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Title VII of Public Law
109-177 > The Combat Meth Act of 2005 - Questions & Answers
Procedures for Establishment of Individual
Import, Manufacturing, and Procurement Quotas
Assessment of Annual Needs
Questions and Answers
[as of 07/10/2007]
Introduction
Q. What is the Combat Methamphetamine
Epidemic Act of 2005?
A. The Combat Methamphetamine Epidemic Act of 2005 (CMEA)
was signed into law on March 9, 2006, to regulate, among other
things, retail over-the-counter sales of ephedrine,
pseudoephedrine, and phenylpropanolamine products. Retail
provisions of the CMEA include daily sales limits and 30-day
purchase limits, placement of product out of direct customer
access, sales logbooks, customer ID verification, employee
training, and self-certification of regulated sellers. The
CMEA is found as Title VII of the USA PATRIOT Improvement and
Reauthorization Act of 2005 (Public Law 109-177).
Q. Why was the CMEA passed?
A. Ephedrine, pseudoephedrine, and phenylpropanolamine are
precursor chemicals used in the illicit manufacture of
methamphetamine or amphetamine. They are also common
ingredients used to make cough, cold, and allergy products.
Methamphetamine laboratories have been found in homes, cars,
hotel rooms, storage facilities – these are generally
referred to as "clandestine labs". Passage of the
CMEA was accomplished to curtail the illicit production of
methamphetamine. States that have enacted similar or more
restrictive retail regulations have seen a dramatic drop in
small clandestine labs.
Methamphetamine
Q. What is methamphetamine?
A. Methamphetamine, which is chemically related to
amphetamine, is a powerfully addictive drug that severely
affects users’ minds and bodies, ruins lives, and endangers
communities and the environment. Chronic use can lead to
extremely violent behavior, the neglect of the user’s
children, and an inability to cope with the ordinary demands
of life. Unfortunately, methamphetamine, unlike other highly
abused controlled substances such as cocaine and heroin, can
be easily manufactured with common household agents. The
manufacturing process, however, is dangerous, and those
engaging in the process run the risk of chemical explosions
and exposing their families and communities to toxic
chemicals.
Q. Are methamphetamine production and abuse a nationwide
problem?
A. Methamphetamine or "meth" has become a
tremendous challenge for the entire nation. At least one
clandestine methamphetamine laboratory has been found in every
state over the past five years. A July 18, 2006, National
Association of Counties Survey found that meth is the leading
drug-related local law enforcement problem in the country. The
survey of 500 county law enforcement officials in 44 states
found that meth continues to be the number one drug problem
– 48% of the counties report that meth is the primary drug
problem – more than cocaine (22%), marijuana (22%) and
heroin (3%) combined. In addition, according to the survey,
crimes related to meth continue to grow – 55% of law
enforcement officials report an increase in robberies or
burglaries in the last year and 48% report an increase in
domestic violence.
Q. Does methamphetamine production have an impact on the
environment?
A. Clandestine methamphetamine laboratories pose a
significant danger in the community, as they contain highly
flammable and explosive materials. Additionally, for each
pound of methamphetamine produced, five to seven pounds of
toxic waste remain, which is often introduced into the
environment via streams, septic systems, and surface water
run-off.
CMEA Requirements
regarding the Importation and Manufacture of Ephedrine,
Pseudoephedrine, and Phenylpropanolamine
Q. What requirements does the Combat Methamphetamine Epidemic
Act (CMEA) establish for quotas for the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine?
A. The CMEA mandates that DEA establish total annual
requirements for these chemicals for the United States, and
provide individual import, manufacturing and procurement
quotas to DEA-registered importers and manufacturers that wish
to conduct import and manufacturing activities with these
chemicals.
The CMEA places additional regulatory controls upon the
manufacture, retail sale, importation and exportation of the
three List I chemicals. Specifically, CMEA amended the
Controlled Substances Act (CSA) by adding ephedrine,
pseudoephedrine, and phenylpropanolamine to 21
U.S.C. § 826. Section 826 requires DEA to establish total
annual needs for each of the three chemicals and to limit
manufacturing of these chemicals to the amount needed to
provide for the estimated medical, scientific, research, and
industrial needs of the United States, for lawful export
purposes, and for the maintenance of reserve stocks, as are
also applied to schedule I and II controlled substances. CMEA
also added ephedrine, pseudoephedrine, and phenylpropanolamine
to 21 U.S.C.
§ 952, to stipulate that importation of these three
chemicals is prohibited except for that amount which the
Attorney General (DEA by delegation) finds to be necessary for
medical, scientific, or other legitimate purposes.
Q. How is DEA implementing these requirements?
A. To implement these new requirements, DEA is establishing
the assessment of annual needs (AAN) for ephedrine,
pseudoephedrine and phenylpropanolamine.
DEA has promulgated new regulations establishing the
procedures by which the assessment of annual needs, as well as
individual import, manufacturing, and procurement quotas, will
be administered.
Q. To whom do these requirements apply?
A. The establishment of procedures for the administration
of import, manufacturing, and procurement quotas, as well as
the assessment of annual needs, will be of interest to persons
importing the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine or products containing those List I
chemicals. It will also be of interest to persons
manufacturing the List I chemicals ephedrine, pseudoephedrine,
or phenylpropanolamine, and products containing those List I
chemicals. The term "manufacture" is defined in the
CSA as "the production, preparation, propagation,
compounding, or processing of a drug or other substance, …
and includes any packaging or repackaging of such substance or
labeling or relabeling of its container; except that such term
does not include the preparation, compounding, packaging, or
labeling of a drug or other substance in conformity with
applicable State or local law by a practitioner as an incident
to his administration or dispensing of such drug or substance
in the course of his professional practice." [21
U.S.C. 802(15)]
Q. To whom do these requirements not apply?
A. The requirements regarding establishment of procedures
for the administration of import, manufacturing, and
procurement quotas, as well as the assessment of annual needs,
do not apply to exporters, distributors, regulated sellers,
and mail order distributors.
Assessment and
Establishment of Annual Needs
Q. What is the assessment of annual needs?
A. The assessment of annual needs (AAN) represents the
total quantity of ephedrine, pseudoephedrine, and
phenylpropanolamine determined to be necessary to be
manufactured and imported during the 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.
The proposed AAN was published on October 19, 2006 in the
Federal Register. Interested parties had the opportunity to
provide public comments on the proposed AAN. The comment
period closed December 4, 2006. After considering all comments
received, DEA will publish the established AAN for 2007. The
AAN will be revised at least once during the calendar year to
which it applies.
Q. How did DEA assess the annual needs?
A. Since the manufacture and importation of ephedrine,
pseudoephedrine, and phenylpropanolamine have not been
previously regulated through the establishment of an
assessment of annual needs, DEA received assistance from a
private independent contractor, IMS Health (IMS) in assessing
the medical needs of the United States for ephedrine and
pseudoephedrine. IMS’ methodology and initial estimates used
in the proposed assessment (IMS Report) were based on making
three independent measures derived from 2005 data. After each
of the three independent measures was calculated for ephedrine
and pseudoephedrine, IMS then took a weighted average of the
three individual estimates in order to derive its initial
estimate which DEA then considered.
The
IMS Report is part of the public docket for the Assessment of
Annual Needs Federal Register notice.
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. Therefore, for purposes of
calculating the medical needs of the United States for
phenylpropanolamine, DEA considered the drug’s use in
veterinary products only. DEA contacted the Food and Drug
Administration to identify those companies that sold
veterinary products containing phenylpropanolamine and then
contacted each company to obtain information relating to sales
of their phenylpropanolamine-containing products.
For the proposed 2007 assessment of annual needs, after DEA
considered the medical needs for ephedrine, pseudoephedrine
and phenylpropanolamine (veterinary products), it then
considered: 1) industrial needs of the United States, 2)
lawful export requirements, and 3) maintenance of reserve
stocks to determine the assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine.
For the proposed 2007 assessment of annual needs, in
consideration of the industrial needs of the United States for
these three chemicals, DEA considered the use of ephedrine for
the domestic manufacture of pseudoephedrine in 2005 and the
amount of phenylpropanolamine used for the domestic
manufacture of amphetamine in 2005.
For the proposed 2007 assessment of annual needs, in
consideration of the requirements for lawful export purposes
for these three chemicals, DEA considered all 2005 exports of
these chemicals, as provided by DEA-registered exporters on
the DEA Form 486 "Import/Export Declaration – Precursor
and Essential Chemicals."
