FDA Proposes Eased Compounding Monitoring

By Walter F. Roche Jr.

The head of the U.S. Food and Drug Administration is proposing an easement in the oversight of drug compounders even as he acknowledges that current inspections have turned up evidence that the practices of some of those in the field "present serious public health risks."
Commissioner Scott Gottlieb, in an announcement issued late last week, said that a revised proposal for compounder regulation sets a higher threshold to trigger closer scrutiny of drug compounders who are shipping their products over state lines. Originally the FDA had proposed in 2015 that drug compounders shipping more than 30 percent of their products over state lines get greater scrutiny. The revised proposal sets a 50 percent threshold.
The new policy would effectively change the definition of an "inordinate amount" from 30 percent to 50 percent.
The new proposal is the FDA's latest effort to implement a 2013 law,the Drug Quality and Security Act. That law was passed in the wake of the 2012 fungal meningitis outbreak which sickened 778 patients across the country, killing 76 of them. The culprit was a Massachusetts drug compounder that was mass producing steroids and other drugs and shipping them across the country. Thousands of vials of methylprednisolone acetate contaminated with deadly fungi were shipped from the New England Compounding Center.
In his statement Gottlieb said the goal of the revision was "to collaborate with the states, so that, working together, we can have the greatest public health impact, while also maximizing our resources."
The new threshold would be included in memorandums of understanding between the FDA and state boards regulating pharmacies.
The original proposal prompted protests from state pharmacy boards and drug compounders who warned that the stricter regulation would lead to a shortage of needed drugs, thus hurting patients.
Traditionally local pharmacists compounded drugs to meet the needs of specific patients,such as a child who was allergic to one of the ingredients in a mass produced drug. As the 2012 outbreak demonstrated some of those local pharmacies had morphed into manufacturers, but were eluding the increased scrutiny required for manufacturers.
In his statement issued Friday, Gottlieb acknowledged that regulators continue to identify "insanitary conditions" at some drug compounding operations "that present a serious health risk." He said those include finding mold growth and animal hair in areas where sterile drugs were being prepared.
"Sometimes," he continued, "these involve situations where the compounders have already been warned to correct violations of law."
"This field is in need of vigilant oversight," Gottlieb said, adding that the goal of the new proposal was to "streamline our operations to expedite enforcement actions."
Gottlieb noted that there were increased risks when compounders ship their products over state lines.
"(I)t can be very difficult to gather information about possible adverse events associated with those drugs, connect them to the compounder and undertake coordinated action to address a potentially serious public health problem," he wrote.
Under the revised proposal state boards signing an MOU would agree to notify the FDA when they find drug compounders who, in any given month, ship more than 50 percent of their compounded prescriptions to out-of-state customers.
"States that enter into the MOU will investigate complaints and advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues, like drug contamination," Gottlieb said.
Michael Carome of Public Citizen, an advocacy group, noted that the revision still includes a provision requiring states that sign an MOU to notify the FDA within 3 business days of any complaint relating to a drug product compounded by a pharmacist or pharmacist and distributed outside the state involving a serious adverse drug experience or serious product quality issue.
In states where there is no MOU, the threshold for identifying out of state compounders would be 5 percent.
In his statement Gottlieb said his agency will also be issuing new policies relating to insanitary conditions that have been encountered in inspections of drug compounders. He noted that the revisions do not effect a new class of drug compounders who are licensed as mass producers under a provision of the new law.
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