reglab/statecodes huggingface dataset:
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.107 - Pharmacy Equipment (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022,
					 465.022(1)(h)
					 FS. Law Implemented 465.022(1)(h)
					 FS.
New 5-19-72, Repromulgated 12-18-74, Amended 4-8-80,
					 4-26-84, Formerly 21S-1.10, Amended 4-4-88, Formerly 21S-1.010, Amended
					 7-31-91, Formerly 21S-28.107, 61F10-28.107, Amended 6-4-97, Formerly
					 59X-28.107, Amended 2-4-99, Repealed
					 5-4-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.108 - All Permits - Labels and Labeling of Medicinal Drugs

Current through Reg. 50, No. 138; July 16, 2024
Each container of medicinal drugs dispensed shall have a
				  label or shall be accompanied by labeling. Every pharmacy that dispenses a
				  medicinal drug to a patient or agent of the patient shall ensure that the
				  pharmacy's policy and procedures manual covers dispensing to the blind or
				  visually impaired. The manual must make certain to address that those with
				  visual impairments are fully informed of all the information required to be
				  part of the label or labeling.
(1)
				Definitions.
(a) "Controlled substance" means
				any substance named or described in Schedules II-V of Section
				 893.03, F.S.
(b) "Customized medication package" means a
				package that:
1. Is prepared by a pharmacist
				for a specific patient.
2. Is a
				series of containers.
3. Contains
				two (2) or more solid oral dosage forms.
(c) "Labeling" means a label or other
				written, printed, or graphic material upon an agent or product or any of its
				containers, wrappers, drug carts, or compartments thereof, as well as a
				medication administration record (MAR) if a medication administration record is
				an integral part of the unit dose system.
(d) "Radiopharmaceutical" means any substance
				defined as a drug in 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 of those drugs
				intended to be made radioactive. This 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 which are carbon-containing compounds or
				potassium-containing compounds or potassium-containing salts which contain
				trace quantities of naturally occurring radionuclides.
(e) "Serial number" means a prescription
				number or other unique number by which a particular prescription or drug
				package can be identified.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.10801 - All Permits - Delivery of Medicinal Drugs

Current through Reg. 50, No. 138; July 16, 2024
(1) Neither a pharmacy
				nor a pharmacist shall dispense or deliver any adulterated medicinal
				drugs.
(2) All pharmacies regulated
				under Chapter 465, F.S., must have and follow policies and procedures to ensure
				medicinal drugs are not adulterated as defined in Section
				 499.006, F.S, at the time of
				reciept by the patient or their agent.
(3) The policies and procedures must include
				providing instructions to the patient on reporting concerns with delivery and
				storage of medicinal drugs.
Rulemaking Authority
					 465.005,
					 465.022(1) FS.
					 Law Implemented 465.022(1)(a)
					 FS.
New 10-29-19.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.1081 - Regulation of Daily Operating Hours; Commencement of Operations

Current through Reg. 50, No. 138; July 16, 2024
(1) Any person who receives a community
				pharmacy permit pursuant to Section
				 465.018, F.S., and commences to
				operate such an establishment, shall keep the prescription department of the
				establishment open for a minimum of twenty (20) hours per week.
(a) "Commences to Operate" means the
				compounding, dispensing, storage, or sale of medicinal drugs or the filling or
				dispensing of prescriptions.
(b)
				The Board recognizes that a delay may exist between the time a pharmacy
				receives a Florida pharmacy permit and commences to operate. Accordingly, upon
				receipt of a Florida pharmacy permit, a community pharmacy may delay
				commencement of operations in compliance with the following:
1. Within fourteen (14) days of receipt of
				the Florida pharmacy permit, the permittee shall notify the Board office, in
				writing, of the permittee's election to delay commencement of operations and
				the reason(s) therefore,
2. The
				permittee shall display a sign in block letters not less than one inch in
				height at the main entrance of the establishment stating that the pharmacy is
				not yet open for business and that medicinal drugs may not be dispensed or sold
				nor prescriptions filled or dispensed,
3. Within two (2) business days of
				commencement of operations, the permittee shall notify the Board office in
				writing that the permittee has commenced to operate and the date of
				commencement.
(c) Any
				pharmacy permittee that does not commence to operate within six (6) months of
				the date of receipt of the Florida pharmacy permit shall provide a written
				statement to the Board office, which shall include the reason(s) the pharmacy
				has not yet commenced operations, the efforts the pharmacy has made to commence
				to operate, and the date the pharmacy expects to commence to
				operate.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.109 - Prescription Department; Padlock; Sign: "Prescription Department Closed."

