reglab/statecodes huggingface dataset:
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-4 - Continuing Pharmacy Education Requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A licensed pharmacist shall complete a
				minimum of thirty CPE hours every two years, inclusive of any CPE requirements
				for consultant pharmacist registration, pharmacist immunization registration,
				and drug diversion training and best practice prescribing of controlled
				substances training, in order to renew his or her license to practice pharmacy
				in West Virginia, and each reporting period thereafter.
4.2. Hours earned may only be used to meet
				the requirements for one reporting period. Hours in excess of the number
				required at the end of each reporting period shall not be transferred or
				applied to future reporting periods to satisfy future CPE requirements. Hours
				earned in a new reporting period but used to meet the requirements of a prior
				reporting period may only be used for the prior reporting period.
4.3. Six hours of the thirty CPE hours
				required every two years shall be obtained through a live presentation
				requiring the direct presence of the pharmacist at the CPE activity.
4.4. Every pharmacist shall complete a
				minimum of two hours of drug diversion training and best practice prescribing
				of controlled substances training within one year of receiving his or her
				initial license from the Board.
4.4.a. Said
				two hours of CPE shall be a part of the 30 hours of CPE required and is not two
				additional hours.
4.4.b. For
				purposes of this subsection, "drug diversion training and best practice
				prescribing of controlled substances training" means a training course of at
				least two CPE hours which includes drug diversion training, best-practice
				prescribing of controlled substances training, and training on prescribing and
				administration of an opioid antagonist that has been approved by the
				Board.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-5 - Methods of Acquiring Continuing Pharmacy Education

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. Continuing pharmacy education hours of
				credit may be earned by licensed pharmacists in the following manner:
5.1.a. Live Activities, which means CPE
				activities that provide for a direct interaction between faculty and learners,
				and may include lectures, symposia, live teleconferences, live webinars,
				workshops, and other similar venues;
5.1.b. Home study by print, webinar,
				computer-based training, video, or other non-live approved activities or
				audio-visual presentations;
5.1.c.
				Credit earned from a United States accredited college/school or university for
				post-graduate courses in pharmaceutical sciences or other courses applicable to
				pharmacy practice;
5.1.d.
				Continuing pharmacy education activities granted credit by other states;
				and
5.1.e. Any activity approved by
				ACPE.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-6 - Activity Administration

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1.
				The board has the statutory responsibility for the oversight of CPE as required
				for licensure renewal and to appoint a Continuing Pharmacy Education
				Committee.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-7 - Continuing Pharmacy Education Committee

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. The Continuing Pharmacy Education
				Committee shall be composed of equal representation from the West Virginia
				Board of Pharmacy, each accredited school of pharmacy located in the State of
				West Virginia, the West Virginia Pharmacists Association, and the West Virginia
				Society of Health System Pharmacists.
7.2. The members of the CPE Committee shall
				be selected by the board and shall serve for a period of three years and may be
				reappointed.
7.3. The chairman of
				the CPE Committee shall be selected by the members of the committee.
7.4. The CPE Committee is responsible for
				approval of each activity offered by a non-accredited ACPE provider of CPE
				credit.
7.5. The CPE Committee
				shall:
7.5.a. perform necessary correspondence
				and communication with professional groups, organizations, and individuals who
				have interest in CPE; and
7.5.b.
				recommend to the board for its approval those providers of continuing pharmacy
				education activities who have been certified as meeting the criteria
				established for this purpose.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-8 - Responsibilities of Providers

