reglab/statecodes huggingface dataset:
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.810 - Special Pharmacy - Limited Community Permit

Current through Reg. 50, No. 138; July 16, 2024
A Special-Limited Community Permit shall be obtained by a
				  Class II or Class III Institutional Pharmacy that dispenses medicinal drugs,
				  including controlled substances to:
(1) Employees, medical staff and their
				dependents for their personal use;
(2) Patients of the hospital who are under a
				continuation of a course of therapy not to exceed a three (3) day
				supply;
(3) Patients obtaining
				medical services in the facility's emergency room and, whenever it is otherwise
				appropriate, as indicated in the applicant's policy and procedure manual; and,
(4) Discharged patients of the
				hospital who are under a continuation of a course of therapy using multi-dose
				medicinal drugs if the following requirements are met:
(a) The label affixed to a container used in
				dispensing multi-dose medicinal drugs contains at least the following
				information:
1. The name of and contact
				information of the pharmacy.
2. The
				name of the prescriber.
3. The name
				of the patient.
4. The date of the
				original filling and any applicable expiration date.
5. The prescription number or other
				prescription identification adequate to readily identify the
				prescription.
6. The directions for
				use.
7. The name, strength, and
				size of the medicinal drug dispensed; and,
8. The quantity of the drug in the
				container.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.820 - Sterile Products and Special Parenteral/Enteral Compounding

Current through Reg. 50, No. 138; July 16, 2024
(1) Sterile Products and Parenteral/Enteral
				Compounding.
(a) A sterile products and
				parenteral/enteral compounding pharmacy is a type of special pharmacy as
				provided by Section  465.0196, F.S., which is limited
				in scope of pharmacy practice to render sterile products and parenteral/enteral
				compounding functions. This pharmacy practice facilitates the utilization of
				certain institutional therapeutic measures by patients in the home environment
				or by patients in an institutional environment where such pharmacy service is
				unavailable. Pharmacy services, sterile products and parenteral/enteral
				products provided by a special sterile products and parenteral/enteral
				compounding pharmacy pursuant to prescription as defined by Section
				 465.003(13),
				F.S., shall be limited to the compounding and/or dispensing of:
1. Sterile preparations for parenteral
				therapy, parenteral nutrition; and/or
2. Sterile preparations for jejunostomy
				feeding and sterile irrigation solutions; and/or
3. Sterile preparations of cytotoxic or
				antineo-plastic agents; and/or
4.
				Sterile products (i.e., injectables, eye drops, etc.).
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.830 - Special - Closed System Pharmacy

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				Special - Closed System Pharmacy permit is a type of special pharmacy as
				provided for by section
				 465.0196, F.S., which dispenses
				medicinal drugs, utilizing closed delivery systems, to facilities where
				prescriptions are individually prepared for the ultimate consumer, including
				nursing homes, jails, ALF's (Adult Congregate Living Facilities), ICF-IIDs
				(Intermediate Care Facilities - Developmentally Delayed, also known as ICF -
				Individuals with Intellectual Disabilities), or other custodial care facilities
				when defined by AHCA rules and which the Board may approve.
(2) A special - closed system pharmacy
				permittee shall maintain a policy and procedure manual including drug
				procurement, storage, handling, compounding, dispensing, record keeping and
				disposition, as well as procedures for preventing the dispensing of controlled
				substances based upon fraudulent prescriptions.
(3) A special - closed system pharmacy
				permittee shall provide twenty-four-hour emergency and on-call
				service.
(4) A special - closed
				system pharmacy permittee may dispense parenteral and enteral medications as
				provided by rule.
(5) A special -
				closed system pharmacy permittee shall be under the supervision of a
				prescription department manager who is responsible for maintaining all drug
				records, providing security of the prescription department and following other
				rules as relate to the practice of pharmacy. The prescription department
				manager of a closed system pharmacy shall not be the prescription department
				manager of any other pharmacy permit except when the permit is within the
				premises of a community pharmacy permit.
(6) The utilization of registered pharmacy
				interns and registered pharmacy technicians is as provided by rules
				 64B16-26.400,
				 64B16-27.4001,
				 64B16-27.410, and
				 64B16-27.420,
				F.A.C.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.0196,
					 465.022
					 FS.
New 7-31-91, Amended 10-1-92, Formerly 21S-28.830,
					 61F10-28.830, 59X-28.830, Amended 1-1-10,
					 5-8-18.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.840 - Special - Non Resident (Mail Service) (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022,
					 465.0156 FS. Law Implemented
					 465.0156
					 FS.
New 10-14-91, Formerly 21S-28.840, 61F10-28.840,
					 59X-28.840, Amended 10-27-09, Repealed
					 4-26-17.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.850 - Special Pharmacy - ESRD

