reglab/statecodes huggingface dataset:
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. "Biological
				product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
				blood component or derivative, allergenic product, protein (except any
				chemically synthesized polypeptide), or analogous product, or arsphenamine or
				derivative or arsphenamine (or any other trivalent organic arsenic compound),
				applicable to the prevention, treatment, or cure of a disease or condition of
				human beings.
2.2. "Biosimilar"
				means a biological product that has been licensed as a biosimilar pursuant to
				42 U.S.C. §
										262(k), reflecting that it
				is highly similar to the specific reference biological product notwithstanding
				minor differences in clinically inactive components, and that there are no
				clinically meaningful differences between the reference biological product in
				terms of safety, purity, and potency of the product.
2.3. "Brand name" means the proprietary or
				trade name selected by the manufacturer and placed upon a drug or drug product,
				its container, label, or wrapping at the time of packaging.
2.4. "Interchangeable biological product"
				means a biological product that the federal Food and Drug Administration has
				licensed and determined meets the standards for interchangeability pursuant to
				42 U.S.C §
										262(k)(4) or determined is
				therapeutically equivalent as set forth in the latest edition of or supplement
				of the federal Food and Drug Administration's Approved Drug Products with
				Therapeutic Equivalence Evaluations.
2.5. "Original prescription" means either the
				original written prescription drug order, or the original verbal or electronic
				prescription drug orders reduced to writing either manually or electronically
				by the pharmacist.
2.6. "Proper
				name" means the nonproprietary name of a biological product.
2.7. "Reference biological product" means the
				single biological product licensed pursuant to
				42 U.S.C. §
										262(a) against which a
				biological product is evaluated in an application submitted to the U.S. Food
				and Drug Administration for licensure of biological products as biosimilar or
				interchangeable pursuant to 42 U.S.C. §
										262(k).
2.8. "Substitute" means to dispense without
				the prescriber's express authorization an interchangeable biological product in
				the place of the drug ordered or prescribed.
2.9. "Therapeutically equivalent" means
				pharmaceutically equivalent drug products that, if administered in the same
				amounts, will provide the same therapeutic effect, identical in duration and
				intensity.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-3 - Substitution Requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. A
				pharmacist may dispense an interchangeable biological product if:
3.1.1. The interchangeable biological product
				costs the patient less than or the same amount as the prescribed drug
				product;
3.1.2. The patient does
				not refuse the substitution; and
3.1.3. The practitioner does not certify on
				the prescription form that a specific prescribed brand is medically necessary
				as specified in a dispensing directive described in subsection (c) of this
				section.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-4 - Patient Notification

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1.
				Substitution notification. Before delivery of a prescription for an
				interchangeable biological product, a pharmacist must personally, or through
				his or her agent or employee inform the patient or the patient's agent that a
				less expensive interchangeable biological product is available for the brand
				prescribed; and ask the patient or the patient's agent to choose between the
				interchangeable biological product and the brand prescribed.
4.2. Exceptions. A pharmacy is not required
				to comply with the provisions of subsection 4.1. of this section:
4.2.1. in the case of the refill of a
				prescription for which the pharmacy previously complied with subsection 4.1. of
				this section with regard to the same patient or patient's agent; or
4.2.2. if the patient's physician or
				physician's agent advises the pharmacy that:
4.2.2.a. the physician has informed the
				patient or the patient's agent that a less expensive interchangeable biological
				product is available for the brand prescribed; and
4.2.2.b. the patient or the patient's agent
				has chosen either the brand prescribed or the less interchangeable biological
				product.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-5 - Communication with prescriber

