Source: https://www.law.cornell.edu/cfr/text/21/part-300/subpart-B
Timestamp: 2017-10-21 20:23:43
Document Index: 753386253

Matched Legal Cases: ['art 300', 'art 300', 'art 300', '§ 300', 'art 300', 'arts 300']

21 CFR Part 300, Subpart B - Combination Drugs | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 300 › Subpart B
21 CFR Part 300, Subpart B - Combination Drugs
§ 300.50 Fixed-combination prescription drugs for humans.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 300 after this date.
81 FR 22549 - Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period
FR Doc. 2016-08888
RIN 0910-AF89
Docket No. FDA-2015-N-1260
Submit either electronic or written comments by May 18, 2016.
21 CFR Parts 300, 330, and 610
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments.
80 FR 79776 - Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph
FR Doc. 2015-32246
Submit either electronic or written comments on this proposed rule by March 22, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by January 22, 2016 (see the “Paperwork Reduction Act of 1995” section of this document). See section IX of this document for the proposed effective date of a final rule based on this document.
The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.