Health protection requirements for pharmacies and their structural units

This Regulation establishes health protection requirements for general, veterinary and hospital pharmacies and their branch pharmacies.

(1) [Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(2) The walls, ceilings, floors and surfaces of fittings of sales halls, preparation rooms and storage rooms shall be smooth, made of water-rejecting material, easily cleanable, without holes or crevices, and able to tolerate the required disinfection measures.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(3) Wiring, pipelines, etc. shall be installed in such a way as to minimise protruding parts and sections that cannot be easily cleaned. Sewerage pipes shall not be installed under the ceiling in sales halls, preparation rooms and storage rooms.

(4) The transition between the walls and the floors shall be smooth and shall not contain any crevices. Where cover mouldings or joining strips are used, these shall be installed without leaving any spaces.

[ RTL 2009, 93, 1351 - entry into force 01.01.2010]

(5) Preparation rooms and storage rooms shall not be fitted with textile window covers, non-work-related items, flowers, etc.

(1) Artificial lighting shall be used to ensure uniform, diffused lighting.

(2) [Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(3) In preparation rooms, general lighting equipment shall be installed within or against the ceiling.

(1) A pharmacy shall have access to water supply, hot water at least in the preparation rooms, and a sewerage system.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(2) The heating system shall ensure stable temperature levels in all rooms. Stove heating may be used in pharmacies outside urban areas. The mouth of the stove shall not open to the preparation room.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(3) The auxiliary room, airlock of the sterilisation section and the toilet room shall have a hand wash sink.

(4) Where the toilet room is not located within the pharmacy complex, the pharmacy shall have an extra sink outside the preparation room.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(5) The washing room and the combined dividing-up room and washing room shall have at least a two-compartment sink for washing pharmacy utensils. Where a pharmacy prepares sterile medicinal products, the sink shall have at least three compartments, or an extra sink shall be installed.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(6) Where water is distilled in the preparation rooms, an extra sink shall be installed for the cooling water, or the cooling water shall be disposed directly into the sewerage system.

(7) Where a pharmacy not engaged in the preparation of medicinal products has a combined dividing-up and washing room with a two-compartment sink, no separate hand wash sink shall be required.

(1) Pharmacy premises shall be ventilated. The auxiliary room and the washing room shall be provided with a filter-equipped supply and exhaust ventilation system. In the washing room, mechanical air supply may be replaced with transferred air supply, if the surrounding areas are equipped with a mechanical supply and exhaust ventilation system. The ventilation system calibration and maintenance documents shall be available at the pharmacy. The dividing-up room and, in a pharmacy not engaged in the preparation of medicinal products, the washing room shall be equipped at least with mechanical exhaust ventilation.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(2) The auxiliary room shall have an air change rate of five times per hour. The auxiliary room of the sterilisation section shall have excess pressure against the surrounding rooms (approximate excess pressure of 10 Pa).

(3) The air supplied to the airlock and auxiliary room of the sterilisation section shall be filtered through filters of suitable efficiency. The air change rate shall be 15 times per hour.

(1) Pharmacy premises shall be kept clean and adhere to the requirements set forth in the Annex to this Regulation with regard to microbiologial cleanliness.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(2) The windows and doors of preparation rooms shall be kept closed at all times.

(3) Only damp-cleaning is allowed on pharmacy premises; disinfectants shall be used in the toilet room and, if necessary, elsewhere.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(4) – (5) [Repealed –RTL 2009, 93, 1351 - entry into force 01.01.2010]

(6) Cleaning equipment shall be kept in a separate, ventilated room with a drying facility, or in a naturally ventilated locker. Toilet cleaning equipment shall be kept separately from other cleaning equipment, or in the toilet room. Cleaning equipment intended for other premises may not be kept in the toilet room.

(7) Cleaning equipment may not be kept in the preparation room.

(8) Hands and dishes may not be washed in the sink used for washing pharmacy utensils, except in the case provided in subsection 4 (7).

[Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(1) [Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(2) Pharmacy staff members shall wear working clothes and footwear. Working clothes shall be kept clean.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(3) [Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(4) Working clothes and footwear shall not be worn outside the pharmacy.

(5) Outdoor clothing may not be worn in preparation rooms and storage rooms. Where goods are delivered to the storage room, the deliverer may enter the storage room for delivery of the goods.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(6) Working clothes shall be kept in a separate locker or a section of the locker separated by a partition wall.

[RTL 2009, 93, 1351 - entry into force 01.01.2010]

(7) [Repealed – RTL 2009, 93, 1351 - entry into force 01.01.2010]

(8) A hand wash sink shall be equipped with the supplies required for washing and disinfecting hands. Single-use towels or an electric hand-dryer shall be used for hand drying.

(9) Electric hand-dryers may not be installed in preparation rooms.

(10) The toilet room door may not open to the preparation room or storage room. The pharmacy's toilet room may only be used by the pharmacy staff. If the toilet room is not located within the pharmacy complex, the toilet room may only be used by the pharmacy staff and health care service providers and, in case of a veterinary pharmacy, staff of the veterinary clinic located in the same building.

(1) In pharmacies operating in rural areas and in towns with a population of less than 3,000 prior to 1 January 2004, the requirements stipulated in section 5 and subsection 7 (1) with regard to cleanness of air in auxiliary rooms shall be applied from 1 February 2007 onwards.

(2) This Regulation shall enter into force on 1 March 2005.

Annex to the Ministry of Social Affairs Regulation No 21, 17 February 2005, "Health protection requirements for pharmacies and their structural units" [RTL 2005, 105, 1604 – entry into force 21.10.2005]

Maximum number of living organisms Air CFU//m3 Air deposition method, plate with a diameter of 90 mm CFU1/4 hours2 Surfaces contact method, plate with a diameter of 55 mm, total area 24 cm2 CFU per plate Hand test 5 fingers CFU Auxiliary room 200 100 50 none Auxiliary room of sterilisation section 100 50 25 none Dividing-up room – – 50 none

1 CFU - colony forming unit.

2 Single plates may be kept open for a maximum of 4 hours. Samples are taken during working time.