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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

41 rows where docket_id = "FDA-2018-N-3240" sorted by posted_date descending

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posted_year 6

  • 2020 16
  • 2021 8
  • 2022 8
  • 2023 6
  • 2019 2
  • 2018 1

document_type 3

  • Supporting & Related Material 25
  • Notice 10
  • Other 6

agency_id 1

  • FDA 41
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-3240-0376 FDA None FDA-2018-N-3240 Reference 1 - FDA Proposal Not to Include Ephedrine Sulfate on the 503B Bulks List RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-28T04:00:00Z 2023 8     2023-08-28T16:19:35Z   0 0 0900006485f02240
FDA-2018-N-3240-0375 FDA None FDA-2018-N-3240 Reference 3 - Part 1 Evaluation for Hydroxychloroquine Sulfate RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-23T04:00:00Z 2023 8     2023-08-23T20:14:40Z   0 0 0900006485edb7aa
FDA-2018-N-3240-0374 FDA None FDA-2018-N-3240 Reference 2 - Supplemental clinical need evaluation for ephedrine sulfate in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act RE List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2023-08-21T04:00:00Z 2023 8     2023-08-21T19:04:48Z   0 0 0900006485ecb128
FDA-2018-N-3240-0373 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2023-08-21T04:00:00Z 2023 8     2023-08-21T12:58:21Z 2023-17881 0 0 0900006485ec9ee6
FDA-2018-N-3240-0371 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice Announcement 2023-04-06T04:00:00Z 2023 4 2023-04-06T04:00:00Z   2023-04-10T14:30:49Z 2023-07217 0 0 09000064858f25e1
FDA-2018-N-3240-0372 FDA None FDA-2018-N-3240 Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Prescription Requirements Under Section 503 A Under the Federal Food Drug and Cosmetic Act Supporting & Related Material Background Material 2023-04-06T04:00:00Z 2023 4     2023-04-06T15:50:49Z   0 0 09000064858f2ed2
FDA-2018-N-3240-0369 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2022-11-23T05:00:00Z 2022 11 2022-11-23T05:00:00Z 2023-01-24T04:59:59Z 2023-01-24T02:01:08Z 2022-25549 0 0 09000064854fe4c0
FDA-2018-N-3240-0367 FDA None FDA-2018-N-3240 Reference 7 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:47:57Z   0 0 09000064854f8e4b
FDA-2018-N-3240-0368 FDA None FDA-2018-N-3240 Reference 8 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:48:00Z   0 0 09000064854f8e4c
FDA-2018-N-3240-0363 FDA None FDA-2018-N-3240 Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:47:44Z   0 0 09000064854f8e47
FDA-2018-N-3240-0364 FDA None FDA-2018-N-3240 Reference 4 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:47:48Z   0 0 09000064854f8e48
FDA-2018-N-3240-0365 FDA None FDA-2018-N-3240 Reference 5 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:47:51Z   0 0 09000064854f8e49
FDA-2018-N-3240-0366 FDA None FDA-2018-N-3240 Reference 6 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2022-11-21T05:00:00Z 2022 11     2022-11-21T20:47:54Z   0 0 09000064854f8e4a
FDA-2018-N-3240-0362 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2022-01-27T05:00:00Z 2022 1 2022-01-27T05:00:00Z   2022-01-27T15:00:40Z 2022-01558 0 0 0900006484f3c6ef
FDA-2018-N-3240-0284 FDA None FDA-2018-N-3240 Reference 2 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2021-03-25T04:00:00Z 2021 3     2021-03-25T13:05:02Z   0 0 0900006484a79779
FDA-2018-N-3240-0285 FDA None FDA-2018-N-3240 Reference 3 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2021-03-25T04:00:00Z 2021 3     2021-03-25T13:06:50Z   0 0 0900006484a7a04d
FDA-2018-N-3240-0286 FDA None FDA-2018-N-3240 Reference 4 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2021-03-25T04:00:00Z 2021 3     2021-03-25T13:07:55Z   0 0 0900006484a7a04f
FDA-2018-N-3240-0287 FDA None FDA-2018-N-3240 Reference 5 re List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2021-03-25T04:00:00Z 2021 3     2021-03-25T13:08:59Z   0 0 0900006484a7a050
FDA-2018-N-3240-0283 FDA None FDA-2018-N-3240 Reference 1 re: List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Supporting & Related Material Background Material 2021-03-25T04:00:00Z 2021 3     2021-03-25T13:03:59Z   0 0 0900006484a79778
