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Register Notices > Rules - 200 8
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Registration Requirements for Importers and Manufacturers
of Prescription Drug Products Containing Ephedrine,
Pseudoephedrine, or Phenylpropanolamine
8
FR Doc E8-774 [Federal Register: January 18, 2008 (Volume 73,
Number 13)] [Proposed Rules] [Page 3432-3441] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja08-20]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1309
[Docket No. DEA-294P] RIN 1117-AB09
Registration Requirements for Importers and Manufacturers
of Prescription Drug Products Containing Ephedrine,
Pseudoephedrine, or Phenylpropanolamine
AGENCY: Drug Enforcement Administration (DEA),
Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: The Combat Methamphetamine Epidemic Act of
2005 (CMEA), which was enacted on March 9, 2006, requires DEA to
establish an assessment of annual need for the importation and
manufacture of ephedrine, pseudoephedrine, and
phenylpropanolamine. Because of the new CMEA mandates for
importation, import quotas, and production quotas for these
chemicals, DEA must revise its registration provisions. The
changes made by the CMEA render current DEA regulations
inadequate for two reasons. First, although DEA registers bulk
manufacturers of the three chemicals in the United States and
importers of the bulk chemicals, some of those chemicals are
distributed to non-registered companies that process them into
prescription drugs. Under the Controlled Substances Act, section
826, production quotas are available only to registered
manufacturers. DEA cannot meet the CMEA mandate to establish
annual need and import quotas, and then issue individual quotas
for each of the chemicals unless all manufacturers manufacturing
or procuring the chemicals and manufacturing drug products that
contain the chemicals are registered as manufacturers, even if
the distribution of the final drug products is not regulated.
DEA also must know the quantity of prescription drug products
containing the three chemicals being imported. Without this
information, DEA would not be able to determine an assessment of
annual need for these chemicals. Any person importing
prescription drug products containing any of the three chemicals
must register although the distribution of these products would
not be subject to DEA regulation.
Second, persons currently registered to import, distribute,
or dispense controlled substances who manufacture drug products
using ephedrine, pseudoephedrine, or phenylpropanolamine, are
not necessarily registered to do so. This must also be changed
so that controlled substance registrants will only receive a
waiver from the requirement of separate chemical registration if
they engage in the same activity for both lawfully marketed drug
products containing List I chemicals and controlled substances
(as is already the case for bulk manufacture, imports, and
exports.) In this way, any registrant that must obtain a quota
to manufacture or procure one or more of the chemicals will be a
registered manufacturer, as required by the CSA.
Were DEA not to issue this rule, it would have no mechanism
to issue production or import quotas for persons handling
prescription drug products containing ephedrine, pseudoephedrine,
or phenylpropanolamine. If these persons were not required to
register, there would be no mechanism by which they would be
permitted to apply for production or import quotas. Therefore,
these persons would have no means by which to acquire the List I
chemicals ephedrine, pseudoephedrine, or phenylpropanolamine
necessary for them to conduct business.
Accordingly, DEA is proposing to amend its registration
regulations to ensure that every location that manufactures or
imports one of these chemicals or drug products that contain
ephedrine, pseudoephedrine, or phenylpropanolamine is a DEA
registered manufacturer or importer. These amendments will make
it possible to establish the system of quotas and assessment of
annual needs for the manufacturing that Congress
[[Page 3433]]
mandated for ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Written comments must be postmarked, and
electronic comments must be sent, on or before March 18, 2008.
ADDRESSES: To ensure proper handling of comments,
please reference "Docket No. DEA-204'' on all written and
electronic correspondence. Written comments being sent via
regular mail should be sent to the Deputy Assistant
Administrator, Office of Diversion Control, 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 formats 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 the comment, in redacted form, will be 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 at (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 legitimate medical,
scientific, 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,
distribution, 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). Much of CMEA is self-implementing; the
provisions related to importation of ephedrine, pseudoephedrine,
and phenylpropanolamine, import quotas, manufacturing quotas,
and procurement quotas became effective on March 9, 2006.
CMEA Requirements and Impact on Registration
CMEA amended the CSA to include ephedrine, pseudoephedrine,
and phenylpropanolamine in 21
U.S.C. 826 (Production quotas for
controlled substances) and section 952(a) (Importation of
controlled substances). Congress essentially imposed the same
requirements for importation of ephedrine, pseudoephedrine, and
phenylpropanolamine as are imposed on narcotic raw
materials--crude opium, poppy straw, concentrate of poppy straw,
and coca leaves. That is, imports of ephedrine, pseudoephedrine,
and phenylpropanolamine are prohibited except for such amounts
as the Attorney General (DEA by delegation) finds to be
necessary to provide for medical, scientific, or other
legitimate purposes. Congress also imposed the same requirements
on the manufacture of ephedrine, pseudoephedrine, and
phenylpropanolamine as are established for Schedule I and II
controlled substances. That is, Congress mandated the
establishment of a total need for ephedrine, pseudoephedrine,
and phenylpropanolamine to be manufactured each calendar year to
provide for the estimated medical, scientific, research, and
industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of
reserve stocks. These requirements apply equally to products
containing these three List I chemicals as they do to the List I
chemicals themselves.
