House Bill 7077 will become law on October 1, 2014 as Chapter 2014-148, Laws of Florida. This law creates s. 465.0158, F.S., to require nonresident pharmacies and outsourcing facilities to obtain a permit in order to ship, mail, deliver or dispense compounded sterile products into Florida.
This law amends the following Florida Statutes:
- s. 465.003, F.S., providing definitions for the terms “compounding”, “outsourcing facility”, and “compounded sterile product”;
- s. 465.0156, F.S., makes the failure to comply with s. 465.017(2), F.S., which governs the filling of prescriptions, dispensing of medicinal drugs, and recordkeeping, and the newly created s. 465.0158, F.S., grounds for administrative discipline of a nonresident permittee;
This section also provides the board with expanded authority to take immediate disciplinary action against nonresident permittees. The bill allows the board to sanction permittees for conduct that could cause harm instead of conduct that has already done so. The bill clarifies that nonresident permittees are subject to s. 456.0635, F.S., grounds for initial licensure and renewal denial;
- s. 465.465.017, F.S., authorizes the Department of Health to inspect nonresident pharmacies and nonresident sterile compounding facilities.
The complete bill language may be viewed at: http://laws.flrules.org/2014/148
Stay tuned to the Board of Pharmacy website for future updates on this new law.