reglab/statecodes huggingface dataset:
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-12 - Immunizations Administered by Pharmacists and Pharmacy Interns, and Pharmacy Technicians › Section 15-12-5 - Immunizations

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. A licensed
				pharmacist may order and a licensed pharmacist, pharmacy intern or pharmacy
				technician may administer immunizations in accordance with this rule.
5.2. Immunizations authorized by this rule
				shall be administered:
5.2.a. in accordance
				with a prescription order from a healthcare provider for a person age 3 years
				and up; or
5.2.b. in accordance
				with definitive treatment guidelines for immunizations promulgated by the
				latest notice from the U.S. Department of Health and Human Services, CDC,
				including, but not limited to, CDC's recommended immunization schedule for
				adults and children and adolescents, including the footnotes provided for each
				schedule, available at
https://www.cdc.gov/vaccines/
or a
				successor webpage created for the same purpose. Such immunizations administered
				to a person age three to seventeen years shall be given only:
5.2.b.1. with parental written, informed
				consent;
5.2.b.2. provided there
				are no contraindications to that person receiving that vaccine; and
5.2.b.3. after informing the patient and the
				adult caregiver accompanying the patient of the importance of a well-child
				visit with a pediatrician or other licensed primary-care provider and referral
				for patients as appropriate.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-12 - Immunizations Administered by Pharmacists and Pharmacy Interns, and Pharmacy Technicians › Section 15-12-6 - Record-keeping and reporting

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. An
				immunization questionnaire and consent form shall be completed for each person
				receiving an immunization. When the immunization is for a minor age three
				through seventeen years of age, the questionnaire and consent form shall
				include written informed parental consent for the minor.
6.2. A record of the immunization
				administration shall be forwarded to the primary care physician or other
				licensed health care provider as identified by the person receiving the
				immunization, within 30 days of the date of the administration. In the event
				that the patient affirmatively indicates in writing that he or she does not
				have a primary care physician or other health care provider to whom to forward
				the report, the pharmacist, pharmacy intern, or pharmacy technician shall
				document such in the immunization record and provide a record of the
				immunization administration to the patient. The record shall contain the name
				of the pharmacist, and, where applicable, the name of the pharmacy intern or
				pharmacy technician administering the immunization.
6.3. The pharmacist shall report the
				administration of the patient immunization to the West Virginia Statewide
				Immunization Information (WVSII) database in the format and containing such
				information as may be required by the WVSII within 30 days of the date of the
				administration.
6.4. The
				immunization questionnaire, consent form and record of the immunization
				administration shall be filed in the pharmacy in a manner that will allow
				timely retrieval and shall be kept on file for a time period not less than five
				years from the date of the immunization. All such records shall be maintained
				in the pharmacy where the immunization is administered. In the event it is
				administered off-site, then the records shall be maintained in the pharmacy
				where the pharmacist, pharmacy intern, or pharmacy technician who administered
				the immunization is employed or otherwise practicing at the time the
				immunization is given.
6.5. A
				pharmacist shall report all adverse events to the Vaccine Adverse Events
				Reporting System (VAERS), and promptly provide a copy of all reports to the
				Board; the West Virginia Department of Health and Human Resources Bureau for
				Public Health, Office of Epidemiology and Prevention Services, Division of
				Immunization Services; and the patient's primary care physician or other
				licensed health care provider as identified by the person receiving the
				immunization in accordance with subsection 6.2.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-12 - Immunizations Administered by Pharmacists and Pharmacy Interns, and Pharmacy Technicians › Section 15-12-7 - Emergencies

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. A pharmacist, pharmacy intern, or
				pharmacy technician authorized to administer immunizations under this rule may
				administer epinephrine and diphenhydramine in the management of an acute
				allergic reaction to an immunization following guidelines issued by
				CDC.
7.2. A pharmacist, pharmacy
				intern, or pharmacy technician shall have a readily retrievable emergency
				response plan as outlined by the CDC and maintain a readily retrievable
				emergency kit to manage an acute allergic reaction to an immunization
				administered.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-12 - Immunizations Administered by Pharmacists and Pharmacy Interns, and Pharmacy Technicians › Section 15-12-8 - Immunization Training Programs

