OTC Records Inspection Concerns Raised At FDA, CHPA Meeting
This article was originally published in The Tan Sheet
Potential industry concerns regarding implementation of the FDA Modernization Act's new OTC records inspection provisions were raised during an "explor-atory" meeting between FDA and the Consumer Healthcare Products Association Sept. 15.
You may also be interested in...
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.
Perrigo promotes in pricing, planning
Combe sells most of its OTC brands