The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: AN UNSPOKEN OPPORTUNITY FOR PHARMACISTS.

A high-level assessment of recent U.S. Food and Drug Administration audits of 503A facilities indicates that a regulatory paradigm shift is occurring. Data and rationale further indicates that the agency seems to be taking a proactive approach for how it monitors these facilities. The auditing practices and observations are eerily similar to those which are seen for 503B Outsourcing Facilities, as well as Current Good Manufacturing Practices Drug and Device Manufacture plants. Perhaps the U.S. Food and Drug Administration is attempting to avoid any major medical outbreaks that may stem from under-supervised drug preparation centers. This report presents the rationale that may be behind the U.S. Food and Drug Administration's motive for increased 503A scrutiny. In addition, new market incentives are also highlighted, as it seems that firms, which are able to maintain good graces with the agency, will be uniquely positioned to obtain greater market share. All signs indicate that for 503A facilities, regulatory compliance may be the key to greater market share.