Protecting Patients Through Due Diligence
The popularity of personalized medicine is growing, with patients relying on the integrity of treatments obtained at compounding pharmacies. These pharmacies serve a vital role in the continuum of care, but they’re also vulnerable to unscrupulous or careless suppliers—with dire consequences.
From 2001 to 2013, there were 19 reported outbreaks linked to compounding pharmacies. A 2012 meningitis outbreak at one such pharmacy resulted in over 800 sick patients and 76 deaths across 20 states. All of these were due to contaminated steroid injections. Recognizing the danger tainted APIs pose to the public health, the FDA has begun to approach the field with greater scrutiny.
Anticipating more stringent FDA guidelines, QPI has implemented our own measures to support product purity. Here’s how we protect our customers, partners, and their patients:
Unmatched Quality Standards
We exclusively repackage APIs from FDA-verified suppliers and provide manufacturer-to-product traceability. We’ve partnered with third-party labs to rigorously retest the bulk ingredients we receive to ensure they adhere to USP standards. They are then repackaged in sterile rooms in full compliance with ISO standards, following cGMP and 21 CFR 210 & 211 processes. We issue a detailed certificate of analysis for each product.
Attention to Detail in API Storage and Packaging
All materials are either stored in a temperature and humidity-controlled environment or in refrigerated or freezing conditions, depending on product requirements. We’ve also carried out stability testing on all of the packaging configurations we utilize in the distribution of APIs. QPI’s container closure systems maintain potency and decrease the chance of impurity or degradant growth through the life cycle of the product.
Rigorous Vetting and Re-Vetting of Suppliers
The FDA vets our suppliers, but so do we. We carry out paper and on-site audits of every manufacturer we do business with. Before fully qualifying a supplier, we always pre-test three lots of API to verify their purity. We then schedule annual follow-ups to verify they remain current in all of their filings and have no regulatory or quality issues. Our due diligence is peace of mind for our customers—and we wouldn’t have it any other way.