Compounding Pharmacy Bill Increases FDA Oversight

November 19, 2013 — The New York Times reports that President Obama is expected to sign into law a bill that would give the U.S. Food and Drug Administration (FDA) significantly more authority over compounding pharmacies.

Small-scale compounding pharmacies act as modern-day apothecaries, mixing custom medications for doctors and hospitals. In recent years, some pharmacies have moved beyond mixing drugs for individual patients and act like mini pharmaceutical companies.

Unlike pharmaceutical companies, compounding pharmacies were regulated under a patchwork of federal and state laws. The FDA had limited authority to inspect records, facilities, or review problems with compounded medicines.

The regulatory shortcomings became strikingly apparent last year, when an outbreak of fungal meningitis was traced to contaminated injections manufactured by New England Compounding Center (NECC) of Massachusetts. At least 17,000 people were exposed to moldy spinal injections, which introduced an infectious fungus directly into the spine of its victims. The outbreak sickened at least 751 people, including 64 who died.

Under the Drug Quality and Security Act, compounding pharmacies that mass-produce drugs must register as “outsourcing facilities,” and they will be subject to more FDA oversight, including stricter regulations on quality control.

Compounding pharmacies that do not want to register with the FDA as an “outsourcing facility” can continue to custom-mix medicines for individual patients. They will not be required to open their records to the FDA, even when contaminated medicines injure patients.

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