405 Heron Drive Suite 200
Swedesboro, NJ 08085
Ph 800.331.8272

How to Choose a Compounding Pharmacy

Prescribe with confidence.

Wedgewood Pharmacy maintains strict quality controls (see Quality Assurance and our Due Diligence Checklist.). Our pharmacists prepare your prescriptions in our 40,000 square-foot state-licensed facility that houses independently certified Class 1000 clean rooms, Class 100 laminar airflow hoods and laboratory suites with HEPA filtration. Our quality control and assurance programs ensure every prescription meets your specifications. When you select a compounding pharmacy, be sure to ask questions like these:

Question Wedgewood Pharmacy Other Compounding Pharmacy
Are you PCAB® accredited?
Are you committed to compliance with the USP <797> guidelines for sterile compounding?
Do you have an independent, 3rd party lab perform sterility analysis on every batch of sterile compounds?
Do you have an independent, 3rd party lab perform endotoxin analysis on every batch of sterile compounded injections?
To achieve sterility, do you filter (0.2 micron) in an ISO Class 5 laminar air-flow hood contained in an ISO Class 7 clean room?
When filtration is not appropriate, do you terminally sterilize via autoclave or gamma-irradiation to achieve sterility?
Do you perform post-filtration filter integrity testing?
Do you conduct monthly lab-tests of air and surface samples in your clean room and other controlled environments?
Is the air quality in your sterile compounding lab engineered for HEPA filtration to minimize particulates?
Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods?
Do you have a sterile environmental monitoring program in place to help ensure aseptic conditions?
Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers?
Do you obtain Certificates of Analyses for all compounding ingredients?
Do you maintain both master formulas and lot-specific batch records for all compounds?
Can you immediately trace a prescription back to the original batch record and the source of the ingredients?
Do you verify the potency of finished compounds through weight, volume and yield checks?
Do you perform pH testing on injections, ophthalmic preparations and other compounds?
Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use?
Do you have systems in place for handling complaints, sterility failures, adverse events and, if necessary, issuing a recall?
Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
Are laboratory technicians assessed semi-annually for competency, including independent-laboratory potency-testing of dosage forms they are certified to prepare?
Medicine For People

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Medicine For Pets

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