201 KAR 2:180.
RELATES TO: KRS
AUTHORITY: KRS 315.035(6), 315.191(1), (5)
FUNCTION, AND CONFORMITY: There is no existing uniform administrative
regulation for which the Kentucky Board of Pharmacy can monitor a pharmacy for
cleanliness. Existing administrative regulations pertain only to food handling
facilities. The purpose of this administrative regulation is to provide the
board with the authority to require standards for compliance.
Section 1. The
designated pharmacy area(s) shall be used exclusively for the compounding and
dispensing of drugs and other usual procedures incidental to compounding and
dispensing of drugs. This area shall be maintained in a clean and sanitary
condition, adequately lighted and ventilated.
Section 2. No
compounding or dispensing of drugs shall be carried on in any room used as a
dwelling or for usual household purposes.
Section 3. Hot
and cold water shall be readily accessible. Adequate facilities, separate and distinct
from toilets and washrooms, shall be provided for maintaining clean and
Section 4. All
equipment used in the storage, compounding, and dispensing of drugs or
medicines shall be kept in a clean and sanitary manner.
Proper temperatures shall be maintained for compounding and dispensing of drugs
and medicines. Controlled room temperatures shall be fifteen (15) to thirty
(30) degrees Centigrade, fifty-nine (59) to eighty-six (86) degrees Fahrenheit.
Refrigeration temperatures shall be two (2) to eight (8) degrees Centigrade,
thirty-six (36) to forty-six (46) degrees Fahrenheit. Freezer temperatures
shall be minus twenty (-20) to minus ten (-10) degrees Centigrade, minus four
(-4) to fourteen (14) degrees Fahrenheit. Under nonspecific conditions, it is
to be understood that the storage conditions include protection from moisture,
freezing, and excessive heat.
Violation of any provision of this administrative regulation constitutes
unethical or unprofessional conduct in accordance with KRS 315.121. (10 Ky.R.
951; eff. 2-1-84.)