An updated version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been introduced by the Therapeutic Goods Administration (TGA). Major changes to the URPTG that are now in effect include:
- The introduction of two new recall actions; and
- Product defect correction. This term replaces ‘recall for product correction’ and is undertaken to correct a specific or potential deficiency. In some cases, the therapeutic good can continue to be used until a permanent correction is implemented. For example, pharmacies may be asked to replace plain bottle closures with child-resistant caps while awaiting the supply of new stock with the appropriate closure.
- Product defect alert. This is used to raise awareness of concerns regarding safety, quality, or performance while describing actions that may be taken to mitigate risks. This type of alert may be issued when discontinuation of treatment is considered a greater risk than continued use of the affected product. It is generally reserved for critical therapeutic goods that do not have an alternative and for which a recall action would result in a medicine shortage or interruption of patient treatment. A product defect alert may be followed by a recall once unaffected or alternative products become available.
- Introduction of one new type of non-recall action.
- A quarantine may be initiated when a defect is identified in released goods that has the potential to result in safety, efficacy, or performance issues. This suspends further supply and distribution of the goods while investigations are conducted, the results of which determine any further action that will be taken.
Further information on the other categories of recall and non-recall actions can be found at the TGA. HPS Pharmacies will continue to provide timely advice on drug recalls, safety, and supply issues via DrugAlert communications.
- Department of Health. Uniform Recall Procedure for Therapeutic Goods (URPTG). Woden: Therapeutic Goods Administration; 2019.