OTC Labeling Reg Inapplicable To Professional-Use Kits - Becton Dickinson

FDA's OTC labeling rules should not apply to blood culture "convenience" kits containing OTC drug components used by health care professionals, Becton, Dickinson & Co. asserts.

In a July 6 request seeking exemption from labeling format and content requirements, the medical diagnostics maker says the rule is inapplicable because its Bactec Blood Culture Procedural Tray "is not intended to be sold over-the-counter to consumers."

"The regulation does not appear to be directed at combination products such as convenience kits sold exclusively to health care organizations for use in health care settings by health care professionals," the Franklin Lakes, N.J.-based company asserts.

The Bactec kit, which is used by phlebotomists in the recovery and culture of organisms (bacteria and yeast) from the blood, contains blood culture bottles, a blood collection set, tourniquet, gloves, bandages, gauze and two OTC products - Persist swab stick (povidone iodine .75% skin prep) and alcohol prep pad (70% isopropyl alcohol).

"While it is possible that products such as alcohol prep pads and povidone iodine swabs could be used by nonprofessionals, the procedural kit itself is only intended for professional use, and the likelihood of lay use of this combination product is extremely low," Becton tells FDA.

"In general, buying decisions for this kit are made by hospital purchasing organizations or group purchasing organizations, which compare product on the basis of specific hospital requirements, including kit composition, cost and quality," the company notes.

BD points to the OTC labeling reg's failure to address nonprescription items contained in such kits. "This combination product, and others of its type, does not appear to have been considered when this regulation was published as a proposed rule, nor was it considered when the final regulation was published," BD says.

"Since these products are packaged, distributed and sold in a completely different manner than consumer OTC drugs, they should have been addressed in the proposed regulation if the regulation was intended to cover them," the company maintains.

Requiring a "Drug Facts" box on the kit's label would be "impractical," necessitating "additional extensive labeling specific to the drug component of the kit on the kit packaging," the company adds.

Becton currently lists all Bactec components and their quantity on kit labeling. "For components requiring additional instructions for use, these are provided in the package insert that accompanies the product," BD says, adding: "Use of the povidone iodine swab to prepare a site for sample collection, and use of an alcohol pad post phlebotomy is a procedure commonly known to the health care professionals employing the kit."

BD also requests an exemption for the OTC drugs' unit package labeling.

BD purchases the individual OTC components in bulk; the company then places two alcohol prep packages and one povidone iodine package in each kit. The OTC product unit packages do not carry the "Drug Facts" labeling and "would have to be re-packaged or overlabeled to provide such labeling," the firm notes.

"This operation would add considerably to the expense of the product without improving information to the prospective user," BD says. "The user would not see such labeling until they had opened the kit package."

Several companies have petitioned FDA for exemption from OTC labeling reg provisions, although BD's request is the first to address a "combination" product used only by health care professionals.

In a March exemption request, Australia-based tea tree antiseptic manufacturer Thursday Plantation asserted its label size "is too small to fit bar lines and all the wording in the font size required" by the final rule format (¹ (Also see "Thursday Plantation" - Pink Sheet, 30 Apr, 2001.)).

FDA, however, has taken a skeptical view of requests focusing on insufficient labeling space. In a December draft guidance, the agency reiterated it would not routinely grant exemptions for products claiming to be too small to satisfy the final reg's provisions, but would consider deferral requests to allow packaging changes (² (Also see "OTC Labeling Exemption, Deferral Timelines Depend On Complexity - FDA" - Pink Sheet, 1 Jan, 2001.)).

Last year, the agency rejected exemption requests for Whitehall-Robins' Chap Stick Flava-Craze lip balm and Block Drug's BC analgesics powder.

Exemption requests and citizen petitions to allow use of the phrase "may contain" to list inactive ingredients in OTCs are pending.