The 2023 Florida Statutes (including Special Session C)

Title XXXII
REGULATION OF PROFESSIONS AND OCCUPATIONS

Chapter 465
PHARMACY

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F.S. 465.003

465.003 Definitions.—As used in this chapter, the term:

(1) “Acute and postacute hospital care at home” means acute and postacute health care services provided in a clinically qualified patient’s permanent residence, as defined in s. 196.012(17), through a program approved by the Centers for Medicare and Medicaid Services and the Agency for Health Care Administration.

(2) “Administration” means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption.

(3) “Automated pharmacy system” means a mechanical system that delivers prescription drugs received from a Florida licensed pharmacy and maintains related transaction information.

(4) “Board” means the Board of Pharmacy.

(5) “Central distribution facility” means a facility under common control with a hospital holding a Class III institutional pharmacy permit that may dispense, distribute, compound, or fill prescriptions for medicinal drugs; prepare prepackaged drug products; and conduct other pharmaceutical services.

(6) “Centralized prescription filling” means the filling of a prescription by one pharmacy upon request by another pharmacy to fill or refill the prescription. The term includes the performance by one pharmacy for another pharmacy of other pharmacy duties such as drug utilization review, therapeutic drug utilization review, claims adjudication, and the obtaining of refill authorizations.

(7) “Common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise.

(8) “Compounded sterile product” means a drug that is intended for parenteral administration, 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 United States Food and Drug Administration.

(9) “Compounding” means combining, mixing, or altering the ingredients of one or more drugs or products to create another drug or product.

(10) “Consultant pharmacist” means a pharmacist licensed by the department and certified as a consultant pharmacist pursuant to s. 465.0125.

(11) “Data communication device” means an electronic device that receives electronic information from one source and transmits or routes it to another, including, but not limited to, any such bridge, router, switch, or gateway.

(12) “Department” means the Department of Health.

(13) “Dispense” means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription order for potential adverse reactions, interactions, and dosage regimen she or he deems appropriate in the exercise of her or his professional judgment, and the pharmacist shall certify that the medicinal drug called for by the prescription is ready for transfer. The pharmacist shall also provide counseling on proper drug usage, either orally or in writing, if in the exercise of her or his professional judgment counseling is necessary. The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration shall not be considered dispensing.

(14) “Institutional formulary system” means a method whereby the medical staff evaluates, appraises, and selects those medicinal drugs or proprietary preparations which in the medical staff’s clinical judgment are most useful in patient care, and which are available for dispensing by a practicing pharmacist in a Class II or Class III institutional pharmacy.

(15) “Medicinal drugs” or “drugs” means those substances or preparations commonly known as “prescription” or “legend” drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined.

(16) “Nuclear pharmacist” means a pharmacist licensed by the department and certified as a nuclear pharmacist pursuant to s. 465.0126.

(17) “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.

(18) “Patent or proprietary preparation” means a medicine in its unbroken, original package which is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof and which is not misbranded under the provisions of the Florida Drug and Cosmetic Act.

(19) “Pharmacist” means any person licensed pursuant to this chapter to practice the profession of pharmacy.

(20)(a) “Pharmacy” includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy.

1. The term “community pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis.

2. The term “institutional pharmacy” includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as “health care institutions,” where medicinal drugs are compounded, dispensed, stored, or sold.

3. The term “nuclear pharmacy” includes every location where radioactive drugs and chemicals within the classification of medicinal drugs are compounded, dispensed, stored, or sold. The term “nuclear pharmacy” does not include hospitals licensed under chapter 395 or the nuclear medicine facilities of such hospitals.

4. The term “special pharmacy” includes every location where medicinal drugs are compounded, dispensed, stored, or sold if such locations are not otherwise defined in this subsection.

5. The term “Internet pharmacy” includes locations not otherwise licensed or issued a permit under this chapter, within or outside this state, which use the Internet to communicate with or obtain information from consumers in this state and use such communication or information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. Any act described in this definition constitutes the practice of the profession of pharmacy.

(b) The pharmacy department of any permittee shall be considered closed whenever a Florida licensed pharmacist is not present and on duty. The term “not present and on duty” shall not be construed to prevent a pharmacist from exiting the prescription department for the purposes of consulting or responding to inquiries or providing assistance to patients or customers, attending to personal hygiene needs, or performing any other function for which the pharmacist is responsible, provided that such activities are conducted in a manner consistent with the pharmacist’s responsibility to provide pharmacy services.

(21) “Pharmacy intern” means a person who is currently registered in, and attending, a duly accredited college or school of pharmacy, or who is a graduate of such a school or college of pharmacy, and who is duly and properly registered with the department as provided for under its rules.

(22) “Practice of the profession of pharmacy” includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and conducting other pharmaceutical services. For purposes of this subsection, the term “other pharmaceutical services” means monitoring the patient’s drug therapy and assisting the patient in the management of his or her drug therapy, and includes reviewing, and making recommendations regarding, the patient’s drug therapy and health care status in communication with the patient’s prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or a similar statutory provision in another jurisdiction, or such provider’s agent or such other persons as specifically authorized by the patient; and initiating, modifying, or discontinuing drug therapy for a chronic health condition under a collaborative pharmacy practice agreement. This subsection may not be interpreted to permit an alteration of a prescriber’s directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law or specifically authorized by s. 465.1865 or s. 465.1895. The term “practice of the profession of pharmacy” also includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. The practice of the profession of pharmacy also includes the administration of vaccines to adults pursuant to s. 465.189; the testing or screening for and treatment of minor, nonchronic health conditions pursuant to s. 465.1895; and the preparation of prepackaged drug products in facilities holding Class III institutional pharmacy permits. The term also includes the ordering and evaluating of any laboratory or clinical testing; conducting patient assessments; and modifying, discontinuing, or administering medicinal drugs pursuant to s. 465.0125 by a consultant pharmacist.

(23) “Prescription” includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. The term also includes an orally transmitted order by the lawfully designated agent of such practitioner. The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of her or his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. The term “prescription” also includes a pharmacist’s order for a product selected from the formulary created pursuant to s. 465.186. Prescriptions may be retained in written form or the pharmacist may cause them to be recorded in a data processing system, provided that such order can be produced in printed form upon lawful request.

History.—ss. 1, 7, ch. 79-226; s. 322, ch. 81-259; ss. 14, 15, ch. 81-302; ss. 2, 3, ch. 81-318; ss. 1, 2, ch. 82-179; s. 1, ch. 83-101; s. 36, ch. 83-216; s. 3, ch. 83-265; s. 29, ch. 83-329; s. 1, ch. 85-35; ss. 2, 26, 27, ch. 86-256; s. 1, ch. 88-172; s. 1, ch. 89-77; s. 59, ch. 91-137; s. 6, ch. 91-156; s. 4, ch. 91-429; s. 123, ch. 94-218; s. 239, ch. 97-103; s. 87, ch. 97-264; s. 118, ch. 99-397; s. 1, ch. 2002-182; s. 1, ch. 2004-25; s. 1, ch. 2004-387; s. 2, ch. 2007-152; s. 2, ch. 2012-60; s. 1, ch. 2014-148; s. 1, ch. 2018-95; s. 2, ch. 2020-7; s. 1, ch. 2020-8; s. 3, ch. 2022-35.

F.S. 465.003 on Google Scholar

F.S. 465.003 on Casetext

Amendments to 465.003

Arrestable Offenses / Crimes under Fla. Stat. 465.003

Level: Degree
Misdemeanor/Felony: First/Second/Third

Current data shows no reason an arrest or criminal charge should have occurred directly under Florida Statute 465.003.

