Washington

At the end of May, a federal rule requiring the “sterile” manufacture of certain inhalable respiratory drugs took effect, prompting some in the respiratory industry to ask, “Are drug manufacturers ready?”

The sterile rule — which the U.S. Food and Drug Administration published nearly two years ago in response to reports of adverse drug reactions from contaminated inhalation drugs — says that all aqueous-based inhalation solutions must be manufactured free from microbiological organisms by May 27, 2002. To comply with the rule, manufacturers and compounding pharmacies that previously were not manufacturing sterile must submit a “supplemental abbreviated new drug application” to the FDA establishing the sterility of their current drug-making processes.

After May 27, the FDA will consider drugs not proven to be sterile “adulterated” and subject to regulatory action. Additionally, “the agency will refuse to approve a new or abbreviated application for a drug product that fails to comply with this rule,” according to the FDA's Web site.

An FDA spokesman told HomeCare that the agency does not yet know what percentage of respiratory drug manufacturers have complied with the rule, but he asserted that the FDA does not expect the sterile requirements to cause any drug shortages in the respiratory market.

Soon, the FDA will begin inspecting manufacturers' respiratory drug-making procedures to determine whether the manufacturers are compliant, the spokesman added. At that time, the agency will track the number of manufacturers who remain in the market.

Ronald Asinari, a spokesman for Kenilworth, N.J.-based Schering Plough — whose subsidiary, Warrick, manufactures the market's leading generic albuterol product — says that his company will comply with the sterile rule. “For this product,” he explained, “we plan to meet the FDA requirements and time frame by outsourcing production to a third-party sterile manufacturer.”

Most legitimate drug compounders follow FDA directives and are responsive to FDA suggestions, according to Michael DeCarlo, an attorney with the Washington-based law firm Dickstein Shapiro Morin & Oshinsky.

However, home medical equipment providers who are concerned about the pharmacy to which they refer respiratory clients “should inquire as to what the pharmacy has done to come into compliance with the rule,” DeCarlo said. “And, if there has been an FDA investigation, [the HME providers] should inquire as to what the outcomes were.”

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