For the proposed 2007 assessment of annual needs, DEA
considered additional requirements for the maintenance of
reserve stock requirements.
Q. How is the assessment of annual needs established?
A. DEA published its proposed assessment of annual needs
for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine on October
19, 2006 (71 FR 61801). DEA sought comments regarding this
proposal. The comment period closed December 4, 2006. After
consideration of all comments received, DEA will publish the
initial established assessment of annual needs in the Federal
Register. Thereafter, DEA will revise this assessment at least
once during the calendar year.
Q. Can DEA provide individual import, manufacturing and
procurement quotas to DEA-registered importers and manufacturers
prior to finalizing the assessment of annual needs?
A. The assessment of annual needs for ephedrine,
pseudoephedrine and phenylpropanolamine must be finalized
prior to DEA issuing individual import, manufacturing and
procurement quotas.
Q. Will DEA issue individual import, manufacturing and
procurement quotas to DEA-registered importers and manufacturers
when the 2007 assessment of annual needs is finalized?
A. DEA will not issue individual import, manufacturing and
procurement quotas to DEA-registered importers and
manufacturers of ephedrine, pseudoephedrine,
phenylpropanolamine, and the products derived therefrom, in
2007 after finalizing the 2007 assessment of annual needs.
Rather, DEA will use this finalized assessment as the basis
for proposing the establishment of the 2008 assessment of
annual needs. DEA will seek comment on this proposed
assessment and, as quotas are issued for a calendar year, will
issue quotas for calendar year 2008.
However, DEA is requesting applications for individual
quotas for the 2008 calendar year. Since the April 1 and May
1, 2007 deadline for 2008 import, manufacturing and
procurement quotas has passed, DEA-registered importers and
manufacturers of these chemicals, and drug products containing
these chemicals, should submit applications as soon as
possible so that individual quota applications may be
processed prior to January 1, 2008.
Import quotas:
Q. What is an import quota?
A. An individual import quota represents the maximum amount
of ephedrine, pseudoephedrine, and phenylpropanolamine that a
DEA-registered importer is authorized to import in a calendar
year.
Q. Who must apply for an import quota?
A. Any person who imports ephedrine, pseudoephedrine or
phenylpropanolamine, whether in bulk, in-process, or final
dosage forms must apply for an individual import quota.
Q. The requirement of registration is waived for any person
who imports a product containing a List I chemical that is
regulated pursuant to 21
CFR 1300.02(b)(28)(i)(D), if that person is registered with
the Administration to engage in the same activity with a
controlled substance (21
CFR 1309.24(c)). Does a person whose requirement of
registration has been waived pursuant to 21 CFR 1309.24(c) need
to obtain a registration before applying for an import quota?
A. A separate import registration is not required so long
as the registrant conducts the same activity with the listed
chemical as is conducted with the controlled substance—that
is, importation. DEA-registered importers of controlled
substances whose registrations can be utilized to import
listed chemicals pursuant to 21 CFR 1309.24(c) must identify
the List I chemicals they handle as part of their controlled
substances registration. Importers meeting this requirement
should contact their local DEA office to request the addition
to the controlled substances importer registration of the
chemical codes for the chemicals handled. List I chemicals,
and their chemical code numbers, are found at 21
CFR 1310.02.
Q. Does an importer need an import quota for 2007?
A. DEA is soliciting applications for 2008 import quotas at
this time; a DEA-registered importer does not need to obtain
an import quota in 2007 prior to importing ephedrine,
pseudoephedrine or phenylpropanolamine during the remainder of
the 2007 calendar year.
Q. How does a DEA-registered importer apply for an import
quota?
A. Each DEA-registered importer that wishes to import
ephedrine, pseudoephedrine, phenylpropanolamine, or the
products derived therefrom, must complete and file a DEA Form
488 each year for each chemical the importer wishes to import.
Individual applications are required for importing either
"bulk" chemical or finished dosage forms. The
importer must provide on each application the following
information:
- The type of product (bulk chemical or finished forms to
be transferred to a manufacturer or product to be sold for
distribution);
- The quantity of each type of product; and
- For the previous two years:
- the name, address and DEA registration number (if
applicable) of each customer and the amount sold;
- inventory as of December 31 for each form of the
product (i.e., bulk chemical, in-process material, or
finished dosage form); and
- acquisitions (imports)
Q. Is an importer required to provide additional information
to DEA in connection with an import quota application?