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1.
				CPE providers are responsible for submitting CPE activities to the board for
				approval.
8.2. Providers shall
				submit an application for approval of any CPE activity in writing to the board
				at least thirty days prior to their offering in order that potential
				participants will know whether the activity is approved. The board may approve
				activities submitted later provided proper cause is shown for late
				submission.
8.3. The proposed CPE
				activity shall contain all required information on forms provided by the board,
				including, but not limited to, the course name, provider name, proposed dates
				the activity will be offered, agenda, content overview, learning objectives and
				faculty name with biography.
8.4.
				The board may revoke or suspend approval of providers for submission of
				fraudulent information concerning CPE.
8.5. Changes to the content of an ongoing
				approved activity shall require the provider to submit a new application for
				the activity.
8.6. Providers shall
				retain a file of participants of each accredited activity for four
				years.
8.7. Providers not
				accredited by ACPE shall provide a statement of credit of participation to each
				participant or report course completion to the CPE Monitor for each participant
				who attends and successfully completes an activity. The statement of credit
				shall include at a minimum, the course name, date completed, total CPE hours
				earned, and the provider's name, address, phone number, and board CPE
				number.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-9 - Responsibilities of Pharmacists

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1.
				Pharmacists shall keep valid records, receipts, and certifications of
				continuing pharmacy education activities completed for four years and submit
				certifications of participation and completion to the board upon request. The
				records may be kept in whole or in part in the pharmacist's personal account in
				the CPE Monitor.
9.2. The board may
				take disciplinary action against a pharmacist for submission of fraudulent
				statements or certificates concerning CPE.
9.3. A Pharmacist shall submit, on forms
				provided by the board, a list of accredited CPE activities completed in the
				preceding reporting period with their renewal license application.
9.4. In the event a pharmacist fails to
				submit a list of completed CPE activities with his or her renewal application,
				the board shall notify the pharmacist at his or her last known address that
				disciplinary action shall be taken for failure to comply with CPE
				requirements.
9.5. A pharmacist may
				request a waiver from the board from the CPE requirements for reasons of
				illness, injury, incapacity, retirement, or other extenuating
				circumstances.
9.6. A pharmacist
				shall keep the board informed of his or her current mailing address.
9.7. A pharmacist may only transfer CPE hours
				from another state if that state accepts the transfer of West Virginia CPE
				hours to its state.
9.8. A West
				Virginia licensed pharmacist who resides in another state requiring CPE and who
				does not practice in West Virginia may renew his or her West Virginia license
				by certifying on his or her CPE report form that he or she has a current and
				valid license to practice in the state in which he or she is residing. The
				following statement shall be placed on the form, and the form signed, dated,
				notarized, and returned to the West Virginia Board of Pharmacy with the renewal
				application and fee:
"I declare under penalties of falsification that I hold a
				  current and valid pharmacist license, No. [___] in the State of [______], and
				  that I do not presently practice pharmacy in the State of West Virginia. I
				  hereby agree to notify the West Virginia Board of Pharmacy if I return and
				  commence practice in West Virginia."
9.9. A pharmacist may request CPE credit only
				once in a reporting period for each activity attended or completed.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-10 - Approval of Continuing Pharmacy Activities

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. Providers shall submit all CPE
				activities for approval by the board except as provided for in subsections 10.2
				and 10.3 of this section.
10.2. The
				board has approved all activities developed and presented by ACPE accredited
				providers.
10.3. Approval of a CPE
				activity is valid for a three-year period if the content remains the
				same.
10.4. All activities shall
				meet the criteria utilized by ACPE and additionally shall meet the following
				criteria:
10.4.a. The activity shall be
				relevant, timely, and applicable to pharmacy practice;
10.4.b. The activity content shall be well
				organized with stated objectives, and an orderly flow of material, with
				appropriate examples and/or illustrations; and
10.4.c. The activity shall be appropriately
				presented, with the mode/method of presentation appropriate to the
				topic.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-11 - Activity Evaluation

Current through Register Vol. XLI, No. 28, July 12, 2024
11.1. The
				provider or sponsor shall have an evaluation mechanism for the purpose of
				allowing the participant to assess achievement of personal
				objectives.
11.2. The provider or
				sponsor shall develop and employ evaluation techniques that will assess the
				effectiveness of the CPE activities and the level of fulfillment of the stated
				objectives, with the goal of CPE improvement by the provider or
				sponsor.
11.3. The provider or
				sponsor shall compile the results of participants' evaluations and submit them
				to the board upon request.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-03 - Board of Pharmacy Rules for Continuing Education for Licensure of Pharmacists › Section 15-3-12 - Credits and Records

