Lack of GMP Training is Expensive: Lessons from Compounding Pharmacies

Since the passage of the Compounding Quality Act in late 2013, compounding pharmacies have had a rough experience trying to comply with tough GMP rules. Of the almost 60 compounding pharmacies that voluntarily registered with the FDA, almost 50 have gone through FDA’s audit for GMP compliance and all but one were found to be in significant GMP violations and received FDA 483s. Of the 50 pharmacies audited, 12 received Warning Letters, and three were subject to product recalls. In addition to the pharmacies registered with the FDA, audits were conducted at numerous other compounding pharmacies and 483s issued. A review of the findings by FDA auditors indicates that most findings were in fundamental GMP areas such as facility design, sterile processes, contamination control, hygienic practices, packaging, and documentation. Most of these are easily addressable by basic training in GMP rules. Almost all the pharmacies inspected lacked pharmaceutical GMP training for their personnel. When the Compounding Quality Act was passed, several pharmacies rushed to get registered by FDA, seeking to capitalize on the “FDA Registered” label. But in their rush pharmacies ignored the cardinal rule for compliance: ignorance is not an excuse and compliance is not gradual. You are either complaint or not, and FDA does not allow non-compliance slide just because you are voluntarily registering. It is expected that strict enforcement by FDA will slowly bring the compounding pharmacies into compliance.