I 
108TH CONGRESS 
2D SESSION 
H. R. 4395 
To amend the Controlled Substances Act with respect to the regulation 
of ephedrine alkaloids, including ephedrine and pseudoesphedrine. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2004 
Mr. CARSON of Oklahoma (for himself and Mr. SULLIVAN) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To amend the Controlled Substances Act with respect to 
the regulation of ephedrine alkaloids, including ephedrine 
and pseudoesphedrine. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ephedrine Alkaloids 
Regulation Act of 2004’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows:
(1) The United States faces increasing danger 
related to methamphetamine trafficking, production, 
and abuse. 
(2) Methamphetamine is a highly addictive drug 
that can be readily made from products and precur-
sors purchased from retail stores. Step-by-step rec-
ipes can easily be found on the Internet, which is a 
factor in the dramatic increase in the number of 
clandestine labs in recent years. 
(3) 
Methamphetamine-producing 
clandestine 
laboratories have been identified by the Drug En-
forcement Administration as a significant threat to 
the Nation’s public health and safety. The manufac-
ture of methamphetamine produces highly toxic and 
unstable chemicals that threaten the well-being of 
first responders, law enforcement officers, and the 
community at-large. 
(4) Methamphetamine production, once exclu-
sively found in West Coast States, has rapidly 
moved eastward to the Midwest. Production can now 
be found on the East Coast, in the States of New 
York and Florida. 
(5) Methamphetamine abuse is indiscriminate 
of age, socioeconomic level, or race.
(6) Pseudoephedrine is a necessary precursor 
chemical in the production of methamphetamine, 
which prompted the Drug Enforcement Administra-
tion to initiate investigations regarding the chemi-
cal’s sale and distribution. 
(7) Efforts to reduce access to pseudoephedrine 
by methamphetamine producers, such as blister 
packaging and sales thresholds, have not been effec-
tive deterrents, and pseudoephedrine tablets remain 
pervasive in the illicit production of methamphet-
amine. 
(8) Pseudoephedrine in liquid gel and liquid 
forms have not been found to be used in meth-
amphetamine production. 
(9) As States and communities attempt to com-
bat and control methamphetamine through restrict-
ing the sale of pseudoephedrine products, it is in-
cumbent upon the Congress to develop a uniform 
standard for the distribution of pseudoephedrine in 
tablet form. 
SEC. 2. CONTROLLED SUBSTANCES; ADDITION OF EPHED-
RINE ALKALOIDS TO SCHEDULE V. 
(a) IN GENERAL.—Effective upon the expiration of 
30 days after the date of the enactment of this Act, ephed-
rine alkaloids (including ephedrine and pseudoesphedrine),
and their salts, optical isomers, and salts of optical iso-
mers, shall be considered to be listed in schedule V of the 
schedules of controlled substances established under sec-
tion 202(c) of the Controlled Substances Act, subject to 
subsection (b). The Attorney General shall amend part 
1308 of title 21, Code of Federal Regulations, accordingly. 
(b) CERTAIN FORMS OF PSEUDOEPHEDRINE.—Sub-
ject to the authority of the Attorney General under the 
Controlled Substances Act to designate drugs or other 
substances as controlled substances or listed chemicals— 
(1) 
subsection 
(a) 
does 
not 
apply 
to 
pseudoephedrine when contained in a drug that is in 
liquid or gel form and is marketed or distributed 
lawfully in the United States under the Federal 
Food, Drug, and Cosmetic Act; and 
(2) pseudoephedrine when so contained shall be 
considered a listed chemical. 
SEC. 3. REGULATION OF TRANSACTIONS INVOLVING LIST-
ED CHEMICALS; EXEMPTION FOR CERTAIN 
DOSAGE FORMS OF PSEUDOEPHEDRINE. 
(a) DEFINITION OF REGULATED TRANSACTION.— 
Section 102(39)(A)(iv) of the Controlled Substances Act 
(21 U.S.C. 802(39)(A)(iv)) is amended—
(1) in the matter preceding subclause (I), by 
striking ‘‘unless—’’ and inserting ‘‘unless, subject to 
clause (v)—’’; 
(2) in subclause (I), by inserting ‘‘in liquid or 
gel form’’ after ‘‘pseudoephedrine’’ the first place 
such term appears; and 
(3) in subclause (II)— 
(A) by inserting ‘‘in liquid or gel form’’ 
after ‘‘pseudoephedrine’’ the first place such 
term appears; and 
(B) by striking ‘‘except that’’ and all that 
follows and inserting the following: ‘‘except that 
the threshold for any sale of products con-
taining pseudoephedrine products in liquid or 
gel form, or containing phenylpropanolamine 
products, by retail distributors or by distribu-
tors required to submit reports by section 
310(b)(3) shall be 9 grams of pseudoephedrine 
or 9 grams of phenylpropanolamine in a single 
transaction and sold in package sizes of not 
more than 3 grams of pseudoephedrine base or 
3 grams of phenylpropanolamine base; or’’. 
(b) DEFINITION OF ORDINARY OVER-THE-COUNTER 
PSEUDOEPHEDRINE OR PHENYLPROPANOLAMINE PROD-
UCT.—Section 102(45) of the Controlled Substances Act
(21 U.S.C. 802(45)) is amended in the matter preceding 
subparagraph 
(A) 
by 
striking 
‘‘containing 
pseudoephedrine or phenylpropanolamine that’’ and in-
serting ‘‘containing pseudoephedrine in liquid or gel form, 
or containing phenylpropanolamine, that’’. 
Æ