Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published October 1999
Beginning with this issue, PMP News will routinely publish a question and answer session with an industry expert. |
Q&A
FDA Explains Labeling Regulations
The agency plans to launch a Web site that will give users information about handling exemption requests, bar codes, and small packages.
Cazemiro R. Martin, Center for Drug Evaluation and Research, Division of Over-the-Counter Drug Products
This month, Cazemiro R. Martin, regulatory review chemist for FDA's Center for Drug Evaluation and Research, Div. of Over-the-Counter Drug Products, discusses the latest developments in the new over-the-counter (OTC) labeling regulations.
Q. Industry believes that an extension of the implementation date might be needed because of the time required to understand the rule and to obtain feedback from FDA on potential changes. Is an extension a possibility?
A. The final rule was published on March 17, 1999. We think it is too early at this stage to consider issuing an across-the-board extension of implementation dates. Section 201.66(e) of the OTC labeling regulation provides a mechanism for extension requests.
Q. Have there been exemption requests yet? How many, and what procedure is used to handle them?
A. We have received some exemption requests and anticipate that there will be additional requests. An internal committee has been formed to review the individual exemption requests. A feedback letter with the agency's decision on the exemption request will be issued to the sponsor or manufacturer.
Q. Has accommodating bar codes been an issue?
A. In the OTC labeling final rule, the agency noted that the universal product code (UPC) symbol may appear on the same panel as some of the Drug Facts information, but must not appear in the Drug Facts box or otherwise interrupt the content and format of the new OTC labeling requirements. Further, the agency indicated that for those OTC drug packages that are considered "small," the new labeling requirements provide several modifications. Use of these modifications is permitted if more than 60% of the total surface area available to bear labeling on the entire outside container or wrapper, or on the immediate container label if there is no outside container or wrapper, would be needed to present FDA-required labeling. This formula is consistent with the idea that 40% of available labeling space is generally reserved for the UPC symbol and the principal display panel.
During the June 29 public meeting, the Uniform Code Council (UCC) presented information on the standards of the UPC. Council members showed a number of existing small packages, most of which appeared not to adhere to the 0.8 standard (the UPC must be at least 0.8 times the standard size). The size of the UPC varied as a function of the size and the shape of the package. Manufacturers have been modifying the size and the shape of the UPC on their packaging prior to the implementation of the OTC labeling final rule. Thus, the agency finds no basis to give a general exemption to exclude the UPC area from the calculation of the total surface area available to bear labeling. We are waiting for more information from the UCC, particularly the UPC guidelines for small packages.
Q. What further developments do you anticipate in the near future?
A. We are creating an Internet site that will include responses to exemption requests. We hope it will inform users about these issues and their resolution. For the present, users can do a search on our home page.
The issue of confidentiality was mentioned during the June 29 meeting. Manufacturers should be aware that the agency intends to make its decisions on any exemption or deferral requests public in the docket in the FDA Dockets Management Branch. While certain information may be treated as confidential upon receipt, some aspects of that information may become public when a copy of the agency's letter to the manufacturer is placed in the docket. All confidentiality requests with reasons for these requests must be submitted in writing with the exemption request. The agency will make its decisions regarding confidentiality shortly after receiving the request. This complex issue will require more discussions between industry and the agency.
