• Notices of Development of Proposed Rules and Negotiated Rulemaking (2)
    • The Board proposes the rule amendment to specify documents to be provided for approval of continuing education providers.
    • The purpose and effect of the proposed rule amendment will be to revise the established minimum surface water levels for Lake Como, Banana Lake, Little Lake Como, and Lake Trone in Putnam County.
  • Notices of Changes, Corrections and Withdrawals (2)
    • Standards Relating to Gross Immorality and Acts of Moral Turpitude
    • Standards for Approval of Registered Pharmacy Technician Training Programs, Standards for Approval of Courses and Providers, Continuing Education Records Requirements
  • Petitions and Dispositions Regarding Rule Variance or Waiver (5)
    • waiver of certain requirements of Rule 69K-18.004(3), FAC. The petition was filed on behalf of Stonemor Florida Subsidiary LLC, which is acquiring certain funeral establishments that are currently training agencies. Stonemor Florida Subsidiary LLC seeks a waiver such that the number of cases done by the prior owner of the funeral establishment should count against the requirement of the cited rule, so that the training agency status of the funeral establishments may be continued, thus preventing the imposition of serious hardship to the interns currently training at the said funeral establishment.
    • variance or waiver filed by Deborah Leveen. Although no specific rule is mentioned in the petition, it appears that the Petitioner is seeking a waiver or variance of Rule 64B2-13.004, Florida Administrative Code, which requires that for the purpose of renewing a license, an applicant must demonstrate to the Board that he or she participated in at least forty (40) classroom hours of continuing chiropractic education during the past two years.
    • of the issuance of an Order regarding the Petition for Variance or Waiver, filed on July 28, 2014, by Richard R. Green. The Notice of Petition for Waiver or Variance was published in Vol. 40, No. 150, of the August 4, 2014, Florida Administrative Register. Petitioner sought a variance of Rule 61J2-24.003, F.A.C., classifying his violation of Section 475.25(1)(n) and (e), Florida Statutes and Rule 62J2-2.027(2), F.A.C., to be a minor violation and allowing the violation to be reclassified as inactive.. The Commission considered the instant Petition at a duly-noticed public meeting held on August 19, 2014, in Orlando, Florida. The Commission’s Order, filed on September 17, 2014, denied the petition because the Petitioner has not demonstrated how he is substantially affected or how the purpose of the underlying statute will be or has been achieved by other means by the Petitioner. In addition, the Petitioner has not shown how application of the rule creates a substantial hardship or violates principles of fairness.
    • of the issuance of an Order regarding the Petition for Variance or Waiver, filed on June 27, 2014, by Phyllis K. Moore. The Notice of Petition for Waiver or Variance was published in Vol. 40, No. 130, of the July 7, 2014, Florida Administrative Register. Petitioner sought a waiver of the late fee for the renewal of her license, alleging that she did not receive a bill from the Department of Business and Professional Regulation. The Commission considered the instant Petition at a duly-noticed public meeting held on August 19, 2014, in Orlando, Florida. The Commission’s Order, filed on September 17, 2014, denied the petition because the Petitioner has not demonstrated how the purpose of the underlying statute will be or has been achieved by other means by the Petitioner. In addition, the Petitioner has not shown how application of the rule creates a substantial hardship or violates principles of fairness.
    • variance or waiver, filed by Richard A. Vannucci. The Petitioner seeks a waiver of the financial responsibility and stability requirements of Rule 61G4-15.006, F.A.C., so he will not be required to obtain the Construction License Irrevocable Letter of Credit. Comments on this petition should be filed with Construction Industry Licensing Board at the address below within 14 days of publication of this notice.
  • Notices of Meetings, Workshops and Public Hearings (12)
    • Title: Reply Opening and Review of Mandatory Requirements for Comprehensive Refugee Services for Refugees and Entrants in Leon County (ITN# 06K14BS1). Description: As provided for in Sections 2.5 and 2.9 of this ITN which was published to the Vendor Bid System (VBS) on July 10, 2014. The VBS can be accessed at: http://www.myflorida.com/apps/vbs/vbs_www.main_menu. The purpose of the Reply Opening and Review of Mandatory Requirements is to ensure prospective Vendors have complied with all Mandatory Requirements as required in Section 5.1 in order to be considered for selection under this ITN. ; Thursday, October 16, 2014, @4:45 p.m.; Florida Department of Children and Families 1317 Winewood Blvd. Bldg. 6, Conference Room A Tallahassee, FL 32399-0700
    • To conduct the regular business of the Agency on Bay Management; October 9, 2014, 9:00 a.m.; 4000 Gateway Centre Blvd, Suite 100, Pinellas Park, FL 33782
    • Adopted Board meeting schedule for the Tampa Bay Water Board of Directors.; 2015 Board Meetings: February 16, 2015, 9:00 a.m.; April 20, 2015, 9:00 a.m.; June 15, 2015, 9:00 a.m.; August 17, 2015, 9:00 a.m.; October 19, 2015, 9:00 a.m., and December 14, 2015, 9:00 a.m. unless otherwise set by the Board of Directors.; Tampa Bay Water Administrative Offices, 2575 Enterprise Road, Clearwater, FL 33763.