Current through Reg. 50, No. 138; July 16, 2024
(1) The prescription department of any
				community pharmacy permittee shall be considered closed whenever the
				establishment is open and a pharmacist is not present and on duty. A sign with
				bold letters not less than two (2) inches in width and height, shall be
				displayed in a prominent place in the prescription department so that it may
				easily be read by patrons of that establishment. The sign shall contain the
				following language: "Prescription Department Closed."
(2) The term "not present and on duty" shall
				not be construed to prevent a pharmacist from exiting the prescription
				department for the purpose of consulting or responding to inquiries or
				providing assistance to patients or customers, attending to personal hygiene
				needs, taking a meal break pursuant to Rule
				 64B16-27.1001, F.A.C., or
				performing any other function for which the pharmacist is responsible, provided
				that such activities are conducted in a manner consistent with the pharmacist's
				responsibility to provide pharmacy services.
(3) At all times when the prescription
				department is closed, either because of the absence of a pharmacist or for any
				other reason, it shall be separated from the remainder of the establishment by
				partition or other means of enclosure, thereby preventing access to the
				prescription department by persons not licensed in Florida to practice the
				profession of pharmacy.
(4) The
				partition or other means of enclosure shall be securely locked or padlocked and
				only a pharmacist shall have the means to gain access to the prescription
				department.
(5) Whenever the
				prescription department of any community pharmacy establishment is closed, no
				person other than a pharmacist shall enter, be permitted to enter or remain in
				the prescription department.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022
					 FS.
New 8-20-63, 5-19-72, Repromulgated 12-18-74, Amended
					 5-6-80, Formerly 21S-1.14, 21S-1.014, Amended 7-31-91, Formerly 21S-28.109,
					 61F10-28.109, 59X-28.109, Amended 6-15-98,
					 4-10-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.110 - Outdated Pharmaceuticals

Current through Reg. 50, No. 138; July 16, 2024
Under no circumstances may prescription drugs,
				  pharmaceuticals or devices which bear upon the container an expiration or
				  beyond use date which has been reached be sold or dispensed to the public.
				  Accordingly, all outdated, damaged, deteriorated, misbranded, or adulterated
				  prescription drugs and pharmaceuticals shall be removed or quarantined from
				  active stock.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022,
					 465.023(1)(c),
					 499.006(9),
					 499.0121(5)
					 FS.
New 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.17,
					 21S-1.017, 21S-28.110, 61F10-28.110, 59X-28.110, Amended
					 4-4-19.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.111 - Storage of Equipment (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022
					 FS.
Promulgated 12-18-74, Formerly 21S-1.19, 21S-1.019,
					 21S-28.111, 61F10-28.111, 59X-28.111, Repealed
					 4-10-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.112 - Violations (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1)
					 FS.
New 8-20-63, Amended 5-19-72, Promulgated 12-18-74,
					 Formerly 21S-1.23, 21S-1.023, Amended 7-31-91, Formerly 21S-28.112,
					 61F10-28.112, 59X-28.112, Repealed
					 4-10-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.113 - Permits; Single Entity; Single Location

Current through Reg. 50, No. 138; July 16, 2024
A Board of Pharmacy permit shall be issued only to a single
				  entity at a single location. The service provided by the permit shall be
				  consistent with the issued permit. A single location shall be defined
				  as:
(1) A contiguous area under the
				control of the permit holder. For purposes of this section, a public
				thoroughfare will be considered to have not broken the area of contiguity; and,
(2) An area not more than one-half
				mile from the central location of the permit.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.003(11)(a),
					 465.018,
					 465.019,
					 465.0193,
					 465.0196
					 FS.
New 1-30-96, Formerly
					 59X-28.113.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.1135 - Change of Ownership (Transferred)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.003(11)(a),
					 465.018,
					 465.019,
					 465.0193,
					 465.0196,
					 465.022(7)
					 FS.
New 4-19-00, Amended 1-2-02, Transferred to
					  64B16-28.2021.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.114 - Prescription Refills (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.016(1),
					 465.022,
					 465.022(1)(a),
					 893.04 FS. Law Implemented
					  465.022 FS.
New 12-18-74, Formerly 21S-1.28, 21S-1.028, Amended
					 7-31-91, Formerly 21S-28.114, 61F10-28.114, 59X-28.114, Amended 2-4-02, 7-1-02,
					 Repealed 10-5-09.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.118 - Unit Dose and Customized Patient Medication Package Returns

