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federal_register: 2019-10953

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2019-10953 Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Rule The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Section 503A Bulks List Final Rule Questions and Answers--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2019-05-24 2019 5 https://www.federalregister.gov/documents/2019/05/24/2019-10953/section-503a-bulks-list-final-rule-questions-and-answers-guidance-for-industry-small-entity https://www.govinfo.gov/content/pkg/FR-2019-05-24/pdf/2019-10953.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Section 503A Bulks List Final Rule Questions and Answers--Small Entity Compliance Guide." The small entity compliance guide...

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