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1.
				Credits and records of CPE shall be based on a CPE hour or approved
				fifteen-minute increments.
12.2. A
				pharmacist who develops and/or presents an approved CPE activity shall receive
				credit for the number of continuing pharmacy education hours of that activity
				for his or her initial presentation.
12.3. All providers and pharmacists shall
				retain their records for four years in a manner that will enable their ready
				retrieval upon request of the board, its authorized agent or
				Committee.
12.4. Graduates
				providing documentation of enrollment in graduate programs of health-related
				fields or participation in a residency program in a health-related field are
				not required to provide additional documentation of participation in CPE. If a
				graduate discontinues his or her pursuit of graduate study, the prevailing CPE
				requirements apply for his or her continued licensure.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. --
				Recordkeeping requirements, and outlining the proper use of an automated Data
				Processing System.
1.2. Authority.
				-- W. Va. Code §
									30-5-7.
1.3. Filing Date. -- June 24, 2016.
1.4. Effective Date. - July 1,2016.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-2 - Use of Automated Data Processing Systems - General Provisions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. A pharmacy may
				establish and use an automated data processing system to keep records of
				prescription drugs which it dispenses.
2.2. Two or more pharmacies may establish and
				use an automated data processing system as a common data file or database to
				maintain required or pertinent prescription drug dispensing information.
				Pharmacies using a common file are not required to transfer prescriptions or
				information for dispensing purposes between or among the pharmacies
				participating in the same common prescription file or data base: Provided that
				any common file must contain complete and adequate records of each prescription
				and renewal dispensed.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-3 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. Except as
				otherwise specifically stated in this rule, the definitions set forth in Title
				15, Series 1, Section 2 are incorporated by reference, and are fully applicable
				hereto.
3.2. "Automated Data
				Processing System (ADP)" means a system utilizing computer software and
				hardware for the purpose of recordkeeping.
3.3. "Printout" means a readable printed copy
				of the output of a computer.
3.4.
				"Common database" means a file or collection of information created by the
				automated data processing system that enables authorized users to have common
				access to the file regardless of physical location.
3.5. "On-line retrieval" means the producing
				of sight-readable documents on a suitable computer screen or monitor.
3.6. "Hardware" is the fixed components of a
				computer, server, or other such devices used for the electronic storage and
				retrieval of data.
3.7. "Software"
				is a computer program used to direct the operation of a computer, as well as
				the documentation giving instructions on how to use it, and directs the storage
				of required data on the hardware.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-4 - Record of Dispensing Prescription Drugs

Current through Register Vol. XLI, No. 28, July 12, 2024
Records of dispensing of prescription drugs for original and
				  refill prescriptions are to be made and kept by pharmacies for five (5) years.
				  Information must be immediately accessible for a period of not less than one
				  (1) year from the date of last dispensing. Information beyond one (1) year but
				  up to five (5) years from the date of dispensing may be maintained other than
				  on-line, but must be produced within forty-eight (48) hours upon request by
				  proper authorities. The information contained in the records shall include, but
				  not be limited to:
4.1. the
				information required to be placed upon the label for the dispensed medication
				as set forth in Title 15, Series 1, Section 22;
4.2. the full name of the pharmacist
				responsible for dispensing the drug; and
4.3. a record of renewals to date.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-5 - Record of Retrieval (Documentation of Activity)

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. The pharmacy must be able to provide a
				current history of all authorized prescription activity required to be kept by
				section 4. In addition, this information must be capable of production on a
				patient-by-patient basis in the form of patient profiles which allows immediate
				review of at least the following data about the patient which may be reasonably
				obtained by the pharmacist:
(a) The patient's
				biographical data;
(b) The
				patient's medications;
(c) The
				patient's disease states and drug allergies;
(d) The pharmacist's notes; and
(e) Any other data necessary to make rational
				judgments about pharmacist care.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-6 - Auxiliary Recordkeeping System

