On May 9, the FDA warned that unless it gets additional authority to regulate compounding facilities, we will likely see a recurrence of the multistate meningitis outbreak that killed nearly 50 people and sickened more than 700. In the meantime, though, the FDA has followed through on its promise to inspect “high-risk” facilities, which has already resulted in four recalls from compounding centers in Georgia, Florida, and New Jersey.
The Ongoing Impact of the Fungal Meningitis Outbreak
The CDC continues to identify new cases related to contamination at the New England Compounding Center (NECC). Ten new cases were identified in April, and officials warn that the incubation period for the disease is longer than anticipated. Many of the new cases are showing up in people who previously tested infection-free.
Based on previous cases, mostly a 2002 outbreak of the disease, officials believed that infections should show up within about five months after exposure. With new cases continuing to show up every week, more than six months after the contaminated injections were pulled from the market, officials now admit they have little experience with this type of infection, though they hopefully state that slow-growing infections should be less serious than the serious meningitis cases, which showed up quickly.
FDA Lacks Power to Effectively Regulate Compounding Facilities
Compounding facilities are not adequately regulated under the current system, according to numerous experts in the field. Under current regulations, local compounding facilities are regulated by state boards, but larger interstate compounding facilities fall into a grey area.
Although technically regulated by state boards of pharmacy, the state level regulators lack the ability to collect and compile adverse event reports from multiple states to identify potential problems and take necessary action. The rules for compounding facilities are also generally based on the model of the individual pharmacist-compounder who made small batches of relatively simple preparations to meet special prescriptions. They do not address the inspection and regulation needs of large producers of complex sterile preparations.
The FDA, although it is able to collect data about potential health threats, lacks clear regulatory authority over the compounding facilities and is only able to act in concert with state authorities or in cases where an imminent danger has been identified.
The FDA’s Short-Term Solution
Although there is proposed legislation that would give the FDA the authority it needs to regulate compounding facilities, the FDA has taken preemptive action in an attempt to limit potential health threats posed by compounding facilities. Working with state officials, the FDA has over the last couple months inspected 31 compounding facilities that had been identified as “high risk” because they produce or have produced sterile preparations.
Even though they worked with state regulators, FDA inspectors found their efforts were hampered by uncooperative facilities that did not fully acknowledge the FDA’s regulatory authority. According to FDA commissioner Dr. Margaret A. Hamburg, “our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting.”
Despite difficulties, the FDA has completed numerous inspections, and has issued several recalls based on some of the terrible conditions they discovered, including:
- Med Prep Consulting of Tinton Falls, NJ (3/18/2013): All lots of all products were recalled after a nurse noticed that bags of IV solution from Med Prep had white floating particulates, which were later determined to be mold. An inspection report notes that the FDA found that there was no attempt to explain and therefore correct deviations from specifications, and had incorrectly prepared, mislabeled, or mispackaged 20 injectable drug products in the last 24 months. They didn’t monitor sterility or even have a scientific sampling plan.
- Clinical Specialties Compounding Pharmacy of Augusta, GA (3/21/2013): All lots of sterile products recalled after some patients experienced eye infections from injectable medication Avastin. An inspection report states that there was no lab testing to ensure injectable medications were sterile. In addition, the facility was found to have inadequate sterilization facilities, and a lack of lab testing to ensure products met specifications.
- ApotheCure and NuVision of Dallas, TX (4/15/2013): All sterile products by ApotheCure and sterile lyophilized products by NuVision were recalled. Inspections showed there were inadequate assurances that the products were truly sterile, and employees did not attempt to determine why batches didn’t meet quality guidelines. The firm didn’t have written guidelines to prevent contamination of compounds.
- Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, FL (4/21/2013): All lots of sterile nonexpired drug products were recalled following an inspection that showed the facility had inadequate assurance that products were sterile. The inspection report noted that products were sold even if they failed to meet quality control or sterility standards. The facility tested products, but they were sold even if they were found to be defective.
- The Compounding Shop of St. Petersburg, FL (5/8/2013): All lots of all sterile products were recalled after the results of an inspection at the facility. The inspection showed that the company had no established guidelines for preventing infection of sterile products, what guidelines did exist were not written, and these guidelines were rarely followed. There were no laboratory testing procedures for sterile products, and utensils were not cleaned often enough to prevent infection.
In all cases, the FDA relied on “voluntary” recalls by the compounding facilities, though there is no word about what types of coercion were used to obtain the voluntary recalls, nor word on which additional facilities have been asked or may be asked to initiate recalls.
Although these recalls and state-driven ones like the Pallimed Solutions recall may make it seem like authorities have the power to identify potential problems, the above recalls represent only a small fraction of the relatively unregulated compounding market. It is unknown how many more potential problems might have been found if larger-scale surprise inspections were carried out.