federal_register: 94-14503
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 94-14503 | Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products | Uncategorized Document | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking in the form of an amended tentative final monograph that would establish conditions under which over-the-counter (OTC) topical health-care antiseptic drug products are generally recognized as safe and effective and not misbranded. FDA is issuing this notice of proposed rulemaking to amend the previous notice of proposed rulemaking on topical antimicrobial drug products (see the Federal Register of January 6, 1978, 43 FR 1210) after considering the public comments on that notice and other information in the administrative record for this rulemaking. FDA is also requesting data and information concerning the safety and effectiveness of topical antimicrobials for use as hand sanitizers or dips. This proposal is part of the ongoing review of OTC drug products conducted by FDA. | 1994-06-17 | 1994 | 6 | https://www.federalregister.gov/documents/1994/06/17/94-14503/topical-antimicrobial-drug-products-for-over-the-counter-human-use-tentative-final-monograph-for | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking in the form of an amended tentative final monograph that would establish conditions under which over-the-counter (OTC) topical health-care antiseptic drug products are... |