Annotations, Discussions, Cases:

Cases from cite.case.law:

CINCINNATI INSURANCE COMPANY, v. QUORUM MANAGEMENT CORP. a k a J. a s o s s, 186 F. Supp. 3d 1307 (M.D. Fla. 2016)

. . . . § 465.003(10), (11). . . . Stat. § 465.003(13). . . . act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003 . . . commercially available products”, as used in this section, means any medicinal product as defined by Sections 465.003 . . .

MOORE, v. STATE, 172 So. 3d 491 (Fla. Dist. Ct. App. 2015)

. . . Unlike selling, dispensing as defined by section 465.003(6), Florida Statutes, can only apply to a pharmacist . . . pharmacist excludes his actions in this case from the statutory definitions of “dispense” found in 465.003 . . .

OLECKNA, v. DAYTONA DISCOUNT PHARMACY,, 162 So. 3d 178 (Fla. Dist. Ct. App. 2015)

. . . Section 465.003(6), Florida Statutes (2011), provides that [a]s an element of dispensing, the pharmacist . . .

RAMIREZ, v. STATE, 125 So. 3d 171 (Fla. Dist. Ct. App. 2013)

. . . This extension derives from sections 465.003(6) and 893.04(2)(a), Florida Statutes (2009), which allow . . . See § 465.003(6), Fla. . . .

UNITED STATES v. FRANCK S LAB, INC., 816 F. Supp. 2d 1209 (M.D. Fla. 2011)

. . . . § 465.003(13) (" ‘Practice of the profession of pharmacy’ includes compounding, dispensing, and consulting . . . and conferring upon the Board the duty to regulate the practice of pharmacy within the state); id. § 465.003 . . .

RODRIGUEZ v. STATE, 67 So. 3d 326 (Fla. Dist. Ct. App. 2011)

. . . . § 465.003(6), Fla. Stat. (2005) # (emphasis added). . . . This blatantly ignores the language of section 465.003(6) which requires that a pharmacist transfer the . . .

McCOY, v. STATE, 56 So. 3d 37 (Fla. Dist. Ct. App. 2010)

. . . Pursuant to section 465.003(6), Florida Statutes (2008), pharmacies may lawfully dispense medications . . .

B. DIRGA, v. A. BUTLER, M. D., 39 So. 3d 388 (Fla. Dist. Ct. App. 2010)

. . . For example, section 465.003(13), Florida Statutes (2003) refers to health care providers specifically . . .

ESTATE OF J. JOHNSON, JOHNSON, v. BADGER ACQUISITION OF TAMPA LLC,, 983 So. 2d 1175 (Fla. Dist. Ct. App. 2008)

. . . .” § 465.003(3), Fla. Stat. (2001). . . . Further, section 465.003(13) mandates that “nothing in this subsection may be interpreted to permit an . . . See § 465.003(13), Fla. Stat. (2001). . . .

FONTANEZ, v. PARENTERAL THERAPY ASSOCIATES, INC., 974 So. 2d 1101 (Fla. Dist. Ct. App. 2007)

. . . act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003 . . . commercially available products,” as used in this section, means any medicinal products as defined by Sections 465.003 . . .

O HARA, v. STATE, 964 So. 2d 839 (Fla. Dist. Ct. App. 2007)

. . . subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003 . . . Of those listed statutes, section 465.003(8), Florida Statutes (2004), provides the simplest definition . . . the State dismisses the possibility that the statute we discussed in the preceding paragraph, section 465.003 . . .

DENT, v. DENNIS PHARMACY, INC., 924 So. 2d 927 (Fla. Dist. Ct. App. 2006)

. . . Code R. 64B16-27.820(l)(d), (e) (2006); § 465.003(6), Fla. Stat. (2005). . . .

POWERS, v. H. THOBHANI, M. D. B. A. L. d b a, 903 So. 2d 275 (Fla. Dist. Ct. App. 2005)

. . . According to § 465.003(6), Fla. . . .

