“Hospital Use Only” OTC Line Considered By Novartis For Bar Code Reg

Novartis Consumer Healthcare is considering developing a "hospital use only" line of OTC drugs to comply with FDA's new bar code regulations.

"Creation of a 'hospital use only' line of products" that carry bar codes on drug packaging is an "option [that] appears promising but leads to some questions," Novartis says in recent comments addressing the agency's proposed rule on bar codes for drugs dispensed in hospitals.

"Currently, this option requires both extensive human readable and bar code information on packages," Novartis points out. However, "since the bar code would be used to identify the product, the products could be sold with a minimum of human readable information on the smallest units," the company suggests.

As a result, Novartis proposes 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.'"

The firm also maintains child-resistant packaging should not be mandated, "as the affected products would not be intended for use as 'household substances.'"

Finally, Novartis says it "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 is currently stipulated by existing regulation.

The firm notes it considered two other strategies to meet the proposed requirements, which would mandate bar codes on OTCs that are "commonly used in hospitals and dispensed pursuant to an order" from a healthcare provider. One approach would require the addition of bar codes to existing SKUs, while another would involve the creation of new SKUs that meet requirements for sale in both retail and hospital environments.

Addressing the first approach, Novartis states "the distinct disadvantage...is that the product UPC codes must include product NDC numbers. The complexities and expenses involved in changing a product UPC code [are too great]."

"Due to the challenges this [approach] would raise for our retail customers and the expected resultant economic consequences to Novartis Consumer Healthcare, this option was deemed an unacceptable approach," Novartis continues.

Concerning the second option of creating SKUs that meet requirements for sale in both retail and hospital settings, Novartis says that while it "overcomes the UPC issue, it requires both human readable and bar code information on packages which are already limited in label space."

"The expense and size of packaging needed to bear consumer-friendly information along with a bar code on the various levels of packaging is under evaluation," the firm adds.

Novartis OTCs likely to be affected by the rule include Triaminic pediatric cough/cold products and Maalox antacids. FDA published the proposed rule, which applies mainly to Rx drugs, in an effort to reduce medication errors in hospitals (¹ (Also see "FDA Oversight Among Hot Button Issues In 112^th Congress" - Pink Sheet, 10 Jan, 2011.), p. 9).

In addition to enumerating ways in which it might adapt to new bar code regulations, Novartis recommends several changes to the proposal.

Specifically, the firm advises FDA to "allow the use of any symbology for which the EAN.UCC has issued appropriate standards" instead of "limiting the industry to linear bar codes so hospitals do not have to invest in either new or updated equipment."

Novartis also says the agency's proposed intention of holding OTC drugs "commonly used in hospitals" and "dispensed pursuant to an order" subject to bar code requirements does not "provide clear direction to the OTC industry."

"To avoid confusion and inconsistent application throughout the...industry, FDA should list those products/categories of products and/or ingredients that do not require bar codes," the company maintains, thereby clarifying the "regulation via exclusion rather than inclusion."

The Consumer Healthcare Products Association also requested further clarification on which OTCs would be covered under the rule in June 11 comments to FDA (² (Also see "OTCs Covered Under Bar Code Proposed Rule Clarification Requested By CHPA" - Pink Sheet, 16 Jun, 2003.), p. 8).