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 documents that concern registration and fees for registration have been finalized. This final guidance helps acquaint outsourcing facilities with the logistics of the process for registering with FDA and provides specifics on how to re-register and de-register. In addition, FDA has outlined the specific fees that are required for registration, how the fees can be submitted, penalties for failure to pay the fees, and qualifications a small business entity would need to provide in order to apply for reduced fees.
The third document is a revised draft guidance that addresses the electronic submission of drug products compounded by the facility. When the outsourcing facility initially registers with FDA, the registrant must provide a drug product report that identifies all drugs compounded by the facility. The report must be submitted twice each year, with documentation on all drugs that were compounded within the previous six months.
The draft guidance for electronic reporting of drug products is available for public comment for 60 days.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, click here.