Bioterrorism Phase 2 Enforcement Implemented

Phase 2 enforcement of the FDA Bioterrorism Prior Notice program was implemented 3/12/04. CBP and FDA have agreed that penalties will not be issued until the latter part of this phase. During the first phase FDA will provide info to CBP regarding companies that have failed to file Prior Notice data as required. CBP will issue informed compiance notices. There is the possibility that continuous or serious lapses will be dealt with more harshly.

Any questions contact Tony Collini by phone at 410-863-0211 or tonyc@jsconnor.com.