Current through Register Vol. XLI, No. 28, July 12, 2024
An auxiliary recordkeeping system shall be established by
				  each pharmacy for the documentation of renewals if the ADP is inoperative.
				  Information regarding prescriptions dispensed and renewed during the
				  inoperative period shall be entered into the automated data processing system
				  within seventy-two (72) hours.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-7 - Operating the ADP System

Current through Register Vol. XLI, No. 28, July 12, 2024
Only authorized pharmacy personnel licensed or registered by
				  the Board may have access to the ADP.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-04 - Record Keeping and Automated Data Processing Systems › Section 15-4-8 - Records of Provision of Pharmacist Care Outside of a Licensed Pharmacy

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1 A pharmacist
				practicing pharmacist care services outside the premises of a licensed pharmacy
				shall maintain the records or other patient-specific information used in such
				activities in a readily retrievable form in a system that is secured and
				managed by the pharmacy with whom the pharmacist is providing such services;
				or, if acting independent of a pharmacy without the dispensing of prescription
				drugs to provide direct patient-care activities of patient counseling and
				medication therapy management, when the patient is unable to present to the
				pharmacy for a personal, face-to-face interaction, a secure system maintained
				by the pharmacist. The records or information shall:
(a) provide accountability and an audit
				trail;
(b) be provided to the Board
				upon request;
(c) be preserved for
				a period of at least five years from the date relied upon or consulted for the
				purposes of performing any such function; and
(d) secure from unauthorized access and
				use.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- To
				establish rules for the federal Drug Quality and Security Act, and Prescription
				Drug Marketing Act, as amended, for the licensing by this state of persons who
				engage in wholesale distributions, provision of third-party logistics, and
				manufacturing, of prescription drugs in interstate commerce within and into
				this state.
1.2. Authority. - W.
				Va. Code §
									60A-8-9.
1.3. Filing Date. -- May 11, 2021
1.4. Effective Date. -- June 11,
				2021
1.5. Sunset Date -- This rule
				shall terminate and have no further force or effect upon June 11,
				2031.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. Except as
				otherwise specifically stated in this rule, the definitions set forth in Title
				15, Series 1, Section 2 are incorporated by reference as if set forth fully
				herein, and are fully applicable hereto.
2.2. "Affiliate" means a business entity that
				has a relationship with a second business entity if, directly or indirectly:
2.2.1. one business entity controls, or has
				the power to control, the other business entity; or
2.2.2. a third party controls, or has the
				power to control, both of the business entities.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-3 - Wholesale Drug Distributor and Third-Party Logistics Provider Licensing and Manufacturer Permit Requirements

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1.
				Every wholesale distributor, wherever located, who engages in the wholesale
				distribution of drugs into, out of, or within the state must be licensed by the
				West Virginia Board of Pharmacy (hereinafter, the "Board") in accordance with
				the laws and regulations of this state before engaging in the wholesale
				distribution of prescription drugs. Every wholesale distributor, wherever
				located, who engages in the wholesale distribution of drugs into, out of, or
				within the state shall report discipline from any jurisdiction within thirty
				days of the entry of the final order.
3.2 Any person operating as a manufacturer of
				prescription drugs must obtain a manufacturing permit issued by the Board in
				accordance with the laws and regulations of this state before engaging in
				manufacturing of prescription drugs in this state.
3.3 Notwithstanding any other provision to
				the contrary, each entity that meets the definition of a third-party logistics
				provider shall obtain a license as a third-party logistics provider and is not
				required to obtain a license as a wholesale distributor if the entity never
				assumes an ownership interest in the product it handles.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-4 - Minimum Required Information For Wholesale Drug Distributor or Third-Party Logistics Provider Licensure, and Manufacturer Permit; Applications and Renewals

