reglab/statecodes huggingface dataset:
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.1042 - Rebates Prohibited; Violations Defined

Current through Reg. 50, No. 138; July 16, 2024
As provided in Section
				   465.185(1),
				  F.S., acts which will be considered as falling within the range of activities
				  which would justify discipline against a pharmacist or permittee as provided in
				  Section  465.016(1)(e) 
				  or  465.023(1)(c),
				  F.S., shall include:
(1) Offering or
				providing cash, or goods, or entertainment (including, money, food or
				decorations) to a health care facility (as defined in Section
				 408.032(7),
				F.S.) or its representative in exchange for favorable consideration in
				obtaining or maintaining the business of the facility;
(2) Offering or providing supplies or
				equipment to a health care facility (as defined in Section
				 408.032(7),
				F.S.) at no charge or below market value when these items are not integral
				elements of the medication distribution system;
(3) Paying rent to a health care facility (as
				defined in Section  408.032(7),
				F.S.) for space that is not used or is unusable or paying a rental rate for
				space that is significantly greater than the usual and customary rental rate
				for similar space;
(4) Offering or
				providing computers, FAX machines, or other electronic devices to a health care
				facility (as defined in Section
				 408.032(7),
				F.S.) when that equipment is not an integral element in providing pharmacy or
				consultant services;
(5) Offering
				or providing a health care facility (as defined in Section
				 408.032(7),
				F.S.) consultant pharmacist services, or providing patient medical record
				systems, or any personnel services outside the practice of pharmacy, at no
				charge, below market value, or below cost in exchange for obtaining or
				maintaining the business of the facility.
Rulemaking Authority
					 465.005,
					 465.0155 FS. Law Implemented
					 465.185,
					 465.0155
					 FS.
New 3-9-94, Formerly 61F10-27.1042,
					 59X-27.1042.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.105 - Transfer of Prescriptions (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.0155 FS. Law Implemented
					 465.026
					 FS.
New 1-3-79, Formerly 21S-1.33, 21S-1.033, Amended 7-30-91,
					 Formerly 21S-27.105, 61F10-27.105, Amended 9-19-94, Formerly 59X-27.105,
					 Amended 6-15-98, Repealed 10-8-15.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.120 - Ordering and Evaluation of Laboratory Tests (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.0125(3) FS.
					 Law Implemented 465.0125(2)
					 FS.
New 2-23-98, Repealed
					 11-25-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.200 - Purpose and Effect (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.186(2) FS.
					 Law Implemented 465.186
					 FS.
New 5-1-86, Formerly 21S-18.001, 21S-27.200, 61F10-27.200,
					 59X-27.200, Repealed 10-8-15.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.210 - General Terms and Conditions to Be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products

Current through Reg. 50, No. 138; July 16, 2024
Pursuant to the authority of the Formulary Committee in
				  Section  465.186, F.S., a pharmacist may
				  order the medicinal drug products listed in Rule
				   64B16-27.220, F.A.C., subject to
				  the following terms and limitations:
(1) Injectable products shall not be ordered
				by the pharmacist.
(2) No oral
				medicinal drugs shall be ordered by a pharmacist for a pregnant patient or
				nursing mother.
(3) In any case of
				dispensing hereunder, the amount or quantity of drug dispensed shall not exceed
				a 34-day supply or standard course of treatment unless subject to the specific
				limitations in this rule. Patients shall be advised that they should seek the
				advice of an appropriate health care provider if their present condition,
				symptom, or complaint does not improve upon the completion of the drug
				regimen.
(4) The directions for use
				of all prescribed medicinal drugs shall not exceed the manufacturer's
				recommended dosage.
(5) The
				pharmacist may only perform the acts of ordering and dispensing in a pharmacy
				which has been issued a permit by the Board of Pharmacy.
(6) The pharmacist shall create a
				prescription when ordering and dispensing medicinal drug products which shall
				be maintained in the prescription files of the pharmacy. The pharmacist shall
				place the trade or generic name and the quantity dispensed on the prescription
				label, in addition to all other label requirements.
(7) The pharmacist shall maintain patient
				profiles, separate from the prescription order, for all patients for whom the
				pharmacist orders and dispenses medicinal drug products and shall initial and
				date each profile entry. Such profiles shall be maintained at the pharmacy
				wherein the ordering and dispensing originated for a period of four (4)
				years.
(8) In the patient profiles,
				the pharmacist shall record as a minimum the following information if a
				medicinal drug product is ordered and dispensed.
(a) Patient's chief complaint or condition in
				the patient's own words.
(b) A
				statement regarding the patient's medical history.
(c) A statement regarding the patient's
				current complaint which may include, onset, duration and frequency of the
				problem.
(d) The medicinal drug
				product ordered and dispensed.
(e)
				The pharmacist ordering and dispensing the medicinal drug product shall initial
				the profile.
(f) The prescription
				number shall be recorded in the patient's profile.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.211 - Prescription Refills