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. Not
				later than the fifth business day after the date of dispensing a biological
				product, the dispensing pharmacist or the pharmacist's designee shall
				communicate to the prescribing practitioner the specific product provided to
				the patient, including the name of the product and the manufacturer or national
				drug code number.
5.2. The
				communication must be conveyed by making an entry into an interoperable
				electronic medical records system or through electronic prescribing technology
				or a pharmacy benefit management system or a pharmacy record, which may include
				information submitted for the payment of claims, that a pharmacist reasonably
				concludes is electronically accessible by the prescribing practitioner.
				Otherwise, the pharmacist or the pharmacist's designee shall communicate the
				biological product dispensed to the prescribing practitioner, using facsimile,
				telephone, electronic transmission, or other prevailing means, provided that
				communication is not required if:
5.2.1. there
				is no interchangeable biological product approved by the United States Food and
				Drug Administration for the product prescribed; or
5.2.2. a refill prescription is not changed
				from the product dispensed on the prior filling of the prescription.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-6 - Records

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. When a
				pharmacist dispenses an interchangeable biological product, the following
				information shall be noted on the original prescription or in the pharmacy's
				data processing system:
6.1.1. any
				substitution instructions communicated orally to the pharmacist by the
				practitioner or practitioner's agent; and
6.1.2. the name and strength of the actual
				drug product dispensed shall be noted on the original or hard-copy prescription
				drug order. The name shall be either:
6.1.2.a.
				the brand name and strength; or
6.1.2.b. the name of the interchangeable
				biological product, strength, and name of the manufacturer or distributor of
				such generic drug or interchangeable biological product. (The name of the
				manufacturer or distributor may be reduced to an abbreviation or initials,
				provided the abbreviation or initials are sufficient to identify the
				manufacturer or distributor. For combination drug products having no brand
				name, the principal active ingredients shall be indicated on the
				prescription.)
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-17 - Board of Pharmacy Rules for the Substitution of Biological Pharmaceuticals › Section 15-17-7 - Dispensing Responsibilities

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1.
				The determination of the drug product to be substituted as authorized by West
				Virginia Code of State Rules §15-17 et seq. is the professional
				responsibility of the pharmacist, and the pharmacist may not dispense any
				product that does not meet the requirements of the West Virginia Code of State
				Rules §15-17 et seq.
7.2.
				Pharmacists shall use as a basis for the determination of interchangeability as
				defined in West Virginia Code of State Rules §15-17 et seq., most recent
				edition or supplement of the United States Food and Drug Administration's
				references (e.g. the Purple Book).
7.3. Pharmacists shall use Lists of Licensed
				Biological Products with Reference Product Exclusivity and Biosimilarity or
				Interchangeability Evaluations (Purple Book) and current supplements published
				by the Federal Food and Drug Administration, within the limitations stipulated
				in that publication, to determine biosimilarity to or interchangeability with a
				reference biological product.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-18 - Application for Waiver of Initial Licensing Fees for Certain Individuals › Section 15-18-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- This
				rule establishes procedures for waiving the initial licensing fee for low
				income individuals and military personnel and their spouses.
1.2. Authority. -- W. Va. Code §
									30-5-7 and §
									30-1-22.
1.3. Filing Date. - April 27, 2020.
1.4. Effective Date. - April 27,
				2020.
1.5. Sunset Provision. --
				This rule shall terminate and have no further force or effect on April 27,
				2025.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-18 - Application for Waiver of Initial Licensing Fees for Certain Individuals › Section 15-18-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. "Board" means
				the West Virginia Board of Pharmacy.
2.3. "Initial license" means an individual
				applying for a pharmacist intern, pharmacist, pharmacy technician, or pharmacy
				technician trainee license in West Virginia for the first time;
2.4 "Local labor market" means every county
				in West Virginia, and any county outside of West Virginia if any portion of
				that county is within fifty miles of the border of West Virginia, pursuant to
				W.Va. Code §
									21-1C-2;
2.5. "Low-income individual" means an
				individual in the local labor market as defined in §21-1C-2, whose
				household adjusted gross income is below 130 percent of the federal poverty
				line. This term also includes any person enrolled in a state or federal public
				assistance program including, but not limited to, the Temporary Assistance for
				Needy Families Program, Medicaid, or the Supplemental Nutrition Assistance
				Program;
2.6. "Military families"
				means any person who serves as an active member of the armed forces of the
				United States, the National Guard, or a reserve component as described in
				38 U. S. C. §
										101, honorably discharged veterans of those
				forces, and their spouses. This term also includes surviving spouses of
				deceased service members who have not remarried; and
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-18 - Application for Waiver of Initial Licensing Fees for Certain Individuals › Section 15-18-3 - Application for Waiver of Initial Licensure Fees

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. An applicant seeking a low income or
				military family waiver of the initial licensing fee shall apply for licensure
				to the board and provide the required documentation.
3.2. The Board shall provide the application
				form and instructions on what documentation is necessary to submit with the
				license application requesting the low income or military family initial
				licensing fee waiver.
3.3. An
				applicant shall submit all required documentation to the board and upon the
				submission of a complete application, the board shall review the application
				and issue a decision within 30 days of receipt of the completed
				application.
3.4. The board may
				issue a license to an applicant who meets the requirements of W. Va. Code
				§
									30-5-1
et seq
.,
				the rules promulgated by the board, and the board shall waive the initial
				licensing fee for an applicant that meets the requirement of "low-income
				individuals" or "military families" as defined in W.Va. Code §
									30-1-22.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-18 - Application for Waiver of Initial Licensing Fees for Certain Individuals › Section 15-18-4 - Required Documentation for Waiver of Initial Licensure Fees

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. Individuals
				requesting a waiver of initial licensure fees for low income or military
				service personnel and their spouses, shall submit with the application for
				licensure the initial licensure waiver forms provided by the board and the
				appropriate documentation as specified in this section.
4.2. To establish low income eligibility for
				the initial licensing fee waiver, an applicant shall submit to the board
				evidence that the adjusted gross income of the household of the applicant is at
				or below 130% of the federal poverty level by submitting documentation of
				eligibility for:
4.2.1. Temporary Assistance
				for Needy Families Program;
4.2.2.
				Medicaid;
4.2.3. Supplemental
				Nutrition Assistance Program; or
4.2.4. A Federal Tax Return.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. --
				Inspection process for the West Virginia Board of Pharmacy.
1.2. Authority -- W. Va. Code §§
									30-5-7.
1.3. Filing date -- May 2, 2023
1.4. Effective date -- May 2, 2023
1.5. Sunset Provision -- This rule will
				terminate and have no further force or effect on August 1, 2027.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-3 - Inspector Qualifications

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. In
				order to qualify for the position of inspector, a candidate must be a WV
				licensed pharmacist and have at least ten (10) years of pharmacy practice
				experience.
3.2. Upon being hired,
				each inspector shall complete a training program in accordance with the Board's
				training manual, complete the National Investigator and Inspector Training
				Basic Course, and complete the National Association of Boards of Pharmacy
				Certification for Inspecting Sterile Compounding Facilities.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-4 - Regions

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1 The Board shall
				establish regions within the state. Each region shall have approximately the
				same amount of licensed facilities requiring inspection pursuant to W. Va. Code
				§
									30-5-1
et
				seq.
4.2. Each inspector
				shall be assigned a region.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-5 - Scheduling of Inspections

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1.
				Inspections shall be conducted within ninety days of the regularly scheduled
				inspection frequency, unless circumstances make compliance with this timeframe
				unattainable.
5.2. Inspectors shall
				schedule Inspections by notifying the facility to be inspected at least one
				week in advance of the inspection.
5.3. Unscheduled inspections shall be
				conducted by each Inspector on an annual basis for an amount of inspections not
				to exceed 10% of the facilities within the Inspector's region.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-6 - Conducting Inspections

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. At a
				minimum, the methods established by the Board for conducting inspections shall
				include the following:
6.1.1. presentation of
				credentials;
6.1.2. copies of the
				inspection forms to be used;
6.1.3.
				details on the use of electronic inspection forms;
6.1.4. a listing of documents to be reviewed;
				and
6.1.5. listing of staff that
				may be interviewed.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-7 - Inspection Forms

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. The Board
				shall create inspection forms for each type of facility inspected. The
				inspection forms shall contain citations to relevant laws and appropriate Board
				of Pharmacy Rules.
7.2. The
				inspection forms used by the Board shall be made available to the public on the
				Board's website
www.wvbop.com
.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-19 - Inspections › Section 15-19-8 - Inspection Frequency

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. The
				following facility types shall be inspected annually:
8.1.1. outpatient pharmacies;
8.1.2. institutional pharmacies;
8.1.3. charitable clinic
				pharmacies;
8.1.4. nuclear
				pharmacies;
8.1.5. sterile
				compounding facilities;
8.1.6.
				non-sterile compounding facilities.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. - To
				establish requirements and process for donated drug repository
				programs
1.2. Authority - W. Va.
				Code §60B-l-8
1.3. Filing Date
				- May 2, 2023
1.4. Effective Date -
				May 2, 2023
1.5. Sunset Date - This
				rule shall terminate and have no further force or effect on August 1,
				2028.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-3 - Waivers

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. A donor or
				eligible recipient may request a waiver from the board with regard to any rule
				related to this program by demonstrating the waiver is in the interest of
				public health and safety.
3.2. The
				donor or eligible recipient seeking the waiver will receive correspondence from
				the board with the decision.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-4 - Authorization process for eligible recipients

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. To be eligible for participation in the
				program, a pharmacy, wholesaler, reverse distributor, hospital, federally
				qualified health center, nonprofit clinic, healthcare facility, an entity
				participating in a drug donation or repository program pursuant to another
				state's law, or private office of a healthcare professional shall be in
				compliance with all applicable federal and state laws, including laws
				applicable to the storage and distribution of drugs and all the appropriate
				licensure standards, and shall hold active, state-issued licenses or
				registrations in good standing.
4.2. An eligible recipient may establish a
				donated drug repository program at an authorized address.
4.3. The eligible recipient shall provide
				written notification to the Board of participation in the program on the form
				provided on the Board of Pharmacy website at
www.wvbop.com
.
4.4. Each eligible recipient shall make a
				separate notification to the board for each drug repository program
				address.
4.5. Each donated drug
				repository program must designate a responsible individual.
4.6. Each donated drug repository program
				notification shall be accompanied by a notification fee of $50
				annually.
4.7. The notification
				shall serve for participation in the program for a period of one year, unless
				revoked by the Board. The eligible recipient may renew its authority via
				renotification annually by June 30.
4.8. Withdrawal from participation. A donated
				drug repository program may withdraw from the Program at any time by providing
				written notice to the Board on a form provided and available on the Board's
				website.
4.9. Failure to comply
				with any provision of §
									60B-1-1
et seq.
or statutes governing prescription drugs may result in revocation of authority
				to participate in the program. Revocation shall be provided as a written notice
				including the specific requirements that were violated and corrective actions
				necessary to reinstate its authority to participate in the program.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-5 - Eligible Drugs

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. Any
				individual who is 18 years of age or older may donate legally obtained
				prescription drugs or supplies to a drug repository program if the drugs meet
				the requirements of this rule, as determined by the pharmacist or responsible
				healthcare provider of the drug repository program. The 18 year or older parent
				or guardian of a minor may donate the minor's legally obtained drugs or
				supplies if all requirements are met.
5.1.1.
				The donor shall remove or redact any patient names and prescription numbers on
				donated drugs or otherwise maintain patient confidentiality by executing a
				confidentiality agreement with the eligible recipient.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-6 - Storage and handling of donated drugs by eligible recipients

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1 A licensed
				pharmacist or the responsible healthcare professional for the donated drug
				repository program shall inspect the donated drugs prior to dispensing to
				determine, to the extent reasonable possible in their professional judgement,
				that the drugs are not adulterated or misbranded, are safe and suitable for
				dispensing.
6.2 The eligible
				recipient shall store and maintain donated drugs in a secure and
				temperature-controlled environment that meets the drug manufacturers'
				recommendations and United States Pharmacopeia Standards.
6.3 If a recall notification is received, the
				donated drug repository program shall identify all recalled prescription
				product in the facility, dispose of all recalled drug as directed in the
				recall, and document the disposal in the records for the donated drug
				repository program. If a recalled drug has been dispensed, the donated drug
				repository program shall immediately notify the recipient of the recalled drug
				pursuant to established drug recall procedures.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-7 - Eligible Patients

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1 An
				individual must meet the following criteria to be eligible to receive
				medication from a donated drug repository:
7.1.1 Income is at or below the income
				eligibility requirements of the West Virginia Medicaid Program;
7.1.2 Uninsured;
7.1.3 Underinsured; or
7.1.4 Enrolled in a public assistance health
				benefits program.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-8 - Dispensing of donated drugs

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1.
				Donated drugs may only be dispensed to eligible patients pursuant to a valid
				prescription order.
8.2. A donated
				drug repository program shall dispense donated prescription drugs in compliance
				with federal and state laws and regulations for dispensing prescription drugs,
				including but not limited to all requirements relating to packaging, labeling,
				record keeping, drug utilization review, and patient counseling. The eligible
				patient will be counseled and sign an acknowledgement that the drug was
				donated.
8.3. Donated drugs may not
				be resold and shall be considered nonsalable. However, reimbursement for any
				handling fee does not constitute reselling. A donated drug repository program
				may charge the eligible recipient a handling fee not to exceed the reasonable
				costs of participating in the program including, but not limited to, the
				current and anticipated costs of educating eligible donors, providing technical
				support to participating donors, shipping and handling, labor, storage,
				licensing, utilities, advertising, technology, supplies, and
				equipment.
8.4. The fees charged,
				and costs listed in 15 CSR 20-8.3 shall be included in the audit information
				made available to the Board.
8.5.
				Nothing in the preceding paragraph limits an eligible recipient from charging
				fees, including, but not limited to, a usual and customary charge, to donors,
				eligible recipients, health plans, pharmacy benefit managers, and other
				entities.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-9 - Required Records

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. Prior to
				accepting a donation into inventory, a donated drug repository program that
				dispenses donated drugs or supplies to an eligible patient shall maintain a
				written or electronic inventory of each donated drug or supply that shall
				include the following information:
9.1.1. The
				transaction date;
9.1.2. The name,
				strength, and quantity of each accepted drug; and
9.1.3. The name, address, and phone number of
				the eligible donor providing each drug or supply.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-20 - Donated Drug Repository Program › Section 15-20-10 - Exemption from disciplinary action, civil liability or criminal prosecution

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. Unless an
				action or omission constitutes willful or wanton misconduct, the following
				persons or entities shall not be subject to criminal or civil prosecution,
				criminal or civil liability from injury, death, or loss to person or property,
				or other criminal or civil action, or disciplinary actions by licensing,
				professional, or regulatory agencies:
10.1.1.
				A person who donates or gives drugs to an eligible recipient, including a drug
				wholesaler, drug manufacturer, reverse distributor, pharmacy, third-party
				logistics provider, government entity, hospital or health care
				entity;
10.1.2. An eligible
				recipient;
10.1.3. A healthcare
				professional who prescribes or dispenses a donated drug;
10.1.4. The Board of Pharmacy;
10.1.5. An intermediary that helps administer
				the program by facilitating the donation or transfer of drugs to eligible
				recipients;
10.1.6. A repackager or
				manufacturer of a donated drug; and
10.1.7. Any employee, volunteer, trainee, or
				other staff of individuals and entities listed in (1) through (6)
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- This
				legislative rule describes and defines requirements for licensure as well as
				nature of practice for physical therapists, physical therapist assistants and
				support personnel.
1.2. Authority.
				-- W. Va. Code §
									30-20-1,
				et. seq.
1.3. Filing Date. --
				April 6, 2021.
1.4. Effective
				Date. -- April 6, 2021.
1.5.
				Sunset Provision. -- This rule shall terminate and have no further force or
				effect upon August 1, 2031.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-3 - Applications