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A wholesale
				drug distributor or third-party logistics provider, and a manufacturer,
				including prescription drug manufacturers and outsourcing facilities, as part
				of the initial licensing procedure and as part of any renewal of license, shall
				provide on the application form as required by the Board:
4.1.1. The name, full business address, and
				telephone number of the licensee;
4.1.2. All trade or business names used by
				the licensee;
4.1.3. Addresses,
				telephone numbers, and the names of contact persons for the facility used by
				the licensee for the storage, handling, and distribution of prescription
				drugs;
4.1.4. The type of ownership
				or operation (i.e. partnership, corporation, or sole proprietorship)
				and
4.1.5. The name of the owner
				and/or operator of the licensee, including:
4.1.5.a. If a person, the name of the
				person;
4.1.5.b. If a partnership,
				the name of each partner, and the name of the partnership;
4.1.5.c. If a corporation, the name and title
				of each corporate officer and director, the corporate names, and the name of
				the state of incorporation, and the name of the parent company, if
				any;
4.1.5.d. If a sole
				proprietorship, the full name of the sole proprietor and the name of the
				business entity.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-5 - Minimum Qualifications

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. The
				Board shall consider, at a minimum the following factors in reviewing the
				qualifications of persons who engage in wholesale distribution of prescription
				drugs, act as a third-party logistics provider, or manufacturer prescription
				drugs within or into the state:
5.1.1. Any
				convictions of the applicant under any Federal, State, or local laws relating
				to drug samples, drug manufacturing, wholesale or retail drug distribution, or
				distribution of controlled substances;
5.1.2. Any felony convictions of the
				applicant under Federal, State, or local laws;
5.1.3. The applicant's past experience in the
				manufacture or distribution of prescription drugs, including controlled
				substances;
5.1.4. The furnishing
				by the applicant of false or fraudulent material in any application made in
				connection with drug manufacturing or distribution or acting as a third-party
				logistics provider;
5.1.5.
				Suspension or revocation by Federal, State, or local government of any license,
				permit, or other authorization currently or previously held by the applicant
				for the manufacture or distribution of, or acting as a third-party logistics
				provider related to, any drugs, including controlled substances;
5.1.6. Compliance with licensing requirements
				under previously granted licenses, if any;
5.1.7. Compliance with requirements to
				maintain and/or make available to the Board or to Federal, State, or local law
				enforcement officials those records required under this section;
5.18. An outsourcing facility must complete
				an initial inspection satisfactory to the board; and
5.1.9. Any other factors or qualifications
				the Board considers relevant to and consistent with the public health and
				safety.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-6 - Personnel

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. As a condition
				for receiving and retaining a wholesale drug distributor or third-party
				logistics provider license or manufacturer permit, the licensee or permittee
				shall require each person employed in any prescription drug wholesale
				distribution activity to have education, training, and experience, or any
				combination thereof, sufficient for that person to perform the assigned
				functions in such manner as to provide assurance that the drug product quality,
				safety and security will at all times be maintained as required by
				law.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-7 - Violations and Penalties

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. The
				Board may reprimand, suspend, restrict, or revoke any licenses or permits
				granted under this series upon conviction of violations of Federal, State, or
				local drug laws or regulations. Before any license or permit may be
				reprimanded, suspended, restricted, or revoked, a licensee or permittee under
				this series shall have a right to prior notice and a hearing pursuant to
				Chapter 29A-1-1 et seq., Administrative
				Procedures Act of the Code of West Virginia.
7.2. The Board may reprimand, suspend,
				restrict, or revoke any license or permit granted under this section for
				violations of these regulations.
7.3. In any case where the Board finds that
				any licensee or permittee under this section shall be disciplined as set forth
				above, the Board may also levy an administrative penalty not to exceed one
				thousand dollars per day per violation, and may assess administrative costs
				against the licensee.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-8 - Minimum Requirements for Wholesale Drug Distributors for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Records

Current through Register Vol. XLI, No. 28, July 12, 2024
The following constitutes the minimum requirements for the
				  storage and handling of prescription drugs, and for the establishment and
				  maintenance of prescription drug distribution records by wholesale drug
				  distributors and their officers, agents, representatives, and employees.
8.1. Facilities. All facilities at which
				prescription drugs are stored, warehoused, handled, held, offered, marketed, or
				displayed shall:
8.1.1. Be of suitable size
				and construction to facilitate cleaning, maintenance, and proper
				operations;
8.1.2. Have storage
				areas designed to provide adequate lighting, ventilation, temperature,
				sanitation, humidity, space, equipment, and security conditions;
8.1.3. Have a quarantine area for storage of
				prescription drugs that are outdated, damaged, deteriorated, misbranded, or
				adulterated, or that are in immediate or sealed, secondary containers that have
				been opened;
8.1.4. Be maintained
				in a clean and orderly condition; and
8.1.5. Be free from infestation by insects,
				rodents, birds, or vermin of any kind.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-9 - Minimum Requirements for Third-Party Logistics Providers and Manufacturers for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Records