Current through Reg. 50, No. 138; July 16, 2024
(1) An ESRD
				Pharmacy is a type of special pharmacy as provided by Section
				 465.0196, F.S., which is limited
				in scope of pharmacy practice to the provision of dialysis products and
				supplies to persons with chronic kidney failure for self-administration at the
				person's home or specified address. Pharmacy services and dialysis supplies and
				products provided by an ESRD pharmacy shall be limited to the distribution and
				delivery of legend drugs included in schedule subsection (3), below; or legend
				devices included in schedule subsection (4), below; which are ordered by a
				physician for administration or delivery to a person with chronic kidney
				failure for self-administration at the person's home or specified address. All
				dialysis supplies and products provided by an ESRD pharmacy shall be
				prepackaged and shall be covered by an approved NDA or 510 (k) application
				issued by the Federal Food and Drug Administration.
(2) Prior to engaging in an ESRD pharmacy
				practice an entity shall obtain a special ESRD pharmacy permit as provided
				herein.
(3) Schedule of legend
				drugs:
(a) Saline Solutions.
(b) Porcine Heparin.
(c) Beef Heparin.
(d) Dextrose Solutions.
(e) Doxercalciferol.
(f) Epoetin Alfa.
(g) NACL INJ 50 MEQ/20 ML.
(h) Levocarnitine.
(i) Lidocaine.
(j) Vitamin Preparations (dialysate use
				only).
(k) Paricalcitrol.
(l) Peritoneal Dialysate Solutions.
(m) Protamine Sulfate.
(n) Potassium 20 MEQ/10ML (dialysate use
				only).
(o) Sodium Ferric Gluconate
				Complex or equivalent.
(p) Sterile
				Water for Irrigation.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.860 - Special Pharmacy - Parenteral/Enteral Extended Scope Permit

Current through Reg. 50, No. 138; July 16, 2024
(1)
(a) A
				Special Parenteral/Enteral Extended Scope permit, as authorized by Section
				 465.0196, F.S., is required for
				pharmacies to compound patient specific enteral/parenteral preparations in
				conjunction with institutional pharmacy permits, provided requirements set
				forth herein are satisfied. Prior to engaging in a parenteral/enteral
				compounding pharmacy practice as described in this section, an entity shall
				obtain a Special Parenteral/Enteral Extended Scope pharmacy permit.
(b) Special Parenteral/Enteral Extended Scope
				pharmacies and institutional pharmacy permits shall create and comply with
				Policy and Procedure Manuals that delineate duties and responsibilities of each
				entity, including the following provisions:
1. When dispensing patient specific
				prescriptions provided by an institutional pharmacy permit, the Special
				Parenteral/Enteral Extended Scope pharmacy shall confirm accuracy of the
				prescription and dosage.
2. The
				institutional pharmacy permit shall maintain records appropriate to ensure the
				provision of proper patient care.
3. The institutional pharmacy permit designee
				shall inspect and log in all medicinal drugs provided by the Special
				Parenteral/Enteral Extended Scope pharmacy.
4. A pharmacist for the Class II
				institutional pharmacy shall provide drug utilization review and shall review
				each prescription order prior to transmission to the Special Parenteral/Enteral
				Extended Scope pharmacy.
5. The
				Policy and Procedure Manual for a Special Parenteral/Enteral Extended Scope
				pharmacy shall also meet the policy and procedure manual requirements of
				paragraph  64B16-28.820(3)(d),
				F.A.C.
(c) Such Policy
				and Procedure manuals shall be made available to the Board or Department upon
				request.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.870 - Special-ALF

Current through Reg. 50, No. 138; July 16, 2024
(1) The Special-ALF permit is an optional
				facility license for those Assisted Living Facilities providing a drug delivery
				system utilizing medicinal drugs provided in unit dose packaging.
(2) Medicinal Drugs.
(a) Medicinal drugs may not be dispensed on
				the premises.
(b) All medicinal
				drugs must be maintained in individual prescription containers for the
				individual patient.
(c) Medicinal
				drugs dispensed to the residents of a Special-ALF permit shall meet the
				labeling requirements of Rules
				 64B16-28.502 and
				 64B16-28.108, F.A.C.
(d) Medicinal drugs may not be dispensed on
				the premises. Medicinal drugs dispensed to patients of Special-ALF permits may
				be returned to the dispensing pharmacy's stock under the provisions of Rule
				 64B16-28.118, F.A.C. Dispensed
				controlled substances that have been discontinued shall be disposed of under
				the provisions of Rule
				 64B16-28.301,
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.900 - Definitions - Nuclear Pharmacy

