Fla. Admin. Code Ann. R. 64J-4.004 - Donated Drug Inspection and Recordkeeping

(1) The inspecting pharmacist must complete DH9008-EPCS-07/2021 "Donation Form", which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13987, which verifies that the donor and prescription drug or supply meets the criteria of Section 465.1902(5) and (6), F.S., and must attach the Donation Form to the inventory required in subsection (3), below.

(2) A repository that receives prescription drugs or supplies from another repository is not required to reinspect such drugs or supplies.

(3) A repository must maintain a physical or electronic inventory of donations, the transaction date, and donor information as required in DH9010-EPCS-12/2021 "Repository Inventory Form", which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13988.

(4) In the event that controlled substances are mistakenly received by a repository and it is not possible or practicable to return the controlled substances to the donor, such abandoned controlled substances must be documented and destroyed beyond reclamation pursuant to Rule 64B16-28.303, F.A.C. (04/2014), which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-13989.

(5) A repository must maintain a physical or electronic record of all drug Donation and Transfer forms and submit copies of all forms for the previous month to the Department of Health by email at PrescriptionDrugDonationProgram@FLHealth.gov or mail to DOH Bureau of Public Health Pharmacy, Drug Donation Program, 104-2 Hamilton Park Dr., Tallahassee, FL 32304 by the 5th day of each month.

Notes

Fla. Admin. Code Ann. R. 64J-4.004

Rulemaking Authority 465.1902(7)(b), (13) FS. Law Implemented 465.1902 FS.

Adopted by Florida Register Volume 48, Number 021, February 1, 2022 effective 2/13/2022.

New 2-13-22.