Ways Forward for Compounding: Liability, Inspection, and Regulation

Representatives of the NABP and the ASHP discussed the crisis surrounding compounding pharmacy, including liability for purchasers of medication from compounders, a plan to inspect more pharmacies, and the possibility of new regulation of compounding.

As the crisis associated with contaminated steroids produced by the New England Compounding Center (NECC) has grown to include more than 600 cases and at least 39 deaths, it has come to seem inevitable that compounding pharmacy will soon be subjected to increased regulation and oversight. The outbreak and possible details of this increased oversight were discussed at a session titled “A Compounding Tragedy—A National Response” held on December 5, 2012, at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in Las Vegas.

Carmen Catizone, RPh, executive director of the National Association of Boards of Pharmacy (NABP), opened with a sobering assessment of the compounding crisis. “Every single one of us was responsible for this tragedy,” he told the roomful of health-system pharmacists. “The regulatory system broke down. The pharmacy compounding system broke down. The collaboration between the FDA and the states broke down. … Everyone shares that responsibility.”

Drug shortages were a major contributor to the tragedy, Catizone explained, and compounding seemed to be a viable solution for getting ahold of medications that were otherwise difficult to source. However, as the ongoing tragedy illustrates, the structure required to fill the drug shortage gap through compounding while upholding safety standards was not in place. The primary problem, Catizone suggested, is that state boards of pharmacy do not have adequate resources to oversee compounding pharmacies. “Some pharmacies haven’t been inspected in as long as 20 years,” he said. “That’s unacceptable.” To help increase these resources, Catizone urged pharmacists to push for registration fees paid by pharmacies to go directly to the budget of their state board rather than into the general fund, which is what occurs in almost every state.

Catizone noted that questions remain as to why the Massachusetts Board of Pharmacy did not take stronger action against the NECC based on allegations that it was breaking state law. Nonetheless, he emphasized, “If any of your institutions purchased medication from NECC, and they were not per-prescription based, if they were for office use or clinic use, you broke the law.” As a result, Catizone said, these institutions could face lawsuits from patients who received the medications and in these lawsuits, the institution’s insurance would most likely be declared invalid because it broke the law.

Given the regulatory problems exposed by the NECC crisis, Catizone noted that institutions that purchased medications will no longer be able to claim that they thought a given compounding pharmacy was reputable because it was licensed by its state board of pharmacy. More due diligence by the purchaser will be expected. To help provide information on many pharmacies that provide medications across state lines, Catizone announced that the NABP and the Iowa Board of Pharmacy have teamed up to inspect all 582 nonresident pharmacies registered in the state. The NABP will be a designated agent of the Iowa board and if a given pharmacy refuses the inspectors access, it may risk losing its nonresident pharmacy license. The NABP planned to begin the inspections earlier this month, and plans to set up a database providing information on their results.

Later in the session, Joseph Hill, director of federal legislative affairs at ASHP, discussed possible new legislation that would change how compounding pharmacy is regulated. He noted that the ASHP had told Congress in response to inquiries that compounding is essential to health-system pharmacists, emphasizing that it provides medications that patients need. So far, Hill noted that US Rep Edward Markey (D-MA) has introduced the only bill (HR 6584) in response to the crisis. Markey’s bill attempts to distinguish between traditional and non-traditional compounding pharmacies, leaving traditional compounding pharmacies under the authority of state boards of pharmacy and putting non-traditional compounding pharmacies (which behave more like drug manufacturers) under the authority of the FDA.

Hill noted that a potential problem with the Markey bill is that it seems to define anticipatory compounding as non-traditional compounding. However, the FDA would be allowed to issue waivers to an entity such as a hospital that would place it under joint oversight by the FDA and the state board, allowing it to proceed with anticipatory compounding. Another potential problem with the Markey bill is that it includes a list of medications that cannot be compounded.

The question, Hill noted, is how to get manufacturer-like compounders under FDA authority, and the answer is not straightforward. The Markey bill does provide flexibility to the FDA, but it is not clear that the FDA has the resources necessary to inspect all the compounding pharmacies that would fall under its jurisdiction. The ASHP is still gathering information on the Markey bill, Hill said, and has not made a decision as to whether to support it.

Rather than draw a strict line between compounding and non-compounding pharmacies, Hill said, an alternative approach would be to have a continuum with manufacturing at one end and traditional compounding at the other end. This could give the FDA and state boards of pharmacy flexibility to determine who should have oversight over a given pharmacy, based on criteria such as volume of production, how much of the production is sent out of state, and whether patient prescriptions are obtained in advance of compounding.