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.

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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.

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  • Under the proposed Memorandum could the patient and their physician be forced to choose between using compounded drugs that are lower in quality (than those produced by an out-of-state compounding pharmacy) or foregoing needed treatment altogether?

    Wouldn’t it be ironic if the law that was enacted to protect patients’ winds up harming them instead?

  • If a local compounding pharmacy is producing unsterile products but not shipping over state lines, under the proposed FDA Memorandum it is not the FDA’s problem or safety concern?

  • This article, which is transparently written from the regulated industry’s perspective, is long on advocacy and short on history. What needs to be stated more clearly here is that over a period of time “compounding pharmacies” in many cases morphed into “compounding drug manufacturers” that were acting far outside the realm of state-regulated pharmacy practices. It was bad actors like NECC who brought the spotlight onto a huge problem that had routinely put patients at risk: certain compounders weren’t pharmacies at all but were posing as pharmacies in order to avoid federal drug safety oversight. Having brought this problem on itself, the industry is now saying that the FDA is being too strict in making sure that this pattern doesn’t get repeated. The issue is straightforward. What the FDA is saying is that if you act like a drug manufacturer we’re going to treat you like a drug manufacturer (or “outsourcing facility” as it’s called under the 2013 law).

    I make no comment on whether the FDA has properly followed the Administrative Procedures Act. I just wish to point out that this article, under the guise of a request for a “practical framework,” seems mostly to be a longing for the good old days when compounders could pose as pharmacies no matter how much they looked and acted like drug manufacturers. And in those good old days, compounders who should have been subject to drug safety rules labored hard to avoid FDA oversight designed to ensure patient safety.

    Sure patients want access to the right drugs. They also want to be confident that what they are getting has been proven to be safe.

  • I know that a large number of compounding pharmacies are issued FDA warning letters and 483 which are serious. As a consumer what safeguards are in place when these firms now can send these meds out of state? A hard line should be drawn to limit interstate transport. Not a pro business position I agree but a poor quality firm can put patient safety at riskmany miles away.

  • NECC was not even a pharmacy. NECC was a manufacturer pretending to be a pharmacy. So punishing real pharmacies for the sins of NECC is unfair. I am outraged that Barry Cadin, the owner of NECC ony got 6 years, after his greed killed over 60 people and injured hundreds. He should have received life in prison without any chance of parole. Just goes to show, white collar crime pays. People go to jail longer than 6 years for holding up a convenience store with a gun, even when no one is injured in the robbery.

  • The NECC scandal in Massachusetts was the failure of the Massachusetts Dept. of Public Health alone, and not federal authorities. The Secretary of Health and Human Services, Dr Judy Ann Bigby, was derelict in her statutory obligation to ensure that an individual prescription exists for every compounded medicine made and sold. Not hard at all.

    Dr Bigby and DPH LIED that NECC fell in between the cracks of federal and state regulations in order to misdirect people away from the documented fact that Boston’s powerful hospitals ordered compounded drugs from NECC in BULK without the statutorily required prescription for an individual patient because it was cheaper than purchasing those same drugs from the open market. These cheaper drugs included infusions used during cardiac bypass operations. The Boston Globe actually reported this.

    Every single person at those hospitals knew he/she was breaking state law. Massachusetts does not have the spine or ethics to hold powerful hospitals and their staff responsible for violating state law just to increase hospital profits.

    The sole exception was Dana Farber Cancer Center, which did not purchase drugs in bulk from NECC.

    NECC was a wholly Massachusetts problem. New federal regulations will do nothing to make Massachusetts DPH care about enforcing the law on hospital goliaths.

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