Glycolic Acid
Glycolic Acid Pharmacy Compounding Advisory Committee Meeting November 3, 2016 Jane Liedtka, MD Clinical Reviewer Division of Dermatology and Dental Products, Office of Drug Evaluation III Glycolic Acid Review Team Jane Liedtka, MD, Clinical Reviewer, DDDP, ODE3 Ben Zhang, PhD, Chemistry Reviewer, OPQ Jianyong Wang, PhD, Pharmacology/Toxicology Reviewer, DDDP, ODE3 Doanh Tran, PhD., Clinical Pharmacology Team Leader, DCP3, OCP www.fda.gov 2 Nomination • Glycolic acid, 0.08% to 70%, has been nominated for inclusion on the list of bulk drug substances for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for topical use in the treatment of hyperpigmentation disorders and photodamaged skin www.fda.gov 3 Background • Glycolic acid is currently available in cosmetic formulations (creams, pads, and lotions) and present as excipient in some topical drug products www.fda.gov 4 Regulatory Definitions: Drugs and Cosmetics • Whether a product is a cosmetic or a drug under the law is determined by a product's intended use; different laws and regulations apply to each type of product • A drug is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or an article (other than food) that is intended to affect the structure or function of the body • A cosmetic is an article (other than soap) intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance – Regulated by CFSAN – No premarket approval of products or ingredients (except color additives) www.fda.gov 5 Cosmetic and Drug Uses of Topical Acids • Topical Acids cause exfoliation, or shedding of the skin surface.
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