Source: http://www.wvlegislature.gov/Bill_Status/bills_text.cfm?billdoc=hb4047%20intr.htm&yr=2012&sesstype=RS&i=4047
Timestamp: 2018-04-20 23:18:16
Document Index: 328572900

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HB 4047 Text
Introduced Version House Bill 4047 History
H. B. 4047
(By Delegates Morgan, Stephens, Givens,Hartman, Hatfield, Martin, Staggers, Swartzmiller, Cowles, C. Miller and Rowan)
A BILL to repeal §30-5-1a, §30-5-1b, §30-5-2a, §30-5-3a, §30-5-5a, §30-5-5b, §30-5-6a, §30-5-7a, §30-5-7b, §30-5-7c, §30-5-9a, §30-5-10a, §30-5-12b, §30-5-12c, §30-5-14a, §30-5-14b, §30-5-16a, §30-5-16b, §30-5-16c and §30-5-22a of the Code of West Virginia, 1931, as amended; to amend and reenact §16-5A-9a of said code; to amend and reenact §30-5-1, §30-5-2, §30-5-3, §30-5-4, §30-5-5, §30-5-6, §30-5-7, §30-5-8, §30-5-9, §30-5-10, §30-5-11, §30-5-12, §30-5-13, §30-5-14, §30-5-15, §30-5-16, §30-5-17, §30-5-18, §30-5-19, §30-5-20, §30-5-21, §30-5-22, §30-5-23, §30-5-24, §30-5-25, §30-5-26, §30-5-27, §30-5-28, §30-5-29 and §30-5-30 of said code; to amend said code by adding thereto four new sections, designated §30-5-31, §30-5-32, §30-5-33 and §30-5-34; and to amend and reenact §60A-10-3 of said code, all relating to the practice of pharmacist care; prohibiting the practice of pharmacist care without a license; permitting a licensed practitioner to dispense in certain settings; providing other applicable sections; providing definitions; providing for board composition; setting forth the powers and duties of the board; clarifying rule-making authority; continuing a special revenue account; establishing license, registration and permit requirements; creating a scope of practice; creating a temporary permit; establishing renewal requirements; providing for exemptions from licensure; providing requirement to participate in collaborative pharmacy practice; providing requirement for dispensing generic drugs; requiring the registration of pharmacies requiring a permit for mail-order pharmacies and manufacturing of drugs; providing requirements of filling prescriptions; providing requirements for the display of a board authorization; permitting the board to file an injunction; setting forth grounds for disciplinary actions; allowing for specific disciplinary actions; providing procedures for investigation of complaints; providing for judicial review and appeals of decisions; setting forth hearing and notice requirements; providing for civil causes of action; providing criminal penalties; and updating references.
That §30-5-1a, §30-5-1b, §30-5-2a, §30-5-3a, §30-5-5a, §30-5-5b, §30-5-6a, §30-5-7a, §30-5-7b, §30-5-7c, §30-5-9a, §30-5-10a, §30-5-12b, §30-5-12c, §30-5-14a, §30-5-14b, §30-5-16a, §30-5-16b, §30-5-16c and §30-5-22a of the Code of West Virginia, 1931, as amended, be repealed; that §16-5A-9a of said code be amended and reenacted; that §30-5-1, §30-5-2, §30-5-3, §30-5-4, §30-5-5, §30-5-6, §30-5-7, §30-5-8, §30-5-9, §30-5-10, §30-5-11, §30-5-12, §30-5-13, §30-5-14, §30-5-15, §30-5-16, §30-5-17, §30-5-18, §30-5-19, §30-5-20, §30-5-21, §30-5-22, §30-5-23, §30-5-24 §30-5-25, §30-5-26, §30-5-27, §30-5-28, §30-5-29 and §30-5-30 of said code be amended and reenacted; that said code be amended by adding thereto four new sections, designated §30-5-31, §30-5-32, §30-5-33 and §30-5-34; and that §60A-10-3 of said code be amended and reenacted; all to read as follows:
A hospital or other health care facility may not interfere with the physician-patient relationship by restricting or forbidding the intravenous use of amygdalin (laetrile) as certified in accordance with section sixteen-a, article five, chapter thirty of this code, as an adjunct to recognized, customary or accepted modes of therapy in the treatment of any malignancy for terminally ill cancer patients when it is prescribed or administered by a physician holding an unlimited license for the practice of medicine in the State of West Virginia and the patient has signed the "written informed request" therefor as set forth in this section: Provided, That a parent or guardian may sign the "written informed request" on a minor's behalf.
