Month: July 2018

Time to Start your Compliance process

  Complying with all the current compounding regulations can seem like a steep hill to climb for health facilities professionals. Trying to understand all of the standards that must be met, facility and budget obstacles that pose challenges to implementing the measures needed to be in full compliance, and uncertainty over what lies ahead make …

Time to Start your Compliance process Read More »

FDAs 2018 Compounding Policy Priorities Plan

    We are pleased to share the FDA’s 2018 Compounding Policy Priorities Plan. This plan provides an overview of the key priorities our agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission. As we undertake these steps, we must continue to recognize the importance of compounders’ …

FDAs 2018 Compounding Policy Priorities Plan Read More »

Choosing Engineering Controls Under USP 800

  The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer …

Choosing Engineering Controls Under USP 800 Read More »