Singapore legislation
Regulation 59
Regulation 59
Supply of therapeutic products compounded under contractual agreement with licensed manufacturer
Subregulation 1
Without limiting any other provision in these Regulations, the prohibition in section 15(1) of the Act against the supply of a health product, unless the health product is registered, does not apply to a therapeutic product that is compounded in accordance with paragraph (2) and is supplied in any of the following cases:
by a licensed manufacturer of the therapeutic product to —
[Deleted by S 811/2023 wef 18/12/2023](ii)a specified healthcare service licensee for the use of a patient of the specified healthcare service licensee;
[Deleted by S 811/2023 wef 18/12/2023](c)by a specified healthcare service licensee to a patient of the specified healthcare service licensee.
Subregulation 2
For the purposes of paragraph (1), the therapeutic product must be compounded —
under an agreement between the licensed manufacturer of the therapeutic product and the specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c);
in accordance with the chemical composition and the written instructions of a qualified practitioner who is a personnel of —
[Deleted by S 811/2023 wef 18/12/2023](ii)the specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c) (as the case may be) for the use solely by or in connection with the patient mentioned in that paragraph;
in premises approved by the Authority; and
in accordance with the terms and conditions specified in the manufacturer’s licence held by the licensed manufacturer of the therapeutic product.
Subregulation 3
Paragraph (2)(b) does not apply to prohibit the supply of a therapeutic product that is not registered to any patient of a specified healthcare service licensee mentioned in paragraph (1)(a)(ii) or (c), if the requirements mentioned in paragraph (2)(a), (c) and (d) are satisfied and the compounding consists only of repacking for the purpose of dispensing the therapeutic product.