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. The applicant
				must complete the application form provided by the Board and supply the
				following:
3.1.1. Personal information;
3.1.2. Educational information;
3.1.3. History of previous work
				experience, if applicable;
3.1.4.
				License verification(s) from other jurisdictions that regulate the practice of
				physical therapy in their jurisdictions.
3.1.5. Written responses to questions
				regarding criminal offenses;
3.1.6. Written responses to questions
				regarding child support obligations;
3.1.7. Name and address of prospective
				employer in West Virginia if known;
3.1.8. Photo identification; and
3.1.9. Applicable fee(s).
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-4 - Scores

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. The applicant
				must take the National Physical Therapy Exam (NPTE) and obtain a passing score
				as determined by the Board.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-5 - Issuance, Renewal or Reinstatement of License

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. The Board reserves the right to evaluate
				the applicant according to the testing, licensure, and procedural requirements
				as initiated by the agency responsible for the ownership and development of the
				National exam.
5.2. Licenses
				expiring on December 31 of each particular year must be renewed by payment of
				applicable fee along with completed renewal application.
5.3. A license not renewed without specific
				request to place it in "inactive" status will automatically be placed on
				delinquent status.
5.4. Delinquent
				licensee is responsible for penalty fees including but not limited to:
				application fee, delinquent license fee, and the current year renewal fee. A
				licensee must also complete and show proof of board approved continuing
				education requirements.
5.5. To
				reinstate an "inactive" license, the licensee must submit an application for
				renewal along with a non-refundable application fee and license renewal fee.
5.6. A volunteer license will be
				marked as a "volunteer" license and is restricted to practicing in accordance
				with W. Va. Code §
									30-20-13.
5.7. Any change in personal contact and
				employer/supervisor information must be submitted in writing to the Board as
				changes occur.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-7 - Temporary Permit for Physical Therapists and Physical Therapist Assistants

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1.
				An individual possessing a temporary permit issued by the Board to practice
				physical therapy or act as a physical therapist assistant in the state of West
				Virginia shall practice under the on-site supervision of a physical therapist.
				All progress notes written by the physical therapist or physical therapist
				assistant with a temporary permit shall be cosigned by a physical therapist
				supervisor within 24 hours .
7.2. A
				temporary permit may be issued only to individuals who have met the eligibility
				criteria set forth in W. Va. Code §
									30-20-8,
				§
									30-20-10,
				and §
									30-20-12, and
				who have submitted proper application and identification as determined by the
				Board:
7.2.1. Pending examinations, to any
				physical therapist or physical therapist assistant applicant who is a new
				graduate of a program approved by the Commission on Accreditation in Physical
				Therapy Education (CAPTE).
7.2.2.
				To a person who possesses an unencumbered license in another state or territory
				or possession of the United States and who is a graduate of a program approved
				by CAPTE.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-8 - Scope of Practice for Physical Therapists

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. A physical therapist may perform the
				following:
8.1.1. Examine, evaluate and test
				patients/clients with mechanical, physiological and developmental impairments,
				functional limitations, and disabilities or other health and movement related
				conditions in order to determine a diagnosis, prognosis and plan of treatment
				intervention, and to assess the ongoing effects of intervention: provided, that
				electromyography examination and electro diagnostic studies other than the
				determination of chronaxia and strength duration curves shall not be performed
				except under the supervision of a physician electromyographer and electro
				diagnostician;
8.1.2. Alleviate
				impairments, functional limitations and disabilities by designing, implementing
				and modifying treatment intervention that may include, but are not limited to:
				therapeutic exercise, functional training in self-care in relation to motor
				control function; mobility; and in home, community or work integration or
				re-integration; manual therapy techniques including but not limited to
				mobilization of the joints and dry needling; therapeutic massage; fabrication
				of assistive, adaptive, orthotic, prosthetic, protective and supportive devices
				and equipment; airway clearance techniques; integumentary protection and repair
				techniques; patient-related instruction, mechanical and electrotherapeutic
				modalities, and physical agent or modalities including, but not limited to,
				heat, cold, light, air, water, and sound;
8.1.3. Reduce the risk of injury, impairment,
				functional limitation and disability, including the promotion and maintenance
				of fitness, health and wellness in population of all ages; and,
8.1.4. Engage in administration,
				consultation, and research.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-9 - Supervision of a Physical Therapist Assistant