Current through Reg. 50, No. 138; July 16, 2024
(1) Definitions. As used herein:
(a) A "unit dose system" means a system
				wherein all individually sealed unit doses are physically connected as a unit.
				For purpose of this rule, a product in an unopened, sealed, manufacture's
				container is deemed to be a unit dose package.
(b) A "customized patient medication package"
				means a system wherein all USP approved multi-dose units are physically
				connected (also referred to as a "container"). The use of customized patient
				medication packages must comply with the provisions of subsection
				 64B16-28.108(5),
				F.A.C.
(c) A "closed drug delivery
				system" is a system in which the actual control of the unit dose or customized
				patient medication package is maintained by the facility rather than by the
				individual patient.
(d) For
				purposes of this rule, "facility" shall mean any health care institution
				operating with a Class I, Class II, Modified Class II, or Special ALF
				permit.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.119 - Data Processing Systems in Pharmacy (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.0155,
					 465.022 FS. Law Implemented
					 465.022,
					 465.026,
					 893.07
					 FS.
New 9-21-83, Formerly 21S-1.38, 21S-1.038, Amended 7-31-91,
					 Formerly 21S-28.119, Amended 3-16-94, Formerly 61F10-28.119, 59X-28.119,
					 Repealed 7-15-99.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.1191 - Unclaimed Prescriptions

Current through Reg. 50, No. 138; July 16, 2024
Prescriptions that are unclaimed may be retained by a
				  pharmacy and reused for a period up to one year from the date of filling;
				  however, any product reaching the product's expiration date prior to one year
				  or any product subject to a recall shall not be reused. If the unclaimed
				  product is in its original manufacturer's packaging, then the expiration date
				  shall revert back to the date as listed on the original manufacturer's
				  packaging.
Rulemaking Authority
					 465.0255 FS. Law Implemented
					 465.0255
					 FS.
New 4-10-05, Amended
					 2-7-23.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.120 - All Permits - Storage of Legend Drugs; Prepackaging

Current through Reg. 50, No. 138; July 16, 2024
(1) All medicinal drugs or drug preparations
				as defined by Section
				 465.003(8),
				F.S., shall be stored:
(a) Within the
				confines of the prescription department of a community pharmacy permittee as
				defined in Section  465.018, F.S.
(b) In a Class II Institutional pharmacy as
				defined by Section  465.019(2)(b),
				F.S., within the confines of the pharmacy provided, however, that those
				medicinal drugs established by the consultant pharmacist as supportive to
				treatment procedures such as medical drugs, surgical, obstetrical, diagnostic,
				etc., may be permitted to be stored in those areas where such treatment is
				conducted consistent with proper control procedures as provided by the policy
				and procedure manual of the pharmacy.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.121 - Permit Fees (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022
					 FS.
New 7-31-91, Formerly 21S-28.121, 61F10-28.121, 59X-28.121,
					 Amended 10-30-00, Repealed 4-10-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.130 - Transmission of Prescription Orders (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.0155,
					 465.022 FS. Law Implemented
					 465.022,
					 465.026,
					 893.07
					 FS.
New 3-16-94, Formerly 61F10-28.130, 59X-28.130, Repealed
					 4-10-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.141 - Requirements for an Automated Pharmacy System in a Community Pharmacy (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.018,
					 465.022
					 FS.
New 11-29-04, Amended 12-30-07, 1-1-10, 7-5-18, Repealed
					 6-24-21.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.150 - Record Maintenance Systems for Institutional and Animal Shelter Permits (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.0155,
					  465.022,
					 828.055 FS. Law Implemented
					 465.022,
					  465.019,
					  465.026,
					  893.07,
					  828.055 FS.
New 4-12-95, Formerly 59X-28.150, Repealed
					 5-3-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.201 - Definitions (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022,
					 465.022(1)(g)
					 FS. Law Implemented 465.022(1)(g)
					 FS.
New 12-26-79, Amended 4-28-83, 4-30-85, Formerly 21S-16.01,
					 21S-16.001, Amended 7-31-91, Formerly 21S-28.201, 61F10-28.201, 59X-28.201,
					 Repealed 4-5-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.202 - Closing of a Pharmacy; Transfer of Prescription Files

