Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.023 - Restricted Prescription Drug Distributor Permits; Special Provisions

Current through Reg. 50, No. 138; July 16, 2024
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.