[Federal Register Volume 59, Number 195 (Tuesday, October 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25070]
[[Page Unknown]]
[Federal Register: October 11, 1994]
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DEPARTMENT OF JUSTICE
21 CFR Parts 1310 and 1313
Elimination of Threshold for Ephedrine
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: This final rule is issued by the Deputy Administrator of the
Drug Enforcement Administration (DEA) to eliminate the threshold for
ephedrine under provisions of the Controlled Substances Act (CSA) as
amended by the Chemical Diversion and Trafficking Act of 1988 (CDTA)
and the Domestic Chemical Diversion Control Act of 1993 (DCDCA) in
order to reduce the diversion of ephedrine to clandestine laboratory
operators. This will subject all transactions involving bulk ephedrine
and single entity ephedrine drug products to the applicable provisions
of the Controlled Substances Act (CSA).
EFFECTIVE DATE: November 10, 1994.
FOR FURTHER INFORMATION CONTACT: Howard McClain Jr., Chief, Drug and
Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537 Telephone (202) 307-
7183.
SUPPLEMENTARY INFORMATION: On March 17, 1994, the Acting Administrator
of the DEA published a proposed rule in the Federal Register (59 FR
12562) to eliminate the threshold for ephedrine under provisions of the
Controlled Substances Act (CSA) as amended by the Chemical Diversion
and Trafficking Act of 1988 (CDTA) and the Domestic Chemical Diversion
Control Act of 1993 (DCDCA). Interested parties had until May 2, 1994
to submit comments and objections.
Ephedrine is the primary precursor utilized in the clandestine
synthesis of methamphetamine and methcathinone, both potent central
nervous system (CNS) stimulants controlled under the CSA. The public
health risks from the abuse of these drugs are well known and
documented.
Ephedrine is a listed chemical under the Chemical Diversion and
Trafficking Act of 1988 (CDTA) (Pub. L. 100-690). Under provisions of
the CDTA (21 U.S.C. 802 (39)(A)), thresholds were originally assigned
to each listed chemical. The CDTA imposes reporting, recordkeeping and
notification requirements for regulated transactions which meet or
exceed these threshold amounts of a listed chemical.
The Domestic Chemical Diversion Control Act (DCDCA) of 1993 (Pub.
L. 103-200) became effective on April 16, 1994. This Act amends the CSA
via modification of 21 U.S.C. 802 (39)(A) by redefining the term
``regulated transaction'' as a ``distribution, receipt, sale,
importation, or exportation, or an international transaction involving
shipment of a listed chemical, or if the Attorney General establishes a
threshold amount for a specific listed chemical, a threshold amount,
including a cumulative threshold amount for multiple transactions'' of
a listed chemical. All regulated transactions in a listed chemical,
regardless of size, are subject to CSA reporting, recordkeeping and
notification requirements if no threshold is established.
In addition, the DCDCA further modifies the definition of a
``regulated transaction'' by removing the exemption for those
transactions involving products which are marketed or distributed
lawfully in the U.S. under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), if these products contain ephedrine (or its salts,
optical isomers, or salts of optical isomers) as the only active
medicinal ingredient or contain ephedrine (or its salts, optical
isomers, or salts of optical isomers) in combination with
therapeutically insignificant quantities of another active medicinal
ingredient (21 U.S.C. 802 (39)(A)(iv)). The DCDCA also provides that
the Attorney General shall by regulation remove this exemption for drug
products that the Attorney General finds are being diverted in order to
obtain a listed chemical for use in the illicit production of a
controlled substance.
The threshold for ephedrine was originally established as 1.0
kilogram for domestic, import and export transactions (54 FR 31657).
The threshold of 1.0 kilogram of ephedrine base is equivalent to
greater than 48,000 ephedrine 25 mg dosage units.
Thresholds are continuously reviewed by DEA to determine if they
are satisfactory to prevent diversion. Current evidence shows that the
threshold for ephedrine of 1.0 kilogram is not adequate to prevent the
diversion of ephedrine to clandestine laboratory operators in the
United States. Clandestine laboratory operators are obtaining ephedrine
in quantities much less than the current 1.0 kilogram threshold for use
in the illicit production of methamphetamine and methcathinone. DEA had
determined that in order to ensure the maximum effectiveness of the CSA
in curtailing the diversion of ephedrine, there should be no threshold
for ephedrine. Subsequently, all regulated transactions of ephedrine
would be subject to reporting, recordkeeping and notification
requirements of the CSA regardless of size.
