The Florida Senate

“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.

“Board” means the Board of Pharmacy.

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

“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.

“Department” means the Department of Health.

“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.

“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 institutional pharmacy.

“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.

“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.

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

“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.

“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 other pharmaceutical services. For purposes of this subsection, “other pharmaceutical services” means the monitoring of the patient’s drug therapy and assisting the patient in the management of his or her drug therapy, and includes review of the patient’s drug therapy and communication with the patient’s prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or similar statutory provision in another jurisdiction, or such provider’s agent or such other persons as specifically authorized by the patient, regarding the drug therapy. However, nothing in this subsection may 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. “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 influenza virus immunizations to adults pursuant to s. 465.189.

“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.

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

“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.

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

The Board of Pharmacy is created within the department and shall consist of nine members to be appointed by the Governor and confirmed by the Senate.

Seven members of the board must be licensed pharmacists who are residents of this state and who have been engaged in the practice of the profession of pharmacy in this state for at least 4 years and, to the extent practicable, represent the various pharmacy practice settings. Of the pharmacist members, one must be currently engaged in the practice of pharmacy in a community pharmacy, one must be currently engaged in the practice of pharmacy in a Class II institutional pharmacy or a Modified Class II institutional pharmacy, and five shall be pharmacists licensed in this state irrespective of practice setting. The remaining two members must be residents of the state who have never been licensed as pharmacists and who are in no way connected with the practice of the profession of pharmacy. No person may be appointed as a consumer member who is in any way connected with a drug manufacturer or wholesaler. At least one member of the board must be 60 years of age or older.

As the terms of the members expire, the Governor shall appoint successors for terms of 4 years, and such members shall serve until their successors are appointed.

All provisions of chapter 456 relating to activities of the board shall apply.

Any person desiring to be licensed as a pharmacist shall apply to the department to take the licensure examination. The department shall examine each applicant who the board certifies has:

The department may permit an applicant who has satisfied all requirements of subsection (1), except those relating to age or the internship program, to take the written examination, but the passing of the examination shall confer no rights or privileges upon the applicant in connection with the practice of pharmacy in this state.

Except as provided in subsection (2), the department shall issue a license to practice pharmacy to any applicant who successfully completes the examination in accordance with this section.

The department shall issue a license by endorsement to any applicant who applies to the department and remits a nonrefundable fee of not more than $100, as set by the board, and whom the board certifies:

An applicant licensed in another state for a period in excess of 2 years from the date of application for licensure in this state shall submit a total of at least 30 hours of board-approved continuing education for the 2 calendar years immediately preceding application.

The department may not issue a license by endorsement to any applicant who is under investigation in any jurisdiction for an act or offense that would constitute a violation of this chapter until the investigation is complete, at which time the provisions of s. 465.016 apply.

The department may not issue a license by endorsement to any applicant whose license to practice pharmacy has been suspended or revoked in another state or who is currently the subject of any disciplinary proceeding in another state.

The department shall renew a license upon receipt of the renewal application, verification of compliance with s. 465.009, and receipt of a fee set by the board not to exceed $250.

The department shall adopt rules establishing a procedure for the biennial renewal of licenses.

Any person licensed under this chapter for 50 years or more is exempt from the payment of the renewal or delinquent fee, and the department shall issue a lifetime license to such a person.

No license renewal shall be issued by the department until the licensee submits proof satisfactory to the board that during the 2 years prior to her or his application for renewal the licensee has participated in not less than 30 hours of continuing professional pharmaceutical education in courses approved by the board.

The board shall approve only those courses that build upon the basic courses offered in the curricula of accredited colleges or schools of pharmacy, and the board shall require that the provider meets the educational standards for the program design, administration, and evaluation established by the board.

Upon initial licensure, the department may reduce the number of required hours consistent with the requirements of biennial renewal.

The department may make exception from the requirements of this section in an emergency or hardship case.

