About Us / Quality and sourcing
Quality and sourcingQuality you can ask us about.
We exceed the compounding standards required in the state of Florida. Every compounded medication starts with a verified ingredient and a formula adjusted to that exact lot, and every batch of sterile product is tested by Pharmetric Labs, an independent laboratory, before it reaches you.
- Established suppliersIngredients from Medisca, Fagron, PCCA and Specialized Rx.
- Potency-adjusted formulasWe calculate each batch from the lot's certificate of analysis.
- Every sterile batch testedPharmetric Labs tests each batch for sterility, endotoxins and potency.
- Beyond Florida's requirementsWe exceed the compounding standards required in the state of Florida.
It starts with the ingredient.
We buy active ingredients and bases from established compounding suppliers. Active pharmaceutical ingredients come from FDA-registered and inspected facilities, and each lot arrives with a certificate of analysis that documents its identity and potency.
Medisca
Fagron
PCCA
Specialized RxWe adjust every formula to the lot we're using.
No two lots of an ingredient are exactly alike. Instead of assuming 100% potency, we use each lot's certificate of analysis to calculate how much to weigh, so your dose is what your prescriber ordered.
Batch variability
When a new lot comes in, we update the calculation for that lot before we compound with it.
Salt and base conversions
When an ingredient comes as a salt or hydrate, we convert so the amount of active drug matches the prescription.
Weight thresholds
We set minimum weights for our balances, so even small quantities are measured accurately.
Example for illustration. Actual adjustments depend on each lot's certificate of analysis and the formulation.
Two kinds of compounding, two sets of standards.
Nonsterile compounding lab
Capsules, creams, troches, suspensions, treats and other nonsterile preparations. Our lab is USP <800> compliant for handling hazardous drugs safely, protecting patients and our team.
- USP <800> compliantHazardous drug handling and containment.
- Potency-adjusted formulasEvery batch calculated from its lot's certificate of analysis.
- Tested hoods, calibrated equipmentHoods are tested and balances and equipment are calibrated.
- Pharmacist verificationA pharmacist checks every preparation before it's dispensed.
Select sterile products that meet USP <797>
Our sterile compounding meets USP <797> standards. Every batch is sent to Pharmetric Labs, an independent laboratory, for testing before release.
Every sterile batch is tested by Pharmetric Labs.
- Certified clean roomOur clean room is certified on a regular schedule.
- Environmental monitoringWe monitor the air and surfaces where sterile products are made.
- Tested hoods and calibrated equipmentHoods are tested and equipment is calibrated.
From ingredient to your hands.
- Verify the ingredientEach lot is received with its certificate of analysis from our supplier.
- Calculate for the lotThe formula is adjusted for that lot's potency and form.
- CompoundPrepared under hoods we test, in a lab that meets USP standards.
- Test and checkPharmetric Labs tests every sterile batch for sterility, endotoxins and potency. A pharmacist verifies every preparation.
- Dispense and counselWe explain how to use it and stay available for questions.
Accredited
Accredited by The Compliance Team, which recognizes pharmacies for exemplary service and quality.
Veterinary certified
Our pharmacists hold Veterinary Compounding Specialty certification from Pharmacon.
Questions welcome
Prescribers and patients can ask a pharmacist about how any preparation is made and tested.
Compounded medications are not FDA-approved. They are prepared for an individual patient based on a prescription.
Ask your pharmacy what standards it holds itself to.
Not every pharmacy works to the same standards. Before you fill a compounded prescription anywhere, it's fair to ask a few questions. Here are our answers.
| Are you USP <800> compliant? | Yes. We meet USP <800> standards for handling hazardous drugs. |
|---|---|
| Do your sterile products meet USP <797>? | Yes. And our hoods are tested. |
| Who tests your sterile products? | Pharmetric Labs, an independent lab, tests every batch for sterility, endotoxins and potency. |
| Is your clean room certified and monitored? | Yes. We certify our clean room, monitor the environment and calibrate our equipment. |
| Are you accredited? | Yes, by The Compliance Team. |
| Do you adjust formulas for ingredient potency? | Yes. Every batch is calculated from its lot's certificate of analysis. |
| Do you just meet the state minimum? | No. We exceed the compounding standards required in Florida. |
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.