I 

109TH CONGRESS 

1ST SESSION H. R. 3568 

To amend the Controlled Substances Act to provide for the transfer of 

ephedrine, pseudoephedrine, and phenylpropanolamine to schedule V of 

the schedules of controlled substances, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 28, 2005 

Mr. LATHAM (for himself, Mr. BOSWELL, Mr. LEACH, and Mr. NUSSLE) 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 to provide for the 

transfer of ephedrine, pseudoephedrine, and phenylpropanolamine to schedule V of the schedules of controlled substances, and for other purposes. 

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 ‘‘Angie Fatino Save Our 

5 Children from Meth Act of 2005’’. 
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1 SEC. 2. SCHEDULES OF CONTROLLED SUBSTANCES; TRANS2 FER OF EPHEDRINE, PSEUDOEPHEDRINE, 

3 AND PHENYLPROPANOLAMINE TO SCHEDULE 

4 V. 

5 (a) IN GENERAL.—The Controlled Substances Act 

6 (21 U.S.C. 801 et seq.) is amended by inserting after sec7 tion 202 the following section: 

8 ‘‘SEC. 202A. SCHEDULING OF EPHEDRINE, 

9 PSEUDOEPHEDRINE, AND PHENYL10 PROPANOLAMINE. 

11 ‘‘(a) SCHEDULE V.—With respect to schedule V of 

12 the schedules of controlled substances established under 

13 section 202(c), the Attorney General shall by regulation, 

14 not later than 90 days after the date of the enactment 

15 of the Angie Fatino Save Our Children from Meth Act 

16 of 2005, transfer to such schedule the following chemicals, 

17 subject to subsection (b): 

18 ‘‘(1) Ephedrine. 

19 ‘‘(2) Pseudoephedrine. 

20 ‘‘(3) Phenlypropanolamine. 

21 ‘‘(4) Each of the salts, optical isomers, and 

22 salts of optical isomers of the chemicals specified in 

23 paragraphs (1) through (3). 

24 ‘‘(b) PSEUDOEPHEDRINE IN CERTAIN PRODUCTS; 

25 CONTINUED REGULATION AS LIST I CHEMICAL.—Subject 

26 to the authority of the Attorney General under this Act 
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1 to designate substances as controlled substances or listed 

2 chemicals: 

3 ‘‘(1) Subsection (a) does not apply to 

4 pseudoephedrine when contained in a product that—

5 ‘‘(A) is in the form of a liquid, liquid cap6 sule, or liquid-filled gel capsule; 

7 ‘‘(B) does not contain more than 360 milli8 grams of pseudoephedrine; and 

9 ‘‘(C) is approved under section 505 of the 

10 Federal Food, Drug, and Cosmetic Act. 

11 ‘‘(2) Pseudoephedrine, when contained in such 

12 a product, shall be considered a list I chemical.’’. 

13 (b) DEFINITIONS.—Section 102 of the Controlled 

14 Substances Act (21 U.S.C. 102) is amended by adding at 

15 the end the following paragraph: 

16 ‘‘(46)(A) The term ‘pseudoephedrine’ includes 

17 each of the salts, optical isomers, and salts of optical 

18 isomers of pseudoephedrine. 

19 ‘‘(B) The term ‘schedule V pseudoephedrine 

20 product’ means a product that contains 

21 pseudoephedrine and—

22 ‘‘(i) is not a list I pseudoephedrine prod23 uct; and 

24 ‘‘(ii) is approved under section 505 of the 

25 Federal Food, Drug, and Cosmetic Act. 
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1 ‘‘(C) The term ‘list I pseudoephedrine product’ 

2 means a product that contains pseudoephedrine and 

3 is described in section 202A(b)(1).’’. 

4 SEC. 3. REGULATION OF PSEUDOEPHEDRINE AS LIST I 

5 CHEMICAL; EXCEPTIONS FROM DEFINITION 

6 OF REGULATED TRANSACTION; CONFORMING 

7 AMENDMENTS REGARDING SCHEDULE V 

8 PRODUCTS. 

9 (a) IN GENERAL.—Section 102 of the Controlled 

10 Substances Act (21 U.S.C. 802) is amended— 

11 (1) in paragraph (39)(A), by amending clause 

12 (iv) to read as follows: 

13 ‘‘(iv)(I) subject to to subclause (II), any 

14 transaction in a listed chemical that is con15 tained in a drug that may be marketed or dis16 tributed lawfully in the United States under the 

17 Federal Food, Drug, and Cosmetic Act un18 less— 

19 ‘‘(aa) the Attorney General has deter20 mined under section 204 that the drug or 

21 group of drugs is being diverted to obtain 

22 the listed chemical for use in the illicit pro23 duction of a controlled substance; and 

24 ‘‘(bb) the quantity of the listed chem25 ical contained in the drug included in the 
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1 transaction or multiple transactions equals 

2 or exceeds the threshold established for 

3 that chemical by the Attorney General; or 

4 ‘‘(II) any transaction in a list I 

5 pseudoephedrine product, unless the Attorney 

6 General has determined under section 204 that 

7 the product is being diverted to obtain 

8 pseudoephedrine for use in the illicit production 

9 of a controlled substance; or’’; 

10 (2) by striking paragraph (45); and 

11 (3) by redesignating the paragraph (46) that 

12 relates to retail distributor as paragraph (45). 

13 (b) CONFORMING AMENDMENT.—Section 

14 310(b)(3)(D)(ii) of the Controlled Substances Act (21 

15 U.S.C. 830(b)(3)(D)(ii)) is amended by striking 

16 ‘‘102(46)’’ and inserting ‘‘102(45)’’. 

