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.

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

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.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Angie Fatino Save Our Children from Meth Act of 2005'.

SEC. 2. SCHEDULES OF CONTROLLED SUBSTANCES; TRANSFER OF EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE TO SCHEDULE V.

(a) In General- The Controlled Substances Act (21 U.S.C. 801 et seq.) is amended by inserting after section 202 the following section:

`SEC. 202A. SCHEDULING OF EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE.

`(a) Schedule V- With respect to schedule V of the schedules of controlled substances established under section 202(c), the Attorney General shall by regulation, not later than 90 days after the date of the enactment of the Angie Fatino Save Our Children from Meth Act of 2005, transfer to such schedule the following chemicals, subject to subsection (b):

`(1) Ephedrine.

`(2) Pseudoephedrine.

`(3) Phenlypropanolamine.

`(4) Each of the salts, optical isomers, and salts of optical isomers of the chemicals specified in paragraphs (1) through (3).

`(b) Pseudoephedrine in Certain Products; Continued Regulation as List I Chemical- Subject to the authority of the Attorney General under this Act to designate substances as controlled substances or listed chemicals:

`(1) Subsection (a) does not apply to pseudoephedrine when contained in a product that--

`(A) is in the form of a liquid, liquid capsule, or liquid-filled gel capsule;

`(B) does not contain more than 360 milligrams of pseudoephedrine; and

`(C) is approved under section 505 of the Federal Food, Drug, and Cosmetic Act.

`(2) Pseudoephedrine, when contained in such a product, shall be considered a list I chemical.'.

(b) Definitions- Section 102 of the Controlled Substances Act (21 U.S.C. 102) is amended by adding at the end the following paragraph:

`(46)(A) The term `pseudoephedrine' includes each of the salts, optical isomers, and salts of optical isomers of pseudoephedrine.

`(B) The term `schedule V pseudoephedrine product' means a product that contains pseudoephedrine and--

`(i) is not a list I pseudoephedrine product; and

`(ii) is approved under section 505 of the Federal Food, Drug, and Cosmetic Act.

`(C) The term `list I pseudoephedrine product' means a product that contains pseudoephedrine and is described in section 202A(b)(1).'.

SEC. 3. REGULATION OF PSEUDOEPHEDRINE AS LIST I CHEMICAL; EXCEPTIONS FROM DEFINITION OF REGULATED TRANSACTION; CONFORMING AMENDMENTS REGARDING SCHEDULE V PRODUCTS.

(a) In General- Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended--

(1) in paragraph (39)(A), by amending clause (iv) to read as follows:

`(iv)(I) subject to to subclause (II), any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act unless--

`(aa) the Attorney General has determined under section 204 that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and

`(bb) the quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General; or

`(II) any transaction in a list I pseudoephedrine product, unless the Attorney General has determined under section 204 that the product is being diverted to obtain pseudoephedrine for use in the illicit production of a controlled substance; or';

(2) by striking paragraph (45); and

(3) by redesignating the paragraph (46) that relates to retail distributor as paragraph (45).

(b) Conforming Amendment- Section 310(b)(3)(D)(ii) of the Controlled Substances Act (21 U.S.C. 830(b)(3)(D)(ii)) is amended by striking `102(46)' and inserting `102(45)'.

SEC. 4. RESTRICTIONS ON NONPRESCRIPTION RETAIL SALES OF PSEUDOEPHEDRINE PRODUCTS.

(a) List I and Schedule V Products; Registration Conditions- Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following subsection:

`(i)(1) With respect to list I pseudoephedrine products, a registration under this section that includes authority for the sale of such products at retail (including a registration for a pharmacy) shall provide that, for the general physical location for which the registration is issued, the registration is subject to the following conditions:

`(A) In offering the products for sale, the registrant places the products such that customers do not have direct access to the products (commonly known as behind the counter).

`(B) The registrant does not sell such a product that is in the form of a package that can be further broken down or subdivided into two or more separate and distinct packages.

`(C) The registrant does not knowingly sell to an individual more than one such product during a 24-hour period.

`(D) The registrant maintains a written list of sales of such products that identifies the products, the purchasers, and the dates and times of the sales (which list is referred to in this subsection as the `logbook').

`(E) The registrant does not sell such a product unless--

`(i) the prospective purchaser--

`(I) is 18 years of age or older;

`(II) presents an identification card that provides a photograph and is issued by a State or the Federal Government; and

`(III) legibly signs the logbook and prints in the logbook his or her name, address, and the date and time of the sale; and

`(ii) the registrant determines that the name signed and printed in the logbook corresponds to the name provided on such identification and that the date and time entered are correct.

`(F) After a volume of the logbook is full, the registrant maintains possession of the volume for not fewer than 12 months after the date of the last sale entered in the logbook.

`(G) The registrant does not offer a promotion in which, as part of a purchase transaction, such a product is provided without charge.

`(H) On the premises of the location, the registrant posts a clear and conspicuous notice providing as follows: `Federal law prohibits the over-the-counter purchase of more than one product containing pseudoephedrine in a 24-hour period, and prohibits the over-the-counter purchase of more than 7,500 milligrams of pseudoephedrine within a 30-day period. If you make an over-the-counter purchase of such a product, you are required to sign a logbook that may be accessible to law enforcement officers.'.

`(2) With respect to schedule V pseudoephedrine products that do not require prescriptions, a registration under this section for a pharmacy shall provide that, for the general physical location involved, the registration is subject to the following conditions:

`(A) The registrant does not dispense such a product unless--

`(i) the prospective purchaser is 18 years of age or older; and

`(ii) in any case in which the prospective purchaser is not known to the pharmacist involved, such purchaser presents an identification card that provides a photograph, is issued by a State or the Federal Government, and indicates the age of such purchaser.

`(B) The registrant maintains a record for the dispensing of such a product that contains, for each sale of the product--

`(i) the name and address of the purchaser;

`(ii) the name and quantity of the product purchased;

`(iii) the date of the purchase; and

`(iv) the name or unique identification of the pharmacist involved.

`(C) The record under subparagraph (B) is in one or more of the following forms:

`(i) A hard-copy record.

`(ii) A record in an electronic prescription-dispensing system.

`(iii) A record in an electronic data collection system that contains the information required in this subparagraph and that is capable of producing a hard-copy printout of the record.'.

(b) Penalties- Section 402(a) of the Controlled Substances Act (21 U.S.C. 842(a)) is amended--

(1) in paragraph (10), by striking `or' after the semicolon at the end;

(2) in paragraph (11), by striking the period at the end and inserting `; or'; and

(3) by inserting after paragraph (11) the following paragraph:

`(12) who is a registrant to violate any of the registration conditions described in section 303(i) (relating to the sale of list I and schedule V pseudoephedrine products).'.

SEC. 5. RESTRICTIONS ON PURCHASES OF PSEUDOEPHEDRINE.

Section 404(a) of the Controlled Substances Act (21 U.S.C. 844(a)) is amended by inserting after the second sentence the following: `It shall be unlawful for any person to knowingly or intentionally purchase at retail without a prescription more than one list I pseudoephedrine product during a 24-hour period, or to knowingly or intentionally purchase such a product at retail without legibly signing the appropriate logbook referred to in section 303(i)(1)(D). It shall be unlawful for any person to knowingly or intentionally purchase at retail without a prescription more than 7,500 milligrams of pseudoephedrine in list I or schedule V pseudoephedrine products during a 30-day period.'.

END