Current through Reg. 50, No. 138; July 16, 2024
No prescription may be filled or refilled in excess of one
				  (1) year from the date of the original prescription was written. No
				  prescription for a controlled substance listed in Schedule II may be refilled.
				  No prescription for a controlled substance listed in Schedules III, IV, or V
				  may be filled or refilled more than five (5) times within a period of six (6)
				  months after the date on which the prescription was written.
Rulemaking Authority
					 465.005,
					 465.016(1),
					  465.022 (1)(a)
					 FS. Law Implemented 465.022,
					  893.04 FS.
New 11-18-07.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.220 - Medicinal Drugs Which May Be Ordered by Pharmacists

Current through Reg. 50, No. 138; July 16, 2024
A Pharmacist may order and dispense from the following
				  formulary, within their professional judgment, subject to the stated
				  conditions.
(1) Oral analgesics for
				mild to moderate pain. The pharmacist may order these drugs for minor pain and
				menstrual cramps for patients with no history of peptic ulcer disease. The
				prescription shall be limited to a six (6) day supply for one treatment. If
				appropriate, the prescription shall be labeled to be taken with food or milk.
(a) Magnesium salicylate/phenyltoloxamine
				citrate.
(b) Acetylsalicylic acid
				(Zero order release, long acting tablets).
(c) Choline salicylate and magnesium
				salicylate.
(d) Naproxen
				sodium.
(e) Naproxen.
(f) Ibuprofen.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.230 - Fluoride Containing Products

Current through Reg. 50, No. 138; July 16, 2024
Oral medicinal drug products containing fluoride may be
				  ordered by pharmacists for their patients who do not have fluoride supplement
				  in their drinking water, pursuant to the following limitations:
(1) The fluoride content of drinking water
				does not exceed 0.5 ppm.
(2) Once a
				fluoride treatment has been initiated with one specific fluoride medicinal drug
				product it should not be interchanged with a product of a different
				manufacturer for the course of the treatment.
(3) If the fluoride content is less than 0.5
				ppm then the following dosage schedule for oral usage shall be followed.
(a)
1. For
				ages 0-6 months.
a. Less than 0.3 ppm in water
				- no supplementation,
b. 0.3-0.6
				ppm in water - no supplementation,
c. 0.6 ppm in water - no supplementation,
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.300 - Standards of Practice - Continuous Quality Improvement Program

Current through Reg. 50, No. 138; July 16, 2024
(1) "Continuous Quality Improvement Program"
				means a system of standards and procedures to identify and evaluate
				quality-related events and improve patient care.
(2) "Quality-Related Event" means the
				inappropriate dispensing or administration of a prescribed medication
				including:
(a) A variation from the
				prescriber's prescription order, including, but not limited to:
1. Incorrect drug,
2. Incorrect drug strength,
3. Incorrect dosage form,
4. Incorrect patient, or
5. Inadequate or incorrect packaging,
				labeling, or directions.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.400 - Practice of Pharmacy (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.0155 FS. Law Implemented
					 465.003(11)(b),
					 (13),
					 465.014,
					 465.026
					 FS.
New 2-14-77, Formerly 21S-4.01, 21S-4.001, Amended 7-30-91,
					 Formerly 21S-27.400, 61F10-27.400, Amended 1-30-96, 10-1-96, Formerly
					 59X-27.400, Amended 4-13-00, Repealed
					 10-5-09.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.4001 - Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist

Current through Reg. 50, No. 138; July 16, 2024
(1) Delegation: A
				pharmacist shall not delegate more tasks than he or she can personally
				supervise and ensure compliance with this rule. A pharmacist may delegate those
				non-discretionary delegable tasks enumerated in Rule
				 64B16-27.420, F.A.C., to the
				following types of pharmacy technicians:
(a)
				Registered Pharmacy Technicians (RPT): are those technicians who are duly
				registered with the board pursuant to Section
				 465.014(2),
				F.S.;
(b) Pharmacy Technicians in
				Training (PTT): are those technicians who are receiving practical
				(non-didactic) training in delegable tasks as part of employer-sponsored or
				non-employer sponsored board-approved pharmacy technician training programs who
				are not required to be duly registered with the board as pharmacy
				technicians.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.410 - Registered Pharmacy Technician to Pharmacist Ratio