The board may adopt rules within the requirements of this section that are necessary for its implementation, including a rule creating a committee composed of equal representation from the board, the colleges of pharmacy in the state, and practicing pharmacists within the state, whose purpose shall be to approve the content of each course offered for continuing education credit prior to the time such course is offered.

The board shall prescribe by rule continuing education requirements as a condition of reactivating a license. The continuing education requirements for reactivating a license shall be at least 15 classroom hours for each year the license was inactive in addition to completion of the number of hours required for renewal on the date the license became inactive.

The board shall adopt rules relating to application procedures for inactive status, to the biennial renewal of inactive licenses, and to the reactivation of licenses. The board shall prescribe by rule an application fee for inactive status, a renewal fee for inactive status, a delinquency fee, and a fee for the reactivation of a license. None of these fees may exceed the biennial renewal fee established by the board for an active license. The department may not reactivate a license unless the inactive or delinquent licensee has paid any applicable biennial renewal or delinquency fee, or both, and a reactivation fee.

The department shall issue or renew a consultant pharmacist license upon receipt of an initial or renewal application which conforms to the requirements for consultant pharmacist initial licensure or renewal as promulgated by the board by rule and a fee set by the board not to exceed $250. The consultant pharmacist shall be responsible for maintaining all drug records required by law and for establishing drug handling procedures for the safe handling and storage of drugs. The consultant pharmacist may also be responsible for ordering and evaluating any laboratory or clinical testing when, in the judgment of the consultant pharmacist, such activity is necessary for the proper performance of the consultant pharmacist’s responsibilities. Such laboratory or clinical testing may be ordered only with regard to patients residing in a nursing home facility, and then only when authorized by the medical director of the nursing home facility. The consultant pharmacist must have completed such additional training and demonstrate such additional qualifications in the practice of institutional pharmacy as shall be required by the board in addition to licensure as a registered pharmacist.

Notwithstanding the provisions of subsection (1), a consultant pharmacist or a doctor of pharmacy licensed in this state may also be responsible for ordering and evaluating any laboratory or clinical testing for persons under the care of a licensed home health agency when, in the judgment of the consultant pharmacist or doctor of pharmacy, such activity is necessary for the proper performance of his or her responsibilities and only when authorized by a practitioner licensed under chapter 458, chapter 459, chapter 461, or chapter 466. In order for the consultant pharmacist or doctor of pharmacy to qualify and accept this authority, he or she must receive 3 hours of continuing education relating to laboratory and clinical testing as established by the board.

The board shall promulgate rules necessary to implement and administer this section.

A person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of pharmacy, except that a licensed pharmacist may delegate to pharmacy technicians who are registered pursuant to this section those duties, tasks, and functions that do not fall within the purview of s. 465.003(13). All such delegated acts shall be performed under the direct supervision of a licensed pharmacist who shall be responsible for all such acts performed by persons under his or her supervision. A pharmacy registered technician, under the supervision of a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests. A licensed pharmacist may not supervise more than one registered pharmacy technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one but not more than three pharmacy technicians.

Any person who wishes to work as a pharmacy technician in this state must register by filing an application with the board on a form adopted by rule of the board. The board shall register each applicant who has remitted a registration fee set by the board, not to exceed $50 biennially; has completed the application form and remitted a nonrefundable application fee set by the board, not to exceed $50; is at least 17 years of age; and has completed a pharmacy technician training program approved by the Board of Pharmacy. Notwithstanding any requirements in this subsection, any registered pharmacy technician registered pursuant to this section before January 1, 2011, who has worked as a pharmacy technician for a minimum of 1,500 hours under the supervision of a licensed pharmacist or received certification as a pharmacy technician by certification program accredited by the National Commission for Certifying Agencies is exempt from the requirement to complete an initial training program for purposes of registration as required by this subsection.

A person whose license to practice pharmacy has been denied, suspended, or restricted for disciplinary purposes is not eligible to register as a pharmacy technician.

