FDA Extends Comment Deadline On Drug Code Proposed Rule, Sets Meeting

Consumer Healthcare Products Association concerned significant National Drug Code changes suggested in proposed rule could affect OTC monograph drug makers.

FDA plans a public meeting to discuss proposed changes to the National Drug Code (NDC) system in the agency's proposed rule on "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs."

The Dec. 11 meeting at FDA's Rockville, Md. office was scheduled after issuance of the proposed rule to "give interested parties the benefit of reviewing the agency's proposal prior to the meeting, which would facilitate more focused comments during the meeting on issues raised in the proposed rule," according to a notice published in the Oct. 31 Federal Register.

Furthermore, to provide interested parties additional time to submit comments, the agency has extended to Jan. 26, 2007 the comment period deadline for the proposed rule, the notice states.

FDA's decision to extend the original comment deadline of Nov. 27 by 60 days came in response to requests by the Consumer Healthcare Products Association and others.

CHPA sent a letter to FDA Oct. 12 requesting an extension of the comment period on the proposed rule because the group was concerned it would make "substantial changes" to the OTC monograph system (¹ 'The Tan Sheet' Oct. 23, 2006, In Brief).

The proposed rule, published in the Aug. 29 Federal Register, seeks to "reorganize, consolidate, clarify and modify current regulations concerning who must register establishments and list human drugs," biologic human drugs and animal drugs.

According to the agency, "the proposed rule would make certain changes to the NDC system and add a requirement that the appropriate NDC number appear on the labels of all drugs subject to the listing requirements."

A drug's NDC number is a unique 10-digit number composed of three code segments: labeler, product and package, FDA explains.

"NDC numbers are an important, standardized identification system for drug products used in data or claims processing and for a variety of other purposes where identification of drug products is essential," the agency states.

In its letter to the agency, CHPA states that more time was needed to collect comments from member companies because the detailed proposed rule could generate "complex scenarios" for companies along the supply chain.

CHPA expresses concern "about substantial changes the proposed rule may have on the monograph system in general, and (in particular) the effect of agency assignment of a National Drug Code number to manufacturers of OTC monograph drugs, which reach the market without prior approval from FDA."

The proposed changes would revise the formatting of NDC numbers, "make FDA responsible for assigning new product and package codes for any changes made to a marketed drug and require the appropriate NDC number to be displayed on the labels of drug products subject to the listing requirements," according to CHPA.

Although the proposed rule would affect all pharmaceutical manufacturers, members of the nonprescription drug industry could feel some of the changes "more acutely," the trade association says.

"The impact may depend on whether the product is marketed pursuant to an approved new drug application or under an OTC monograph, or it may depend on whether the product is already marketed or first reaches the market after the effective date of the new regulations," according to the group's letter.

FDA said it limited the scope of the meeting to NDC-related issues. Other registration or listing issues will not be discussed, according to the agency.

Written or electronic comments to be considered and requests to speak at the meeting must be submitted by Nov. 24.

-Jessica Lake ([email protected])

[Editor's note: This story appears courtesy of the editorial staff of ² 'The Tan Sheet', your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]