Proposed legislation would allow the FDA to track the volume and distribution of drugs produced at compounding pharmacies, provide more information to the public about compounded drugs, and institute a waiver system in times of public need.
Representative Edward J. Markey (D, MA) recently introduced legislation that would give the FDA new authority over the activities of compounding pharmacies currently overseen by state law. The Verifying Authority and Legality In Drug (VALID) Compounding Act contains many of the provisions included in a similar proposal from 1997, save a few elements that led to its rejection then.
An outbreak of fungal meningitis associated with contaminated steroids produced by a compounding facility in Framingham, Massachusetts, has brought a great deal of media attention to the practices of compounding pharmacies—much of it critical. (As of November 7, 2012, the outbreak has caused 31 deaths and 424 illnesses in 19 states.) In addition to Rep Markey's proposed federal legislation, state-level authorities have taken steps in reaction to the meningitis outbreak. On November 1, 2012, Massachusetts Governor Deval Patrick announced
emergency regulations to enhance the oversight of compounding pharmacies. These new rules allow the state to track production volume and distribution at compounding pharmacies to determine if they are operating as manufacturing facilities. The emergency rules also require compounding pharmacies to report to the state when they are the subject of an investigation by another state or federal authority.
Rep Markey's proposed legislation would allow compounding pharmacies to operate more or less as they currently do, only mandating FDA intervention in specific circumstances. According to a brief
summarizing the legislation on Rep Markey’s website, a drug made by a compounding pharmacy would be exempt from FDA scrutiny if 3 criteria are fulfilled: the drug is compounded by a licensed pharmacist or physician for an identified patient with a valid prescription; it is compounded using safe and approved ingredients and good manufacturing practices; and it is not a copy of a commercially available drug. In essence, the legislation defers to existing state regulations when the compounding pharmacy is operating within the state law’s definition of a compounding pharmacy.
The FDA would step in to regulate the activity of compounding pharmacies only when a pharmacy operates outside of these conditions. If a compounding pharmacy is producing large volumes of medications, and the agency classifies these activities as drug manufacturing, the FDA would require the pharmacy to register as a drug manufacturer, thereby allowing tighter oversight by the agency.
The act would also require a pharmacy wishing to compound a drug before receiving a valid individual prescription to request a waiver from the agency allowing it to do so. The waiver system would apply to “hospital pharmacies, community pharmacies that wished to make small batches of compounded drugs for their regular customers, or compounding pharmacies that have small sterile compounding facilities.” State regulatory authorities could take over the role of granting waivers provided that they have the resources to properly monitor the facilities, the brief on Rep Markey's website noted.
In the event of a drug shortage, the FDA would have the power to waive its “individual prescription” rule based on need and in the interest of public health. The FDA could also waive the requirement that the drug not be a copy of a commercially available drug based on its determination of public need. In both of these instances, Rep Markey’s proposed legislation indicates that waivers granted would be valid for a period of 1 year unless the drug shortage warranted an extension.
Finally, the act would require that the public be informed that compounded drugs are not produced under FDA guidelines. The FDA would create and maintain a list of drugs that are “not safe or effective when compounded” and would release this list to the public and to state regulators in a comprehensive “Do Not Compound” list. All drugs produced under a waiver would be subject to inspection by the FDA, and all adverse reactions to compounded medications would have to be reported to the FDA.
Governor Patrick expressed support for Rep Markey’s proposed legislation in a letter
to the congressman, writing, “Your legislation will close the regulatory gaps thousands of compounding pharmacies nationwide fall through right now, and deliver much needed patient protections that states cannot provide on their own.” Governor Patrick added that he and his colleagues are in the process of forming a special commission to examine compounding best practices in other states.
“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Rep Markey, who is a senior member of the Energy and Commerce Committee, in a press release
. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward.”