Rules - 2011
[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Rules and Regulations]
[Pages 74696-74699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30630]
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.
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:
- In the case of an electronic logbook, the device must capture
the signature in an electronic format.
- 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.
- 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
- 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.
- 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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
