Published on:

Compounding Pharmacy Regulations Put Patients in Danger

With the recent news that two Massachusetts compounding pharmacies were closed after failing a surprise state inspection, it has become increasingly clear that unsafe compounding pharmacies are, in many cases, a public menace.

Of course, as our Boston injury lawyers know, the biggest disaster to-date was a meningitis outbreak that caused more than 700 illnesses and 50 deaths as a result of products from New England Compounding Center (NECC), which were contaminated with fungus. However, the bad news just keeps coming and the FDA is now engaged in a fight with a compounding pharmacy that is refusing to recall products that could potentially lead to life-threatening infections. getting-the-needle-for-lockjaw-1090112-m.jpg

The fight between the FDA and a compounding pharmacy called NuVision not only underscores the fact that many compounding pharmacies are taking dangerous risks with people’s health, but also shows the clear need for tougher regulations and better rules on who, exactly is responsible for regulating compounding pharmacies. Tougher regulations are necessary as NuVision has refused the FDA’s request for an immediate recall because the company believes it is in compliance with all current legal requirements.

Compounding Pharmacy Refuses FDA Recall Request

In April of 2013, investigators visited NuVision and conducted an inspection. The inspectors identified poor sterile practice procedures, which led the FDA to believe that the practices at the compounding pharmacy raise the risk that sterile drug products coming from NuVision aren’t actually sterile.

If a drug product is marked as sterile and isn’t, then the microbial contamination in the product could potentially cause life-threatening infections to patients. The FDA was very concerned about what the investigators found and the potential risk to the public health and determined that the NuVision products should not be used. On May 18, 2013, the FDA issued an alert to that effect.

The FDA subsequently sent a letter to NuVision on July 26, 2013, requesting an immediate recall of all non-expired products due to the lack of sterility assurance. NuVision declined to recall its products. With the products still on the market, The Tennessean reported that the FDA issued yet another warning in mid-August. In its latest statement, the FDA reminded healthcare providers not to use any “sterile” products from NuVision because of the potential risk to patients.

Despite the concern from the Food and Drug Administration, NuVision has refused to comply with repeated recall requests. The statement on its website reads, in part, “NuVision pharmacy is a compounding pharmacy… We are not a manufacturer. We are in compliance with (U.S. Pharmacopia rules 795 and 797) which are the standards of law for compounding pharmacy. The FDA has been inspecting compounding pharmacies based on a different set of standards for manufacturers called FDA 210 and 211. The FDA manufacturing law is different than USP. The current state laws do not require compounding pharmacies to follow the standards for manufacturing.”

The problem is that the laws related to compounding pharmacies and the rules for regulating these pharmacies were designed when compounding pharmacies produced made-to-order drugs for specific patients and operated on a much smaller scale.

What NuVision and other compounding pharmacies like NECC are doing is essentially manufacturing drugs even though they don’t call it that. Thus, these pharmacies likely should be subject to stricter rules. Lawmakers are trying to change the laws, and the fact that NuVision appears to be using the current lack of oversight and regulation as a reason to refuse a recall the FDA says is necessary lends support to the fact that something needs to change in the law to protect the public.

If you or a loved one was injured, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

More Blog Entries
Meningitis Victims Sue Sister Company of New England Compounding Pharmacy, Boston Personal Injury Attorney Blog, July 29, 2013.