About Us / How to choose a compounding pharmacy
Patient guideHow to choose a compounding pharmacy.
A compounded medication is made for you, one prescription at a time, so the pharmacy that makes it matters. Here's what to look for, the questions worth asking, and how we answer them.
- AccreditedReviewed by an independent accrediting organization.
- Meets USP standardsUSP <795>, <797> and <800>.
- A controlled labCertified, monitored and calibrated.
- Known ingredient sourcesA certificate of analysis for every lot.
- Independent testingSterile batches tested before release.
- Written proceduresAnd a pharmacist check on every preparation.
- A pharmacist you can reachFor you and for your prescriber.
Eight things a careful compounding pharmacy should be able to show you.
Any pharmacy you trust with a compounded prescription should be glad to answer these. Here's why each one matters and what we do.
1. Accreditation
Accreditation means an outside organization has reviewed how the pharmacy compounds and holds it to a published set of standards. It's voluntary, so not every pharmacy has it.
What we do: We're accredited by The Compliance Team.
2. USP standards
The United States Pharmacopeia (USP) sets the national standards for compounding: USP <795> for nonsterile preparations, USP <797> for sterile preparations and USP <800> for handling hazardous drugs safely.
What we do: Our nonsterile lab meets USP <795>, our sterile products meet USP <797>, and we're USP <800> compliant.
3. Laboratory standards
The room and equipment a medication is made with affect its quality. Look for a certified clean room for sterile work, monitoring of the air and surfaces, tested hoods and calibrated balances.
What we do: Our clean room is certified on a regular schedule, we monitor the environment where sterile products are made, our hoods are tested, and our balances and equipment are calibrated.
4. Product sourcing
A compounded medication is only as good as its ingredients. Ask where they come from and whether each lot arrives with a certificate of analysis documenting its identity and potency.
What we do: We buy from established compounding suppliers: Medisca, Fagron, PCCA and Specialized Rx. Active ingredients come from FDA-registered and inspected facilities, and every lot arrives with a certificate of analysis.
5. State standards
Every state sets minimum requirements for compounding. Ask whether a pharmacy simply meets the minimum or holds itself to more.
What we do: We exceed the compounding standards required in the state of Florida.
6. Independent testing
Sterile preparations should be tested by an independent laboratory before they're released, not just checked in-house.
What we do: Pharmetric Labs, an independent laboratory, tests every sterile batch for sterility, endotoxins and potency.
7. Policies and procedures
Written procedures make every preparation consistent, no matter who makes it. Ask whether the pharmacy follows documented procedures and whether a pharmacist checks every preparation before it goes out.
What we do: We follow written procedures for how we compound, clean, label and check our work. A pharmacist verifies every preparation before it's dispensed, and every label shows a beyond-use date.
8. A pharmacist you can reach
You and your prescriber should be able to talk to a pharmacist about the formulation, how to use it and what to expect.
What we do: A real person answers the phone, and our pharmacists talk directly with patients, prescribers and veterinary teams. Our pharmacists also hold Veterinary Compounding Specialty certification from Pharmacon.
Bring these questions to any compounding pharmacy.
A good pharmacy will answer them plainly. If you'd like to hear our answers, call and ask for a pharmacist.
- Are you accredited, and by whom?
- Do you meet USP <795>, <797> and <800>?
- Where do your ingredients come from, and does each lot have a certificate of analysis?
- Do you meet or exceed your state's compounding standards?
- Who tests your sterile preparations, and for what?
- Is your clean room certified and monitored?
- Does a pharmacist check every preparation?
- Can my prescriber talk to your pharmacist directly?
Signs to slow down and ask more.
No clear answer about ingredients
If a pharmacy can't tell you where an ingredient comes from or whether it was tested, ask before you fill.
No way to reach a pharmacist
Compounded medications often need a conversation. You should be able to talk to the person responsible for making yours.
No mention of USP standards
Every compounding pharmacy should be able to tell you which USP chapters it follows and how.
Sterile products without outside testing
For sterile preparations, ask whether batches are tested by an independent laboratory before release.
See exactly how we make and test your medication.
Our quality page covers sourcing, our two labs and how sterile batches are tested.
Compounded medications are not FDA-approved. They are prepared for an individual patient based on a prescription. The FDA does not review compounded drugs for safety, effectiveness or quality before they are dispensed. Learn more from the FDA.
Call us. A person will answer.
Tell us what you need and we'll help you get it handled, whether it's a transfer, a compound or a question for your pharmacist.