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Sterile Compounding

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As a testament of our commitment to quality, Triangle Compounding Pharmacy took the steps to become North Carolina’s First FDA Registered Compounding Outsourcing Facility. In 2007 we became the first compounding pharmacy to be accredited by PCAB (Pharmacy Compounding Accreditation Board www.pcab.org). Only 135 pharmacies in the United States hold this accreditation. As a PCAB accredited pharmacy, we are committed to the continual adherence to USP guidelines in our compounding processes.

We are thankful for the opportunity to serve providers, patients and the medical community in provision of compounded unique medications including sterile injectable preparations. Please contact us toll free at (866) 858-0809 to speak with any of our pharmacists for more information.

Backordered Products

We would like to provide you a readily available source for backordered products and compounded medications.

Backordered products have become a common and frustrating challenge to institutional pharmacies. Temporary backordered products that were expected to be available within weeks, have been difficult to obtain for months from manufacturers and wholesalers. We at Triangle Compounding Pharmacy recognize the challenges and have institutional preparation experience to assist you.

Website for reviewing drug shortage status: www.ashp.org/DrugShortages/Current/

Please feel free to contact us with any questions to address your therapeutic challenges.

We look forward to serving you!

Additional Information

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, has developed a list of questions patients and providers should consider when selecting a compounding pharmacy, particularly one that makes sterile products:

Below are some of the critical questions you should ask, and how Triangle Compounding Pharmacy complies with each.

Is the Pharmacy PCAB Accredited?

Triangle Compounding is the first 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 onsite inspection.
  • Meets or exceeds rigorous national standards.
  • Uses only the highest quality chemicals and equipment.
  • Maintains a continuous quality improvement system.
  • Employs a highly qualified staff.

Is the Pharmacy USP Compliant?

The United States Pharmacopeia sets standards for quality medicines, dietary supplements and food ingredients worldwide.

Triangle Compounding is compliant with applicable USP standards. Triangle Compounding addresses some of the 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.

Does the Facility Have “State of the Art” Equipment?

Triangle Compounding prepares all sterile products in an ISO Class 5 cleanroom 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.

Triangle Compounding 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.

What Technology is currently being used?

  • 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.

Does the Pharmacy Test Their Preparations?

Triangle Compounding utilizes multiple sterile medication testing programs. USP testing and environmental monitoring program are also implemented.

Does the Pharmacy Have Standard Operating Procedures?

Triangle Compounding’s policies and procedures have been reviewed by PCAB and found to meet their extensive requirements.

Any Unresolved Complaints with the Board of Pharmacy?

Triangle Compounding 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.

Still have questions or concerns?
Contact a pharmacist today for more information.