Controlled substances are subject to a closed system of
controls that ensures that no person may manufacture,
distribute, import, export, or dispense unless that person is a
DEA registrant, or exempted from the requirement of
registration. Production of Schedule I and II controlled
substances is limited to the quantity that DEA has determined is
required to meet the legitimate medical, scientific, research,
and industrial needs of the United States; for
[[Page 3434]]
lawful export requirements; and for establishment and
maintenance of reserve stocks (21 U.S.C.
826(a)). After DEA
establishes the total annual need, DEA issues individual
manufacturing and procurement quotas to manufacturers; under
section 826, quotas may be issued only to registered
manufacturers. Manufacturers may not produce or purchase more of
a substance than is available under their individual quotas.
Under the CSA, "manufacture'' is defined to include all of the
following:
- The manufacturing of a substance or chemical in bulk,
either by extraction from raw materials, chemical synthesis,
or a combination of extraction and chemical synthesis.
- The processing of the substance or chemical into products,
such as drugs in dosage form.
- The packaging or repackaging of the processed substances
or chemicals or labeling or relabeling of containers holding
the chemicals.
Until the passage of CMEA, chemical importers were required
to notify DEA of imports of ephedrine, pseudoephedrine, and
phenylpropanolamine before or at the time of importation under
21 U.S.C. 971. DEA had no authority to limit the importation or
manufacture of ephedrine, pseudoephedrine, and
phenylpropanolamine, except the ability to suspend a proposed
import under 21 U.S.C. 971 on the ground that it may be diverted
to the clandestine manufacture of a controlled substance. Most
of the ephedrine, pseudoephedrine, and phenylpropanolamine used
in the United States is imported rather than manufactured
domestically, although at least one company in the United States
manufactures the chemicals in bulk. The three chemicals are used
to produce drug products lawfully marketed under the Federal
Food, Drug and Cosmetic Act (FFD&CA), many of which are
prescription drugs. DEA has not subjected these prescription
drug products to all List I chemical regulatory requirements
because they are available only in response to a prescription
and are stored in and dispensed at pharmacies. These chemicals
are also used in over-the-counter (OTC) drug products (lawfully
marketed under the FFD&CA). These products have been widely
used in the illegal manufacture of methamphetamine and
amphetamine. CMEA defined these OTC drug products as scheduled
listed chemical products. DEA has regulated the distribution,
import, and export of scheduled listed chemical products.
DEA, in 1995, first imposed registration requirements on
firms that manufacture, distribute, import, and export List I
chemicals. Although section 822 of the CSA states that any
person who manufactures or distributes a controlled substance or
List I chemical must register with DEA, DEA limited chemical
registration for manufacturers to firms that manufacture to
distribute List I chemicals. Some manufacturers were not
required to register under the "manufacture for distribution''
policy. Those that manufactured and chemically consumed and
transformed all of the chemical in their own processes; those
that purchased List I chemicals in bulk and manufactured
prescription drug products that contain a List I chemical; and
those that repackaged or relabeled prescription drug products
that contain a List I chemical were not required to obtain a DEA
chemical registration. Firms that manufacture a List I chemical
in bulk and distribute to wholesalers or to other manufacturers
were already required to register and file reports with DEA.
Firms that manufacture scheduled listed chemical products
(nonprescription/OTC drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine) also distribute those
products, were already required to obtain a DEA chemical
registration.
As a consequence of the "manufacture for distribution''
policy, firms that manufactured prescription drugs containing
ephedrine, pseudoephedrine, and phenylpropanolamine were not
required to register because distributions of the prescription
drug products were not regulated. DEA, in Sec.
1309.22, listed
only four activities involving List I chemicals that required
registration: Retail distributing, non- retail distributing,
importing, and exporting. On the application for registration
form, firms were required to indicate whether they were seeking
to be registered as manufacturers or distributors (e.g.,
wholesalers), but the regulation did not distinguish between
those who manufacture to distribute and those who simply
distribute. In addition, in Sec.
1309.24, DEA waived the
chemical distribution registration requirement for firms that
manufacture or distribute drug products lawfully marketed under
the FFD&CA containing the three chemicals for any firm that
is registered to manufacture, distribute, or dispense a
controlled substance. Note that this waiver (from the
requirement to obtain a separate DEA chemical registration) was
only provided for drug products containing a listed chemical
which is in final packaged/ labeled form which is lawfully
marketed under the FFD&CA. Drug products not in final
packaged/labeled form were not provided this waiver. For
example, an importer of bulk tablets containing a listed
chemical, intended for a drug product marketed in the United
States, would still have to obtain a chemical importer
registration, and would not be able to use their controlled
substance registration for such activity.
The waiver does not apply in the reverse; a firm that handles
controlled substances must register for the applicable
controlled substance activity even if it is already registered
to conduct the same activity with List I chemicals.
