Quality you can see in every preparation.
Compounded medications are only as good as the pharmacy that prepares them. EpitomeRx was designed from the ground up around the standards that govern compounding, so patients and prescribers can count on every preparation being made the same careful way, every time.
A licensed 503A compounding pharmacy
EpitomeRx is a 503A compounding pharmacy, the federal category for pharmacies that prepare medications for individual patients from a valid prescription. We are licensed by the California State Board of Pharmacy.
503A pharmacies are different from drug manufacturers and from 503B outsourcing facilities. Every medication we prepare is made for a specific patient to the prescriber's exact order. Compounded medications are not FDA approved.
Built to national and state standards
Our work follows the United States Pharmacopeia (USP) standards for compounding, California State Board of Pharmacy regulations and FDA rules for 503A pharmacies.
Nonsterile compounding
Creams, capsules, troches, oral liquids and other nonsterile preparations are made in a dedicated general compounding room, under documented procedures with defined beyond-use dates and quality checks.
Hazardous drugs
Hazardous drugs, including many hormones, are compounded in a dedicated negative-pressure room with containment equipment and procedures that protect the people who handle them, our patients and the medication. Most of our hormone preparations are made here.
State and federal rules
We are licensed by the California State Board of Pharmacy and follow its compounding regulations, along with FDA requirements for 503A pharmacies.
Dedicated compounding rooms
- State-of-the-art modular compounding rooms
- A general compounding room for nonsterile, non-hazardous preparations
- A dedicated USP <800> room for hazardous drug compounding, with negative-pressure containment, certified for its required air changes per hour
- Certified containment hoods
- Licensed by the California State Board of Pharmacy
Advanced equipment
- Planetary mixers for smooth, uniform creams and gels with even drug distribution
- Closed-jar electronic mixing systems that mix and dispense in the same container
- High-shear homogenizers for fine, stable emulsions and suspensions
- Three-roll ointment mills for fine particle size and a smooth, even texture
- Containment ventilated enclosures (CVEs) for weighing ingredients, to protect both the people in the room and the preparation
- Calibrated analytical balances, with weights recorded electronically in our pharmacy system
Quality ingredients & bases
- Active pharmaceutical ingredients (APIs) that meet USP or NF standards, from FDA-registered suppliers. We require a certificate of analysis (COA) for every lot.
- Bases chosen for the problem being treated, many with published stability and compatibility data
- Research and formulation support through our membership in Professional Compounding Centers of America (PCCA)
The right base for the right problem
The base is the cream, gel or vehicle that carries the medication. It affects how well a drug reaches the skin, how it feels and how long it stays stable. We don't use one base for everything.
- Hormone delivery. Bases designed and studied for moving hormones such as estradiol, progesterone and testosterone into and through the skin, including anhydrous (water-free) options.
- Problem and sensitive skin. Bases built for acne, rosacea and oily skin that accept actives like tretinoin, azelaic acid, clindamycin and metronidazole, plus noncomedogenic, fragrance-free options for sensitive areas.
- Penetration where it's needed. Penetration bases designed for topical preparations meant to be absorbed through the skin.
- Mucosal and vaginal use. Bases that adhere to mucosal tissue for oral and vaginal preparations.
- Backed by data. Many of the PCCA bases we use have published permeation and beyond-use date studies, so we know how a formula holds up over time.
Inside EpitomeRx
Our state-of-the-art modular compounding rooms and containment equipment in Arcadia.
A pharmacist checks every prescription
Every prescription is reviewed, compounded under the supervision of, and checked by a licensed pharmacist. Our Pharmacist-in-Charge, Dr. Christine Poon Lin, is residency trained with nearly two decades of clinical experience and is board certified as a BCSCP and BCPS.
Meet Dr. LinHave questions about personalized compounding?
Call our pharmacist to talk through your prescription, pricing and options.