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Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 1 : Professional Standard for Premises

1.8 Minimum Standards Specifically Relating to a Storage Area for Pharmaceuticals Outside the Physical Premises of a Pharmacy

 

1.8.1 Management of a storage facility

 

Any storage area, which is not physically an integral part of the premises of a pharmacy, must constitute part of a pharmacy licensed by the Department of Health and recorded with Council. Such a storage area must fall under the authority of the responsible pharmacist of the pharmacy of which it forms a part, and be operated in compliance with Good Pharmacy Practice. Thus, such a storage area cannot exist/operate independently of a pharmacy.

 

1.8.2 Condition of the storage area

 

(a) The walls, floors, windows, ceiling, woodwork and all other parts of the storage area must:
(i) be kept clean; and
(ii) be kept in such good order, repair and condition as to enable them to be effectively cleaned and to prevent, as far as is reasonably practicable, any risk of infestation.
(b) Walls must be finished in a smooth, washable and impermeable material, which is easy to maintain in a hygienic condition.
(c) The storage area must have an air-conditioner in good working order;
(d) Light conditions, temperature and humidity within the storage area must comply with the requirements for the storage of medicine, other pharmaceutical products, raw materials and packaging materials.
(e) The temperature in the storage area must be below 25 °C.
(f) Storage areas must have sufficient shelving constructed from a smooth, washable and impermeable material, which is easy to maintain in a hygienic condition.
(g) Storage areas for Pharmaceuticals must be self-contained and secure.
(h) Storage areas must be large enough to allow for orderly arrangement of stock and proper stock rotation.
(i) No medicine may be stored on the floor.

 

1.8.3 Control of access to the storage area

 

(a) The pharmacist must ensure that every key, key card or other device, or the combination of any device, which allows access to a storage area when it is locked, is kept only on his/her person.
(b) Control of access to the storage area must be of such a nature that only a person authorised by the responsible pharmacist has direct access to medicine.
(c) A procedure must be in place to ensure access to the storage area in an emergency situation in compliance with the Occupational Health and Safety Act, 1993.