Pharmacy Compounding Accreditation
Accreditation typically involves an independent organization reviewing a company’s operations to ensure they are meeting the highest standards. These include standards for issues like quality control and patient safety.
Pharmacy Compounding Accreditation Board (PCAB®)
As the demand for compounded medications has increased, the pharmaceutical profession saw a need for a system of standards by which each compounding pharmacy can test its quality processes. To address this need, eight of the nation’s leading pharmacy organizations joined together, contributing their time, money and leadership, to create PCAB: a voluntary quality accreditation designation exclusively for the compounding industry.
As part of our accreditation, our labs are certified to meet the highest safety standards and our compounding facility is regularly tested to ensure requirements are exceeded. In addition, our compounded medications are regularly tested by an outside laboratory to ensure product potency and consistency are maintained.
United Credentialing & Accreditation Program (UCAP)
Premier Pharmacy has become accredited by the United Credentialing & Accreditation Program (UCAP). The UCAP program includes a review of business practices, attestation to a code of conduct, and compounding specific requirements. By undergoing UCAP accreditation, Premier Pharmacy has met regulatory inspection requirements for nonresident licensure in several states. Given the stringent quality and best practice requirements, UCAP accreditation instills confidence in PBMs, payers, physicians, and patients for continued access and affordability of compounded medications.
Newest Lab Equipment & Technology
Premier Pharmacy is proud to incorporate the SpeedMixer™ into our everyday routine. The SpeedMixer™ is bladeless, which results in bubble-free mixing with no clean up required. The SpeedMixer is an advanced tool for mixing, grinding/milling and dispersing. This non-invasive mixing technology can be used to process any combination of powders, pastes, putties and liquids from 1g to 5Kg. The SpeedMixer™ removes air bubbles while homogenizing the sample in seconds and there is absolutely no clean up.
The mixing procedure of the SpeedMixer™ series is based on the double rotation of the mixing cup (hence the designation “Dual Asymmetric Centrifuge” or DAC). This combination of centrifugal forces acting on different levels enables very rapid mixing of the entire cup. The precision construction of the units gives the opposing forces an equilibrium with near zero vibration and low-noise operation.
Third Party Formulation Testing
Premier Pharmacy completes the quality circle by testing our compounded preparations through an independent laboratories. With regards to testing of non-sterile compounds, the focus is testing for potency of final compounded preparations to ensure proper procedures are being followed.
This test measures the concentration of the active ingredient at a specific point in time.
A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding. A study commonly includes: a stability indicating method assay, pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits, and the absence of specified organisms.
Microbiological Examination of Nonsterile Products: Tests for Specified Organisms USP <62>
These tests verify the absence of objectionable microorganisms in drug products and raw materials.
Quality Chemical Suppliers
Premier Pharmacy only uses cGMP, FDA and DEA registered manufacturers as a source of Active Pharmaceutical Ingredients (API)