Labeling

Overview

Labeling requirements and bar code technology play an increasingly important role in the cellular therapy communities. FDA-approved labeling — often referred to as the professional labeling, package insert, direction circular, and package circular — contains information to ensure the safe and effective use of biological products. Labels and bar codes — machine-readable representations of information — include critical information necessary to accurately identify, store, ship, track, and distribute blood and cellular therapy products. Use of bar code technology has been shown to increase the efficiency and accuracy of tracing products through manufacturing processes.

The labeling standards for licensed biological products are listed in 21 CFR 610 Subpart G. Furthermore, the labeling requirements in 21 CFR 201 apply to licensed biological products, which address, but are not limited to manufacturer information, National Drug Code (NDC) information, directions for use, ingredients, and expiration date. Recent updates to the requirements for the content and format of labeling for human prescription drug and biological products were published by the FDA on Jan. 24, 2006. Among other things, these updates require the labeling of new and recently approved products to include highlights of prescribing information, a table of contents and minor content changes, and to set minimum graphical requirements.

The Federal Food Drug and Cosmetic Act requires establishments to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. The NDC number is a unique 10-digit number, composed in three segments, which serves as a universal product identifier for human drugs to fulfill this requirement. The requirements for using the NDC system are found in 21 CFR Parts 201 and 207 Subparts C and D.

However, a sponsor may request an exemption from the NDC bar code requirement under 21 CFR 201.25(d). The cellular therapy community has been using the ISBT 128 system, which is an international standard for terminology, coding and labeling. All major standard-setting organizations in this field have committed to using ISBT 128. AABB and seven other organizations presented a joint statement on the implementation of the NDC. The statement highlighted the duplicative nature of implementing the NDC for cellular therapy products subject to licensure and described the advantages of ISBT 128 specific to the community. Some licensed cellular therapies have been exempted from using the NDC because the FDA determined that an alternative regulatory program or method (namely, ISBT 128) rendered the bar code unnecessary to ensure patient safety for that specific cellular therapy.

Sponsors are eligible to request a proprietary or trade name for licensable biological products. Proprietary names may be used for commercial distribution of the product and to identify the specific product in the marketplace, once it has been approved by the Center for Biologics Evaluation and Research. Requests for proprietary names should be submitted for FDA review as soon as the recommended supporting information is available; the request may be submitted during the investigational new drug stage, but not earlier than at the end of phase 2 of the IND process. Primarily, the FDA reviews proprietary name requests to avoid potential medication errors related to look-alike and sound-alike proprietary names, and to avoid names that are fanciful or misleading. The FDA has published a guidance document titled "Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names," February 2010, to help sponsors prepare for such submissions.