Comments
Seven comments were received in response to the March 17, 1994,
Notice of proposed rulemaking. Some comments pertained to provisions of
the DCDCA which are not related to the ephedrine threshold. These
comments will not be addressed in this Federal Register Notice, but DEA
will consider them in preparing the Notice of Proposed Rulemaking
pertaining to the DCDCA. A summary of relevant comments received is
provided below:
A comment submitted by the National Wholesale Druggist Association
(NWDA) did not raise any objections to the elimination of the ephedrine
threshold. NWDA, however, raised the issue that the March 17, 1994,
Notice of Proposed Rulemaking does not change the definition of
``regulated transaction'' in Section 1310.01 (f) to be consistent with
the DCDCA. This will be remedied when the DEA publishes proposed
regulations which implement the DCDCA in the near future.
A comment was also received from the National Association of Boards
of Pharmacy (NABP). The NABP strongly supports the elimination of the
ephedrine threshold. Furthermore, the NABP expresses its support for
the more restrictive actions taken by certain state authorities whereby
single entity ephedrine products have been placed in controlled
substance schedules or placed on prescription-only status. The NABP
also states that a nationwide Federal effort is needed to better
monitor the distribution of single entity ephedrine products.
A comment was submitted on behalf of BDI Pharmaceuticals and raised
the following issues:
BDI's comment states that the elimination of the threshold is
prohibitory and will remove single entity ephedrine products from
retail stores. However, the elimination of the threshold only imposes
recordkeeping, reporting and notification requirements and will not
remove products from the market. BDI states that the increased
recordkeeping burden from the elimination of the threshold will
decrease the number of retail stores willing to sell ephedrine
products. BDI states that 21 CFR 1310.06(d) estimates that it will take
approximately ten minutes to fulfill the recordkeeping requirements for
each sale. BDI further states that this is an excessive burden which
will be a major factor in a merchant's decision to drop the product.
However, 21 CFR 1310.06(d) does not provide an estimate of the time
required to keep sales records of each regulated chemical transaction
and it is estimated that creating and storing a transaction record
requires an average of only one minute per record. Conversely, 21 CFR
1310.06(d) pertains to the amount of time needed for the filing of
reports of suspicious transactions, unusual losses or domestic
regulated transactions in a tableting or encapsulating machine as
outlined in 21 CFR 1310.05. These situations, whereby reports should be
filed, occur infrequently.
BDI's comment makes the point that asthma is a serious condition
and elimination of the threshold for ephedrine will have an adverse
impact upon asthma patients because the single entity product will
become unavailable. DEA recognizes that asthma is a serious condition
for which ephedrine has an approved treatment indication. DEA, in an
effort to ensure that the elimination of the ephedrine threshold would
not adversely effect the availability of medications for the treatment
of patients suffering from this condition, has circulated the March 17,
1994, Notice of Proposed Rulemaking to the U.S. Food and Drug
Administration (FDA). Within FDA, this Notice of Proposed Rulemaking
was circulated to several offices for review and consideration. DEA has
received an official response that FDA supports the proposed threshold
elimination in order to address the misuse, diversion and trafficking
associated with single entity ephedrine products. In addition, FDA's
formal response also states that FDA believes that there may be other
ephedrine products that may also need to be considered for regulation
under the CSA as amended by the CDTA and DCDCA.
The comment received from the National Association of Boards of
Pharmacy (NABP) which strongly supports the elimination of the
ephedrine threshold also states that ``NABP agrees that adoption of the
proposed rule should have no significant impact on pharmacies,
hospitals, or points of distribution that distribute medications
containing ephedrine for the treatment of asthma and other
conditions.'' The NABP comment also notes that other products are also
available for the treatment of asthma.
BDI's comment claims that DEA is biased against single entity
ephedrine products while many advertised combination products are not
considered safe and effective. On the contrary, DEA is not supporting
the use of one product over another for the treatment of asthma or any
other medical condition. It is not DEA's mandate to make such
determinations. It is, however, DEA's responsibility to prevent the
diversion of chemicals for the illicit production of controlled
substances. The DCDCA removes the exemption for single entity ephedrine
products. However, it is important to note that the DCDCA also provides
for the removal of an exemption for any drug or group of drugs that are
being diverted to obtain the listed chemical for use in the illicit
production of a controlled substance. Under such provisions,
combination products used in the illicit production of controlled
substances can lose their exemptions and thus be subjected to
recordkeeping, reporting, notification and registration requirements.
