There has been a considerable amount of press and concern about the validity of compounding pharmacies. As these entities are essential to my practice of medicine, I would like to debunk some misinformation.
I work closely with compounding pharmacies on a daily bases. Not only are they essential in providing custom prescriptions for my patients, they have been essential to my education.
I was initially introduced to the concept of bio-identical hormones by a compounding pharmacist. I have attended many seminars and been exposed to this aspect of medicine because they have been generous in educating me. This has resulted in my ability to offer medication options to patients not otherwise available.
Excellent compounding pharmacies are held to a standard by themselves and their credentialing body, the Professional Compounding Accreditation Board or PCAB. They must adhere to rigorous standards to be certified by this organization. The standards are more stringent than those imposed by the North Carolina Pharmacy Board for compounding.
Air Quality-clean room that is tested by an independent agency every six months. This is important in assuring the sterility of the products
Sterility testing-this occurs intermittently to ensure the sterile compounded products maintain sterility. This testing is not complete for 14 days.
Compounder Assessment– All staff are trained in the sterile compounding process including a test based on USP guidelines. This test is repeated every 6 months.
Potency testing-this process insures the authenticity of the product with a Certificate of Analysis including lot numbers so these products may be followed and recalled if necessary. Products are periodically sent to independent labs to verify their potency.
There are compounding pharmacies that I work with frequently. If I recommend a pharmacy, it has proven to be knowledgeable, with a reliable product. I urge you to delve into your pharmacy’s policies and professional connections. The excellent pharmacies won’t mind that you do!