E9-11089. Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency's over-the-counter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004.

DATES:

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

ADDRESSES:

Submit written requests for single copies of this compliance 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 compliance 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 compliance guidance document.

FOR FURTHER INFORMATION CONTACT:

Marina Y. Chang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5418, Silver Spring, MD 20993-0002, 301-796-2090.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a compliance guidance for small business entities entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. 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 (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 existing 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 December 9, 2004 (69 FR 71420), announcing the availability of a draft compliance guidance for small business entities entitled “Labeling OTC Human Drug Products; Small Entity Compliance Guide.” The draft compliance guidance summarizes the new Drug Facts labeling requirements set forth in § 201.66. The draft compliance guidance also describes how to list those inactive ingredients that are different when a finished OTC drug product is obtained from multiple suppliers.

The notice invited interested persons to submit comments on the draft compliance guidance by February 7, 2005. FDA did not receive any comments in response to the notice, and is announcing the availability of this final compliance guidance with only editorial revisions to the draft guidance.

This compliance guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The compliance guidance represents the agency's current thinking on how OTC drug product labeling can be converted to the new OTC Drug Facts format labeling. 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.

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.

May 4, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.