The rule prescribes labeling required to be used on the drug products’ principal display panel and Drug Facts labeling, and describes the methods for conducting two effectiveness test procedures required to be able to make certain claims, namely the sun protection factor (SPF) Test (21 CFR 201.327(i)) and the Broad Spectrum Test (21 CFR 201.327(j)). The 2011 sunscreen final rule applies to OTC sunscreen drug products that are marketed without an approved new drug application (NDA) or abbreviated new drug application (ANDA) and that contain any of the ingredients described in section III., Questions and Answers, Question 1. The compliance date for all other drug products subject to the final rule is December 17, 2012. Manufacturers of drug products with annual sales less than $25,000 must comply with the final rule by December 17, 2013. After reviewing information submitted in response to the proposed rule and other pertinent information, we published the 2011 sunscreen final rule, which is codified in FDA regulations as 21 CFR 201.327. The rule proposed labeling and testing requirements for ultraviolet A radiation (UVA) and ultraviolet B radiation (UVB) protection.
In the Federal Register of Aug(72 FR 49070), we published a proposed rule that included labeling and testing for OTC sunscreen drug products. II. SUMMARY OF THE REGULATION AND THIS GUIDANCE The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. This guidance was prepared in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).įDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. On May 11, 2012, we published a 6-month delay of the compliance dates in the 2011 sunscreen final rule, 77 FR 27591. The 2011 sunscreen final rule also requires that these drug products be tested according to specific testing procedures that ensure product effectiveness. Drug products subject to the 2011sunscreen final rule must bear specific labeling to promote their safe and effective use. On June 17, 2011, we published the final rule “Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use” (2011 sunscreen final rule), 76 FR 35620. This guidance is intended to help small businesses understand and comply with the Food and Drug Administration’s (FDA’s) labeling and testing regulations for certain over-the-counter (OTC) sunscreen drug products. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. Labeling and Effectiveness Testing: Sunscreenĭrug Products for Over-the-Counter Human Use. SUMMARY OF THE REGULATION AND THIS GUIDANCE Tel: 30 Fax: 30 E-mail: Department of Health and Human Services Office of Communications, Division of Drug Informationġ0903 New Hampshire Ave. Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use - Small Entity Compliance Guide Department of Health and Human ServicesĬenter for Drug Evaluation and Research (CDER)
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