FDA inspections find unsafe practices in compounding pharmacies

BMJ 2013; 346 doi: (Published 16 April 2013) Cite this as: BMJ 2013;346:f2414
  1. Michael McCarthy
  1. 1Seattle

Inspections of 31 compounding pharmacies have found numerous safety violations, the US Food and Drug Administration reports.1

Compounding firms are licensed to combine, mix, and otherwise alter drug ingredients to create prescription drugs tailored to the needs of an individual patient.2 The inspections were conducted in response to an outbreak of fungal meningitis and abscesses in 2012 that were linked to methylprednisolone acetate products used for spinal and paraspinal injections prepared by New England Compounding Center, a Massachusetts compounding firm.3

By 8 April this year, a total of 733 cases (including 53 deaths) linked to the injections had been reported in 20 states.

Although the FDA has some authority over compounding pharmacies, the firms are licenced by state pharmacy boards, and are not required to register with the FDA or report to the agency what drugs they are making; nor are they required to submit their compounded products for FDA approval.

In general, the FDA has far less authority over the manufacturing standards of compounding pharmacies than it does over pharmaceutical manufacturers.

In a blog post, about the inspection program, FDA Commissioner Margaret A Hamburg said the agency used a “risk-based” model to select which firms it would subject to inspection.

This model took into account reports of serious adverse events, historical inspection data, and reports of quality problems. The inspections focused on each firm’s processing of sterile drugs.

Among the findings were “unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in ‘clean rooms’ where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats,” Hamburg writes.

In response to the inspections, several firms voluntarily recalled their products or temporarily suspended production until they had addressed the deficiencies identified by the FDA inspectors, Hamburg writes.

Some firms, however, resisted the inspections, and in two cases the FDA had to obtain federal warrants to complete the inspections.

“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” Hamburg writes.

In a statement issued in response to the FDA inspections, the International Academy of Compounding Pharmacists (IACP) charged that the agency has been “holding these individual compounding pharmacies to different and inappropriate standards, those that it uses for large commercial drug manufacturers.”

The statement added: “These actions may threaten the viability of companies that provide safe, high quality, and valuable services. This sudden and legally questionable change in standards does not further public safety.”

“Americans can be confident that compounding pharmacies across the US provide safe, customized medications for many patients who need them, such as cancer patients whose oncology medications are not commercially available or a child who needs a pediatric strength of an adult drug,” the IACP said.

The inspections come on the eve of hearings before the House Committee on Energy and Commerce’ s Subcommittee on Oversight and Investigations scheduled for 16 April to look into whether the outbreak could have been prevented by stronger FDA oversight.

In a letter addressed to the Representative Tim Murphy, a Pennsylvania Republican, four Democratic representatives called on the committee to ask a representative of the International Academy of Compounding Pharmacists (IACP), the national organization representing compounding pharmacists, to testify.

Documents obtained by the committee, the representatives write, “reveal that for almost two decades, IACP lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies. Even when individuals at the organization’s highest levels were aware of significant public health risks from compounding, IACP acted to prevent effective FDA oversight.”


Cite this as: BMJ 2013;346:f2414