Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

Regulatory NewsRegulatory News | 18 January 2018 |  By 

The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight.


In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 2013.

Additionally, the DQSA created a new class of drug compounders that operate on a larger-scale than traditional pharmacy compounders, referred to as outsourcing facilities that must follow current good manufacturing practice (cGMP) requirements.

2018 Priorities

FDA Commissioner Scott Gottlieb said the plan will help increase FDA's oversight of compounded drugs while making it easier for certain compounders to transition to becoming registered outsourcing facilities by taking a risk based approach to good manufacturing practices (GMPs) such facilities must adhere to.

"FDA is fully committed to implementing these requirements in a way that preserves the legitimate practice of pharmacy and promotes access to these important drugs while protecting patients," Gottlieb said.

The plan focuses on five issues related to compounded drugs:

  • Manufacturing standards for outsourcing facilities;
  • Regulating compounding from bulk drug substances;
  • Restricting compounding of drugs that are essentially copies of FDA-approved drugs;
  • Boosting FDA's partnership with state-level regulators that oversee pharmacists and compounders;
  • Developing new guidance on other aspects of drug compounding

To promote more compounders registering as outsourcing facilities, FDA said it plans to propose new regulations that set out specific GMPs that outsourcing facilities must follow. In the meantime, FDA said it will revise its 2014 draft guidance on GMPs for outsourcing facilities to adopt a risk-based approach to manufacturing standards.

Alongside the announcement, FDA finalized three other guidances related to compounding detailing restrictions on compounding drugs that are "essentially copies" of commercially available or approved drugs and the conditions for when compounders can mix, dilute or repackage biologicals outside the scope of an approved biologics license application.

And earlier this month, FDA issued revised versions of two guidance documents explaining the use of bulk drug substances in compounding and clarifying situations where the agency does not plan to take action against certain outsourcing facilities and compounded drugs.

FDA Statement

Guidance: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Guidance: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy