Knowledgebase

Understanding Pharmacy Regulation and Inspection Print

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What oversight examines.

WHAT BODIES TYPICALLY HAVE AUTHORITY

The pharmacy regulatory council, over premises and practitioners The medicines regulator, over products Drug law enforcement, over controlled substances State health authorities Local authorities

WHAT INSPECTIONS EXAMINE

Premises registration and its currency The supervising pharmacist's presence and registration Products stocked, and whether they are registered Storage conditions and refrigeration records Expired stock Controlled substance register and stock Dispensing records Waste handling

WHAT COMMONLY PRODUCES FINDINGS

Expired stock on shelves Unregistered products Refrigeration records missing Controlled register not reconciled Pharmacist absent during operation

WHAT TO DO

Address each of those as routine practice, not as inspection preparation.

WHY

Preparation visible as preparation is itself a finding.

WHAT TO KEEP READY

Licences and registrations Purchase records and invoices Temperature logs Controlled substance register Dispensing records Disposal records

WHAT TO DO WHEN INSPECTORS ARRIVE

Verify identity and authority Cooperate Record what was examined and said Obtain any findings in writing

WHY RECORD

It is your account of what happened.

WHAT TO DO ABOUT FINDINGS

Address them, and evidence that you did.

WHAT TO BE CAUTIOUS OF

Anyone demanding payment without official process.

WHAT TO INSIST ON

Official receipts.


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