While I'm not privy to all of the facts surrounding the case in Framington, MA, i wll begin by stating that any organization or person that breaks the law (local, state or federal) is subject to the consquences.  Pharmacies and Pharmacists are not excluded.

Having said this, i'm a licensed pharmcist.  I've also been in quality for over ten years as a consultant and trainer for many ISO based systems, including ISO 13485 and 21 CFR part 820...I have been involved in several FDA "audits".  If i compare the "competency" of a FDA Investigator to the traditional ISO auditor, the ISO auditor wins hands down.  My experience is that FDA investigaors suffer from the beauracratic mess that strangles our government.  Again, my experience, valid audit findings (of conformance and non-conformance) are more prevalent with credentialled ISO auditors.

The FDA does have authority of USP Chapers 1-999.  This includes 797, which is what this mess is all about.  Here is a clip from ASHP Reference Guide to Chapter 797..."In 1906, the Food and Drugs Act and the USP/NF became the official standard for drugs in the United States. In 1938, Congress passed the Federal Food, Drug, and Cosmetic (FD&C) Act, which was a revision of the 1906 Act. The FD&C Act recognized USP/NF as the official compendia of drug standards. The FDA is responsible for the enforcement of the FD&C Act.Each chapter of the USP/NF is assigned a num- ber, which appears in brackets along with the chapter name. The general chapters numbered <1> to <999> are enforceable by the FDA and official monographs and standards of the USP/NF; general chapters num- bered from <1000> to <1999> are considered infor- mational and not enforceable, and chapters above <2000> apply to nutritional supplements. FDA defers to the states to regulate the practice of pharmacy and to perform inspections.17 However, the FDA does have the authority to inspect pharmacies and enforce USP Chapter <797> in the interest of public health."

Not sure of your vague refernences to States Board of Pharmacies and Congress, protecting compounding pharmacies.  There are likely more details that should be shared before we brush with such a broad stroke.  I do admit that lobbyists exist for every profession and this is very likely a factor in your statements where you throw these two groups under the bus. These groups are not exempt from criticism, however, being an auditor, i always look for objective evidence.

The big issue that you discuss in your article is concerning USP 797, Compounding Sterile Products.  I have to wonder what these other compounding issues were that was silenced by your bosses at the FDA.  I'm sure that you are aware of efforts earlier in the 1990's to prohibit pharmacies from compounding non-sterile products....for example- Mixing liquids (Miracle Mouthwash) or mixing two creams for topical applications...this may also play a part in what you are sharing in your article.  To the reader, who is not familiar with this background information, your article seems quite skewed.

There are many lessons to learn here....i've had many coversations with physicians, nurses in the last several weeks about this issue.  ISO is llke USP 797...it tell's you what to do and the how is to be determined by the organization. There are many principles from ISO9001 that are in play here...methinks you missed an opportunity to link quality management system requirements to this unfortunate issue and you could have described how a comprehensive process validation process might have mitigated this issue.  Instead, i feel that you misused the platform of Quality Digest in your article and appear to defer blame from an agency that does have skins in this game.

Ted Schmidt, RPh