The California Assembly Committee passed AB 2605 on April 29. The bill imposes a statewide licensing requirement on third-party logistics providers in the pharmaceutical supply chain. The legislation is inconsistent with federal requirements under the Drug Quality and Security Act.
It creates a license for third-party logistics providers and nonresident 3PL providers, subject to regulation by the Board of Pharmacy (BOP). This bill:
- Establishes an annual license requirement for 3PLs based in California and nonresident 3PLs operating in California.
- Requires a 3PL to have a designated representative who shall be responsible for compliance with applicable state and federal laws.
- Requires a 3PL to keep records of the manufacture, acquisition, or disposition of dangerous drugs, and current inventory, as specified.
- Requires a 3PL to post a surety bond, as specified.
- Establishes fees for a 3PL and nonresident 3PL license, as specified.
- Makes other conforming and technical changes, as specified.
This bold move opens the door for other states to adopt similar licensing that will create more risk to the security of the supply chain, due to confusion and complication to be compliant with federal and state laws. It also adds costs to businesses operating inside/outside of a state.
IWLA has opposed this legislation from the day it was introduced, and is actively pursuing further amendments to the bill with the California Assembly Committee, senate and the Board of Pharmacy. Stay tuned for updates.