FDA delivers warning letters to 28 of 29 pharmacies recently inspected
Following up on the NECC meningitis crisis which, at latest count, is responsible for 53 deaths and 733 injuries, the Pew Charitable Trusts (Washington, DC) published a proceedings of a “stakeholder summit” held in February on the topic. This occurred just at the House Energy and Commerce committee was scheduling new hearings on the question of initiating legislation that would broaden FDA’s oversight of compounding pharmacies.
Among other statistics, the group found that compounded pharmaceuticals have been responsible for 75 deaths and 1,022 illnesses since 2001—primarily in compounded sterile products (CSPs)—of which the NECC product, steroidal formulations for joint pain, was an example. Representatives from the American Soc. of Health-System Pharmacists (ASHP) and the American Hospital Assn. (AHA) noted that their member hospitals, when they use outsourced compounding pharmacies, assume that the necessary state and federal regulations and inspections are in place, but often they are not.
For its part, FDA Commissioner Margaret Hamburg recently updated agency information on a task force of inspectors that identified 31 pharmacies where new inspections were a priority, and completed 28 of the inspections by early April. Form 483 warning letters were issued to 28 of the 29; the 29th was not engaged in handling CSPs. (A warning letter, which most manufacturers are familiar with, is an identification of a possible deficiency; generally, FDA and the business entity work together to resolve the deficiency or, if there is no resolution, FDA takes more severe action.) Over the past couple months, there have been voluntary recalls announced by Green Valley Drugs (Henderson, NV), Clinical Specialty Compounding Pharmacy (Augusta, GA) and Med Prep Consulting (Tinton Falls, NJ); the Clinical Specialty recall involved eye infections caused by Roche’s Avastin (bevacizumab) being compounded for macular degeneration, an unapproved indication.
Additionally, according to summit participants, something of a Catch-22 exists with current regulation and guidance for compounding. Manufacturers must comply with the body of policies established by FDA as current good-manufacturing practices (cGMPs); but compounding pharmacies are not, by some interpretations, manufacturing facilities. There exists a USP guidance, Chap. <797>, that can guide state boards of pharmacy—but only some states have adopted it. And <797> does not have the same structure as cGMPs (one problem is that, strictly speaking, a compounded product is a one-off—to test its quality would be to destroy it. The reality is, however, that some compounding pharmacies are producing hundreds or thousands of dosages at a time.)
There is a belief that there is a need for a new category of pharmacy—those that produce bulk shipments of compounded products—and that their operations should be overseen by FDA. But that belief will be attacked by the International Academy of Compounding Pharmacies (Missouri City, TX), which wants to keep pharmacy compounding regulated at the state level. The group’s annual meeting will be held in Arlington, VA, on June 1-4, and it is planning a “Compounders on Capitol Hill” campaign “to protect pharmacy compounding.”