The purpose of the rule is to implement the cancer drug donation program authorized by section "1" of Florida Session Law 2006-310. The rule will implement the Florida Cancer Drug Donation statute

 

DEPARTMENT OF HEALTH
Division of Family Health Services

RULE NO: RULE TITLE
64F-12.026: Cancer Drug Donation Program
PURPOSE AND EFFECT: The purpose of the rule is to implement the cancer drug donation program authorized by section "1" of Florida Session Law 2006-310. The rule will implement the Florida Cancer Drug Donation statute.
SUMMARY: The rule implements a new statutory section that authorizes the Florida Cancer Drug Donation Program.
SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 499.029 (8) FS.
LAW IMPLEMENTED: 499.029 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R. Ph., Executive Director, Board of Pharmacy-Drugs Devices and Cosmetics, 4052 Bald Cypress Way, Mail Bin C-04 Tallahassee, Florida 32399

THE FULL TEXT OF THE PROPOSED RULE IS:

64F-12.026 Cancer Donation Program.

The purpose of this section is to establish and maintain a cancer 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.

(b) Unless benefits have been exhausted, or a certain cancer drug or supply is not covered by the prescription drug program, a Florida resident is ineligible to participate in the program if the person is eligible to receive 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.

(2) Donor Requirements.

Any of the following persons may donate legally obtained cancer drugs or supplies to a cancer drug donation program if the drugs and supplies meet the requirements in subsection (6) below, as determined by a pharmacist who is employed by or under contract with a cancer drug donation program participant facility:

(a) A patient or patient’s representative whose cancer drugs or supplies have been maintained within closed drug delivery systems such as health care facilities, nursing homes, hospices, or hospitals with closed drug delivery systems.

(b) A physician licensed under Chapter 458 or 459, F.S. who receives cancer drugs or supplies directly from a drug manufacturer, drug wholesaler, or pharmacy.

(c) A pharmacy.

(d) A drug manufacturer.

(e) A medical device manufacturer or supplier.

(f) A wholesaler of drugs or supplies.

(g) Cancer drugs or supplies may not be donated to a specific cancer patient.

(3) Participant facility requirements include:

(a) Eligibility: Only a Class II Institutional Pharmacy, permitted under Chapter 465, F.S. that accepts, stores and dispenses donated 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 the following:

1. The name, 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 (2)(a), herein.

(c) Withdrawal from participation: A pharmacy may withdraw from participation in the program upon at least 10 days written notification to the department.

(d) Storage:

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

(e) Dispensing:

1. Drugs and supplies shall be dispensed by a licensed pharmacist pursuant to the requirements in Chapter 465, F.S.

2. The pharmacist shall inspect cancer drugs and supplies for adulteration, misbranding, mislabeling, and the date of expiration before dispensing. 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 program recipient form and shall be orally notified that the drug or supply may have been previously dispensed.

4. 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 drugs or supplies from the cancer drug donation program.

(f) Recordkeeping requirements:

1. Donor and Recipient Forms shall be maintained at least 3 years.

2. Destruction of donated drugs or supplies records 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) Required Forms for Program Participants:

(a) Cancer Drug Donation Program Recipient Record, DOH form_______, effective_______ and incorporated herein by reference

(b) Cancer Drug Donation Program Donation, and Destruction Record, DOH Form ______, effective ______, and incorporated herein by reference.

(c) Cancer Drug Donation Program Notice of Participation or Withdrawal, DOH Form ____, effective _____, and incorporated herein by reference.

The above referenced required forms are available by contacting the Department of Health Drugs Devices and Cosmetics program at The Department of Health, Drugs Devices and Cosmetics Program, 4052 Bald Cypress Way, Mail Bin C-04, Tallahassee, Florida 32399, or by downloading them from the Program’s web site.

(5) Dispensing Fees:

A cancer drug program participant facility may charge the recipient of the drug or supply a handling fee of no more than 300% of the Medicaid dispensing fee or no more than $15.00, whichever is less, for each cancer drug or supply dispensed.

(6) Categories of drugs and supplies eligible for donation.

(a) Cancer drugs. A cancer drug is eligible for donation under the cancer drug donation program only if all the following requirements are met:

1. The donation is accompanied by a completed cancer drug donation program donor form that is signed by the person making the donation or that person’s authorized representative;

2. The drug’s expiration date is at least 6 months later than the date that the drug was donated and its tamper resistant packaging is intact;

3. The drug is in its original, unopened, sealed, tamper-evident unit dose packaging that includes the drug’s lot number and expiration date. Single-unit dose drugs may be accepted if the single-unit dose packaging is unopened;

4. Cancer drugs billed to and paid for by Medicaid in long-term care facilities are not eligible for donation unless not reimbursable by Medicaid.

(b) Cancer supplies. Cancer supplies are eligible for donation under the cancer drug donation program only if the supplies meet all the following requirements:

1. The supplies have not been tampered with or mislabeled; the supplies are in their original, unopened, sealed packaging;

2. The supplies are accompanied by a completed cancer drug program form that is signed by the person making the donation or that person’s authorized representative.

(c) Drugs and supplies not eligible for donation. All of the following drugs are ineligible for donation or acceptance under the cancer drug donation program.

1. Substances listed in Schedule II, Schedule III, Schedule IV or Schedule V of Section 893.03, F.S.;

2. Drugs and supplies that do not meet the criteria under paragraph (6)(b), herein;

3. Drugs that expire less than 6 months after the date of donation.

(7) The Department shall establish a website to maintain the list of the Class II Institutional Pharmacies participating in the Cancer Drug Donation Program. The website shall also contain links to cancer drug manufacturers that offer drug assistance programs or free medication.

Specific Authority 499.029(8) FS. Law Implemented 499.029 FS. History–New________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Rebecca Poston

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 8, 2007

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: August 4, 2006