federal_register: 03-30394

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
03-30394 Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Rule The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM). 2003-12-09 2003 12 https://www.federalregister.gov/documents/2003/12/09/03-30394/skin-protectant-drug-products-for-over-the-counter-human-use-final-monograph-technical-amendment https://www.govinfo.gov/content/pkg/FR-2003-12-09/pdf/03-30394.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing... 0910-AA01

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