As a consequence of these decisions, there are firms
manufacturing drug products lawfully marketed under the FFD&CA
containing ephedrine, pseudoephedrine, or phenylpropanolamine
that are not registered with DEA at all because they do not
handle controlled substances and the only products they produce
containing the three chemicals are prescription drugs. There are
also firms that manufacture scheduled listed chemical products,
but only distribute or dispense controlled substances. Because
they are registered as controlled substance distributors or
dispensers, they are not currently required to register as
chemical manufacturers. Finally, there may be some firms that
are not registered that import prescription drug products that
contain the three chemicals.
Because of the new CMEA mandates for importation, import
quotas, and production quotas for these chemicals, DEA is
proposing to revise its registration provisions. The changes
made by the CMEA render current DEA regulations inadequate for
two reasons. First, although DEA registers bulk manufacturers of
the three chemicals in the United States and importers of the
bulk chemicals, some of those chemicals are distributed to
non-registered companies that process them into prescription
drugs. Under the CSA section 826, production quotas are
available only to registered manufacturers. DEA cannot meet the
CMEA mandate to establish an annual need and import quotas, and
then issue individual quotas for each of the chemicals unless
all manufacturers manufacturing or procuring the chemicals and
manufacturing drug products that contain the chemicals are
registered as manufacturers, even if the distribution of the
final drug products is not regulated. DEA also must know the
quantity of prescription drug products containing the three
chemicals being
[[Page 3435]]
imported; without this information, DEA would not be able to
determine an assessment of annual need for the chemicals. Any
person importing prescription drug products containing any of
the three chemicals must register although the distribution of
these products would not be subject to DEA regulation.
The second inadequacy is that the existing language allows a
controlled substance distributor or dispenser to avoid
registration as a chemical manufacturer if they manufacture
scheduled listed chemical products or other products containing
a List I chemical that is described and included in the
definition of "regulated transaction'' in Sec.
1300.02(b)(28)(i)(D).
(DEA notes that there may be a limited number of drug products
containing List I chemicals other than ephedrine,
pseudoephedrine, and phenylpropanolamine which meet this
description.) This provision must also be changed so that
controlled substance registrants will not need to obtain a
chemical registration only if they engage in the same activity
for both drug products containing List I chemicals and
controlled substances as is already the case for bulk
manufacture, imports, and exports. In this way, any registrant
that must obtain a quota to manufacture or procure one or more
of the chemicals will be a registered manufacturer, as required
by the CSA.
DEA recognizes that this change will require some
manufacturers and locations to register that had not previously
been subject to DEA regulations; other registrants will be
required to obtain separate registrations for chemicals and
controlled substances. The proposed new requirements, however,
are both consistent with the statutory language on registration
and the CMEA amendments and with the intent of the CMEA
requirements to establish a system of quotas for the manufacture
of these three chemicals and the products that contain them.
Without these changes, DEA would not be able to meet the CMEA
mandates. In addition, without these changes, companies that
manufacture and import prescription drug products containing the
three chemicals would not be able to purchase the chemicals
legally nor would the assessment of annual needs reflect their
requirements.
Explanation of DEA Categories of Registration and Effect
of This Rule Regarding DEA Registration
As noted above, the CSA defines the term "manufacture'' to
include the physical manufacture of a chemical or product, as
well as the packaging, labeling, repackaging, and relabeling of
that product (21 U.S.C.
802(15)).
If this rule is finalized as proposed, persons who
manufacture or import ephedrine, pseudoephedrine, or
phenylpropanolamine, or who manufacture or import a product
containing ephedrine, pseudoephedrine, or phenylpropanolamine,
or who plan to engage in such activities, would be required to
register with DEA if they are not already registered for the
appropriate business activity. As required by the CSA,
registration is location-specific; a person must obtain a
registration for each principal place of business at one general
physical location where controlled substances or List I
chemicals are handled. If a person manufactures controlled
substances at one location and drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine at another
location, the person would be required to obtain a separate
registration for each location. Under the waiver previously
described in this rulemaking, persons who are currently
registered as controlled substances manufacturers at a location
where drug products containing these List I chemicals are also
manufactured would not be required to register separately to
conduct the same activity, manufacturing, with these List I
chemicals. A controlled substances registration for that one
physical location would cover both the manufacturing of
controlled substances and drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine, at that location.
Controlled substances manufacturers would, however, be required
to identify to DEA the List I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine they handle as part of
their next registration renewal. DEA notes that the manufacture
of bulk List I chemicals requires a separate chemical
registration; this is not a change from existing regulations.
However, if a person manufactures a drug product containing
ephedrine, pseudoephedrine, or phenylpropanolamine at a
location, but is registered to conduct other (nonmanufacturing)
activities with controlled substances at that location (e.g.,
distribution), the person would need to obtain a List I chemical
manufacturing registration for the location. The following table
indicates the changes in registration requirements being
proposed for various business activities.
Current
|
Proposed
|
Chemical Manufacturers (No Controlled Substances)
|
All bulk manufacturers of List I chemicals must register
unless all of the chemical produced is consumed internally and
is not available for use in products.
|
No change.
|
Manufacturers of scheduled listed chemical products register if
distribute.
Manufacturers of prescription products ** containing List I
chemicals do not register.
|
All manufacturers of drug products containing List I chemicals *
would register. |
Chemical Distributors
|
Distributors of List I chemicals and scheduled listed chemical
products register.