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				"nuclear pharmacy" is a pharmacy which provides radiopharmaceutical
				services.
(2) A "nuclear
				pharmacist" is a pharmacist who has met the training qualifications as
				described in rule  64B16-26.303, F.A.C., and has
				been licensed by the Board of Pharmacy.
(3) A "radiopharmaceutical service" shall
				include, but shall not be limited to, the procurement, storage, preparation,
				labeling, quality assurance testing, distribution, record keeping and disposal
				of radiopharmaceuticals.
(4) A
				"radiopharmaceutical" is any substance defined as a drug by Section 201(g)(1)
				of the Federal Food, Drug and Cosmetic Act which exhibits spontaneous
				disintegration of unstable nuclei with the emission of nuclear particles or
				photons and includes any such drug which is intended to be made radioactive.
				This definition includes nonradioactive reagent kits and nuclide generators
				which are intended to be used in the preparation of any such substance but does
				not include drugs such as carbon-containing compounds or potassium-containing
				salts which contain trace quantities of naturally occurring
				radionuclides.
(5)
				"Radiopharmaceutical quality assurance" includes, but is not limited to, the
				performance of appropriate chemical, biological and physical tests on
				radiopharmaceuticals, and the interpretation of the resulting data to determine
				their suitability for use in humans and animals, including internal test
				assessment, authentication of product history and the keeping of proper
				records.
(6) "Authentication of
				product history" includes, but is not limited to, identifying the purchasing
				source, the ultimate fate, and intermediate handling of any component of a
				radiopharmaceutical or other drug.
Rulemaking Authority
					 465.005 FS. Law Implemented
					 465.003(14),
					 465.022(1)(e)
					 FS.
New 1-7-76, Formerly 21S-3.01, Amended 4-4-88, Formerly
					 21S-3.001, Amended 7-31-91, 4-15-92, 10-1-92, Formerly 21S-28.900,
					 61F10-28.900, 59X-28.900, Amended
					 4-5-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.901 - Nuclear Pharmacy - General Requirements

Current through Reg. 50, No. 138; July 16, 2024
The process employed by any permit holder in this state
				  concerning the handling of radioactive materials must involve appropriate
				  procedures for the purchase, receipt, storage, manipulation, compounding,
				  distribution and disposal of radioactive materials. In order to insure the
				  public health and safety in this respect, a nuclear pharmacy in this state
				  shall meet the following general requirements:
(1) Each nuclear pharmacy shall designate a
				nuclear pharmacist as the prescription department manager who shall be
				responsible for compliance with all laws and regulations, both state and
				federal pertaining to radiopharmaceuticals and radiopharmaceutical services. A
				nuclear pharmacist must personally supervise the operation of only one nuclear
				pharmacy during all times when radiopharmaceutical services are being
				performed.
(2) The nuclear pharmacy
				area shall be secured from access by unauthorized personnel.
(3) Each nuclear pharmacy shall maintain
				accurate records of the acquisition, inventory, distribution, and disposal of
				all radiopharmaceuticals.
(4) All
				nuclear pharmacies shall provide a secured radioactive storage and decay
				area.
(5) Nuclear pharmacies shall
				comply with all applicable laws and regulations of federal and state agencies
				for the procurement, secure storage, inventory, preparation, distribution and
				disposal of radiopharmaceuticals and other drugs.
(6) Radiopharmaceuticals are to be
				distributed only upon a prescription order from an authorized licensed medical
				practitioner or through the practitioner's agent.
(7) A nuclear pharmacist may transfer
				radioactive materials in accordance with all applicable laws and
				regulations.
(8) A nuclear
				pharmacist upon receiving an oral prescription order for a radiopharmaceutical
				shall immediately have the prescription order reduced to writing. The
				pharmacist may delegate this duty to a registered pharmacy technician only as
				authorized by Rule  64B16-27.410, F.A.C. The
				prescription order shall contain at least the
				following:
(a) The name of the user or his
				agent;
(b) The date of distribution
				and the time of calibration of the radiopharmaceutical;
(c) The name of the procedure;
(d) The name of the
				radiopharmaceutical;
(e) The dose
				or quantity of the radiopharmaceutical;
(f) Any specific instructions; and,
(g) The initials of the person who
				received the prescription order.
(h) The patient's name must be obtained and
				recorded prior to dispensing, if the prescription order is for a therapeutic or
				blood product radiopharmaceutical.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.902 - Nuclear Pharmacy - Minimum Requirements

Current through Reg. 50, No. 138; July 16, 2024
In order to insure compliance with the general safety
				  requirements as previously set forth above, the following minimum requirements
				  shall be met by a nuclear pharmacy. These requirements are in addition to the
				  general requirements for space and equipment for other types of pharmacies, the
				  requirements of the Department of Health for the control of radiation hazards,
				  and the applicable requirements of the Federal Food and Drug Administration.
				  Such minimum permit requirements are set forth as follows:
(1) Space:
(a) The area for the storage, compounding,
				distribution and disposal of radiopharmaceuticals shall be adequate to
				completely separate such radioactive pharmaceuticals from pharmacy areas which
				contain non-radioactive medicinal drugs;
(b) The Hot lab, storage area, and
				compounding and dispensing area shall be a minimum of 150 square
				feet.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.903 - Training Qualifications (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.003(14),
					 465.0126
					 FS.
New 4-17-76, Amended 4-8-80, 6-23-83, Formerly 21S-3.05,
					 Amended 8-11-86, 4-4-88, Formerly 21S-3.005, Amended 7-31-91, Formerly
					 21S-28.903, 61F10-28.903, Amended 6-12-96, Formerly 59X-28.903, Repealed
					 1-18-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.904 - Nuclear Pharmacist - Continuing Education (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.0126,
					 465.022 FS. Law Implemented
					 465.009(5),
					 465.0126
					 FS.
New 10-28-91, Formerly 21S-28.904, 61F10-28.904,
					 59X-28.904, Amended 1-12-03, 10-19-03, Repealed
					 1-18-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.905 - Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities (Transferred)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.0158 FS. Law Implemented
					 465.0158
					 FS.
New 12-24-15, Transferred to
					  64B16-32.015.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.001 - Definition

