Dispensing Practitioners: Key Regulatory Elements for Florida Physicians

If you have ever wondered what is required to become a dispensing practitioner – that is, to dispense prescription drugs directly to patients from within your office – consider some of the following key regulatory elements. Under Florida Statute 465.0276, a person may not dispense medicinal drugs unless licensed as a pharmacist or otherwise authorized to do so. However, “practitioners” (e.g., physicians) are exempt from this limitation to the extent that they are authorized by law to prescribe drugs, the dispensing takes place in the regular course of their practice, and the dispensing is otherwise in compliance with section 465.0276.

Both the Florida Board of Medicine and Board of Osteopathic Medicine require dispensing physicians to comply with Florida Statute 465.0276. Under the statute, a physician who dispenses medicinal drugs for a fee or remuneration of any kind, whether direct or indirect, must comply with the following:

(a) Register with their professional licensing board as a dispensing practitioner and pay the $100 registration fee. The form can be found on the Board websites.

(b) Comply with and be subject to “all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter and chapters 499 [the “Florida Drug and Cosmetic Act”] and 893 [the “Florida Comprehensive Drug Abuse Prevention and Control Act”] and all federal laws and federal regulations.” (Part of the intent of this requirement is to ensure proper labeling, storage, and security.)

(c) Before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner's office or at any pharmacy.

(d) Before dispensing a controlled substance to a person not known to the dispenser, require the person to present valid photographic identification or other verification of his or her identity. There are limited exceptions to the photo I.D. requirement.

See Fla. Stat. Ann. § 465.0276(2)(a)-(d). Note, the registration requirement does not apply in an institutional setting or to a long-term care facility, including, but not limited to, an assisted living facility or a hospital to which patients are admitted. Likewise, the requirement does not apply to physicians that limit their activities to the dispensing of complimentary packages of medicinal drugs (i.e., samples) to their own patients in the regular course of practice, but only if they do not receive direct or indirect payment of any fee or remuneration for the drugs and if the physician themselves dispenses such drugs. Such drugs must be dispensed in the manufacturer’s labeled package with the physician’s name, patient’s name, and date dispensed, or in a container with the same information and the name and strength of drug and directions for use.

With respect to dispensing of controlled substances, registered dispensing physicians may not dispense a controlled substance listed in Schedule II or Schedule III, except this limitation does not apply to:

1. The dispensing of properly labeled complimentary packages or samples of medicinal drugs.
2. The dispensing of controlled substances in the health care system of the Department of Corrections.
3. The dispensing of a controlled substance listed in Schedule II or Schedule III in connection with the performance of a surgical procedure, subject to further limitations outlined in the statute.
4. The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial.
5. The dispensing of methadone in a facility licensed under Fla. Stat. 397.427 where medication-assisted treatment for opiate addiction is provided.
6. The dispensing of a controlled substance listed in Schedule II or Schedule III to a patient of a Florida licensed hospice facility.
7. The dispensing of controlled substances listed in Schedule II or Schedule III which have been approved by the FDA for the purpose of treating opiate addictions, including, but not limited to, buprenorphine and buprenorphine combination products, by a practitioner authorized under 21 U.S.C. 823 to the practitioner’s own patients for the medication-assisted treatment of opiate addiction.

See Fla. Stat. Ann. § 465.0276(2)(a)-(d).

With respect to physician assistants (“PA”), a supervisory physician may delegate to the PA the authority to dispense any medication used in the supervisory physician’s practice unless such medication is listed in the formulary in Rules 64B8-30.008 or 64B15-6.0038 of the Florida Administrative Code. Note, a prescribing PA may only dispense for a supervisory physician who is registered with the Board of Medicine/Board of Osteopathic Medicine as a dispensing practitioner. Delegation of this authority to the PA must also be documented with the respective Board by completing a “Physician Assistant Dispensing Notification”, available on the Board websites.

This article is non-exhaustive and not intended to provide legal advice. If you are a current dispensing practitioner, or are thinking of becoming one, take time to review the requirements and consult with your health care attorney to ensure compliant prescribing and dispensing. Please feel free to reach out to me, Michael Elkins, with any questions at michael.elkins@quarles.com or (239) 434-4908.