New legislation would allow the FDA to track the volume and distribution of drugs produced at compounding pharmacies, increase the transparency of compounded drugs, and institute a waiver system in times of public need.
Representative Edward J. Markey (D, MA) recently introduced legislation that would allow the FDA to have new authority over the activities of compounding pharmacies previously governed exclusively by state law. The Verifying Authority and Legality In Drug (VALID) Compounding Act contains many of the provisions that existed in a similar proposal from 1997, save a few provisions that led to its initial rejection.
Recent events involving contaminated steroids from a facility in Framingham, Massachusetts, that led to 28 deaths and 377 illnesses in 19 states brought the practice of compounding pharmacy into focus in the media—and not all of the reports framed the practice in a positive light. Indeed, politicians had already begun responding to the meningitis outbreak before Rep Markey’s proposed legislation. 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 volume and distribution at compounding pharmacies to determine if they are operating as manufacturing facilities. The emergency legislation requires that compounding pharmacies report to the state when they are the subject of an investigation by another state or federal authority.
The legislation proposed by Rep Markey would essentially allow compounding pharmacies to operate status quo ante and would only mandate FDA intervention in specific circumstances.
According to a brief summarizing the legislation on Rep Markey’s website
, a drug made by compounding pharmacies would be exempt from FDA scrutiny if 1) the drug is compounded by a licensed pharmacist or physician for an identified patient with a valid prescription, 2) the drug is compounded using safe and approved ingredients using good manufacturing practices, and 3) the drug 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 these pharmacies to register their company as a drug manufacturer, thereby allowing tighter control by the FDA over the products being distributed.
The VALID Compounding Act would also require pharmacies that wanted to compound a drug before the receipt of a valid individual prescription to submit a waiver with the agency requesting permission to produce the drug. 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 act of granting these waivers as long as they had the resources to properly monitor the facilities, the brief noted.
In the event of a drug shortage, the FDA would have the power to waive their own “individual prescription” rule based on need and in the interest of public health. In light of public need, the FDA could also waive the provision stating that the drug cannot be a copy of a commercially available drug. In both of these instances, Rep Markey’s proposed legislation indicates that waivers granted in these circumstances would be valid for a period of 1 year unless the drug shortage warranted an extension.
Lastly, the Act would increase the transparency of compounded drugs by letting the public know that they were 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 under the proposed legislation, and any adverse reactions to any compounded material would have to be reported to the FDA.
Governor Deval Patrick supported 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.” He also noted in the letter 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, senior member of the Energy and Commerce Committee. “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.”