Distributors of prescription products ** containing List I
chemicals do not register.
|
No change.
|
Chemical Importers and Exporters
|
Importers of List I chemicals and scheduled listed chemical
products register.
Importers of prescription products ** containing List I
chemicals do not register. |
Importers of List I chemicals and all drug products containing
List I chemicals * would register. |
Exporters of List I chemicals and scheduled listed chemical
products register.
Exporters of prescription products ** containing List I
chemicals do not register.
|
No change.
|
Manufacturers and Distributors of Controlled Substances and
Drug Products Containing List I Chemicals
|
Manufacturers of both controlled substances and drug products
containing List I chemicals may register as only controlled
substance manufacturers.
|
No change
|
Manufacturers of drug products containing any List I chemical *
who distribute or dispense controlled substances may register
for only their controlled substance activity. A separate
registration for the chemical activity is permissible.
|
Manufacturers of drug products containing any List I chemical *
would register as manufacturers. If they distribute or dispense
controlled substances they would register separately for those
activities
|
Distributors of both controlled substances and drug products
containing List I chemicals may register as only controlled
substance distributors.
|
No change.
|
Importers/Exporters of Controlled Substances and Drug
Products Containing List I Chemicals
|
Importers of both controlled substances and drug products
containing List I chemicals register as controlled substance
importers.
|
No change
|
Exporters of both controlled substances and drug products
containing List I chemicals register as controlled substance
exporters.
|
No change
|
Manufacturers, Distributors, Importers, and Exporters of Bulk
List I Chemicals
|
Manufacturers, distributors, importers, and exporters of bulk
List I chemicals register, regardless of whether they handle
controlled substances.
|
No change.
|
* "Drug products containing List I chemicals'' refers to
scheduled listed chemical products or other products containing
a List I chemical that is described and included in the
definition of "regulated transaction'' in Sec. 1300.02(b)(28)(i)(D).
Such drug products must be in packaged/labeled form as required
under the FFD&CA for lawful marketing.
** "Prescription products,'' for purposes of this chart,
refers to "any transaction in a List I chemical that is
contained in a drug that may be marketed or distributed lawfully
in the United States under the Federal Food, Drug, and Cosmetic
Act * * *'' (21 U.S.C. 802(39)(a)(iv)). To comply with the
marketing and distribution requirements of the Federal Food,
Drug, and Cosmetic Act for prescription drugs, such drugs must
be packaged and labeled in accordance with the Federal Food,
Drug and Cosmetic Act as prescription drugs.
Proposed Requirements of This Rule
DEA is proposing that a person who manufactures or imports a
prescription drug product containing ephedrine, pseudoephedrine,
or phenylpropanolamine would be required to comply with the
following:
Registration. Any person who manufactures or imports a drug
product containing ephedrine, pseudoephedrine, or
phenylpropanolamine, or proposes to engage in the manufacture or
importation of a drug product containing ephedrine,
pseudoephedrine, or phenylpropanolamine, would be required to
obtain a registration under the CSA (21
U.S.C. 822 and 958).
Regulations describing registration for List I chemical handlers
are set forth in 21 CFR part
1309.
A separate registration is required for manufacturing,
distribution, importing, and exporting, except that a person
registered to manufacture or import a List I chemical or a
product containing ephedrine, pseudoephedrine, or
phenylpropanolamine may distribute that List I chemical or drug
product without obtaining a separate registration to do so. A
separate registration is required for each principal place of
business at one general physical location where the List I
chemicals are manufactured, distributed, imported, or exported
by a person (21 CFR
1309.23).
As a result of the change, any person manufacturing or
importing a prescription drug product containing ephedrine,
pseudoephedrine, or phenylpropanolamine would become subject to
the registration requirement under the CSA. DEA recognizes,
however, that it is not possible for persons who would be newly
subject to the registration requirement to complete and submit
an application for registration and for DEA to issue
registrations for those activities immediately. Therefore, to
allow continued legitimate commerce, DEA is proposing to
establish in Sec. 1309.25 a temporary exemption from the
registration requirement for persons desiring to engage in
manufacturing or importing prescription drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine, provided
that DEA receives a properly completed application for
registration on or before 30 days from the date of publication
of a Final Rule in the Federal Register. The temporary exemption
for such persons will remain in effect until DEA takes final
action on their application for registration.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, will remain in effect.
Additionally, the temporary exemption does not suspend
applicable Federal criminal laws relating to these chemicals,
nor does it supersede State or local laws or regulations. All
manufacturers and importers of ephedrine, pseudoephedrine, or
phenylpropanolamine, or any product containing any of these
three List I chemicals, must comply with applicable State and
local requirements in addition to the CSA regulatory controls.
Importation. All persons importing ephedrine, pseudoephedrine,
or phenylpropanolamine, or drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine would be required to
comply with all requirements regarding importation.
