- Non-sterile preparations include capsules, oral liquids, topicals, troches, and suppositories.
- They're prepared in a designated, clean compounding area with trained staff.
- Each preparation follows a written formula and is documented in a compounding record.
- Beyond-use dates depend on the type of preparation and whether it contains water.
- Hazardous drugs also fall under USP <800>.
Common non-sterile dosage forms
| Form | Often used when |
|---|---|
| Capsules | A strength isn't available, or a filler or dye needs to be left out |
| Oral liquids and suspensions | Someone can't swallow tablets, or a child needs a measured dose |
| Creams, gels, ointments | A medication works better applied to the skin |
| Troches and lozenges | The medication dissolves in the mouth |
| Suppositories | Taking medication by mouth isn't practical |
The compounding space
Non-sterile compounding doesn't require a cleanroom, but it does require control:
- A designated area separated from other pharmacy activities, cleaned on a set schedule.
- Calibrated balances and clean equipment, so doses are accurate and nothing carries over between preparations.
- Hand hygiene and gloves, plus other garb as the task requires.
- Separate handling and containment for hazardous drugs under USP <800>.
Ingredients and records
- Ingredients should meet USP or NF standards where they exist and come from FDA-registered facilities with a certificate of analysis.
- A master formulation record is the written recipe: ingredients, amounts, equipment, steps, and the beyond-use date.
- A compounding record documents each time the preparation is made: who made it, ingredient lot numbers, and the checks performed.
Beyond-use dates
When there's no specific stability data, <795> sets default beyond-use dates based on the type of preparation. Preparations that contain water can support microbial growth, so they get shorter dates.
| Type of preparation | Default beyond-use date |
|---|---|
| Water-based, no preservative | 14 days, refrigerated |
| Water-based, with preservative | 35 days |
| Non-aqueous (oils, ointments, some liquids) | 90 days |
| Solid dosage forms (capsules, tablets) | 180 days |
A longer date is allowed when it's supported by a stability study. Your label always shows the date that applies to your medication.
Training and competency
Staff who compound must be trained before they start and demonstrate competency at least every 12 months, covering hand hygiene, garbing, cleaning, and the compounding steps themselves.
What you can do at home
- Follow the storage instructions and beyond-use date on your label.
- Shake suspensions before each dose so the medication is evenly mixed.
- Use the measuring device that came with a liquid, not a kitchen spoon.
- If something looks, smells, or feels different than usual, call your pharmacy.
Pharmaneek and compounding
Our role
Pharmaneek does not compound medications. This guide explains how compounding pharmacies and FDA-registered outsourcing facilities are regulated. For questions about a specific prescription, contact your prescriber or dispensing pharmacy.
Contact Pharmaneek or browse our patient education resources.
Frequently asked questions
Why does my compounded cream have a shorter date than store-bought?
Manufactured products have expiration dates backed by long stability studies. A compounded preparation gets a beyond-use date under USP rules, which is usually shorter unless stability data supports more.
Why do I have to shake my liquid medication?
Many compounded liquids are suspensions, where the medication settles over time. Shaking spreads it evenly so each dose is correct.
Can a pharmacy leave out an ingredient I'm allergic to?
Often, yes. If your prescriber orders it, a compounding pharmacy can prepare a version without a specific inactive ingredient, such as a dye or lactose. Ask your prescriber and pharmacist.
Educational content only. It is not medical advice and does not replace advice from your prescriber or pharmacist. Compounded medications are not FDA-approved and require a valid prescription. Last updated October 2026.