Tag Archive for FDA

A New Draft Guidance on FDA Expectations for Cosmetic GMP

Scott Sutton, Ph.D.
Microbiology Network, Inc.

 

There is a good deal of interest from FDA in the cosmetics industry and the Quality systems in place at manufacturing facilities.  The only published guidance, until recently, was the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (originated February 12, 1997; Updated April 24, 2008).  This guidance situation has recently changed with the release of the draft Guidance for Industry Cosmetic Good Manufacturing Practices (released June 24, 2013).

The draft “Guidance for Industry” released late in June of 2013 is a complete rewrite of the previous guidance document.  This was much needed, as the previous document was in truth a training document for FDA inspectors preparing to audit a cosmetics manufacturer and not a “Guidance to Industry” in any real sense.  Read more

The Current Tragedy of Compounding Pharmacies is Not a Surprise

Scott Sutton, Ph.D.
The Microbiology Network, Inc.

The current fungal meningitis crisis is a tragedy, but one that could have been avoided if clear warning signs had been heeded. To understand the risks we have been running, we need to understand clearly the differences in controls and intents between GMP pharmaceutical manufacture of sterile products and a pharmacy compounding “sterile” products.   These differences are reflected in the regulation of pharmaceutical manufacturing by 21 CFR 211 (GMP) vs the regulation of compounding pharmacies by individual states relying on USP <797> “Pharmaceutical Compounding – Sterile Preparations” as the source document.    The fundamentally different approaches to preparation of sterile product taken reflects the different purposes – the GMP is designed to ensure a reproducible, stable drug product suitable for interstate commerce and storage, the pharmacist’s preparation is meant for for immediate use, made in small amounts for a specific patient in response to a doctor’s script.  This basic difference in intent has led, predictably, to this situation as externally sourced “compounding pharmacies” have begun to manufacture in batch sizes up in the thousands of units for national distribution.

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What Is Going On With The Compounding Pharmacy Scandal?

Scott Sutton, Ph.D.
Microbiology Network, Inc.

Background

A compounding pharmacy, New England Compounding Center’s (NECC), released over 13,000 vials of methylprednisolone acetate injection from the Framingham, Massachusetts site.  These were distributed across 23 states.  As of October 18, 2012, 257 cases of meningitis (and 20 fatalities) have been traced to this medication, and several other compounded mixtures (with enormous batch sizes) have also raised concerns (UPI 2012).  Amazingly, this manufacturing operation, or rather, “compounding pharmacy”, existed outside the authority of FDA as it exploited a provision in the law meant to protect hospital pharmacies manufacturing small numbers of specific medications under a doctor’s direct instruction.

Clearly something has gone awry.

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