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. 13, March 30, 2007 issue of the Florida Administrative Weekly.

The changes are in response to comments from staff of the Joint Administrative Procedures Committee.

The changes are as follows:

64F-12.026 Cancer Drug Donation Program.

The purpose of this section is to establish and maintain a cancer drug donation program under which unused cancer prescription drugs and cancer supplies may be donated and dispensed to eligible individuals who are diagnosed with cancer. This rule applies to the department or any person who donates, receives, dispenses or otherwise participates or wishes to participate in the cancer drug donation program.

(1) Recipient Eligibility Requirements.

(a) A Florida resident who is diagnosed with cancer is eligible to receive drugs or supplies under the cancer drug donation program unless the person falls under paragraph 64F-12.026(1)(b), F.A.C.

(b) A Florida resident is ineligible to participate in the cancer drug donation program if the person is eligible to receive cancer drugs or supplies through the Medicaid program, third-party insurer or any other prescription drug program funded in whole or in part by the Federal Government, unless these benefits have been exhausted, or a certain cancer drug or supply needed by the patient is not covered by the prescription drug program as stated in Section 499.029(9), F.S.

(2) Donor Eligibility Requirements.

Any person defined as a donor in Section 499.029(3), F.S., is determined to be eligible to be a donor.

(3) Participant Facility Requirements.

(a) Eligibility: Only a Class II Institutional Pharmacy, permitted under Chapter 465, F.S. that accepts, stores and dispenses donated cancer drugs and supplies may participate in the cancer drug donation program.

(b) Notice of Participation: Participation in the cancer drug donation program is voluntary. To be eligible for participation in the cancer drug donation program, a Class II Institutional Pharmacy must elect to participate and provide the department with all of the following as set forth in Form DH-MQA 1100, 2/07, incorporated by reference in subsection (4):

1. The name, permit number, street address, and telephone number of the pharmacy;

2. The name and telephone number of a pharmacist or another contact as determined by the pharmacist who is employed by or under contract with the pharmacy;

3. A statement indicating the pharmacy meets the eligibility requirements under paragraph (3)(a) herein.

(c) Withdrawal from participation: A pharmacy may withdraw from participation in the cancer drug donation program upon at least 10 days written notification to the department as set forth in Form DH-MQA 1100, 2/07, incorporated by reference in subsection (4).

(d) Storage:

Cancer drugs and supplies donated under the cancer drug donation program shall be stored in a secure storage area under environmental conditions appropriate for the cancer drugs or supplies being stored. Donated cancer drugs and supplies may not be stored with non-donated inventory.

(e) Dispensing:

1. Cancer drugs and supplies shall be dispensed by a licensed pharmacist, whether or not employed by or under contract with a participant facility, pursuant to the requirements in Chapter 465, F.S.;

2. The pharmacist shall inspect the donated cancer drugs and supplies for adulteration, misbranding, mislabeling, and the date of expiration before dispensing. Cancer drugs or supplies that are tampered with, expired, adulterated, mislabeled or misbranded may not be dispensed;

3. Before a cancer drug or supply may be dispensed to a recipient, the recipient shall sign a cancer drug donation program Recipient Record, Form DH-MQA 1098, 2.07, incorporated by reference in subsection (4), and shall be notified, both orally and in writing, that the cancer drug or supply may have been previously dispensed;

4. Cancer drugs and supplies shall be dispensed only to recipients who meet the following eligibility requirements:

i. Individuals who are uninsured;

ii. All other individuals who are otherwise eligible under subsection (1) herein to receive cancer drugs or supplies from the cancer drug donation program.

5. Cancer drugs or supplies may not be donated to a specific cancer patient.

(f) Recordkeeping requirements:

1. Donor and Recipient Records as reflected in Forms DH-MQA 1099, 2/07 and 1098, 2/07, incorporated by reference in subsection (4) shall be maintained at least 3 years by the participant facility.

2. Destruction Records for donated drugs or supplies as reflected in Form DH-MQA 1099, 2/07, incorporated by reference in subsection (4) shall be maintained at least 3 years by the participant facility. For each drug or supply destroyed the record shall include all of the following information:

i. The date of destruction;

ii. The name, strength and quantity of the cancer drug destroyed;

iii. The name of the person or firm that destroyed the drug;

iv. The source of the drugs or supplies destroyed.

(4) through (6) No change.

(7) The Department shall establish a website at www.doh.state.fl.us/mqa/DDC/Cancer/index.html to maintain the registry of participant facilities. The website shall also contain links to cancer drug manufacturers that offer drug assistance programs or free medication.