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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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