64B16-32.015. Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities

(1) Designation as Prescription Department Manager.

(a) Initial Designation. Pursuant to Sections 465.018, 465.0197, and 465.022, F.S., a permit for a community or internet pharmacy may not be issued unless a licensed pharmacist is designated as the prescription department manager. Designation is accomplished as part of the application for a Community Pharmacy Permit, utilizing Form DH-MQA 1214, Community Pharmacy Permit Application and Information, incorporated in Rule 64B16-28.100, F.A.C., or as part of the application for an Internet Pharmacy Permit, utilizing Form DH-MQA 1220, Special Pharmacy Permit Application and Information, incorporated in Rule 64B16-28.100, F.A.C.

(b) Change of prescription department manager. No later than ten (10) days after a change of designated prescription department manager for a community pharmacy, or thirty (30) days for an internet pharmacy, both the pharmacy Permittee and the newly designated prescription department manager shall notify the Board of the change and the identity of the newly designated prescription department manager. Notification shall be accomplished by completing Form DOH/MQA/PH10, 12/16, Change of Prescription Department Manager, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-07929, the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or the Board's website at http://floridaspharmacy.gov/Applications/app-change-perscription-dept-manager.pdf.

(c) Submission of Fingerprints. In addition to submission of Form DOH/MQA/PH10, the newly designated prescription department manager shall comply with the fingerprinting requirements of Sections 456.0135 and 465.022, F.S. This paragraph does not apply to persons fingerprinted pursuant to these statutes on or after July 1, 2013.

(2) Responsibilities of Prescription Department Managers. Prescription department managers are responsible for ensuring the pharmacy permittee’s compliance with all statutes and rules governing the practice of the profession of pharmacy, including maintenance of all drug records and ensuring the security of the prescription department, and shall competently and diligently exercise their responsibilities as a prescription department manager.

(3) All community and internet pharmacy Permittees shall continuously maintain a designated prescription department manager at all times the pharmacy is open and in operation.

(4) Pursuant to Section 465.022(11)(b), F.S., a registered pharmacist may not serve as prescription department manager at more than one pharmacy location unless otherwise approved by the Board.

Rulemaking Authority 465.005, 465.0155, 465.022(1), (10) FS. Law Implemented 456.0135, 465.018(2), 465.0197(1), (3)(b), 465.022(2), (3), (10), (11) FS. History–New 3-9-17, Formerly 64B16-27.450.