Current through Reg. 50, No. 138; July 16, 2024
(1) The term
				"prescription files" as used herein shall mean the drug dispensing records of a
				pharmacy which shall include all orders for drugs or medicinal supplies as
				defined by Section  465.003(7),
				F.S., inclusive of dispensing records for medicinal drugs listed within the
				provisions of Section
				 893.03, F.S., issued by a duly
				licensed practitioner, which serve to transfer possession of medicinal drugs
				from the pharmacy to the ultimate consumer.
(2) The term "closing of a pharmacy" as used
				herein shall mean the cessation or termination of professional and business
				activities within a pharmacy for which a permit has been issued under Chapter
				465, F.S.
(3) Prior to closure of a
				pharmacy the permittee shall notify the Board of Pharmacy in writing as to the
				effective date of closure, and shall:
(a)
				Return the pharmacy permit to the Board of Pharmacy office or arrange with the
				local Bureau of Investigative Services of the Department to have the pharmacy
				permit returned to the Board of Pharmacy;
(b) Advise the Board of Pharmacy which
				permittee is to receive the prescription files.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.2021 - Change of Ownership

Current through Reg. 50, No. 138; July 16, 2024
(1) A pharmacy
				permit is not transferable. If upon the sale of an existing pharmacy, there is
				any change in the identity of the natural person, partnership, or business
				entity which holds the permit, a new application must be filed and a new permit
				obtained. For purposes of this rule, the test for determining change of
				identity shall be whether the person or entity's Federal Employer
				Identification Number (FEIN) remains the same following the sale.
(2) Permits held by business entities with no
				change in identity. In those cases where the permit is held by a business
				entity (e.g. a corporation, limited liability company, limited partnership,
				etc.) which entity continues to hold the permit without change in identity, the
				transfer of the ownership interests of said business entity to another person
				or business entity does not constitute a change of ownership (requiring
				application for and issuance of a new pharmacy permit). Upon transfer of the
				ownership interests in the business entity, the following steps shall be taken:
(a) Within fifteen (15) days of closing the
				transfer, the permittee shall notify the Board office of the transfer of
				ownership interests; and,
(b) As
				specified in Section  465.022(3),
				F.S., all persons, members, partners, officers, directors, and agents having an
				ownership or other financial interest of greater than five percent (5%), and
				all persons who directly or indirectly manage, oversee, or control the
				operation of the business entity, must file with the board a set of
				fingerprints as specified in paragraph
				 64B16-28.100(1)(c),
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.301 - Destruction of Controlled Substances - Institutional Class I Pharmacies (Nursing Homes)

Current through Reg. 50, No. 138; July 16, 2024
(1) Controlled
				substances that have been dispensed and not used by the patient shall not be
				returned to the pharmacy and shall be securely stored by the nursing home until
				destroyed.
(2) For each controlled
				substance destroyed, documentation must be completed showing the name and
				quantity of the drug, strength and dosage form, patient's name, prescription
				number and name of the institution. Destruction of the controlled substance
				shall be witnessed by at least two (2) of the following individuals:
(a) Consultant pharmacist;
(b) Director of nursing
(c) Facility administrator;
(d) A licensed physician, mid-level
				practitioner, nurse, or another pharmacist employed by or under contract or
				written agreement with the facility, or
(e) A sworn law enforcement officer.
Those individuals witnessing the destruction of the
				  controlled substance shall sign the completed
				  documentation.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.303 - Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes)

Current through Reg. 50, No. 138; July 16, 2024
(1) Controlled
				substances that cannot be retained as usable shall be securely stored in the
				pharmacy/prescription department of the permittee pharmacy until
				destroyed.
(2) Permittees are
				required to complete a United States Drug Enforcement Administration (D.E.A.)
				Form DEA-41 "Registrant Record of Controlled Substances Destroyed" (Expiration
				Date 01/31/2024), herein incorporated by reference, available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-15213
or
http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/
.
				This form, at the time of destruction, shall be witnessed and signed by the
				prescription department manager or the consultant pharmacist of record and
				D.E.A. agent, or a Department inspector.
(3) Another method of destruction shall be
				conducted by at least two persons: One will be the prescription department
				manager or the consultant pharmacist of record. The other will be one of the
				following: medical director or his/her physician designee, director of nursing
				or his/her licensed nurse designee, or a sworn law enforcement officer. These
				persons shall serve as the witnesses for the Form DEA-41 and the
				destruction.
(4) In lieu of
				destruction on the premises as outlined in subsections (2) and (3) above,
				controlled substances may also be shipped to reverse distributors for
				destruction in conformity with federal guidelines.
(5) For patient specific controlled substance
				prescriptions in a Modified Institutional Class II B pharmacy, the destruction
				method in subsection  64B16-28.301(2),
				F.A.C., must be followed.
(6) All
				records shall be maintained as required by Section
				 465.022,
				F.S.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022,
					 465.018
					 FS.
New 4-21-87, Formerly 21S-19.003, Amended 7-31-91, Formerly
					 21S-28.303, 61F10-28.303, Amended 1-30-96, Formerly 59X-28.303, Amended 2-5-07,
					 10-27-09, 2-1-12, 4-20-14, 3-20-23.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.402 - Labels and Labeling of Medicinal Drugs - Community Pharmacy Permit (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1),
					 465.0255
					 FS.
New 7-3-91, Formerly 21S-28.402, Amended 12-27-93, Formerly
					 61F10-28.402, 59X-28.402, Amended 9-17-97, Repealed
					 5-11-05.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.404 - Regulation of Daily Operating Hours (Repealed)

