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. 33 No. 7, February 16, 2007 issue of the Florida Administrative Weekly.

The changes are in response to comments from staff of the Joint Administrative Procedures Committee and to comments made at a public hearing held on the rule.

The changes are as follows:

(1) The exemption from the definition of wholesale distribution in Section 499.012(1)(a)2.b., F.S., for “emergency medical reasons” includes:

(a) No change.

(b) Transfers of prescription drugs by a health care entity to an emergency transport vehicle which is under the direction of a medical director of an emergency medical service provider licensed under Chapter 401, F.S., for use in the treatment of persons transported to that health care entity to immediately restock a licensed vehicle or an emergency medical kit for prescription drugs used on that person or to immediately restock prescription drugs on the vehicle which have become unsuitable for use. This exception does not extend to the stocking of supply inventory or for warehousing of prescription drugs used by emergency medical service providers;

(c) Emergency transfers of prescription drugs as authorized in Rule 59A-4.112, F.A.C., for nursing homes or Rule 64B16-28.6021, F.A.C., of the Florida Board of Pharmacy; or

(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

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

3. The prescription drugs are delivered to a Pharmacy licensed under Chapter 465, F.S.;

(f) through (g) No change.

(h) Transfers of prescription drugs by or on behalf of the Department of Health to a health care entity authorized to purchase prescription drugs, for storage and use in the treatment of persons in need of emergency medical services, including controlling communicable diseases or providing protection from unsafe conditions that pose an imminent threat to public health;

(i) Transfers of prescription drugs by or on behalf of the Department of Health to the licensed medical director of a government agency health care entity, authorized to purchase prescription drugs, for storage and use in the treatment of persons in need of emergency medical services, including controlling communicable diseases or providing protection from unsafe conditions that pose an imminent threat to public health.

(2) through (4) No change.

Specific Authority 499.012, 499.014, 499.03, 499.05 FS. Law Implemented 499.012, 499.014, 499.03 FS. History–New 7-1-96, Formerly 10D-45.0525, Amended 1-26-99, 4-17-01, 1-1-04,_________.