The Specialty Sterile Pharmaceutical Society launches, with its own product and safety standards standards and a plan to march on Washington.
As of July 1, 63 patients had died of fungal meningitis and 749 more had become gravely ill after tainted steroids manufactured by the New England Compounding Center were administered last fall to patients in 20 U.S. states, according to figures from the Centers for Disease Control and Prevention [bit.ly/cdcfungal].
While lawmakers in Congress consider S. 959, a bill defining regulatory oversight of compounding manufacturers, a new professional body established by members of the nontraditional pharmaceutical industry has taken up the challenge of ensuring product quality and safety.
The Specialty Sterile Pharmaceutical Society held its inaugural meeting April 16 in Little Rock, Ark. Its five founding members are executives with Cantrell Drug, Unique Pharmaceuticals, Advanced Pharma, SCA Pharmaceuticals, and Central Admixture Services, which, according to a recent press statement, jointly account for roughly a third of the country’s specialty pharmaceutical production.
“The time is now for specialty pharmaceutical manufacturers to come together and form an alliance that effectively communicates the key messages of our industry – strict safety standards, assurances of patient safety, and the life-saving importance of sterile pharmaceutical preparations to our country’s healthcare system,” said the society’s new president “Dell” McCarley, PD, in the statement. McCarley is president and chief pharmacist of the Cantrell Drug Company, based in Little Rock.
A spokesman for the group, Charles M. West, PD, ScD, told Drug Topics that the society was conceived as a “third tier” of the pharmaceutical industry, to represent interests separate from those of the pharmaceutical industry and traditional industry compounding.
The first order of business for the new society, West said, was the creation and promotion of stringent practice and safety standards. The resulting 8-page document will be posted at the society’s website, http://sterilepharma.net.
“We encourage everyone to look at the standards,” said West. “What we’re offering here is a solution to the problem [of how to manage and oversee specialty pharmaceutical production]. It has taken three months to create these standards and it has been a thorough process. Rather than responding to existing bills that are circulating through Congress, we plan to go forward with the standards we’ve developed.”
The society has established staff representation in Washington, D.C.,
A third priority of the new organization is to ensure continued hospital access of to specialty drugs and pharmaceutical products in short supply.
“Hospitals and clinics across the country count on sterile pharmaceutical manufacturers to produce the essential specialty drugs that help fill shortages and save thousands of lives,” said McCarley in the press statement.
Membership information may be obtained through the website or by contacting Charles West (firstname.lastname@example.org).