Current through all regulations passed and filed through September 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 percent of the
corporation's 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 of 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 the following:
(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 or
agency 4729 of the Administrative Code.
