Category Archives: Pharmacy Licensing

New Law Allows Pharmacists to Diagnose and Treat Certain Medical Conditions

On March 11, 2020, Governor Ron DeSantis signed HB 389 into law. This law allows qualified pharmacists the ability to treat chronic illnesses and to test, diagnose, and treat certain minor, non-chronic illnesses.

Treatment of Chronic Illnesses

This new law creates Florida Statute § 465.1865 entitled “Collaborative Pharmacy Practice for Chronic Health Conditions.” This section sets forth the requirements for a pharmacist to treat certain chronic health conditions. Importantly, these chronic health conditions are limited to:

  • Arthritis;
  • Asthma;
  • Chronic obstructive pulmonary diseases;
  • Type 2 Diabetes;
  • Human immunodeficiency virus or acquired immune deficiency syndrome;
  • Obesity; and
  • Other chronic conditions that the Board of Pharmacy may allow by future rule making.

Fla. Stat. § 465.1865(1).

To be able to treat these chronic conditions, a pharmacist must enter into a “Collaborative Pharmacy Practice Agreement” with the patient’s licensed physician. This agreement must include:

  • The name of the patient(s) for whom a pharmacist may provide services;
  • The chronic health condition(s) to be managed;
  • The specific drugs to be managed;
  • The circumstances under which the pharmacist may order and evaluate laboratory or clinical tests;
  • The conditions upon which the pharmacist must notify the physician;
  • The beginning and end dates of the treatment; and
  • A statement that the agreement can be terminated at any time by either the pharmacist or the physician.

Fla. Stat. § 465.1865(3)(a).

Additionally, before a pharmacist can treat these chronic conditions, the pharmacists must be certified by the Board of Pharmacy. To obtain this certification, the pharmacists must:

  • Have an active pharmacy license;
  • Have a Doctor of Pharmacy or have completed five years as a licensed pharmacist;
  • Complete a 20-hour course on Collaborative Treatment of Chronic Health Conditions that is approved by the Board of Pharmacy;
  • Maintain at least $250,000 of professional liability insurance; and
  • Have an established system for keeping patient records.

Fla. Stat. § 465.1865(2).

As this law was recently passed, rulemaking has not yet begun. However, as the Board of Pharmacy promulgates rules on collaborative treatment of chronic illnesses, we will provide update with any new developments.

Treatment of Non-Chronic Health Conditions

Additionally, the new law created Florida Statute § 465.1895, which allows for the testing and treatment of minor, non-chronic health conditions by a pharmacist. Minor, non-chronic health conditions include:

  • Influenza;
  • Streptococcus;
  • Lice;
  • Certain skin conditions; and
  • Minor, uncomplicated infections.

Fla. Stat. § 465.1895(1)(a).

Much like the treatment of chronic conditions, a pharmacist who wishes to treat non-chronic, minor illnesses must do so under the supervision of a physician and pursuant to written protocol between the pharmacist and the physician. This protocol must contain:

  • The categories of patients the pharmacist s authorized to treat;
  • The physician’s instruction for obtaining relevant patient medical history;
  • The physician’s instructions for the treatment of the condition based on the patients age, symptoms, and test results; and
  • A process and schedule for the physician to review the pharmacist’s actions and for the pharmacist to notify the physician of his or her actions.

Fla. Stat. § 465.1895(5).

As rule making progresses, new requirements may be added to this list.

Finally, any pharmacist who wishes to treat minor, non-chronic health conditions must be certified by the Board of Pharmacy to do so. To obtain this certification, the pharmacist must, among other things:

  • Hold an active license to practice pharmacy in Florida;
  • Take a 20-hour board approved education course on assessing and treating minor, non-chronic health conditions;
  • Maintain at least $250,000 of liability coverage;
  • Upon request, furnish patient health care records to a health care practitioner designated by the patient; and
  • Maintain patient records for five years.

Fla. Stat. § 465.1895(2).


This new law takes effect on July 1, 2020. Right now, the Board of Pharmacy is in the beginning stages of developing rules to implement this new law. As these rules progress, we will provide any important updates.

If you are a pharmacist who would like to take advantage of this new law and have questions about how to obtain licensing, you should contact an attorney at Smith & Associates to discuss your options.

New Sterile Compounding Law to Tighten Florida’s Borders

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Beginning October 1, 2014, nonresident pharmacies and outsourcing facilities that wish to ship, mail, deliver or dispense any compounded sterile pharmaceutical drug or product into Florida will need a Nonresident Sterile Compounding Permit (NSCP) from the Florida Board of Pharmacy in addition to a Nonresident Pharmacy Permit. Previously, such nonresident pharmacies shipping compounded sterile pharmaceuticals were only required to have a Nonresident Pharmacy Permit.