Current through Reg. 50, No. 138; July 16, 2024
An "animal control shelter" is a county or municipal animal
				  control agency or Humane Society registered with the Secretary of State which
				  holds a modified Class II Institutional Pharmacy permit issued by the
				  Department of Health pursuant to certification of compliance with Rule
				   64B16-29.002, F.A.C., by the
				  Board of Pharmacy. An animal control shelter is issued a pharmacy permit for
				  the sole purpose of obtaining the drugs, sodium pentobarbital and sodium
				  pentobarbital with lidocaine, Tiletamine Hydrochloride, alone or combined with
				  Zolazepam (including Telazol), Xylazine (including Rompun), Ketamine,
				  Acepromazine Maleate (also Acetylpromazine, and including Atravet or Acezine),
				  alone or combined with Etorphine (including Immobilon), and Yohimbine
				  Hydrochloride, alone or combined with Atipamezole (including Antisedan), for
				  euthanization or chemical immobilization of animals within their lawful
				  possession.
Rulemaking Authority
					 465.005,
					 828.055 FS. Law Implemented
					 828.055
					 FS.
New 10-17-79, Formerly 21S-14.01, Amended 4-24-88, Formerly
					 21S-14.001, 21S-29.001, 61F10-29.001, 59X-29.001, Amended
					 3-3-13.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.002 - General Requirements

Current through Reg. 50, No. 138; July 16, 2024
(1) Application
				for an Animal Control Shelter Pharmacy permit shall be made on Board of
				Pharmacy approved form DOH-MQA/PH/107 "Animal Control Pharmacy Permit
				Application and Information, " effective October 2009, which is incorporated by
				reference. To obtain an application, contact the Board of Pharmacy at 4052 Bald
				Cypress Way, Bin #C04, Tallahassee, FL 32399-3254, or (850)488-0595, or
				download the application from the board's website at
http://www.doh.state.fl.us/mqa/pharmacy
.
(a) The application fee for animal shelters
				applying for the Modified Class II Institutional permit shall be fifty dollars
				($50.00).
(b) The biennial permit
				renewal fee for animal shelters holding the Modified Class II Institutional
				permit shall be fifty dollars ($50.00).
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.003 - Drug Requirement (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 828.055 FS. Law Implemented
					 828.055
					 FS.
New 10-17-79, Formerly 21S-14.03, Amended 4-24-88, Formerly
					 21S-14.003, 21S-29.003, 61F10-29.003, 59X-29.003, Repealed
					 3-28-12.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.004 - Records

Current through Reg. 50, No. 138; July 16, 2024
Animal control shelter permittees shall maintain records of
				  purchases and administration of drugs for euthanization or chemical
				  immobilization for a period of not less than four (4) years. Records of
				  administration shall contain:
(1) The
				date of use;
(2) Identification of
				the animal;
(3) The amount of the
				drug used;
(4) The signature of the
				person administering the drug;
(5)
				The signature of the on-site manager certifying the accuracy of the
				administration of sodium pentobarbital and sodium pentobarbital with lidocaine
				not less than once per month; and,
(6) The signature of the on-site manager
				certifying to the accuracy of the records. These records are subject to audit
				by the Drug Enforcement Administration or authorized employees of the
				Department to determine adequacy, accuracy and validity of the record
				keeping.
Rulemaking Authority
					 465.005,
					 828.055 FS. Law Implemented
					 828.055
					 FS.
New 10-17-79, Formerly 21S-14.04, Amended 4-24-88, Formerly
					 21S-14.004, 21S-29.004, 61F10-29.004, 59X-29.004, Amended
					 2-7-13.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.0041 - Record Maintenance Systems for Animal Shelter Permits

