Call for Revisions to FDA's Bar Code Rule
OTC drug manufacturer submits comments on FDA's proposed rule.
Novartis Consumer Health (NCH) supports efforts to reduce medication errors, which may ultimately reduce adverse drug events in healthcare settings. However, the company believes FDA's proposed bar code rule leaves many questions un-answered and raises new ones for the OTC industry. While NCH supports FDA's efforts, we suggest the following revisions and have notified the agency in writing:
- Provide exemptions for OTC samples and specific product categories. The company requests that FDA exclude OTC samples from the rule in the same manner by which prescription samples were excluded. Furthermore, FDA should list those individual products and ingredients, and/or categories of products and ingredients that do not require bar codes. Such a list would provide clear direction to industry as to FDA's intent.
- Include precise definitions for "hospital" and "institution." Throughout the proposed rule, FDA refers to hospitals; however, "institutional use" also appears. The word "institution" may be defined in many ways. FDA should clearly define the sites to which bar coded product must be distributed. Either the rule should be specific to hospitals, or the word "institution" must be defined in the narrowest terms.
- Provide exemption from child-resistant package requirements for SKUs labeled "for hospital use only." Child-resistant packaging should not be required, because the affected products would not be intended for use as household substances. NCH does not believe a product labeled "for hospital use only" should be required to bear the statement, "This Package for Households Without Young Children," as required by 16CFR1700.5(a)(1).
- Limit the amount of required human-readable text on SKUs that include bar codes and are labeled "for hospital use only." NCH suggests that the final rule establish the minimum human readable information required to appear on the smallest unit of bar coded packaging when the SKU is labeled "for hospital use only."
- Allow product catalogs and price lists intended to solicit hospitals sales to include non–bar coded SKUs when a bar coded SKU is offered. NCH believes that if one SKU of a product is made available with a bar code in compliance with the final regulation, then the other non–bar coded SKUs of that same product should be allowed to remain in the company's catalog or price list used to generate sales from hospitals. This was not clear in the proposed rule.
- Allow the use of any symbology for which the EAN.UCC has issued appropriate standards. NCH agrees with the proposal to use EAN.UCC standards. However, the company believes the symbologies should not be limited to linear. The company requests that FDA consider allowing industry to use any symbology for which the EAN.UCC has issued appropriate standards.
- Provide for an implementation period that considers the compliance date for the proposed rule to redefine the NDC number/drug listing requirements. NCH does not believe that shortening the implementation period will be of significant benefit as the vast majority of hospitals are not presently ready to use bar codes to reduce medication errors. The three-year time period replicates what was allowed for Drug Facts. NCH does not see merit in moving forward to execute the bar code initiative until the new NDC regulations are published and analyzed for impact by the OTC drug industry.
NCH supports the bar code initiative and looks forward to working on innovative solutions that will help the hospital community use the company's products safely and effectively.
Jill K. Jarusiewicz is a manager, regulatory affairs, Novartis Consumer Health Inc. (Parsippany, NJ), the U.S. over-the-counter affiliate of Novartis AG. She can be reached at firstname.lastname@example.org.