Subject: Re: DEA cracks down on Ephedrine today
From: [email-masked] (Lamont Granquist)
Date: 17 Apr 1994 08:10:50 GMT
Newsgroups: alt.drugs,alt.psychoactives

[email-masked] (Mark Farone) writes:
>And your taxes are due, too.
>
>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...

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

<ARTICLE>
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"
<HEADER>
DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

Elimination of Threshold for Ephedrine

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Proposed rule.
</HEADER>
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 (202) 307-7183.

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

------------------------------------------------------
The Contents entry for this article reads as follows:

Chemical Diversion and Trafficking Act of 1988; implementation:
  Ephedrine; threshold elimination, 12562
</ARTICLE>

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