282 lines
13 KiB
Plaintext
282 lines
13 KiB
Plaintext
From: lamontg@u.washington.edu (Lamont Granquist)
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Newsgroups: alt.drugs,alt.psychoactives
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Subject: Re: DEA cracks down on Ephedrine today
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Date: 17 Apr 1994 08:10:50 GMT
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Message-ID: <2oqqua$s04@news.u.washington.edu>
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Mark_Farone@sfa.ufl.edu (Mark Farone) writes:
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>And your taxes are due, too.
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>
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>I'm going repost this because it seems pretty bloody important.
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>Since I asked for this post, I've found that it really is happening.
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>April 15th---Wave goodbye!
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>
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>Thus you can still probably buy it until November, but it will be very hard
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>to find after stores' stocks run out. After that, its on the watched
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>chemical list for *any* purchased amount.
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>
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>What do you think about this?
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Here is the text. I think buried somewhere down in here it states something
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which might be interpreted as exempting OTC sales of Primatine Tabs and
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such... its pretty vague, though. There's also an amazingly long list
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of exemptions which was listed in the Federal Register. I don't know who
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makes Primatine, so i didn't check to see if there was an exemption
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listed for OTC products...
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<PLAINTEXT>
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This section is from the document '/ByQuarter/94Q1/94Q1/031794.27'.
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<ARTICLE>
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Date="03/17/94"
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Citation="59 FR 12562"
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Group=""
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Type="PROPOSED RULE"
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Department="DEPARTMENT OF JUSTICE"
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Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE"
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Subject="Elimination of Threshold for Ephedrine"
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<HEADER>
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DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
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21 CFR Part 1310
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Elimination of Threshold for Ephedrine
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AGENCY: Drug Enforcement Administration (DEA), Justice.
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ACTION: Proposed rule.
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</HEADER>
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DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
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21 CFR Part 1310
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Elimination of Threshold for Ephedrine
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AGENCY: Drug Enforcement Administration (DEA), Justice.
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ACTION: Proposed rule.
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+
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------------------------------------------------------------
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SUMMARY: The DEA proposes to eliminate the threshold for ephedrine
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under provisions of the Chemical Diversion and Trafficking Act
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of 1988 (CDTA) in order to reduce the diversion of ephedrine
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to clandestine laboratory operators. This would subject all
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transactions involving bulk ephedrine and single entity ephedrine
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drug products to the applicable provisions of the Controlled
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Substances Act (CSA).
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DATES: Written comments and objections must be received on or
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before May 2, 1994.
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ADDRESSES: Comments and objections should be submitted in quintuplicate
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to the Administrator, Drug Enforcement Administration, Washington,
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DC 20537, Attention: DEA Federal Register Representative/CCR.
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FOR FURTHER INFORMATION CONTACT:
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Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section,
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Office of Diversion Control, Drug Enforcement Administration,
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Washington, DC 20537 Telephone (202) 307-7183.
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SUPPLEMENTARY INFORMATION: Ephedrine is the primary precursor
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utilized in the clandestine synthesis of methamphetamine and
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methcathinone, both potent central nervous system (CNS) stimulants
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controlled under the CSA. The public health risks from the abuse
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of these drugs are well known and documented.
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Ephedrine is a listed chemical under the Chemical Diversion
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and Trafficking Act of 1988 (CDTA) (Pub. L. 100-690). Under
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provisions of the CDTA (21 U.S.C. 802(34)(c)), thresholds were
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originally assigned to each listed chemical. The CDTA imposes
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reporting and recordkeeping requirements for regulated transactions
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which meet or exceed these threshold amounts of a listed chemical.
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The Domestic Chemical Diversion Control Act (DCDCA) of 1993
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(Pub. L. 103-200) was recently enacted and will become effective
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on April 16, 1994. This Act amends the CSA to permit that no
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threshold be established for a listed chemical via modification
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of 21 U.S.C. 802(39)(A) by redefining the term ``regulated transaction''
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as a ``distribution, receipt, sale, importation, or exportation,
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or an international transaction involving shipment of a listed
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chemical, or if the Attorney General establishes a threshold
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amount for a specific listed chemical, a threshold amount, including
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a cumulative threshold amount for multiple transactions'' of
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a listed chemical. By not establishing a threshold for a listed
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chemical, all regulated transactions regardless of size are
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subject to CDTA reporting and recordkeeping requirements.