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. The Board shall approve a course or
				program in immunization administration for pharmacists and pharmacy interns to
				be used to meet the qualification requirement of section 3.1.b. In order to be
				approved by the Board, the course or program, at a minimum, shall include
				practical training and instruction on the following:
8.1.a. basic immunology, including the human
				immune response;
8.1.b. adverse
				reactions, contraindications, warnings and precautions;
8.1.c. response to emergency situations,
				including administration of epinephrine and diphenhydramine;
8.1.d. storage and handling
				requirements;
8.1.e. recordkeeping
				and reporting requirements, including screening and informed consent
				documentation;
8.1.f. proper
				environment for administration and observation;
8.1.g. legal and regulatory issues,
				including, but not limited to, state law and regulations, OSHA compliance,
				biohazard control, and such other relevant and applicable standards;
				and
8.1.h. policies and procedures
				for establishing and implementing appropriate immunization treatment
				guidelines.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- This
				rule establishes the requirements for charitable clinic pharmacies to operate
				in West Virginia to prepare and dispense prescriptions to patients of the
				clinics in this State.
1.2.
				Authority. -- W. Va. Code §§
									30-5-14
				and
				30-5-19.
1.3. Filing Date. -- June 9, 2009.
1.4. Effective Date. -- July 1,
				2009.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. The following
				terms and phrases as used in this Rule shall have the following meanings:
2.1.1. "Charitable clinic pharmacy" means a
				clinic or facility organized as a not-for-profit corporation that offers
				pharmaceutical care and dispenses prescriptions free of charge to appropriately
				screened and qualified patients. A charitable clinic pharmacy shall meet the
				minimum standards for a pharmacy as set forth in W. Va. Code §
										30-5-1, et
				seq., and by this rule, but may not be charged any applicable licensing fees. A
				charitable clinic pharmacy may have pharmacists-in-charge, as that term is
				defined in this section, who volunteers his or her services. A charitable
				clinic may also receive donated drugs. It is not the intent of this rule to
				affect any organizations which are merely operating a prescribing
				practitioner's or clinic's free sample drug room.
2.1.2. "Charitable organization" means an
				organization which operates a clinic or facility organized as a not-for-profit
				corporation which is qualified as a charitable organization pursuant to Section
				501(c)(3) of the Internal Revenue Code, or its successor.
2.1.3. "Legend drug sample" for purposes of
				this Series means an unopened package of a manufacturers legend drug product
				that has been distributed to either a practitioner or the charitable clinic
				pharmacy in accordance with the provisions of the Prescription Drug Marketing
				Act of 1987, 21 U.S.C. §301 et seq, or its successor.
2.1.4. "Qualified patient" means a patient of
				the charitable clinic pharmacy that has been screened and approved by the
				charitable organization as meeting the organization's mission of providing
				pharmaceutical care to those who are without sufficient funds to obtain needed
				legend drugs. The requirements and screening process employed by the charitable
				organization must be in accordance with the "Guidelines" and other program
				requirements developed by the West Virginia Department of Health and Human
				Resources, Office of Community Health Systems, Division of Primary Care, for
				eligibility to receive funding as a "Free Clinic" for "Uncompensated Care and
				Equipment and Capital Costs Funding".
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-3 - Charitable Clinic Pharmacy Permit Required

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. A charitable clinic pharmacy is
				considered to be a pharmacy and must follow all federal and state laws, rules,
				and regulations that pertain to pharmacies and the practice of pharmacy, except
				as otherwise provided specifically herein. A charitable clinic pharmacy permit
				is required for a charitable organization to operate a pharmacy in this State
				to dispense prescription drugs to qualified patients. No fee is required to
				apply for or obtain the permit.
3.2. Permits obtained pursuant to this
				section expire on June 30 of each calendar year. Renewal will be conducted in
				accordance with the laws and rules for renewing pharmacy permits as outlined in
				this rule.
3.3. Charitable Clinic
				Pharmacies may petition the Board for exemptions from portions of the
				requirements set forth in this rule which are not addressed here on a case by
				case basis, including, but not limited to, such things as the requirement for
				weights and measures if no compounding is to be done, the requirement for
				separate security features and alarms if they are available on the clinic
				building as a whole, and other such requirements.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-4 - Controlled Substances Restricted; Prescriptions to qualified patients

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A charitable
				clinic pharmacy shall not purchase, possess, trade, distribute, or dispense
				controlled substances.
4.2. Patient
				Dispensing. Prescriptions filled in a charitable clinic pharmacy may only be
				dispensed to qualified patients of that pharmacy on lawful orders or
				prescriptions of practitioners authorized by law to prescribe or administer
				said drugs.
4.2.1. All prescriptions filled by
				the charitable clinic pharmacy must be checked by a pharmacist or a prescribing
				practitioner licensed as such in the State of West Virginia prior to being
				dispensed; Provided That any prescribing practitioner licensed in this State
				may access the charitable clinic pharmacy to fill, check, or dispense
				prescriptions when no pharmacist is present, provided that he or she insures
				proper labeling and documentation of the dispensing.
4.2.2. Any other rule notwithstanding, in the
				absence of a pharmacist, a prescribing practitioner who is licensed in the
				State of West Virginia may also supervise the work of pharmacy technicians
				within the pharmacy, so that they may continue to work during that period of
				time.
4.2.3. Any other rule
				notwithstanding, if there is no pharmacist or prescribing practitioner who is
				licensed in the State of West Virginia present to supervise the pharmacy
				technicians, the pharmacy technicians may continue to process and fill
				prescriptions, and perform all other duties which may be performed by a
				pharmacy technician, for up to two hours during the charitable clinic
				pharmacy's regular hours of operation provided that no actual dispensing may
				occur until the prescriptions filled are checked in accordance with subsection
				4.2.1 above.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-5 - Prescription Drug Samples

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1.
				Except insofar as it may conflict with federal law, charitable clinic
				pharmacies are exempt from any State law or rule which restricts who may
				receive sample drugs from a manufacturer. Specifically, unless it conflicts
				with federal law, a charitable clinic pharmacy may accept donated prescription
				drugs in their unbroken original packaging from pharmacies, licensed
				prescribers, wholesalers, or manufacturers provided appropriate records of
				transfer, donation, and receipt are maintained: Provided That the samples have
				been stored under the proper conditions required by the manufacturer and
				applicable law to prevent deterioration or contamination. However, a charitable
				clinic pharmacy may only receive, possess, and dispense prescription drug
				samples if the following conditions are satisfied:
5.1.1. The samples are dispensed at no charge
				to qualified patients of that charitable clinic pharmacy;
5.1.2. The samples are possessed in
				compliance with the Federal Prescription Drug Marketing Act of 1987, 21 U.S.C.
				§301 et seq, or its successor;
5.1.3. The samples are in the original
				container in which they were placed by the manufacturer and the container is
				clearly marked sample;
5.1.4. Prior
				to being furnished or dispensed, the samples have been stored under the proper
				conditions to prevent deterioration or contamination;
5.1.5. The samples are clearly marked with an
				expiration date and lot number;
5.1.6. The samples are not expired;
				and
5.1.7. The samples are not a
				controlled substance.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-6 - Pharmacist-In-Charge Responsibilities

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1.
				The pharmacist-in-charge at the charitable clinic pharmacy is responsible for
				implementing policies and procedures and a quality assurance program for
				operation of the charitable clinic pharmacy.
6.2. The pharmacist-in-charge at the
				charitable clinic pharmacy shall ensure through implementation of policies and
				procedures that the following occurs at the charitable clinic pharmacy:
6.2.1. donated drugs dispensed from pharmacy
				are properly labeled;
6.2.2.
				donated drugs that are expired, adulterated, misbranded, recalled,
				deteriorated, not kept under proper conditions, or did not have the identifying
				drug information on them as required are not dispensed to patients;
6.2.3. donated drugs are inspected prior to
				dispensing to determine that the donated drugs meet all federal and state
				requirements for product integrity;
6.2.4. donated drugs that are expired,
				adulterated, misbranded, recalled, deteriorated, not kept under proper
				conditions, or did not have the identifying drug information on them as
				required are destroyed; and
6.2.5.
				manifests for donated drugs that are dispensed pursuant to prescriptions from
				the charitable clinic pharmacy are created and maintained at the charitable
				clinic pharmacy as required for all prescription records.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-7 - Limitations of Charitable Clinic Pharmacies

