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2007 >
Record Requirements for Chemical Distributors
FR Doc E7-18530 [Federal Register: September 21, 2007 (Volume 72, Number
183)] [Proposed Rules] [Page 53973-53977] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr21se07-21]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-302P] RIN 1117-AB14
Record Requirements for Chemical Distributors
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Proposed Rulemaking (NPRM).
SUMMARY: In March 2006, Congress enacted the Combat Methamphetamine
Epidemic Act of 2005, which mandates
[[Page 53974]]
that regulated sellers of scheduled listed chemical products self- certify
with DEA before they are allowed to sell these products at retail. DEA is
proposing to revise its recordkeeping requirements to include a requirement
that manufacturers, distributors, and importers obtain and maintain the
certification number issued by DEA to regulated sellers in their records of
sales. This change will ensure that registrants verify that the regulated
sellers to whom they distribute have successfully completed the mandatory
self-certification process imposed by the CMEA for sales of scheduled listed
chemical products.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before November 20, 2007.
ADDRESSES: To ensure proper handling of comments, please reference "Docket
No. DEA-302'' on all written and electronic correspondence. Written comments
being sent via regular mail should be sent to the Deputy Assistant
Administrator, Drug Enforcement Administration, Washington, DC 20537,
Attention: DEA Federal Register Representative/ ODL. Written comments sent via
express mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA
22301. Comments may be directly sent to DEA electronically by sending an
electronic message to dea.diversion.policy@usdoj.gov. Comments may also be
sent electronically through http://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document is
also available at the http://www.regulations.gov Web site. DEA will accept
attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF,
or Excel file formats only. DEA will not accept any file format other than
those specifically listed here. Posting of Public Comments: Please note that
all comments received are considered part of the public record and made
available for public inspection online at http://www.regulations.gov and in
the Drug Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be posted online
or made available in the public docket, you must include the phrase "PERSONAL
IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must
also place all the personal identifying information you do not want posted
online or made available in the public docket in the first paragraph of your
comment and identify what information you want redacted.
If you want to submit confidential business information as part of your
comment, but do not want it to be posted online or made available in the
public docket, you must include the phrase "CONFIDENTIAL BUSINESS
INFORMATION'' in the first paragraph of your comment. You must also
prominently identify confidential business information to be redacted within
the comment. If a comment has so much confidential business information that
it cannot be effectively redacted, all or part of that comment may not be
posted online or made available in the public docket.
Personal identifying information and confidential business information
identified and located as set forth above will be redacted and posted online
and placed in the Drug Enforcement Administration's public docket file. If you
wish to inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537; telephone: (202) 307-7297.
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 (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 1399. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for medical, scientific, and other
legitimate 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, distribution, retail sale, import, and export 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.
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 amends the CSA by adding
new provisions related to the importation, production, and sale of ephedrine,
pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, and
salts of optical isomers, and products that contain any of the three
chemicals. Products that contain any of the three chemicals and which may be
marketed or distributed lawfully in the United States under the Federal Food,
Drug, and Cosmetic Act as a nonprescription drug (an "over-the-counter'' drug)
are defined 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, a Schedule II controlled substance. Products
containing these List I chemicals also have legitimate medical uses. Ephedrine
is used in some products for treating asthma. Pseudoephedrine, a decongestant,
is a common ingredient in cold and allergy medications. In November 2000, the
Food and Drug Administration (FDA) issued a public health advisory concerning
phenylpropanolamine and requested that all drug companies discontinue
marketing products containing phenylpropanolamine due to risk of hemorrhagic
stroke. In response, many companies voluntarily reformulated their products to
exclude phenylpropanolamine. Subsequently, on December 22, 2005, FDA published
a Notice of Proposed Rulemaking (70 FR 75988) proposing to categorize all
over-the-counter nasal decongestants and weight control drug products
containing phenylpropanolamine preparations as Category II, nonmonograph,
i.e., not generally recognized as being safe for human consumption. Most
products containing phenylpropanolamine intended for humans have been
[[Page 53975]]
withdrawn from the market, but phenylpropanolamine is still sold by
prescription for veterinary uses.