Current through Reg. 50, No. 138; July 16, 2024
(1) General requirements
				for records maintained in an electronic system.
(a) If a permitted animal shelter's data
				processing system is not in compliance with the Board's data processing
				requirements, the facility must maintain a manual recordkeeping system meeting
				the requirements of Rule
				 64B16-29.004, F.A.C.
(b) Requirements for back-up systems. The
				facility shall maintain a back-up copy of information stored in the data
				processing system using disk, tape, or other electronic back-up and up-date
				this back-up copy on a regular basis, at least monthly, to assure that data is
				not lost due to system failure.
(c)
				Change or discontinuance of a data processing system.
1. Records of dispensed and returned
				medicinal drugs. A permitted animal shelter that changes or discontinues use of
				a data processing system must:
a. Transfer the
				records to the new data processing system, or
b. Purge the records to a printout which
				contains the same information as required on the audit trail printout as
				specified in Rule  64B16-29.004,
				F.A.C.
2. Other records.
				A pharmacy that changes or discontinues use of a data processing system must:
a. Transfer the records to the new data
				processing system, or
b. Purge the
				records to a printout which contains all of the information required on the
				original document.
3.
				Maintenance of purged records. Information purged from a data processing system
				must be maintained by the pharmacy for four (4) years from the date of initial
				entry into the data processing system.
(d) Loss of data. The shelter manager for
				permitted animal shelters shall report to the Board in writing any significant
				loss of information from the data processing system within 10 days of discovery
				of the loss.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-29 - ANIMAL CONTROL SHELTER PERMITS › Section 64B16-29.005 - Storage

Current through Reg. 50, No. 138; July 16, 2024
All controlled substances, medicinal drugs or legend drugs
				  shall be stored in a safe place. At a minimum, this shall require that the
				  drugs be kept in a securely locked cabinet within a locked storage room.
				  Schedule II order forms are to be stored under the same conditions. Records of
				  purchases of all controlled substances, medicinal drugs or legend drugs shall
				  be maintained in a separate file from the records of administration. The
				  records of purchases and administration shall be maintained at the
				  location.
Rulemaking Authority
					 465.005,
					 828.055 FS. Law Implemented
					 828.055
					 FS.
New 10-17-79, Formerly 21S-14.05, Amended 4-24-88, Formerly
					 21S-14.005, 21S-29.005, 61F10-29.005, 59X-29.005, Amended
					 6-17-13.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-30 - DISCIPLINARY GUIDELINES › Section 64B16-30.002 - Minor Violations

Current through Reg. 50, No. 138; July 16, 2024
(1) The Board sets
				forth the following guidelines for use by Department investigators when a
				licensee is in noncompliance of an initial offense of a minor violation. The
				Board deems the following violations, depending upon severity, to be consistent
				with section  456.073(3),
				F.S.
(a) Outdated pharmaceuticals - rule
				 64B16-28.110, F.A.C.
(b) Failure to meet regulation of daily
				operating hours - rule
				 64B16-28.404, F.A.C.
(c) Generic substitution sign not displayed -
				section  465.025(7),
				F.S.
(d) Information required on
				controlled substance prescriptions: practitioner's address, practitioner's DEA
				registration number, patient's address - section
				 893.04, F.S.
(e) Failure to have certified by dispensing
				pharmacists the daily hard-copy printout or daily log - paragraph
				 64B16-28.140(3)(c) or
				(e), F.A.C.
(f) Failure to have pharmacy minimally
				equipped i.e. references, compounding equipment, and a current copy of the laws
				and rules governing the practice of pharmacy in the State of Florida - rule
				 64B16-28.107, F.A.C.
(g) Failure to
				properly identify pharmacy technicians - rule
				 64B16-27.410, F.A.C.
(h) Results of P&E quality assurance
				program not documented or available for inspection - paragraph
				 64B16-28.820(3)(d),
				F.A.C.
(i) Improper storage of
				legend drugs - rule  64B16-28.120, F.A.C.
(j) Improper documentation of destruction of
				controlled substances - rules
				 64B16-28.301,
				 64B16-28.303, F.A.C.
(k) Consultant pharmacist's monthly reports
				not current or available for inspection - rule
				 64B16-28.501, subsection
				 64B16-28.702(2),
				F.A.C.
(l) Controlled substance
				prescription labels lack transfer crime warning labeling - paragraph
				 64B16-28.502(2)(c),
				F.A.C.
(m) Failure to maintain
				proof of licensure, display licenses/registrations or notices, or to properly
				identify pharmacy staff - rule
				 64B16-27.100, F.A.C.
(n) Failure to have a continuously designated
				Prescription Department Manager or Consultant Pharamcist of Record, if the gap
				between designations is less than fifteen (15) business days - rules
				 64B16-27.450 and
				 64B16-28.501,
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-30 - DISCIPLINARY GUIDELINES › Section 64B16-30.0035 - Mediation

Current through Reg. 50, No. 138; July 16, 2024
(1) "Mediation" means a process whereby a
				mediator appointed by the Department acts to encourage and facilitate
				resolution of a legally sufficient complaint. It is an informal and
				nonadversarial process with the objective of assisting the parties to reach a
				mutually acceptable agreement.
(2)
				The Board finds that mediation is an acceptable method of dispute resolution
				for the following violation as it is economic in nature or can be remedied by
				the licensee: failure of the licensee to timely pay any assessed administrative
				fines or costs.
(3) A "mediator"
				means a person who is certified in mediation by the Florida Bar, the Florida
				Supreme Court, or the Division of Administrative Hearings.
Rulemaking Authority
					 456.078 FS. Law Implemented
					 456.078
					 FS.
New 11-21-94, Formerly
					 59X-30.0035.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.001 - Collaborative Practice Certification (CPC)

