Groups Urge Stronger FDA Enforcement at Compounding Pharmacies

Six public health groups and pharmaceutical industry associations 2/7 sent House and Senate appropriators a letter urging lawmakers “to support strong federal oversight of drug compounding” and tougher FDA enforcement to protect patients from adulterated compounded products. “Language that impedes FDA’s ability to enforce compounding law, including prescription and quality standard requirements, should not be included in FY2017 appropriations legislation,” the groups say. “Traditional pharmacies, primarily regulated by the states, should not produce supplies of compounded drugs without prescriptions, also known as ‘office stock’ compounding.” Quality standards applied to pharmacies are appropriate for traditional compounding practices, but not for operations on a larger scale where more patients are exposed, they say. The letter was signed by Pew Charitable Trusts, PhRMA, BIO, GPhA, APhA, and Trust for America’s Health.