Compounders Face Firmer Oversight Following Deadly Meningitis Outbreak
Compounding pharmacies across the nation face tighter regulations following the 2012 fungal meningitis outbreak from tainted drugs distributed by the New England Compounding Center.
Compounding pharmacies across the nation face tighter regulations following the 2012 fungal meningitis outbreak from tainted drugs distributed by the New England Compounding Center (NECC).
Years later, the memory of the incident that caused the deaths of 64 individuals remains, and compounding pharmacies still feel the aftershock.
Lisa Faast, PharmD, a pharmacy business specialist and Pharmacy Development Services (PDS) member, told Pharmacy Times that a few bad apples may have tainted the reputation of compounding pharmacists for some, but they do not represent compounders as a whole.
“For the majority of compounders out there, they’re the most outstanding, most educated pharmacists out there,” Dr. Faast told Pharmacy Times.
Since the 2012 fungal meningitis outbreak, pharmacists have become more acutely aware of the consequences of improper compounding, Dr. Faast said. Reactions have varied; some pharmacists stopped sterile compounding operations, while others expanded them.
Nevertheless, the incident spurred a good discussion on proper procedures, and Dr. Faast suggested that compounding pharmacists have become more educated since 2012 about best practices.
Massachusetts instituted a new law in 2014 that tightened regulations on compounding pharmacies in response to NECC incident. This new legislation included new licensing, labeling, education, and oversight requirements, and also instituted new penalties and fines.
The Massachusetts Board of Registration has the power to drop in on pharmacies to determine whether they are following standards and must publicly report on its investigations. Massachusetts compounding pharmacies were also asked to provide more information to the state’s Department of Public Health for public view.
“In the 2-plus years since that event, legislators and state regulators have worked to significantly tighten oversight and regulation of compounding pharmacies across the nation,” David G. Miller, RPh, EVP, and CEO of the International Academy of Compounding Pharmacists (IACP), told Pharmacy Times. “Legislators in Massachusetts, where NECC was located, say the state now has one of the toughest compounding laws in the nation.”
The federal government has also played a bigger role in overseeing compounding pharmacies following the fungal meningitis outbreak.
In 2013, President Barack Obama signed into law the Drug Quality and Security Act (DQSA), which created more oversight on compounded drug manufacturing. Part of the new law created a category for compounding facilities that produce large amounts of sterile medications that are not for patient-specific prescriptions.
Title 1 of the DQSA, the Compounding Quality Act, altered some provisions in section 503A of the Federal Food, Drug, and Cosmetic Act (FCDA). It also addressed a newly created section, 503B, which stipulates that a compounder can become an outsourcing facility and may qualify for exemption from FDA approval requirements and requirements related to labeling products with adequate directions for use.
However, these outsourcing facilities must comply with current good manufacturing practices and can be inspected by the FDA. They also must provide the FDA with certain information about the products they compound and meet other conditions, such as reporting adverse events.
Compounding pharmacies can choose to apply to qualify for 503A or 503B, or they will have to meet the same requirements as conventional manufacturers.
Beyond these FDA requirements, the agency has maintained that state pharmacy boards would be responsible for their own oversight and regulation of compounding pharmacies.
The proposed US Pharmacopeia General Chapter <800> could also have an effect on compounding pharmacies. For example, <800> will call for a “containment segregated compounding area.” In other words, compounding facilities will need a separate, negative-pressure room with at least 12 air changes per hour when compounding hazardous drugs. (This revised chapter is still open to public comment until May 31, 2015.)
More recently, the FDA released several guidelines for compounding pharmacies, and a few of the documents have been met with some criticism, according to The Wall Street Journal. For example, pharmacies will have to limit the amount of interstate-distributed compounded drugs to less than 30% of their total distributed drugs during that month. Critics say this cap will make it harder for patients to obtain medications easily.
Another file in the FDA’s most recent guidelines that is causing a stir concerns repackaging biologics. Any biologic mixed, diluted, or repackaged will have to be taken by the patient within 4 hours. If microbial testing is performed, however, the length of time is extended to 24 hours, and outsourcing facilities may be allowed more time if additional studies are done. Some critics say these expiration dates will lead to more products going to waste.
What some pharmacists may not know is that the DQSA does not only apply to compounding pharmacies; it impacts anyone who compounds, including doctors, nurses, and dentists. As a result, some health care providers may be forced to use different, more expensive products or consider repackaging products in their own practice space in response to the expiration dates, Dr. Miller said. This will raise concerns for health care providers who currently lack the facilities and training to compound specific products.
The FDA had not addressed expiration dates before these guidelines, so health care professionals relied on package inserts and published scientific studies to determine appropriate beyond-use dates, according to Dr. Miller.
Looking to the future, compounders will need to focus on how to realign federal and state laws that may conflict with their best practices.