Records and Reports. The CSA (21
U.S.C. 830) requires certain
records to be kept and reports to be made involving listed
chemicals. Regulations describing recordkeeping and reporting
[[Page 3437]]
requirements are set forth in 21 CFR part
1310. A record must
be made and maintained for two years after the date of a
regulated transaction involving a List I chemical. Each
regulated bulk manufacturer of a regulated mixture must submit
manufacturing, inventory, and use data on an annual basis (21
CFR 1310.05(d)). Bulk manufacturers producing the chemicals
solely for internal consumption are not required to submit this
information; internal consumption does not include using the
chemical to produce drug products. Existing standard industry
reports containing the required information are acceptable,
provided the information is readily retrievable from the report.
Under 21 CFR 1310.05, regulated persons are required to
report to DEA any regulated transaction involving an
extraordinary quantity, an uncommon method of payment or
delivery, or any other circumstance that causes the regulated
person to believe that the listed chemical will be used in
violation of the CSA. Regulated persons are also required to
report to DEA any proposed regulated transaction with a person
whose description or other identifying information has been
furnished to the regulated person. Finally, regulated persons
are required to report any unusual or excessive loss or
disappearance of a listed chemical.
Security. All applicants and registrants must provide
effective controls against theft and diversion of chemicals as
described in 21 CFR
1309.71.
Administrative Inspection. Places, including factories,
warehouses, or other establishments and conveyances, where
regulated persons may lawfully hold, manufacture, distribute,
dispense, administer, or otherwise dispose of ephedrine,
pseudoephedrine, or phenylpropanolamine, or products containing
ephedrine, pseudoephedrine, or phenylpropanolamine, or where
records relating to those activities are maintained, are
controlled premises as defined in 21 CFR
1316.02(c). The CSA (21
U.S.C. 880) allows for administrative inspections of these
controlled premises as provided in 21 CFR part 1316, subpart A.
Section by Section Analysis of Proposed Rule Changes
DEA is proposing to amend Sec. Sec. 1309.11 and
1309.12 to
replace "manufacture for distribution'' with "manufacture.''
In addition, in both sections, DEA is proposing to remove
references to retail distributors. In amendments to 21 U.S.C.
823(h) the CMEA expressly stated that distributors of scheduled
listed chemical products at retail are not required to register
under the Controlled Substances Act. To avoid confusion, DEA
decided to address all registration revisions related to CMEA
implementation in this rulemaking.
Section 1309.21 is proposed to be revised to state that every
person who manufactures or proposes to manufacture a List I
chemical or a drug product containing a List I chemical must
register. The change would require manufacturers of prescription
drug products containing ephedrine, pseudoephedrine, or
phenylpropanolamine to register even though they are not
required to register to distribute or export the products. DEA
is also proposing to add a table to the section, similar to the
table in Sec. 1301.13 on controlled substance registration
requirements, to summarize the requirements for each business
activity. As discussed above, this revision would not alter the
registration requirements for bulk manufacturers of List I
chemicals and for manufacturers of scheduled listed chemical
products.
Section 1309.22 is proposed to be revised to remove retail
distributing as a registration activity and to add
manufacturing. As explained above, CMEA explicitly states that
retail distributors of scheduled listed chemical products are
not required to register. DEA is also proposing to add a new
paragraph to state that a person registered to manufacture a
List I chemical is authorized to distribute that chemical under
the manufacturing registration. The registrant may not
distribute, under a manufacturer's registration, any List I
chemical that is not covered in the manufacturing registration.
This limitation parallels the existing limitation for importers.
In Sec. 1309.24 paragraph (b) is proposed to be revised to
clarify that a person who manufactures or distributes a
scheduled listed chemical product or other product containing a
List I chemical that is described and included in the definition
of "regulated transaction'' in Sec.
1300.02(b)(28)(i)(D) is
exempted from registration only if registered to conduct the
same activity with controlled substances. Paragraph (c) is
proposed to be revised to clarify that a person who imports or
exports a scheduled listed chemical product or other product
containing a List I chemical that is described and included in
the definition of "regulated transaction'' in Sec.
1300.02(b)(28)(i)(D) is exempted from registration only if
registered to conduct the same activity with controlled
substances. Paragraph (e) waiving registration for retail
distributors is proposed to be removed because CMEA statutorily
does not require them to register. The remaining paragraphs (f)
through (l) would be redesignated (e) through (k). DEA notes
that the waiver of the requirement of registration continues for
bulk manufacturers who manufacture and consume all of the List I
chemical internally.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this
rulemaking has been drafted in accordance with the provisions of
the Regulatory Flexibility Act (5 U.S.C. 601-612). The Combat
Methamphetamine Epidemic Act of 2005 amended the Controlled
Substances Act to require production quotas for manufacturers
handling the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. CMEA also authorized the Attorney General (DEA
by delegation), to establish import quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine. The Controlled
Substances Act requires that quotas be issued to registrants.
Were DEA not to issue this rule, it would have no mechanism to
permit the registration of persons handling prescription drug
products containing ephedrine, pseudoephedrine, or
phenylpropanolamine. If these persons were not permitted to
register, there would be no mechanism by which they would be
permitted to apply for production or import quotas. Therefore,
these persons would have no means by which to acquire the List I
chemicals ephedrine, pseudoephedrine, or phenylpropanolamine
necessary for them to conduct business.