Current through Reg. 50, No. 138; July 16, 2024
(1) General Conditions.
				When the pharmacist delegates tasks to a registered pharmacy technician, such
				delegation must enhance the ability of the pharmacist to practice pharmacy to
				serve the patient population. A pharmacist shall not supervise more than one
				(1) registered pharmacy technician nor shall a pharmacy allow a supervision
				ratio of more than one (1) registered pharmacy technician to one (1) pharmacist
				(1:1), unless specifically authorized to do so pursuant to the provisions of
				this rule.
(2) Required
				Documentation. Regardless of the technician ratio, every pharmacy, pharmacist,
				Prescription Department Manager (PDM) and Consultant Pharmacist (CP) that
				employs or utilizes registered pharmacy technicians must comply with the
				following conditions:
(a) Establish and
				maintain a written Policy and Procedures Manual regarding the number of
				registered pharmacy technician positions and their utilization that includes
				the specific scope of delegable tasks of the technicians, job descriptions, and
				task protocols. The Policy and Procedures Manual or Manuals must include
				policies and the procedures for implementing the policies for each category
				enumerated below:
1. Supervision by a
				pharmacist;
2. Minimum
				qualifications of the registered pharmacy technician as established by statute
				and rule;
3. In-service education
				or on-going training and demonstration of competency specific to the practice
				site and job function;
4. General
				duties and responsibilities of the registered pharmacy technicians;
5. All functions related to prescription
				processing;
6. All functions
				related to prescription legend drug and controlled substance ordering and
				inventory control, including procedures for documentation and
				recordkeeping;
7. All functions
				related to retrieval of prescription files, patient files, patient profile
				information and other records pertaining to the practice of pharmacy;
8. All delegable tasks and non-delegable
				tasks as enumerated in Rule
				 64B16-27.420, F.A.C.;
9. Confidentially and privacy laws and
				rules;
10. Prescription refill and
				renewal authorization;
11.
				Registered pharmacy technician functions related to automated pharmacy systems;
				and,
12. Continuous Quality
				Improvement Program.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.420 - Pharmacy Technician - Delegable and Non-Delegable Tasks

Current through Reg. 50, No. 138; July 16, 2024
A pharmacy technician may only assist a pharmacist in
				  executing or carrying out the practice of the profession of pharmacy, but shall
				  never themselves engage in the practice of the profession of pharmacy as
				  defined in Chapter 465, F.S. Therefore, pharmacy technicians may only perform
				  delegable tasks as identified and defined pursuant to this rule.
(1) Delegable Tasks - Delegable tasks are
				those tasks that are performed pursuant to a pharmacist's direction, without
				the exercise of the pharmacy technician's own judgment and discretion, and
				which do not require the pharmacy technician to exercise the independent
				professional judgment that is the foundation of the practice of the profession
				of pharmacy.
(2) Non-Delegable
				Tasks - The following tasks may not be delegated and the pharmacy technician
				shall not:
(a) Receive new non written
				prescriptions or receive any change in the medication, strength, or directions
				of an existing prescription;
(b)
				Interpret a prescription or medication order for therapeutic acceptability and
				appropriateness;
(c) Conduct final
				verification of dosage and directions;
(d) Engage in prospective drug
				review;
(e) Monitor prescription
				usage;
(f) Override clinical alerts
				without first notifying the pharmacist;
(g) Transfer a prescription;
(h) Prepare a copy of a prescription or read
				a prescription to any person for purposes of providing reference concerning
				treatment of the person or animal for whom the prescription was
				written;
(i) Engage in patient
				counseling;
(j) Receive therapy or
				blood product procedures in a permitted nuclear pharmacy, or
(k) Engage in any other act that requires the
				exercise of a pharmacist's professional
				judgment.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.430 - Responsibilities of the Pharmacist (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.014
					 FS.
New 2-14-77, Formerly 21S-4.03, Amended 9-1-87, Formerly
					 21S-4.003, 21S-27.430, 61F10-27.430, 59X-27.430, Amended 1-1-10, Repealed
					 10-8-15.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.440 - Policies and Procedures (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.014
					 FS.
New 2-14-77, Formerly 21S-4.04, 21S-4.004, Amended 9-9-92,
					 Formerly 21S-27.440, 61F10-27.440, 59X-27.440, Amended 1-1-10, Repealed
					 10-8-15.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.500 - Negative Drug Formulary