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. In all practice settings, the following
				are required:
9.1.1. An initial visit shall be
				made by a physical therapist for evaluation of the patient and establishment of
				a plan of care.
9.1.2. The physical
				therapist shall make the final visit to terminate the plan of care unless the
				patient or physician terminates the plan of care.
9.1.3. No more than 4 physical therapist
				assistants, physical therapist assistants holding a temporary permit, or
				physical therapy aides, or any combination thereof, can be supervised by a
				physical therapist at any one time.
9.1.4. The only exceptions to the level of
				supervision or supervisory ratio are subsections 9.5 and 9.6, and 9.7 of this
				section.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-10 - Licensing Individuals outside the United States

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. An applicant for a physical therapist
				license who was educated outside of the United States shall meet the following
				criteria in order to be eligible for licensure by the Board:
10.1.1. Credentials:
10.1.1.a. The foreign-educated applicant
				shall present a certificate issued by a board approved prescreening
				certification agency.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-11 - Continuing Education

Current through Register Vol. XLI, No. 28, July 12, 2024
11.1.
				A "unit" is one clock hour spent in a continuing education activity unless
				otherwise defined in this section.
11.2. All licensees desiring to remain
				"active" and in good standing must complete 24 units of board approved
				continuing education within the 2-year licensing period. If the licensee does
				not complete the 24 units of board approved continuing education within the
				license period, that licensee will be placed on delinquent status and will be
				subject to all fees associated with delinquent status.
11.2.1. For those applicants reinstating
				their license for a period of six months or less, only six units are required
				for that year.
11.2.2. Volunteer
				licensees need only to complete 20 units of board approved continuing education
				activities within a two-year renewal cycle.
11.2.3. Accumulated CEU's may not be carried
				over from one renewal period to another.
11.2.4. A new graduate does not need
				continuing education hours for the current year of graduation.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-01 - General Provisions for Physical Therapist and Physical Therapist Assistant › Section 16-1-12 - Telehealth

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1. Telehealth
				services may only be used to provide physical therapy services to a patient who
				is physically located at an originating site in West Virginia other than the
				site where the physical therapist or physical therapist assistant is located,
				whether or not in West Virginia.
12.2. Physical Therapy telehealth services
				must be provided by a physical therapist or physical therapist assistant under
				the supervision of the physical therapist who possesses a current:
12.2.1. unrestricted West Virginia license;
				or
12.2.2. Compact Privilege to
				practice in West Virginia.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1 Scope. -- This
				rule specifies the procedure for the adjudication of contested case hearings
				before the Board.
1.2. Authority.
				-- W. Va. Code ''30-20-1 et seq. and 30-1-1 et seq.
1.3. Filing Date. -- December 11,
				2000.
1.4. Effective Date. --
				January 15, 2001.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
The following words and phrases as used in this rule have the
				  following meanings, unless the context otherwise requires:
2.1. "Board" means the West Virginia Board of
				Physical Therapy.
2.2. "Demanding
				party" means an individual who has been denied a license to practice Physical
				Therapy by the Board and who, as a result, demands that a hearing be held
				before the Board on the issue of such denial.
2.3. "Charged party" means an individual who
				holds a license to practice Physical Therapy issued by the Board and who has
				been charged by the Board as described in Section 6.5. of these
				rules.
2.4. "License" means a
				license or temporary permit issued by the Board to practice Physical Therapy or
				to assist in the practice of Physical Therapy pursuant to W. Va. Code
				'30-20-1. et.
				seq.
2.5. "Licensee" means an
				individual who holds a license to practice Physical Therapy or to assist in the
				practice of Physical Therapy issued by the Board.
2.6. "Permittee" is a person who holds a
				temporary permit to practice Physical Therapy or to assist in the practice of
				Physical Therapy issued by the Board.
2.7. "Practice of Physical Therapy" means the
				practice of Physical Therapy as defined in W. Va. Code '30-20-2. This
				includes Physical Therapists, Physical Therapist Aides, and Physical Therapist
				Assistants.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-3 - Conferences; Informal Disposition of Cases