Notwithstanding the requirements of this section or any other provision of law, a pharmacy technician student who is enrolled in a pharmacy technician training program that is approved by the board may be placed in a pharmacy for the purpose of obtaining practical training. A pharmacy technician student shall wear identification that indicates his or her student status when performing the functions of a pharmacy technician, and registration under this section is not required.

Notwithstanding the requirements of this section or any other provision of law, a person who is licensed by the state as a pharmacy intern may be employed as a registered pharmacy technician without paying a registration fee or filing an application with the board to register as a pharmacy technician.

As a condition of registration renewal, a registered pharmacy technician shall complete 20 hours biennially of continuing education courses approved by the board or the Accreditation Council for Pharmacy Education, of which 4 hours must be via live presentation and 2 hours must be related to the prevention of medication errors and pharmacy law.

The board shall adopt rules that require each registration issued by the board under this section to be displayed in such a manner as to make it available to the public and to facilitate inspection by the department. The board may adopt other rules as necessary to administer this section.

If the board finds that an applicant for registration as a pharmacy technician or that a registered pharmacy technician has committed an act that constitutes grounds for discipline as set forth in s. 456.072(1) or has committed an act that constitutes grounds for denial of a license or disciplinary action as set forth in this chapter, including an act that constitutes a substantial violation of s. 456.072(1) or a violation of this chapter which occurred before the applicant or registrant was registered as a pharmacy technician, the board may enter an order imposing any of the penalties specified in s. 456.072(2) against the applicant or registrant.

It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have charge of, either alone or with another person or persons, a pharmacy:

It is unlawful for any person:

Any person who violates any provision of subsection (1) or subsection (3) commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083. Any person who violates any provision of subsection (2) commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. In any warrant, information, or indictment, it shall not be necessary to negative any exceptions, and the burden of any exception shall be upon the defendant.

Any pharmacy which is located outside this state and which ships, mails, or delivers, in any manner, a dispensed medicinal drug into this state shall be considered a nonresident pharmacy, shall be registered with the board, shall provide pharmacy services at a high level of protection and competence, and shall disclose to the board the following specific information:

Applications for nonresident pharmacy registration under this section shall be made on a form furnished by the board. The board may require such information as the board deems reasonably necessary to carry out the purposes of this section. The board may grant an exemption from the registration requirements of this section to any nonresident pharmacy which confines its dispensing activity to isolated transactions. The board may define by rule the term isolated transactions.

The registration fee and the biennial renewal fee shall be the fee specified in s. 465.022.

The board may deny, revoke, or suspend registration of, or fine or reprimand, a nonresident pharmacy for failure to comply with s. 465.025 or with any requirement of this section in accordance with the provisions of this chapter.

In addition to the prohibitions of subsection (4) the board may deny, revoke, or suspend registration of, or fine or reprimand, a nonresident pharmacy in accordance with the provisions of this chapter for conduct which causes serious bodily injury or serious psychological injury to a resident of this state if the board has referred the matter to the regulatory or licensing agency in the state in which the pharmacy is located and the regulatory or licensing agency fails to investigate within 180 days of the referral.

It is unlawful for any nonresident pharmacy which is not registered pursuant to this section to advertise its services in this state, or for any person who is a resident of this state to advertise the pharmacy services of a nonresident pharmacy which has not registered with the board, with the knowledge that the advertisement will or is likely to induce members of the public in this state to use the pharmacy to fill prescriptions.

This section does not apply to Internet pharmacies required to be permitted under s. 465.0197.

Notwithstanding s. 465.003(10), for purposes of this section, the registered pharmacy and the pharmacist designated by the registered pharmacy as the prescription department manager or the equivalent must be licensed in the state of location in order to dispense into this state.

The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):

The board may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or who is found guilty of violating any provision of s. 456.072(1).

The board shall not reinstate the license of a pharmacist, or cause a license to be issued to a person it has deemed unqualified, until such time as it is satisfied that she or he has complied with all the terms and conditions set forth in the final order and that such person is capable of safely engaging in the practice of pharmacy.

