The deaths of 64 people and sickening of nearly 800 due to criminal negligence by employees of the New England Compounding Center in 2012 marked a profound failure of state and federal regulatory enforcement.
That horrific episode led to Congress including in the Drug Quality and Security Act of 2013 provisions to create a more robust regulatory framework for compounding pharmacies — both small, local compounding pharmacies and larger distributors.
The legislation instructed the FDA to create regulations within parameters set by Congress that would assure patient safety while permitting local compounders to continue to meet patient needs by providing customized compounded medications using FDA-approved substances.
But the FDA has overreached in implementing the provisions, all but halting common compounding practices that have been safely performed for years and on which patients with legitimate needs for compounded medications rely. Not only that, but the FDA has done so by circumventing the federal Administrative Procedure Act, issuing “guidance documents” to implement policies rather than following the statutory rule-making process that requires stakeholder input regarding proposed regulations.
It’s no small concern. Many patients have unique health needs that off-the-shelf, manufactured medications cannot meet. For decades, compounding pharmacists have provided these patients with personalized solutions — prescribed by licensed practitioners and prepared by trained, licensed pharmacists — that often are their only way to better health. Working with a physician, a compounding pharmacist can meet the individual needs of children, adults, and even animals. Whether it’s an allergy to a dye or an ingredient, the need for a different strength or dosage, or a combination of medications, compounding pharmacists across America provide patients with safe, effective solutions to their medication needs.
The FDA, on its own authority and acting outside of ongoing directives from congressional committees — as well as without heeding input from pharmacist, physician, and patient groups — is now redefining terms like “dispense” and “distribute” in ways that restrict what has been a basic function of pharmacists for more than a century. Those restrictions, in turn, are likely to cause difficulty for patients in accessing and affording the medications they need.
Which is to say that the FDA is about to throw out the baby with the bathwater.
Many of the problems the FDA has created can be fixed without formal action by Congress. It can listen to and work with state boards of pharmacy as well as pharmacist, prescriber, and patient groups to find middle ground: a regulatory framework that respects the primary role of states in regulating compounding pharmacies while assuring practices that thoroughly protect the patients who rely on compounded medications. A coalition of compounding pharmacy groups that includes the International Academy of Compounding Pharmacists, the National Community Pharmacists Association, and others believes that middle ground surely exists and is committed to working with the FDA to find it.
That coalition is asking members of Congress to sign letters from the House and Senate urging the FDA to step back and reconsider some of the more severe requirements it is asking states to agree to in a memorandum of understanding required under the Drug Quality and Security Act. One of the issues the letters address is FDA’s redefining the term “distribution” to include the patient-specific “dispensing” of compounded medications.
The letters urge the FDA to reconsider the burden that the memorandum of understanding places on state boards of pharmacy — terms that many states are rejecting outright. This means that pharmacies in states that do not sign the memorandum of understanding will be capped at “distributing” (which FDA has redefined to include patient-specific dispensing) no more than 5% of their compounded medications over state lines. Because the FDA has redefined “distribution” to include medications prescribed by a physician for a specific patient, a 5% cap could severely disadvantage patients who get their compounded medications from out-of-state pharmacies.
Interstate shipping of compounded medications is essential to patient access, since most compounders specialize in particular therapies. A compounded medication that a New Jersey patient needs may be most affordably available from a compounding pharmacy in Georgia or Kansas or Arizona. A stringent cap on medications shipped out of state could result in patients losing access to compounded medications from the licensed pharmacy of their choosing.
In the event that the FDA continues on its present path, Congress may need to weigh in. That’s why the coalition is also supporting the Preserving Patient Access to Compounded Medications Act (H.R. 1959), a bipartisan bill introduced in March by Rep. Henry Cuellar (D-Texas) and Rep. Morgan Griffith (R-Va.) that would bring needed clarity to compounding provisions in the Drug Quality and Security Act and settle these matters once and for all.
America’s compounding pharmacists and pharmacy owners are not seeking to operate in an unregulated or underregulated environment. And they don’t want incidents like the New England Compounding Center tragedy to ever happen again. The fact is that this industry — and the patients it serves — benefit from a strong regulatory framework.
But it needs to be a practical framework, too: one that recognizes there is a proper role for compounding pharmacists in serving patients. One that assures that patients have continued access to safe, affordable compounded medications. And one that doesn’t throw out the baby with the bathwater.
Scott Brunner is the executive vice president of the International Academy of Compounding Pharmacists.