    • Discuss Incubator Policies & Procedures and the EDA Process.; Monday, 10/06/14 at 8:30 a.m.; 412 West Orange Street, Room 102 Wauchula, Florida 33873
    • The North Florida Broadband Authority (NFBA) Board of Directors announces that a regular monthly meeting will be held on Wednesday, September 17, 2014, and all interested persons are invited. The NFBA is a public body created by Interlocal Agreement pursuant to Section 163.01, Florida Statutes. The Board will address general policy and operational matters of the NFBA.; Monday, September 29, 2014, 10:00 a.m.; City Hall, 205 N. Marion Ave., Lake City, FL 32055
    • General baord business.; Friday, October 31, 2014, commencing at 8:30 a.m.; Rosen Plaza - 9700 International Drive, Orlando, FL 32819.
    • The South Florida Water Management District will be accepting public comments on the 2014 update of the existing Allapattah Flats Management Area Land Management Plan. The draft Management Plan is available for review at www.sfwmd.gov/land.; October 6, 2014, 5:00 PM; South Florida Water Management District, Auditorium 3301 Gun Club Road West Palm Beach, FL 33406
    • The workshop will be held to solicit comments and suggestions from interested persons relative to Florida Housing’s proposed Request for Applications (RFAs) 2014-114 - Housing Credit Financing for Affordable Housing Developments Located in Medium and Small Counties and 2014-115 - Housing Credit Financing for Affordable Housing Developments Located in Large Counties. The call-in information is posted on the Florida Housing websites http://www.floridahousing.org/Developers/MultiFamilyPrograms/Competitive/2014-114/ and http://www.floridahousing.org/Developers/MultiFamilyPrograms/Competitive/2014-115/ .; October 23, 2014, 1:30 p.m., Eastern Time; The workshop will be available by telephone or interested parties may attend in person at Florida Housing’s offices located at 227 N. Bronough Street, Seltzer Room, Suite 6000, Tallahassee, Florida.
    • Rules associated with the implementation of House Bill 7077, Non-Resident Sterile Compounding Permit & Application, Rule 64B16-27.700, and old business.; Monday, October 6, 2014, 2:00p.m.; Embassy Suites South - LBV, 4955 Kyngs Heath Road, Kissimmee, FL 34746, (407) 597-4000.
    • The quarterly meeting of the Wekiva River Basin Commission.; October 30, 2014, 2:30 p.m.; Wekiva Island, 1000 Miami Springs Road, Barr Education Center Meeting Room, Longwood, Florida 32779
    • New Business: Rule 64B16-27.410, Rule 64B16-28.303, Rule 64B16-27.104; Old Business: 64b16-27.210, Rule 64b16-27.320, Rule 64B16-27.800, and Rule 64B16-27.851.; Tuesday, October 7, 2014, 9:00a.m.; Embassy Suites South - LBV, 4955 Kyngs Heath Road, Kissimmee, FL 34746, (407) 597-4000.
    • EMS Advisory Council conference call meeting.; October 23, 2014, 10:00 a.m.; Teleconference: dial (toll free) 1 (877) 309-2070; access code: 140-873-365; audio PIN: shown after joining the meeting.
