Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

General Regulations

Permits, Licensing and Authorisation

44. Destruction of medicines or scheduled substances

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(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 Management: Waste Act, 2008 (Act No. 59 of 2008).

 

(2)No medicines or scheduled substances other than those as determined by the Authority shall be disposed of into municipal sewerage systems.

 

(3)The destruction or disposal 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.

 

(4)A Schedule 0 medicine or Schedule 1, 2, 3 or 4 substance or medicine must be destroyed at a site in terms of subregulation (1) and such destruction must be certified as determined by the Authority.

 

(5)A Schedule 5 or 6 substance or medicine shall be destroyed in terms of subregulation (1) in the presence of—
(a)an inspector;
(b)a pharmacist; or
(c)any other person authorised by the Chief Executive Officer.

 

(6)A Schedule 7 or 8 substance or medicine shall be destroyed in terms of subregulation (1) in the presence of—
(a)an inspector;
(b)two pharmacists; or
(c)any other person authorised by the Chief Executive Officer.

 

(7)The waste treatment facility shall issue a certificate and maintain a record of the destruction contemplated in subregulations (4), (5) and (6) which shall contain the following information:
(a)the name of the medicine or scheduled substance, if known; or the schedule of the medicine or scheduled substance concerned;
(b)the quantity destroyed;
(c)the date of destruction of the medicine or scheduled substance;
(d)the name and designation of the person in whose presence such destruction took place; and
(e)any other information as determined by the Authority.