A. Registrants are required to submit a completed Form 488,
Application for Import Quota for Ephedrine, Pseudoephedrine,
and Phenylpropanolamine, for DEA to process each individual
request. However, certain quota requests might require
additional information to be processed such as product
development requirements or unknown requirements necessary to
complete bona fide scientific research/clinical trials. DEA
has significant expertise regarding the processing of these
types of quota applications for manufacturers of controlled
substances in Schedules I and II and will work with quota
applicants to obtain information necessary to process these
types of quota requests.
Q. When are applications for 2008 import quotas due?
A. Applications for individual import quotas are due by
April 1 of the year preceding the year for which the quota is
being applied. Therefore, applications for 2008 import quotas
were due to DEA by April 1, 2007. Applicants that have not
filed 2008 applications should submit applications as soon as
possible so applications can be considered and individual
import quotas processed prior to January 1, 2008. Applications
should be sent to the following address:
DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152
Q. How long will it take DEA to process import quota
applications for 2008?
A. Initial 2008 import quotas will be issued in December
2007. Applications for adjustments to individual 2008 import
quotas which are received during the 2008 calendar year must
be approved or denied within 60 days of receiving a completed
request for such adjustment, otherwise the request is deemed
approved (21
CFR 1315.36).
Q. Is an importer required to obtain an import quota prior to
submitting a DEA-486, Import/Export Declaration for List I and
List II Chemicals?
A. Effective January 1, 2008, DEA-registered importers must
have an import quota issued by DEA prior to submitting a
DEA-486 to DEA for the importation of ephedrine,
pseudoephedrine, phenylpropanolamine or the products derived
therefrom.
Q. Is an importer permitted to request an increase in its
import quota during the calendar year?
A. Applications for adjustments to an individual import
quota which are received during the calendar year must be
denied by DEA within 60 days of receiving a completed request
for such adjustment, otherwise the request is deemed approved
(21 CFR 1315.36).
Q. If an importer returns a product to its overseas supplier,
will the importer receive a credit for its import quota?
A. The importer will not receive a credit for its import
quota. However, a return to an overseas supplier could form
the basis for a request to adjust (increase) an individual
import quota. Requests for adjustments may be made at anytime
during the year.
Q. Will unused portions of an importer’s 2008 quota carry
over into 2009?
A. Import quotas are issued on a calendar year basis and
can only be used during the calendar year for which they were
issued. If a DEA-registered importer wishes to import
ephedrine, pseudoephedrine, phenylpropanolamine, or the
products derived therefrom in 2009, then the importer must
submit a DEA Form 488 by the April 1, 2008, deadline.
Q. If an importer submits a DEA-486 for an import of
ephedrine, pseudoephedrine, or phenylpropanolamine which will be
in transit to the United Sates as of January 1, 2008, is the
importer required to have a 2008 import quota to receive the
material even though the import declaration (DEA-486) was filed
in 2007?
A. The DEA importer registrant must have an individual
import quota on the date that the in-transit shipment arrives
in the United States, as noted in Section 4b of the registrant’s
DEA Form-486, "Import/Export Declaration for List I and
List II Chemicals" filed with the DEA pursuant to 21
CFR 1313.
Bulk Manufacturers:
Q. What is a manufacturing quota?
A. An individual manufacturing quota represents the maximum
amount of ephedrine, pseudoephedrine, and phenylpropanolamine
a DEA registrant is authorized to bulk manufacture in a
calendar year.
Q. Who must apply for a manufacturing quota?
A. Only DEA-registered bulk manufacturers will be eligible
to apply for individual manufacturing quotas. The term
"manufacture" is defined in the CSA as "the
production, preparation, propagation, compounding, or
processing of a drug or other substance, … and includes any
packaging or repackaging of such substance or labeling or
relabeling of its container; except that such term does not
include the preparation, compounding, packaging, or labeling
of a drug or other substance in conformity with applicable
State or local law by a practitioner as an incident to his
administration or dispensing of such drug or substance in the
course of his professional practice." [21
U.S.C. 802(15)]
Q. Does a manufacturer need a manufacturing quota for 2007?
A. DEA is soliciting applications for 2008 manufacturing
quotas at this time; a DEA-registered bulk manufacturer does
not need to obtain a manufacturing quota prior to bulk
manufacturing ephedrine, pseudoephedrine or
phenylpropanolamine during the remainder of the 2007 calendar
year.
