| (a) |
compounding a medicine for sale in terms of section 14(4) of the Act must only compound a quantity that is related to a treatment regimen of a particular person or animal to be used by the person or for the animal for not more than 30 consecutive days from the date of sale; |
| (b) |
must indicate clearly on the label of a medicine compounded for sale in the retail trade in terms of section 14(4)(b) of the Act the— |
| (i) |
dates of compounding and sale; and |
| (ii) |
statement "Use within X days", where X relates to the number of days within which the medicine should be used; and |
| (c) |
may, in the case of medicine intended for the retail trade, based on the amount of medicine compounded previously for a particular period, compound such medicine in anticipation of supply thereof within such particular period. |
[Regulation 3 substituted by section 3(a) of Notice No. 2853, GG47673, dated 8 December 2022]
| (2) |
Any medicine compounded in terms of section 14(4) may not be advertised or displayed for sale. |
| (3) |
No medicine may be compounded by a pharmacist, veterinarian or a person licensed in terms of section 22C(1)(a) of the Act to compound a medicine for sale— |
[Words preceding (3)(a) regulation 3 substituted by section 3(b) of Notice No. 2853, GG47673, dated 8 December 2022]
| (a) |
[Regulation 3(a) deleted by section 3(c) of Notice No. 2853, GG47673, dated 8 December 2022]; |
| (b) |
which has been declared undesirable in terms of section 23 of the Act or prohibited in terms of section 36A of the Act in the case of a veterinary medicine; |
[Regulation 3(b) substituted by section 3(d) of Notice No. 2853, GG47673, dated 8 December 2022]
| (c) |
for the purpose of growth promotion or performance enhancement; |
| (d) |
for the purpose of administering to food-producing animals if— |
| (i) |
Maximum Residue Limits (MRL); and |
| (ii) |
appropriate withdrawal times, |
have not been established;
| (e) |
for use by a patient not under the professional care of an authorised prescriber or pharmacist; |
| (f) |
[Regulation 3(f) deleted by section 3(e) of Notice No. 2853, GG47673, dated 8 December 2022]; |
| (g) |
unless the compounding thereof is performed in accordance with good compounding as determined by the Authority. |
[Regulation 3(g) substituted by section 3(f) of Notice No. 2853, GG47673, dated 8 December 2022]
Publication of guidelines
| (4) |
The Authority must Within six (6) months of the date of publication of this regulation in the government gazette, publish draft guidelines on good compounding practice for public comment. |
[Regulation 3(4) (Publication of guidelines) inserted by section 4 of Notice No. 2853, GG47673, dated 8 December 2022]
Protection of Businesses Act, 1978
