Non-sterile compounding documentation services
Three document sets cover the core documents the standards ask a compounding pharmacy to write. Order one, or all three. Every set is written for your pharmacy by a pharmacist, delivered as editable Word files that are yours to keep, and quoted at a fixed price before work starts. There is no software to learn and no subscription.
How an engagement runs
- Intake. For master formulation records and risk assessments, send your list of preparations with the formulas as you make them. For procedures, complete the intake questionnaire, which takes about 40 minutes.
- Call. For procedure work we hold a 45-minute call with your compounding supervisor. A live video walk-through of the compounding area is the most useful part.
- Gap analysis and quote. You receive a list of what is missing or out of date and a fixed quote for the documents you choose.
- Drafting. Work starts on receipt of the signed agreement and a 50% deposit. Typical delivery is within 30 days for master formulation records and risk assessments, and within 60 days for a procedure set.
- Review and sign-off. One round of revisions is included if requested within 14 days of delivery. Your supervisor then approves, signs and dates the final documents.
What every set includes
- Documents in Microsoft Word, in your pharmacy’s name, that you can edit and maintain
- References for beyond-use dates, hazard classifications and risk levels
- A confidentiality clause covering your formulas and business information
- Ownership of the documents once the fee is paid
What is not included
Laboratory, stability or analytical testing; hood or room certification; facility design; and updates after the revision period, which are quoted separately. Changing a formula after drafting has started may change the fee.
Pricing
Fees are 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. Send your list and we will reply with a fixed quote. You pay for the documents you order, and there is no subscription.
Compounding software or finished documents?
Compounding software gives your team a system for building and managing records. It suits a pharmacy that wants batch records, training and equipment tracking in one place, and has staff time to set it up and keep it running. Our service delivers the documents themselves.
| Compounding software | Our service | |
|---|---|---|
| What you get | A system for building and managing your records | Finished records and procedures, written for your pharmacy |
| Who does the work | Your team enters or imports each formula and procedure, and checks what the system produces | A pharmacist writes each document from your formulas and safety data sheets. Your supervisor reviews and signs |
| Getting started | Accounts and roles to set up, records to import, staff to train | Send your list of preparations. For procedures, a 40-minute questionnaire and a 45-minute call |
| How you pay | A subscription, for as long as you use it | One fixed price per document set, quoted before work starts |
| Where your documents live | In the vendor’s system | In your own files, as editable Word documents |
| Day-to-day records | Batch records, logs and reminders kept in the system | A compounding record form and the logs your procedures call for, kept on paper or on your own computer |
The two also work together. Software stores and manages records, but someone still has to prepare each one and check it. If you use a platform now, or adopt one later, the documents we write can be brought into it.
Common questions
We already have some documents. Can you work with them?
Yes. Send what you have, in any format. The gap analysis shows what can stay, what needs updating and what is missing, and the quote covers only that.
Do you cover hazardous preparations?
Yes. Risk assessments and procedures address hazardous drugs and materials, including the extra procedures the standards require of pharmacies that handle them: receiving and storage, cleaning of the containment device, spills, accidental exposure and hazardous waste.
Do you write documents for veterinary compounding?
Yes. The standards apply to preparations for animals as well as people.
Can the documents be in French?
Procedures can be delivered in English, French or both.
Do you help with sterile compounding?
No. This service covers non-sterile compounding only.