61N-1.023. Restricted Prescription Drug Distributor Permits; Special Provisions

The following Restricted Prescription (Rx) Drug Distributor permits will be issued by the department:

(1) Restricted Rx Drug Distributor – Charitable Organization. This permit is required for a charitable organization to authorize the possession or transfer of prescription drugs, including prescription drug samples. A charitable institution which is otherwise licensed to use, administer, or dispense prescription drugs and which does not distribute or transfer prescription drugs is not required to obtain this permit.

(a) Transfers authorized by this permit are limited to nonprofit affiliates of the permittee authorized to possess prescription drugs, exports to charitable organizations in other countries in compliance with applicable federal and state exportation laws, and the daily transfer to a Florida licensed practitioner authorized to administer or dispense for the purpose of administering or dispensing the prescription drug to patients of the charitable organization with the daily return by the practitioner to the charitable organization permittee of the unused prescription drugs.

(b) Each Restricted Rx Drug Distributor – Charitable Organization permittee shall comply with the following procedures for soliciting and receiving donated prescription drugs, including samples:

1. An identification document shall be provided to any employee or agent authorized to act on behalf of the permittee in soliciting or receiving donations of prescription drugs. The identification document must be in a form which prevents alteration and shall be valid for a limited term. At a minimum it must identify the expiration date; the name, address, FDA central file number, if adopted by the FDA, and state license or permit number of the charitable organization; exhibit the name, signature, and photograph of the authorized employee or agent; and an affirmative statement that the person identified on the document is authorized by the institution to solicit and receive donations of prescription drugs on behalf of the permittee. Upon termination of these responsibilities by the employee or agent or expiration of the identification document, the document must be returned to the permittee for destruction.

2. Maintain a current listing of all employees or agents authorized to solicit and receive prescription drugs on behalf of the permittee.

3. A permittee may only receive a donated prescription drug in its original, unopened packaging with its labeling intact.

(c) The charitable organization may transfer prescription drugs on a daily basis to a Florida licensed medical practitioner providing services to patients of the charitable organization on behalf of the charitable organization. If the practitioner leaves the charitable organization establishment with prescription drugs of the charitable organization, a record documenting the daily transfer to the practitioner must be prepared as well as a record of the prescription drugs administered or dispensed and the prescription drugs returned by the practitioner to the charitable organization upon completion of providing services for the charitable organization on that date.

(2) Restricted Rx Drug Distributor – Health Care Entity. This permit is required for a hospital or health care entity as defined in Section 499.003(15), F.S., for the limited purpose of transferring prescription drugs among hospitals or other health care entities that are (1) under common control as provided in Section 499.012(1)(a)3., F.S.; or (2) members of a group purchasing organization as provided for in Section 499.012(1)(a)1., F.S. For the purpose of this permit and transfers thereunder, an independent contractor cannot be under “common control” as defined in Section 499.012(1)(a)3., F.S. Transfers are limited to a facility under common control or member of the group purchasing organization, either of which must be licensed with a pharmacy permit that authorizes the acquisition and possession of prescription drugs. This permit also authorizes a warehouse or purchasing depot of a university to transfer prescription drugs to practitioner or non-practitioner researchers for university sponsored research conducted in accordance with Section 240.241, F.S. All requirements of paragraph (6) of this rule related to the Restricted Rx Drug Distributor – Institutional Research permit must be complied with for transfers under this provision.

(3) Restricted Rx Drug Distributor – Reverse Distributor. This permit is required for persons engaged in the handling, processing and removal of expired or otherwise adulterated or unsuitable prescription drugs on behalf of licensed pharmacies, practitioners, wholesalers, or other persons authorized to possess prescription drugs, hereafter referred to as the “owner establishment” for return to the manufacturer or source of the prescription drug or for destruction. This permit authorizes the reverse distribution of prescription drugs removed from the owner establishment to the manufacturer or source or to a person authorized to arrange for destruction of prescription drugs. This permit is not required if a person only performs the service of processing prescription drugs (preparing the inventory) for return or destruction and does not physically remove any prescription drugs from the owner establishment. A Restricted Rx Drug Distributor – Reverse Distributor permit cannot be issued to the same address or to an address adjacent to a prescription drug wholesaler or prescription drug manufacturer.

(a) As a part of the audit trail and documentation required by Rule 61N-1.012, F.A.C., records must identify at a minimum the name of the prescription drug product and whether it is a prescription drug sample, the manufacturer, and the quantity for each prescription drug removed from the establishment. The NDC code may be used to identify the manufacturer. For partially filled containers, the quantity at a minimum must be estimated.

(b) If the reverse distributor sends prescription drugs to any establishment other than to the manufacturer, that establishment must be authorized to receive adulterated prescription drugs for reverse distribution or destruction purposes. Once a prescription drug has been accepted by a reverse distributor for processing, it cannot be returned to the owner establishment without the written approval of the department.

(c) If a reverse distributor also arranges for the destruction of prescription drugs, dual permitting as a Restricted Rx Drug Distributor – Destruction is not required; however, the reverse distributor must follow all requirements of the Restricted Rx Drug Distributor – Destruction permittee prescribed by subsection (4) of this section.

(d) In addition to the requirements included here, Controlled Substances must be handled in accordance with D.E.A. provisions. If any conflict exists between D.E.A. provisions and those enumerated herein, the D.E.A. provisions must be followed.

