Ohio Administrative Code
Title 4729 - State Board of Pharmacy
Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products
Section 4729-12-08 - Petitions for exception of ephedrine-containing products
Universal Citation: OH Admin Code 4729-12-08
Current through all regulations passed and filed through December 16, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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