FDA Modernization Act: Implications For OTCs

9 December 1997

Expansion of the US Food and Drug Administration's factory inspectionsauthority to over-the-counter drugs is unlikely to be significant, Douglas Ellsworth, district director for the FDA's New Jersey Division, has told a seminar on the FDA Modernization and Accountability Act's implications for OTCs (Marketletters passim). He forecast no real change in the OTC procedure even long term, and certainly not overnight.

OTC as well as prescription drugmakers are already subject to Current Good Manufacturing Practice requirements, including all record-keeping, said Mr Ellsworth; FDA field inspectors already ask to see these records voluntarily, and most companies comply. If a firm had previously refused, the FDA would use other inspectional techniques.

The Act clarifies FDA inspection authority and helps assure long-term compliance, he said. It also addresses international concerns at the lack of FDA inspectional authority for OTC GMP records which might have affected other nations' reliance on FDA inspections under Mutual Recognition Agreements. The change will provide a future benefit for US industry in the global market, he said; the FDA will work with industry to assure compliance.

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