Laws and Rules

This information is provided in the most accessible format possible. To request a more accessible version of the documents on this page, please send an email to MQA_Pharmacy@doh.state.fl.us.

Laws and Rules for the Practice of Pharmacy

For Florida Statutes, you will be connected to the Florida Legislature website, which is the official custodian of the statutes. The three steps to retrieving the information you are seeking are:

1. Select the statute year from the dropdown, if it is not displayed when the page opens.
2. Choose the appropriate Title that includes your statute(s).
3. Select the statute from the listing.

• Chapter 465, Florida Statutes: Pharmacy
• Chapter 893, Florida Statutes: Drug Abuse Prevention and Control
• Chapter 456, Florida Statutes: Health Professions and Occupations: General Provisions
• Chapter 120, Florida Statutes: Administrative Procedure Act
• Chapter 499, Florida Statutes: Drug, Cosmetic, and Household Products

For Florida Administrative Code, you will be connected to the Florida Department of State, Florida Administrative Code Online website.

• Chapter 64B16, Florida Administrative Code: Board of Pharmacy
• Chapter 64F-12, Florida Administrative Code: Regulations for Drugs, Devices and Cosmetics

Laws and Rules Updates

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 is pleased to announce that changes to rule 64B16-28.850, Florida Administrative Code (doc),Special Pharmacy - ESRD, became effective on June 24, 2008.

NEW! 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.

NEW!  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.

NEW! Federal Pseudoephedrine Law (pdf - 22kb)