FDA Compounding Pharmacy Plan Seeks to Improve Safety, Lower Costs

FDA seeks to change policies to ensure balance between the need to preserve access and ensure safety of appropriately compounded drugs for patients whose needs cannot be met by FDA-approved products.

Officials with the FDA have issued 2 final guidance documents to help implement the 2018 Compounding Policy Priorities Plan, which explain the agency’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

The 2018 Compounding Policy Priorities Plan specifically details how the FDA will:

  • address manufacturing standards for outsourcing facilities;
  • regulate compounding from bulk drug substances;
  • restrict compounding of drugs that are essentially copies of FDA-approved drugs;
  • solidify the FDA’s partnership with state regulatory authorities; and
  • provide guidance on other activities that compounders undertake.

A large part of the plan focuses on changing policies to better ensure balance between the need to preserve access to appropriately compounded drugs for patients whose needs cannot be met by FDA-approved products but also to help protect patients from poor quality compounded drugs that could cause significant harm.

"For instance, we’re taking steps to make it more feasible for certain compounders to become outsourcing facilities by taking a risk-based approach to how we will implement good manufacturing requirements on these facilities," FDA Commissioner Scott Gottlieb, MD said in a statement. "The goal is to make it more feasible, and lower cost, for a larger swath of pharmacies to transition to becoming outsourcing facilities."

The guidance documents describe the characteristics of drugs that may be considered “essentially a copy” and the FDA’s policies regarding prescriber review of changes between compounded drugs and commercially available or approved drugs to determine whether they produce a significant or clinical difference for individual patients.

The FDA also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them, according to a statement from the agency.

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