Repository

Thank you for your interest in becoming a repository in the Florida Rx Connects program. In addition to the eligibility criteria, repositories must agree to the following:

• Repository may dispense an eligible donation to a state resident who is indigent (income is 200% below the federal poverty level), or uninsured, or underinsured who has a valid prescription for such donation.
  
  
• Notify the Florida Department of Health of its intent to participate in the program as a repository before accepting or dispensing any donations under the program. The notification must be made using the Florida Rx Connects Repository Application and Withdrawal form.
  
  
• Application form must be signed and dated by the responsible pharmacist affirming that the intended repository meets the eligibility requirements of the program.
  
  
• Participating repositories may withdraw at any time from the program by providing written notice using the Florida Rx Connects Repository Application and Withdrawal form.
  
  
  • Upon withdrawal, repositories must agree to the transfer (using the Transfer form) or disposition of donated prescription drugs and supplies in their possession. Repositories are encouraged to transfer any unused drugs (if the requirements for donated drugs is met), to another repository if possible.
  • Any destroyed drugs must be reported on the Destruction of Drugs form and submitted monthly to PrescriptionDrugRepositoryProgram@FLHealth.gov.
    
    
• By the 5th of each month, a repository must submit to the department a summary of each Patient Application and Dispensing form obtained during the previous month.
  
  
• A donated drug may only be dispensed to an eligible patient who has submitted a Patient Application and Dispensing form and has shown the dispenser a valid prescription for such drug.
  
  
• A claim or other reimbursement from any public or private third-party payor may not be submitted for any donated drug or supply.
  
  
• Each repository must maintain records of prescription drugs and supplies that are accepted, donated, dispensed, distributed, or destroyed under the program.
  
  
• Required records must be maintained in accordance with any applicable practice act.
  
  
• All required forms must be submitted monthly to the Florida Department of Health.
  
  
• All donated drugs and supplies must be recorded on the Inventory form and kept at the repository to manage donated inventory.

Repositories must also agree to the following:  

Upon receipt of an approved donation, a licensed pharmacist employed by or under contract with a repository shall inspect the donation to ensure that each donation meets the requirements listed below:

Eligible Donated Drugs 

•  All donations must be approved by a participating repository prior to the donor shipping any drugs or supplies.

• Donations must come from eligible donors.
  
  
• Donated drug(s) must be approved for medical use in the United States.
  
  
• Drug(s) must be in unopened, tamper-evident packaging.
  
  
• Drug(s) must have been stored according to manufacturer or federal storage requirements.
  
  
• Drug(s) cannot have any physical signs of tampering or adulteration and there is no reason to believe that the drug is adulterated.
  
  
• Packaging cannot have any physical signs of tampering, misbranding, deterioration, compromised integrity, or adulteration.
  
  
• Packaging must indicate the expiration date of the drug. If the lot number is not retrievable, all specified medications must be destroyed.
  
  
• Drug(s) must have an expiration date that is more than 3 months after the date on which the drug was donated.
  
  
• Drug(s) must have been donated on the premises of the property to a person designated by the repository. A drop-box may not be used to accept a donation. Drugs may be shipped with approval from the receiving repository.
  
  
• Donated items cannot be sold or resold.

Inspection and Storage 

• Repository must quarantine a donation until the licensed pharmacist has inspected and approved drug for dispensing. A repository that has received drugs and/or supplies from another Florida repository is not required to reinspect such drugs and supplies.
  
  
• The inspecting pharmacist must sign a Donation Form verifying that the prescription drug or supply meets the criteria stated under Eligible Donated Drugs.
  
  
• Repository must store donations in a secure area under the environmental conditions specified by the manufacturer or federal storage requirements. DONATIONS MUST BE CLEARLY IDENTIFIED OR KEPT SEPARATELY FROM OTHER (non-donated repository) INVENTORY.
  
  
• Repository must maintain an inventory of donated drugs that includes:
  
  • Name of drug(s)
  • Strength
  • Available quantity
  • Expiration date of donations
  • Transaction date
  • Name, street address, and telephone number of donor

The repository must also record inventory on the Donation Form and submit by the 5th of each month. All donations received during the previous month must be included.

The Donation Form must be submitted to the Florida Rx Connects email address: PrescriptionDrugRepositoryProgram@FLHealth.gov.

Recalled Prescription Drugs 

• Repository shall establish and follow a protocol for notifying recipients/patients if a prescription drug donated under the program is recalled.
  
  
• Repository shall destroy all donated prescription drugs that are recalled, expired, or unsuitable for dispensing.
  
  
• Repository must complete a Destruction of Drugs form for all such destroyed drugs and submit each month to the Florida Department of Health.

Immunity from Liability and Disciplinary Action

Any donor of prescription drugs or supplies and any participant in the program who exercises reasonable care in donating, accepting, distributing, or dispensing prescription drugs or supplies under the program is immune from civil or criminal liability and professional disciplinary action by the state for any injury, death, or loss to person or property relating to such activities.

A pharmaceutical manufacturer who exercises reasonable care is not liable for any claim or injury arising from the donation of any prescription drug or supply under this section, including, but not limited to, liability for failure to transfer or communicate product or consumer information regarding the donated prescription drug or supply, including its expiration date.

If you would like additional information about becoming a repository, please review the Repository Application form and Rx Connects Handbook.

Questions may be sent to:

PrescriptionDrugRepositoryProgram@FLHealth.gov. Please allow at least 24 hours for a response.