Singapore legislation
Regulation 48
Regulation 48
Compounding of therapeutic products at licensed retail pharmacies without manufacturer’s licence
Subregulation 1
The holder of a pharmacy licence relating to a licensed retail pharmacy may compound a therapeutic product without holding a manufacturer’s licence, if —
the therapeutic product is compounded from an active ingredient or another therapeutic product;
the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore;
the compounding is carried out —
at the licensed retail pharmacy;
by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist;
for the purposes and under the conditions described in paragraph (2), (3) or (4), whichever is applicable; and
in the case of a sterile therapeutic product, at premises where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and
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.
Subregulation 2
If the therapeutic product is to be compounded for the use of any patient under the care of a qualified practitioner and it 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, it must be compounded in accordance with —
a valid prescription given by the qualified practitioner; or
the written instructions of the qualified practitioner, if the qualified practitioner is a personnel of a specified healthcare service licensee.
Subregulation 3
Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product.
Subregulation 4
If the therapeutic product is to be compounded for the purpose of supplying for use on a ship, the therapeutic product must —
be required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. 181/2014) or any other written law, for the treatment of persons on board that ship; and
be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence.
Subregulation 5
If the therapeutic product is to be compounded for the purpose of supplying for use on an aircraft, the therapeutic product must —
form part of the medical supplies required under the Air Navigation Order (O 2) or any other written law, for the treatment of persons on board the aircraft; and
be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence.
Subregulation 6
For the purposes of section 45 of the Act, any holder of a retail pharmacy licence 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), (4) or (5).
Subregulation 7
A person who fails to comply with paragraph (6) 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.
Subregulation 8
For the purposes of section 41 of the Act, the Authority may require the holder of a retail pharmacy licence who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d).