BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding

Regulatory NewsRegulatory News | 14 June 2017 |  By 

The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act

"If FDA is not permitted to maintain that line between traditional compounding and outsourcing facilities, patients are put at risk, states and compounding pharmacies will not have clear regulatory guidance, and the lessons of the national meningitis outbreak will have been forgotten," the letter says, mentioning an outbreak of fungal meningitis associated with contaminated spinal injections manufactured by a Massachusetts compounding pharmacy.

The groups note that Congress created the new outsourcing facility sector to fill a need, but if traditional pharmacies are permitted to supply compounded drugs without prescriptions and without complying with good manufacturing practices, outsourcing facilities will have no incentive to register with the FDA and adhere to the more rigorous quality standards for larger-scale compounding.

"Continued clarity from FDA on the line between traditional compounding and outsourced compounding will support state regulators, outsourcing facilities, and traditional compounders in their efforts to ensure that patients have access to safe compounded drugs while reducing the risks associated with sterile drugs produced in bulk," the letter reads.

Letter to Senate to Preserve Prescription Requirement in Compounding Law

Letter to House of Representatives

Report Language for Lawmakers to Preserve Prescription Requirement in Compounding Law


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