Non-sterile compounding documentation for pharmacies
We write the master formulation records, risk assessments and policies and procedures that the non-sterile compounding standards require, specific to your preparations, your equipment and your compounding area. You receive finished Word files that are yours to keep, at a fixed price. There is no software to learn and no subscription.
Done for you, and yours to keep
You do not get a system to fill in. You get the documents.
We do the writing
You send your formulas and safety data sheets and, for procedures, answer a questionnaire. A pharmacist writes each record, assessment and procedure for your pharmacy. Your staff do not have to learn a system or enter data.
You own the files
Everything arrives as editable Word files in your pharmacy’s name, and it is yours once the fee is paid. Print it, keep it on your own computer, or bring it into whatever system you use.
One fixed price
You get a quote before work starts and pay for the documents you order. There is no subscription and no per-user fee. Later updates and reviews are quoted the same way, only when you want them.
Compounding software gives your team a system to build records in. We give you the records. How the two compare
We handle the paperwork. You handle the patient care.
Pharmacy Compounding Compliance is a documentation service run by a practising Ontario pharmacist. Under the standards in force in Ontario, Alberta and other provinces, a pharmacy that compounds needs a risk assessment and a master formulation record for every preparation, written procedures for everything from hand hygiene to recalls, and a quality assurance program that shows the procedures are followed.
Writing all of that properly takes weeks that most dispensaries do not have. That is the part we do. Who we are
Three document sets, ordered separately or together
Each set is written from your own formulas, safety data sheets, equipment list and floor plan. Nothing is a fill-in-the-blank template.
Master formulation records
Risk assessments
Policies and procedures (SOPs)
Written to the standards your regulator has adopted
Ontario and several other provinces have adopted the Model Standards for Pharmacy Compounding of Non-Sterile Preparations, with its guidance document, as their requirement, and Alberta publishes its own adapted version. Each college assesses pharmacies in its own way, and some, such as Ontario’s, publish their assessment criteria. Our documents follow the standards section by section and are adjusted to what your college asks for.
A risk assessment for every preparation
The standards require a documented risk assessment for each preparation, kept under regular review: at least every 12 months under the national model. Ours identifies the hazards of every ingredient from the NIOSH list and the safety data sheets, weighs quantity, frequency and cumulative exposure, states the complexity, and gives a reasoned Level A, B or C with the controls that apply in your pharmacy. About the risk assessment service
- Hazards identified from the NIOSH 2024 list and WHMIS
- Quantity, frequency and cumulative risk weighed
- A level rationale an assessor can follow
A master formulation record for every formula
A master formulation record holds everything needed to make a preparation the same way every time: ingredients and quantities, calculations, equipment, the compounding method, quality controls, packaging, labelling, storage, and a beyond-use date with the references behind it. We write one for each formula you send us, in the layout the guidance document sets out. About the MFR service
Policies and procedures that match what you actually do
The guidance document lists 33 policy and procedure topics, from attire and hand hygiene to hazardous waste and recalls. We start with a questionnaire and a video walk-through of your compounding area, compare what you have with that list, and write the procedures that are missing or out of date. About the SOP service
- Gap analysis against the 33 topics
- Procedures in your pharmacy's name and numbering
- Each one reviewed with your supervisor before sign-off
How it works
- Tell us what you compound. Send your list of preparations, or ask for our intake questionnaire. For procedures we also book a 45-minute call with your compounding supervisor, with a video walk-through of the compounding area.
- Get a fixed quote. The quote is per document set and states what will be delivered and when. Work starts when the agreement is signed and the deposit is received.
- Review the drafts. Master formulation records and risk assessments are usually delivered within 30 days, a full procedure set within 60. One round of revisions is included.
- Sign and file. You receive editable Word files. Your supervisor reviews, signs and dates them, and they become your pharmacy’s own records.
Who writes your documents
Every document set is written and checked by Dumitru Musteata, RPh, an Ontario pharmacist who manages a community pharmacy that compounds non-sterile preparations. He works under the same standards as the pharmacies he writes for. More about the service
Common questions
Do you guarantee that we will pass an assessment?
No, and no one can. The documents give your pharmacy what the standards ask for in writing. Your regulator also looks at your facility, your equipment, your training records and whether staff follow the procedures. Responsibility for compounding practice stays with the pharmacy’s manager and compounding supervisor.
Which provinces do you work with?
Ontario, Alberta and British Columbia have their own pages on this site. For another province or territory, tell us your regulator and we will confirm what it requires, and whether we can help, before quoting. Requirements by province
Is this software?
No. It is a service. A pharmacist writes your documents and sends them to you as Word files. There is nothing to install, no login, and no data entry for your staff. How this compares with compounding software
How is the price set?
Per document set: by the number of preparations for master formulation records and risk assessments, and by the number of procedures for policies and procedures. You get a fixed quote before anything starts.
Is there a monthly fee?
No. You pay once for the documents you order. Updates after delivery and the 12-month review of risk assessments are quoted separately, only if you want them.
What do you need from us?
Your formulas as you make them now, your supplier list and the safety data sheets you have, and for procedures a completed questionnaire. We never need patient information.