Quality Standards

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.

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

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.

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.

• 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.

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.

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

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

• 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.

• Our employees are all highly-trained individuals, especially our pharmacists who have all gone through rigorous training in pharmacy school, along with additional training here at TCP as well as outside training.
• We have a full quality team dedicated to ensuring our facility and our employees are all appropriately certified and qualified for the highest quality preparations we can compound and provide to our customers and patients.Do the personnel appear competent from observation and questions asked?
• Compounded medications are made in highly sophisticated ways, we use analytical balances that accurately measure down to 2mg, computer software that links each chemical barcode to the ingredient list in the master formulation, and multiple double checks to make sure what we hand to you is what we would feel comfortable handing to our favorite family member. Nothing goes out the door we’re unhappy with, you can trust our pharmacy staff.

• When prescriptions first come to us, we have an input technician that enters the initial order, this is then handed to a pharmacist for an initial verification step.
• Our support staff will contact the patient or client to discuss the new prescription with you, and you will have a chance to speak to a pharmacist if you have any questions about your prescription.
• Once we receive approval to fill your order, it returns to the lab and a compounding technician will compound your order and transfer it to a finished prescription device (bottle, syringes, topi-click, etc.).

• A pharmacist will review the finished preparation, review the finalized batch record, all the labeling, visually inspect the finished preparation and all information that is with the order. Once he/she is satisfied with the prescription, it will be sent out to our shipping department or to our front desk for pickup orders.
• You may be contacted when your order is complete and it will be placed in our ready for pickup bin or it will be shipped to you.

• Compounded medications are made especially for you or your pet based on your prescriber’s order!
• Compounded medications typically contain minimal fillers, less or no dyes, less or no allergens.
• Manufactured products are mass produced by a manufacturing company at a large plant similar to one that makes cars, soda, and candy.
• Manufactured products have to have stability studies showing they can last 3-10 years on the shelf as is, which typically means they need stabilizers, antioxidants, preservatives, and additional fillers. Typical inactive ingredients include: lactose, parabens, and propylene glycol.

• Compounded medications may have a beyond use date of somewhere between 24 hours and 6 months, but no longer. Because the shelf life of a compounded medication is much shorter than manufactured products, those additional ingredients (which a lot of people are allergic or sensitive to, or are just trying to avoid them) are not necessary ingredients, thus making compounded preparations typically “cleaner” than manufactured products.
• Compounded preparations can be made with different flavors! Manufactured products are typically limited to 1 flavor, I’m sure we’ve all had the dreaded “cherry” flavored antibiotic at least once in our lives? Compounded oral medications can usually be flavored with lots of different options. Mint, citrus, peanut butter, vanilla-butternut, strawberry, raspberry, grape, chocolate, mango-passionfruit. Ask us what your other options are! Chocolate-Raspberry or Orange-mango-passionfruit anyone?