From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration (FDA) has issued five draft guidances related to drug compounding and repackaging that are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.
The draft guidances apply to a new category of outsourcing facilities that was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.Outsourcing facilities are subject to current good manufacturing practice (cGMP) requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
The draft guidances are:
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities. The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
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