201 KAR 2:180. Pharmacies sanitation

Link to law: http://www.lrc.ky.gov/kar/201/002/180.htm
Published: 2015

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      201 KAR 2:180.

Pharmacies sanitation.



Chapter 315


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

sanitary conditions.


      Section 4. All

equipment used in the storage, compounding, and dispensing of drugs or

medicines shall be kept in a clean and sanitary manner.


      Section 5.

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.


      Section 6.

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.)