This rule proposes to codify provisions necessary for
implementation of the Combat Methamphetamine Epidemic Act. As
discussed further below, DEA has examined the potential impacts
of this rule. DEA has no basis for estimating the number of
firms that may be small, but given the definition of small
entities, it is likely that a substantial number of the new
registrants will be small. The cost of compliance, however,
would not impose a significant economic burden. The only cost is
the $2,293 registration fee for manufacturers, and the $1,147
registration fee for importers, respectively. The recordkeeping
and reporting requirements can be met using existing business
and manufacturing records. The security provisions are general
and require the registrant to provide effective controls and
procedures to guard against theft and and diversion of List I
chemicals. Any
[[Page 3438]]
manufacturer approved by the FDA and complying with good
manufacturing practices or currently registered to handle
controlled substances will have internal controls that meet this
requirement. The smallest pharmaceutical firms (with 1 to 4
employees) had an average value of shipments of $824,000 in 2002
($886,000 in 2007 dollars, based on GDP). Even for these firms,
which are unlikely to be producing the covered drug products,
the $2,293 registration fee would represent less than 0.3
percent of sales and, therefore, is not a significant burden.
Therefore, this rule will not have a significant economic impact
on a substantial number of small entities.
Executive Order 12866
The Deputy Assistant Administrator further certifies that
this rulemaking has been drafted in accordance with the
principles in Executive Order 12866 section 1(b). It has been
determined that this is "a significant regulatory action.''
Therefore, this action has been reviewed by the Office of
Management and Budget. As discussed above, this action is
necessary to implement statutory provisions. DEA has,
nonetheless, reviewed the potential costs.
DEA has a limited basis for determining the number of
manufacturers of prescription drug products that will need to
obtain a DEA registration for the first time. DEA reviewed a
list of pseudoephedrine products and ephedrine prescription drug
products and identified 230 firms based on their labeler codes.
Of all firms identified, 164 do not appear to be registered with
DEA as manufacturers and 95 are not registered as either
manufacturers or controlled substance distributors. The firms
currently registered to manufacture controlled substances may
not manufacture List I chemical drugs at the same locations.
Seventy firms are currently registered as controlled substance
distributors. There may be some firms that import prescription
drug products that are not now registered to import either
controlled substances or List I chemicals. DEA estimates that
approximately 200 firms may have to obtain a new DEA
registration. As noted above, the only cost imposed by the rule
is the registration fee of $2,293 for the registration of each
manufacturing location, and $1,147 for each importing location.
The total cost of these rule changes will be less than $500,000.
The cost to individual firms is relatively small, compared with
their revenues. The benefit of the rule is that it will make it
possible for DEA to meet the statutory mandate to assess the
annual need for the chemicals accurately and provide
manufacturers with the quotas they need to continue to produce
drug products containing the three chemicals. As DEA discussed
throughout this rulemaking, the Controlled Substances Act
provides that quotas may only be issued to registrants. Were DEA
not to issue this rule, it would have no mechanism to permit the
registration of persons handling prescription drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine.
If these persons were not permitted to register, there would be
no mechanism by which they would be permitted to apply for
production or import quotas. Therefore, these persons would have
no means by which to acquire the List I chemicals ephedrine,
pseudoephedrine, or phenylpropanolamine necessary for them to
conduct business.
Paperwork Reduction Act
This Notice of Proposed Rulemaking would require that certain
persons who were not previously registered with DEA obtain a
registration to handle the List I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine. Specifically, persons
manufacturing prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine were not previously
required to register, but now would be required to obtain a
registration so that they may be eligible to apply for
individual quotas for these List I chemicals. Additionally,
importers of prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine who were not previously
registered as List I chemical importers would be required to
register so that they may be eligible to apply for import quotas
for ephedrine, pseudoephedrine, and phenylpropanolamine. DEA
estimates that approximately 200 firms may have to obtain a new
DEA registration. DEA assumes that these firms complete the
registration application electronically, with each application
taking 15 minutes to complete. The receipt of these additional
applications increases the hour burden by 50 hours annually.
Therefore, DEA is proposing to revise an existing approved
information collection, "Application for Registration under
Domestic Chemical Diversion Control Act of 1993 and Renewal
Application for Registration Under Domestic Chemical Diversion
Control Act of 1993'' (OMB 1117-0031), to reflect the increase
in population associated with this rule.
Further, DEA is proposing to amend the forms associated with
the existing approved information collection "Application for
Registration (DEA Form 225) and Application for Registration
Renewal (DEA Form 225a)'' (OMB 1117-0012) to include a listing
of all List I chemicals on the application forms. Currently,
controlled substances registrant applicants, who use these forms
to apply for DEA registration, are not required to identify the
List I chemicals they handle. Without this identification, it is
not possible for these persons to apply for individual quotas
for these chemicals. The addition of the List I chemicals will
allow persons to identify which chemicals they handle. New
applicants would be required to identify the List I chemicals
they handle upon their initial application; persons renewing
their registration will identify the chemicals at the time of
their renewal. This information must merely be verified for each
succeeding renewal. Thus, the addition of this list will not
have a measurable effect on the time needed to complete the
application. Therefore, DEA is not proposing to revise the
collection itself, but rather is proposing to make changes only
to the application forms themselves.
