Friday, September 27, 2013

Bill would regulate large-scale compounding pharmacies

A bipartisan group of federal lawmakers has unveiled a pharmacy bill in response to a yearlong meningitis outbreak that has killed 64 patients throughout the United States.

The legislation, called the Drug Quality and Security Act, would clarify the U.S. Food and Drug Administration’s authority to regulate the practice of pharmacy compounding and establish a nationwide system to track and trace prescription drugs along the pharmaceutical supply chain, proponents said.

Compounding is the traditional pharmacy practice of mixing medications from scratch to meet the medical needs of individual patients. But compounding pharmacists, who now are regulated by state boards of pharmacy, do not have to adhere to the same safety and quality standards that large pharmaceutical manufacturers must meet.

A large batch of contaminated steroid medicine used in spinal injections, produced last year at a Massachusetts compounding pharmacy, sickened more than 700 patients in 20 states, prompting renewed congressional efforts to strengthen safeguards.

The Kansas City Star first reported such concerns in a series more than a decade ago.

The legislation, unveiled Wednesday night, would create a category of large-scale drug producers, called “outsourcing facilities,” that would have to meet safety standards set by the FDA. Traditional compounders would continue to be regulated by state boards.

U.S. Sen. Pat Roberts of Kansas, who has worked to improve pharmacy safety since the Robert Courtney drug-dilution scandal in 2001, said the bill strikes the right balance between federal regulation and state oversight of small compounders.

“This legislation protects traditional pharmacy while giving patients more confidence in the quality and safety of their compounded drugs,” Roberts, a Republican, said in a written statement.

Allan Coukell, senior director for drug and medical devices for the Pew Charitable Trusts, said his group supported the bill, which he described in a letter to Congress on Thursday as “a major advance for the security of U.S. drug distribution and a step toward regulatory clarity and higher quality standards for compounded medicines.”

The largest trade group representing compounders, the International Academy of Compounding Pharmacists, reacted with caution in an online statement to its members.

“IACP is meeting with (Capitol) Hill staff today to communicate our many concerns with this compromise bill,” the statement read.

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