Q. How does a DEA-registered bulk manufacturer apply for a
manufacturing quota?
A. Each DEA-registered bulk manufacturer, i.e., a
manufacturer that wishes to produce bulk ephedrine,
pseudoephedrine or phenylpropanolamine via extraction or
chemical synthesis, must complete and file a DEA Form 189 if
the manufacturer plans to bulk manufacture one of these
chemicals beginning January 1, 2008. The applicant must
provide the following information on its application:
- For the current and preceding two years:
- the actual quantity manufactured,
- actual net disposals, and
- actual inventory as of December 31 of each year; and
- For the year for which quota is being applied:
- the desired quota,
- the name and registration number of each customer
and the amount estimated to be sold to each, and
- any additional factors the applicant finds relevant
to fixing the quota.
Q. Is a bulk manufacturer required to provide additional
information to DEA in connection with the manufacturing quota
application?
A. Registrants are required to submit a completed Form 189
application in order for DEA to process each individual
request. However, certain quota requests might require
additional information to be processed such as product
development requirements or unknown requirements necessary to
complete scale-up batches for FDA requirements. DEA has
significant expertise regarding the processing of these types
of quota applications for manufacturers of controlled
substances in Schedules I and II and will work with quota
applicants to obtain information necessary to process these
types of quota requests.
Q. When are applications for 2008 manufacturing quotas due?
A. Applications for individual manufacturing quotas are due
by May 1 of the year preceding the year for which the quota is
being applied. Therefore, applications for 2008 manufacturing
quotas were due to the DEA by May 1, 2007. Applicants that
have not filed 2008 applications should submit applications as
soon as possible so applications can be considered and
individual manufacturing quotas processed prior to January 1,
2008. Applications should be sent to the following address:
DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152
Q. How long will it take DEA to process 2008 manufacturing
quota applications?
A. Initial 2008 manufacturing quotas will be issued in
December 2007. Applications for adjustments in an individual’s
2008 manufacturing quota which are received during the 2008
calendar year will be processed on a "first come, first
served" basis.
Q. Is a manufacturer permitted to request an increase in its
manufacturing quota during the calendar year?
A. Requests for adjustments in manufacturing quotas can be
made at any time so long as information supporting the need
for the increase is also provided.
Q. If a manufacturer receives a return from its customer and
then destroys that material, will the manufacturer automatically
receive a credit for its manufacturing quota?
A. The manufacturer will not receive a credit for its
manufacturing quota. However, a return from a manufacturer’s
customer could form the basis for a request to adjust
(increase) a DEA registrant’s individual manufacturing quota
if that material could not be salvaged or reworked into a
saleable product.
Q. Will unused portions of a manufacturer’s 2008
manufacturing quota carry over into 2009?
A. Manufacturing quotas are issued on a calendar year basis
and can only be used during the calendar year for which they
were issued. If a DEA-registered bulk manufacturer wishes to
bulk manufacture ephedrine, pseudoephedrine, or
phenylpropanolamine in 2009, then the manufacturer must submit
a DEA Form 189 by the May 1, 2008, deadline.
Q. Can a DEA-registered manufacturer bulk manufacture
ephedrine, pseudoephedrine, or phenylpropanolamine prior to
obtaining a manufacturing quota from DEA?
A. As of January 1, 2008, DEA-registered bulk manufacturers
of ephedrine, pseudoephedrine, and phenylpropanolamine must
obtain an individual manufacturing quota before bulk
manufacturing of the substance may commence.
Procurement Quota:
Q. What is a procurement quota?
A. An individual procurement quota represents the maximum
amount or quantity of ephedrine, pseudoephedrine, and
phenylpropanolamine that a DEA-registered manufacturer is
authorized to acquire or procure in a calendar year. A
procurement quota authorizes a DEA-registered manufacturer to
procure and use quantities of each chemical for the purpose of
manufacturing such chemical into dosage forms or into other
substances.
