Compounding of therapeutic products

Understand the requirements on compounding therapeutic products by licensed hospitals, medical clinics and retail pharmacies.

Overview

Compounding of therapeutic products includes activities such as formulating, mixing, assembling or repacking of therapeutic products. Healthcare institutions (HCI) or retail pharmacies should only resort to compound their own therapeutic products if there are no commercially available registered products available.

Note: Dilution or reconstitution of a therapeutic product in accordance with the directions for use on the product’s label is not considered a compounding activity.

HCI or retail pharmacies can compound a therapeutic product without holding a manufacturer’s licence under the following conditions:

  1. The final compounded therapeutic product is not commercially available in Singapore.
  2. The compounding is done at the licensed HCI or retail pharmacy premise. For sterile therapeutic products, the compounding must be done at a practice setting within the licensed HCI or pharmacy where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented.
  3. The compounding must be done by or under the supervision of a qualified practitioner or pharmacist practising in the licensed HCI or pharmacy.
  4. An appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, must accompany the compounded therapeutic product.
  5. Therapeutic products containing an active ingredient of a Prescription-only medicines (POM) and intended for a patient's use must be compounded in accordance with a valid prescription or the written instructions of a qualified practitioner who is responsible for the patient's care. This does not apply if the compounding only involves repacking of a therapeutic product for the purpose of dispensing it. For the product to be compounded for regular clinical use, the written instructions have to be documented and maintained for at least two years.

Licensed HCI

Transfer of compounded therapeutic products to another healthcare institution

Hospitals and medical clinics may transfer their compounded therapeutic products to another licensed healthcare institution, if these preparations are not commercially available.

Medical clinics need to seek prior approval from us to perform the transfer of compounded therapeutic products to another HCI. You can submit your request, with the following information:

  • Name, designation and curriculum vitae of pharmacist responsible for compounding services.
  • List of compounded therapeutic products prepared at the medical clinic (indicating the active ingredients, final form or packaging of the compounded products and their appropriate expiry dates, where applicable).
  • For sterile compounded therapeutic products, include a description of the adopted practice setting, clean rooms, equipment and quality standards.

Note:

Select "Health Products Regulation" under "Case Classification" and "Good Manufacturing Practice (GMP) under "Type".

HCIs do not need a wholesaler’s licence to perform the transfer of their compounded therapeutic product to another HCI. However, the HCI responsible for compounding the therapeutic product is expected to comply with the following legal obligations and duties:

  • Maintain records of receipt and supply.
  • Make records available to us upon request.

Outsource of compounding to a third party

HCIs intending to outsource the compounding of therapeutic products to a third party must ensure that the following conditions are met:

  • The third party is a manufacturer licensed by us.
  • Compounding is performed:
    • At the approved premise and under the conditions specified in their manufacturer’s licence issued by us.
    • In accordance with the chemical composition and the written instructions of a qualified practitioner practising at the hospital or medical clinic. This does not apply if the activity only consists of repacking of the therapeutic product for the purpose of dispensing.
  • A contractual agreement between the hospital or medical clinic and the licensed manufacturer must be established.

Licensed retail pharmacies

Supply of compounded therapeutic products to ships or aircrafts

A licensed retail pharmacy can compound a therapeutic product to supply to a ship or aircraft for the treatment of persons on board only if the compounded therapeutic product:

  • Is not commercially available.
  • Is required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Cap. 179, Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. 181/2014) or form part of the medical supplies required on board the aircraft under the Air Navigation Order (Cap. 6, O 2).
  • Is compounded in accordance with the terms and conditions specified in their valid pharmacy licence.
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