Chapter 4729-12 Ephedrine and Ephedrine-Containing Products

4729-12-01 Definition of ephedrine.

Ephedrine is a -[-(Methylamino)ethyl]benzene-methanol; a -[1-(methylamino) ethyl]benzyl alcohol; 2-methylamino-1-phenyl-1-propanol; 1-phenyl-1-hydroxy-2-methylaminopropane; 1-phenyl-2- methylaminopropanol; a - hydroxy-b -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 l-ephedrine as well as d- and l-pseudoephedrine with l-ephedrine and d-pseudoephedrine as the naturally occurring isomers.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.66

Rule Amplifies: 3719.01 , 4729.01

Prior Effective Dates: 08/16/94 (Emer), 11/25/94

4729-12-02 Registration and licensure.

(A) 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.

(B) This rule does not apply if the ephedrine product is a food product or a dietary supplement that is specifically excepted in division (K) (2) of section 3719.44 of the Revised Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.26 , 4729.66

Rule Amplifies: 3719.03 , 3719.05 , 3719.07 , 3719.09 , 3719.13 , 3719.15 , 3719.16 , 3719.27 , 4729.28 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer), 11/25/94

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

(A) 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.

(B) This rule does not apply if the ephedrine product is a food product or a dietary supplement that is specifically excepted in division (K)(2) of section 3719.44 of the Revised Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.26 , 4729.66

Rule Amplifies: 3719.03 , 3719.05 , 3719.07 , 3719.09 , 3719.13 , 3719.15 , 3719.16 , 3719.27 , 4729.28 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer), 11/25/94

4729-12-04 Inventory.

(A) 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.

(B) This rule does not apply if the ephedrine product is a food product or a dietary supplement that is specifically excepted in division (K)(2) of section 3719.44 of the Revised Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.26 , 4729.66

Rule Amplifies: 3719.03 , 3719.05 , 3719.07 , 3719.09 , 3719.13 , 3719.15 , 3719.16 , 3719.27 , 4729.28 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer), 11/25/94

4729-12-05 Records.

(A) 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.

(B) This rule does not apply if the ephedrine product is a food product or a dietary supplement that is specifically excepted in division (K)(2) of section 3719.44 of the Revised Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.26 , 4729.66

Rule Amplifies: 3719.03 , 3719.05 , 3719.07 , 3719.09 , 3719.13 , 3719.15 , 3719.16 , 3719.27 , 4729.28 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer), 11/25/94

4729-12-08 Petitions for exception of ephedrine-containing products.

(A) 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:

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

(a) 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 per cent of the stock.

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

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

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

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

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

(a) 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.

(b) 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.

(5) 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.

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

(7) 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 (A)(6) of this rule.

(B) This rule does not apply if the ephedrine product is a food product or a dietary supplement that is specifically excepted in division (K)(2) of section 3719.44 of the Revised Code.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.26 , 4729.66

Rule Amplifies: 3719.03 , 3719.05 , 3719.07 , 3719.09 , 3719.13 , 3719.15 , 3719.16 , 3719.27 , 4729.28 , 4729.54 , 4729.55

Prior Effective Dates: 08/16/94(Emer), 11/25/94

4729-12-09 Exceptions.

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 excepted 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 TM" herb tea.

(C) "Bronkaid TM Dual Action" caplets.

(D) "Hydrosal TM" hemorrhoidal ointment.

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

(F) "Primatene TM" tablets.

(G) "SnoreStop TM" tablets.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.66

Rule Amplifies: 3719.44

Prior Effective Dates: 08/24/94(Emer), 12/15/94, 01/10/96

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

(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.

R.C. 119.032 review dates: 12/01/2009 and 12/01/2014

Promulgated Under: 119.03

Statutory Authority: 3719.28 , 4729.66

Rule Amplifies: 3719.44

Prior Effective Dates: None