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Patrick Stone

FDA Compliance

Give the FDA More Authority Over Compounding Pharmacies

They are currently protected from the big bad regulatory wolf

Published: Thursday, October 25, 2012 - 09:13

Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no interstate sales). This means that compounding pharmacies do not have to operate under the Food and Drug Administration’s (FDA) current good manufacturing practice (cGMP) regulations for compounding their drug products.

The FDA routinely inspects compounding pharmacies for verification that compounded drug products are for a specific patient’s prescription and not for a bulk manufacturing process. We need compounding pharmacies to provide safe products because many drugs do not come in the right strength or dosage for children or special needs patients. Many times FDA auditors find that in fact the inspected compounding pharmacy is manufacturing bulk drug product.

Sometimes FDA auditors observe sterile drug product compounding without sterility and environmental controls in place. Historically speaking, since the 1990s the FDA has gone after many compounding pharmacy operations. However, the FDA has been told many times by state judges they have no jurisdiction and ruled in favor of the compounding pharmacy. Congress has also shielded compounding pharmacies from FDA review for various reasons, including protecting home district businesses from the big bad regulatory wolf.

The problem here is not the FDA. The real culprits are the compounding pharmacies, the state pharmacy boards, and Congress. In this case, the FDA is doing its job with its hands tied behind its back. I know because during my time at the FDA, I inspected many compounding pharmacies and observed firsthand how they operate. FDA management always told me to drop it and move on because we couldn’t do anything about these compounding pharmacies.

The New England Compounding Center (NECC) in Framingham, Massachusetts, has been tied to more than 20 reported deaths, and more than 257 patients have had fungal infections following injections of steroids that NECC manufactured. Between May 21 and Sept. 24, 2012, patients in up to 23 U.S. states may have received injections of products from this compounding pharmacy. This is going beyond compounding pharmacy practice into national distribution of a sterile drug product.

The NECC has been in the FDA’s radar since about 2002, when it was first inspected and found to be operating out of control for sterile drug product manufacturing. The main point here is that this is only one of thousands of compounding pharmacies across the nation operating under similar assumptions of sterile conditions without GMP controls.

In a time when drug shortages are at a critically high level, compounding pharmacies can help—but are they really helping? If these operations are not following the FDA drug manufacturing regulations, they are not interested in patient safety. They are only interested in distributing compounded drug products and the resulting profit margins.

State pharmacy boards should be inspecting firms that compound sterile drug products for conformance with general chapter 797 “Pharmaceutical Compounding—Sterile Preparations” from the United States Pharmacopeia–National Formulary (USP–NF), which are published in USP on Compounding: A Guide for the Compounding Practitioner. The problem with this is that many state pharmacy boards do not have auditors trained to conduct this type of audit and instead focus strictly on Drug Enforcement Administration (DEA) aspects, pharmacy practice, and business aspects.

The FDA should be able to regulate these companies under strict drug manufacturing laws with the systems approach method of inspection. These companies always claim it will be too expensive to operate under cGMP guidelines. Congress is now going to have to decide whether or not to provide the FDA with proper regulatory oversight for this type of drug manufacturing operation. Only time will tell if the FDA has to keep its hands tied, or if public safety measures will be put in place to keep this type of outbreak from happening again.

Let’s hope the FDA gets the authority it needs to better protect the public.

This article first appeared in the Oct. 23, 2012, edition of the AssurX blog.


About The Author

Patrick Stone’s picture

Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.


The FDA has skins in this game...

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