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In anticipation of new Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new whitepaper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA, it is available to download at http://www.microtestlabs.com/whitepaper from Microtest Laboratories.
The FDA requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, the operations of large-scale compounders do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government, said white paper author Steven Richter, PhD, president and scientific director of Microtest Laboratories and a former FDA official.
In the whitepaper, Richter advises compounding pharmacies on the critical issues to resolve prior to an FDA or state inspection, including sterile compounding regulations, quality testing, sterility testing of compounded articles, disinfectant validations, and endotoxin testing.
In the aftermath of the NECC case, FDA and state actions regarding compounding pharmacies are relatively certain: regulations and inspections will both tighten and increase. The FDA, in some instances, will assume the role of lead auditor for the compounding pharmacys operations, Richter says. It is critical for compounding pharmacies to maintain a state of control in their controlled environments. While there may always be excursions, it is the actions that are undertaken after the excursions that will influence an inspectors responses and observations during an on-site investigation and inspection.
Microtest Laboratories is a Massachusetts-based, FDA-audited company whose environmental sciences group helps clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.
Source: Microtest Laboratories