OHIO STATE BOARD OF PHARMACY

77 S. High Street, 17th Floor
Columbus, Ohio 43266-0320
614/466-4143 (FAX: 614/752-4836)

EPHEDRINE

KEY: ORC Ohio Revised Code OAC Ohio Administrative Code

Section 3719.41 Schedules of controlled substances.

[ORC: 07/01/76, 05/19/93, 07/21/94]

* * *

SCHEDULE V

* * *

(C) Stimulants

Unless specifically exempted or excluded under federal drug abuse control laws or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including their salts, isomers, and salts of isomers:

(1) Ephedrine, except as provided in division (K) of section 3719.44 of the Revised Code;

(2) Pyrovalerone.

Section 3719.44 State board of pharmacy may change schedules.

[ORC: 07/01/76, 07/21/94]

* * *

(K) 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:

(1) Amesec capsules;

(2) Bronitin tablets;

(3) Bronkotabs;

(4) Bronkolixir;

(5) Bronkaid tablets;

(6) Efedron nasal jelly;

(7) Guiaphed elixir;

(8) Haysma;

(9) Pazo hemorrhoid ointment and suppositories;

(10) Primatene "M" formula tablets;

(11) Primatene "P" formula tablets;

(12) Tedrigen tablets;

(13) Tedral tablets, suspension, and elixir;

(14) T.E.P.;

(15) Vatronol nose drops.

At the request of any person, the board may except any other drug product containing ephedrine from being included as a schedule V controlled substance if it determines that the product does not contain any other controlled substance. The board shall make the determination in accordance with this section and by rules adopted in accordance with Chapter 119. of the Revised Code.

Rule 4729-11-09 Sale of schedule V controlled substance products without a prescription.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.05, 3719.28, 4729.26, 4729.28, 4729.51, 4729.66)

A schedule V controlled substance product which is not a prescription drug as determined under the "Federal Food, Drug and Cosmetic Act" may be sold at retail by a pharmacist without a prescription to
a purchaser at retail, provided that:

(A) The sale is made only by a pharmacist and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities in this section, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist).

(B) The purchaser is at least eighteen years of age.

(C) The pharmacist requires every purchaser of a controlled substance under this rule not known to him to furnish suitable identification (including proof of age where appropriate).

(D) A bound record book is maintained which contains the true name and complete address of the purchaser, the legible signature of the purchaser, name and quantity of controlled substances sold, date of each sale, and the name and legible initials of the pharmacist who sold the controlled substance at retail. This book shall be maintained for a period of three years from the date of the last transaction and must be made available for inspection and copying by persons authorized to enforce the federal and state drug laws.

(E) The schedule V controlled substance product is sold at retail.

(F) Not more than two hundred forty cubic centimeters (eight ounces) nor more than fortyeight solid dosage units of any schedule V controlled substance product containing opium, nor more than one hundred twenty cubic centimeters. (four ounces) nor more than twentyfour solid dosage units of any other narcotic controlled substance may be sold at retail to the same purchaser in any given fortyeighthour period.

(G) Not more than one hundred solid dosage units of any schedule V controlled substance stimulant product may be sold to any one person in any one thirtyday period.

(H) The schedule V controlled substance is sold at retail for a legitimate medical need and the purchaser furnishes information to the pharmacist which establishes the legitimate medical need for the controlled substance.

Rule 4729-12-01 Definition of ephedrine.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.01, 3719.28, 4729.02, 4729.66)

Ephedrine is -[-(Methylamino)ethyl]benzene-methanol; -[1-(methylamino) ethyl]benzyl alcohol; 2-methylamino-1-phenyl-1-propanol; 1-phenyl-1-hydroxy-2-methylaminopropane; 1-phenyl-2-methylaminopropanol; - hydroxy--methylaminopropylbenzene; a product which occurs in the Chinese herb Ma Huang (Ephedra vulgaris, Ephedra sinica Stapf., Ephedra equisetina Bunge, Gnetaceae) and in several other Ephedra spp. Isomeric forms include d and lephedrine as well as d and lpseudoephedrine with lephedrine and d-pseudoephedrine as the naturally occurring isomers.

Rule 4729-12-02 Registration and licensure.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.03, 3719.05, 3719.07, 3719.09, 3719.13, 3719.15, 3719.16, 3719.27, 3719.28, 4729.26, 4729.28, 4729.54, 4729.55, 4729.66)

Any person who manufactures, sells at wholesale or retail, dispenses, imports or exports products containing ephedrine, its salts or isomers, or who proposes to engage in such activities, shall submit an application for registration as a wholesaler of dangerous drugs and controlled substances or for licensure as a category III terminal distributor of dangerous drugs to conduct such activities in accordance with Chapters 3719. and 4729. of the Revised Code.

Rule 4729-12-03 Security, storage, and sale.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.03, 3719.05, 3719.07, 3719.09, 3719.13, 3719.15, 3719.16, 3719.27, 3719.28, 4729.26, 4729.28, 4729.54, 4729.55, 4729.66)

Schedule V products containing ephedrine may be sold at wholesale or retail, and must be maintained in accordance with Chapters 3719. and 4729. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code.