Current through Register Vol. XLI, No. 28, July 12, 2024
Charitable Clinic Pharmacies shall comply with the
				  following:
7.1. All drug therapies and
				prescriptions shall be prescribed on an individual basis.
7.2. A Charitable Clinic Pharmacy may not
				accept lost identity or unknown drugs.
7.3. Misbranded drugs may not be accepted by
				the Charitable Clinic Pharmacy.
7.4. A Charitable Pharmacy may accept donated
				and unadulterated prescription drugs in their unbroken original manufacturer
				packaging from pharmacies, licensed prescribers, wholesalers or manufacturers,
				the State of West Virginia, the Board of Pharmacy or by other means, provided
				appropriate records of receipt are maintained.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-8 - Continuing Education Credits for Volunteering in Charitable Clinic Pharmacy

Current through Register Vol. XLI, No. 28, July 12, 2024
A pharmacists who volunteers as a pharmacist-in-charge or a
				  staff pharmacist in a charitable clinic pharmacy may earn up to a maximum of
				  six live continuing education credits for such activities. For every eight
				  hours worked in a charitable clinic pharmacy as the PIC, the PIC may earn one
				  hour of live continuing education credit. For every ten hours worked in a
				  charitable clinic pharmacy as a staff pharmacist, the pharmacist may earn one
				  hour of live continuing education credit.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-13 - Regulation Of Charitable Clinic Pharmacies › Section 15-13-9 - Inspection and Investigation of Charitable Clinic Pharmacies

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. The Board of Pharmacy will use an
				Inspection Form which is consistent with the requirements under which a
				Charitable Clinic Pharmacy shall operate as contemplated by W. Va. Code §
									30-5-1b.
9.2. Upon receipt of the completed inspection
				form, the Board of Pharmacy and any appointed Quality Control Committee or
				other such body of the Charitable Clinic Pharmacy may meet and confer to
				address and resolve issues which may impact the health and safety of the
				pharmacy's patients. To the extent necessary, corrective plans may result from
				such meeting(s) with timeframes established by the Board of Pharmacy for the
				resolution of Quality control issues.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-14 - Board of Pharmacy Rules for Centralized Prescription Processing › Section 15-14-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope -- To
				establish standards for central prescription processing.
1.2. Authority -- W. Va. Code §
									30-5-7.
1.3. Filing date -- May 3, 2024.
1.4. Effective date -- May 3, 2024.
1.5. Sunset Date -- This rule shall terminate
				and have no further force or effect on August 1, 2034.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-14 - Board of Pharmacy Rules for Centralized Prescription Processing › Section 15-14-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. The following
				words and phrases have the following meanings:
2.1.a. "Central fill pharmacy" means a
				pharmacy or central filling operation registered as a pharmacy by the Board
				acting as an agent of or under contract with the originating or delivering
				pharmacy to fill or refill a prescription.
2.1.b. "Central prescription filling" means
				filling of a new or refilling of a prescription drug order by a central fill
				pharmacy at the request of an originating or delivering pharmacy for delivery
				to the patient or patient's agent pursuant to the lawful order of a
				practitioner.
2.1.c. "Originating
				pharmacy" means a pharmacy registered with the Board that uses a central fill
				pharmacy to fill or refill a prescription order received by or transferred to
				that pharmacy by the patient, the patient's agent, or the patient's
				prescriber.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-14 - Board of Pharmacy Rules for Centralized Prescription Processing › Section 15-14-3 - General Requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1.
				Any other rule notwithstanding, a pharmacy may outsource a prescription drug
				order filling
,
excluding prescription drug orders for
				Schedule II controlled substances listed in West Virginia Code §
									60A-2-206, to another pharmacy
				via central prescription filling provided the pharmacies:
3.1.a. Have the same owner; or
3.1.b. Have entered into a written contract
				or agreement which outlines the services to be provided and responsibilities
				and accountabilities of each pharmacy in compliance with federal and state laws
				and regulations, and include confidentiality of patient information;
				and
3.1.c. Share a common
				electronic file or have appropriate technology or interface to allow secure
				access to sufficient information necessary or required to fill or process a
				prescription drug order.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-14 - Board of Pharmacy Rules for Centralized Prescription Processing › Section 15-14-4 - Remote Order Entry and Remote Order Review

