Fla. Admin. Code R. 61N-2.018 (2026)

A Restricted Prescription Drug Distributor – Blood Establishment Permit is required for any establishment located in this state that collects blood and blood components only from volunteer donors as defined in Section 381.06014, F.S., or pursuant to an authorized practitioner’s order for medical treatment or therapy and engages in the wholesale distribution of a prescription drug not described in Section 499.003(48)(j), F.S., to a healthcare entity. An applicant wishing to obtain a Restricted Prescription Drug Distributor – Blood Establishment Permit as required under Section 499.01(2)(h), F.S., shall submit a complete application to the department on Form DBPR-DDC-234, Application for Restricted Prescription Drug Distributor – Blood Establishment Permit, effective December 2017, incorporated herein by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-09236, together with the appropriate fees. A copy of Form DBPR-DDC-234, Application for Restricted Prescription Drug Distributor – Blood Establishment Permit, can be obtained at https://www.myfloridalicense.com or by contacting the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, (850)717-1800.

Rulemaking Authority 499.01, 499.012, 499.041(4), 499.05 FS. Law Implemented 499.005(6), 499.0051(13), 499.01, 499.012, 499.0121, 499.041(4), 499.05, 499.051(1), 559.79 FS. History‒New 5-8-18.

Effective: 5/8/2018.