Current through Reg. 50, No. 138; July 16, 2024
The negative drug formulary is composed of medicinal drugs
				  which have been specifically determined by the Board of Pharmacy and the Board
				  of Medicine to demonstrate clinically significant biological or therapeutic
				  inequivalence and which, if substituted, could produce adverse clinical
				  effects, or could otherwise pose a threat to the health and safety of patients
				  receiving such prescription medications. Except where certain dosage forms are
				  included on the negative drug formulary as a class, all medicinal drugs are
				  listed by their official United States Pharmacopoeia Non-Proprietary (generic)
				  name. The generic name of a drug shall be applicable to and include all
				  brand-name equivalents of such drug for which a prescriber may write a
				  prescription. Substitution by a dispensing pharmacist on a prescription written
				  for any brand name equivalent of a generic named drug product listed on the
				  negative formulary or for a drug within the class of certain dosage forms as
				  listed, is strictly prohibited. In cases where the prescription is written for
				  a drug listed on the negative drug formulary but a brand name equivalent is not
				  specified by the prescriber, the drug dispensed must be one obtained from a
				  manufacturer or distributor holding an approved new drug application or
				  abbreviated new drug application issued by the Food and Drug Administration,
				  United States Department of Health and Welfare permitting that manufacturer or
				  distributor to market those medicinal drugs or when the former is
				  non-applicable, those manufacturers or distributors supplying such medicinal
				  drugs must show compliance with other applicable Federal Food and Drug
				  Administration marketing requirements. The following are included on the
				  negative drug formulary:
(1)
				Digitoxin.
(2) Conjugated
				Estrogen.
(3) Dicumarol.
(4) Chlorpromazine (Solid Oral Dosage
				Forms).
(5) Theophylline
				(Controlled Release).
(6)
				Pancrelipase (Oral Dosage Forms).
Rulemaking Authority
					 465.005,
					 465.025(6) FS.,
					 Chapter 2001-146, Laws of Florida. Law Implemented
					 465.025(6) FS.,
					 Chapter 2001-146, Laws of Florida.
New 12-14-76, Amended 3-17-77, 7-2-79, 4-9-81, 9-14-82,
					 9-26-84, Formerly 21S-5.01, Amended 3-30-89, 7-1-90, Formerly 21S-5.001,
					 Amended 12-25-90, 10-1-92, Formerly 21S-27.500, Amended 2-21-94, Formerly
					 61F10-27.500, 59X-27.500, Amended 12-4-01,
					 3-18-10.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.510 - Identification of Manufacturer (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.025
					 FS.
New 3-16-77, Formerly 21S-5.02, 21S-5.002, 21S-27.510,
					 61F10-27.510, 59X-27.510, Repealed
					 10-8-15.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.520 - Positive Drug Formulary

Current through Reg. 50, No. 138; July 16, 2024
A positive formulary of generic and brand name drug products
				  is required of each community pharmacy pursuant to Section
				   465.025(5),
				  F.S. Those medicinal drugs on the positive formulary shall be obtained from
				  manufacturers or distributors holding an approved new drug application or
				  abbreviated new drug application issued by the Food and Drug Administration,
				  U.S. Department of Health, Education and Welfare permitting that manufacturer
				  or distributor to market those medicinal drugs or when the former is
				  non-applicable, those manufacturers or distributors supplying those medicinal
				  drugs must show compliance with other applicable Federal Food and Drug
				  Administration marketing requirements.
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.025(5)
					 FS.
New 12-7-77, Formerly 21S-5.03, 21S-5.003, 21S-27.520,
					 61F10-27.520, 59X-27.520.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.530 - Duty of Pharmacist to Inform Regarding Drug Substitution

Current through Reg. 50, No. 138; July 16, 2024
Prior to the delivery of the prescription, a pharmacist must
				  inform the person presenting a prescription of any substitution of a generic
				  drug product for a brand name drug product, of any retail price difference
				  between the two, and of the person's right to refuse the substitution. This
				  information must be communicated at a meaningful time such as to allow the
				  person to make an informed choice as to whether to exercise the option to
				  refuse substitution without undue inconvenience to the presenter of the
				  prescription or to the consumer of the drug. This information shall be
				  communicated to the person presenting the prescription in a manner determined
				  to be appropriate by the pharmacist using professional discretion and
				  judgment.
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.025(3)(a)
					 FS.
New 11-10-80, Formerly 21S-5.04, 21S-5.004, 21S-27.530,
					 61F10-27.530, 59X-27.530, Amended
					 11-18-07.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.615 - Possession and Disposition of Sample Medicinal Drugs

