Health Products (Therapeutic Products) Regulations 2016

Division 2 — Requirements for retail supply of registered therapeutic products

Supply by retail sale of prescription-only medicine

11. A person must not supply by retail sale any prescription-only medicine unless —

(a)

the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) and (2) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);

(b)

the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee;

[S 811/2023 wef 18/12/2023]

(c)

the following requirements are satisfied:

(i)	the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner;
(ii)	the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018]

(d)

the person is specified in the first column of the Third Schedule, the prescription‑only medicine is of the type specified in the corresponding paragraph in the second column of that Schedule, and the supply is in accordance with the conditions specified in the corresponding paragraph in the third column of that Schedule.

Supply by administration of prescription-only medicine

12. A person must not administer a prescription-only medicine unless —

(a)	the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner; or [S 119/2018 wef 01/03/2018]
(b)	the person is specified in the first column of the Third Schedule, the prescription-only medicine is specified in the corresponding paragraph in the second column of that Schedule, and the administration of the prescription-only medicine is in accordance with the conditions specified in the third column of that Schedule.

Supply by retail sale of pharmacy-only medicine

13.—(1) A person must not supply by retail sale any pharmacy-only medicine unless —

(a)

the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);

(b)

[S 811/2023 wef 18/12/2023]

(c)

the following requirements are satisfied:

(i)	the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner;
(ii)	the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner. [S 119/2018 wef 01/03/2018]

(2) A person who supplies by retail sale any pharmacy-only medicine must keep, at the premises where or from which the medicine is supplied, a record of every such supply, and the record must contain all of the following particulars in relation to each supply:

(a)	the date of the supply;
(b)	the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied;
(c)	the name, strength and total amount of pharmacy-only medicine to be supplied;
(d)	the dosage, and the frequency and purpose of the treatment for which the supply is made.

(3) The record required under paragraph (2) must be made on the day on which the pharmacy-only medicine is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.

(4) A supplier of a pharmacy-only medicine by retail sale must make available for inspection by the Authority at all reasonable times any record made under paragraph (2).

(5) This regulation does not apply to the supply of any pharmacy-only medicine by administration to, or application in, any person in the course of any diagnosis, treatment or test.

Restrictions on supply by retail sale of codeine cough preparations

14.—(1) A qualified practitioner or qualified pharmacist who supplies by retail sale any codeine cough preparation must not supply more than the following to any individual within a period of 7 days:

(a)	where codeine cough preparations are supplied to the individual in liquid form only — an aggregate amount of 240 ml of codeine cough preparations;
(b)	where codeine cough preparations are supplied to the individual in solid form only or in both liquid and solid forms — an aggregate amount of 355 mg of codeine (calculated as codeine base) contained in the codeine cough preparations supplied.

(2) A qualified practitioner or qualified pharmacist who supplies by retail sale any codeine cough preparation must, on each occasion of the supply of the codeine cough preparation to an individual, provide professional counselling on the use of the codeine cough preparation.

(3) A qualified practitioner who supplies by retail sale any codeine cough preparation must, on each occasion of the supply of the codeine cough preparation to an individual, in addition to complying with regulation 16, record the purpose of the treatment for which the codeine cough preparation was supplied.

[S 732/2021 wef 01/10/2021]

Supply of general sale list medicine by retail sale vending machine

15. A person may supply by retail sale any general sale list medicine by means of an automatic vending machine, if all of the following requirements are satisfied:

(a)	the person’s name and contact information is prominently displayed on the automatic vending machine;
(b)	the automatic vending machine is sufficiently equipped and secure to ensure appropriate storage conditions for the medicine;
(c)	the medicine is labelled and packaged in accordance with the conditions attached by the Authority to the registration of the medicine under the Act;
(d)	the package size of the medicine is the same as the package size specified for the registration of the medicine, and the total amount of the medicine in each package does not exceed a total dosage of 3 months per individual.

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