GAO Asks State Pharmacy Regulators to Rate Interactions with the FDA

April 6, 2017

More than a dozen state pharmacy regulatory authorities told the GAO they have trouble communicating with the FDA on drug compounding issues.

Overall, 25 states reported no challenges in communicating or interacting with the FDA, compared to 15 saying they did. Ten said they either had no interactions or did not respond to the survey. Most states said they found the FDA’s webpages on applicable laws and guidance documents to be useful resources in dealing with drug compounding.

The most frequent complaints focused on problems in getting the FDA to respond to requests for information and to questions on oversight of drug compounding, according to the results of a GAO survey. Some states reported difficulty in getting complete information from Form 483s following pharmacy inspections, or in getting notifications from the FDA after the agency finds a pharmacy out of compliance.

The survey, completed in April 2016, is a companion to a larger GAO report on FDA challenges to regulating compounding pharmacies, published in November 2016.

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