Have you outgrown the “approved” premises of your pharmacy business?

When you applied to register your pharmacy premises, do you remember that the Inspector came to the premises to check each area in the plan accompanying your application, before your pharmacy could open?  Do you remember that the Pharmacy Council’s approval was given for your pharmacy to operate in the area identified in that plan?

Has your pharmacy business grown so much that you have moved your compounding or dose administrative aids packing to another part of the building?  Or even down the road?  Was that room, or the separate premises, included in the plan when the Pharmacy Council registered your pharmacy? Here  are a few tips to consider:

Do I need a professional services room?  Two things.  Preparing and packaging drugs, or simply packaging drugs, for supply to individual patients, or to patients or residents of a health care facility, or for the storage of those drugs so prepared and packaged, or just packaged, can only be done on the “approved” premises of your pharmacy OR in a professional services room which is referred to as associated with your pharmacy business.  But vaccination, consultations, use as a lunchroom (or any other activity), is not allowed in a professional services room!

Two more things.  Importantly, is there a pharmacist in charge at the professional services room all the time?  Also, is the professional services room accessible to the public?

Supervision by separate pharmacist in charge.  It is very important to note the requirement that drug preparation and packaging, or drug packaging, must be supervised by a pharmacist in charge (not a provisional, limited or non-practising registration holder) present at the professional services room premises.  Furthermore, when the pharmacy, and the professional services room with which it is associated are both operating simultaneously, each must have its own pharmacist in charge present – that is, there must be 2 pharmacists in charge at work at the same time.

No public access.  It is important to note also that unlike the pharmacy, the professional services room must be restricted from access to the public, and each owner and pharmacist in charge of the professional services room, must take all reasonable steps to prevent public access to the professional services room.  No one surplus to the compounding or dose administrative aids packing carried out in a professional services room should be there.

Prior approval & inspection / Annual Renewal of registration on or before 30 June each year.  Defined as part of a pharmacy business with which it is associated in the pharmacy’s current registration, and as premises on which pharmacy business is carried out, a professional services room must be approved (and inspected) by the Pharmacy Council before it begins operation.  Likewise, approval and inspection are required before relocation, change of address, renovation, expansion or reduction in size, before operation begins.

A professional services room must be subject to a current approval (and a separate approval fee is required).  But it is automatically included in the annual registration renewal of a pharmacy and only a single fee is payable for a pharmacy and its approved associated professional services room.

Forms, plans, documents / Approval standards and Publications.  As with pharmacy premises approval, the Pharmacy Council’s application form must be used, and the application must be supported by scaled floor plans with dimensionsOther accompanying documents needed are listed on the application form.  Standards for the approval of professional services room premises are set out in clause 13 of the Regulations to the National Law (NSW).  A second set of publications is needed for the professional services room; these are set out in Schedule 6 of the Regulations.  These clauses 13 and Schedule 6 requirements are different from those applying to a pharmacy.