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.
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.