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.
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 information collection-related aspects
of this rule are encouraged. Your comments 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,
[[Page 3439]]
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 Information Collection 1117-0031
(1) Type of information collection: Revision of an
existing collection.
(2) Title of form/collection: Application for
Registration under Domestic Chemical Diversion Control Act of
1993 and Renewal Application for Registration Under Domestic
Chemical Diversion Control Act of 1993.
(3) Agency form number, if any, and the applicable
component of the Department of Justice sponsoring the collection:
Form Number: DEA Forms 510 and 510a. 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: Not-for-profit, government agencies.
Abstract: The Domestic Chemical Diversion Control Act requires
that manufacturers, distributors, importers, and exporters of
List I chemicals which may be diverted in the United States for
the production of illicit drugs must register with DEA.
Registration provides a system to aid in the tracking of the
distribution of List I chemicals.
(5) An estimate of the total number of respondents and the
amount of time estimated for an average respondent to respond:
DEA estimates that 2,776 persons respond to this collection
annually. DEA estimates that it takes 30 minutes for an average
respondent to respond when completing the application on paper,
and 15 minutes for an average respondent to respond when
completing an application electronically. This application is
submitted annually.
(6) An estimate of the total public burden (in hours)
associated with the collection: DEA estimates that this
collection has a public burden of 927 hours annually.
Form
|
Number of respondents
|
Total burden hours
|
DEA-510 (paper)
|
286
|
143
|
DEA-510 (electronic)
|
478
|
119.5
|
DEA-510a (paper)
|
644
|
322
|
DEA-510a (electronic)
|
1,368
|
342
|
Total
|
2,776
|
926.5
|
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 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 1309
Administrative practice and procedure; Drug traffic control;
Exports; Imports; Security measures.
For the reasons set out above, 21 CFR part 1309 is proposed
to be amended as follows:
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS,
IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1. The authority citation for part 1309 continues to read
as follows:
Authority: 21
U.S.C. 821, 822, 823, 824, 830, 871(b), 875,
877, 886a, 958.
2. Section 1309.11 is revised to read as follows:
Sec. 1309.11 Fee amounts.
(a) For each application for registration or reregistration
to manufacture the applicant shall pay an annual fee of
$2,293.
(b) For each application for registration or reregistration
to distribute, import, or export a List I chemical, the
applicant shall pay an annual fee of $1,147.
3. Section 1309.12 is revised to read as follows:
Sec. 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration
to manufacture, distribute, import, or export, the applicant
shall pay the fee when the application for registration or
reregistration is submitted for filing.
(b) Payments should be made in the form of a credit card; a
personal, certified, or cashier's check; or a money order made
payable to "Drug Enforcement Administration.'' Payments made
in the form of stamps, foreign currency, or third party
endorsed checks will not be accepted. These application fees
are not refundable.
4. Section 1309.21 is revised to read as follows:
Sec. 1309.21 Persons required to register.
(a) Unless exempted by law or under Sec. Sec. 1309.24
through 1309.26, the following persons must annually obtain a
registration specific to the List I chemicals to be handled:
(1) Every person who manufactures or imports or proposes to
manufacture or import a List I chemical or a drug product
containing ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Every person who distributes or exports or proposes to
distribute or export any List I chemical, other than those
List I chemicals contained in a product exempted under Sec.
1300.02(b)(28)(i)(D) of this chapter.
(b) Only persons actually engaged in the activities are
required to obtain a
[[Page 3440]]
registration; related or affiliated persons who are not
engaged in the activities are not required to be registered.
(For example, a stockholder or parent corporation of a
corporation distributing List I chemicals is not required to
obtain a registration.)
(c) The registration requirements are summarized in the
following table:
Summary of Registration Requirements and Limitations
Business activity
|
Chemicals
|
DEA forms
|
Application fee
|
Registration period (years)
|
Coincident activities allowed
|
Manufacturing |
List I, Drug Products containing ephedrine,
pseudoephedrine, phenylpropanolamine.
|
New--510
Renewal--510a
|
$2,293
2,293
|
1
|
May distribute that
chemical for which registration was issued; may not distribute any chemical
for which not registered. |
Distributing
|
List I, Scheduled listed chemical
products.
|
New--510
Renewal--510a
|
1,147
1,147 |
1 |
|
Importing
|
List I, Drug Products containing ephedrine,
pseudoephedrine, phenylpropanolamine |
New--510
Renewal--510a
|
1,147
1,147
|
1
|
May distribute that chemical for which registration was issued; may not distribute
any chemical for which not registered. |
Exporting
|
List I,
Scheduled listed chemical products.
|
New--510
Renewal--510a
|
1,147
1,147
|
1
|
|
5. Section 1309.22
is revised to read as follows:
Sec. 1309.22 Separate registration for independent
activities.
(a) The following groups of activities are deemed to be
independent of each other:
(1) Manufacturing of List I chemicals or drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Distributing of List I chemicals and scheduled listed
chemical products.