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. Remote-order-entry or
				remote-order-review of prescription orders for prescriptions received at a
				pharmacy registered by this state is permitted to be performed by another
				pharmacy registered by the state, Provided that:
4.1.a. for purposes of data entry, the data
				entry must be performed by a licensed pharmacist, licensed pharmacy intern, or
				registered pharmacy technician or pharmacy technician trainee who is located at
				the other pharmacy registered by the state which shares a common automated data
				processing system, and such system creates an audit trail of which pharmacist,
				pharmacy intern, or pharmacy technician or pharmacy technician trainee entered
				the data; and
4.1.b. for purpose of
				drug regimen review, the review must be performed by a licensed pharmacist who
				is located at the other pharmacy registered by the state which shares a common
				automated data processing system, and such system creates an audit trail of
				which pharmacist provided the drug regimen review.
4.1.c. Nothing in this Section shall prohibit
				an individual licensed pharmacist licensed in the state, who is an employee of
				or under contract with a licensed pharmacy, or a licensed pharmacy technician
				or pharmacy intern, working under the supervision of the pharmacist, from
				accessing that pharmacy's electronic database from inside or outside the
				pharmacy and performing the prescription drug order processing functions
				permitted by the W.Va. Code 30-5.1
et seq
., if the following
				conditions are met:
4.1.c.1. The pharmacy
				establishes controls to protect the confidentiality and integrity of Protected
				Health Information; and
4.1.c.2. No
				part of the database is duplicated, downloaded, or removed from the pharmacy's
				electronic database; and
4.1.c.3.
				The pharmacy's electronic database shall only be accessed outside of the
				pharmacy via a virtual private network (VPN).
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. --
				Licensure and regulations governing pharmacy permits.
1.2. Authority -- W. Va. Code §§
									30-5-7.
1.3. Filing date -- May 3, 2024.
1.4. Effective date -- May 3, 2024.
1.5. Sunset Date -- This rule
				shall terminate and have no further force or effect on August 1, 2034.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-2 - Registration

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. A pharmacy
				shall obtain a registration from the Board and comply fully with W. Va. Code
				§
									30-5-22 before it may lawfully
				conduct a pharmacy.
2.2. A pharmacy
				shall obtain a registration biennially. Not more than one registration may be
				issued in any one name in more than one location. Every registered pharmacy
				shall be under the direct charge of a pharmacist, designated the
				Pharmacist-in-charge, and shall operate in compliance with the state and
				federal laws and rules and regulations.
2.2.1.
				The application for a new registration shall be completed on a form prescribed
				and furnished by the Board.
2.2.2.
				Each pharmacy shall make a separate application and a separate registration
				shall be issued for each pharmacy.
2.2.3. A pharmacy shall have applicable
				current references readily available according to practice setting as required
				by this rule.
2.2.4. An initial
				application for a pharmacy registration shall be accompanied by a fee of
				$150.00.
2.2.5. A pharmacy
				compounding compounded sterile preparations shall also apply for a compounding
				permit as required by this rule.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-3 - Issuance of Permit

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. The Board
				shall issue a registration to conduct a pharmacy to the applicant after a
				satisfactory inspection of the facility.
3.2. The registration is not transferrable.
				It is issued on the joint application of the owner and the
				pharmacist-in-charge, on the sworn statement that it will be conducted in
				accordance with the provisions of the federal and state laws, rules and
				regulations.
3.3. A registration
				shall be posted in a visibly conspicuous place.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-4 - Renewal of registration

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1.
				The biennial renewal of a registration takes place on the first day of July of
				each year. The fee for the biennial renewal is $150.00. Registrations expire on
				the thirtieth day of June of each calendar year. Renewal applications shall be
				completed and submitted to the Board office by the fifteenth day of June to
				allow time for processing. Pharmacies shall have a grace period for renewal
				until July 31 of the year in which the permit expires; however, renewal
				applications received in the Board office after June 30 of the year in which
				the registration expires shall require the payment of a late fee in the amount
				of $150.00 in addition to the application fee of $150.00, for a total amount of
				$300.00.
4.2. If a pharmacy does
				not make application for renewal by the first day of August biennially, to
				renew an expired registration the Board shall re-inspect the pharmacy and the
				permittee shall pay the required renewal fee and late fee totaling $300.00 for
				the registration, and $300.00 for the re-inspection, for a total amount of
				$600.00.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-5 - Surrender of registration

