Sterile Compounding

The Compounding Pharmacy routinely prepares a wide variety of sterile products including:

 * Intrathecal Pump Reservoir MedicationsSterile (with or without Reservoir)
 * Trimix Injections
 * Ophthalmic Drops and Injections

• Chemotherapy - Mechlorethamine
• Dermatology - Cantharidin, Nitrogen Mustard Ointment, Mechlorethamine
• Opthamology - Avastin, Trypan Blue, Acyclovir Sterile Opthalmic Ointment, Autologous Serum eye drops
• Respiratory - Glutathione
• Sterile Compounding - Glutathione, Infusion services, Sulfan Blue
• Veterinary medicine
• Veterinary chemotherapy

...and many others.

Making sterile products is the most critical and difficult type of compounding.

Dr. Loyd V. Allen, Jr., Ph.D., R.Ph, Editor in Chief of the International Journal of Pharmaceutical Compounding, suggests that patients and providers should consider a list of questions when selecting a compounding pharmacy, particularly one that makes sterile products:

Is the Pharmacy PCAB accredited?
Is the Pharmacy USP Compliant?
Does the Facility have "State of the Art" equipment?
Does the Pharmacy Test their preparations?
Does the Pharmacy have "Standard Operating Procedures"?
Are there any unresolved complaints with the NC Board of Pharmacy?
Can we see your facility?

Is the Pharmacy PCAB accredited?

The Compounding Pharmacy is the third pharmacy in North Carolina to be accredited by the   Pharmacy Compounding Accreditation Board (PCAB). Less than 1% of the compounding pharmacies in the United States are accredited by PCAB. PCAB accreditation means our pharmacy has:

• Passed an extensive on site inspection.
• Meets or exceeds rigorous national standards.
• Uses only the highest quality chemicals and equipment.
• Maintains a continuous quality improvement system.
• Highly qualified staff.

Is the Pharmacy USP Compliant?

The United States Pharmacopoeia sets standards for quality medicines, dietary supplements and food ingredients wordwide.

The Compounding Pharmacy is compliant with applicable USP standards. The additional items in this table detail how The Compounding Pharmacy addresses some of critical requirements of USP 797 including:

• *Quality Assurance/Quality Improvement practices appropriate to each Risk Level of medications prepared.
• *Verification of compounding accuracy and sterilization.
• *Personnel training and evaluation in aseptic techniques.
• *Environmental quality control.
• *Finished product release tests and checks.

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Does the Facility have "State of the Art" equipment?

The Compounding Pharmacy prepares all sterile products in an ISO Class 5 clean room as required by USP 797.

All weighing and manipulation of ingredients also occurs in a separate ISO class 5 area, separated from the sterile manipulation area by a barrier and positive pressure.

The Compounding Pharmacy maintains an array of state of the art equipment including computerized autoclave, microprocessor controlled convection oven, USP quality water system, laboratory grade dishwasher with USP quality water supply, electronic pH meters and many others.

We are absolutely State of The Art

• Barcode Readers, Computers and Scales work together to improve accuracy, prevent errors and capture important information.
• All formulas are computer based.
• Barcode scan assures the chemical being used matches the one required by the formula.
• The scan also records the lot number and expiration date.
• Scales and computers interface to assure the amount weighed is within 5% of the amount required.
• Detailed data about any compound, including dispensing data and shipping status is instantly available electronically.

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Does the Pharmacy Test their preparations?

The Compounding Pharmacy maintains multiple sterile medication testing programs including:

• Internal: Sterility Testing using dual media (tryptic soy broth and sodium thioglycollate) per USP guidelines.
• Internal: Endotoxin testing of sterile products per USP guidelines.
• External: Samples are sent to an outside laboratory for potency analysis.

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Does the Pharmacy have "Standard Operating Procedures"?

The Compounding Pharmacy's policies and procedures have been reviewed by PCAB and found to meet their extensive requirements.

Are there any unresolved complaints with the NC Board of Pharmacy?

The Compounding Pharmacy and its licensed staff are all in good standing with the NC Board of Pharmacy.

Can we see your facility?

• What does the facility look like?
• Can we observe compounding personnel at work?
• Do the personnel appear competent from observation and questions asked?
• Is the pharmacy clean and well organized?
• These questions are best addressed with an on site tour. We invite you to schedule an on-site visit.