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. At any time prior to the hearing or
				thereafter, the Board, or its designee may hold conferences for the following
				purposes:
3.1.1. To dispose of procedural
				requests, prehearing motions or similar matters;
3.1.2. To simplify or settle issues by
				consent of the parties; or,
3.1.3.
				To provide for the informal disposition of cases by stipulation or
				agreement.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-4 - Depositions

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. Evidentiary
				depositions may be taken and read or otherwise included into evidence as in
				civil actions in the circuit courts of this State.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-5 - Subpoenas

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. Subpoenas to
				compel the attendance of witnesses and subpoenas duces tecum to compel the
				production of documents may be issued by any member of the Board, its Executive
				Secretary/Administrator, or its Assistant Administrator.
Such subpoenas shall be issued pursuant to W. Va. Code
				  '29A-5-1(b).
5.2. Written requests by a party
				for the issuance of subpoenas or subpoenas duces tecum as provided in
				subsection 5.1. of this section must be received by the Board no later than ten
				(10) days before a scheduled hearing. Any party requesting the issuance of
				subpoenas duces tecum must have them properly served in accordance with W. Va.
				Code '29A-5-1(b).
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-7 - Transcription of Testimony and Evidence

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. All testimony, evidence, arguments and
				rulings on the admissibility of testimony and evidence will be reported by
				stenographic notes and characters or by mechanical means.
7.2. All reported materials will be
				transcribed. The Board has the responsibility to make arrangements for the
				transcription of the reported testimony and evidence.
7.3. Upon the motion of the Board or any
				party assigning error or omission in any part of any transcript, the Board
				Chair or presiding member will settle all differences arising as to whether the
				transcript truly discloses what occurred at the hearing and will require that
				the transcript be corrected and/or revised as appropriate so as to make it
				conform to the truth.
7.4. A
				transcript of the hearing will be provided to all members of the Board for
				review at least ten (10) days before the vote it taken on its decision in any
				licensure or temporary permit disciplinary matter.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-8 - Submission of Proposed Findings of fact and Conclusions of Law

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. Any party may
				submit proposed findings of fact and conclusions of law at a time and manner
				designated by the Board.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-9 - Orders

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. Any final
				order entered by the Board following a hearing conducted pursuant to this rule
				will be made pursuant to the provisions of W. Va. Code ''29A-5-3 and 30-1-8(d).
				All final orders must be entered within sixty (60) days following the
				submission of all documents and materials necessary for the proper disposition
				of the case, including transcripts, and must contain findings of fact and
				conclusions of law.
9.2. The
				findings of fact and conclusions of law must be approved by a majority of the
				Board either by a poll or vote at a regular meeting, before a final order is
				entered. A copy of the final order approved by a majority of the Board must be
				served upon the demanding or charged party and/or his or her attorney of
				record, if any, within ten (10) days after entry by the Board by personal
				service or by registered or certified mail.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-02 - Contested Case Hearing Procedure › Section 16-2-10 - Appeal

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. An appeal
				from any final order entered in accordance with this rule will comply with the
				provisions of W. Va. Code ''30-1-9. and 29A-6-1. et seq.
West Virginia Code of State Rules › Agency 16 - Physical Therapy › Title 16 - LEGISLATIVE RULE WV BOARD OF PHYSICAL THERAPY › Series 16-03 - Disciplinary And Complaint Procedures › Section 16-3-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- This
				rule specifies a procedure for the investigation and resolution of complaints
				against Physical Therapists, Physical Therapy Aides, Physical Therapist
				Assistants, Permittees, and Applicants.
1.2. Authority. -- W. Va. Code ''30-20-1 et
				seq. and 30-1-1 et seq.
1.3. Filing
				Date. -- December 11, 2000.
1.4.
				Effective Date. -- January 15, 2001.