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withdrawn,object_id FDA-2023-N-0061-0050,FDA,FDA-2023-N-0061,TAB C - 2013-930-Drug Products-PRIA-FINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:02:05Z,,0,0,0900006486800148 FDA-2023-N-0061-0045,FDA,FDA-2023-N-0061,TAB A - 2013-930-Drug Products-Proposed Rule-ORIGINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:01:31Z,,0,0,0900006486800149 FDA-2023-N-0061-0049,FDA,FDA-2023-N-0061,TAB B - 2013-930-Drug Products-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:01:59Z,,0,0,0900006486800147 FDA-2023-N-0061-0046,FDA,FDA-2023-N-0061,TAB B - 2013-930-Drug Products-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:01:38Z,,0,0,090000648680014a FDA-2023-N-0061-0048,FDA,FDA-2023-N-0061,TAB A - 2013-930-Drug Products-PRIA-ORIGINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:01:54Z,,0,0,0900006486800144 FDA-2023-N-0061-0047,FDA,FDA-2023-N-0061,TAB C - 2013-930-Drug Products-Proposed Rule-FINAL,Supporting & Related Material,Background Material,2024-11-06T05:00:00Z,2024,11,,,2024-11-06T17:01:44Z,,0,0,090000648680014b FDA-2023-N-0061-0044,FDA,FDA-2023-N-0061,"Memorandum - Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act (Proposed Rule)",Other,Memorandum,2024-11-06T05:00:00Z,2024,11,2024-11-06T05:00:00Z,,2024-11-06T17:00:18Z,,0,0,09000064867ffe78 FDA-2023-N-0061-0004,FDA,FDA-2023-N-0061,Reference 02 PCAC transcript March 9 2016,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:37:08Z,,0,0,0900006486487b7d FDA-2023-N-0061-0012,FDA,FDA-2023-N-0061,Reference 09 PCAC briefing May 8-9 2017,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:47:41Z,,0,0,09000064864886b6 FDA-2023-N-0061-0013,FDA,FDA-2023-N-0061,Reference 10a PCAC briefing Nov 20-21 2017,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:48:46Z,,0,0,09000064864886a3 FDA-2023-N-0061-0007,FDA,FDA-2023-N-0061,Reference 05 PCAC transcript Nov 21 2017,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:40:06Z,,0,0,0900006486487b80 FDA-2023-N-0061-0001,FDA,FDA-2023-N-0061,"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2024-03-20T04:00:00Z,2024,3,2024-03-20T04:00:00Z,2024-06-19T03:59:59Z,2024-06-20T01:00:32Z,2024-05801,0,0,090000648648745b FDA-2023-N-0061-0009,FDA,FDA-2023-N-0061,Reference 07a PCAC briefing March 8-9 2016,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:44:38Z,,0,0,09000064864886b3 FDA-2023-N-0061-0006,FDA,FDA-2023-N-0061,Reference 04 PCAC transcript May 8-9 2017,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:39:08Z,,0,0,0900006486487b7f FDA-2023-N-0061-0010,FDA,FDA-2023-N-0061,Reference 07b PCAC briefing March 8-9 2016 errata and addendum,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:45:43Z,,0,0,09000064864886b4 FDA-2023-N-0061-0008,FDA,FDA-2023-N-0061,Reference 06 PCAC briefing June 17-18 2015,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:41:55Z,,0,0,09000064864886b2 FDA-2023-N-0061-0003,FDA,FDA-2023-N-0061,Reference 01 PCAC transcript June 18 2015,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:36:09Z,,0,0,0900006486487b7c FDA-2023-N-0061-0005,FDA,FDA-2023-N-0061,Reference 03 PCAC transcript Nov 3 2016,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:38:12Z,,0,0,0900006486487b7e FDA-2023-N-0061-0011,FDA,FDA-2023-N-0061,Reference 08 PCAC briefing Nov 3 2016,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:46:39Z,,0,0,09000064864886b5 FDA-2023-N-0061-0002,FDA,FDA-2023-N-0061,Reference Summary List for Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under sections 503A and 503B,Supporting & Related Material,Background Material,2024-03-20T04:00:00Z,2024,3,,,2024-03-20T15:34:54Z,,0,0,0900006486487b7b