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. Third-party logistics providers and
				manufacturers shall meet the minimum requirements for the storage and handling
				of prescription drugs, and for the establishment and maintenance of
				prescription drug distribution records as required by the Federal Food and Drug
				Administration.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-05 - Licensure of Wholesale Drug Distributors, Third-Party Logistics Providers, and Manufacturers › Section 15-5-10 - The West Virginia Board of Pharmacy inspection powers and access to licensee and permittee records

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. A person authorized by the board may
				inspect during normal business hours any premises being used by a wholesale
				drug distributor, third-party logistics provider, or manufacturer in this state
				in the course of its business.
10.2. Licensees and permittees under this
				series may keep records regarding purchase and sales transactions at a central
				location apart from the principal office of the licensee or permittee or the
				location at which the drugs were manufactured, housed, or stored by the
				licensee or permittee, and from which they were shipped: Provided, That such
				records shall be made available for inspection within two working days after a
				request to inspect by the board is made. Such records may be kept in any form
				permissible under federal law applicable to prescription drugs record
				keeping.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- To
				establish rules for the Mail-order pharmacy and non-resident
				pharmacies.
1.2. Authority. -- W.
				Va. Code §
									30-5-7.
1.3. Filing Date. -- April 28,
				2017.
1.4. Effective Date. -- April
				28, 2017.
1.5. Sunset Date -- This
				rule shall terminate and have no further force or effect on April 28,
				2027.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1. "Mail-order
				pharmacy" means a pharmacy, regardless of its location, which dispenses greater
				than twenty-five percent prescription drugs via the mail or other delivery
				services.
2.2. "Non-resident
				pharmacy" means a pharmacy outside of this state where drugs are dispensed and
				pharmacist care is provided to residents into this state.
2.3. "Pharmacy" means a place within this
				state where drugs are dispensed and pharmacist care is provided and a place
				outside of this state where drugs are dispensed and pharmacist care is provided
				to residents of this state.
2.4.
				"Prescription or prescription drug order" means a lawful order from a
				practitioner for a drug or device for a specific patient, including orders
				derived from collaborative pharmacy practice, where a valid
				patient-practitioner relationship exists, that is communicated to a pharmacist
				in a pharmacy.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-3 - Registrations for Mail-Order Pharmacies

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. A mail-order pharmacy shall apply for a
				registration for authorization to dispense prescription drugs or medicines in
				West Virginia. A non-resident pharmacy shall be registered in this state in the
				same manner as a mail-order pharmacy pursuant to this Series by issuance of a
				mail order registration.
3.2. A
				mail-order pharmacy or non-resident pharmacy shall submit the application for
				the registration to the West Virginia Board of Pharmacy. The application shall
				contain the following information:
3.2.a. The
				owner of the mail-order pharmacy or non-resident pharmacy, whether an
				individual, a partnership, or a corporation.
3.2.b. The names and titles of all individual
				owners, partners or corporate officers.
3.2.c. The pharmacy manager.
3.2.d. The pharmacist-in-charge.
3.2.e. The complete address, telephone number
				and fax number of the mail-order pharmacy or non-resident pharmacy.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-4 - Prescription record and reporting

Current through Register Vol. XLI, No. 28, July 12, 2024
The mail-order pharmacy or non-resident pharmacy shall
				  maintain prescription records which are available for review if required by the
				  Board. The mail order pharmacy shall comply with the reporting requirements of
				  the West Virginia Controlled Substances Monitoring Program as set forth in West
				  Virginia Code §
									60A-9-1 and the rules
				  enacted in support thereof.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-5

