Revisions to Compounding Guidance?  Where Will That Take Us?

It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities.  Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to date, only about 70 firms have done so since the law went into effect), in the next 2 months, the Agency will release guidance reflecting its intention to adjust its enforcement priorities.  This will allow smaller firms making “low-risk” drugs to be subjected to less onerous requirements than larger outsourcing facilities.

Encouraging small compounders to register as 503B outsourcing facilities may bring more compounders under the GMP umbrella, but it will be interesting to see how FDA accomplishes its new enforcement strategy since, as compounders of sterile drugs, even small outsourcing facilities may be considered high-risk operations (in most cases).  It is also noteworthy that during the Reuters interview, the Commissioner reportedly indicated that he expects no slowdown in terms of enforcement. The publication of FY 2018 Outsourcing facility fees (see yesterday’s post here) certainly may discourage smaller compounders to take the outsourcing facilities plunge.