FDA Issues Final Rule on Electronic Registration

August 31, 2016

The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients.

The rule is an effort to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and the agency alike.

In addition, the rule supports the implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

The FDA estimates the one-time total costs of the electronic register will be around $59.7 million. The largest cost elements will be for registrants reading and understanding the final rule and making changes to their standard operating procedures.

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