What You Need to Know About Drug Compounding

Drug Compounding is the process of combining, mixing or altering ingredients to an existing drug to customize a drug to suit the needs of a particular patient.  For example, if someone needs a drug prepared without a certain dye because of an existing allergy.  However, the safety and efficacy of such a compounded drug have not been evaluated and approved by the FDA, so this runs the risk of resulting in severe adverse events or even death of the patient. 

In fact, the fungal meningitis outbreak of 2012, that resulted in 60 deaths and hundreds seriously harmed, was linked to the dispensing of contaminated compounded drugs.   Because of this incident and numerous other, Congress added the Compounding Quality Act to the Federal Food, Drug, and Cosmetic Act (FD&C Act), in 2013, to ensure proper regulatory inspections were enforced.  The details of what the FDA has been doing can be read here

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Some of the report highlights are as follows

The FDA has conducted more than 350 inspections of compounding laboratories and the result of such inspections include the following:

  • 130 warning letters have been issued to advise compounders of significant violations of federal law
  • 30 letters of inspection findings to state regulatory agencies have been issued
  • 100 recalls of compounded drugs have been performed
  • 18 draft guidances, 7 final guidances, 2 proposed rules, a final rule, and a draft memorandum of understanding have been issued
  • 6 scientific, technical, and medical advisory committee meetings on drug compounding have been conducted
  • 4 intergovernmental working meetings with state regulators have taken place
  • 4 sets of listening sessions with more than 75 stakeholders have occured

Although these inspections have raised awareness and begun the process of developing safer processes, the fact is that there are still a number of adverse events reported with compound drugs.  Follow-up inspections still clearly show that compounders are still failing to comply with the law. To that end, the FDA is working with the Department of Justice to develop a series of civil and criminal enforcement actions regarding drug compounding.

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