  • Notices of Petitions and Dispositions Regarding Declaratory Stat (1)
    • Michael J. Glazer, Ausley McMullen, Post Office Box 391, 123 South Calhoun Street, Tallahassee, Florida 32301, on behalf of H.D. Smith Wholesale Drug Company.; The Petitioner is substantially affected by the statutes and rules cited in paragraphs 11A-G above and has standing to seek a declaratory statement from the department. The Department is authorized to enforce the provisions of Chapter 499, Florida Statutes, and the administrative rules adopted pursuant to the statute. Prior to November 27, 2013, the provisions of Chapter 499, Florida Statutes and of the Florida Administrative Code cited in paragraphs 11A-G above, were interpreted by the Department to require a prescription drug pedigree to be provided by the wholesale distributor prior to or simultaneously with the distribution of a prescription drug; the pedigree had to include the information enumerated in the statute; the pedigree paper had to be authenticated in one or more of the ways set forth in Rule 61N-1.013(5)(d); electronic pedigrees had to be authenticated according to that rule; if a pedigree could not be authenticated, the prescription drugs had to be quarantined and the Department notified; returns of drugs from a pharmacy, health care entity or licensed health care practitioner that were the result of a mistake in ordering or shipment need not be included in a pedigree; returns not in that category had to be included in a pedigree and had to otherwise comply with paragraph 61N-1.012(3)(f), Florida Administrative Code. Effective November 27, 2013, the Drug Quality and Security Act (DQSA) was signed into law. The Act is comprised of Title I, the Compounding Quality Act, and Title II, the Drug Supply Chain Security Act. The DQSA Title II requires a uniform national system for tracking and tracing prescription drugs through the supply chain, and a uniform licensing system for prescription drug wholesale distributors, repackagers, and third party logistics providers. The Act applies to human finished dosage forms of prescription drugs only. The DQSA contains preemption language regarding tracking and tracing prescription drugs through the supply chain and regarding licensing of prescription drug manufacturers, wholesale distributors, and third party logistics providers. Currently, wholesale distributors are still required to obtain a permit from the Department to operate in this state, and to be in compliance with federal law. See, Sections 582-585, Drug Quality and Security Act. The preemption language in Section 585 of the Act as cited in paragraph 12 above, makes it clear that states may not establish or continue in effect any requirement for tracing products through the distribution system (including any requirement with respect to statements of distribution history, transaction history, transaction information, or transaction statement of a product as the product changes ownership in the supply chain, or verification, investigation, disposition, notification or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 503(e) (as amended by such Act). The Department has previously taken the position that the Florida pedigree requirements are preempted by the federal law. See, Declaratory Statement, In Re Petition for Declaratory Statement, Publix Supermarkets, Inc., Petitioner, Declaratory Statement Case Number DS2014-007. The DQSA does not have any specific references to or provisions requiring authentication. The Department takes the position that the Florida requirements for authentication are inconsistent with, more stringent than or in addition to the requirements in the amended federal law, and are preempted. With respect to returns, the provisions of the DQSA categorizes returns from dispensers and those from a wholesale distributor differently, and requires no transaction history, transaction statement, or transaction information for most returns. By contrast, the Florida provisions on returns require information to be included in a pedigree except in limited circumstances set forth in Florida Administrative Code paragraph 61N-1.012(3)(f). Because the provisions for returns under Florida law are inconsistent with, and more stringent than, the provisions in the DQSA, those provisions are preempted as well. The amended federal tracking and tracing requirements become effective January 1, 2015. The Department has previously taken the position that in the interim period before the effective date of the tracking and tracing requirements of the provisions of the DQSA, current federal minimum standards for wholesale distribution of prescription drugs, set forth in 21 C.F.R. §203, the Prescription Drug Marketing Act (PDMA), are applicable, and states may enforce those requirements of the PDMA. See, Declaratory Statement, In Re Petition for Declaratory Statement, Publix Supermarkets, Inc., Petitioner, Declaratory Statement Case Number DS2014-007. However, Petitioner asserts that it is an authorized distributor of record, and the PDMA, by its terms, does not address requirements for documenting the movement of prescription drugs for those in Petitioner’s status as an authorized distributor of record. In addition, the PDMA does not address returns of prescription drug product. It is not clear how Petitioner is to handle tracking and tracing requirements for distributions or returns in the interim period. While Petitioner implies that the grandfathering product provision of the DQSA operates retroactively to govern Petitioner’s distributions that occur prior to January 1, 2015, the Department cannot address the applicability of the DQSA provisions to Petitioner’s facts. However, as discussed above, the Department will not pursue administrative enforcement action against Petitioner if Petitioner does not comply with pedigree, authentication and returns requirements. Accordingly, applying the foregoing to Petitioner’s facts, Petitioner’s request for a declaratory statement is answered as follows: A. The Department will not pursue an administrative enforcement action against HDS if HDS does not comply with the pedigree and authentication requirements of Section 499.01212, Florida Statutes, and Rule 61N-1.013, Florida Administrative Code. B. The Department will not pursue an administrative enforcement action against HDS if HDS does not comply with the return requirements set forth in Florida Administrative Code Rule 61N-1.012. C. Nothing herein shall be construed as affecting or negating requirements of federal law for wholesale distribution of prescription drugs as such requirements apply to Petitioner.