Q. Who must apply for a procurement quota?
A. Only DEA-registered manufacturers will be eligible to
apply for individual procurement quotas. The term
"manufacture" is defined in the CSA as "the
production, preparation, propagation, compounding, or
processing of a drug or other substance, … and includes any
packaging or repackaging of such substance or labeling or
relabeling of its container; except that such term does not
include the preparation, compounding, packaging, or labeling
of a drug or other substance in conformity with applicable
State or local law by a practitioner as an incident to his
administration or dispensing of such drug or substance in the
course of his professional practice." [21
U.S.C. 802(15)
Q. The requirement of registration is currently waived for
any person who distributes (e.g., manufactures to distribute) a
product containing a List I chemical that is regulated pursuant
to §1300.02(b)(28)(i)(D),
if that person is registered with DEA to manufacture, distribute
or dispense a controlled substance (21
CFR 1309.24(b)). Does a person whose requirement of
registration has been waived pursuant to 1309.24(b) need to
obtain a procurement quota?
A. A DEA-registered manufacturer of controlled substances
whose requirement of registration has been waived for the
manufacture of products containing ephedrine, pseudoephedrine
or phenylpropanolamine pursuant to 21 CFR 1309.24(b) must
obtain a manufacturing quota. However, a separate chemical
manufacturing registration is not required to apply for a
manufacturing quota. As quota may be issued only to DEA-registered
manufacturers, the person must be registered with DEA to
manufacture either controlled substances or List I chemicals.
Manufacturers meeting this requirement should contact their
local DEA office to request the addition to the controlled
substances manufacturer registration of the chemical codes for
the chemicals handled. List I chemicals, and their chemical
code numbers, are found at 21
CFR 1310.02.
Q. The requirement of registration is currently waived for
any person who distributes (e.g., manufactures to distribute) a
prescription drug product containing a List I chemical that is
regulated pursuant to §1300.02(b)(28)(i)(D) of this chapter (21
CFR 1309.24(d)). Does a person whose requirement of registration
has been waived need to register with DEA to manufacture with
ephedrine, pseudoephedrine, and phenylpropanolamine? Does such a
person need to obtain procurement quota to manufacture
prescription products containing ephedrine, pseudoephedrine, or
phenylpropanolamine?
A. A DEA-registered manufacturer of controlled substances
whose requirement of registration has been waived for the
manufacture of prescription drug products containing
ephedrine, pseudoephedrine or phenylpropanolamine, must obtain
a procurement quota. As quota may be issued only to DEA-registered
manufacturers, the person must be registered with DEA to
manufacture either controlled substances or List I chemicals.
These registrants must identify the chemicals they manufacture
as part of their controlled substances registration.
Manufacturers meeting this requirement should contact their
local DEA office to request the addition to the controlled
substances manufacturer registration of the chemical codes for
the chemicals handled. List I chemicals, and their chemical
code numbers, are found at 21 CFR 1310.02.
Q. 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
(21 CFR
1309.24(h). Does a person whose requirement of registration
is waived pursuant to 21 CFR 1309.24(h) need to obtain a
registration before applying for a procurement quota?
A. Ephedrine, pseudoephedrine, and phenylpropanolamine
which are to be used in manufacturing processes are obtained
only after the issuance of quota. As DEA may only provide
quota to registered manufacturers for the purposes of
manufacturing, those who procure ephedrine, pseudoephedrine
and phenylpropanolamine solely for internal consumption must
obtain a chemical manufacturing registration from DEA for this
purpose.
Q. 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
(21 CFR 1309.24(h). Is such a manufacturer permitted to continue
to procure ephedrine, pseudoephedrine, and phenylpropanolamine
until such time as the manufacturer obtains its registration
from DEA?
A. As of January 1, 2008, DEA-registered manufacturers as
well as those persons originally waived from the registration
requirements pursuant to 21 CFR 1309.24(h) must obtain an
individual procurement quota before procuring ephedrine,
pseudoephedrine, phenylpropanolamine, or the products derived
therefrom.
Q. Does a manufacturer need a procurement quota for 2007?
A. DEA is soliciting applications for 2008 procurement
quotas at this time; a DEA-registered manufacturer does not
need to obtain a procurement quota prior to manufacturing
dosage form ephedrine, pseudoephedrine or phenylpropanolamine,
or packaging, repackaging, labeling, or relabeling dosage form
ephedrine, pseudoephedrine, or phenylpropanolamine during the
remainder of the 2007 calendar year.
