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Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.
Fed Regist. 2003 Feb 19; 68(33):7919-21.FR

Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Drug LabelingHumansLegislation, DrugNonprescription DrugsOphthalmic SolutionsUnited StatesUnited States Food and Drug AdministrationWater

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12593411

Citation

Food and Drug Administration, HHS. "Ophthalmic Drug Products for Over-the-counter Human Use; Final Monograph; Technical Amendment. Final Rule; Technical Amendment." Federal Register, vol. 68, no. 33, 2003, pp. 7919-21.
Food and Drug Administration, HHS. Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. Fed Regist. 2003;68(33):7919-21.
Food and Drug Administration, HHS. (2003). Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. Federal Register, 68(33), 7919-21.
Food and Drug Administration, HHS. Ophthalmic Drug Products for Over-the-counter Human Use; Final Monograph; Technical Amendment. Final Rule; Technical Amendment. Fed Regist. 2003 Feb 19;68(33):7919-21. PubMed PMID: 12593411.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ophthalmic drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. A1 - ,, PY - 2003/2/21/pubmed PY - 2003/3/1/medline PY - 2003/2/21/entrez SP - 7919 EP - 21 JF - Federal register JO - Fed Regist VL - 68 IS - 33 N2 - The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) ophthalmic drug products are generally recognized as safe and effective and not misbranded. This amendment clarifies the active ingredient in OTC eyewash drug products and the labeling of the active ingredient and its purpose. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12593411/Ophthalmic_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -