federal_register: 96-29302

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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
96-29302 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC First Aid Antibiotic Drug Products Rule The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) first aid antibiotic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). The amendment adds a warning statement concerning allergic reactions resulting from topical antibiotic drug products containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, or polymyxin B sulfate. This final rule is part of the ongoing review of OTC drug products conducted by FDA. 1996-11-15 1996 11 https://www.federalregister.gov/documents/1996/11/15/96-29302/topical-antimicrobial-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph-for https://www.govinfo.gov/content/pkg/FR-1996-11-15/pdf/96-29302.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) first aid antibiotic drug products (the regulation that establishes conditions under which these drug products are generally recognized as...  

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