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1.
				When a pharmacist-in-charge changes at a pharmacy, both the
				pharmacist-in-charge and pharmacy must notify the Board in writing within
				fourteen (14) days. The original permit should be copied and the change in
				pharmacist-in-charge written on the original and copy of the permit. The copy
				of the modified permit shall be posted in the pharmacy. The original modified
				permit should be surrendered to the Board along with a ten-dollar ($10.00) fee
				for the new registration reflecting the new pharmacist-in-charge. Upon receipt
				of the notification, the Board shall provide for the new registration to the
				pharmacy. An Interim pharmacist-in-charge may be designated for a period not to
				exceed sixty (60) days. If an interim pharmacist-in-charge is designated who is
				not the permanent pharmacist-in-charge, the fee shall not be charged, and a new
				permit shall not be issued until a permanent pharmacist-in-charge is
				designated.
5.2. A pharmacy that
				moves to a new address or a different location within the current building
				shall apply for a new registration and submit the appropriate fees. The Board
				shall inspect the facility before a new registration may be issued.
5.3. When a pharmacy changes ownership the
				registration expires, and a new registration shall be obtained from the
				Board.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-6 - Security

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. A board
				approved operating plan shall be implemented if a pharmacy is to be operated
				for a period less than regular business hours of the entire store or
				institution.
6.2. A device for the
				detection of breaking and/or entering shall be installed in each prescription
				department in each pharmacy. The installation and the device shall be based on
				accepted burglar alarm industry standards, and are subject to the following
				conditions:
6.2.1. The device shall be
				maintained in functioning order and shall have an auxiliary source of
				power;
6.2.2. Deactivation of the
				alarm system for the prescription department shall be restricted to the
				pharmacists working at the pharmacy, and the system shall be activated whenever
				a pharmacist is not on duty. The pharmacy registration holder may deactivate
				the system for security or surveillance purposes as long as the reason for the
				deactivation, the person deactivating the system, and time and date of
				deactivation are documented and readily retrievable to the Board; and
6.2.3. This subsection does not apply to
				pharmacies which are open and staffed by pharmacists twenty-four (24) hours a
				day;
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-7 - Professional Work Environment

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1 A
				pharmacist, pharmacy intern, and pharmacy technician who works eight continuous
				hours or longer per day shall take, at a minimum, one thirty-minute
				uninterrupted meal break during that work period. If such a pharmacist,
				pharmacy intern, or pharmacy technician is required to work twelve continuous
				hours per twenty-four hours, at a minimum, the individual qualifies for an
				additional twenty-minute break. A pharmacist, pharmacy intern, or pharmacy
				technician, who is entitled to take such breaks shall not be required to work
				more than five continuous hours, excluding a twenty-minute break, before being
				given the opportunity to take a thirty-minute uninterrupted meal
				break.
7.2 A pharmacy shall not
				require a pharmacist, pharmacy intern, or pharmacy technician to work longer
				than twelve continuous hours per twenty-four-hour period, inclusive of the
				required breaks under 7.1.
7.3 A
				pharmacy shall keep and maintain a complete and accurate record showing its
				pharmacists' daily break periods.
7.4 In the case of an emergency, as deemed by
				the professional judgement of the pharmacist, a pharmacist, pharmacy intern, or
				pharmacy technician may work longer than twelve continuous hours, work without
				taking meal breaks, or have a break interrupted in order to minimize immediate
				health risks for patients. The pharmacist must document and date the amount of
				time worked beyond the twelve hours limit or breaks missed along with the
				reason and make it available to the Board.
7.5 The pharmacist-in-charge or designee
				shall determine the work schedule for pharmacy technicians based upon prior
				dispensing records. The pharmacist shall ensure adequate staffing levels based
				on prior dispensing records and patient care tasks. The pharmacist-in-charge
				shall have final approval of the work schedule. Any decision overriding such
				control of the PIC may be grounds for disciplinary action against the pharmacy
				permit.
7.6 The pharmacist on duty
				or the pharmacy registrant shall notify the pharmacist-in-charge via telephone,
				e-mail, or text message whenever a prescription error, loss of drugs, or a
				violation of any statute or rule occurs and the pharmacist-in-charge is not
				present.
7.7 A pharmacy shall not
				use advertisements or make solicitations that may jeopardize the health,
				safety, or welfare of patients, including, but not limited to, the use of
				advertisements or solicitations that:
7.7.1
				Are false, fraudulent, deceptive, or misleading;
7.7.2 Include any claim regarding a
				professional service or product or the cost or price thereof that cannot be
				substantiated by the licensee.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-8 - Notification

