USA – Industry seeks delay for reporting manufacturing volume data

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up the necessary systems to comply with the manufacturing volume reporting provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to meet the February deadline set by the US Food and Drug Administration (FDA).

The Section 3112 of the CARES Act established new reporting requirements for manufacturers of finished dosage forms, API suppliers, over-the-counter drugs and animal drugs to report annually the amount of each drug that is manufactured, prepared, propagated, compounded or processed for commercial distribution. The manufacturing volume reporting requirement initially set to begin in September 2020, but FDA postponed the requirement a month before the statutory deadline as it had not yet set up a portal for submitting the data…