NEW! The Board of Pharmacy is pleased to announce that changes to rule 64B16-27.700, Florida Administrative Code, Definition of compounding, became effective on October 7, 2008.
NEW! The Board of Pharmacy approved the following rule drafts for rule development at its August 13, 2008 meeting.
64B16-26.203 (pdf - 26kb), Florida Administrative Code, Licensure by Examination, Foreign Pharmacy Graduates
64B16-28.140 (pdf - 135kb), Florida Administrative Code, Record Maintenance
64B16-27.410 (pdf - 73kb), Florida Administrative Code, Pharmacy Technician to Pharmacist Ratio
The Board of Pharmacy is pleased to announce that changes to rule 64B16-28.850, Florida Administrative Code (doc), Special Pharmacy - ESRD, became effective on June 24, 2008.
The Board of Pharmacy is pleased to announce that rule 64B16-27.797, Florida Administrative Code (doc), Standards of Practice for Compounding Sterile Preparations – (CSPs), became effective on Wednesday, June 18, 2008.
June 2008 Rule Report (pdf - 53kb)
The Board of Pharmacy is pleased to announce that rule developments for rules 64B16-26.203 (pdf - 13kb) and 64B16-26.204 (pdf - 15kb), Florida Administrative Code were filed with the Bureau of Administrative Code on June 13, 2008, for publication in the Florida Administrative Weekly on June 27, 2008.
The Board of Pharmacy is pleased to announce that rule 64B-3.005 (doc), Florida Administrative Code, Counterfeit-resistant Prescription Blanks for Controlled Substance Prescribing, will become effective on June 26, 2008. A summary of the rule is provided below for your information.
This rule was developed as a result of the passage of HB 1155 during the 2007 legislative session. A summary of the rule is below.
- Provides that a prescribing practitioner may use a counterfeit-resistant prescription drug blank when writing hard copy prescription(s) for controlled substances in schedules II, III, and IV of Section 893, Florida Statutes.
- Provides that the counterfeit resistant prescription blank must contain the following security features:
- The background color must be green or blue and resist reproduction.
- The blank must be printed on watermarked paper.
- The blank must resist erasures and alterations.
- The word ‘void” or “illegal” must appear on any photocopy or reproduction, however the word “void” or “illegal” shall not obstruct or render illegible any portion of the drug name, quantity or directions for use.
- Provides that the counterfeit-resistant prescription blank contain the following information:
- The preprinted name, address, and category of professional licensure of the prescribing practitioner.
- A space for the prescribing practitioner’s federal Drug Enforcement Administration registration number for controlled substances.
- Provides that the counterfeit-resistant prescription blank is nontransferable and shall not be used by anyone other than the authorized prescriber.
Reporting of Serious Adverse Events Associated with OTC Human Drug Products and Dietary Supplements
Public Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, was signed by President George Bush on December 22, 2006. Public Law 109-462 amends the Federal Food, Drug, and Cosmetic Act (the Act) to add safety reporting requirements for OTC drug products that are marketed without an approved application under section 505 of the Act (21 U.S.C. 355): http://www.fda.gov/cder/regulatory/public_law_109462.pdf. (PDF) These reporting requirements become effective December 22, 2007.
Nonprescription Drug Products
- Guidance to Industry for reporting post-marketing serious adverse events associated with nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application. This document provides guidance on:
- the minimum data elements that should be included in a serious adverse event report using MedWatch Form 3500A
- the label that should be included with the report
- reporting formats for paper and electronic submissions, and
- how and where to submit the reports.
- Additional information on adverse event reporting requirements which apply to the manufacturers, packers, and distributors of over-the-counter (OTC) or behind-the-counter (BTC) products
Dietary Supplements
DEA’s Final Ruling on “Issuance of Multiple Prescriptions for Schedule II Controlled Substances, Effective December 19, 2007(pdf - 151kb)
Podiatric Physician Residents’ Prescriptive Authority(pdf - 11kb) |
