Each year pharmaceutical companies must fulfill annual deadlines to become and remain compliant with the FDA. Each company responsible for submitting drug product listings, be they drug manufacturers or distributors, will have unique schedules for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods throughout the year for various electronic drug product submissions. These include Drug Sample Distribution Reports, GDUFA Self-Identification submissions, Establishment Registrations and No Change notifications for Drug Product Listings. Most of these deadlines fall within the final quarter of the year; however, some may vary. It is also pertinent to consider that as the deadlines approach, FDA gets inundated with many submissions and their turn around time could potentially increase causing your file to process after the due date. It is best to submit well before the applicable deadlines. Below learn more about some of the various, required submissions.
Drug Sample Distribution Reports
Drug Sample Distribution Reports require manufacturers and authorized distributors of record (ADRs) of applicable drugs to annually report the identity and quantity of drug samples that were requested and distributed. This particular deadline is April 1st of each year. It is advisable to start preparing before the new year or early in the year.
In general, manufacturers and authorized distributors of record (ADR) are both responsible for submitting the drug sample information. In instances where both entities possess the same drug sample information, only one should be reporting it. As FDA requires a written agreement to be in place between manufacturers and ADRs, they suggest deciding which party will be reporting the drug sample data and stating it in the written agreement.
GDUFA Self-Identification Submissions
The Generic Drug User Fee Amendment (GDUFA) requires that human generic drug facilities and certain sites and organizations identified in a generic drug submission report annually to FDA with identification information. By collecting this information, the FDA can set annual facility fees and target their inspections to provide quality, affordable generic drugs. The deadline for GDUFA is September 30th of each year.
A public site exists of current drug establishments that manufacture, prepare, propagate, compound or process drugs distributed in or imported to the United States of America. An establishment is required to list within 5 days of beginning operations and they are required to update their registration annually. The deadline for Establishment Registration is December 31st of each year.
To maintain a current and accurate status with FDA, every year, Electronic Drug Listings need to be updated, even if there are no changes to report. A company should submit just one blanket no-change certification for all their listings that do not require a change. The deadline for No-Change Notification is December 31st of each year.
However, if a company does have updates to their drug listings, those need to be submitted individually. Depending on when the information change occurred, updates and are due by June or December within the same year.
Each of these submissions must be prepared as an Extensible Markup Language (XML) file in the Structured Product Labeling (SPL) format. These submissions may then be submitted through the FDA Electronic Submission Gateway (ESG). Reed Tech specializes in these preparations and submissions. To learn more about Reed Tech and their services, contact [email protected].