federal_register: 2013-28980

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-28980 Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations Proposed Rule The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination. 2013-12-04 2013 12 https://www.federalregister.gov/documents/2013/12/04/2013-28980/drug-products-that-present-demonstrable-difficulties-for-compounding-under-sections-503a-and-503b-of https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/2013-28980.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested...

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