Current through Register Vol. XLI, No. 28, July 12, 2024
Mail-order pharmacies or non-resident pharmacies shall have a
				  toll free accessible telephone for consumers to obtain counseling with a
				  licensed pharmacist during regular working hours and the telephone number shall
				  be prominently identified on the prescription container or on the prescription
				  container label.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-6 - Doing Business in West Virginia

Current through Register Vol. XLI, No. 28, July 12, 2024
Mail-order pharmacies or non-resident pharmacies soliciting,
				  receiving, and dispensing and delivering orders comprising prescription drugs
				  and scheduled controlled drug substances as defined in 21 USC 1 et seq., and 21
				  CFR 1 et seq., and delivered to ultimate consumers in West Virginia constitutes
				  doing business in West Virginia.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-7 - Resident Agent

Current through Register Vol. XLI, No. 28, July 12, 2024
Mail-order pharmacies or non-resident pharmacies doing
				  business in West Virginia by dispensing and delivering prescription orders to
				  West Virginia consumers shall designate a resident agent for purposes of
				  service of process and notice.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-06 - Mail-Order and Non-Resident Pharmacies › Section 15-6-8 - Pharmacist-In-Charge Licensure requirement

Current through Register Vol. XLI, No. 28, July 12, 2024
The pharmacist in charge or at least one designated
				  pharmacist of the out-of-state mail order pharmacy or non-resident pharmacy
				  shall be licensed to practice pharmacist care in West Virginia and act as the
				  PIC of the registration, and any other pharmacist providing pharmacist care
				  from the out-of-state mail order pharmacy or non-resident pharmacy shall be
				  licensed in the state where the pharmacy is located.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-07 - Board of Pharmacy Rules for Registration of Pharmacy Technicians › Section 15-7-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- To
				establish standards for the training and regulation of pharmacy technicians and
				pharmacy technician trainees.
1.2.
				Authority. -- W. Va. Code§§
									30-5-7 and
				30-5-11a.
1.3. Filing Date. -- May 3, 2024.
1.4. Effective Date. -- May 3,
				2024.
1.5. Sunset Provision -- 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 15-07 - Board of Pharmacy Rules for Registration of Pharmacy Technicians › Section 15-7-2 - Definitions

Current through Register Vol. XLI, No. 28, July 12, 2024
2.1 "Cashier" means
				a pharmacy employee who only handles a prescription drug at the point of sale
				to provide the prescription drug to a patient and handles the financial
				transaction of the pharmacy.
2.2.
				"Certified Pharmacy Technician" or "CPhT" means a person who holds a current
				certification as a nationally certified pharmacy technician granted by NHA or
				PTCB.
2.3. "Medication
				Reconciliation" means the process of identifying the most accurate list of all
				medications that the patient is taking, including name, dosage, frequency, and
				route, by comparing the medical record to an external list of medications
				obtained from a patient, hospital, or other provider.
2.4. "National Healthcare Association" or
				"NHA" means the association which includes the ExCPT Certification Board, which
				develops, maintains, promotes, and administers a nationally accredited
				certification and recertification program for pharmacy technicians to become a
				CPhT, including its ExCPT Pharmacy Exam (ExCPT), which was originally
				established by the Institute for the Certification of Pharmacy
				Technicians.
2.5. "Pharmacy
				Technician" means a person registered with the board to practice certain tasks
				related to the practice of pharmacist care in this State within the scope of
				practice permitted by West Virginia Code Section
				30-5-12, as provided, permitted,
				and limited by the laws and rules governing the practice of pharmacist
				care.
2.6. "Pharmacy Technician
				Certification Board" or "PTCB" means the entity established by its five
				governing organizations, the American Pharmacists Association, American Society
				of Health-System Pharmacists, Illinois Council of Health-System Pharmacists,
				Michigan Pharmacists Association, and National Association of Boards of
				Pharmacy, which develops, maintains, promotes, and administers a nationally
				accredited certification and recertification program for pharmacy technicians
				to become a CPhT, including its Pharmacy Technician Certification Exam
				(PTCE).
2.7. "Pharmacy Technician
				Trainee" means an individual currently engaged in a competency-based pharmacy
				technician education and training program which has been approved by the Board
				and who is performing the duties of a pharmacy technician under the direct
				supervision of a pharmacist.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-07 - Board of Pharmacy Rules for Registration of Pharmacy Technicians › Section 15-7-3 - Qualifications For Registration as a Pharmacy Technician; 20 Hour Training Program

