Pharmacy Act, 1974 (Act No. 53 of 1974)Board NoticesRules Relating to Good Pharmacy Practice4. Legislative Requirements |
4.1 | A medicine containing Schedule 1, 2, 3, and 4 substances may only be destroyed in the presence of a pharmacist or an authorised person in charge of a place where medicines or scheduled substances are kept. Such pharmacist or authorised person shall certify such destruction; |
4.2 | For medicines containing a Schedule 5 and 6, 7 or 8, the Responsible pharmacist of the institution/facility where the medicines are kept, should first obtain approval for destruction from the MRA. The request should be made on the institution/facility letterhead stating the following details: |
a) | Name, quantity, strength, batch numbers (if applicable) and dosage form of the medicines or scheduled substance; |
b) | Date of expiry; |
4.3 | The medicines in Rule 4.2 may only be destroyed in the presence of an inspector, an officer of the South African Police Service or any other person authorized by the Director General. Such inspector or person or officer, as the case may be, shall issue a certificate confirming the destruction of the medicine and in the case of an officer, the case number must be entered in the register, |
4.4 | Notwithstanding the Rule 4.1 and 4.2 the Medicines Control Council may authorize in writing the destruction of specified schedule 5 and 6 substances by a manufacturer of such substances in the absence of an inspector. |