DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
RULE NO.:RULE TITLE:
61N-1.011Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 159, August 15, 2019 issue of the Florida Administrative Register.
61N-1.011 Wholesale Distribution of Prescription Drugs – Exceptions and Specific Distributions Authorized
(1) The exemption from the definition of wholesale distribution in section 499.003(48)(b)2., F.S., for “emergency medical reasons” includes:
(a) through (d) No change.
(e) Transfers of prescription drugs in an emergency declared pursuant to Section 252.36, F.S. until the state of emergency is lifted, under the following conditions:
1. The manufacturer, wholesaler, or other person supplying the prescription drugs is authorized by Florida law to distribute prescription drugs in or into Florida; and either:
a.2. The prescription drugs are delivered to a temporary emergency medical station, officially designated by the state emergency operation center as a Disaster Medical Assistance Team or State Medical Response Team site; or
b.3. The prescription drugs are delivered to a Pharmacy licensed under chapter 465, F.S.;
2. The prescription drugs are transferred by a prescription drug wholesale distributor located outside of this state and not permitted by the Department on behalf of a prescription drug wholesale distributor located in the State of Florida for the purposes of supplying prescription drugs to authorized customers located in Florida, if the out-of-state prescription drug wholesale distributor meets the following conditions:
a. The out-of-state prescription drug wholesale distributor holds a current and active license as a wholesale distributor in its resident state, or is currently licensed as a prescription drug wholesale distributor pursuant to the federal act; and
b. The Florida prescription drug wholesale distributor holds a current and active prescription drug wholesale distributor permit with the Department; and
c. Both the in-state and out-of-state prescription drug wholesale distributors are under common ownership. For the purposes of this subsection, “common ownership” means that one prescription drug wholesale distributor owns the other prescription drug wholesale distributor or both prescription drug wholesale distributors share a common owner or ultimate parent company that has the authority to control the management and operations of both entities; and
d. The permitted Florida prescription drug wholesale distributor shall be responsible for ensuring the activities of the out-of-state prescription drug wholesale distributor conducted in Florida on its behalf during the state of emergency are in compliance with applicable Florida and federal requirements; and
e. The distributions of prescription drugs pursuant to this section shall terminate no more than thirty (30) days after the expiration of the state of emergency.
(f) through (j) No change.
(k) The distribution of a prescription drug during a state of emergency declared by the Governor pursuant to s. 252.36, F.S., by a prescription drug wholesale distributor located outside of this state and not permitted by the Department on behalf of a prescription drug wholesale distributor located in the State of Florida for the purposes of supplying prescription drugs to authorized customers located in Florida, if the out-of-state prescription drug wholesale distributor meets the following conditions:
1. The out-of-state prescription drug wholesale distributor holds a current and active license as a wholesale distributor in its resident state, or is currently licensed as a prescription drug wholesale distributor pursuant to the federal act;
2. The Florida prescription drug wholesale distributor holds a current and active prescription drug wholesale distributor permit with the Department;
3. Both the in-state and out-of-state prescription drug wholesale distributors are under common ownership. For the purposes of this subsection, “common ownership” means that one prescription drug wholesale distributor owns the other prescription drug wholesale distributor or both prescription drug wholesale distributors share a common owner or ultimate parent company that has the authority to control the management and operations of both entities.
4. The permitted Florida prescription drug wholesale distributor shall be responsible for ensuring the activities of the out-of-state prescription drug wholesale distributor conducted in Florida on its behalf during the state of emergency are in compliance with applicable Florida and federal requirements.
5. The distributions of prescription drugs pursuant to this section shall terminate no more than thirty (30) days after the expiration of the state of emergency.
(2) through (4) No change.
