| Title: | FDA End-dating Affirmation of Compliance (AofC) Codes BPL and BFL |
|---|---|
| Date: | 2011-10-19 |
| To: | abi |
| Links: | previous, original, next |
Title: FDA End-dating Affirmation of Compliance (AofC) Codes BPL and BFL
The Food and Drug Administration will end-date two AofC codes effective October 24, 2011.
The codes being end-dated are BPL - Biologic Product License Number and BFL - Biologic Establishment License Number. FDA originally announced the creation of two new AofC codes (STN - Submission Tracking Number and BLN - Biologics License Number) for our Center for Biologics Evaluation and Research and the end-date of the referenced codes back in 2008. The new codes were added but unfortunately the end-dates were not put in place for BPL and BFL and those codes are being transmitted in error.
See the definitions of AofCs STN and BLN which were added in 2008:
STN - Submission Tracking Number
The qualifier for this code should be the Submission Tracking Number issued by FDA's Center for Biologics Evaluation and Research for the licensed biological product identified in the FDA line. The Submission Tracking number is the biologics license application number.
BLN - Biologics License Number
The qualifiier for this code should be the four digit U.S. Biologics License Number issued by FDA's Center for Biologics Evaluation and Research to the manufacturer of the biological product identified in the FDA line. The Biologics License Number is the U.S. license number (not the STN number).