Current through Reg. 50, No. 138; July 16, 2024
(1) Pharmacies may not
				be in possession of sample medicinal drugs except:
(a) Pharmacies may possess the sample
				medicinal drugs that are listed within Rule
				 64B16-27.220, F.A.C., Medicinal
				Drugs That May be Ordered by Pharmacists.
(b) Institutional pharmacies may possess
				sample medicinal drugs upon the written request of the prescribing
				practitioner. Such possession must be in accordance with the provisions of
				Section 499.028(3)(e)2., F.S.
(c)
				Those community pharmacies that are pharmacies of health care entities, as
				defined by Sections  499.003(3) and
				(14), F.S., may possess sample medicinal
				drugs upon the written request of the prescribing practitioner. Such possession
				must be in accordance with the provisions of Section 499.028(3)(e)2.,
				F.S.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.620 - Disposition of Complimentary or Sample Medicinal Drugs Which Are Unsuitable for Dispensing (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022,
					 499.028 FS. Law Implemented
					 465.022
					 FS.
New 12-26-79, Formerly 21S-15.03, 21S-15.003, 21S-27.620,
					 Amended 11-4-93, Formerly 61F10-27.620, 59X-27.620, Repealed
					 10-5-09.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.630 - Additional Immunizations or Vaccines Which May Be Administered (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.189 FS. Law Implemented
					 465.189
					 FS.
New 7-14-16, Amended 4-12-18, Repealed
					 11-18-21.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.650 - Additional Immunizations or Vaccines Which May be Administered

Current through Reg. 50, No. 138; July 16, 2024
In addition to those vaccines and immunizations authorized by
				  Section  465.189, F.S., the Board hereby
				  authorizes the following additional licensed or approved vaccines or
				  immunizations that may be administered by those properly certified:
(1) COVID19 Vaccines and
(2) Respiratory Syncytial Virus
				Vaccines.
Rulemaking Authority
					 465.189 FS. Law Implemented
					 465.189
					 FS.
New 7-25-23.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.700 - Definition of Compounding

Current through Reg. 50, No. 138; July 16, 2024
"Compounding" is the professional act by a pharmacist or
				  other practitioner authorized by law, employing the science or art of any
				  branch of the profession of pharmacy, incorporating ingredients to create a
				  finished product for dispensing to a patient or for administration by a
				  practitioner or the practitioner's agent; and shall specifically include the
				  professional act of preparing a unique finished product containing any
				  ingredient or device defined by Sections
				   465.003(7) and
				  (8), F.S. The term also includes the
				  preparation of nuclear pharmaceuticals and diagnostic kits incident to use of
				  such nuclear pharmaceuticals. The term "commercially available products, " as
				  used in this section, means any medicinal product as defined by Sections
				   465.003(7) and
				  (8), F.S., that are legally distributed in
				  the State of Florida by a drug manufacturer or wholesaler.
(1) Compounding includes:
(a) The preparation of drugs or devices in
				anticipation of prescriptions based on routine, regularly observed prescribing
				patterns.
(b) The preparation
				pursuant to a prescription of drugs or devices which are not commercially
				available.
(c) The preparation of
				commercially available products from bulk when the prescribing practitioner has
				prescribed the compounded product on a per prescription basis and the patient
				has been made aware that the compounded product will be prepared by the
				pharmacist. The reconstitution of commercially available products pursuant to
				the manufacturer's guidelines is permissible without notice to the
				practitioner.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.797 - The Standards of Practice for Compounding Sterile Products

Current through Reg. 50, No. 138; July 16, 2024
The purpose of this section is to assure positive patient
				  outcomes through the provision of standards for 1) pharmaceutical care; 2) the
				  preparation, labeling, and distribution of sterile pharmaceuticals by
				  pharmacies, pursuant to or in anticipation of a prescription drug order; and 3)
				  product quality and characteristics. These standards are intended to apply to
				  all sterile pharmaceuticals, notwithstanding the location of the patient (e.g.,
				  home, hospital, nursing home, hospice, doctor's office, or ambulatory infusion
				  center).
(1) Adoption of the United
				States Pharmacopeia: Beginning on October 1, 2014, all sterile compounding
				shall be performed in accordance with the minimum practice and quality
				standards of the following chapters of the United States Pharmacopeia (USP):
(a) Chapter 797, Pharmaceutical
				Compounding-Sterile Preparations;
(b) Chapter 71, Sterility Tests;
(c) Chapter 85, Bacterial Endotoxins
				Test;
(d) Chapter 731, Loss on
				Drying.
All referenced chapters of the USP, in subsection (1), are
				  specifically referring to the United States Pharmacopeia, 36th revision, Second
				  Supplement, which is hereby incorporated and adopted by reference with the
				  effective chapter dates of December 1, 2013. A subscription to all relevant
				  chapters is available for purchase at
www.uspnf.com
. The Board has determined that
				  posting the incorporated material on the Internet would constitute a violation
				  of federal copyright law. At the time of adoption, the copyrighted incorporated
				  material will be available for public inspection and examination, but may not
				  be copied, at the Department of Health, 4052 Bald Cypress Way, Tallahassee,
				  Florida 32399-3254, and at the Department of State, Administrative Code and
				  Register Section, Room 701, The Capitol, Tallahassee, Florida
				  32399-0250.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.800 - Requirement for Patient Records

