Senate OKs measure to tighten compounding, pharmaceutical supply chain

A measure to ensure the safety of compounded drugs — and to track all prescription drugs from manufacturer to drugstore — was approved Monday in the Senate.

The Drug Quality and Security Act gives the FDA expanded authority to regulate sterile drug compounding companies that ship across state lines.

The legislation is in response to a deadly outbreak of fungal meningitis in 2012 traced to the New England Compounding Center in Framingham, Mass. That outbreak claimed more than 50 lives.

The new law distinguishes traditional compounders from those making large volumes without individual prescriptions, according to a press release from the Senate Committee on Health, Education, Labor and Pensions.

“This is a big step toward preventing another nightmare for Tennesseans like last year’s tragic meningitis outbreak, which the FDA commissioner tells us will happen again if we don’t fix the uncertainty over who’s in charge of compounding facilities … ,” Sen. Lamar Alexander, R-Tenn., said in September.

The measure passed Monday in the Senate by voice vote and now heads to the White House where President Barack Obama is expected to sign it into law.

Support for the measure varied among industry stakeholders. Professional Compounding Centers of America believes the measure will result in "FDA oversight of the pharmacy profession," plus the "unintended consequence of restricting access to compounded medications for hundreds of thousands, if not millions of patients each year," said the association in a statement when the bill was sent to the Senate in September.

The International Academy of Compounding Pharmacists said in a press release that the measure "contains significant gaps because it does not provide key definitions to govern compounding practice; and does not take into account any of the input from the compounding profession provided to Congress over the last year."

The Healthcare Distribution Management Association backed the measure in a statement issued Monday, saying "...the 50-state patchwork of regulations will be replaced with one federal solution, ensuring the seamless movement and traceability of pharmaceuticals throughout the supply chain."

The measure also was praised by the National Association of Chain Drug Stores on Monday. "This is a large step in helping avoid tragedies such as last year's national meningitis outbreak," the association said in a press release. "At the same time, we appreciate the bill's protection of traditional compounding practices largely performed by retail pharmacists."