The board shall by rule establish guidelines for the disposition of disciplinary cases involving specific types of violations. Such guidelines may include minimum and maximum fines, periods of supervision or probation, or conditions of probation or reissuance of a license.

Duly authorized agents and employees of the department shall have the power to inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician’s office, or any other place in the state in which drugs and medical supplies are manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for the purpose of:

Any institution desiring to operate an institutional pharmacy shall apply to the department. If the board certifies that the application complies with the laws of the state and the rules of the board governing pharmacies, the department shall issue the permit.

The following classes of institutional pharmacies are established:

Medicinal drugs shall be stocked, stored, compounded, dispensed, or administered in any health care institution only when that institution has secured an institutional pharmacy permit from the department.

Medicinal drugs shall be dispensed in an institutional pharmacy to outpatients only when that institution has secured a community pharmacy permit from the department. However, an individual licensed to prescribe medicinal drugs in this state may dispense up to a 24-hour supply of a medicinal drug to any patient of an emergency department of a hospital that operates a Class II institutional pharmacy, provided that the physician treating the patient in such hospital’s emergency department determines that the medicinal drug is warranted and that community pharmacy services are not readily accessible, geographically or otherwise, to the patient. Such dispensing from the emergency department must be in accordance with the procedures of the hospital. For any such patient for whom a medicinal drug is warranted for a period to exceed 24 hours, an individual licensed to prescribe such drug must dispense a 24-hour supply of such drug to the patient and must provide the patient with a prescription for such drug for use after the initial 24-hour period. The board may adopt rules necessary to carry out the provisions of this subsection.

All institutional pharmacies shall be under the professional supervision of a consultant pharmacist, and the compounding and dispensing of medicinal drugs shall be done only by a licensed pharmacist. Every institutional pharmacy that employs or otherwise uses registered pharmacy technicians shall have a written policy and procedures manual specifying those duties, tasks, and functions that a registered pharmacy technician is allowed to perform.

In a Class II institutional pharmacy, an institutional formulary system may be adopted with approval of the medical staff for the purpose of identifying those medicinal drugs and proprietary preparations that may be dispensed by the pharmacists employed in such institution. A facility with a Class II institutional permit which is operating under the formulary system shall establish policies and procedures for the development of the system in accordance with the joint standards of the American Hospital Association and American Society of Hospital Pharmacists for the utilization of a hospital formulary system, which formulary shall be approved by the medical staff.

Any person desiring a permit to operate an Internet pharmacy shall apply to the department for an Internet pharmacy permit. If the board certifies that the application complies with the applicable laws and rules of the board governing the practice of the profession of pharmacy, the department shall issue the permit. A permit may not be issued unless a licensed pharmacist is designated as the prescription department manager for dispensing medicinal drugs to persons in this state. The licensed pharmacist shall be responsible for maintaining all drug records and for providing for the security of the area in the facility in which the compounding, storing, and dispensing of medicinal drugs to persons in this state occurs. The permittee shall notify the department within 30 days after any change of the licensed pharmacist responsible for such duties. A permittee that employs or otherwise uses registered pharmacy technicians shall have a written policy and procedures manual specifying those duties, tasks, and functions that a registered pharmacy technician is allowed to perform.

An Internet pharmacy must obtain a permit under this section to sell medicinal drugs to persons in this state.

An Internet pharmacy shall provide pharmacy services at a high level of protection and competence and shall disclose to the board the following specific information:

Notwithstanding s. 465.003(10), for purposes of this section, the Internet pharmacy and the pharmacist designated by the Internet pharmacy as the prescription department manager or the equivalent must be licensed in the state of location in order to dispense into this state.

The board shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter. Such rules shall include, but shall not be limited to, rules relating to:

A pharmacy permit shall be issued only to a person who is at least 18 years of age, a partnership whose partners are all at least 18 years of age, or to a corporation that is registered pursuant to chapter 607 or chapter 617 whose officers, directors, and shareholders are at least 18 years of age.