Current through Reg. 50, No. 138; July 16, 2024
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1)
					 FS.
New 8-20-65, Amended 5-19-72, Repromulgated 12-18-74,
					 Amended 5-6-80, 3-31-81, Formerly 21S-1.24, Amended 7-14-88, Formerly
					 21S-1.024, Amended 7-31-91, 3-15-92, Formerly 21S-28.404, 61F10-28.404, Amended
					 9-21-94, Formerly 59X-28.404, 59X-28.404, Repealed
					 2-28-07.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.450 - Centralized Prescription Filling, Delivering and Returning

Current through Reg. 50, No. 138; July 16, 2024
(1) As used
				herein:
(a) The term "originating pharmacy"
				means a pharmacy wherein the prescription which will be filled by the central
				fill pharmacy is initially presented; and,
(b) The term "central fill pharmacy" means a
				pharmacy which performs centralized prescription filling, delivering, and
				returning for one or more originating pharmacies.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.451 - Pharmacy Common Database; Exceptions for Prescription Drug Processing Only Pharmacies

Current through Reg. 50, No. 138; July 16, 2024
(1) A pharmacy
				licensed under this chapter may perform prescription drug processing for other
				pharmacies, provided that all pharmacies are under common ownership, utilize a
				common database, and are properly licensed, permitted or registered in this
				state or another state. Nothing in this subsection shall prohibit a pharmacist
				employee of said pharmacies who is licensed in Florida or in another state from
				remotely accessing the pharmacy's electronic database from outside the pharmacy
				in order to process prescriptions, provided the pharmacy establishes controls
				to protect the privacy and security of confidential records.
(2) Prescription drug processing shall
				include the following:
(a) Receiving,
				interpreting, or clarifying a prescription;
(b) Entering prescription data into the
				pharmacy's record;
(c) Verifying or
				validating a prescription;
(d)
				Performing prospective drug review as defined by the Board;
(e) Obtaining refill and substitution
				authorizations;
(f) Interpreting or
				acting on clinical data;
(g)
				Performing therapeutic interventions;
(h) Providing drug information concerning a
				patient's prescription; and,
(i)
				Providing patient counseling.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.501 - Consultant Pharmacist of Record; Initial Designation; Change

Current through Reg. 50, No. 138; July 16, 2024
(1) Designation as Consultant Pharmacist of
				Record.
(a) Initial Designation. Pursuant to
				sections  465.019 and
				 465.022, F.S., a permit for an
				Institutional pharmacy may not be issued unless a licensed pharmacist is
				designated as the consultant pharmacist of record. In addition, pursuant to
				rule  64B16-28.870, F.A.C., an
				application for a Special Assisted Living Facility pharmacy permit requires the
				supervising licensed pharmacist be designated as the consultant pharmacist of
				record. Finally, applications for Special Sterile Compounding Permits
				associated with an Institutional pharmacy require the pharmacist-in-charge be
				designated as the consultant pharmacist of record. Initial designation is
				accomplished as part of the application process using the appropriate
				application form incorporated in rule
				 64B16-28.100, F.A.C.
(b) Change of Consultant Pharmacist of
				Record.
No later than ten (10) days after a change of designated
				  consultant pharmacist for an Institutional, Special Assisted Living Facility
				  pharmacy, or a Special Sterile Compounding Permitee, both the pharmacy
				  permittee and the newly designated consultant pharmacist of record shall notify
				  the Board of the change and the identity of the newly designated consultant
				  pharmacist. Notification shall be accomplished by completing Form DH-MQA 1184
				  (01/18), Consultant Pharmacist of Record (COR) Designation and Privacy
				  Statement Acknowledgement, which is hereby incorporated by reference and which
				  can be obtained from
http://www.flrules.org/Gateway/reference.asp?No=Ref-09437
or the Board's website at
http://floridaspharmacy.gov/Applications/app
- change - consultant - pharmacist.pdf . In addition, an outgoing consultant
				  pharmacist of record may choose to notify the Board they will no longer serve
				  as consultant pharmacist of record using this form.
(c) Submission of Fingerprints. In addition
				to submission of Form DH-MQA 1184, the newly designated consultant pharmacist
				shall comply with the fingerprinting requirements of sections
				 456.0135 and
				 465.022, F.S. Electronic
				fingerprint information ("EFI") that has been submitted to the Florida Agency
				for Health Care Administration may be accessible by the Florida Department of
				Health for a period of sixty (60) months. If the Department is able to access
				EFI from AHCA, applicants will not be required to resubmit EFI for additional
				or new applications submitted during this time period. After sixty (60) months,
				new electronic fingerprint information must be submitted as part of all
				applications.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.502 - Class I, Class II and Class III Institutional Permit - Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home

