Florida

Board

of

Pharmacy

A prepackaged drug product as a drug that originally was in finished packaged form sealed by a manufacturer and that is placed in a properly labeled container by a pharmacy or practitioner authorized to dispense pursuant to Chapter 465, F.S. for the purpose of dispensing or by a facility holding a Class III permit.

A central distribution facility as a facility under common control with a hospital holding a Class III institutional pharmacy permit that may dispense, distribute, compound, or fill prescriptions for medicinal drugs; prepare prepackaged drug products; and conduct other pharmaceutical services.

The term “common control” is defined as the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise.

A Class III permit holder is required to maintain policies and procedures addressing:

• The consultant pharmacist responsible for pharmaceutical services.
• Safe practices for the preparation, dispensing, prepackaging, distribution, and transportation of medicinal drugs and prepackaged drug products.
• Recordkeeping to monitor the movement, distribution, and transportation of medicinal drugs and prepackaged drug products.
• Recordkeeping of pharmacy staff responsible for each step in the preparation, dispensing, prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug products.
• Medicinal drugs and prepackaged drug products that may not be safely distributed among Class III permit holders.

Entities under common control that hold either a Class III permit or Health Care Clinic Establishment permit holders are exempt from obtaining a Restricted Prescription Drug Distributor permit and Prescription Drug Repackager permit in order to distribute medical drugs or prepackaged drug products between themselves. Additionally, a hospital-affiliated institutional pharmacy with multiple locations permitted as a Class III pharmacy will no longer be required to obtain additional permits from the Department of Business and Professional Regulation DBPR for each of its permitted locations that are under common control.

The legislation which established Class III Institutional Pharmacies removed the exemption for a health care entity with a Prescription Drug Repackager permit from obtaining a Restricted Prescription Drug Distributor permit, because it is no longer necessary due to the bill’s removal of the requirement for a Prescription Drug Repackager permit for health care entities and hospitals with Class III Institutional permits under common control.

Additionally, there is an exemption for hospitals which participate in the Section 340B Drug Discount Program from obtaining a Restricted Prescription Drug Distributor permit when arranging for a prescription drug wholesale distributor to distribute prescription drugs covered by the Section 340B Drug Discount Program directly to its contract pharmacy.