FMD – PSI Compliance Approach

Since the end of the FMD ‘Use & Learn’ period on 30 May 2022, while compliance with the directive has been high across the community pharmacy sector, some members are receiving emails from the PSI about scanning activity in their pharmacy. Following discussion with individual pharmacies about this correspondence, on 20 July we met with the PSI to discuss the approach taken to enforcing compliance with FMD.

We outlined to the PSI that there are quite a few medicinal products and medical devices that do not require authentication (e.g., test strips, ULMs, nutritional supplements, foods, OTCs, etc.). Furthermore, such items and other factors (broken bulk, split packs, software, hardware) contribute for the pharmacy’s prescription register (daily audit log) and the FMD Scanning Activity report will rarely match.

It was agreed with the PSI that the initial approach was heavy-handed, and the PSI’s current focus is now on the very few pharmacies that are not scanning to decommission. In general, the PSI is encouraged that compliance with FMD is very high and it will now explore introducing compliance into their routine inspections.

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