (B) Signing a bound paper book.
    (1) The bound paper book must include, for such purchaser, either--
    (i) A printed sticker affixed to the bound paper book at the time 
of sale that 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
    (ii) A unique identifier that can be linked to that information and 
that is written into the book by the seller at the time of sale.
    (2) The purchaser must sign adjacent to the printed sticker or 
written unique identifier related to that sale. The bound paper book 
must display the warning notice in paragraph (d) of this section.
    (C) Signing a printed document that includes, for the 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. The document must 
be printed by the seller at the time of the sale. The document must 
contain a clearly identified signature line for a purchaser to sign. 
The printed document must display the warning notice in paragraph (d) 
of this section. Each signed document must be inserted into a binder or 
other secure means of document storage immediately after the purchaser 
signs the document.
    (3) The regulated seller must enter in the logbook the name of the 
product and the quantity sold. Examples of methods of recording the 
quantity sold include the weight of the product per package and number 
of packages of each chemical, the cumulative weight of the product for 
each chemical, or quantity of product by Universal Product Code. These 
examples do not exclude other methods of displaying the quantity sold. 
Such information may be captured through electronic means, including 
through electronic data capture through bar code reader or similar 
technology. Such electronic records must be provided pursuant to 
paragraph (g) of this section in a human readable form such that the 
requirements of paragraph (a) of this section are satisfied.
    (c) The logbook maintained by the seller must include the 
prospective purchaser's name, address, and the date and time of the 
sale, as follows:
    (1) If the purchaser enters the information, the seller must 
determine that the name entered in the logbook corresponds to the name 
provided on the identification and that the date and time entered are 
correct.
    (2) If the seller enters the information, the prospective purchaser 
must verify that the information is correct.
    (3) Such information may be captured through electronic means, 
including through electronic data capture through bar code reader or 
similar technology.
    (d) The regulated seller must include in the written or electronic 
logbook or display by the logbook, the following notice:

WARNING: Section 1001 of Title 18, United States Code, states that 
whoever, with respect to the logbook, knowingly and willfully 
falsifies, conceals, or covers up by any trick, scheme, or device a 
material fact, or makes any materially false, fictitious, or 
fraudulent statement or representation, or makes or uses any false 
writing or document knowing the same to contain any materially 
false, fictitious, or fraudulent statement or entry, shall be fined 
not more than $250,000 if an individual or $500,000 if an 
organization, imprisoned not more than five years, or both.

    (e) The regulated seller must maintain each entry in the written or 
electronic logbook for not fewer than two years after the date on which 
the entry is made.
    (f) A record under this section must be kept at the regulated 
seller's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
seller if the regulated seller has notified the Administration of the 
intention to do so. Written notification must be submitted by 
registered or certified mail, return receipt requested, to the Special 
Agent in Charge of the DEA Divisional Office for the area in which the 
records are required to be kept.
    (g) The records required to be kept under this section must be 
readily retrievable and available for inspection

[[Page 74699]]

and copying by authorized employees of the Administration under the 
provisions of section 510 of the Act (21 U.S.C. 880).
    (h) A record developed and maintained to comply with a State law 
may be used to meet the requirements of this section if the record 
includes the information specified in this section.

    Dated: November 22, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2011-30630 Filed 11-30-11; 8:45 am]
BILLING CODE 4410-09-P