Are your sterile compounding needs being met by a PCAB Accredited Pharmacy?

Important question to ask your compounding pharmacy:

Does it have accreditation from the Pharmacy Compounding Accreditation Board (PCAB)? You may check the status of your pharmacy by logging onto www.pcab.org. You can locate a pharmacy on that site and view the rigorous standards that have been met. Using a PCAB Accredited Pharmacy ensures that the pharmacy you choose to service you and your patients has met the highest standard of care set forth by the only recognized compounding accreditation body. This standard of care is paramount for patient safety and effective therapy. It also guarantees that you have chosen a pharmacy that has been given a legitimate stamp of approval, thereby lowering physician liability.

Fallon Wellness Pharmacy is a PCAB Accredited Pharmacy.

Experience and training

• Fallon Wellness Pharmacy has been compounding sterile preparations for 28 years.
• Fallon Wellness Pharmacy only employs highly trained pharmacists, Doctors of Pharmacy and pharmacy technicians.
• Our sterile compounding pharmacists and technicians are formally trained at PCCA’s sterile compounding training facility in Houston, Texas. 
• Every employee must pass semi-annual evaluations to ensure proper aseptic technique.

Clean Room Quality

• Our Clean room laboratory is an ISO class 5 environment (very low particle count). 
• 1 out of every 4 particles contains an infectious bacteria, fungus or virus.  By eliminating particles, we decrease the chance for product contamination.
• Humans shed thousands of particles per hour, therefore our employees wear sterile, full body suits from head to toe when compounding.  Skin is a major source of bacteria which is why we cover it up completely.
• Temperature and humidity are monitored daily.
• Hood is sterilized after every use.
• Hoods are inspected and certified by a 3rd party testing facility every 6 months.
• Floors are disinfected daily.  Walls and ceilings weekly.


How can you assure me that your products are potent and sterile?

• Fallon Wellness has a state-of-the-art clean room laboratory.
• Every batch of a sterile product is tested for potency, sterility, and endotoxins according to USP 797 regulations.  This is not just an idle claim. We have proven we do this to on-site PCAB inspectors.
• Every batch of product is assigned a lot # specific to that batch.
• We have available, upon your request, the MSDS (Material Safety Data Sheet) and certificate of analysis for all products used. All of our ingredients are pure and meet USP or NF quality standards.
• We use only high quality ingredients from FDA approved suppliers.
• Every batch of each compounded drug product is quarantined until testing results are completed.  Only after passing every test is it then approved for dispensing to patients.
• We will send you the sterility testing results for the specific lot number of the product you have prescribed for dispensing upon request.
• Refrigeration and next day shipping are provided for heat labile compounded drug products.

We are here to service our health care providers and their patients, and will provide prompt and friendly service.

Sincerely Yours,

Tania Durante, R.Ph.

Director of Sterile Compounding
Fallon Wellness Pharmacy