Rule 4729-12-04 Inventory.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.03, 3719.05, 3719.07, 3719.09, 3719.13, 3719.15, 3719.16, 3719.27, 3719.28, 4729.26, 4729.28, 4729.54, 4729.55, 4729.66)

Every registrant or licensee required to keep records who possesses any quantity of ephedrine or schedule V drug products containing ephedrine shall take an inventory pursuant to rules 4729-9-14 and 4729-9-16 of the Administrative Code.

Rule 4729-12-05 Records.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.03, 3719.05, 3719.07, 3719.09, 3719.13, 3719.15, 3719.16, 3719.27, 3719.28, 4729.26, 4729.28, 4729.54, 4729.55, 4729.66)

All practitioners, registrants, and licensees required to keep records pursuant to Chapter 3719. of the Revised Code and Chapters 4729-9 and 4729-11 of the Administrative Code shall maintain such records for ephedrine and schedule V drug products containing ephedrine.

Rule 4729-12-08 Petitions for exception of ephedrinecontaining products.

[OAC: 08/16/94, 11/25/94]

(Amplifies 3719.03, 3719.05, 3719.07, 3719.09, 3719.13, 3719.15, 3719.16, 3719.27, 3719.28, 4729.26, 4729.28, 4729.54, 4729.55, 4729.66)

A petition requesting that a drug product containing ephedrine be excepted by the board of pharmacy from being legally classified as a schedule V controlled substance stimulant may be submitted by any person engaged in the legitimate manufacture or wholesale sale of such products in the United States. The petition shall include the following information:

(A) Full name, address, and telephone number of the manufacturer.

(1) If incorporated, the petition must include copies of the
incorporation papers and the names, dates of birth, addresses,
and social security numbers of the officers of the corporation
and
all stockholders holding more than ten percent of the stock.

Rule 4729-12-08 (cont'd)

(2) If a proprietorship, the petition must include the name, address, date of birth, and social security number of the owner(s).

(3) If a partnership, the petition must include the names, addresses, dates of birth, and social security numbers of the partners.

(B) A description of the package sizes and the manner of packaging the drug product.

(C) A limited number of samples of each dosage form marketed in the final marketed packages.

(D) The manner of distribution, advertising, and promotion of the product, including but not limited to:

(1) The full name and address of all accounts located in Ohio
to which the products have been or will be distributed at wholesale
based on other products marketed by the petitioner.

(2) Copies of all advertisements used to promote the product
within the last twelve months shall be included with the petition.
A list of the publications in which the advertisements appeared
or will appear if not presently marketed. If the product has
not yet been marketed, copies of other products marketed by the
petitioner shall be submitted with the petition.

(E) A listing of all ingredients in the product, indicating the quantity of each ingredient, whether or not it has any therapeutic value, and its purpose for being included in the product. Documentation of the therapeutic value of all active ingredients in the product shall be included with the petition.

(F) A list of all names the product is marketed or will be marketed under in the United States or any other country.

(G) Any information regarding the product's abuse or potential for abuse in the United States or other countries where the product is marketed or will be marketed under any of the names listed in paragraph (F) of this rule.

Rule 47291209 Exceptions.

[OAC: 08/24/94, 12/15/94, 01/10/96]

(Amplifies 3719.28, 3719.44, 4729.66)

Pursuant to division (K) of section 3719.44 of the Revised Code, each of the following products containing ephedrine, its salts, its isomers, or the salts of its isomers is declared to be exempt from classification as a schedule V controlled substance:

(A) All products that contain the isomer known as pseudoephedrine or its salts, but do not also contain any of the isomer known as ephedrine or its salts.

(B) "Breathe Easy®" herb tea.

(C) "Bronkaid® Dual Action" caplets.

(D) "Hydrosal®" hemorrhoidal ointment.

(E) "Primatene® Dual Action Formula" tablets.

(F) "Primatene®" tablets.

Rule 4729-12-10 Criteria to be considered in denying a petition for exemption or removing a drug product exemption.

[OAC: 03/13/95]

(Amplifies 3719.28, 3719.44, 4729.66)

(A) The board shall consider the following factors in determining whether a particular over-the-counter (OTC) drug product containing the schedule V controlled substance ephedrine is manufactured and distributed for legitimate use in a manner consistent with the pertinent OTC tentative or final monograph issued by the federal food and drug administration and in a manner that reduces the likelihood of inappropriate use and/or abuse:

(1) The package size and the manner of packaging;

(2) Distribution, advertising, and promotion of the product;

(3) Labeling and the name of the product;

(4) The potential, duration, scope, and significance of inappropriate
use and/or abuse;

(5) Other facts as may be relevant to and consistent with the
public health and safety.

(B) The board shall remove a drug product exception for a particular drug product if it determines
that the drug product is not manufactured and distributed for legitimate use and in a manner that reduces the likelihood of abuse.


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