Any person, partnership, or corporation before engaging in the operation of a pharmacy shall file with the board a sworn application on forms provided by the department.

The department or board shall deny an application for a pharmacy permit if the applicant or an affiliated person, partner, officer, director, or prescription department manager of the applicant has:

After the application has been filed with the board and the permit fee provided in this section has been received, the board shall cause the application to be fully investigated, both as to the qualifications of the applicant and the prescription department manager or consultant pharmacist designated to be in charge and as to the premises and location described in the application.

The Board of Pharmacy shall have the authority to determine whether a bona fide transfer of ownership is present and that the sale of a pharmacy is not being accomplished for the purpose of avoiding an administrative prosecution.

Upon the completion of the investigation of an application, the board shall approve or disapprove the application. If approved, the permit shall be issued by the department.

Permits issued by the department are not transferable.

The board shall set the fees for the following:

The department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under s. 465.022(3), has:

If a pharmacy permit is revoked or suspended, the owner, manager, or proprietor shall cease to operate the establishment as a pharmacy as of the effective date of such suspension or revocation. In the event of such revocation or suspension, the owner, manager, or proprietor shall remove from the premises all signs and symbols identifying the premises as a pharmacy. The period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed 1 year. In the event that the permit is revoked, the person owning or operating the establishment shall not be entitled to make application for a permit to operate a pharmacy for a period of 1 year from the date of such revocation. Upon the effective date of such revocation, the permittee shall advise the Board of Pharmacy of the disposition of the medicinal drugs located on the premises. Such disposition shall be subject to continuing supervision and approval by the Board of Pharmacy.

A pharmacy may provide pharmacy services to a long-term care facility or hospice licensed under chapter 400 or chapter 429 or a state correctional institution operated under chapter 944 through the use of an automated pharmacy system that need not be located at the same location as the pharmacy.

Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy providing pharmacy services to that facility, hospice, or institution, and drugs delivered by the automated pharmacy system are considered to have been dispensed by that pharmacy.

The operation of an automated pharmacy system must be under the supervision of a Florida-licensed pharmacist. To qualify as a supervisor for an automated pharmacy system, the pharmacist need not be physically present at the site of the automated pharmacy system and may supervise the system electronically. The Florida-licensed pharmacist shall be required to develop and implement policies and procedures designed to verify that the medicinal drugs delivered by the automated dispensing system are accurate and valid and that the machine is properly restocked.

The Legislature does not intend this section to limit the current practice of pharmacy in this state. This section is intended to allow automated pharmacy systems to enhance the ability of a pharmacist to provide pharmacy services in locations that do not employ a full-time pharmacist. This section does not limit or replace the use of a consultant pharmacist.

The board shall adopt rules governing the use of an automated pharmacy system by January 1, 2005, which must specify:

It is declared that the unrestricted use of certain controlled substances, causing abnormal reactions that may interfere with the user’s physical reflexes and judgments, may create hazardous circumstances which may cause accidents to the user and to others, thereby affecting the public health, safety, and welfare. It is further declared to be in the public interest to limit the means of promoting the sale and use of these drugs. All provisions of this section shall be liberally construed to carry out these objectives and purposes.

No pharmacist, owner, or employee of a retail drug establishment shall use any communication media to promote or advertise the use or sale of any controlled substance appearing in any schedule in chapter 893.

This section shall not prohibit the advertising of any medicinal drugs, other than those controlled substances specified in chapter 893, or any patent or proprietary preparation, provided the advertising is not false, misleading, or deceptive.

As used in this section:

A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is:

unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber’s overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary.

Each pharmacist shall maintain a record of any substitution of a generically equivalent drug product for a prescribed brand name drug as provided in this section.

Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. This formulary shall be revised following each addition, deletion, or modification of said formulary.

The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary of generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication.

