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PCCA Louisiana600-3

When choosing powders to be used in compounding, USP Chapters and both dictate that the highest-grade powders available are to be used. Beyond this, there is no specific guidance. When choosing a powder, the USP grade is preferable when available. However, many compounders do not realize that there are differences in the USP grade powder from one manufacturer to another. If you look at the monographs for the individual active pharmaceutical ingredients, you will see an acceptable potency range is given for the individual product. Certain manufacturers will produce a product that has purity on the lower end of the acceptable range for sale to their vendors. This product usually is lower in price when compared to another USP grade powder of higher purity. The lower-purity product usually has a higher concentration of impurities in it, which can affect solubility significantly. This becomes problematic when working with formulas where the concentration of the active ingredient is close to the saturation point for that active.

Our Pharmacy Consulting Department (PCD) addresses calls from members with this issue on a weekly basis. Usually, the culprit is a lower-quality powder from another vendor that has been used in a PCCA formula in place of our higher-quality powder we originally used when the formula was written. This has occurred with formulas that contain testosterone cypionate, leucovorin, cysteine, and alpha lipoic acid – and these are just a few examples.

 

Particle Size Also Varies From Vendor to Vendor

This includes active pharmaceutical ingredients as well as excipients. In one instance, another manufacturer’s products were used to make Triamcinolone Acetonide 80 mg/mL Ophthalmic Suspension (PF). The formula was followed exactly as written, only using the other vendor’s products. The suspension came out with clumps clinging to the side of the vial, and the active ingredient significantly settled on the bottom of the vial. When the product was compounded with PCCA chemicals, no problems were observed.

Particle size also is very important when it comes to absorption and systemic effect. One time, when PCCA’s Special Micronized Progesterone (PCCA # 30-3530) was on backorder, I used a different vendor’s Progesterone USP Micronized in my practice. I had patients call, inquiring what I had changed in my formulation because they had lost control of symptoms or “it was just not working as well as before.” PCCA Special Micronized Progesterone USP has a particle size of 5 microns in 99% of the particles, where the other vendor’s Progesterone USP Micronized has a particle size of 20 microns or less. This would account for the difference in symptom control.

 

The Bottom Line

Saving money is definitely a must in everyone’s budget, but using a lower-quality product that does not work, forcing you to make the formula multiple times to try to get it to work, results in spending more money in the long run.

At PCCA, we will not compromise on quality because patients’ lives depend on it.

  • Our Quality Control/Quality Assurance department rejects almost 200 chemical lots each year, or just over three chemical lots received per work week.
  • Fourteen quality checks are done on every chemical lot as it comes in and is repackaged.
  • Each chemical lot is identified before it is repackaged, and again after it is repackaged.
  • At PCCA, whenever a vendor change is made, in addition to the testing done by Quality Control, our PCD lab also tests the chemical to make sure it still works in the formulas we have written with that particular chemical. If not, the chemical is rejected.

 

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