(3) Importing List I chemicals or drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine.
(4) Exporting List I chemicals and scheduled listed
chemical products.
(b) Except as provided in paragraphs (c) and (d) of this
section, every person who engages in more than one group of
independent activities must obtain a separate registration for
each group of activities, unless otherwise exempted by the Act
or Sec. Sec. 1309.24 through
1309.26.
(c) A person registered to import any List I chemical shall
be authorized to distribute that List I chemical after
importation, but no other chemical that the person is not
registered to import.
(d) A person registered to manufacture any List I chemical
shall be authorized to distribute that List I chemical after
manufacture, but no other chemical that the person is not
registered to manufacture.
6. In Sec. 1309.23 paragraph (a) is revised to read as
follows:
Sec. 1309.23 Separate registration for separate locations.
(a) A separate registration is required for each principal
place of business at one general physical location where List
I chemicals are manufactured, distributed, imported, or
exported by a person.
* * * * *
7. Section 1309.24 is revised to read as follows:
Sec. 1309.24 Waiver of registration requirement for
certain activities.
(a) The requirement of registration is waived for any agent
or employee of a person who is registered to engage in any
group of independent activities, if the agent or employee is
acting in the usual course of his or her business or
employment.
(b) The requirement of registration is waived for any
person who manufactures or distributes a scheduled listed
chemical product or other product containing a List I chemical
that is described and included in the definition of "regulated transaction'' in
Sec.
1300.02(b)(28)(i)(D), if
that person is registered with the Administration to engage in
the same activity with a controlled substance.
(c) The requirement of registration is waived for any
person who imports or exports a scheduled listed chemical
product or other product containing a List I chemical that is
described and included in the definition of "regulated
transaction'' in Sec. 1300.02(b)(28)(i)(D), if that person is
registered with the Administration to engage in the same
activity with a controlled substance.
(d) The requirement of registration is waived for any
person who only distributes a prescription drug product
containing a List I chemical that is regulated pursuant to
Sec. 1300.02(b)(28)(i)(D) of this chapter.
(e) The requirement of registration is waived for any
person whose activities with respect to List I chemicals are
limited to the distribution of red phosphorus, white
phosphorus, or hypophosphorous acid (and its salts) to:
another location operated by the same firm solely for internal
end-use; or an EPA or State licensed waste treatment or
disposal firm for the purpose of waste disposal.
(f) The requirement of registration is waived for any
person whose distribution of red phosphorus or white
phosphorus is limited solely to residual quantities of
chemical returned to the producer, in reusable rail cars and
intermodal tank containers which conform to International
Standards Organization specifications (with capacities greater
than or equal to 2,500 gallons in a single container).
(g) The requirement of registration is waived for any
person whose activities with respect to List I chemicals are
limited solely to the distribution of Lugol's Solution
(consisting of 5 percent iodine and 10 percent potassium
iodide in an aqueous solution) in original manufacturer's
packaging of one fluid ounce (30 ml) or less.
(h) The requirement of registration is waived for any
manufacturer of a List I chemical, if that chemical is
produced solely for internal consumption by the manufacturer
and there is no subsequent distribution or exportation of the
List I chemical.
(i) If any person exempted under paragraph (b), (c), (d),
(e), or (f) of this section also engages in the distribution,
importation, or exportation of a List I chemical, other than
as described in such paragraph, the person shall obtain a
registration for the activities, as required by Sec. 1309.21
of this part.
[[Page 3441]]
(j) The Administrator may, upon finding that continuation
of the waiver would not be in the public interest, suspend or
revoke a waiver granted under paragraph (b), (c), (d), (e), or
(f) of this section pursuant to the procedures set forth in
Sec. Sec. 1309.43 through 1309.46 and Sec. Sec. 1309.51
through 1309.55 of this part. In considering the revocation or
suspension of a person's waiver granted pursuant to paragraph
(b) or (c) of this section, the Administrator shall also
consider whether action to revoke or suspend the person's
controlled substance registration pursuant to 21
U.S.C. 824 is
warranted.
(k) Any person exempted from the registration requirement
under this section must comply with the security requirements
set forth in Sec. Sec. 1309.71 through 1309.73 of this part
and the recordkeeping and reporting requirements set forth
under parts 1310 and
1313 of this chapter.
8. Section 1309.25 is amended by adding a new paragraph (c)
to read as follows:
Sec. 1309.25 Temporary exemption from registration for
chemical registration applicants.
* * * * *
(c) Each person required by section 302 of the Act (21
U.S.C. 822) to obtain a registration to manufacture or import
prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine is temporarily
exempted from the registration requirement, provided that the
person submits a proper application for registration on or
before [DATE 30 DAYS AFTER PUBLICATION OF A FINAL RULE IN THE
Federal Register]. The exemption will remain in effect for
each person who has made such application until DEA has
approved or denied the application. This exemption applies
only to registration; all other chemical control requirements
set forth in this part and parts
1310, 1313, and
1315 of this
chapter remain in full force and effect.
Dated: January 11, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion
Control.
[FR Doc. E8-774 Filed 1-17-08; 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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