Application for Restricted Prescription Drug Distributor – Blood Establishment Permit  

  •  

    DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

    Drugs, Devices and Cosmetics

    RULE NO.:RULE TITLE:

    61N-2.018Application for Restricted Prescription Drug Distributor – Blood Establishment Permit

    NOTICE OF CHANGE

    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 244, December 20, 2017 issue of the Florida Administrative Register.

    Summaries of Substantive Changes to Form DBPR-DDC-234 and Rule 61N-2.018 are as follows:

    Form DBPR-DDC-234:

    The department has revised the form to reflect December 2017, as the effective date to correspond with the established effective date set forth in proposed rule 61N-2.018, F.A.C.

    On page 1, pursuant to subparagraph 499.041(4), F.S., “the department shall assess an applicant that is required to have a restricted prescription drug distributor permit an annual fee of not less than $200 or more than $300”.  Further, pursuant to subparagraph 499.012(5)(a), F.S., “the department shall adopt rules for the biennial renewal of permits; Fees for such renewal may exceed the fees caps set forth in s. 499.041 on an annualized basis as authorized by law”. Therefore, the department has added the word “biennial” between “nonrefundable” and “fee” in the Application Requirements section of the form to denote that the fee is a biennial fee as authorized pursuant to subparagraphs 499.041(4) and 4989.012(5)(a), F.S.

    On page 1, the form provided reference to subparagraph “499.012(4)(a)f.” regarding use of social security numbers in the “Please Note” section of the form. The reference citation was incomplete and has been amended to reflect the complete citation of subparagraph 499.012(4)(a)5.f, Florida Statutes.

    On page 1, the department provided citation to subparagraph 499.63(2), Florida Statutes, as authority for the agency’s use of social security numbers. This provision is applicable only to ether establishments regulated pursuant to Part II of Chapter 499, F.S., and is not applicable to Restricted Prescription Drug Distributors regulated pursuant to Part I of Chapter 499, F.S.  Therefore, the department has removed the citation to subparagraph 499.63(2), Florida Statutes.

    On page 7, the department has revised the form to amend the explanatory parenthetical in question number one. of the “Background Questions” section to reflect “defined above” instead of “defined below”.

     

    61N-2.018 Application for Restricted Prescription Drug Distributor – Blood Establishment Permit:

    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, Florida Statutes,  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), Florida Statutes,  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), Florida Statutes, 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, https://www.flrules.org/gateway/reference.asp?no=Ref-XXXXX, 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, 499.012499.04(4), 499.05 FS. Law Implemented 499.01, 499.012, 499.0121, 499.041(4), 499.05, 559.79 FS. History‒New __________.

Document Information

Related Rules: (1)
61N-2.018.