On Friday, more than a year after the fungal meningitis outbreak began that has sickened 750 people and killed 64, the U.S. House of Representatives passed the Drug Quality and Security Act.

The bill, which was drafted with input from key leaders of both the House and Senate, passed by voice vote. The purpose of the legislation is to clarify the authority of the U.S. Food and Drug Administration over compounding pharmacies that produce and ship large quantities of medicine. The bill now goes to the U.S. Senate.

U.S. Rep. Marsha Blackburn, R-Tenn., vice chair of the House Committee on Energy and Commerce, which sent the bill up for a vote, noted that 16 Tennesseans had died from the outbreak. People were sickened after receiving injections of steroid medications manufactured by Massachusetts-based New England Compounding Center.

“The cases stemmed from contaminated compounded drugs manufactured in some cases without the consent of the FDA,” Blackburn said. “Traditional compounding is critical for patient needs, and this legislation ensures millions of our most vulnerable relatives, friends and neighbors will continue to have safe access to essential and life-saving medication.”

Alexander pleased

U.S. Sen. Lamar Alexander, R-Tenn, the senior member of the Senate Health Committee, lauded the bill’s passage by the House and called for his colleagues to approve it as well.

“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,” he said in a prepared statement. “The House has passed our agreement to make it clear exactly who is in charge of overseeing each compounding facility, so there will be no questions about who’s on the flagpole.”

The bill was not embraced by the Professional Compounding Centers of America, but the organization did not actively oppose it.

“After carefully reviewing the legislative options, we believe the bill could still have unintended consequences; however, we believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further,” PCCA President L. David Sparks said in a letter submitted to the House.

Another industry organization, the International Academy of Compounding Pharmacists, criticized the bill. It issued a statement saying the bill will not protect the public because of significant gaps in key definitions. The organization also said the bill “does not take into account any of the input from the compounding profession provided to Congress over the last year.”

“For these reasons, IACP regretfully must strongly oppose this bill,” said Wade Siefert, the organization’s president.