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Testing Protocol

PenCol Specialty Pharmacy does significantly more testing than other compounding pharmacies our size.

Unlike most other compounding pharmacies our size or any other in the area, PenCol Specialty Pharmacy INDEPENDENTLY tests EVERY batch of preparations for sterility, endotoxins, and potency. We do so through an independent laboratory, ARL Bio Pharma in Oklahoma City. ARL Bio Pharma is an FDA-registered lab and provides analytical and microbiological testing for us.

We do not independently test every batch.  We perform testing as stated below, and to substantiate assignment of Use by Dates longer than what USP allows without testing.

The PenCol difference begins with the significant amount of testing we do compared to other pharmacies our size. Our accountants don’t love that we do it because it’s not the best, most economical decision for our bottom line. But it is for your health and peace of mind. It assures us that the quality and the dosage your doctor prescribed are exactly the ones you are given by us. Our commitment to quality and patient safety is second to none. The U.S. Pharmacopeia (USP) sets strict guidelines for sterile and non-sterile preparations, all of which we surpass. We are PCAB accredited and therefore are among the top 2.5% of compounding pharmacies in our focus on quality and safety.

We take pride in testing the ingredients we use and the batches we create. This takes extra time, effort, and money, but it is the only way we can know for sure that we are doing things right.

For our physicians, veterinarians, and patients, this ensures that the prescriptions are safe and are the exact dosage that was prescribed.

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

In recent years, there have unfortunately been instances of illness resulting from contaminated compounded sterile preparations. That is the reason PenCol Specialty Pharmacy does so much testing. It’s the only way to ensure your prescriptions are genuinely safe. In addition, the aseptic production of compounded preparations must include quality checks to ensure strength is correct and the absence of bacteria and endotoxins.  PenCol carefully follows regulatory guidelines for testing its sterile products to promote safety and the desired therapeutic outcome. 

Even if it is not mentioned specifically in the regulatory documents, it is important to us to check for the presence of endotoxins in raw materials, at various points in the compounding process, and in finished products before administering a drug to the patient.