Every community pharmacy shall display in a prominent place that is in clear and unobstructed public view, at or near the place where prescriptions are dispensed, a sign in block letters not less than 1 inch in height which shall read: “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW.”

The standard of care to be applied to the acts of any pharmacist performing professional services in compliance with this section when a substitution is made by said pharmacist shall be that which would apply to the performance of professional services in the dispensing of a prescription order prescribing a drug by generic name. In no event when a pharmacist substitutes a drug shall the prescriber be liable in any action for loss, damage, injury, or death to any person occasioned by or arising from the use or nonuse of the substituted drug, unless the original drug was incorrectly prescribed.

The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug product is “A” rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration.

Nothing in this act shall alter or amend s. 465.025 as to existing law providing for the authority of physicians to prohibit generic drug substitution by writing “medically necessary” on the prescription.

The manufacturer, repackager, or other distributor of any medicinal drug shall display the expiration date of each drug in a readable fashion on the container and on its packaging. The term “readable” means conspicuous and bold.

Each pharmacist for a community pharmacy dispensing medicinal drugs and each practitioner dispensing medicinal drugs on an outpatient basis shall display on the outside of the container of each medicinal drug dispensed, or in other written form delivered to the purchaser:

The dispensing pharmacist or practitioner must provide information concerning the expiration date to the purchaser upon request and must provide appropriate instructions regarding the proper use and storage of the drug.

This section does not impose liability on the dispensing pharmacist or practitioner for damages related to, or caused by, a medicinal drug that loses its effectiveness prior to the expiration date displayed by the dispensing pharmacist or practitioner.

The provisions of this section are intended to notify the patient receiving a medicinal drug of the information required by this section, and the dispensing pharmacist or practitioner shall not be liable for the patient’s failure to heed such notice or to follow the instructions for storage.

Prior to dispensing any transferred prescription, the dispensing pharmacist must, either verbally or by any electronic means, do all of the following:

Upon receipt of a prescription transfer request, if the pharmacist is satisfied in her or his professional judgment that the request is valid, or if the request has been validated by any electronic means, the pharmacist or pharmacy must do all of the following:

If a transferred prescription is not dispensed within a reasonable time, the pharmacist shall, by any means, so notify the transferring pharmacy. Such notice shall serve to revalidate the canceled prescription. The pharmacist who has served such notice shall then cancel the prescription in the same manner as set forth in paragraph (2)(c).

In the case of a prescription to be transferred from or to a pharmacy located in another state, it shall be the responsibility of the pharmacist or pharmacy located in the State of Florida to verify, whether by electronic means or otherwise, that the person or entity involved in the transfer is a licensed pharmacist or pharmacy in the other state.

Electronic transfers of prescriptions are permitted regardless of whether the transferor or transferee pharmacy is open for business.

The transfer of a prescription for medicinal drugs listed in Schedules III, IV, and V appearing in chapter 893 for the purpose of refill dispensing is permissible, subject to the requirements of this section and federal law. Compliance with federal law shall be deemed compliance with the requirements of this section.

A pharmacy licensed under this chapter may perform centralized prescription filling for another pharmacy, provided that the pharmacies have the same owner or have a written contract specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which the pharmacies will comply with federal and state laws, rules, and regulations.

Each pharmacy performing or contracting for the performance of centralized prescription filling pursuant to this section must maintain a policy and procedures manual, which shall be made available to the board or its agent upon request. The policy and procedures manual shall include the following information:

The filling, delivery, and return of a prescription by one pharmacy for another pursuant to this section shall not be construed as the filling of a transferred prescription as set forth in s. 465.026 or as a wholesale distribution as set forth in s. 499.003(54).

The board shall adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to implement this section.

All pharmacies involved in the transactions pursuant to which the prescription is dispensed are under common ownership and utilize a common database.

All pharmacies involved in the transactions pursuant to which the prescription is dispensed and all pharmacists engaging in dispensing functions are properly licensed, permitted, or registered in this state or another state.

