Is cosmetic platelet-rich plasma a drug to be regulated by the Food and Drug Administration?
Abstract
In the area of cosmetic dermatology, some physicians have
been injecting activated platelet-rich plasma into the face to promote
cosmesis or using it to enhance fat grafts. However, subtle changes to the
federal drug code (21 CFR 1271.1) made in 2004, when applied to activated
PRP, purport to make this autologous substance a federally regulated drug
requiring an extensive and costly Biologics License Application. Are
autologous cells drugs? Many physicians believe there are significant
problems with this regulatory paradigm.
© 2011 Wiley Periodicals, Inc.
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