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 following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period 

to be subsequently determined by the Speaker, in each case for consideration 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ephedrine Alkaloids 

5 Regulation Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 
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1 (1) The United States faces increasing danger 

2 related to methamphetamine trafficking, production, 

3 and abuse. 

4 (2) Methamphetamine is a highly addictive drug 

5 that can be readily made from products and precur6 sors purchased from retail stores. Step-by-step rec7 ipes can easily be found on the Internet, which is a 

8 factor in the dramatic increase in the number of 

9 clandestine labs in recent years. 

10 (3) Methamphetamine-producing clandestine 

11 laboratories have been identified by the Drug En12 forcement Administration as a significant threat to 

13 the Nation’s public health and safety. The manufac14 ture of methamphetamine produces highly toxic and 

15 unstable chemicals that threaten the well-being of 

16 first responders, law enforcement officers, and the 

17 community at-large. 

18 (4) Methamphetamine production, once exclu19 sively found in West Coast States, has rapidly 

20 moved eastward to the Midwest. Production can now 

21 be found on the East Coast, in the States of New 

22 York and Florida. 

23 (5) Methamphetamine abuse is indiscriminate 

24 of age, socioeconomic level, or race. 
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1 (6) Pseudoephedrine is a necessary precursor 

2 chemical in the production of methamphetamine, 

3 which prompted the Drug Enforcement Administra4 tion to initiate investigations regarding the chemi5 cal’s sale and distribution. 

6 (7) Efforts to reduce access to pseudoephedrine 

7 by methamphetamine producers, such as blister 

8 packaging and sales thresholds, have not been effec9 tive deterrents, and pseudoephedrine tablets remain 

10 pervasive in the illicit production of methamphet11 amine. 

12 (8) Pseudoephedrine in liquid gel and liquid 

13 forms have not been found to be used in meth14 amphetamine production. 

15 (9) As States and communities attempt to com16 bat and control methamphetamine through restrict17 ing the sale of pseudoephedrine products, it is in18 cumbent upon the Congress to develop a uniform 

19 standard for the distribution of pseudoephedrine in 

20 tablet form. 

21 SEC. 2. CONTROLLED SUBSTANCES; ADDITION OF EPHED22 RINE ALKALOIDS TO SCHEDULE V. 

23 (a) IN GENERAL.—Effective upon the expiration of 

24 30 days after the date of the enactment of this Act, ephed25 rine alkaloids (including ephedrine and pseudoesphedrine), 
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1 and their salts, optical isomers, and salts of optical iso2 mers, shall be considered to be listed in schedule V of the 

3 schedules of controlled substances established under sec4 tion 202(c) of the Controlled Substances Act, subject to 

5 subsection (b). The Attorney General shall amend part 

6 1308 of title 21, Code of Federal Regulations, accordingly. 

7 (b) CERTAIN FORMS OF PSEUDOEPHEDRINE.—Sub8 ject to the authority of the Attorney General under the 

9 Controlled Substances Act to designate drugs or other 

10 substances as controlled substances or listed chemicals— 

11 (1) subsection (a) does not apply to 

12 pseudoephedrine when contained in a drug that is in 

13 liquid or gel form and is marketed or distributed 

14 lawfully in the United States under the Federal 

15 Food, Drug, and Cosmetic Act; and 

16 (2) pseudoephedrine when so contained shall be 

17 considered a listed chemical. 

18 SEC. 3. REGULATION OF TRANSACTIONS INVOLVING LIST19 ED CHEMICALS; EXEMPTION FOR CERTAIN 

20 DOSAGE FORMS OF PSEUDOEPHEDRINE. 

21 (a) DEFINITION OF REGULATED TRANSACTION.— 

22 Section 102(39)(A)(iv) of the Controlled Substances Act 

23 (21 U.S.C. 802(39)(A)(iv)) is amended— 
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1 (1) in the matter preceding subclause (I), by 

2 striking ‘‘unless—’’ and inserting ‘‘unless, subject to 

3 clause (v)—’’; 

4 (2) in subclause (I), by inserting ‘‘in liquid or 

5 gel form’’ after ‘‘pseudoephedrine’’ the first place 

6 such term appears; and 

7 (3) in subclause (II)— 

8 (A) by inserting ‘‘in liquid or gel form’’ 

9 after ‘‘pseudoephedrine’’ the first place such 

10 term appears; and 

11 (B) by striking ‘‘except that’’ and all that 

12 follows and inserting the following: ‘‘except that 

13 the threshold for any sale of products con14 taining pseudoephedrine products in liquid or 

15 gel form, or containing phenylpropanolamine 

16 products, by retail distributors or by distribu17 tors required to submit reports by section 

18 310(b)(3) shall be 9 grams of pseudoephedrine 

19 or 9 grams of phenylpropanolamine in a single 

20 transaction and sold in package sizes of not 

21 more than 3 grams of pseudoephedrine base or 

22 3 grams of phenylpropanolamine base; or’’. 

23 (b) DEFINITION OF ORDINARY OVER-THE-COUNTER

24 PSEUDOEPHEDRINE OR PHENYLPROPANOLAMINE PROD25 UCT.—Section 102(45) of the Controlled Substances Act 
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1 (21 U.S.C. 802(45)) is amended in the matter preceding 

2 subparagraph (A) by striking ‘‘containing 

3 pseudoephedrine or phenylpropanolamine that’’ and in4 serting ‘‘containing pseudoephedrine in liquid or gel form, 

5 or containing phenylpropanolamine, that’’. 

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