Last updated: November 21, 2012
The change is intended to help prevent medication errors. Standards in the USP-NF are expressed in a specific monograph, general chapters, and General Notices. Where the requirements of an individual monograph differ from those in a relevant general chapter, the monograph requirements apply and supersede those in the general chapter. Labeling requirements are among those that may be included in a monograph, and must be complied with under the Federal Food, Drug, and Cosmetic Act (note that USP has no role in enforcing its standards). Since the labeling requirements in these two heparin monographs differ from those in General Chapter <1> Injections, and the FDA wishes to make the labeling requirements of <1> applicable to these monographs, it is necessary to revise them. The change will ensure the labels of heparin lock flush solution and heparin sodium injection are consistent in format with those of other injectable products, thereby reducing the potential for error in clinical settings.
The labeling section of the USP Heparin Lock Flush Solution and USP Heparin Sodium Injection monographs are being revised to ensure that the heparin labels comply with the USP General Chapter <1> Injections requirement that states the label should reflect the strength per total volume as the primary expression of strength followed in close proximity by strength per mL enclosed by parentheses. Heparin products will now be labeled the same way as other injectable products.
The process to change the labeling requirement has already begun. An Interim Revision
Announcement was posted for notice and comment in Pharmacopeial Forum (PF) for Heparin Sodium Injection May 1, 2012 and for Heparin Lock Flush Solution September 4, 2012. Manufacturers can go to the PF (see Resources) to review this information. Posting of the official monographs in the “Official Text” section of the USP Web site will occur on January 25, 2013. In the meantime, manufacturers with affected products may receive notification from the FDA that a labeling change is required and should be completed by the date that the monograph will become official which is May 1, 2013. It is likely that complete conversion of all labels will occur over time, since early adoption of revised standards is allowed, but must be completed by May 1, 2013.
In addition to the notice and comment opportunities afforded in PF, and the posting of the final official text on the USP Web site, practitioners and manufacturers will be notified of the changes through letters, webinars and organizational communications.
Currently, as stated above, the labels of other injectables reflect the strength per total volume as the primary expression of strength followed in close proximity by strength per mL enclosed by parentheses. U.S. manufacturers of heparin have not yet begun to change their labels, so USP does not currently have exact label images for heparin injectable products. An example of an acceptable label is expected to be posted to the USP website within the next few months.
The labeling information is located in General Chapter <1> Injections: Labels and Labeling/STRENGH AND TOTAL VOLUME FOR SINGLE- AND MULTIPLE-DOSE INJECTABLE DRUG PRODUCTS. Each Heparin monograph also provides labeling instructions.
Healthcare professionals must be vigilant during the transition period when the old heparin labels and the revised heparin labels appear in the marketplace. The old heparin labels may only display the strength per mL, whereas the revised heparin labels should display both the total drug content as the strength per total volume followed in close proximity by the strength per mL. It is strongly recommended for general heparin safety that facilities put in place heparin protocols, policies and procedures that highlight this label transition period. An independent double-check process that is robust will help practitioners identify the new labeling and apply correct dosing.
The specific wording in the labeling regarding strength and volume for Heparin Sodium Injection and Heparin Lock Flush Solution will be removed from the monographs. In lieu of these specific requirements, the manufacturer must adhere to the labeling standard in the General Chapter <1> Injections related to strength and volume expression for injections. The change will become official on May 1, 2013, at which time, all drug products affected by this change need to be in compliance with the standard.
The labeling change affects Heparin Sodium Injection and Heparin Lock Flush Solution monographs.