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Compounding of therapeutic products at approved permanent premises, etc., of specified healthcare service licensees without manufacturer’s licence

Health Products (Therapeutic Products) Regulations 2016

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—(1) A specified healthcare service licensee may compound a therapeutic product without holding a manufacturer’s licence, if —(a)the therapeutic product is compounded from an active ingredient or another therapeutic product;(b)the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore;(c)the compounding is carried out —(i)[Deleted by S 811/2023 wef 18/12/2023](ii)where the therapeutic product is compounded by a specified healthcare service licensee —(A)at any approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee or, in the case of a sterile therapeutic product, at a practice setting within the approved permanent premises, temporary premises or approved conveyance where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and(B)by or under the supervision of a qualified practitioner or a qualified pharmacist who is a personnel of the specified healthcare service licensee; and(d)an appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, accompanies the compounded therapeutic product.(2) In addition to the requirements in paragraph (1), the therapeutic product must be compounded in accordance with the written instructions of a qualified practitioner, if —(a)the therapeutic product is for the use of any patient under the care of the qualified practitioner; and(b)the therapeutic product contains an active ingredient specified in Part 1 of the Second Schedule or is within any class of therapeutic products specified in Part 2 of that Schedule.(3) Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product.(4) It does not matter whether the patient mentioned in paragraph (2) is or is not a patient —(a)[Deleted by S 811/2023 wef 18/12/2023](b)at the approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee at which the compounding is carried out.(5) A therapeutic product compounded under paragraph (1) by a specified healthcare service licensee who is authorised to provide an outpatient dental service, outpatient medical service or outpatient renal dialysis service at any approved permanent premises, temporary premises or approved conveyance, must not be supplied to any of the following unless the approval of the Authority has been obtained for the supply:(a)[Deleted by S 811/2023 wef 18/12/2023](b)any approved permanent premises of the specified healthcare service licensee (other than the approved permanent premises at which the therapeutic product was compounded);(c)any approved permanent premises of another specified healthcare service licensee.(6) An application for the Authority’s approval under paragraph (5) must be made in the form and manner specified on the Authority’s website.(7) For the purposes of section 45 of the Act, a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) must ensure that the therapeutic product is compounded in accordance with the requirements in paragraph (1)(c) and (d), and, if applicable, paragraph (2).(8) A person who fails to comply with paragraph (7) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.(9) For the purposes of section 41 of the Act, the Authority may require a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d).

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