Quality Assurance


Triangle Compounding Pharmacy has developed and follows a strict quality assurance program. Included in our protocol are detailed SOPs, documentation, verification and testing. We take the time to evaluate and research to ensure that all products meet our high standard for quality.

As a 503B Outsourcing Facility, we are committed to operate under Current Good Manufacturing Practices (cGMP). Non-registered compounding pharmacies are only held to US Pharmacopeia (USP) standards while stringent, are levels below cGMP standards for testing, documentation and assurance of quality. For more information regarding our Quality Assurance program please contact us.

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 maintains multiple sterile medication testing programs including:

Internal: Sterility Testing using dual media per USP guidelines.
External: Samples are sent to an outside laboratory for potency analysis.

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.