Senate Compounding Bill Clears Senate Committee
JUNE 18, 2013
On May 22, 2013, a US Senate committee passed a bipartisan bill that would increase regulation of compounding pharmacies that produce sterile drugs without a prescription and ship them across state lines. The bill, which is expected to be considered by the full Senate in June or July, was developed in response to last fall’s fungal meningitis outbreak caused by contaminated steroids produced by a Massachusetts compounding pharmacy. The outbreak killed 55 and sickened almost 750.
The bill would require “compounding manufacturers” to report adverse events associated with compounded drugs, would give the FDA clear authority to inspect compounders, and would require that compounded drugs be clearly labeled as such. Compounders that only ship within state lines and hospital pharmacies—even those that distribute sterile products to out-of-state hospitals within their system—would continue to be overseen by state boards of pharmacy. The bill would not ban the compounding of any drug, but would allow the FDA to keep a list of drugs that should not be compounded due to safety concerns.
The US Senate Health, Education, Labor, and Pensions Committee also issued a report finding that problems with compounding have continued in the months since the fungal meningitis outbreak. It found that at least 48 compounders produced drugs that were contaminated, were produced in unsafe conditions, or were otherwise in violation of laws. In addition, the report noted that 11 compounders have been ordered by state boards of pharmacy to stop producing some or all drugs and 10 have issued national recalls due to concerns over contamination.