CMEA Requirements
CMEA regulates the sale of scheduled listed chemical products at retail,
including the sale of those products by regulated sellers. CMEA defines
regulated seller to mean a retail distributor (including a pharmacy or a
mobile retail vendor) (21 U.S.C. 802(46)). Retail distributor means a grocery
store, general merchandise store, drug store, or other entity or person whose
activities as a distributor relating to drug products containing
pseudoephedrine or phenylpropanolamine are limited almost exclusively to sales
for personal use, both in number of sales and volume of sales, either directly
to walk-in customers or in face-to-face transactions by direct sales (21 U.S.C.
802(49)). Mobile retail vendor means a person or entity that makes sales at
retail from a stand that is intended to be temporary, or is capable of being
moved from one location to another, whether the stand is located within or on
the premises of a fixed facility (such as a kiosk at a shopping center or an
airport) or whether the stand is located on unimproved real estate (such as a
lot or field leased for retail purposes) (21 U.S.C. 802(47)). [Note that mail
order distributors are not regulated sellers.]
As of September 30, 2006, regulated sellers that wish to sell scheduled
listed chemical products at retail must comply with the requirements in CMEA
for product placement and packaging, recordkeeping, sales limits, and employee
training and must self- certify to DEA that they are in compliance prior to
selling the products. When a regulated seller self-certifies, DEA issues a
self- certification certificate (DEA Form 598) which includes a certification
number. The expiration date of the self-certification is printed on the
self-certification certificate. Self-certifications must be renewed annually
if the regulated seller continues to sell scheduled listed chemical products.
Regulated sellers are not required to register with DEA although many
regulated sellers may be DEA registrants because they also handle controlled
substances. Note that self-certification is independent of DEA registration;
the fact that an entity is a DEA registrant does not negate the requirement
that the entity self-certify with DEA and receive a self-certification
certificate.
Proposed Rule
DEA is proposing to revise 21
CFR 1310.06(a) to require that those DEA registrants who distribute
scheduled listed chemical products to regulated sellers verify that the
regulated seller to whom they are distributing the products has certified to
DEA that the regulated seller is in compliance with the requirements for
retail sales of scheduled listed chemical products. The registrant who
distributes the products must also maintain the certification number as part
of the sales record. This proposal is consistent with the current rule, which
requires registrants to ensure that their customers are eligible to purchase
listed chemicals and to record their DEA numbers, where applicable. Collecting
DEA and certification numbers assists registrants to know their customers and
to be certain that the customers are purchasing the products for legitimate
purposes.
This requirement will primarily affect distributors, although some
manufacturers and importers may sell directly to regulated sellers. Under
current Sec. 1310.06, registrants are required to include the following in
their sales records:
The name, address, and if applicable, the DEA number of each party to the
transaction.
The date of the transaction.
The name, quantity, and form of packaging of the listed chemical.
The method of transfer.
The type of identification used by the purchaser and any unique number on
that identification.
DEA is proposing to add the certification number of the purchaser to the
list of information that must be maintained in sales records. Normal business
records can be used to meet this requirement if they include the required
information. Because mail order distributors are not subject to
self-certification, DEA is not requiring registrants to collect any additional
information from these firms. Under the existing rule, if the mail order
distributor is a DEA registrant, the DEA number must be collected as part of
the sales record.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this rulemaking
has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
601-612). The Regulatory Flexibility Act requires agencies to determine
whether proposed rules would have a significant economic impact on a
substantial number of small entities. DEA expects that some of the
distributors subject to this rule will be small entities. The burden
associated with the rule, however, is de minimis. Registrants will simply have
to ask their purchasers for their DEA certification number and keep that
number in their records. For firms that receive orders electronically and
maintain electronic records, as many do, the certification number can simply
be added to the customer's master record that is associated with individual
orders. If the same customer orders multiple times during a year, the
information could be collected only once a year because certifications will
generally be valid for a year; initial certifications may have longer validity
periods. Because the time required to collect the information and maintain the
record is minimal, the Deputy Assistant Administrator has determined that this
action does not require a regulatory flexibility analysis.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this rulemaking
has been drafted in accordance with the principles in Executive Order 12866
Sec. 1(b). It has been determined that this rulemaking is a significant
regulatory action and, therefore, has been reviewed by the Office of
Management and Budget.
