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Regulating compounding pharmacies.

Ashley Noble1

  • 1NCSL--Denver, USA.

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Since 2001, 27 compounding incidents have caused 89 deaths. New federal regulations in 2013 created outsourcing facilities, with over 50 now registered with the FDA.

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Area of Science:

  • Pharmaceutical compounding safety
  • Drug adverse event reporting

Background:

  • Compounding pharmacies face less stringent adverse event reporting requirements compared to traditional drug manufacturers.
  • A significant number of compounding incidents, resulting in fatalities, have been documented.
  • The U.S. Food and Drug Administration (FDA) oversees drug compounding regulations.

Purpose of the Study:

  • To highlight the safety concerns and regulatory landscape of drug compounding.
  • To inform stakeholders about the evolution of drug compounding oversight in the United States.

Main Methods:

  • Analysis of reported compounding incidents and associated fatalities.
  • Review of federal regulations pertaining to drug compounding, including the establishment of outsourcing facilities.

Main Results:

  • The Pew Charitable Trusts documented 27 compounding incidents leading to 89 deaths since 2001.
  • Compounding pharmacies are not generally mandated to report adverse events to the FDA.
  • The 2013 update to federal law introduced "outsourcing facilities," with over 50 facilities currently registered with the FDA across 23 states.

Conclusions:

  • The current regulatory framework for drug compounding presents potential safety risks due to varied adverse event reporting requirements.
  • The establishment of outsourcing facilities represents a step towards enhanced oversight in drug compounding.
  • Continued vigilance and robust reporting mechanisms are crucial for ensuring the safety of compounded medications.