(4) Restricted Rx Drug Distributor – Destruction. This permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction; other than the manufacturer of that drug or a permitted Restricted Rx Drug Distributor – Reverse Distributor. This includes persons transporting prescription drugs to a destruction facility or to a warehouse awaiting destruction, and persons warehousing prescription drugs prior to destruction. Common carriers are not required to obtain this permit, however, contract or private carriers must obtain this permit prior to obtaining possession of the prescription drugs in Florida. A destruction facility (such as a landfill or incineration facility) is not required to obtain this permit if the prescription drugs are destroyed immediately upon receipt. This permit is not required if a person only performs the service of processing prescription drugs (preparing the inventory) for destruction and does not physically remove any prescription drug products from an establishment. A Restricted Rx Drug Distributor – Destruction permit cannot be issued to the same address or to an address adjacent to a prescription drug wholesaler or prescription drug manufacturer.

(a) A Restricted Rx Drug Distributor – Destruction permittee that warehouses or stores prescription drugs prior to destruction must meet the security requirements of a prescription drug wholesaler as enumerated in Section 499.0121(1)(b), F.S., and subsections 61N-1.013(1) and (2), F.A.C., but is not required to meet temperature storage requirements.

(b) As a part of the audit trail and documentation required by Rule 61N-1.012, F.A.C., records, must identify, at a minimum, the name of the product to be destroyed and whether it is a prescription drug sample, the manufacturer, and the quantity for each prescription drug to be destroyed. The NDC code may be used to identify the manufacturer. For partially filled containers, the quantity, at a minimum, must be estimated. Records are required for each transfer of prescription drugs until the drugs have been destroyed.

(c) A Certificate of Destruction must be received from the facility responsible for the ultimate destruction or incineration of the prescription drugs. This certificate shall provide the weight of the prescription drugs destroyed, the manner of destruction, and the time, date and location of the destruction. The Certificate of Destruction must be attached to the records containing the elements set forth in subsection (4)(b) which details the prescription drugs destroyed.

(d) In addition to the requirements included here, Controlled Substances must be handled in accordance with D.E.A. provisions. If any conflict exists between D.E.A. provisions and those enumerated herein, the D.E.A. provisions must be followed.

(e) In addition to the requirements included here, transporting, storage, and destruction of prescription drugs are also regulated by federal, state and local environmental agencies.

(5) Restricted Rx Drug Distributor – Government Programs. This permit is required for a state or local government agency, or any entity eligible to purchase prescription drugs at public health services prices pursuant to section 602, PL 102-585, hereafter “the entity,” to distribute its prescription drugs to a contract provider or its subcontractor for administering or dispensing to eligible patients of the entity under the eligible program. A prescription drug distributed under this permit may not be sold or transferred for reimbursement or payment of any kind.

(a) The applicant must submit to the department a detailed plan justifying the necessity for this permit which demonstrates that the transfer of a prescription drug under this subsection will enhance the public’s health by improving access, quality, or safety because current drug delivery systems to reach patients of the entity are inadequate. The department will issue the Restricted Rx Drug Distributor – Government Programs permit if the intended distribution enhances accessibility, quality, or safety as set forth in the previous sentence for patients in Florida and does not endanger public health, safety and welfare. To assess the ongoing need for an entity to hold a Restricted Rx Drug Distributor – Government Programs permit, the bureau will periodically request information from the permit holder regarding continued justification under this subsection and may specifically consider inadequate accountability or monitoring as endangering public health, safety and welfare.

(b) The entity must monitor the prescription drugs transferred under this permit. Discrepancies must be investigated and reported by the entity to the bureau.

(6) Restricted Rx Drug Distributor – Institutional Research. This permit is required for a licensed pharmacy of a university to transfer prescription drugs to practitioner or non-practitioner researchers for university sponsored research conducted in accordance with Section 240.241, F.S.

(a) A non-practitioner recipient researcher is not required to obtain an exemption letter pursuant to subsection 61N-1.011(4), F.A.C., if the researcher and research activities are located on the university campus. However, if the researcher is not located on the university campus and the drug is not stored on the university campus, then an exemption letter is required prior to the transfer of any prescription drugs to the researcher.

(b) The Restricted Rx Drug Distributor – Institutional Research permit holder must maintain records that include at a minimum, the researcher; specific research project/grant number; location in which the research is done and/or storage location of the prescription drug and the researcher’s exemption number if applicable; and the name, strength, dosage form, and quantity of the drug transferred to the researcher. The researcher’s DEA number is also required if a controlled substance has been transferred to the researcher. The researcher must sign for the prescription drug with an acknowledgement that the drug cannot be sold, traded or transferred to anyone not directly involved in the specific research project for which the drug was obtained. If the permit holder is a pharmacy, these records must be maintained separate from the pharmacy dispensing records.

(c) The recipient researcher must maintain security over any prescription drugs and adequate recordkeeping to account for disposition of all prescription drugs received.

(d) The university must designate an individual responsible for periodic monitoring of the distributions under this permit. Such monitoring must include, but is not limited to, unannounced inspections and reconciliation of the inventory of prescription drugs in the researcher’s possession and records of prescription drugs used by university researchers. Discrepancies must be investigated and corrective action implemented as indicated.

Rulemaking Authority 499.014, 499.05 FS. Law Implemented 499.01, 499.012, 499.0121, 499.014 FS. History–New 7-1-96, Formerly 10D-45.059, Amended 1-26-99, 4-17-01, Formerly 64F-12.023.