The Food and Drug Administration yesterday released revised draft guidance for facilities that compound human drugs as outsourcing facilities. “We’ve heard the feedback from stakeholders to our proposed 2014 draft guidance that certain [current good manufacturing practice] policies would have made it difficult for outsourcing facilities to fill smaller orders and that some compounded drug products that practitioners requested for office stock were not available from outsourcing facilities due to those policies,” said FDA Commissioner Scott Gottlieb, M.D. “We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality. This revised draft guidance includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between production of sterile and non-sterile drug products.”

Related News Articles

Headline
Hospitals spend close to $360 million each year to manage drug shortages, according to a study released this week by Vizient Inc.
Headline
The Centers for Disease Control and Prevention this week announced an anticipated shortage of Aplisol, one of two TB skin tests licensed by the Food and Drug…
Headline
A federal court in Texas yesterday ordered Pharm D Solutions to stop producing or distributing compounded drugs intended to be sterile until the company…
Headline
The Food and Drug Administration Friday issued final guidance clarifying how sponsors may show that a proposed biosimilar product is interchangeable with a…
Headline
The House Judiciary Committee yesterday approved by voice vote the Creating and Restoring Equal Access to Equivalent Samples Act (H.R. 965).
Headline
Civica Rx, the not-for-profit generic drug company, officially opened its headquarters last week in Lehi, Utah.