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FMD compliance to be included in GPhC pharmacy inspections

The GPhC will be responsible for ensuring community pharmacies are compliant with the EU’s scanning law as part of its inspection process, the regulator has confirmed.

The EU’s medicines scanning law, the Falsified Medicines Directive (FMD), is set to come into force on February 9 and will require all pharmacies to scan barcodes on medicines packaging at the point of dispensing.

In an impact assessment published in July, the Medicines and Healthcare products Regulatory Agency (MHRA) identified a theoretical risk that pharmacists could “fail to decommission products” – scan them to verify their authenticity.

One way to mitigate this risk, the MHRA stated in the impact assessment, would be to use “regulatory inspections” to ensure compliance, as well as “sanctions to enforce” it.

At the time, the General Pharmaceutical Council (GPhC) told C+D it was “too early to say” what its “respective role” would be in monitoring FMD compliance.

However, the regulator confirmed yesterday (January 17) that checking pharmacies were compliant with the scanning law will be part of its pharmacy inspections.

If GPhC inspectors identify breaches of the FMD legislation, “the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action”, the regulator said.

The responsibility for decisions regarding “instigating any enforcement action in relation to the safety features legislation” will fall to the MHRA, the GPhC said.

This “may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches”, it added.

Brexit uncertainty

The GPhC stressed that “all health and care providers, including registered pharmacies, are expected to meet the [FMD] requirements under UK law”.

Last month (December 24), the MHRA confirmed that in the case of a no-deal Brexit, UK “stakeholders” – including pharmacies – will not be able to participate in the system after the country is scheduled to leave the EU on March 29.

However, government officials have suggested pharmacies should prepare for the FMD regardless of a no-deal Brexit, as any UK-focused scheme would be based on a similar system.

C+D revealed earlier this month that 64% of UK contractors in the Salary Survey 2018 said they were unprepared for the FMD, and 77% of contractors said they had not yet bought the scanners required to comply with the legislation.

Have you installed a scanner in your pharmacy?

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