Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation35. Prescription book or permanent record |
| (1) | A prescription book or other permanent record in respect of Schedules 1, 2, 3, 4, 5 and 6 substances shall be kept in hard copy or electronically on all premises where such substances or medicines are sold or dispensed. |
| (2) | In the case of Schedule 1 medicines and substances sold by any person other than a manufacturer or wholesaler, a prescription book or other permanent record contemplated in subregulation (1) shall contain the following particulars: |
| (a) | The name of the person to whom it was sold; |
| (b) | the name and quantity of the substance or medicine; and |
| (c) | the name of the pharmacist, pharmacist intern or pharmacist's assistant who sold it. |
| (3) | In the case of Schedule 2, 3, 4 and 5 medicines and substances sold by any person other than a manufacturer or wholesaler, the prescription book or other permanent record contemplated in subregulation (1) shall contain the following particulars: |
| (a) | The name of the medicine or scheduled substance; |
| (b) | the date on which the prescription was dispensed; |
| (c) | the dosage form and quantity of the medicine or scheduled substance; |
| (d) | the name, identification number and address of— |
| (i) | the patient; |
| (ii) | in the case of a prescription for a neonate, the name, identification number and address a parent or guardian; or |
| (iii) | in the case of a prescription issued by a veterinarian, the person to whom the medicine or scheduled substance was sold; |
| (e) | where applicable, the name of the medical practitioner, dentist, veterinarian or any other authorised person who issued the prescription; and |
| (f) | prescription reference number, which is the reference number or unique identifier assigned at the point of dispensing. |
| (4) | The manufacturer or wholesaler shall keep an accessible permanent record of sales of Schedule 2, 3, 4, 5 and 6 medicines and substances in the form of invoices that shall reflect the— |
| (a) | date and transaction of the sale; |
| (b) | name of the medicine; |
| (c) | name and address of the purchaser; |
| (d) | quantities sold; |
| (e) | batch number; and |
| (f) | price at which the medicine was sold. |
| (5) | A prescription book or other permanent record contemplated in this regulation shall be kept for a period of at least five years after the date of the last entry made therein. |