Text of Statute
(A) Pursuant to this section, and by rule adopted in accordance with Chapter (1) Add a previously unscheduled compound, mixture, preparation, or substance
to any schedule;
(2) Transfer a compound, mixture, preparation, or substance from one schedule
to another, provided the transfer does not have the effect under Chapter (3) Remove a compound, mixture, preparation, or substance from the schedules
where the board had previously added the compound, mixture, preparation, or
substance to the schedules, provided that the removal shall not have the effect
under Chapter (B) In making a determination to add, remove, or transfer pursuant to
division (A) of this section, the board shall consider the following:
(1) The actual or relative potential for abuse;
(2) The scientific evidence of the pharmacological effect of the substance,
if known;
(3) The state of current scientific knowledge regarding the substance;
(4) The history and current pattern of abuse;
(5) The scope, duration, and significance of abuse;
(6) The risk to the public health;
(7) The potential of the substance to produce psychic or physiological
dependence liability;
(8) Whether the substance is an immediate precursor.
(C) The board may add or transfer a compound, mixture, preparation, or
substance to schedule I when it appears that there is a high potential for
abuse, that it has no accepted medical use in treatment in this state, or lacks
accepted safety for use in treatment under medical supervision.
(D) The board may add or transfer a compound, mixture, preparation, or
substance to schedule II when it appears that there is a high potential for
abuse, that it has a currently accepted medical use in treatment in this state,
or currently accepted medical use in treatment with severe restrictions, and
that its abuse may lead to severe physical or severe psychological dependence.
(E) The board may add or transfer a compound, mixture, preparation, or
substance to schedule III when it appears that there is a potential for abuse
less than the substances included in schedules I and II, that it has a currently
accepted medical use in treatment in this state, and that its abuse may lead to
moderate or low physical or high psychological dependence.
(F) The board may add or transfer a compound, mixture, preparation, or
substance to schedule IV when it appears that it has a low potential for abuse
relative to substances included in schedule III, and that it has a currently
accepted medical use in treatment in this state, and that its abuse may lead to
limited physical or psychological dependence relative to the substances included
in schedule III.
(G) The board may add or transfer a compound, mixture, preparation, or
substance to schedule V when it appears that it has lower potential for abuse
than substances included in schedule IV, and that it has currently accepted
medical use in treatment in this state, and that its abuse may lead to limited
physical or psychological dependence relative to substances included in schedule
IV.
(H) Even though a compound, mixture, preparation, or substance does not
otherwise meet the criteria in this section for adding or transferring it to a
schedule, the board may nevertheless add or transfer it to a schedule as an
immediate precursor when all of the following apply:
(1) It is the principal compound used, or produced primarily for use, in the
manufacture of a controlled substance;
(2) It is an immediate chemical intermediary used or likely to be used in the
manufacture of such a controlled substance;
(3) Its control is necessary to prevent, curtail, or limit the manufacture of
the scheduled compound, mixture, preparation, or substance of which it is the
immediate precursor.
(I) Authority to control under this section does not extend to distilled
spirits, wine, or malt beverages, as those terms are defined or used in Chapter (J) Authority to control under this section does not extend to any
nonnarcotic substance if such substance may, under the Federal Food, Drug, and
Cosmetic Act and the laws of this state, be lawfully sold over the counter
without a prescription. Should a pattern of abuse develop for any nonnarcotic
drug sold over the counter, the board may, by rule adopted in accordance with
Chapter (K)(1) A drug product containing ephedrine that is known as one of the
following and is in the form specified shall not be considered a schedule V
controlled substance:
(a) Amesec capsules;
(b) Bronitin tablets;
(c) Bronkotabs;
(d) Bronkolixir;
(e) Bronkaid tablets;
(f) Efedron nasal jelly;
(g) Guiaphed elixir;
(h) Haysma;
(i) Pazo hemorrhoid ointment and suppositories;
(j) Primatene "M" formula tablets;
(k) Primatene "P" formula tablets;
(l) Tedrigen tablets;
(m) Tedral tablets, suspension and elixir;
(n) T.E.P.;
(o) Vatronol nose drops.
(2)(a) A product containing ephedrine shall not be considered a controlled
substance if the product is a food product or dietary supplement that meets all
of the following criteria:
(i) It contains, per dosage unit or serving, not more than the lesser of
twenty-five milligrams of ephedrine alkaloids or the maximum amount of ephedrine
alkaloids provided in applicable regulations adopted by the United States food
and drug administration, and no other controlled substance.
(ii) It contains no hydrochloride or sulfate salts of ephedrine alkaloids.
(iii) It is packaged with a prominent label securely affixed to each package
that states all of the following: the amount in milligrams of ephedrine in a
serving or dosage unit; the amount of the food product or dietary supplement
that constitutes a serving or dosage unit; that the maximum recommended dosage
of ephedrine for a healthy adult human is the lesser of one hundred milligrams
in a twenty-four-hour period for not more than twelve weeks or the maximum
recommended dosage or period of use provided in applicable regulations adopted
by the United States food and drug administration; and that improper use of the
product may be hazardous to a person's health.
(b)(i) Subject to division (K)(2)(b)(ii) of this section, no person shall
dispense, sell, or otherwise give a product described in division (K)(2)(a) of
this section to any individual under eighteen years of age.
(ii) Division (K)(2)(b)(i) of this section does not apply to a physician or
pharmacist who dispenses, sells, or otherwise gives a product described in
division (K)(2)(a) of this section to an individual under eighteen years of age,
to a parent or guardian of an individual under eighteen years of age who
dispenses, sells, or otherwise gives a product of that nature to the individual
under eighteen years of age, or to a person who, as authorized by the
individual's parent or legal guardian, dispenses, sells, or otherwise gives a
product of that nature to an individual under eighteen years of age.
(c) No person in the course of selling, offering for sale, or otherwise
distributing a product described in division (K)(2)(a) of this section shall
advertise or represent in any manner that the product causes euphoria, ecstasy,
a "buzz" or "high," or an altered mental state; heightens
sexual performance; or, because it contains ephedrine alkaloids, increased
muscle mass.
(3) A drug product that contains the isomer pseudoephedrine, or any of its
salts, optical isomers, or salts of optical isomers, shall not be considered a
controlled substance if the drug product is labeled in a manner consistent with
federal law or with the product's over-the-counter tentative final monograph or
final monograph issued by the United States food and drug administration.
(4) At the request of any person, the board may except any product containing
ephedrine not described in division (K)(1) or (2) of this section or any class
of products containing ephedrine from being included as a schedule V controlled
substance if it determines that the product or class of products does not
contain any other controlled substance. The board shall make the determination
in accordance with this section and by rule adopted in accordance with Chapter (L) As used in this section:
(1) "Food" has the same meaning as in section (2) "Dietary supplement" has the meaning given in the "Federal
Food, Drug, and Cosmetic Act," 108 Stat. 4327 (1994), 21 U.S.C.A. 321(ff),
as amended.
(3) "Ephedrine alkaloids" means ephedrine, pseudoephedrine,
norephedrine, norpseudoephedrine, methylephedrine, and methylpseudoephedrine.
HISTORY: 136 v H 300 (Eff 7-1-76); 145 v H 391 (Eff 7-21-94); 146 v H 523
(Eff 3-31-97); 147 v S 66. Eff 7-22-98.
© Copyright 2000
Containing legislation passed and filed through August 1, 2000.