FDA inspection of OTC company records expected after "time, guidance" given industry.
This article was originally published in The Tan Sheet
Executive Summary
FDA INSPECTION OF OTC COMPANY RECORDS is expected to begin only after the agency has provided "sufficient time and guidance" to the OTC drug industry, according to a conference committee "explanatory statement" on the major FDA reform bill, the FDA Modernization Act of 1997, that passed the House and Senate Nov. 9. The bill provides FDA with new authority to inspect OTC drug facilities and records to the same extent as prescription drugs.