The common database maintains a record of all pharmacists involved in the process of dispensing a prescription.

The owner of the common database maintains a policy and procedures manual that governs its participating pharmacies, pharmacists, and pharmacy employees and that is available to the board or its agent upon request. The policy and procedures manual shall include the following information:

The prescription is not for a medicinal drug listed in Schedule II appearing in chapter 893.

The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition.

In the pharmacist’s professional judgment, the interruption of therapy might reasonably produce undesirable health consequences or may cause physical or mental discomfort.

The dispensing pharmacist creates a written order containing all of the prescription information required by this chapter and chapters 499 and 893 and signs that order.

The dispensing pharmacist notifies the prescriber of the emergency dispensing within a reasonable time after such dispensing.

A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind, whether direct or indirect, must:

The department shall inspect any facility where a practitioner dispenses medicinal drugs pursuant to subsection (2) in the same manner and with the same frequency as it inspects pharmacies for the purpose of determining whether the practitioner is in compliance with all statutes and rules applicable to her or his dispensing practice.

The registration of any practitioner who has been found by her or his respective board to have dispensed medicinal drugs in violation of this chapter shall be subject to suspension or revocation.

A practitioner who confines her or his activities to the dispensing of complimentary packages of medicinal drugs to the practitioner’s own patients in the regular course of her or his practice, without the payment of fee or remuneration of any kind, whether direct or indirect, and who herself or himself dispenses such drugs is not required to register pursuant to this section. The practitioner must dispense such drugs in the manufacturer’s labeled package with the practitioner’s name, patient’s name, and date dispensed, or, if such drugs are not dispensed in the manufacturer’s labeled package, they must be dispensed in a container which bears the following information:

Notwithstanding any other provision of this chapter, it is lawful for a pharmacy to dispense medicinal drugs, including controlled substances authorized under subsection (2), based on reception of an electronic facsimile of the original prescription if all of the following conditions are met:

Controlled substances listed in Schedule II as defined in s. 893.03(2) may be dispensed as provided in this section to the extent allowed by 21 C.F.R. s. 1306.11.

It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement in any form whatsoever with any physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a pharmacy registered under this chapter.

The department shall adopt rules which assess administrative penalties for acts prohibited by subsection (1). In the case of an entity licensed by the department, such penalties may include any disciplinary action available to the department under the appropriate licensing laws. In the case of an entity not licensed by the department, such penalties may include:

There is hereby created a committee composed of two members of the Board of Medicine licensed under chapter 458 chosen by said board, one member of the Board of Osteopathic Medicine licensed under chapter 459 chosen by said board, three members of the Board of Pharmacy licensed under this chapter and chosen by said board, and one additional person with a background in health care or pharmacology chosen by the committee. The committee shall establish a formulary of medicinal drug products and dispensing procedures which shall be used by a pharmacist when ordering and dispensing such drug products to the public. Dispensing procedures may include matters related to reception of patient, description of his or her condition, patient interview, patient physician referral, product selection, and dispensing and use limitations. In developing the formulary of medicinal drug products, the committee may include products falling within the following categories:

However, any drug which is sold as an over-the-counter proprietary drug under federal law shall not be included in the formulary or otherwise affected by this section.

The Board of Pharmacy, the Board of Medicine, and the Board of Osteopathic Medicine shall adopt by rule a formulary of medicinal drugs and dispensing procedures as established by the committee. A pharmacist may order and dispense a product from the formulary pursuant to the established dispensing procedure, as adopted by the boards, for each drug in conjunction with its inclusion in the formulary. Any drug product ordered by a pharmacist shall be selected and dispensed only by the pharmacist so ordering, and said order shall not be refilled, nor shall another medicinal drug be ordered for the same condition unless such act is consistent with dispensing procedures established by the committee. Appropriate referral to another health care provider is indicated under such circumstances. On each occasion of such dispensing, the pharmacist shall create and maintain a prescription record in the form required by law.

