FDA’s ORAL DRUG DOSAGE IMPRINT FINAL RULE COULD BE DELAYED

FDA's ORAL DRUG DOSAGE IMPRINT FINAL RULE COULD BE DELAYED if another federal regulation moratorium is imposed by the Bush Administration, FDA Deputy Commissioner for Policy Michael Taylor told a Sept. 16 Nonprescription Drug Manufacturers Association meeting in Washington, D.C. Implying that an extension of this year's temporary halt on regs might catch the pending imprint proposal, Taylor said one of the key factors influencing how fast FDA issues the final reg will be the President's regulatory moratorium. "Whether or how the President's pledge to extend the moratorium [on new regulations] for a year will affect rulemaking in this area, we simply don't know."

FDA could use support from industry to identify the imprint regulation as a beneficial proposal, Taylor indicated. "I think a case would have to be made that there is a positive aspect of this for the industry to do business," Taylor said. "I welcome your engagement on this."

The agency is working on a final version of the imprint reg; the first Federal Register proposal was published on May 15, 1991 ("The Pink Sheet" May 20, 1991, T&G-5). The reg, as proposed, would require manufacturers of prescription and nonprescription solid oral dosage forms to use an identifying mark or logo with at least one alphanumeric character. At the time of the proposal, the agency declined to require a uniform coding system as supported by two major pharmacy groups, the American Society of Hospital Pharmacists and the American Pharmaceutical Association.

The Nonprescription Drug Manufacturers Association has been seeking a flexible federal regulation on imprinting for over three years. The association has asked FDA to set a national standard in the area following action by the state of Washington to require identifying imprints on OTC drugs as of Jan. 1, 1993.

FDA has been attempting to have a final reg out prior to the date of effectiveness of the Washington state rules. Taylor, however, indicated that the process of reviewing the comments to the May 1991 proposal is proceeding slowly. He noted that the final reg "is still being worked on within the Center [for Drug Evaluation and Research]." All FDA regs clear through Taylor's office; he reported that he has not seen the final version yet.

"We know that there is a lot of interest in getting something done" on the imprint reg and the process for approving markings, Taylor commented. "My hope," he added, "is that we will be able to move a document out of the agency on that within the next couple of months." When originally proposed, the reg was intended to become effective one-year after final publication in the Federal Register.