Pursuant to rule
901:3-17-01
of the Administrative Code, the following sections of the 21 C.F.R. 117 are
amended to read as follows:
(A)
21
C.F.R. 117.5(a) delete
existing language and insert:
"Subparts C and G of this part do not
apply to a qualified facility unless the FDA has withdrawn the qualified
facility exemption. Qualified facilities are subject to the modified
requirements in
21 C.F.R.
part 117.201."
(B)
21 C.F.R.
117.201 is amended to add the following
language:
"
(g)
Ohio department of agriculture. All records required by this
part must be made promptly available to a duly authorized representative of the
director of the Ohio department of agriculture for official review and copying
upon oral or written request."
(C)
21
C.F.R. 117.251 delete existing language and
insert:
"The process and procedure for the
withdrawl of a qualified exemption will be handled and administered by the Food
and Drug Administration."
(D)
21 C.F.R.
117.320 delete existing language and
insert:
"All records required by this part must
be made promptly available to a duly authorized representative of the director
of the Ohio department of agriculture for official review and copying upon oral
or written request."
(E)
21 C.F.R.
117.325 delete existing language and
insert:
"Records obtained by the Ohio
department of agriculture in accordance with this part are subject to
disclosure pursuant to Chapter 149. of the Revised Code.
Notes
Ohio Admin. Code
901:3-17-04
Five Year Review (FYR) Dates:
1/31/2024 and
01/31/2029
Promulgated
Under: 119.03
Statutory Authority: 3715.02, 3715.021
Rule Amplifies: 3715.59, 3715.60, 3715.62
Prior
Effective Dates: 10/29/2017
Effective: 10/29/2017
Five Year
Review (FYR) Dates: 10/29/2022
Promulgated Under:
119.03
Statutory
Authority: 3715.02,
3715.021
Rule
Amplifies: 3715.59,
3715.60,
3715.62
