
FDA offers more guidance for “outsourcing facilities”
The documents seek to clarify the regulatory process for compounders of sterile human drugs.
Last Friday, FDA provided additional assistance to help compounders of sterile human drugs that have registered with the agency as “outsourcing facilities” under the Drug Quality and Security Act (DQSA).
The three policy documents produced by the agency outline in greater detail the registration process, the specific fees to be paid for registration, and the requirements for electronics submission of drug product reports.
“As an agency committed to protecting public health, it’s important to the FDA that outsourcing facilities fully understand how to comply with the new law,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
The three documents
The documents that concern
The third document is a revised draft guidance that addresses the
The draft guidance for electronic reporting of drug products is available for public comment for 60 days.
For additional information about the provisions of the DQSA,
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