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

Board Notices

Rules Relating to Good Pharmacy Practice

Chapter 2 : Professional Standard for Services

2.32 Minimum Standards regarding Destruction and Disposal of Medicines and Scheduled Substances

 

Rule 2.32 Minimum Standard for the destruction and disposal of medicines and scheduled substances

 

2.32.1 Introduction

 

The disposal and destruction of medicines and scheduled substances may only take place in accordance with the Medicines and Related Substances Act, 101 of 1965 and other applicable legislation.

 

Regulation 44 of the General Regulations published under the Medicines and Related Substances Act, 101 of 1965 states that—

 

(1) a medicine or scheduled substance shall only be destroyed by a waste treatment facility authorised to destroy medicines or pharmaceutical waste in terms of the National Environmental Waste Management Act, 59 of 2008;
(2) no medicines or scheduled substances other than those as determined by the South African Health Products Regulatory Authority (SAHPRA) shall be disposed of into municipal sewerage systems; and
(3) the disposal and destruction of medicines or scheduled substances must be conducted in such a manner to ensure that the medicines or scheduled substances cannot be salvaged, and the medicine or scheduled substance has been denatured. In addition, pharmacists and persons authorised to handle medicines in terms of the Medicines and Related Substances Act, 101 of 1965, should not dispose of medicines and scheduled substances in refuse that may be destined for landfill or municipal refuse sites.

 

In addition, pharmacists and persons authorised to handle medicines in terms of the Medicines and Related Substances Act, 101 of 1965, should not dispose of medicines and scheduled substances in refuse that may be destined for landfill or municipal refuse sites.

 

2.32.2 Purpose

 

The purpose of this standard is to ensure that the disposal and destruction of medicines and scheduled substances within pharmacies, medicine rooms or Primary Health Care Clinic (PHC) dispensaries is undertaken safely and in accordance with the requirements of Regulation 44 of the General Regulations under the Medicines and Related Substances Act, 101 of 1965, relevant waste management legislation and with due regard to minimising the risk of such an activity causing harm to the environment or harm to the health of the population.

 

2.32.3 Definitions

 

(a) Authority in terms of these Rules shall mean the South African Health Products Regulatory Authority (SAHPRA).
(b) Disposal in terms of these Rules shall mean the removal of medicines and scheduled substances from the pharmacy, medicine room or PHC dispensary for purposes of destruction by a waste treatment facility duly authorised by the National Environmental Waste Management Act, 59 of 2008.
(c) Destruction in terms of these Rules shall mean rendering the medicines and scheduled substances unusable or irretrievable for use or consumption, taking into consideration the environment and harm to the health of the population.
(d) Waste treatment facility means a site licensed in terms of the National Environmental Waste Management Act, 59 of 2008 that may be used to accumulate waste for the purpose of storage, recovery, treatment, reprocessing, recycling or sorting of that waste. N.B. Council requires that the waste treatment facility be in possession of a certificate specifically to dispose of medical waste, in line with Section 51(1)(a) of the National Environmental Waste Management Act, 59 of 2008.

 

2.32.4 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 feasible.

 

(a) All destruction must take place in accordance with local municipal regulations regarding the disposal of chemical or medicinal waste. The person responsible for the destruction may be requested to prove that the method of destruction is in accordance with such regulations.
(b) All medicines and scheduled substances (including medicines and scheduled substances returned by patients) must be disposed of in such a manner that does not allow recovery or retrieval.
(c) For the disposal and destruction of medicines or scheduled substances, refer to Regulation 44 (4-6) of the General Regulations (2017) published under the Medicines and Related Substances Act, 101 of 1965.

 

2.32.5 Minimum requirements for the disposal of medicines and scheduled substances

 

The disposal must be properly documented. All medicines and scheduled substances for disposal must be recorded in a pharmacy stock management system. In the case of specified Schedule 5 (where applicable) and Schedule 6 medicines and scheduled substances, the quantities of medicines and scheduled substances to be disposed of must be indicated in the relevant register and signed by the witnesses required in the procedure.

 

2.32.5.1 The following details should be recorded:
(a) name, quantity, strength, batch numbers (if applicable) and dosage form of the medicines and scheduled substances;
(b) date of expiry of the medicines and scheduled substances;
(c) in the event of the information detailed in Rule 2.32.5.1(a) and (b) not being available, the weight of the medicines and scheduled substances;
(d) name, position and signature of the person and the witness disposing of the medicines and scheduled substances;
(e) reason for the disposal; and
(f) date of disposal.

 

2.32.5.2 Medicines and scheduled substances destined for destruction should be separated into six types and labelled accordingly as these follow different destruction rules:
(a) solid dosage forms;
(b) creams, ointments and powders;
(c) ampoules and liquids (contained in glass);

 

[Rule 2.32 substituted by Board Notice 70, GG44822, dated 9 July 2021]