Affixed to the container containing a medicinal drug dispensed pursuant to this section shall be a label bearing the following information:

Any pharmacist performing the services authorized by this section shall be eligible for reimbursement by third party prescription programs when so provided by contract or when otherwise provided by such program.

Any person ordering or dispensing medicinal drugs in violation of this section shall be guilty of a misdemeanor of the first degree, and such violation shall be punishable as provided in s. 775.082 or s. 775.083.

Notwithstanding any other law, when an audit of the Medicaid-related records of a pharmacy licensed under chapter 465 is conducted, such audit must be conducted as provided in this section.

The Agency for Health Care Administration shall establish a process under which a pharmacist may obtain a preliminary review of an audit report and may appeal an unfavorable audit report without the necessity of obtaining legal counsel. The preliminary review and appeal may be conducted by an ad hoc peer review panel, appointed by the agency, which consists of pharmacists who maintain an active practice. If, following the preliminary review, the agency or review panel finds that an unfavorable audit report is unsubstantiated, the agency shall dismiss the audit report without the necessity of any further proceedings.

This section does not apply to investigative audits conducted by the Medicaid Fraud Control Unit of the Department of Legal Affairs.

This section does not apply to any investigative audit conducted by the Agency for Health Care Administration when the agency has reliable evidence that the claim that is the subject of the audit involves fraud, willful misrepresentation, or abuse under the Medicaid program.

Pharmacists may administer influenza virus immunizations to adults within the framework of an established protocol under a supervisory practitioner who is a physician licensed under chapter 458 or chapter 459. Each protocol shall contain specific procedures for addressing any unforeseen allergic reaction to influenza virus immunizations.

A pharmacist may not enter into a protocol unless he or she maintains at least $200,000 of professional liability insurance and has completed training in influenza virus immunizations as provided in this section.

A pharmacist administering influenza virus immunizations shall maintain and make available patient records using the same standards for confidentiality and maintenance of such records as those that are imposed on health care practitioners under s. 456.057. These records shall be maintained for a minimum of 5 years.

The decision by a supervisory practitioner to enter into a protocol under this section is a professional decision on the part of the practitioner, and a person may not interfere with a supervisory practitioner’s decision as to entering into such a protocol. A pharmacist may not enter into a protocol that is to be performed while acting as an employee without the written approval of the owner of the pharmacy. Pharmacists shall forward immunization records to the department for inclusion in the state registry of immunization information.

Any pharmacist seeking to administer influenza virus immunizations to adults under this section must be certified to administer influenza virus immunizations pursuant to a certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and the Board of Osteopathic Medicine. The certification program shall, at a minimum, require that the pharmacist attend at least 20 hours of continuing education classes approved by the board. The program shall have a curriculum of instruction concerning the safe and effective administration of influenza virus immunizations, including, but not limited to, potential allergic reactions to influenza virus immunizations.

The written protocol between the pharmacist and supervising physician must include particular terms and conditions imposed by the supervising physician upon the pharmacist relating to the administration of influenza virus immunizations by the pharmacist. The written protocol shall include, at a minimum, specific categories and conditions among patients for whom the supervising physician authorizes the pharmacist to administer influenza virus immunizations. The terms, scope, and conditions set forth in the written protocol between the pharmacist and the supervising physician must be appropriate to the pharmacist’s training and certification for immunization. Pharmacists who have been delegated the authority to administer influenza virus immunizations by the supervising physician shall provide evidence of current certification by the Board of Pharmacy to the supervising physician. Supervising physicians shall review the administration of influenza virus immunizations by the pharmacists under such physician’s supervision pursuant to the written protocol, and this review shall take place as outlined in the written protocol. The process and schedule for the review shall be outlined in the written protocol between the pharmacist and the supervising physician.

The pharmacist shall submit to the Board of Pharmacy a copy of his or her protocol or written agreement to administer influenza virus immunizations.