In the event that no recognized, customary or accepted mode of therapy is available for the treatment of any malignancy for a terminally ill cancer patient, the physician may prescribe or administer intravenous amygdalin (laetrile), as certified in accordance with section sixteen-a, article five, chapter thirty of this code, as the sole mode of therapy, providing further that said patient executed the "written informed request" as set forth in this section.
Any physician, hospital or other health care facility participating in any act permitted or required by this section is immune from any civil or criminal liability that otherwise might result by reason of such actions. A physician may not be subjected to disciplinary action by the State Board of Medicine of West Virginia for prescribing or administering intravenous amygdalin (laetrile), in compliance with the provisions of this section.
Nothing in this section shall be construed as constituting an endorsement of amygdalin (laetrile), as certified in accordance with section sixteen-a, article five, chapter thirty of this code, for the treatment of any malignancy, disease, illness or physical condition.
(c) It is unlawful for the proprietor of a pharmacy or a ambulatory health care facility to permit any person not a licensed pharmacist to practice pharmacist care, Provided, That a charitable clinic pharmacy may permit a licensed practitioner to act in place of the pharmacist when no pharmacist is present in the charitable clinic.
The practices authorized under the provisions of this article and the Board of Pharmacy are subject to article one of this chapter, the provisions of this article, and any rules promulgated hereunder.
(1) “Ambulatory health care facility” as defined in section one, article five-b, chapter sixteen of this code, that has a pharmacy, offers pharmacist care, or is otherwise engaged in the practice of pharmacist care.
(7) “Cash Retail Sales Price” means the price paid by the consumer which is not affected by contractual governmental or private third party payors.
(8) “Chain Pharmacy Warehouse” means a permanent physical location for drugs and/or devices that acts as a central warehouse and performs intracompany sales and transfers of prescription drugs or devices to chain pharmacies, which are members of the same affiliated group, under common ownership and control.
(9) “Charitable clinic pharmacy” means a clinic or facility organized as a not-for-profit corporation that has a pharmacy, offers pharmacist care, or is otherwise engaged in the practice of pharmacist care and dispenses its prescriptions free of charge to appropriately screened and qualified indigent patients.
(12) “Common Carrier” means any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs for compensation.
(14) “Confidential information” means information maintained by the pharmacist in the patient record or which is communicated to the patient as part of patient counseling or which is communicated by the patient to the pharmacist. This information is privileged and may be released only to the patient or to other members of the health care team and other pharmacists where, in the pharmacists' professional judgment, the release is necessary to the patient's health and well-being; to health plans, as that term is defined in 45 CFR §160.103, for payment; to other persons or governmental agencies authorized by law to receive the privileged information; as necessary for the limited purpose of peer review and utilization review; as authorized by the patient or required by court order.
(17) “Digital Signature” means an electronic signature based upon cryptographic methods of originator authentication, and computed by using a set of rules and a set of parameters so that the identity of the signer and the integrity of the data can be verified.
(18) “Dispense” or “dispensing” means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation, verification and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
(19) “Distribute” or “Distribution” means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a drug, whether by passage of title, physical movement, or both. The term does not include:
(ii) A health care professional acting at the direction and under the supervision of a practitioner; or the pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample in accordance with the Prescription Drug Marketing Act and regulations to administer or dispense.
(20) “Drop shipment” means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug or by that manufacturer’s colicensed product partner, that manufacturer’s third party logistics provider, that manufacturer’s exclusive distributor, or by an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities whereby:
(C) The pharmacy, pharmacy warehouse or other person authorized by law to dispense or administer such drug receives delivery of the prescription drug directly from the manufacturer or from that manufacturer’s colicensed product partner, that manufacturer’s third party logistics provider, that manufacturer’s exclusive distributor, or from an authorized distributor of record that purchased the product directly from the manufacturer or from one of these entities.