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. To be
				eligible for registration as a pharmacy technician, an individual shall comply
				with West Virginia Code §
									30-5-11, and shall submit an
				application on the forms provided by the board, together with the application
				fee of $25.00 unless the individual qualifies for a fee waiver, evidencing that
				the individual:
3.1.a. was registered as a
				pharmacy technician in the State of West Virginia prior to July 1, 2014, the
				registration was still active and in good standing through June 30, 2014, and
				he or she is otherwise eligible to renew his or her registration; or
3.1.b. for those obtaining registration
				beginning July 1, 2014, and forward:
3.1.b.1
				has either:
3.1.b.1.A. graduated from a
				competency-based pharmacy technician education and training program of a
				learning institution or training center approved by the Board;
3.1.b.1.B. completed a pharmacy-provided,
				on-the-job, competency-based education and training program approved by the
				Board; or
3.1.b.1.C. Obtained a
				national certification as a pharmacy technician and have practiced in another
				jurisdiction for at least one year; and
3.1.b.2. successfully passed the ExCPT
				national examination administered by NHA or the PTCE national examination
				administered by PTCB, and holds a current certification from NHA or PTCB,
				respectively, as a CPhT;
3.1.b.3.
				completed a 20-hour training program as outlined in subsection 3.2 of this
				rule. The pharmacist-in-charge must submit to the Board certification in the
				form of an affidavit from the pharmacist-in-charge that the pharmacy technician
				trainee has adequately completed this training program; and
3.1.b.4. complete a criminal history records
				check as prescribed in § 29 of Title 15, Series 1.
3.1.b.4.A. The criminal history records must
				have been requested within the 12 months immediately before the application is
				filed with the board.
3.1.b.4.B. To
				be qualified for registration, the results of the criminal history records
				check must be unremarkable and verified by a source acceptable to the board
				other than the applicant.
3.1.b.4.C. The board may deny registration to
				any applicant who fails or refuses to submit the criminal history records
				checks required by this subsection.
3.1.c. If the individual is seeking
				registration pursuant to 3.1.b.1.C. then the individual must provide
				satisfactory proof to the Board of his or her licensure status with the board
				of pharmacy in the state in which the individual is licensed. In states where
				there is no Board oversight, then a notarized document of proof of satisfactory
				employment by previous pharmacist-in-charge will suffice.
West Virginia Code of State Rules › Agency 15 - Pharmacy › Title 15 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF PHARMACY › Series 15-07 - Board of Pharmacy Rules for Registration of Pharmacy Technicians › Section 15-7-4 - Learning Institution or Training Center Provided and On-the-Job Pharmacy-Provided Competency-Based Training Program

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. A pharmacy may employ an individual as a
				pharmacy technician trainee and provide on-the-job, competency-based pharmacy
				technician training for the individual to become qualified for registration as
				a pharmacy technician. A pharmacy shall submit its pharmacy technician training
				program to the Board for approval prior to its use. The training program shall
				be outlined in a training manual which shall be used throughout the program. A
				competency-based pharmacy technician education and training program shall, at a
				minimum contain the following:
4.1.a. written
				procedures and guidelines for the use and supervision of pharmacy technicians
				and pharmacy technician trainees. The procedures and guidelines shall:
4.1.a.1. specify the manner in which the
				pharmacist-in-charge responsible for the supervision of pharmacy technicians
				and pharmacy technician trainees, shall supervise the pharmacy technicians and
				pharmacy technician trainees, and verify the accuracy and completeness of all
				acts and functions performed by them; and
4.1.a.2. specify duties which may and may not
				be performed by pharmacy technicians and pharmacy technician trainees;
				and