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In addition, the DCDCA further modifies the definition of
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a ``regulated transaction'' by removing the exemption of those
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transactions involving products which are marketed or distributed
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lawfully in the U.S. under the Federal Food, Drug, and Cosmetic
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Act (21 U.S.C. 301 et seq.), if these products contain ephedrine
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or its salts, optical isomers, or salts of optical isomers as
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the only active medicinal ingredient or contain ephedrine in
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combination with therapeutically insignificant quantities of
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another active medicinal ingredient (21 U.S.C. 802(39)(A)(iv)).
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The DCDCA also provides that the Attorney General shall by regulation
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remove this exemption for drug products that the Attorney General
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finds are being diverted in order to obtain a listed chemical
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for use in the illicit production of a controlled substance.
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The threshold for ephedrine was originally established as
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1.0 kilogram for domestic and import/export transactions, after
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internal study and industry consultation (54 FR 31657). The
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threshold of 1.0 kilogram of ephedrine base is equivalent to
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greater than 48,000 ephedrine 25 mg tablets or capsules.
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Thresholds are continuously reviewed by DEA to determine
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if they are satisfactory to prevent diversion without overburdening
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industry. Current evidence indicates that the threshold for
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ephedrine of 1.0 kilogram is not adequate to prevent the diversion
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of ephedrine to clandestine laboratory operators. Clandestine
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laboratory operators are obtaining and utilizing ephedrine in
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quantities much less than the current 1.0 kilogram threshold
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in the illicit production of methamphetamine and methcathinone.
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The DEA has determined that in order to ensure the maximum effectiveness
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of the CDTA in curtailing the diversion of ephedrine, there
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should be no threshold for ephedrine. Subsequently, all regulated
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transactions of ephedrine are subject to reporting and recordkeeping
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requirements of the CDTA regardless of size.
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While seizures of clandestine methamphetamine laboratories
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have decreased significantly since the passage of the CDTA,
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more than 1200 methamphetaime laboratories have been seized
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in the United States since 1990. The majority of these laboratories
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utilized ephedrine as the precursor. In 1992, greater than 68
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percent of the methamphetamine laboratories seized utilized
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ephedrine. A preliminary review of 1993 methamphetamine laboratory
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seizure data indicates that ephedrine was the precursor utilized
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in approximately 75 percent of these laboratories.
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In addition to its use as the preferred precursor for the
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production of methamphetamine, ephedrine is also utilized in
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the synthesis of methcathinone. The clandestine manufacture
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of methcathinone, a methamphetamine analogue known on the street
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as ``Cat'', has been identified in the U.S. since 1991, when
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five laboratories were seized. Methcathinone was temporarily
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placed in Schedule I on May 1, 1992, pursuant to the emergency
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scheduling provisions of the CSA (21 U.S.C. 811(h)). Effective
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October 15, 1993, methcathinone was permanently controlled in
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Schedule I (58 FR 53404).
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Methcathinone (N-methylcathinone) is manufactured in clandestine
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laboratories via the oxidation of ephedrine. Since June of 1991,
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all clandestine methcathinone laboratories seized utilized ephedrine
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as the precursor. These laboratories were located in Indiana,
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Illinois, Michigan, Washington and Wisconsin. The number of
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methcathinone laboratory seizures continues to grow from six
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in 1992 to 21 laboratories in 1993.
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Methcathinone is usually produced in small batches. Seizures
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of illicit methcathinone laboratories indicate that batch sizes
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routinely utilize less than 20 grams of ephedrine. The vast
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majority of this ephedrine is obtained via the purchase of over-
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the-counter (OTC) ephedrine 25 mg tablets sold in bottles of
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1000 dosage units or less.
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Batch sizes of methamphetamine produced at clandestine labs
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can vary greatly. Recent information indicates that methamphetamine
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is also produced in small batches via a procedure known as the
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``cold process.'' This procedure has utilized quantities of
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40 grams or less of ephedrine.