Current through Reg. 50, No. 138; July 16, 2024
Applicants for CPC shall submit an application using Form
				  DH5059-MQA (eff. 08/20), "Application for Pharmacist Collaborative Practice
				  Certification" that is hereby incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-12225
or
http://floridapharmacy.gov
Applicants for certification shall meet and comply with all requirements in
				  Section  465.1865, F.S.
Rulemaking Authority
					 465.1865 FS. Law Implemented
					 465.1865
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.003 - Collaborative Practice Certification: Initial Certification Course

Current through Reg. 50, No. 138; July 16, 2024
(1) Applicants for Initial Certification
				Course approval shall submit an application using Form DH5061-MQA (eff. 08/20)
				"Application for Initial Collaborative Practice Certification Course" that is
				hereby incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-12226
or
http://floridapharmacy.gov
.
(2) Initial collaborative practice
				certification courses shall be a minimum of 20 hours in duration, and shall
				meet all the following mandatory requirements:
(a) The course may only be offered by a
				program provider who is accredited by the Accreditation Council for Pharmacy
				Education (ACPE), a program provider who is accredited to provide educational
				activities designated for the American Medical Association Physician's
				Recognition Award Category I credit, or a program provider approved by the
				American Osteopathic Association to offer continuing medical education
				credits.
(b) The course content and
				objectives offered by an approved provider shall be developed in conjunction
				with an individual licensed to practice pharmacy and an individual licensed to
				practice pharmacy and an individual who is licensed allopathic or osteopathic
				physician.
(c) The course content
				shall include all those areas enumerated in Section
				 465.1865(2)(c),
				F.S. and shall cover the following areas:
1.
				Laws and rules applicable to the collaborative practice for the treatment of
				chronic health care conditions; and
2. Writing and entering into a collaborative
				practice agreement.
(d)
				No less than 8 hours of the course shall be offered through a live seminar or a
				live video conference.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.005 - Collaborative Practice Certification: Collaborative Pharmacy Practice Agreement Submission

Current through Reg. 50, No. 138; July 16, 2024
(1) Prior to
				providing or implementing patient care services under a Collaborative Pharmacy
				Practice Agreement or immediately after the renewal of such an Agreement, the
				Pharmacist shall submit the executed Agreement to the Board Office through the
				pharmacist's online licensure account at
http://flhealthsource.gov
or via U.S.
				Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399.
(2) In the event of an addendum to the
				material terms of an existing collaborative pharmacy practice agreement, the
				pharmacist shall maintain a copy of the addendum and the initial agreement
				pursuant to Section  465.1865(3)(c),
				F.S. Material terms shall be defined as those terms enumerated in Section
				 465.1865(3)(a),
				F.S.
Rulemaking Authority
					 465.1865 FS. Law Implemented
					 465.1865
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.007 - Collaborative Practice Certification: Chronic Health Conditions

Current through Reg. 50, No. 138; July 16, 2024
Pursuant to Section
				   465.1865, F.S., the Board hereby
				  adopts the following list of chronic health conditions for which a pharmacist
				  certified pursuant to Section
				   465.1865, F.S., can provide
				  specified patient care services to patients of a collaborating physician
				  pursuant to a pending Collaborative Pharmacy Practice Agreement:
(1) Hyperlipidemia:
(2) Hypertension;
(3) Anti-coagulation management;
(4) Nicotine Dependence;
(5) Opioid use disorder;
(6) Hepatitis C
(7) Those chronic health conditions
				enumerated in Section
				 465.1865(1)(b),
				F.S.
Rulemaking Authority
					 465.1865 FS. Law Implemented
					 465.1865
					 FS.
New 10-28-20, Amended 4-29-21,
					 9-27-23.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.009 - Collaborative Practice Certification: Mandatory Continuing Education

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall not be required to complete the 8-hour
				  continuing education related to collaborative pharmacy practice if the initial
				  certificate was issued less than 12 months prior to the expiration date of the
				  license.
Rulemaking Authority
					 465.1865 FS. Law Implemented
					 465.1865
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.033 - Test and Treat Certification (TTC)

Current through Reg. 50, No. 138; July 16, 2024
Applicants for TTC shall submit an application using Form
				  DH5060-MQA (eff. 08/20), "Application for Pharmacist Test and Treat
				  Certification" that is hereby incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-12227
or
http:floridapharmacy.gov
.
				  Applicants for certification shall meet and comply with all requirements in
				  Section  465.1895, F.S.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.035 - Test and Treat Certification: Initial Certification Course