FDA-2018-N-3240-0282 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Act Notice General Notice 2021-03-24T04:00:00Z 2021 3 2021-03-24T04:00:00Z 2021-05-25T03:59:59Z 2022-01-25T02:00:44Z 2021-06060 0 0 0900006484a768eb
FDA-2018-N-3240-0280 FDA None FDA-2018-N-3240 Nomination from Outsourcing Facilities Association Other Electronic Regulation from Form 2021-02-26T05:00:00Z 2021 2 2021-02-26T05:00:00Z   2021-02-26T22:06:59Z   0 0 0900006484a217d2
FDA-2018-N-3240-0274 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Reopening of the Comment Period Notice General Notice 2021-01-08T05:00:00Z 2021 1 2021-01-08T05:00:00Z 2021-02-09T04:59:59Z 2021-03-02T02:00:57Z 2021-00123 0 0 09000064849e8bca
FDA-2018-N-3240-0233 FDA None FDA-2018-N-3240 Request for Extension from Outsourcing Facilities Association Other Request for Extension 2020-09-29T04:00:00Z 2020 9 2020-09-29T04:00:00Z   2020-09-29T14:36:57Z   0 0 0900006484892bae
FDA-2018-N-3240-0229 FDA None FDA-2018-N-3240 Nomination from Wells Pharmacy Network Other Nomination 2020-09-28T04:00:00Z 2020 9 2020-09-28T04:00:00Z   2020-09-28T21:21:19Z   0 0 0900006484877b15
FDA-2018-N-3240-0230 FDA None FDA-2018-N-3240 Nomination from Wells Pharmacy Network Other Nomination 2020-09-28T04:00:00Z 2020 9 2020-09-28T04:00:00Z   2020-09-28T21:25:48Z   0 0 09000064848792b0
FDA-2018-N-3240-0226 FDA None FDA-2018-N-3240 Nomination from Wells Pharmacy Network Other Nomination 2020-09-21T04:00:00Z 2020 9 2020-09-21T04:00:00Z   2020-09-21T17:14:54Z   0 0 0900006484865f7e
FDA-2018-N-3240-0151 FDA None FDA-2018-N-3240 Nomination from iVitalize, Inc. Other Nomination 2020-08-28T04:00:00Z 2020 8 2020-08-28T04:00:00Z   2020-08-28T17:07:01Z   0 0 09000064848269f1
FDA-2018-N-3240-0058 FDA None FDA-2018-N-3240 Reference 9 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:58Z   0 0 09000064847c3cfe
FDA-2018-N-3240-0057 FDA None FDA-2018-N-3240 Reference 10 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:57Z   0 0 09000064847c3cff
FDA-2018-N-3240-0061 FDA None FDA-2018-N-3240 Reference 6 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:59Z   0 0 09000064847c3cfb
FDA-2018-N-3240-0059 FDA None FDA-2018-N-3240 Reference 8 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:58Z   0 0 09000064847c3cfd
FDA-2018-N-3240-0060 FDA None FDA-2018-N-3240 Reference 7 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:59Z   0 0 09000064847c3cfc
FDA-2018-N-3240-0056 FDA None FDA-2018-N-3240 Reference 11 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:57Z   0 0 09000064847c3d00
FDA-2018-N-3240-0055 FDA None FDA-2018-N-3240 Reference 12 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:13:56Z   0 0 09000064847c3d01
FDA-2018-N-3240-0063 FDA None FDA-2018-N-3240 Reference 4 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:14:00Z   0 0 09000064847c1a0f
FDA-2018-N-3240-0064 FDA None FDA-2018-N-3240 Reference 3 re: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:14:01Z   0 0 09000064847c1a0e
FDA-2018-N-3240-0062 FDA None FDA-2018-N-3240 Reference 5 RE: List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Supporting & Related Material Background Material 2020-07-31T04:00:00Z 2020 7     2020-07-31T13:14:00Z   0 0 09000064847c1a10
FDA-2018-N-3240-0054 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2020-07-31T04:00:00Z 2020 7 2020-07-31T04:00:00Z 2020-09-30T03:59:59Z 2020-11-21T02:01:53Z 2020-16649 0 0 09000064847c3b71
FDA-2018-N-3240-0033 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice Request for Comments 2019-09-03T04:00:00Z 2019 9 2019-09-03T04:00:00Z 2019-11-05T04:59:59Z 2019-11-07T02:01:16Z 2019-18932 0 0 0900006483ee2455
FDA-2018-N-3240-0032 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2019-03-04T05:00:00Z 2019 3 2019-03-04T05:00:00Z   2019-03-04T14:44:03Z 2019-03810 0 0 0900006483abadd9
FDA-2018-N-3240-0001 FDA None FDA-2018-N-3240 List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2018-08-28T04:00:00Z 2018 8 2018-08-28T04:00:00Z 2018-10-30T03:59:59Z 2020-11-22T04:06:59Z 2018-18614 0 0 0900006483662c5a

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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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