policies and procedures for non-sterile compounding
A written procedure for each activity the standards cover, from attire and hand hygiene to beyond-use dates, verification, hazardous waste and recalls. Built from a gap analysis of your pharmacy, written in your pharmacy’s name, and reviewed with your supervisor before sign-off.
What the standards ask for
Policies and procedures must exist for all compounding activities, including cleaning. They must be clear and detailed enough to follow, and reviewed at least every 3 years, or sooner when practice or standards change. Ontario’s assessment criteria add that they must be readily retrievable by staff. Pharmacies that handle hazardous products need additional procedures. A generic binder rarely describes your room, your equipment or who does what, and that is what the procedures are for.
The 33 topics
Table 3 of the guidance document lists the policies and procedures a compounding pharmacy may need. We write to that list and keep its numbering unless you prefer your own.
A. Personnel and facilities
- Attire and dress code; health conditions; expected behaviour in compounding areas
- Initial training and assessment; maintenance of competency; cleaning personnel; additional training for complex or hazardous products
- Delegation and supervision
- Access to the compounding area; facilities and equipment; maintenance and calibration; cleaning
B. Compounded preparations
- Beyond-use dates of ingredients and of final preparations
- Hand hygiene and personal protective equipment
- Bringing equipment and products into the room
- Verification of the compounding process and of final preparations
- Labelling, packaging, storage, transport and delivery
- Recording preparations in the patient file; recalls
- For hazardous products: receipt, unpacking and storage; cleaning of the containment device; hazardous waste; accidental exposure; spills
C. Quality assurance program
- Verification and maintenance of equipment; storage of ingredients
- Environmental control of facilities and the containment device
- Monitoring for hazardous contamination
- Quality assurance of compounded preparations
Not every topic applies to every pharmacy. A pharmacy that handles no hazardous products does not need a procedure for cleaning a containment device. The gap analysis settles which ones you need. The full list, explained
How it works
- Questionnaire. About 40 minutes. It covers your scope of compounding, facility, equipment, staff, suppliers and the procedures and logs you already have. Answer as things are done now, not as you would like them to be.
- Call and walk-through. A 45-minute call with your compounding supervisor, including a live video walk through the compounding area.
- Gap analysis and proposal. A topic-by-topic comparison with Table 3 and a fixed quote for what your pharmacy actually needs: a complete set, only the gaps, or an update of existing procedures.
- Drafting. Procedures are typically delivered within 60 days of the agreement.
- Review. Each procedure is reviewed with you before it is finalized for signature.
What you receive
- Each procedure in the structure of the guidance document’s template: aim, personnel concerned, facilities and materials, the procedure itself, logs, references and revision history
- The forms and logs the procedures refer to, or references to the ones you already use
- Word files in your pharmacy’s name, with space for approval signatures and review dates
Common questions
Our procedures are several years old. Do we need new ones?
Under the model standards, procedures must be reviewed at least every 3 years, and sooner when practice or standards change. If yours have not been, start with the gap analysis. Many can be updated and dated again; some will need rewriting.
Our supervisor completed the Ontario training course. Does that cover procedures?
The course explains what is required. It does not supply your pharmacy’s procedures; those still have to be written for your room, your equipment and your staff.
Can you train our staff on the new procedures?
A staff training session can be added to the proposal.
Who approves the procedures?
Your pharmacy does. The supervisor or manager approves and signs each procedure, and that signature is what makes it your pharmacy’s policy.