New compounding rules won’t prevent another tragedy, AMCP says

Congressional action to tighten regulations for compounding pharmacies will not prevent another tragedy such as last year’s fungal meningitis outbreak, according to the Academy of Managed Care Pharmacy (AMCP).

Last week, the U.S. Senate approved tighter regulations for compounding pharmacies and created a national system that tracks prescription drugs from manufacturers to pharmacies. The legislative action came a year after contaminated steroids from the now closed New England Compounding Center in Massachusetts killed 64 people and sickened more than 750 others across the United States.

AMCP said it welcomes the strengthening of the drug distribution chain, but that the legislation did not go far enough to guarantee strict regulation of compounders.

“We're very concerned that the bill's voluntary registration scheme will not achieve the main goal – to protect the public from the unauthorized compounding of drugs. Simply put, the ‘outsourcing facility’ created under the bill will not be required to register with the FDA,” said AMCP CEO Edith A. Rosato, RPh, IOM. “With the bill's limited scope, only those facilities that volunteer to register will be subject to the FDA, which will leave the public no better off. Facilities that compound drugs, are not licensed pharmacies and choose not to register with the FDA will continue to ‘escape’ regulation and oversight,” she said.

AMCP also criticized another loophole in the bill. The new regulations allow a licensed pharmacy, which is already regulated by state pharmacy boards, that registers as an “outsourcing facility” to be subject to FDA regulation. “We believe this dual regulatory scheme will lead to administration and regulatory confusion, creating opportunities for gaps in responsibility and accountability,” Rosato said.