Ohio Admin. Code 901:11-3-01

Current through all regulations passed and filed through November 4, 2024

Section 901:11-3-01 - Definitions

As used in rules 901:11-3-01 to 901:11-3-09 of the Administrative Code:

(A) "21 C.F.R." means Title 21 of the Code of Federal Regulations (April 2023).

(B) "Drug" means:

(1) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary;

(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;

(3) Articles other than food intended to affect the structure or any function of the body of man or other animals; and

(4) Articles intended for use as a component of any articles specified in paragraph (B)(1), (B)(2), or (B)(3) of this rule, but does not include devices or their components, parts, or accessories.

(C) "Federal Food Drug and Cosmetic Act" means "FFD&CA" (March 2024 edition).

(D) "Nutrition Labeling and Education Act" means "NLEA" (November 2014 edition).

(E) "Official Methods" means the "Official Methods of Analysis of the AOAC International (OMA)" 22nd edition, Dr. William Horsitz, editor, published by AOAC International, Suite 500, 481 North Frederick Ave., Gaithersburg, Maryland 20877-2417 USA.

(F) "Officially Designated Laboratory" has the same meaning as defined in the "Grade A Pasteurized Milk Ordinance."

(G) "PMO" means the "Grade A Pasteurized Milk Ordinance" and its appendices (2019 revision) as adopted in rules 901:11-1-01 to 901:11-1-05 of the Administrative Code.

(H) "Standard Methods" means the "Standard Methods for the Examination of Dairy Products (SMEDP)", 18th edition 2024, edited by H. Michael Wehr, PhD, Jeffrey L. Komacki, PhD, Elliot T. Ryser, PhD and Cynthia M. Mangione, BA, American Public Health Association, 800 I Street, N.W., Washington, DC 02001.

Ohio Admin. Code 901:11-3-01

Effective: 10/31/2024
Five Year Review (FYR) Dates: 7/11/2024 and 10/31/2029
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.01
Prior Effective Dates: 09/20/2004, 06/06/2005, 09/19/2007, 01/10/2013, 06/16/2018