[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Rules and Regulations]               
[Page 51362]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

21 CFR Part 310

[Docket Nos. 1978N-0021 and 1978N-021P]
RIN 0910-AF42

Skin Protectant Drug Products for Over-the-Counter Human Use; 
Final Monograph; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.


SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register of June 4, 2003 (68 FR 33362), that established a 
final monograph with conditions under which over-the-counter (OTC) skin 
protectant drug products are generally recognized as safe and effective 
and not misbranded as part of FDA's ongoing review of OTC drug 
products. That final monograph included OTC skin protectant drug 
products for minor cuts, scrapes, burns, chapped skin and lips, poison 
ivy, poison oak, poison sumac, and insect bites. That document also 
amended the regulation that lists nonmonograph active ingredients by 
adding those OTC skin protectant ingredients that were found to be not 
generally recognized as safe and effective. However, that document had 
an incorrect ``approved as of'' date (May 7, 1991, instead of November 
10, 1993) in Sec.  310.545(a)(18)(v)(A) and (a)(18)(vi)(A) in part 310 
(21 CFR part 310) and incorrectly added paragraphs (a)(18)(ii) through 
(a)(18)(vi)(A) to Sec.  310.545(d)(1) when those paragraphs should have 
been included in Sec.  310.545(d)(11). This document corrects those 

DATES: This rule is effective August 19, 2004.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.


List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
310 is amended as follows:


1. The authority citation for 21 CFR part 310 continues to read as 

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

2. Section 310.545 is amended by revising paragraphs (a)(18)(v)(A) and 
(a)(18)(vi)(A) headings and paragraphs (d)(1) and (d)(11) to read as 

Sec.  310.545   Drug products containing certain active ingredients 
offered over-the-counter (OTC) for certain uses.

    (a) * * *
    (18) * * *
    (v) * * *
    (A) Ingredients--Approved as of November 10, 1993.
* * * * *
    (vi) * * *
    (A) Ingredients--Approved as of November 10, 1993.
* * * * *
    (d) * * *
    (1) May 7, 1991, for products subject to paragraphs (a)(1) through 
(a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) 
(except as covered by paragraph (d)(3) of this section), (a)(8)(i), 
(a)(10)(i) through (a)(10)(iii), (a)(12)(i) through (a)(12)(iv)(A), 
(a)(14) through (a)(15)(i), and (a)(16) through (a)(18)(i)(A).
* * * * *
    (11) November 10, 1993, for products subject to paragraphs 
(a)(8)(ii), (a)(10)(v) through (a)(10)(vii), (a)(18)(ii) (except 
products that contain ferric subsulfate as covered by paragraph (d)(22) 
of this section) through (a)(18)(v)(A), (a)(18)(vi)(A), (a)(22)(ii), 
(a)(23)(i), (a)(24)(i), and (a)(25) of this section.
* * * * *

    Dated: August 11, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18975 Filed 8-18-04; 8:45 am]