Paperwork Reduction Act
The Paperwork Reduction Act requires agencies to estimate the burden
imposed by recordkeeping and reporting. The records required under this
proposed rule are standard business records. While many DEA- registered
distributors may maintain the self-certification number of regulated sellers
which purchase scheduled listed chemical products from them, some may not. DEA
believes that the additional information that registrants would be required to
collect once a year imposes a minimal burden that can be met by simply adding
the item to the order form. DEA invites comment regarding whether the
inclusion in distributors' records of the self-certification numbers of
regulated sellers purchasing scheduled listed chemical products imposes a
burden which should be quantified.
The Department of Justice, Drug Enforcement Administration, has submitted
the following information collection request to the Office of Management and
Budget (OMB) for review and clearance in accordance with review procedures of
the Paperwork Reduction Act of 1995. The proposed information collection is
published to obtain comments from the public and affected agencies.
[[Page 53976]]
All comments and suggestions, or questions regarding additional
information, to include obtaining a copy of the proposed information
collection instrument with instructions, should be directed to Mark W. Caverly,
Chief, Liaison and Policy Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected agencies
concerning the proposed collection of information are encouraged. Your
comments regarding the information-collection aspects of this rule should
address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including whether
the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be
collected; and
(4) Minimize the burden of the collection of information on those who are
to respond, including through the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms of
information technology, e.g., permitting electronic submission of responses.
Overview of this information collection:
(1) Type of Information Collection: New collection.
(2) Title of the Form/Collection: [Insert title same as above and on OMB
83-I].
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection: Form Number: None. Office
of Diversion Control, Drug Enforcement Administration. U.S. Department of
Justice.
(4) Affected public who will be asked or required to respond, as well as
a brief abstract: Primary: Business or other for-profit. Other: None.
Abstract: Title 21, United States Code, Section 830, and Title 21, Code of
Federal Regulations, part 1314 require that any person who is a regulated
seller of scheduled listed chemical products to self-certify to DEA that it
has trained its staff in the requirements for selling scheduled listed
chemical products and is in compliance with DEA regulations. To ensure that
persons distributing scheduled listed chemical products sell only to
regulated sellers who are eligible to sell them, DEA is requiring
distributors to collect and retain the certification number DEA issues to
regulated sellers when they self- certify.
(5) An estimate of the total number of respondents and the amount of time
estimated for an average respondent to respond:
DEA estimates that 38,926 persons will respond to this collection
annually, with each response taking an estimated 2 minutes. DEA estimated
the number of responses as follows.
As of August 6, 2007, 75,721 regulated sellers had self- certified to DEA.
Of those, 39,917 certifications were filed by 103 chains. There were,
therefore, 36,804 regulated sellers who filed as individual regulated
sellers. For regulated sellers that belonged to chains that filed
certifications for their stores, DEA assumed that the chain held the master
list and would provide the self- certification numbers of each
self-certified location to distributors from whom the chain orders scheduled
listed chemical products. Thirty of the self-certified chains are also
registered as chemical or controlled substance distributors; these chains,
therefore, do not need to take any additional action to provide information
to the distributor. The number of regulated sellers who would need to
provide the self-certification number to a distributor is the 36,804
individual regulated sellers plus the 73 chains that do not serve as their
owner distributors. In addition, DEA assumes that 2,049 controlled substance
and chemical distributors would have to collect the information. This
estimate is conservative because not all of these distributors handle
scheduled listed chemical products.
(6) An estimate of the total public burden (in hours) associated with the
collection: DEA estimates that this collection will take 1,298 hours
annually.
If additional information is required contact: Lynn Bryant, Department
Clearance Officer, Information Management and Security Staff, Justice
Management Division, Department of Justice, Patrick Henry Building, Suite
1600, 601 D Street, NW., Washington, DC 20530.
Executive Order 12988
This regulation meets the applicable standards set forth in Sec. Sec. 3(a)
and 3(b)(2) of Executive Order 12988, Civil Justice Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State law; nor
does it impose enforcement responsibilities on any State; nor does it 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.
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 $120,000,000 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 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 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, 21
CFR part 1310 is proposed to be amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
2. Section 1310.06
is proposed to be amended by revising paragraph (a) introductory text and by
adding (a)(6) to read as follows:
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03 shall include all of the
following:
* * * * *
(6) For distributions of scheduled listed chemical products to regulated
sellers, the regulated seller's (i.e., the purchaser's) DEA certification
number issued in accordance with section 1314.40(b)
of this chapter.
* * * * *
[[Page 53977]]
Dated: September 12, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E7-18530 Filed 9-20-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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