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

Board Notices

Rules Relating to Good Pharmacy Practice

3. General Considerations

 

Some of the elements in this standard are not statutory requirements but are good practice which pharmacists would be expected to follow whenever practicable.

 

3.1 All destruction must take place in accordance with local municipal regulations regarding the disposal of chemical or medicinal waste. The applicant (person requesting destruction) may be requested to prove that the method of destruction is in accordance with such regulations.
3.2 All medicines or scheduled substances (including medicines returned by patients) must be destroyed in such a manner that does not allow recovery or retrieval.
3.3 The inspector must, on behalf of the Medicines Regulatory Authority (MRA), provide a certificate of destruction and in the case of an officer of the SAPS; a case number must be provided. These references must be kept with the register for a period of 5 years.[1]
3.4 All quantities destroyed must be recorded in the relevant record on the date of destruction and signed by the applicant, indicating the reference to the destruction certificate or case number as the case may be.
3.5 The destruction must be properly documented:-
a) All quantities destroyed must be recorded and in the case of specified schedule 5 and schedule 6 medicines the quantities of medicines to be destroyed must be indicated in the relevant registers and signed by the witnesses required in the procedure;
b) Destruction certificates (where applicable) and the letter of authorisation by the Medicine Regulatory Authority(MRA) must be referenced in, or attached to the relevant specified schedule 5 and schedule 6 register and retained for the same period of time as the register itself. (5 years).
3.6 The following details should be recorded-
a) Name, quantity, strength, batch numbers (if applicable) and dosage form of the medicines or scheduled substance;
b) Date of expiry;
c) The name, position and signature of the person destroying the medicines or scheduled substance and the witness;
d) The reason for the destruction; and
e) Date of destruction.
f) The weight of the medicines or scheduled substances for medicines or scheduled substances returned by patients.

 

[1] Applicable to the destruction of schedule 5, 6,7 and 8