Group 42-Sells Out! - The Information Archive/Group 42 Sells Out (Group 42) (1996).iso/drugs/stimulnt/ephedr2.txt

Text File | 1995-11-30 | 13KB | 269 lines

Newsgroups: alt.drugs,alt.psychoactives

>I'm going repost this because it seems pretty bloody important.
>Since I asked for this post, I've found that it really is happening.
>April 15th---Wave goodbye!
>
>Thus you can still probably buy it until November, but it will be very hard
>to find after stores' stocks run out. After that, its on the watched
>chemical list for *any* purchased amount.
>
>What do you think about this?

Here is the text.  I think buried somewhere down in here it states something
which might be interpreted as exempting OTC sales of Primatine Tabs and
such...  its pretty vague, though.  There's also an amazingly long list
of exemptions which was listed in the Federal Register.  I don't know who
makes Primatine, so i didn't check to see if there was an exemption
listed for OTC products...

This section is from the document '/ByQuarter/94Q1/94Q1/031794.27'.

Date="03/17/94"
Citation="59 FR 12562"
Group=""
Type="PROPOSED RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
Subject="Elimination of Threshold for Ephedrine"

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

Elimination of Threshold for Ephedrine

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

Elimination of Threshold for Ephedrine

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
+
------------------------------------------------------------
SUMMARY: The DEA proposes to eliminate the threshold for ephedrine
under provisions of the Chemical Diversion and Trafficking Act
of 1988 (CDTA) in order to reduce the diversion of ephedrine
to clandestine laboratory operators. This would subject all
transactions involving bulk ephedrine and single entity ephedrine
drug products to the applicable provisions of the Controlled
Substances Act (CSA).

DATES: Written comments and objections must be received on or
before May 2, 1994.

ADDRESSES: Comments and objections should be submitted in quintuplicate
to the Administrator, Drug Enforcement Administration, Washington,
DC 20537, Attention: DEA Federal Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT:

Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537 Telephone [phone].