Current through Reg. 50, No. 138; July 16, 2024
(1) The label affixed to
				a container used in conventional dispensing to a Class I, Class II or Class III
				Institutional permit which, within the scope of its practice, services only the
				inpatients of a nursing home as defined by subsection
				 400.021(5),
				F.S., shall contain at least the following information:
(a) The name of and address of the
				pharmacy;
(b) The name of the
				prescriber;
(c) The name of the
				patient;
(d) The date of the
				original filling or the refill date;
(e) The prescription number or other
				prescription identification adequate to readily identify the
				prescription;
(f) The directions
				for use;
(g) The name of the
				medicinal drug dispensed (except where the health care practitioner prescribing
				the drug specifically denotes that the name is to be withheld);
(h) 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 64B16-28.503 - Transmission of Starter Dose Prescriptions for Patients in Class I or Modified II B Institutional Facilities

Current through Reg. 50, No. 138; July 16, 2024
(1)
				Definitions.
(a) "Vendor pharmacy" means a
				community pharmacy or special closed system pharmacy which has a contract to
				dispense a medicinal drug to a patient in a facility holding a Class I
				Institutional Permit or Modified II B Permit.
(b) "Starter dose pharmacy" means a pharmacy
				that dispenses a medicinal drug pursuant to a starter dose prescription for a
				patient in a facility served by the vendor pharmacy.
(c) "Starter dose prescription" means a
				prescription transmitted by a vendor pharmacy to a starter dose pharmacy for
				the purpose of initiating drug therapy for a patient in a facility served by
				the vendor pharmacy. The term "starter dose prescription" does not include
				prescriptions for controlled substances.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.602 - Institutional Class II Class III Dispensing

Current through Reg. 50, No. 138; July 16, 2024
(1) Pharmaceutical
				preparations which are administered to patients of a hospital by the personnel
				of such institution shall only be taken from the original container, or from a
				container which has been prepared by a Florida licensed pharmacist. Only single
				doses of such preparations shall be removed from the container, and then only
				after the preparation has been prescribed for a specific patient, and the order
				has been duly recorded upon the records of the institution. This requirement
				shall not apply to nor be construed as preventing the administration of
				treatment in bona fide emergency cases, or further as prohibiting any person
				who is a duly licensed physician from dispensing medicinal drugs as defined in
				chapter 465, F.S. A single dose of medicinal drugs based upon a valid
				physician's drug order may also be obtained and administered under the
				supervision of the nurse in charge consistent with good institutional practice
				procedures as established by the consultant pharmacist of record and written in
				the policy and procedure manual which shall be available within the
				pharmacy.
(2) A Class II or Class
				III Institutional pharmacy may contract with a Special Parenteral/Enteral
				Extended Scope pharmacy for the pharmacy services provided for by rule
				 64B16-28.860,
				F.A.C.
(a) 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. The institutional pharmacy permit shall
				maintain records appropriate to ensure the provision of proper patient
				care.
2. The institutional pharmacy
				permit designee shall inspect and log in all medicinal drugs provided by the
				Special Parenteral/Enteral Extended Scope pharmacy.
3. A pharmacist for the institutional
				pharmacy shall provide drug utilization review and shall review each
				prescription order prior to transmission to the Special Parenteral/Enteral
				Extended Scope pharmacy.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.6021 - Institutional Class II and Class III Pharmacy - Emergency Department Dispensing