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1. The violation
				of any of these rules shall be considered cause for disciplinary
				action.
8.2. An employer who
				employs a licensed pharmacist shall notify the Board within fourteen (14) days,
				in writing, of any discharge or termination of the licensed pharmacist or
				change of the status of the pharmacist-in-charge.
8.3. A person who employs a licensed
				pharmacist shall, within three business days from the time of discovery, notify
				the Board, in writing, of any violations of board rules or laws by the licensed
				pharmacist.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-9 - Whistleblower protection

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1 A
				permit or license holder of the Board who is found to be in violation of 11 (c)
				CFR 1977.3 or §6C-1 known as the "Whistle-blower law" may be subject to
				disciplinary action by the Board.
9.2 Nothing in this Section shall be deemed
				to diminish the rights, privileges, or remedies of an employee of a pharmacy
				under any other federal or State law, rule, or regulation or under any
				employment contract.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-15 - Regulations Governing Pharmacy Permits › Section 15-15-10 - Temporary, Permanent, or Emergency Closure of a Pharmacy

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. For a temporary closure of a pharmacy,
				the pharmacy shall:
10.1.1. Post notification
				of closure on each pharmacy entrance as soon as the need to deviate from the
				posted hours is known by the pharmacy, but no later than 2 hours after the
				temporary closure begins. The posting must include:
10.1.1.a. Estimated period of time the
				pharmacy will be closed; and
10.1.1.b. Options for prescription pick-up
				(e.g., another local pharmacy, contact prescriber for new prescription, reverse
				processed prescriptions).
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. --
				Licensure and practice of pharmacist care.
1.2. Authority -- W. Va. Code §§
									30-5-7.
1.3. Filing date -- April 14, 2022.
1.4. Effective date -- April 14,
				2022.
1.5. Sunset Date -- This rule
				shall terminate and have no further force or effect upon August 1,
				2027.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-2 - Examination for Licensure and Registration and Annual Renewal Requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. Application -
				An applicant for examination to become a licensed pharmacist shall apply in
				writing to the Board at least 15 days before the date of examination is to be
				conducted and shall transmit with the application the prescribed fee of
				$125.00. The application shall be made on a form provided by the
				Board.
2.2. The requirements for
				application as a pharmacist are as follows:
2.2.1. An applicant shall be 18 years of age
				or older, proof of which shall be shown by birth certificate or other
				acceptable document.
2.2.2. An
				applicant shall present to the Board satisfactory evidence that he or she is a
				person of good moral character and has not been convicted of a crime that bears
				a rational nexus to the practice of pharmacy. For other convictions not bearing
				a rational nexus to the practice of pharmacy, the Board shall permit the
				applicant to apply for initial licensure if;
2.2.2.a. a period of five years has elapsed
				from the date of conviction or the date of release from incarceration,
				whichever is later;
2.2.2.b. the
				individual has not been convicted of any other crime during the period of time
				following the disqualifying offense; and
2.2.2.c. the conviction was not for an
				offense of a violent or sexual nature: Provided, that a conviction for an
				offense of a violent or sexual nature may subject an individual to a longer
				period of disqualification from licensure, to be determined by the individual
				board.
2.2.3. An
				applicant shall present to the Board satisfactory evidence that he or she is a
				graduate of an approved school of pharmacy, or has met the requirements for
				educational equivalency by obtaining a Foreign Pharmacy Graduate Examination
				Committee Certification through the program administered by the National
				Association of Boards of Pharmacy (NABP).
2.2.4. An applicant shall have acquired 1500
				hours of internship under the supervision of a licensed pharmacist.
2.2.5. An applicant shall complete a criminal
				history records check as prescribed in § 29.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-3 - Examinations