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				patient record system shall be maintained by all pharmacies for patients to
				whom new or refill prescriptions are dispensed. The patient record system shall
				provide for the immediate retrieval of information necessary for the dispensing
				pharmacist to identify previously dispensed drugs at the time a new or refill
				prescription is presented for dispensing. The pharmacist shall ensure that a
				reasonable effort is made to obtain, record and maintain the following
				information:
(a) Full name of the patient for
				whom the drug is intended;
(b)
				Address and telephone number of the patient;
(c) Patient's age or date of birth;
(d) Patient's gender;
(e) A list of all new and refill
				prescriptions obtained by the patient at the pharmacy maintaining the patient
				record during the four (4) years immediately preceding the most recent entry
				showing the name of the drug or device, prescription number, name and strength
				of the drug, the quantity and date received, and the name of the prescriber;
				and,
(f) Pharmacist comments
				relevant to the individual's drug therapy, including any other information
				peculiar to the specific patient or drug.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.810 - Prospective Drug Use Review

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				pharmacist shall review the patient record and each new and refill prescription
				presented for dispensing in order to promote therapeutic appropriateness by
				identifying:
(a) Over-utilization or
				under-utilization;
(b) Therapeutic
				duplication;
(c) Drug-disease
				contraindications;
(d) Drug-drug
				interactions;
(e) Incorrect drug
				dosage or duration of drug treatment;
(f) Drug-allergy interactions;
(g) Clinical
				abuse/misuse.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.820 - Patient Counseling

Current through Reg. 50, No. 138; July 16, 2024
(1) Upon receipt of
				a new or refill prescription, the pharmacist shall ensure that a verbal and
				printed offer to counsel is made to the patient or the patient's agent when
				present. If the delivery of the drugs to the patient or the patient's agent is
				not made at the pharmacy the offer shall be in writing and shall provide for
				toll-free telephone access to the pharmacist. If the patient does not refuse
				such counseling, the pharmacist, or the pharmacy intern, acting under the
				direct and immediate personal supervision of a licensed pharmacist, shall
				review the patient's record and personally discuss matters which will enhance
				or optimize drug therapy with each patient or agent of such patient. Such
				discussion shall be in person, whenever practicable, by toll-free telephonic
				communication, or by an interactive audio and digital image format, and shall
				include appropriate elements of patient counseling. Such elements may include,
				in the professional judgment of the pharmacist, the following:
(a) The name and description of the
				drug;
(b) The dosage form, dose,
				route of administration, and duration of drug therapy;
(c) Intended use of the drug and expected
				action (if indicated by the prescribing health care practitioner);
(d) Special directions and precautions for
				preparation, administration, and use by the patient;
(e) Common severe side or adverse effects or
				interactions and therapeutic contraindications that may be encountered,
				including their avoidance, and the action required if they occur;
(f) Techniques for self-monitoring drug
				therapy;
(g) Proper
				storage;
(h) Prescription refill
				information;
(i) Action to be taken
				in the event of a missed dose;
(j)
				The potential for physical dependence, addiction, misuse, or abuse;
				and
(k) Pharmacist comments
				relevant to the individual's drug therapy, including any other information
				peculiar to the specific patient or drug.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.830 - Standards of Practice - Drug Therapy Management

Current through Reg. 50, No. 138; July 16, 2024
(1) "Prescriber Care
				Plan" means an individualized assessment of a patient and orders for specific
				drugs, laboratory tests, and other pharmaceutical services intended to be
				dispensed or executed by a pharmacist. The Prescriber Care Plan shall be
				written by a physician or physician assistant licensed pursuant to Chapter 458
				or 459, F.S., a podiatric physician licensed under Chapter 461, F.S., or a
				dentist licensed under Chapter 466, F.S., or similar statutory provision in
				another jurisdiction, and may be transmitted by any means of communication. The
				Prescriber Care Plan shall specify the conditions under which a pharmacist
				shall order laboratory tests, interpret laboratory values ordered for a
				patient, execute drug therapy orders for a patient, and notify the
				prescriber.
(2) "Drug Therapy
				Management" means any act or service by a pharmacist in compliance with orders
				in a Prescriber Care Plan.
(3) A
				pharmacist may provide Drug Therapy Management services for a patient,
				incidental to the dispensing of medicinal drugs or as a part of consulting
				concerning therapeutic values of medicinal drugs or as part of managing and
				monitoring the patient's drug therapy. A pharmacist who provides Drug Therapy
				Management services for a patient shall comply with orders in a Prescriber Care
				Plan, insofar as they specify:
(a) Drug
				therapy to be initially dispensed to the patient by the pharmacist,
				or
(b) Laboratory values or tests
				to be ordered, monitored and interpreted by the pharmacist, or
(c) The conditions under which the duly
				licensed practitioner authorizes the execution of subsequent orders concerning
				the drug therapy for the patient, or
(d) The conditions under which the pharmacist
				shall contact or notify the prescriber.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.831 - Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education

