There are a number of guidelines and regulations that effect the supply of compounded medicines. Some of the main ones that many patients and prescribers complain about include:
(1) We cannot compound any product that is “similar” to a commercially available product. This means if a product is commercially available we cannot compound anything that may be considered similar to it. No definition or parameters have been offered by The Pharmacy Board of Australia by what exactly “similar” means, despite many requests to do so, thus many believe is intentional leaving it open to interpretation so it may be used as a means by the authorities to close a compounder down when being targeted. In the USA the parameters are clearly set leaving no room for interpretation which should be the same here in Australia.
(2) We cannot compound anything in anticipation of a sale. We can only compound it once an order has been placed (for non prescription products) or we receive a prescription. This means when you place your order we will not have final ready made product on hand to fulfil your order immediately and thus will require 24hrs to have it compounded for you.
(3) We cannot supply for “clinic use” for unspecified recipients or by wholesale. We can only compound for specific individuals.
(4) For each compounding request a risk assessment using professional judgement must be conducted to assess potential risks to the patient to determine if a product should be compounded or not. For complex compounding requests this risk assessment must be documented for each order. Complex Compounding is defined as sterile products, hazardous compounds such as hormones, doses containing less than 25mg per dose and sustained or modified release preparations. Therefore when you place an order with us as part of our legal obligations we will ask you a series of questions to help our pharmacists conduct this risk assessment.
(5) The Poisons and Therapeutic Regulations state: “An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.” This means we have to ensure the product is being used for an appropriate indication and ensure an excess supply does not occur.
We often receive complaints from customers for Points 4 and 5 listed above who interpret our questioning as either an invasion of their privacy or that we are questioning the doctors ability to prescribe appropriately. This certainly is not the case we are just trying to do our job according to the guidelines so we are not reprimanded by the authorities which are quite hostile towards compounding Pharmacies, especially in NSW.