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. State and
				national examinations required for licensure are administered on behalf of the
				Board by NABP.
3.2. Examinations
				for the North American Pharmacist Licensure Examination (NAPLEX), the
				Multistate Pharmacy Jurisprudence Examination for West Virginia (MPJE), and as
				part of the Foreign Pharmacy Graduate Examination Committee Certification shall
				be done in accordance with the processes and procedures required by
				NABP.
3.3. An applicant for
				licensure as a pharmacist shall pass the NAPLEX and the MPJE, administered by
				NABP.
3.4. An applicant failing to
				achieve the required grades may repeat the failed examination or examinations
				one time without re-applying to the board within 6 months of the date of the
				original application, but one re-examination exhausts the applicant's privilege
				to sit for the examinations under the current application.
3.5. An applicant failing to achieve the
				required grade on each examination a second time may apply for licensure a
				second time, and again have two chances to pass the examinations.
3.6. An applicant failing to achieve the
				required grade on each examination a third time must petition the board before
				making reapplication a third or any subsequent time. At this time the board may
				require the applicant to complete a remediation evaluation and/or program
				before the applicant may reapply for licensure and sit for the
				examinations.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-4 - Certificate of Licensure

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. An
				applicant for licensure who has successfully passed all the required
				examinations may receive a letter signed by the Secretary prior to preparation
				of a permanent certificate, or a permanent certificate evidencing that he or
				she is a licensed pharmacist. The permanent certificate of licensure shall bear
				a serial number, the full name of the applicant, the date of its issuance, the
				seal of the Board, and shall be signed by at least four (4) member of the
				Board, and attested by the President and Secretary. For any duplicate of this
				certificate the Board shall charge $25.00. A certificate is not
				assignable.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-5 - License and registration renewal

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. The board shall charge and collect the
				following fees:
5.1.1. Biennial renewal of
				license of pharmacist: $100.00
,
provided that if the
				applicant is sixty-five (65) years of age or older at the time of renewal then
				the fee shall be $50.00;
5.1.2.
				License of pharmacy intern: $10.00 for the original license; $5.00 for each
				renewal for the remaining periods of his or her internship;
5.1.3. Registration of a consultant
				pharmacist: $20.00 for each application; and
5.1.4. Registration of a pharmacy technician:
				$25.00 for the original registration; $20.00 for each biennial
				renewal
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-6 - Reciprocity; Licensure of Pharmacists From Other States or Countries

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. The Board may
				license and admit to practice pharmacists in this state that have been legally
				licensed or registered as pharmacists in other states or countries if:
6.1.1. The applicant is at least 18 years of
				age;
6.1.2. The applicant is in
				good standing in the state or country from which he is seeking to transfer his
				or her licensure or registration;
6.1.3. The applicant is in fact, competent
				and physically and mentally qualified to function as a pharmacist;
6.1.4. The applicant is of good moral
				character and not addicted to alcohol or a controlled substances;
6.1.5. The applicant has not been convicted,
				or had his or her license in any other state or country suspended or revoked
				for violation of pharmacy, liquor, controlled substance, or food and drug
				laws.
6.1.6. The applicant
				originally passed a written examination in subjects determined by the Board as
				being reasonable; and
6.1.7. The
				applicant passes the West Virginia MPJE.
6.1.8. The applicant must complete a criminal
				history records check as prescribed in § 29.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-16 - Regulations Governing Pharmacists › Section 15-16-7 - Application

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. The applicant
				shall complete a preliminary application form obtained from the National
				Association of Boards of Pharmacy and return it to that organization. After the
				preliminary application data has been verified by the National Association of
				Boards of Pharmacy and the Board receives notification to that effect, the
				Board shall supply the applicant who possesses the necessary qualifications
				with application forms. An applicant must complete the forms and submit a fee
				of $250.00.
7.2. The application
				shall include the following provided by the applicant:
7.2.1. A certified copy of proof of
				experience, or the original pharmacist preceptor's affidavit proving
				experience, that was filed by the applicant when he or she took the examination
				in the state or country in which he or she is licensed or registered;
7.2.2. A recent head shot photograph with a
				statement signed by the applicant that it is a photograph of the applicant and
				has been made within the previous twelve (12) months; and
7.2.3. A signed waiver from the applicant
				allowing the Board to obtain a certified criminal records check on the
				applicant.
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 15-17-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- To
				establish standards for the substitution of biological
				pharmaceuticals.
1.2. Authority. --
				W. Va. Code§§
									30-5-7 and
				30-5-12c.
1.3. Filing Date. -- April 25, 2024
1.4. Effective Date. -- April 25,
				2024
1.5. Sunset Date -- This rule
				shall terminate and have no further force or effect upon August 1,
				2034.