CITY OF ST. PETERSBURG, v. AUSTRINO, 898 So. 2d 955 (Fla. Dist. Ct. App. 2005)

. . . .” § 465.003(14). . . .

ESTATE OF P. MASSAD, WILSON, v. GRANZOW B., 886 So. 2d 1050 (Fla. Dist. Ct. App. 2004)

. . . (c) [t]o sell or dispense drugs as defined in s. 465.003(8) without first being furnished with a prescription . . .

W. SULLIVAN, D. C. v. DEPARTMENT OF HEALTH, BOARD OF CHIROPRACTIC MEDICINE,, 885 So. 2d 873 (Fla. Dist. Ct. App. 2004)

. . . Section 465.003(8) provides: “Medicinal drugs” or “drugs” means those substances or preparations commonly . . . subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003 . . .

NL INDUSTRIES, INC. v. COMMERCIAL UNION INS. COS. COMMERCIAL UNION INS. COS. v. CERTAIN UNDERWRITERS AT LLOYD S, NL INDUSTRIES, INC. v. CERTAIN UNDERWRITERS AT LLOYD S,, 938 F. Supp. 248 (D.N.J. 1996)

. . . . § 465.003 et seq. (reduction of use of toxic substances and hazardous waste generation); Or.St. . . .

H. JOHNSON, v. WALGREEN CO., 675 So. 2d 1036 (Fla. Dist. Ct. App. 1996)

. . . that a 1986 amendment to the definition of “dispense” in the Florida Pharmacy Act, codified at section 465.003 . . . language is apparently of first impression in this state; therefore, we must determine whether section 465.003 . . . intended to create a private cause of action under these circumstances, and the language of section 465.003 . . .

NL INDUSTRIES, INC. v. COMMERCIAL UNION INS. COS. COMMERCIAL UNION INS. COS. v. CERTAIN UNDERWRITERS AT LLOYD S, NL INDUSTRIES, INC. v. CERTAIN UNDERWRITERS AT LLOYD S,, 926 F. Supp. 1213 (D.N.J. 1996)

. . . . § 465.003 et seq. (reduction of use of toxic substances and hazardous waste generation); Or.St. . . .

McDONALD S CORPORATION, a v. WILSON, WILSON v. MOBIL OIL CORPORATION, a, 814 F. Supp. 935 (D. Or. 1993)

. . . This action was brought pursuant to ORS 465.003, et seq. . . .

DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF PHARMACY v. GOLDSTEIN CENTER PHARMACY, 28 Fla. Supp. 2d 224 (Fla. Div. Admin. Hearings 1987)

. . . Tylenol #3 with Codeine and APAP with Codeine 30mg are “medicinal drugs” as defined in Section 465.003 . . . Tylenol #4 with Codeine and APAP with Codeine 60mg are “medicinal drugs” as defined in Section 465.003 . . . Fiorinal #3 with Codeine is a “medicinal drug” as defined in Section 465.003(7), Florida Statutes, which . . . Valium is a brand name of a “medicinal drug” as defined in Section 465.003(7), Florida Statutes, which . . . Tylenol #3 with Codeine is a brand name of a “medicinal drug” as defined in Section 465.003(7), Florida . . .

FEDERGO DISCOUNT CENTER, v. DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF PHARMACY,, 452 So. 2d 1063 (Fla. Dist. Ct. App. 1984)

. . . See § 465.003(3)(a), Fla.Stat. (1981). . . . .

BLOCK, v. STATE, 437 So. 2d 792 (Fla. Dist. Ct. App. 1983)

. . . reads as follows: (2) It is unlawful for any person: (c) To sell or dispense drugs as defined in s. 465.003 . . . 465.015(2)(c), the state had to prove the drug which appellant sold was among those defined in section 465.003 . . . Section 465.003(7) contains the following definition: (7) “Medicinal drugs” or “drugs” means those substances . . .