(23) “Drug therapy management” means the review of drug therapy regimens of patients by a pharmacist for the purpose of evaluating and rendering advice to a physician regarding adjustment of the regimen in accordance with the collaborative pharmacy practice agreement. Decisions involving drug therapy management shall be made in the best interest of the patient. Drug therapy management shall be limited to:
(25) “E-prescribing” means the transmission, using electronic media, of prescription or prescription-related information between a practitioner, pharmacist, pharmacy benefit manager or health plan as defined in 45 CFR §160.103, either directly or through an electronic data intermediary. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the pharmacist. E-prescribing may also be referenced by the terms “electronic prescription” or “electronic order”.
(28) “Emergency medical reasons” include, but are not limited to, transfers of a prescription drug by one pharmacy to another pharmacy to alleviate a temporary shortage of a prescription drug; sales to nearby emergency medical services, i.e., ambulance companies and firefighting organizations in the same state or same marketing or service area, or nearby licensed practitioners of prescription drugs for use in the treatment of acutely ill or injured persons; and provision of minimal emergency supplies of prescription drugs to nearby nursing homes for use in emergencies or during hours of the day when necessary prescription drugs cannot be obtained.
(29) “Equivalent drug product” means a drug product which has the same established name, active ingredient(s), strength or concentration, dosage form, and route of administration and which is formulated to contain the same amount of active ingredient(s) in the same dosage form and to meet the same compendial or other applicable standards (e.g., strength, quality, purity, and identity) and is approved by the United States Food and Drug Administration, but which may differ in characteristics, such as shape, scoring, configuration, packaging, excipients (including colors, flavors, and preservatives), and expiration time.
(B) Is licensed as a wholesale distributor under this chapter. (31) “FDA” means the Food and Drug Administration, a federal agency within the United States Department of Health and Human Services.
(32) “Generic name” means the official title of a drug or drug combination for which a new drug application, or an abbreviated new drug application, has been approved by the FDA.
(33) “Health care entity” means any person that provides diagnostic, medical, community pharmacies, surgical, dental treatment, or rehabilitative care but does not include any retail pharmacy or wholesale distributor.
(38) “Intracompany transaction” means any transaction between a division, subsidiary, parent, and/or affiliated or related company under the common ownership and control of a corporate or other legal business entity.
(46) “Medication therapy management” is a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services are independent of, but can occur in conjunction with, the provision of a medication or a medical device. Medication therapy management encompasses a broad range of professional activities and responsibilities within the licensed pharmacist’s scope of practice. These services may include, but are not limited to, the following, according to the individual needs of the patient:
(47) “Misbranded” means a drug or device that has a label that is false or misleading in any particular; or the label does not bear the name and address of the manufacturer, packer, or distributor and does not have an accurate statement of the quantities of the active ingredients in the case of a drug; or the label does not show an accurate monograph for prescription drugs.
(54) “Pharmacist Care” is the provision of health care by a pharmacist of medication therapy management services, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process, and as provided for in section nine.
(59) “Pharmacy Technician” means s person registered with the board to practice certain tasks related to the practice of pharmacist care as permitted by the board.
(61) “Practice of telepharmacy” means the provision of pharmacist care by properly licensed pharmacists located within United States jurisdictions through the use of telecommunications or other technologies to patients or their agents at a different location that are located within United States jurisdictions.
(62) “Practitioner” means an individual authorized by a jurisdiction of the United States to prescribe drugs in the course of professional practices, as allowed by law.
(63) “Prescription drug” or “legend drug” means a drug which, under federal law, is required to be labeled with either of the following statements prior to being dispensed and delivered:
(C) “Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian”; or a drug which is required by any applicable federal or state law or rule to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only.
(64) “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.
(65) “Primary care” is the first level of contact of individuals, the family, and the community with the health care delivery system, bringing health care as close as possible to where people live and work, and constitutes the first element of a continuing health care process. Areas of primary care where pharmacists provide pharmacist care include, but are not limited to, the following: chronic disease management; smoking cessation; maternal and child health; immunizations; family planning; self-care consulting; Drug selection under protocol; treatment of common diseases and injuries; nutrition; and general health education and promotion.
