Pharmacy Act, 1974 (Act No. 53 of 1974)Board NoticesRules Relating to Good Pharmacy PracticeChapter 2 : Professional Standard for Services2.18 Compounding |
| (a) | Compounding must be done under the direct supervision of a pharmacist, except in circumstances where specific exemption is granted in terms of the applicable legislation. |
| (b) | All compounding processes must be in accordance with SOPs authorised by a pharmacist. |
| (c) | All the necessary requirements must be provided, including: |
| (i) | appropriately trained personnel; |
| (ii) | adequate premises and space; |
| (iii) | suitable equipment and services; |
| (iv) | correct materials, containers and labels; |
| (v) | approved procedures (including cleaning procedures); and |
| (vi) | suitable storage and transport. |
| (d) | Procedures must be written in instructional form and be applicable to the facilities provided. |
| (e) | Compounding may be done by pharmacy support personnel registered with Council who have the appropriate scope of practice and who are competent to perform the procedures concerned. |
| (f) | Records must be kept during the process which demonstrate that all the steps required by the defined procedures were taken and that the quantity and quality produced were those expected. |
| (g) | A system must be in place to recall any batch or product, should it be necessary. |
| (h) | High standards of personal cleanliness must be observed by all those concerned with the compounding process. |
| (i) | Hand-washing facilities must be conveniently available to the personnel involved. |
| (j) | Storage areas must provide adequate space and must be arranged and equipped to allow dry, clean and orderly placement of store materials and products under controlled conditions of temperature and humidity. |
| (k) | Equipment used for compounding must be designed and maintained in such a way as to: |
| (i) | be suitable for its intended use; |
| (ii) | facilitate thorough cleaning when necessary; |
| (iii) | minimise any contamination of drugs and their containers; and |
| (iv) | minimise the risk of confusion or the omission of a processing step such as filtration or sterilisation. |
| (l) | Equipment and utensils must be thoroughly cleaned and, if necessary, sterilised and maintained in accordance with specific written directions. |
| (m) | Before the commencement of any compounding, a check must be made to ensure that all apparatus and equipment to be used have been cleaned/sterilised. |