"The compounding pharmacy industry is trying to convince Congress to prohibit the FDA from enforcing the prescription requirement that Congress instituted 20 years ago and re-affirmed just four years ago. This would allow precisely the circumstances that led to the 2012 outbreak: compounding pharmacies mass producing drugs for healthcare facilities and doctors’ offices around the country without complying with requirements necessary to ensure quality and safety."
Congress, prevent another outbreak Quoted from Congress, prevent another outbreak — Don't roll back drug contamination protections BY JANE AXELRAD, OPINION CONTRIBUTOR The Hill - 07/10/17 09:20 AM EDT
"If Congress eliminates the prescription requirement, it would remove any incentive for compounders to register as outsourcing facilities and comply with the standards that are necessary for the safety of higher volume, non-individualized compounding." Quoted from Congress, prevent another outbreak — Don't roll back drug contamination protections By JANE AXELRAD, OPINION CONTRIBUTOR The Hill - 07/10/17 09:20 AM EDT
"By rolling back current regulations and allowing non-patient specific office-use compounding in large quantities, compounders will have no incentive to register with the FDA as an outsourcing facility voluntarily." Congress shouldn't roll back regulations on tailored medications, Quoted from the Hill, Greg Rockers and Brian Williamson, Opinion Contributors 09/06/17 4:40 PM EDT
"If providers are experiencing difficulty sourcing certain compounded drugs, the solution isn’t to weaken the quality standards that govern how these products are produced. Instead, stakeholders who operate in this industry should work together to ensure that compounded alternatives are widely available in the marketplace, while FDA strengthens its efforts to provide training and technical assistance to sterile compounders who may be considering becoming outsourcing facilities.""Allowing mass production of compounded sterile products without the necessary standards in place will put patient safety at risk. Congress, don’t weaken the DQSA by rolling back the prescription requirement. The safety of patients depends on it." Quoted from the Hill, Greg Rockers and Brian Williamson, Opinion Contributors 09/06/17 4:40 PM EDT
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