Title 201 | Chapter 002 | Regulation 180


201 KAR 2:180.Pharmacies sanitation.

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.

HISTORY: (10 Ky.R. 951; eff. 2-1-1984; Crt eff. 4-17-2019.)

7-Year Expiration: 4/17/2026

Last Action: 12/15/2021


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