Current through Reg. 50, No. 138; July 16, 2024
(1) Individuals
				licensed to prescribe medicinal drugs in this state may dispense from the
				emergency department of a hospital holding a Class II or Class III,
				Institutional pharmacy permit. Such dispensing must meet the requirements
				provided in subsection
				 465.019(4),
				F.S., and this section.
(2) The
				following records of prescribing and dispensing must be created by the
				prescriber/dispenser and maintained by the consultant pharmacist of record
				within the facility:
(a) Patient name and
				address.
(b) Drug and strength
				prescribed/dispensed.
(c) Quantity
				prescribed/dispensed.
(d)
				Directions for use.
(e)
				Prescriber/dispenser.
(f)
				Prescriber DEA registration, if applicable.
(g) Reason community pharmacy services were
				not readily accessible.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.603 - Class II and Class III Institutional Pharmacy Operating Hours

Current through Reg. 50, No. 138; July 16, 2024
Any person who receives a Class II or Class III Institutional
				  permit pursuant to section
				   465.019, F.S., and commences to
				  operate such a pharmacy shall, for the benefit of the institutions' patients'
				  health and welfare, keep the pharmacy of the establishment open for a
				  sufficient number of daily operating hours required to provide adequate and
				  quality pharmaceutical services to the patients of said
				  institution.
Rulemaking Authority
					 465.005,
					 465.022 FS. Law Implemented
					 465.022(1)
					 FS.
New 7-31-91, Formerly 21S-28.603, 61F10-28.603, 59X-28.603,
					 Amended 9-27-18.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.604 - Class II and Class III Institutional Pharmacy Department Security

Current through Reg. 50, No. 138; July 16, 2024
The pharmacy department shall be considered closed whenever a
				  Florida licensed pharmacist is not present and on duty. At all times when the
				  pharmacy department is closed, either because of the absence of a Florida
				  licensed pharmacist or for any other reason, it shall be secured to prevent
				  access. When the pharmacy department is closed, no person other than a Florida
				  licensed pharmacist shall enter, except as authorized by paragraph
				   465.019(2)(b),
				  F.S., and rule  64B16-28.602,
				  F.A.C.
Rulemaking Authority
					 465.005,
					 465.022(1),
					 465.019 FS. Law Implemented
					 465.019,
					 465.022(1)
					 FS.
New 9-21-94, Formerly
					 59X-28.604.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.605 - Class II and Class III Institutional Pharmacies - Automated Distribution and Packaging

Current through Reg. 50, No. 138; July 16, 2024
(1)
				Definitions.
(a) "Automated medication system"
				means a robotic, mechanical or computerized device that is not used for
				medication compounding and is designed to:
1.
				Distribute medications in a licensed health care facility; or
2. Package medications for final distribution
				by a pharmacist.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.606 - Remote Medication Order Processing for Class II or Class III Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities

Current through Reg. 50, No. 138; July 16, 2024
(1) Definitions.
(a) "Remote Medication Order Processing"
				includes any of the following activities performed for a Class II or Class III
				Institutional Pharmacy or for Special Pharmacy Permits servicing Class I, Class
				II, Modified Class II, Class III, and Special ALF permitted facilities from a
				remote location:
1. Receiving, interpreting,
				or clarifying medication orders;
2.
				Entering or transferring medication order data;
3. Performing prospective drug use
				review;
4. Obtaining substitution
				authorizations;
5. Interpreting and
				acting on clinical data;
6.
				Performing therapeutic interventions;
7. Providing drug information;
8. Authorizing the release of a medication
				for administration.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.607 - Automated Pharmacy System - Long-Term Care, Hospice, and Prison

Current through Reg. 50, No. 138; July 16, 2024
(1) Definitions.
(a) "Automated pharmacy system" means a
				mechanical system that performs operations or activities, other than
				compounding or administration, relative to the storage, packaging, counting,
				labeling, and delivery of a medicinal drug, and which collects, controls, and
				maintains a record of each transaction.
(b) "Provider pharmacy" means a pharmacy that
				provides pharmacy services by using an automated pharmacy system at a remote
				site.
(c) "Remote site" means a
				long term care facility or hospice licensed under chapter 400, F.S., or a state
				correctional institution operated under Chapter 944, F.S., that is not located
				at the same location as the provider pharmacy, at which pharmacy services are
				provided using an automated pharmacy system.
(d) "Controlled substance" means a substance
				listed in Chapter 893, F.S., or  21 C.F.R. Part 1308.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.608 - Automated Filling Systems within a Pharmacy

