E8-31321. Guidance for Industry on Labeling Over-the-Counter Human Drug Products-Questions and Answers; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Labeling OTC Human Drug Products—Questions and Answers.” This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter (OTC) drug products in complying with the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This guidance primarily discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors relating to these requirements. The labeling examples in this guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format. This guidance finalizes the draft guidance of the same name published January 13, 2005 (70 FR 2415).

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993-0002, 301-796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Labeling OTC Human Drug Products— Questions and Answers.” This is one of several guidances the agency has developed to help manufacturers, packers, and distributors implement the final rule establishing standardized content and format requirements for the labeling of all OTC drug products. Once finalized, these guidances supersede all other statements, feedback, and correspondence provided by the agency on these matters since the issuance of the final rule.

In the Federal Register of March 17, 1999 (64 FR 13254), FDA published a final rule establishing standardized content and format requirements for the labeling of OTC drug products (§ 201.66 (21 CFR 201.66)). This regulation is intended to standardize labeling for all OTC drug products so consumers can easily read and understand OTC drug product labeling and use these products safely and effectively.

The regulation requires manufacturers to present OTC drug labeling information in a prescribed order and format. The standardized format requires revision of all prior labeling and covers all OTC drug and drug-cosmetic products, whether marketed under a new drug application, abbreviated new drug application, or OTC drug monograph (or drug product not yet the subject of a final OTC drug monograph).

Following issuance of the final rule, the agency received a number of inquiries from manufacturers seeking guidance on how to present the labeling information for their OTC drug products using the standardized content and format requirements. To address these inquiries, FDA published a notice in the Federal Register of January 13, 2005 (70 FR 2415), announcing the availability of a draft guidance for industry entitled “Labeling OTC Human Drug Products—Questions and Answers.” That draft guidance summarized the new Drug Facts labeling requirements as set forth in § 201.66. The draft guidance discussed those industry inquiries and provided labeling examples to show various format and content features of the labeling requirements, and suggested how OTC drug monograph labeling finalized before the new regulation was issued can be converted to the new format. The draft guidance also described how to list inactive ingredients that may or may not be contained in the OTC drug product.

The notice invited interested persons to submit comments on the draft guidance by March 14, 2005. FDA did not receive any comments in response to the notice. Therefore, we are announcing the availability of this final guidance with only editorial changes.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on how OTC drug monograph labeling finalized before or after the new requirements can be converted to the new OTC Drug Facts labeling format. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.regulations.gov.

Dated: December 22, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.