17 SEC. 4. RESTRICTIONS ON NONPRESCRIPTION RETAIL 

18 SALES OF PSEUDOEPHEDRINE PRODUCTS. 

19 (a) LIST I AND SCHEDULE V PRODUCTS; REGISTRA20 TION CONDITIONS.—Section 303 of the Controlled Sub21 stances Act (21 U.S.C. 823) is amended by adding at the 

22 end the following subsection: 

23 ‘‘(i)(1) With respect to list I pseudoephedrine prod24 ucts, a registration under this section that includes au25 thority for the sale of such products at retail (including 
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1 a registration for a pharmacy) shall provide that, for the 

2 general physical location for which the registration is 

3 issued, the registration is subject to the following condi4 tions: 

5 ‘‘(A) In offering the products for sale, the reg6 istrant places the products such that customers do 

7 not have direct access to the products (commonly 

8 known as behind the counter). 

9 ‘‘(B) The registrant does not sell such a prod10 uct that is in the form of a package that can be fur11 ther broken down or subdivided into two or more 

12 separate and distinct packages. 

13 ‘‘(C) The registrant does not knowingly sell to 

14 an individual more than one such product during a 

15 24-hour period. 

16 ‘‘(D) The registrant maintains a written list of 

17 sales of such products that identifies the products, 

18 the purchasers, and the dates and times of the sales 

19 (which list is referred to in this subsection as the 

20 ‘logbook’). 

21 ‘‘(E) The registrant does not sell such a prod22 uct unless— 

23 ‘‘(i) the prospective purchaser— 

24 ‘‘(I) is 18 years of age or older; 
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1 ‘‘(II) presents an identification card 

2 that provides a photograph and is issued 

3 by a State or the Federal Government; and 

4 ‘‘(III) legibly signs the logbook and 

5 prints in the logbook his or her name, ad6 dress, and the date and time of the sale; 

7 and 

8 ‘‘(ii) the registrant determines that the 

9 name signed and printed in the logbook cor10 responds to the name provided on such identi11 fication and that the date and time entered are 

12 correct. 

13 ‘‘(F) After a volume of the logbook is full, the 

14 registrant maintains possession of the volume for 

15 not fewer than 12 months after the date of the last 

16 sale entered in the logbook. 

17 ‘‘(G) The registrant does not offer a promotion 

18 in which, as part of a purchase transaction, such a 

19 product is provided without charge. 

20 ‘‘(H) On the premises of the location, the reg21 istrant posts a clear and conspicuous notice pro22 viding as follows: ‘Federal law prohibits the over-the23 counter purchase of more than one product con24 taining pseudoephedrine in a 24-hour period, and 

25 prohibits the over-the-counter purchase of more than 
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1 7,500 milligrams of pseudoephedrine within a 30-

2 day period. If you make an over-the-counter pur3 chase of such a product, you are required to sign a 

4 logbook that may be accessible to law enforcement 

5 officers.’. 

6 ‘‘(2) With respect to schedule V pseudoephedrine 

7 products that do not require prescriptions, a registration 

8 under this section for a pharmacy shall provide that, for 

9 the general physical location involved, the registration is 

10 subject to the following conditions: 

11 ‘‘(A) The registrant does not dispense such a 

12 product unless—

13 ‘‘(i) the prospective purchaser is 18 years 

14 of age or older; and 

15 ‘‘(ii) in any case in which the prospective 

16 purchaser is not known to the pharmacist in17 volved, such purchaser presents an identifica18 tion card that provides a photograph, is issued 

19 by a State or the Federal Government, and in20 dicates the age of such purchaser. 

21 ‘‘(B) The registrant maintains a record for the 

22 dispensing of such a product that contains, for each 

23 sale of the product—

24 ‘‘(i) the name and address of the pur25 chaser; 
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1 ‘‘(ii) the name and quantity of the product 

2 purchased; 

3 ‘‘(iii) the date of the purchase; and 

4 ‘‘(iv) the name or unique identification of 

5 the pharmacist involved. 

6 ‘‘(C) The record under subparagraph (B) is in 

7 one or more of the following forms: 

8 ‘‘(i) A hard-copy record. 

9 ‘‘(ii) A record in an electronic prescription10 dispensing system. 

11 ‘‘(iii) A record in an electronic data collec12 tion system that contains the information re13 quired in this subparagraph and that is capable 

14 of producing a hard-copy printout of the 

15 record.’’. 

16 (b) PENALTIES.—Section 402(a) of the Controlled 

17 Substances Act (21 U.S.C. 842(a)) is amended— 

18 (1) in paragraph (10), by striking ‘‘or’’ after 

19 the semicolon at the end; 

20 (2) in paragraph (11), by striking the period at 

21 the end and inserting ‘‘; or’’; and 

22 (3) by inserting after paragraph (11) the fol23 lowing paragraph: 

24 ‘‘(12) who is a registrant to violate any of the 

25 registration conditions described in section 303(i) 
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1 (relating to the sale of list I and schedule V 

2 pseudoephedrine products).’’. 

3 SEC. 5. RESTRICTIONS ON PURCHASES OF 

4 PSEUDOEPHEDRINE. 

5 Section 404(a) of the Controlled Substances Act (21 

6 U.S.C. 844(a)) is amended by inserting after the second 

7 sentence the following: ‘‘It shall be unlawful for any per8 son to knowingly or intentionally purchase at retail with9 out a prescription more than one list I pseudoephedrine 

10 product during a 24-hour period, or to knowingly or inten11 tionally purchase such a product at retail without legibly 

12 signing the appropriate logbook referred to in section 

13 303(i)(1)(D). It shall be unlawful for any person to know14 ingly or intentionally purchase at retail without a prescrip15 tion more than 7,500 milligrams of pseudoephedrine in list 

16 I or schedule V pseudoephedrine products during a 30-

17 day period.’’.

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