Current through Reg. 50, No. 138; July 16, 2024
The Board of Pharmacy recognizes that it is important for the
				  patients of the State of Florida to be able to fill valid prescriptions for
				  controlled substances. In filling these prescriptions, the Board does not
				  expect pharmacists to take any specific action beyond exercising sound
				  professional judgment. Pharmacists should not fear disciplinary action from the
				  Board or other regulatory or enforcement agencies for dispensing controlled
				  substances for a legitimate medical purpose in the usual course of professional
				  practice. Every patient's situation is unique and prescriptions for controlled
				  substances shall be reviewed with each patient's unique situation in mind.
				  Pharmacists shall attempt to work with the patient and the prescriber to assist
				  in determining the validity of the prescription.
(1) Definitions: For purposes of this rule
				the following definitions shall apply:
(a)
				Valid Prescription. A prescription is valid when it is based on a
				practitioner-patient relationship and when it has been issued for a legitimate
				medical purpose.
(b) Invalid
				Prescription. A prescription is invalid if the pharmacist knows or has reason
				to know that the prescription was not issued for a legitimate medical
				purpose.
(c) Validating a
				Prescription. Validating a prescription means the process implemented by the
				pharmacist to determine that the prescription was issued for a legitimate
				medical purpose.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-27 - PHARMACY PRACTICE › Section 64B16-27.851 - Record-Keeping for Orthotics and Pedorthics

Current through Reg. 50, No. 138; July 16, 2024
(1) The pharmacist or
				supportive personnel shall prepare and maintain in a timely manner patient
				records which include, at a minimum, the following:
(a) The patient name, address and telephone
				number;
(b) The location and dates
				of all treatment, evaluation or consultation;
(c) The name of the prescribing
				physician;
(d) All prescriptions
				pertaining to services provided to the patient;
(e) A treatment or service plan;
(f) Progress notes for each
				session.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.100 - Pharmacy Permits - Applications and Permitting

Current through Reg. 50, No. 138; July 16, 2024
This rule section establishes the application and permitting
				  requirements for pharmacies regulated under Chapter 465, F.S. Any pharmacy
				  establishment shall apply to the board for the appropriate permit on forms
				  indicated in this rule. Applications and forms referenced in this section may
				  be accessed or downloaded from the web at
http://floridaspharmacy.gov/resources/
or may be obtained by contacting the Board the Board of Pharmacy, at 4052 Bald
				  Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or (850)488-0595.
				  Inquiries regarding the status of the application or license verification may
				  be obtained at
http://www.FLHealthsource.gov
. The
				  application must be accompanied by the appropriate fee as specified by Rule
				   64B16-26.1022, F.A.C.
(1) All Permits:
(a) A permit is valid only for the name and,
				pursuant to Rule  64B16-28.113, F.A.C., physical
				location (address) to which it is issued. The name in which the permit is
				issued must be the name in which the company is doing business, i.e., the name
				that appears on purchase and sales
				invoices.
1. The name in which a permit is
				issued may be changed upon notification to the board. To change the name in
				which a permit is issued the person or establishment must file with the board
				an original Form DH-MQA 1227 "Pharmacy Permit Name Change Form" effective
				December 2010, which is incorporated by reference herein, and is available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-02297
or on the web at
http://floridaspharmacy.gov/resources/
.
2. A pharmacy permit holder may request a
				change of practice location by completing the appropriate section(s) of the
				application form for the permit type.
3. Pharmacy permits are non-transferrable.
				However, pursuant to Rule
				 64B16-28.2021, F.A.C., transfers
				of ownership interests of business entities holding a permit may be allowed. A
				pharmacy permit holder shall notify the Board of changes of ownership interests
				of business entities by completing the appropriate section(s) of the
				application form for the permit type.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.101 - Prescription Area Accessible to Inspection