Current through Reg. 50, No. 138; July 16, 2024
(1) Applicants for Initial Certification
				Course approval shall submit an application using Form DH5062-MQA (eff. 08/20)
				"Application for Initial Test and Treat Certification Course" that is hereby
				incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-12228
or
http://floridapharmacy.gov
.
(2) Initial test and treat certification
				courses shall be a minimum of 20 hours in duration, and shall meet all the
				following mandatory requirements:
(a) The
				course may only be offered by a program provider who is accredited by the
				Accreditation Council for Pharmacy Education (ACPE), a program provider who is
				accredited to provide educational activities designated for the American
				Medical Association Physician's Recognition Award Category 1 credit, or a
				program provider approved by the American Osteopathic Association to offer
				continuing medical education credits.
(b) The course content and objectives offered
				by an approved provider shall be developed in conjunction with an individual
				licensed to practice pharmacy and an individual who is licensed allopathic or
				osteopathic physician.
(c) The
				course content shall include all those areas enumerated in Section
				 465.1895(2)(b),
				F.S., and shall also cover the following areas:
1. Laws and rules applicable to test and
				treat certifications; and
2.
				Writing and entering into a written protocol.
(d) No less than 8 hours of the course shall
				be offered through a live seminar or a live video
				teleconference.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.037 - Test and Treat Certification: Written Protocol and Written Protocol Submission

Current through Reg. 50, No. 138; July 16, 2024
(1) Within 5
				business days of entering into a written protocol with a supervising physician
				pursuant to Section  465.1895, F.S., the pharmacist
				shall submit a copy of the written agreement to the Board office through the
				pharmacist's online licensure account at
http://www.flhealthsource.gov
or
				via U.S. Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL
				32399.
(2) In the event of an
				addendum to the material terms of an existing written protocol, the pharmacist
				shall maintain a copy of the addendum and the initial agreement. Material terms
				shall be defined as those terms enumerated in Section
				 465.1895(5)(a),
				F.S.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.039 - Test and Treat Certification: Formulary of Medicinal Drugs

Current through Reg. 50, No. 138; July 16, 2024
(1) Pursuant to Section
				 465.1895, F.S., the Board hereby
				incorporates all medicinal drugs approved by the United States Food and Drug
				Administration ("FDA") as the formulary of medicinal drugs that a pharmacist
				may prescribe pursuant to a written test and treat protocol and all compounded
				medicinal drugs that utilize only active pharmaceutical ingredients approved by
				the FDA.
(2) A pharmacist may not
				prescribe controlled substances as described in s. 893.03 or
				21 U.S.C. s.
				812.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.041 - Test and Treat Certification: Patient Records

Current through Reg. 50, No. 138; July 16, 2024
Upon receipt of a patient request, a pharmacist shall furnish
				  patient records to a health care practitioner designated by the patient within
				  a reasonable time frame, not to exceed 5 business days.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.043 - Test and Treat Certification: Follow-Up Care

Current through Reg. 50, No. 138; July 16, 2024
A pharmacist must provide written information to patient
				  advising the patient when to seek follow-up care from his or her primary care
				  physician. A pharmacist shall provide follow-up written information:
(1) Immediately prior to performing testing,
				screening, or treatment services on a patient for the first time; or
(2) As outlined in the written protocol;
				and
(3) When the pharmacist
				determines in his or her judgment that the patient should follow-up with his or
				her primary care provider.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 10-28-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-31 - COLLABORATIVE PRACTICE AND TEST AND TREAT CERTIFICATIONS › Section 64B16-31.045 - Test and Treat Certification: Mandatory Continuing Education

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall not be required to complete the 3-hour
				  continuing education related to minor, nonchronic health conditions if the
				  initial certificate was issued less than 12 months prior to the expiration date
				  of the license.
Rulemaking Authority
					 465.1895 FS. Law Implemented
					 465.1895
					 FS.
New 11-22-20.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-32 - NONRESIDENT PHARMACIES › Section 64B16-32.001 - Nonresident Pharmacy Permit

Current through Reg. 50, No. 138; July 16, 2024
This permit is required before a pharmacy that is located
				  outside the geographical boundaries of Florida can ship, mail, or deliver, in
				  any manner, a dispensed medicinal drug into Florida.
(1) This permit does not authorize the
				nonresident pharmacy to ship, mail, deliver, or dispense, in any manner, a
				compounded sterile product into Florida.
(2) An applicant for a nonresident pharmacy
				permit shall submit an application using Form DH-MQA 1217 (eff. 07/16),
				"Nonresident Pharmacy Permit Application, " which is hereby incorporated by
				reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07519
or
http://floridapharmacy.gov
.
				Applicants for a nonresident pharmacy permit must comply with all requirements
				in Section  465.0156,
				F.S.
Rulemaking Authority
					 465.005,
					 465.0156 FS. Law Implemented
					 465.0156,
					 456.065(3),
					 456.0635
					 FS.
New 11-3-16.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-32 - NONRESIDENT PHARMACIES › Section 64B16-32.003 - Nonresident Pharmacy Permit - Mandatory Notification for Change in Location, Change in Pharmacy Name, Change in Corporate Officer and Change in PDM

