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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

8 rows where docket_id = "FDA-2015-D-3539" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2015 2
  • 2016 2
  • 2023 2
  • 2025 2

document_type 3

  • Other 4
  • Notice 3
  • Rule 1

agency_id 1

  • FDA 8
id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2015-D-3539-0030 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice Notice of Availability 2025-01-07T05:00:00Z 2025 1     2025-01-07T18:39:36Z 2024-31545 0 0 09000064868a35df
FDA-2015-D-3539-0031 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry Other Guidance 2025-01-07T05:00:00Z 2025 1 2025-01-07T05:00:00Z   2025-10-17T09:00:21Z   1 0 09000064868a4e3f
FDA-2015-D-3539-0019 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2023-12-07T05:00:00Z 2023 12 2023-12-07T05:00:00Z   2023-12-07T14:46:02Z 2023-26845 0 0 090000648630b16d
FDA-2015-D-3539-0020 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Other Guidance 2023-12-07T05:00:00Z 2023 12 2023-12-07T05:00:00Z 2024-01-09T04:59:59Z 2025-01-07T18:40:04Z   0 0 090000648630bbba
FDA-2015-D-3539-0014 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry Other Guidance 2016-06-10T04:00:00Z 2016 6 2016-06-10T04:00:00Z   2025-01-07T18:39:57Z   0 0 090000648202e5c0
FDA-2015-D-3539-0013 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Rule Correction 2016-06-10T04:00:00Z 2016 6 2016-06-10T04:00:00Z   2016-06-10T19:21:24Z 2016-13798 0 0 090000648202c009
FDA-2015-D-3539-0002 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Other Guidance 2015-10-27T04:00:00Z 2015 10 2015-10-27T04:00:00Z   2019-08-22T19:11:12Z   0 0 0900006481cf1f40
FDA-2015-D-3539-0001 FDA None FDA-2015-D-3539 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Notice Notice of Availability 2015-10-27T04:00:00Z 2015 10 2015-10-27T04:00:00Z 2015-12-29T04:59:59Z 2015-12-29T22:00:40Z 2015-27268 0 0 0900006481cf1660

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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