Current through Reg. 50, No. 138; July 16, 2024
(1) The prescription
				department compounding room or any other place where prescriptions are
				compounded, filled, processed, accepted, dispensed, or stored in each pharmacy
				shall be so situated and located that authorized agents and employees of the
				Department or other persons authorized by law to enter and inspect, can observe
				and survey the confines of said department, room or area and can enter into
				said department, room or area after identifying themselves, for the purpose of
				inspection at a reasonable hour or when the practice of the profession of
				pharmacy is being carried on, as defined in Section
				 465.003, F.S., without having
				been previously detained or announced. Such inspection may be routinely
				conducted at any time by authorized agents of the Department to determine
				whether Chapter 465, F.S., or provisions of these rules have been violated or
				for other lawful purposes, and need not be in response to a complaint filed
				with the Department. There shall be a minimum of one (1) inspection per year
				except as otherwise provided herein or directed by the
				Board.
(a) A pharmacy shall be inspected twice
				during the first year of operation.
(b) A pharmacy which has had passing
				inspections for the most current three years, and no discipline during the most
				current three years shall be inspected every two years.
(c) A pharmacy which fails to obtain a
				passing inspection or which is disciplined during the two year inspection cycle
				will be inspected annually until it achieves passing inspections for the most
				current three years, and no discipline during the most current three years as
				set forth in this subsection.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.102 - Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment

Current through Reg. 50, No. 138; July 16, 2024
There shall be provided for the prescription department of
				  each pharmacy:
(1) An adequate sink in
				workable condition and running water easily accessible to the prescription
				counter that shall be available during the hours when the prescription
				department is normally open for the business related to
				prescriptions.
(2) Sufficient
				shelf, drawer or cabinet space for the neat and orderly storage of
				pharmaceutical stock, prescription containers, prescription labels, the
				required equipment, and all other items, articles or equipment stored therein
				and there shall be sufficient walking space and sufficient work counter space
				within each prescription department of said establishment so as to allow
				employees or pharmacists employed therein to adequately, safely, and accurately
				fulfill their duties related to prescriptions.
(3) Adequate facilities for the proper
				storage of pharmaceuticals which require refrigeration, and such
				pharmaceuticals shall be stored therein, and in such manner as to preserve
				their therapeutic activity.
(4)
				Adequate sanitation to insure the prescription department is operating under
				clean, sanitary, uncrowded, and healthy conditions.
(5) The following items:
(a) A current pharmacy reference compendium
				such as the United States Pharmacopoeia/National Formulary, the U.S.
				Dispensatory, USP DI, (United States Pharmacopoeial Drug Information), the
				Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof
				sufficient in scope to meet the professional practice needs of that pharmacy,
				and a current copy of the laws and rules governing the practice of pharmacy in
				the State of Florida. It shall be acceptable, in lieu of an actual hard copy,
				to maintain these materials in a readily available electronic data
				format.
(b) Such other equipment as
				is necessary to meet the needs of the professional practice of
				pharmacy.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.103 - Sufficient Space in Prescription Department (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022
					 FS.
New 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.03,
					 21S-1.003, 21S-28.103, 61F10-28.103, 59X-28.103, Repealed
					 5-4-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.1035 - Patient Consultation Area

Current through Reg. 50, No. 138; July 16, 2024
A community pharmacy shall provide a private consultation
				  area so all patients of the pharmacy will be able to obtain counseling without
				  being overheard by others in the prescription dispensing area of the pharmacy.
				  The consultation area must be accessible by the patient from the outside of the
				  prescription dispensing area of the pharmacy without having to traverse a
				  stockroom or the prescription dispensing area. In determining whether the area
				  is suitable, consideration shall be given to the proximity of the counseling
				  area to the check-out or cash register area, the volume of pedestrian traffic
				  in and around the consultation area, and the presence of walls or other
				  barriers between the counseling area and the prescription dispensing area of
				  the pharmacy. The consultation area may consist of designated private counter
				  space. The area shall be designated with a sign bearing "Patient Consultation
				  Area, " or words that are substantially similar.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1)
					 FS.
New 9-20-99, Amended
					 5-4-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.104 - Refrigeration (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022
					 FS.
New 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.04,
					 21S-1.004, 21S-28.104, 61F10-28.104, 59X-28.104, Repealed
					 5-4-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.105 - Sanitation (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1)
					 FS.
New 5-19-72, Repromulgated 12-18-74, Amended 1-29-80,
					 Formerly 21S-1.07, 21S-1.007, Amended 7-31-91, Formerly 21S-28.105,
					 61F10-28.105, 59X-28.105, Repealed
					 5-4-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.106 - Right to Inspect Invoices (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.017
					 FS.
New 5-19-72, Repromulgated 12-18-74, Amended 10-10-78,
					 4-30-85, Formerly 21S-1.008, 21S-28.106, 61F10-28.106, 59X-28.106, Repealed
					 5-4-05.