DEA plans to closely monitor such activity, and is prepared to pursue
the removal of exemptions for those products.
BDI's comment implies that the high retail cost of its product line
prevents these products from being a cost effective source of ephedrine
for clandestine laboratory use. Depending upon the package size, BDI
reports that 48,000 ephedrine 25 mg tablets would cost $3,000 to $9,000
at a retail outlet. In contrast, however, based on data available to
DEA regarding the national range of street prices for methamphetamine
in 1993, these products are a cost effective source of ephedrine for
clandestine laboratory use.
BDI's comment states that the comment period should be extended.
However, BDI's request for extension was denied by the Administrator on
the grounds that sufficient information was included in the March 17,
1994, Notice of Proposed Rulemaking and ample time given for comments
to be submitted.
BDI's comment states that the likely source of ephedrine at
clandestine laboratories is bulk ephedrine from Canada. This is not
substantiated by DEA information. Ephedrine tablets have been seized at
many clandestine laboratories. It is important to note, however, that
DEA has emphasized that smuggling from Mexico is also an important
source of ephedrine for clandestine laboratory usage.
BDI's comment states that Congress did not contemplate the complete
elimination of the ephedrine threshold. On the contrary, the language
in the DCDCA is specific, i.e. the DCDCA uses the language ``or if the
Attorney General establishes a threshold amount for a specific listed
chemical''. Such language makes it clear that the normal case would be
that listed chemicals would not have a threshold unless the Attorney
General decides that a threshold is warranted and that the Attorney
General may remove the threshold from chemicals already listed.
BDI's comment states that DEA has no evidence of retail package
diversion. On the contrary, DEA does have evidence of the retail
diversion of ephedrine tablets as a source of precursor material for
clandestine laboratory use. In addition to the smuggling of ephedrine
and purchase via mail order, ephedrine is obtained through the purchase
of ephedrine tablets from gas stations, convenience stores and other
retail outlets. This includes small 6 count packets of ephedrine and
bottles of 24 dosage units. Investigative information shows that
individuals have gone from store to store to buy out the stock of
ephedrine until they obtain sufficient material for desired batch
sizes.
T&M Distributing commented that DEA has not demonstrated that the
current threshold is insufficient to control diversion, and has failed
to consider the burden to public health. These specific issues have
been addressed earlier in this Federal Register Notice.
A comment submitted by Abbott Laboratories requested that
prescription injectable products continue to be exempt under the
definition of ``regulated transaction''. Abbott further states that
there is no evidence of diversion of these products which are sold by
prescription only. While the DEA agrees that it is not currently aware
of the diversion of these single entity ephedrine injectable products,
the CSA does not provide for the exemption of a specific form of single
entity ephedrine products. Therefore, recordkeeping, reporting and
notification requirements will apply to these prescription injectable
products. However, prescription and hospital records kept in the normal
course of medical treatment are adequate to meet the recordkeeping
requirements of 21 CFR part 1310. An Interim Rule, which modifies 21
CFR part 1310 to clarify this, will be published in the Federal
Register.
Several comments proposed alternatives to the elimination of the
threshold. BDI proposed that there be no monthly cumulative threshold
for retail stores which stock only packages of 100 tablets or less and
limit sales to 2.5 grams per transaction. A comment submitted by The
Hammer Corporation suggested an alternative threshold of 61 tablets per
individual transaction and 6000 tablets per month. Mr. G's Manufacturer
and Wholesale Distributors suggested that 6 count or 42 count package
sizes should be exempt at the retail level. T&M Distributing suggested
that a threshold of 12,000 capsules or tablets per month be instituted.
DEA has considered all of these comments and suggested
alternatives. However, given the small batch sizes encountered at U.S.
clandestine methamphetamine and methcathinone laboratories, evidence of
the diversion of ephedrine from various types of outlets, and the
public health threat imposed by the diversion of these ephedrine
products, DEA has determined that none of the suggested alternatives
are sufficient to prevent the diversion of ephedrine consistent with
the intentions of the Domestic Chemical Diversion Control Act of 1993
(DCDCA). Therefore DEA had determined that the elimination of the
ephedrine threshold is necessary.
