FDA Compounding Progress Report

January 2017, FDA released the FDA Compounding Progress Report which summarizes FDA activity in the compounding space in the 3 years following passage of the Drug Quality and Security Act.  A PDF version of the report is available here.

A few highlights as of Nov 27, 2016 FDA has (p.10):

  • Conducted more than 350 inspections of compounding facilities, 85 of which were outsourcing facilities.  Of note, 120 of the 350 inspections were “for cause”.  Meaning the inspection was triggered based on reports of serious adverse events or product quality issues.
  • Issued more than 130 warning letters advising compounders of significant violations of federal law.
  • Issued more than 30 letters referring inspectional findings to state regulatory agencies.
  • Overseen about 100 recalls involving compounded drugs. This includes sterile drugs manufactured under insanitary conditions thus calling into question the sterility of the product, and products that were sub or super potent.
  • Worked with DOJ on a number of civil and criminal enforcement actions.

On page 12, the FDA identified continued concern about the risk to patients from compounded drugs.  Many non outsourcing registered facilities were engaged in large-scale manufacturing.

 

Additionally FDA continues to identify insanitary conditions in many of the facilities inspected.  Pictures in the report identified a few of the conditions encountered during inspection.  One example provided from the report (left) identifies mold on ceiling tiles of a compounding facility.

 

 

Lastly several examples were provided of serious adverse events and product quality related issues of both sterile and non-sterile products including:

  • Super-potent Morphine Sulfate
  • Multivitamin with high amounts of Vitamin D3 recalled after FDA notified of adverse effects
  • Bacteria contaminated sterile drugs (compounded calcium gluconate) after patients developed bacterial bloodstream infections.
  • Bacteria contaminated sterile drugs (methylprednisolone acetate) distributed to 17 states resulted in adverse events including skin abscesses.

Drugs compounded under 503A and B serve a recognized and important need for patients.  However, these drugs need to meet appropriate quality standards to prevent patient harm.  FDA is committed to provide appropriate oversight to protect public health.