SUPPLEMENTARY INFORMATION: 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(34)(c)), thresholds were
originally assigned to each listed chemical. The CDTA imposes
reporting and recordkeeping 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) was recently enacted and will become effective
on April 16, 1994. This Act amends the CSA to permit that no
threshold be established for a listed chemical 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. By not establishing a threshold for a listed
chemical, all regulated transactions regardless of size are
subject to CDTA reporting and recordkeeping requirements.
   In addition, the DCDCA further modifies the definition of
a ``regulated transaction'' by removing the exemption of 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 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 and import/export transactions, after
internal study and industry consultation (54 FR 31657). The
threshold of 1.0 kilogram of ephedrine base is equivalent to
greater than 48,000 ephedrine 25 mg tablets or capsules.
   Thresholds are continuously reviewed by DEA to determine
if they are satisfactory to prevent diversion without overburdening
industry. Current evidence indicates that the threshold for
ephedrine of 1.0 kilogram is not adequate to prevent the diversion
of ephedrine to clandestine laboratory operators. Clandestine
laboratory operators are obtaining and utilizing ephedrine in
quantities much less than the current 1.0 kilogram threshold
in the illicit production of methamphetamine and methcathinone.
The DEA has determined that in order to ensure the maximum effectiveness
of the CDTA in curtailing the diversion of ephedrine, there
should be no threshold for ephedrine. Subsequently, all regulated
transactions of ephedrine are subject to reporting and recordkeeping
requirements of the CDTA regardless of size.
   While seizures of clandestine methamphetamine laboratories
have decreased significantly since the passage of the CDTA,
more than 1200 methamphetaime laboratories have been seized
in the United States since 1990. The majority of these laboratories
utilized ephedrine as the precursor. In 1992, greater than 68
percent of the methamphetamine laboratories seized utilized
ephedrine. A preliminary review of 1993 methamphetamine laboratory
seizure data indicates that ephedrine was the precursor utilized
in approximately 75 percent of these laboratories.
   In addition to its use as the preferred precursor for the
production of methamphetamine, ephedrine is also utilized in
the synthesis of methcathinone. The clandestine manufacture
of methcathinone, a methamphetamine analogue known on the street
as ``Cat'', has been identified in the U.S. since 1991, when
five laboratories were seized. Methcathinone was temporarily
placed in Schedule I on May 1, 1992, pursuant to the emergency
scheduling provisions of the CSA (21 U.S.C. 811(h)). Effective
October 15, 1993, methcathinone was permanently controlled in
Schedule I (58 FR 53404).
   Methcathinone (N-methylcathinone) is manufactured in clandestine
laboratories via the oxidation of ephedrine. Since June of 1991,
all clandestine methcathinone laboratories seized utilized ephedrine
as the precursor. These laboratories were located in Indiana,
Illinois, Michigan, Washington and Wisconsin. The number of
methcathinone laboratory seizures continues to grow from six
in 1992 to 21 laboratories in 1993.
   Methcathinone is usually produced in small batches. Seizures
of illicit methcathinone laboratories indicate that batch sizes
routinely utilize less than 20 grams of ephedrine. The vast
majority of this ephedrine is obtained via the purchase of over-
the-counter (OTC) ephedrine 25 mg tablets sold in bottles of
1000 dosage units or less.
   Batch sizes of methamphetamine produced at clandestine labs
can vary greatly. Recent information indicates that methamphetamine
is also produced in small batches via a procedure known as the
``cold process.'' This procedure has utilized quantities of
40 grams or less of ephedrine.
   The smuggling of bulk ephedrine and the purchase of OTC ephedrine
tablets are the primary sources of ephedrine utilized at these
clandestine laboratories. Ephedrine tablets make up a significant
portion of the more than 10 metric tons of ephedrine reportedly
seized at clandestine laboratories between 1990 and 1992. This
material may be purchased from several different sources at
below threshold quantities. The purchase of regulated chemicals
from several suppliers in quantities below established thresholds
is a common method of diversion and continues to occur with
ephedrine.
   A comparison of U.S. hospital/pharmacy purchase data with
the quantities of ephedrine seized at clandestine laboratories
indicates that the use of ephedrine for clandestine laboratories
is much greater than amounts purchased by these types of distribution
outlets.
   Drug products containing ephedrine are used legitimately
to treat asthma and other conditions. They are available as
OTC products from pharmacies, hospitals and other distribution
outlets. Ephedrine products, which are lawfully marketed and
distributed under the Federal Food Drug and Cosmetic Act and
contain other active medicinal ingredients in therapeutically
significant concentrations, are currently exempt from the reporting
and recordkeeping requirements imposed under the CDTA. Of the
oral OTC products available for medicinal treatment of chronic
asthma, these ephedrine combination products are the products
more frequently dispensed by pharmacies and hospitals. The elimination
of a threshold for ephedrine does not impose any additional
requirements on pharmacies, hospitals or points of distribution
which distribute only those ephedrine products which are exempted.
   The Acting Administrator, Drug Enforcement Administration,
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
proposed rule only eliminates the existing threshold for which
ephedrine transactions must be reported and records maintained.
It only impacts firms involved with small bulk transfers of
ephedrine or distribution of single entity ephedrine tablets/capsules.
This proposed rule is not a significant regulatory action and
therefore need not be 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 proposed rule does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.

List of Subjects in 21 CFR 1310

   Drug Enforcement Administration, Drug traffic control, Reporting
and recordkeeping requirements.
   For reasons as set out above, 21 CFR part 1310 is proposed
to be 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 proposed to be 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 part 1310.
   (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]

   Dated: February 28, 1994.

Stephen H. Greene,
Acting Administrator of Drug Enforcement.

[FR Doc. 94-6234 Filed 3-16-94; 8:45 am]
BILLING CODE 4410-09-M


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The Contents entry for this article reads as follows:

Chemical Diversion and Trafficking Act of 1988; implementation:
  Ephedrine; threshold elimination, 12562