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The smuggling of bulk ephedrine and the purchase of OTC ephedrine
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tablets are the primary sources of ephedrine utilized at these
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clandestine laboratories. Ephedrine tablets make up a significant
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portion of the more than 10 metric tons of ephedrine reportedly
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seized at clandestine laboratories between 1990 and 1992. This
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material may be purchased from several different sources at
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below threshold quantities. The purchase of regulated chemicals
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from several suppliers in quantities below established thresholds
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is a common method of diversion and continues to occur with
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ephedrine.
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A comparison of U.S. hospital/pharmacy purchase data with
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the quantities of ephedrine seized at clandestine laboratories
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indicates that the use of ephedrine for clandestine laboratories
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is much greater than amounts purchased by these types of distribution
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outlets.
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Drug products containing ephedrine are used legitimately
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to treat asthma and other conditions. They are available as
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OTC products from pharmacies, hospitals and other distribution
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outlets. Ephedrine products, which are lawfully marketed and
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distributed under the Federal Food Drug and Cosmetic Act and
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contain other active medicinal ingredients in therapeutically
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significant concentrations, are currently exempt from the reporting
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and recordkeeping requirements imposed under the CDTA. Of the
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oral OTC products available for medicinal treatment of chronic
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asthma, these ephedrine combination products are the products
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more frequently dispensed by pharmacies and hospitals. The elimination
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of a threshold for ephedrine does not impose any additional
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requirements on pharmacies, hospitals or points of distribution
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which distribute only those ephedrine products which are exempted.
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The Acting Administrator, Drug Enforcement Administration,
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hereby certifies that this proposed rulemaking will have no
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significant impact upon entities whose interests must be considered
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under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This
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proposed rule only eliminates the existing threshold for which
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ephedrine transactions must be reported and records maintained.
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It only impacts firms involved with small bulk transfers of
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ephedrine or distribution of single entity ephedrine tablets/capsules.
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This proposed rule is not a significant regulatory action and
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therefore need not be reviewed by the Office of Management and
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Budget pursuant to Executive Order 12866.
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This action has been analyzed in accordance with the principles
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and criteria in E.O. 12612, and it has been determined that
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the proposed rule does not have sufficient federalism implications
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to warrant the preparation of a Federalism Assessment.
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List of Subjects in 21 CFR 1310
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Drug Enforcement Administration, Drug traffic control, Reporting
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and recordkeeping requirements.
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For reasons as set out above, 21 CFR part 1310 is proposed
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to be amended as follows:
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PART 1310-[AMENDED]
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1. The authority citation for part 1310 continues to read
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as follows:
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Authority: 21 U.S.C. 802, 830, 871(b).
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2. Section 1310.04 is proposed to be amended by revising
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the introductory text to paragraph (f); removing paragraph (f)(1)(iii);
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redesignating paragraphs (f)(1)(iv) through (f)(1)(xxiv) as
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(f)(1)(iii) through (f)(1)(xxiii) respectively; and adding a
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new paragraph (g) to read as follows:
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sec 1310.04 Maintenance of records.
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* * * * *
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(f) For those listed chemicals for which thresholds have
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been established, the quantitative threshold or the cumulative
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amount for multiple transactions within a calendar month, to
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be utilized in determining whether a receipt, sale, importation
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or exportation is a regulated transaction is as follows:
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* * * * *
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(g) For listed chemicals for which no thresholds have been
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established, the size of the transaction is not a factor in
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determining whether the transaction meets the definition of
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a regulated transaction as set forth in sec 1310.01(f). All such
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transactions, regardless of size, are subject to recordkeeping
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and reporting requirements as set forth in part 1310.
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(1) Listed Chemicals For Which No Thresholds Have Been Established:
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(i) Ephedrine, its salts, optical isomers, and salts of optical
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isomers
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(ii) [Reserved]
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(2) [Reserved]
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Dated: February 28, 1994.
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Stephen H. Greene,
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Acting Administrator of Drug Enforcement.
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[FR Doc. 94-6234 Filed 3-16-94; 8:45 am]
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BILLING CODE 4410-09-M
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------------------------------------------------------
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The Contents entry for this article reads as follows:
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Chemical Diversion and Trafficking Act of 1988; implementation:
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Ephedrine; threshold elimination, 12562
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</ARTICLE>
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