Or. Admin. Code § 603-058-0190 - Drugs and Feed Additives
(1) Prior
to approval of a registration application and/or approval of a label for
commercial feed which contains additives (including drugs, other special
purpose additives, or non-nutritive additives) the distributor may be required
to submit evidence to prove safety and efficacy of the commercial feed when
used according to the directions furnished on the label.
(2) Satisfactory evidence to prove safety and
efficacy of a commercial feed may include:
(a)
When the commercial feed contains such additives, the use of the additive
conforms to the requirements of the applicable ingredient definition in OAR
603-058-0116 for such intended
use, or
(b) When the commercial
feed is itself a new animal drug as defined in Code of Federal Regulations,
Title 21, Part 510.3 (g) effective as of the date these rules are promulgated
and is generally recognized as safe and effective for the labeled use or is
marketed subject to an application conditionally approved by the Food and Drug
Administration under Sec. 512 [21 U.S.C. 360 b] of the Federal
Food, Drug, and Cosmetic Act, or
(c) When one of the purposes for feeding a
commercial feed is to impart immunity (that is to act through some
immunological process) the constituents imparting immunity have been approved
for the purpose through the Federal Virus, Serum and Toxins Act of 1913,
or
(d) When the commercial feed is
a direct fed microbial product and:
(A) The
product meets the particular fermentation product definition in OAR
603-058-0116, and
(B) The microbial content statement, as
expressed in the labeling, is limited to the following: "Contains a source of
live (viable) naturally occurring microorganisms." This statement shall appear
on the label, and
(C) The source is
stated with a corresponding guarantee expressed in accordance with OAR
603-508-0140(7).
(D) When the
commercial feed is an enzyme product and:
(i)
The product meets the particular enzyme definition as defined in OAR
603-058-0116, and
(ii) The enzyme activity is stated with a
corresponding guarantee expressed in accordance with OAR
603-058-0140(8).
Notes
Statutory/Other Authority: ORS 663.067
Statutes/Other Implemented: ORS 633.006-.089, 633.992, 561.605 & 561.620
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.