Small over-the-counter drug manufacturers fear they will be swamped by new packaging costs if the Food and Drug Administration (FDA) pushes forward with its proposal to require all two-piece hard-gelatin OTC capsules to be sealed. The major over-the-counter makers support sealing but are concerned about other facets of the proposal: a requirement to use the term "tamper evident" on package labels and a two-year deadline to recall all non-sealed capsules. The FDA currently requires two-piece hard-gel capsule packages to employ a minimum of two tamper-resistant technologies. These can include: film wrappers blister or strip packs bubble packs heat shrink bands or wrappers foil pouches container mouth inner seals and a number of protective measures. Capsule sealing is not required. In its January 1994 proposal the FDA recommended that sealing be mandatory. The package would also have to have an additional tamper-resistant feature. Howard Muller an official in the division of regulatory affairs within FDA's Center for Drug Evaluation and Research says a draft final rule is circulating within the agency. He declines to elaborate on its contents. At press time that draft had not yet reached the office of Janet Woodcock the director of the Center. Once she approves a rule it would need the signature of either David Kessler commissioner of the FDA or William Hubbarb the interim deputy commissioner. There is no timetable for the rule to be finalized.