A “compounded sterile product” is defined by statute as a drug that is intended for parenteral administration (e.g., intravenous), an ophthalmic or oral inhalation drug in aqueous format, or a drug or product that is required to be sterile under federal or state law or rule, which is produced through compounding, but is not approved by the U.S. Food and Drug Administration. Section 465.003(20), Florida Statutes. “Compounding” means the combining, mixing, or altering of ingredients of one or more drugs or products to create another drug or product. Section 465.003(18), Florida Statutes.

The new law, codified as section 465.0158, Florida Statutes, was enacted during the last legislative session in response to a national outbreak of fungal meningitis in 2012 that killed 64 people. Seven of the victims were in Florida. According to the Centers for Disease and Control, eight clinics in Florida received contaminated medications from unregulated, nonresident pharmacies. A bill to create tighter controls was first drafted in 2013, but was not passed into law by the Florida Legislature until the last legislative session.

The new law provides additional time to previously licensed nonresident pharmacies so they can continue doing business with Florida until a NSCP is issued. If a nonresident pharmacy was registered pursuant to section 465.0156, Florida Statutes, before October 1, 2014, then the pharmacy may continue to ship, mail, deliver or dispense a compounded sterile product into Florida without a NSCP until February 28, 2015, provided the pharmacy meets the following conditions outlined in section 465. 0158(6), F. S.:

  1. The compounded sterile product meets or exceeds the standards for sterile compounding in Florida;
  2. The product is not compounded in violation of any law or rule of the state, territory or district where the pharmacy is located; and
  3. The pharmacy is issued the new NSCP permit on or before February 28, 2015.

According to the Florida Board of Pharmacy website, NSCP applications must be received by January 15, 2015, to ensure a NSCP is issued prior to the February 28, 2015 deadline. Please note that nonresident pharmacies that became registered per section 465.0156, F. S., on or after October 1, 2014, may not enjoy the benefits of continued shipments to Florida through February 28, 2015, without a NSCP.

NSCP Licensure Requirements

To obtain a NSCP, a completed Nonresident Sterile Compounding Application (Form DH5003-MQA-9/14) and initial filing fee of $255 must be submitted to the Florida Board of Pharmacy along with the following documentation:

  1. Proof of registration as an “outsourcing facility” with the U.S. Department of Health and Human Services, if applicant meets the definition of an outsourcing facility as defined below;
  2. Proof of registration as a Nonresident Pharmacy pursuant to 465.0156, if applicant is a pharmacy;
  3. Written attestation by an owner or officer of the applicant, and by the applicant’s prescription department manager or pharmacist in charge that:
    • The attestor has read and understands the laws and rules for sterile compounding in Florida;
    • The compounded sterile product being shipped, mailed or delivered into Florida meets or exceeds Florida’s standards for sterile compounding; and
    • The compounded sterile product being shipped, mailed or delivered into Florida is not compounded in violation of the laws and rules of the state, territory or district in which the applicant is located.
  4. The applicant’s policies and procedures, which must comply with all pharmaceutical standards in Chapter 797 of the U.S. Pharmacopoeia and either the Florida Board of Pharmacy rules for sterile compounding or good manufacturing practices for an outsourcing facility.
  5. An inspection report from the regulatory or licensing agency in the state where applicant is located or, if such a report cannot be obtained, then an inspection report from a board-approved entity.

The new law will also require all nonresident outsourcing facilities to obtain a Nonresident Sterile Compounding Permit. Outsourcing facilities must obtain this new permit in addition to being registered with the Food and Drug Administration. According to section 465.003(19), Florida Statutes, an “Outsourcing facility” means a single physical location registered as an outsourcing facility under the federal Drug Quality and Security Act, Pub. L. No. 113-54, at which sterile compounding of a drug or product is conducted.

The Board of Pharmacy is authorized to discipline any pharmacy or outsourcing facility for failure to comply with the new NSCP law. Discipline may include any of the following: permit denial, revocation or suspension, fine and reprimand.

Please contact our office if you have any questions about the new Nonresident Sterile Compounding Permit or for assistance with any matter before the Florida Board of Pharmacy.

Corinne T. Porcher is a shareholder in the law firm of Smith & Associates, and has practiced in the area of health care law for over 7 years.

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