FDA Clarifies Conditions for Mixing, Diluting or Repackaging Biologics

The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling.

The agency said it will not take action against pharmacies or outsourcing facilities that meet certain conditions — including only mixing biologics that are not combined with biological products licensed for further manufacturing or with a bulk drug substance, and those that use sterile, pharmaceutical-grade materials in the mixing or diluting process.

If the product is mixed, diluted or repackaged in a state or federal pharmacy, it may only be distributed after receiving a valid prescription for an individual patient directly from the patient or their doctor, the agency said.