Analysis: FDA Must Have More Authority Over Compounding Pharmacies

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Compounding pharmacies nationwide 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 good manufacturing procedures (GMPs) for compounding their drug products.

FDA routinely inspects compounding pharmacies for verification that compounded drug products are for a specific patient 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/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/environmental controls in place. Historically speaking, since the 1990’s FDA has gone after many compounding pharmacy operations. However,  FDA has been told many times by state judges they have no jurisdiction and ruled in favor of the compounding pharmacy operations. 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, FDA is doing its job with its hands tied behind their back. I know because I have inspected many compounding pharmacies during my time at FDA and observed first hand how these companies operate.  FDA management always told me to drop it and move on because we could not do anything about these compounding pharmacies.

The New England Compounding Center (NECC) in Framingham, MA, has been tied to over twenty reported deaths and more than 257 patients have had fungal infections following injections of steroids they manufactured.  Between May 21 and September 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 around 2002 when they were 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 Good Manufacturing Procedures 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 distribution of compounded drug products and profit margins.

State Pharmacy Boards should be inspecting firms that compound sterile drug products for conformance with U.S. Pharmacopoeia (USP) chapter <797> “Pharmaceutical Compounding – Sterile Preparations”. 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 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 Good Manufacturing Procedures (cGMP) guidelines. Congress is now going to have to decide whether or not to provide FDA with proper regulatory oversight for this type of drug manufacturing operation. Only time will tell if 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.

Patrick Stone is President of TradeStone QA and the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Analysis: FDA Must Have More Authority Over Compounding Pharmacies
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Analysis: FDA Must Have More Authority Over Compounding Pharmacies
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Compounding pharmacies nationwide have enjoyed the protection of their state Pharmacy Board, or they don’t distribute outside their home state (no interstate sales).
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