The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. As described in the newsletter, the compounding pharmacies, through IACP, are objecting to the new guidance based on certain portions of the guidance being “subjective” and “unclear”. The newsletter goes on to provide an example from the IACP of this subjectivity and lack of clarity on HEPA filters and guidance restrictions on HEPA filters that are “damaged, dirty or discolored”.
As I read this article, the first thing that popped into my head was:
To someone who has been in the business of FDA-regulated product manufacturing for almost their entire career, it’s funny to see IACP complain about issues of subjectivity and lack of clarity with this “new” guidance. First of all, I’ll take a guidance that says “replace HEPA filters that are damaged, dirty or discolored” any day of the week! If THAT is their example of subjectivity and lack of clarity, good luck with things in the future – it only gets worse. Second, take a look at the guidance: Click Here. Not only is this document not wholly subjective and lacking clarity – at least relative to current 21 CFR 211 and other FDA Guidance (e.g., the 2013 Guidance on Good Manufacturing Practices for Cosmetic Products), it is quite specific with respect to a number of considerations such as particulates, environmental monitoring program requirements and release testing. Also though, there is a lot of information and guidance available on the topic of how FDA expects pharmaceutical manufacturers – now YOU compounders – to act and manage your operations. It’s been close to 36 years since the 1978 GMPs were first introduced and there are many information resources, readily available, describing and detailing how FDA interprets and enforces manufacturing regulations and expectations. This information is easily extrapolated to the practice of “compounding.”
Quality and compliance practice within FDA-regulated industry is not just about finding answers in a book or on the Internet though. You – the regulated company – have a lot of work to do. And with that, it might be a good time to provide an important piece of information – a lesson as it were – to the IACP and the entire compounding industry:
In short —
it is NOT FDA’s job to tell you what you
should and shouldn’t do to “comply” with your specific manufacturing operations.
It is YOUR job to:
- fully and completely understand FDA’s Good Manufacturing Practice requirements and expectations, and
- APPLY those requirements to your VERY SPECIFIC product formulation, delivery form and product risk profile based on therapeutic indication. If you can’t or are unwilling to do this – you should not be manufacturing products for introduction into interstate commerce. And if you ARE willing, but don’t have the knowledge or experience, there are plenty of good consultants that would be more than willing to help you with understanding your role, responsibilities and obligations for meeting all of FDA’s requirements and expectations.
Since 1978, pharmaceutical manufacturers have dealt with the skeleton structure of 21 CFR 211, the pharmaceutical GMPs, and the massive amounts of guidance and interpretation overlaid onto the regulatory structure by individual FDA investigators during enforcement actions. Although the structures of this long-standing regulation and guidance, and the corresponding enforcement activities that flow from them, can be maddeningly challenging and complex, it has generally served the public health well for these 36 years. The IACP and the compounding industry – if they want to restore any shred of credibility after the recent tragedies resulting from product quality failures – need to get on board with the FDA and the rest of the pharmaceutical industry and begin investing, learning and executing on improved quality management systems that are just beginning with this new, interim guidance.