357 Words – 1 minutes and 57 second Read. Written by Dr. Mike Shafor, PharmD. Pharmalabs
In the realm of sterile and non-sterile compounded medications, understanding ‘quality’ is not just beneficial, it’s essential. It’s this quality that acts as a health safeguard, underscoring its importance in our lives. In this Letter from the Pharmacist we’ll be talking about just that..
PharmaLabs, and other traditional pharmacies that perform compounding are held to the standards of the State Boards of Pharmacy in states in which they are licensed. While each state has slightly different statutes, all compounding requirements must meet the minimum standards set forth by the United States Pharmacopeia.
Here at PharmaLabs, we believe that the best way to prepare quality sterile and non-sterile compounded products is to exceed minimum standards, wherever and however we can. One of the primary ways we do so is accreditation through the Accreditation Commission for Health Care (ACHC). By maintaining ACHC accreditation, our compliance is held to a higher standard than most state boards hold. Despite over 40 state licenses, we take extra steps to ensure this. First and foremost, stability studies are performed on all new products and results validating the purity, strength and stability through its expiration date meet all regulatory requirements, prior to the new product release.
This holiday season, we are also re-testing all formulations using stability indicating studies to re-validate the formulations for their established beyond use dates. Once a sterile product is dispensed, PharmaLabs uses temperature sensing technology. This allows us to ensure products shipped do not exceed the storage temperature requirements for the sterile product while it’s in transit.
To ensure the quality of all ingredients used, PharmaLabs guarantees only FDA registered wholesalers and manufacturers are contracted with. We employ a robust vetting assessment strategy to ensure the highest quality ingredients are purchased for the compounding of products, sterile or non-sterile.
Finally, PharmaLabs optimizes production repeatability using on-going product testing and continual personnel observational assessments and training.
These are just a few examples of the PharmaLabs continuous quality assurance program, and if you would like to learn more, feel free to reach out to us for more details.
We wish you a Joyous Holiday Season,
Dr. Mike Shafor PharmD.
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