US FDA issues further guidance on 'insanitary conditions at compounding facilities'

The US Food and Drug Administration (FDA) has published further draft guidance aimed at drug compounders.

Insanitary Conditions at Compounding Facilities: Guidance for Industry makes its clear to pharmacy compounders that while they might be exempt from the FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s ruling on insanitary conditions.

Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a drug is deemed to be adulterated 'if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.'

The guidance lays out what is meant by insanitary conditions and the FDA and other bodies will be monitoring pharmacy compounders for compliance.

It specifically addresses pharmacies, Federal facilities, physicians’ offices (including veterinarians’ offices), and outsourcing facilities that compound or repackage human or animal drugs (including radiopharmaceuticals) or that mix, dilute, or repackage biological products – all of which are otherwise known in the US as compounding facilities.

The guidance follows numerous outbreaks of infections and deaths found to be the result of drug products that were contaminated because they were produced under insanitary conditions.

Most notably, in 2012, injectable drug products produced by a compounding facility and shipped across the country caused a fungal meningitis outbreak that resulted in more than 60 deaths and 750 cases of infection.

The FDA has investigated numerous other serious adverse events, including deaths, associated with contaminated drug products produced by compounding facilities, and it is likely that such adverse events are under reported.

Since the 2012 fungal meningitis outbreak, the FDA has identified insanitary conditions at many of the 60 compounding facilities that it has inspected.

Numerous compounding facilities have voluntarily recalled drug products intended to be sterile and temporarily or permanently ceased sterile operations as a result of those findings.

However, it does not inspect the vast majority compounding facilities in the US because they generally do not register with the regulator unless they elect to become outsourcing facilities.

Compounding facilities that are not registered with FDA as outsourcing facilities are primarily overseen by the individual States and generally are not routinely inspected by FDA.

The FDA is encouraging State regulatory agencies to assess during inspections whether compounding facilities engage in poor practices, as stated in the guidance and, if so, to take action, as appropriate, consistent with State laws and regulations, and to contact the FDA.