Q. How does a DEA-registered manufacturer apply for a
procurement quota?
A. Each DEA-registered manufacturer that wishes to procure
ephedrine, pseudoephedrine, phenylpropanolamine, or the
products derived therefrom, for the purpose of conducting
dosage form manufacturing, packaging, labeling, repackaging or
relabeling, must complete and file a DEA Form 250. The
applicant must provide the following information:
- A statement about the purpose(s) of the requested
chemical and the quantity which will be used for each
purpose during the next calendar year.
- For the current and preceding two years:
- the actual quantity manufactured,
- actual net disposals, and
- actual inventory as of December 31 of each year; and
- If the purpose is to manufacture dosage forms, the
applicant must state the official name, common or usual
name, chemical name, or brand name of that dosage form,
and must include the strength;
- The applicant must state the type of activity intended:
product development, repackaging, relabeling,
manufacturing scheduled listed chemical finished products,
manufacturing prescription finished product; and
- If the purpose is to manufacture a controlled substance
listed in Schedule I or II or another List I chemical, the
applicant must state the quantity of the other substance
or chemical that the applicant has applied to manufacture
under §
1303.22 and the quantity of the first chemical needed
to manufacture a specified unit of the second chemical.
Q. Is a manufacturer required to provide additional
information to DEA in connection with the 2008 procurement quota
application?
A. Registrants are required to submit a completed Form 250,
Application for Procurement Quota for a Basic Class of
Controlled Substance and for Ephedrine, Pseudoephedrine, and
Phenylpropanolamine, for DEA to process each individual
request. However, certain quota requests might require
additional information to be processed such as product
development requirements or unknown requirements necessary to
complete scale-up batches for FDA requirements. DEA has
significant expertise regarding the processing of these types
of quota applications for manufacturers of controlled
substances in Schedules I and II and will work with quota
applicants to obtain information necessary to process these
types of quota requests.
Q. When are applications for 2008 procurement quotas due?
A. Applications for individual procurement quotas are due
by April 1 of the year preceding the year for which the quota
is being applied. Therefore, applications for 2008 procurement
quotas were due to DEA by April 1, 2007. Applicants that have
not filed 2008 applications should submit applications as soon
as possible so applications can be considered and individual
procurement quotas processed prior to January 1, 2008.
Applications should be sent to the following address:
DEA Headquarters
Christine A. Sannerud, Ph.D., Chief
Drug & Chemical Evaluation Section (ODE)
8701 Morrissette Drive
Springfield, Virginia 22152
Q. How long will it take DEA to process 2008 procurement
quota applications?
A. Initial 2008 procurement quotas will be issued in
December 2007. Applications for adjustments in an individual’s
2008 procurement quota which are received during the 2008
calendar year will be processed on a "first come, first
served" basis.
Q. Is a manufacturer permitted to request an increase in its
procurement quota during the calendar year?
A. Requests for adjustments in procurement quotas can be
made at any time so long as information supporting the need
for the increase is also provided.
Q. If a manufacturer receives a return from its customer and
then destroys that material, will the manufacturer automatically
receive a credit for its procurement quota?
A. The manufacturer will not receive a credit for its
procurement quota. However, such a return could form the basis
for a request to adjust (increase) a DEA registrant’s
individual procurement quota.
Q. Will unused portions of a manufacturer’s 2008
procurement quota carry over into 2009?
A. Procurement quotas are issued on a calendar year basis
and can only be used to procure ephedrine, pseudoephedrine,
phenylpropanolamine, or the products derived therefrom during
the calendar year for which the quota was issued. If a DEA-registered
manufacturer wishes to procure ephedrine, pseudoephedrine,
phenylpropanolamine, or the products derived there from in
2009, then the DEA-registered manufacturer must submit a DEA
Form 250 by the April 1, 2008, deadline.
Q. Can a DEA-registered manufacturer continue to procure
(receive) ephedrine, pseudoephedrine, or phenylpropanolamine
prior to obtaining a procurement quota?
A. As of January 1, 2008, a DEA-registered manufacturer of
ephedrine, pseudoephedrine, phenylpropanolamine, and the
products derived therefrom, must obtain an individual
procurement quota before procuring any of these chemicals for
dosage form manufacturing, packaging, repackaging, labeling
and relabeling activities.
110806:041107:071007
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