In making this determination, DEA recognizes that additional
entities which distribute ephedrine products will not be required to
keep records. Many of the entities which distribute ephedrine products
are truckstops, convenience stores, gas stations and liquor stores. DEA
has determined that (1) the sale of ephedrine is not a principal
business activity of these entities and (2) the recordkeeping,
reporting and notification requirements resulting from the elimination
of the threshold are essential to prevent and detect the diversion of
ephedrine products to clandestine laboratories.
The Attorney General has delegated authority under the CSA and all
subsequent amendments to the CSA to the Administrator of the DEA (28
CFR 0.100) The Administrator, in turn, has redelegated this authority
to the Deputy Administrator pursuant to 28 CFR 0.104 (59 FR 23637 (May
6, 1994)). The Deputy Administrator hereby certifies that this proposed
rulemaking will have no significant impact upon entities whose
interests must be considered under the Regulatory Flexibility Act, 5
U.S.C. 601 et seq. This position is further supported by The National
Association of Boards of Pharmacy (NABP) which commented that the
elimination of the ephedrine threshold ``should have no significant
impact on pharmacies, hospitals, or points of distribution that
distribute medications containing ephedrine for the treatment of asthma
and other conditions''.
This final rule is not a significant regulatory action and
therefore has not been reviewed by the Office of Management and Budget
pursuant to Executive Order 12866.
This action has been analyzed in accordance with the principles and
criteria in E.O. 12612, and it has been determined that the final rule
does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 1310
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1313
Drug traffic control, Chemical importation and exportation
requirements. For reasons as set out above, 21 CFR part 1310 is amended
as follows:
PART 1310--[AMENDED]
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b).
2. Section 1310.04 is amended by revising the introductory text to
paragraph (f); removing paragraph (f)(1)(iii); redesignating paragraphs
(f)(1)(iv) through (f)(1)(xxiv) as (f)(1)(iii) through (f)(1)(xxiii)
respectively; and adding a new paragraph (g) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) For those listed chemicals for which thresholds have been
established, the quantitative threshold or the cumulative amount for
multiple transactions within a calendar month, to be utilized in
determining whether a receipt, sale, importation or exportation is a
regulated transaction is as follows:
* * * * *
(g) For listed chemicals for which no thresholds have been
established, the size of the transaction is not a factor in determining
whether the transaction meets the definition of a regulated transaction
as set forth in Sec. 1310.01(f). All such transactions, regardless of
size, are subject to recordkeeping and reporting requirements as set
forth in this part 1310 and notification provisions as set forth in
part 1313 of this chapter.
(1) Listed Chemicals For Which No Thresholds Have Been Established:
(i) Ephedrine, its salts, optical isomers, and salts of optical
isomers
(ii) [Reserved]
(2) [Reserved]
For reasons as set out above, 21 CFR part 1313 is amended as
follows:
PART 1313--[AMENDED]
1. The authority citation for part 1313 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
2. Section 1313.12 is amended by revising the introductory text to
paragraph (a) to read as follows:
Sec. 1313.12 Requirement of authorization to import.
(a) Each regulated person who imports a listed chemical that meets
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is
a listed chemical for which no threshold has been established as
identified in Sec. 1310.04(g) of this chapter, shall notify the
Administrator of the importation not later than 15 days before the
transaction is to take place.
* * * * *
3. Section 1313.21 is amended by revising the introductory text to
paragraph (a) to read as follows:
Sec. 1313.21 Requirement of authorization to export.
(a) No person shall export or cause to be exported from the United
States any chemical listed in Sec. 1310.02 of this chapter, which meets
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is
a listed chemical for which no threshold has been established as
identified in Sec. 1310.04(g) of this chapter, until such time as the
Administrator has been notified. Notification must be made not later
than 15 days before the transaction is to take place. In order to
facilitate the export of listed chemicals and implement the purpose of
the Act, regulated persons may wish to provide notification to the
Administration as far in advance of the 15 days as possible.
* * * * *
Dated: August 24, 1994.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 94-25070 Filed 10-7-94; 8:45 am]
BILLING CODE 4410-09-M
