Statement of Scope
Pharmacy Examining Board
Rule No.
:
|
Ch
apter
Phar 6
|
|
|
|
Relating to
:
|
Temperature and Humidity
Controls
|
1. Finding/nature of emergency (Emergency Rule only):
N/A
2
.
Detailed description of the objective of the
proposed
rule
:
The objective of the proposed rule is to
create rules relating to temperature and humidity requirements to ensure the integrity of the pharmaceuticals prior to dispensing.
3
.
Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives
:
Currently there are not rules relating to the temperature and humidity requirements
for a pharmacy
. Pharmaceuticals
need to be
stored, compounded or maintained
in the correct environment
in order to ensure the product quality, safety and
efficiency
.
4
.
Detailed explanation of statutory authority for the rule
(including
the
statutory citation and language):
15.08
(5)
(b)
The Board shall promulgate rules for its own guidance and for the guidance of the trade or
profession
to which it pertains, and define and enforce professional conduct and unethical
practices not inconsistent with the
law
relating to the particular trade or profession.
450.02
(3)
The Board may promulgate rules relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
450.02
(3)
(d)
The
B
oard may promulgate rules necessary for the administration and enforcement of this chapter and ch.
961
.
450.02
(3)
(e)
The Board may promulgate rules establishing minimum standards for the practice of pharmacy.
5
.
Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule
:
80 hours
6
.
List with description of all entities that
may
be affected by the proposed rule
:
Pharmacies and Pharmacists
7
.
Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule
:
None
8
. Anticipated economic impact of implementing the rule
(note if the rule is likely to have a significant economic impact on small businesses)
:
Minimal economic impact. It is not likely to have a significant economic impact on small business.
Contact Person:
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