Current through Reg. 50, No. 138; July 16, 2024
(1) A change in pharmacy location, pharmacy
				name, corporate officer, or pharmacist serving as the prescription department
				manager shall be timely reported to the Board Office within 30 calendar
				days.
(2) If there is a change in
				the name of the pharmacy or the location of the pharmacy, or both, the
				department shall issue an updated duplicate permit that reflects the change or
				changes.
(3) If a duplicate permit
				is required to be issued pursuant to subsection (2), the permit holder shall
				pay a $25.00 duplicate permit fee before the duplicate permit shall be
				released.
(4) Any notification
				required by this section shall be mailed to Florida Board of Pharmacy, Bin
				#C-04, Tallahassee, Florida 32399. If a duplicate permit is required, make the
				check or money order payable to the Department of Health.
Rulemaking Authority
					 456.025(10),
					 465.005 FS. Law Implemented
					 465.0156,
					 456.025(10)
					 FS.
New 8-21-16.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-32 - NONRESIDENT PHARMACIES › Section 64B16-32.005 - Nonresident Pharmacy Exemption "Isolated Transactions"

Current through Reg. 50, No. 138; July 16, 2024
(1) A nonresident
				pharmacy is exempt from obtaining a nonresident pharmacy permit if the
				nonresident pharmacy limits its dispensing activity to a one time, per calendar
				year, isolated transaction.
(2) An
				isolated transaction is defined as making a one-time delivery of a dispensed
				medicinal drug(s) to a single identifiable patient in Florida.
(3) This exemption is not applicable to the
				delivery of a dispensed medicinal drug that is a compounded sterile
				product.
Rulemaking Authority
					 465.0156(2) FS.
					 Law Implemented 465.0156(2)
					 FS.
New 8-21-16.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-32 - NONRESIDENT PHARMACIES › Section 64B16-32.007 - Nonresident Sterile Compounding Permit for Nonresident Pharmacies

Current through Reg. 50, No. 138; July 16, 2024
This permit is required before a nonresident pharmacy ships,
				  mails, delivers, or dispenses, in any manner, a patient-specific compounded
				  sterile product into Florida.
(1) A
				nonresident pharmacy that obtains a nonresident sterile compounding permit may
				only ship, mail, deliver, or dispense a patient-specific compounded sterile
				product into Florida.
(2) A permit
				issued pursuant to this section shall be issued with the following
				conspicuously displayed on the front of the license: Nonresident Sterile
				Compounding Permit - Patient Specific Prescription Compounding Only.
(3) A nonresident pharmacy applicant seeking
				a nonresident sterile compounding permit shall submit an application using Form
				DH5003-MQA (eff. 07/16), "Nonresident Sterile Compounding Permit Application
				for Nonresident Pharmacies, " which is hereby incorporated by reference. The
				Form is available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-08096
,
				or
http://floridaspharmacy.gov
. An
				applicant for this permit must comply with all provisions of Section
				 465.0158,
				F.S.
Rulemaking Authority
					 456.0158 FS. Law Implemented
					 465.0158,
					 456.065 (3),
					 456.0635,
					 465.0156
					 FS
New 4-12-17.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-32 - NONRESIDENT PHARMACIES › Section 64B16-32.009 - Nonresident Sterile Compounding Permit for an Outsourcing Facility

Current through Reg. 50, No. 138; July 16, 2024
This permit is required before an outsourcing facility that
				  is located outside of Florida, ships, mails, delivers, or dispenses, in any
				  manner a compounded sterile product into Florida.
(1) An outsourcing facility that obtains a
				nonresident sterile compounding permit may ship, mail, or deliver a sterile
				compounded product into Florida for office-use and may ship, mail, deliver, or
				dispense a patient-specific compounded sterile product into Florida. This
				permit does not authorize the shipping, mailing, delivering, or dispensing of a
				non-compounded medicinal drug into Florida.
(2) A permit issued pursuant to this section
				shall be issued with the following conspicuously displayed on the front of the
				license: Outsourcing Facility Nonresident Sterile Compounding Permit - Patient
				Specific Prescription Compounding and Office-Use Compounding.
(3) An outsourcing facility applicant seeking
				a nonresident sterile compounding permit shall submit an application using Form
				DH5004-MQA (eff. 07/16), "Nonresident Sterile Compounding Permit Application
				for Outsourcing Facilities" which is hereby incorporated by reference. This
				Form is available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-08097
,
				or
http://floridaspharmacy.gov
.
Rulemaking Authority
					 456.0158 FS. Law Implemented
					 465.0158,
					 456.065(3)
					 FS.
New 4-12-17.