Current through Reg. 50, No. 138; July 16, 2024
(1) Definitions. The
				following definitions shall be applicable for purposes of this
				rule:
(a) "Automated filling system" means an
				automated system used within a pharmacy to assist in filling a prescription
				drug order by selecting, labeling, filling, or sealing medication for
				dispensing. An "automated filling system" shall not include automated devices
				used solely to count medication, vacuum tube drug delivery systems, or systems
				governed by Rule  64B16-28.606 or
				 64B16-28.607, F.A.C.
(b) "Electronic verification process" means
				an electronic verification, bar code verification, weight verification, radio
				frequency identification (RFID), or similar electronic process or system that
				accurately verifies medication has been properly prepared for dispensing by an
				automated filling system.
(c)
				"Manufacturer Unit of Use Package" means a drug dispensed in the manufacturer's
				original and sealed packaging, or in the original and sealed packaging of a
				repackager.
(d) "Repackager" means
				a repackager registered with the United States Food and Drug Administration
				(FDA), as defined by Section
				 499.003(50),
				F.S.
(e) "Prepacked" means any drug
				that has been removed from the original packaging of the manufacturer or an FDA
				Repackager and is placed in a container for use in an automated filling system,
				as referenced by Section
				 499.003(42),
				F.S.
(f) "System drug identifier
				database" means the database or other system which positively identifies the
				drug to be dispensed by the automated filling system.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.750 - Class III Institutional Pharmacies

Current through Reg. 50, No. 138; July 16, 2024
(1)
(a) Class III Institutional Pharmacies are
				those Institutional Pharmacies authorized by Section
				 465.019(2)(d),
				F.S. All Class III Institutional Pharmacies must be affiliated with a hospital.
				An Institutional Pharmacy may hold only a Class III Institutional Pharmacy
				Permit, or may hold a Class III Institutional Permit in conjunction with other
				permits authorized by Florida statute or administrative rule.
(b) A Class III Institutional Permit may be
				issued to existing Class II or Modified Class II Institutional Pharmacy
				Permittees or as an initial permit to new pharmacy facilities meeting the
				statute's requirements or Central Distribution Facilities under common control
				with a hospital.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.800 - Special Pharmacies

Current through Reg. 50, No. 138; July 16, 2024
(1) Special
				pharmacies are pharmacies providing miscellaneous specialized pharmacy service
				functions. The Board of Pharmacy, by this rule, provides for the establishment
				of the following special pharmacy permits:
(a)
				Special-Limited Community.
(b)
				Special-Parenteral and Enteral.
(c)
				Special-Closed System Pharmacy.
(d)
				Special-End Stage Renal Disease.
(e) Special-Parenteral/Enteral Extended
				Scope.
(f) Special-ALF.
(g) Special Sterile
				Compounding.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.802 - Special Sterile Compounding Permits for Pharmacies and Outsourcing Facilities

Current through Reg. 50, No. 138; July 16, 2024
(1) A Special
				Sterile Compounding Permit (SSCP) is required before any pharmacy may engage in
				the preparation of compounded sterile products. For purposes of this rule, an
				outsourcing facility shall be deemed a pharmacy.
(2) An SSCP shall be issued by the department
				as an additional permit with a separate permit number that differs from the
				permit number of the pharmacy obtaining the SSCP.
(3) All sterile compounding shall be done in
				strict compliance with the standards set forth in Rules
				 64B16-27.700 and
				 64B16-27.797, F.A.C.
(4) An outsourcing facility shall comply with
				current good manufacturing practices as adopted and incorporated in Rule
				 64B16-27.797, F.A.C.
(a) If a pharmacy is not registered as an
				outsourcing facility at the time the pharmacy applies for an SSCP, the
				applicant shall amend the application within 7 business days if the pharmacy
				becomes a registered outsourcing facility before the SSCP is issued.
(b) If a pharmacy is issued an SSCP and later
				becomes registered as an outsourcing facility, the pharmacy will not be
				required to obtain a new or additional SSCP. However, the pharmacy shall comply
				with current good manufacturing practices to be eligible to retain the issued
				SSCP and the pharmacy shall notify the department in writing within 7 business
				days of becoming a registered outsourcing facility.
(c) An outsourcing facility that does not
				engage in patient specific sterile compounding and dispensing pursuant to such
				prescription shall only be required to obtain the SSCP. However, if the
				outsourcing facility engages in patient-specific sterile compounding, in
				addition to the SSCP, the outsourcing facility shall be required to obtain a
				pharmacy permit specific to the type of patient dispensing that the pharmacy
				will be engaged in (i.e., community pharmacy permit or institutional pharmacy
				permit).