(66) “Product Labeling” means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.
(67) “Repackage” means changing the container, wrapper, quantity, or product labeling of a drug or device to further the distribution of the drug or device.
(69) “Substitute” means to dispense without the prescriber's express authorization a therapeutically equivalent generic drug product in the place of the drug ordered or prescribed.
(70) “Therapeutic equivalence” mean drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product which contain the same active ingredient(s); dosage form and route of administration; and strength.
(E) The sale, purchase, or trade of a prescription drug or device or the offer to sell, purchase, or trade a prescription drug or device by a charitable organization described in 503(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
(G) The sale, purchase, or trade of blood and blood components intended for transfusion;
(H) The return of recalled, expired, damaged, or otherwise nonsalable prescription drugs, when conducted by a hospital, health care entity, pharmacy, or charitable institution in accordance with the board’s rules; or
(I) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy or pharmacies from or with another pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets, in accordance with the board’s legislative rules.
(a) The West Virginia Board of Pharmacy is continued. The members of the board in office on July 1, 2012, shall, unless sooner removed, continue to serve until their respective terms expire and until their successors have been appointed and qualified.
(j) Maintain an office, and hire, discharge, establish the job requirements and fix the compensation of employees and contract with persons necessary to enforce the provisions of this article. Inspectors shall be licensed pharmacists;
(p) Keep accurate and complete records of its proceedings, and certify the same as may be necessary and appropriate;
(q) Propose rules in accordance with the provisions of article three, chapter twenty-nine-a of this code to implement the provisions of this article;
(24) Sanitation and equipment requirements for wholesalers, distributers and pharmacies.
(31) Regulations on Methamphetamine Laboratory Eradication Act as provided in article ten, chapter sixty-a; and
(c) The board, the Board of Medicine and the Board of Osteopathy shall jointly agree and propose rules concerning collaborative pharmacy practice for legislative approval in accordance with the provisions of article three, chapter twenty-nine-a of the code;
(d) The board with the advice of the Board of Medicine and the Board of Osteopathy shall propose rules for legislative approval in accordance with the provisions of article three, chapter twenty-nine-a of this code to perform influenza and pneumonia immunizations, on a person of eighteen years of age or older. These rules shall provide, at a minimum, for the following:
(7) That a pharmacist may not delegate the authority to administer immunizations to any other person; unless administered by a licensed pharmacy intern under the direct supervision of a pharmacist of whom both pharmacist and intern have successfully completed all board required training.
(e) The board, the Board of Medicine and the Board of Osteopathy shall propose joint rules for legislative approval in accordance with the provisions of article three, chapter twenty-nine-a of this code to permit licensed pharmacists to administer other immunizations such as Hepatitis A, Hepatitis B, Herpes Zoster and Tetanus. These rules shall provide, at a minimum, the same provisions contained in subsection (d)(1) through (d)(8) of this section
(f) All of the board’s rules in effect on July 1, 2012, shall remain in effect until they are amended, modified, repealed or replaced.
(8) Present to the board satisfactory evidence that he or she is a person of good moral character, has not been convicted of a felony involving controlled substances or violent crime;
(9) Not been convicted in any jurisdiction of a felony or any crime which bears a rational nexus to the individual's ability to practice pharmacist care; and
(7) Provide pharmacist care in all areas of patient care, including collaborative pharmacy practice;
(8) May compound and label drugs and drug devices;
(9) Proper and safe storage of drugs and devices;
(10) Maintain proper records;
(11) Provide patient counseling concerning the therapeutic value and proper use of drugs and devices;
(12) Order laboratory tests in accordance with drug therapy management and medication therapy management; and
(13) Provide medication therapy management.
(c) A person registered to assist in the practice pharmacist care issued by the board prior to July 1, 2012, shall for all purposes be considered registered under this article and may renew pursuant to the provisions of this article.
§30-5-11. Scope practice for registered pharmacy technician.
(a) A registered pharmacy technician shall, under the direct supervision of the licensed pharmacist, but is not limited to, perform the following:
(4) Stock of medications.
(d) Indirect supervision of a registered pharmacy technician is permitted to allow a pharmacist to take one break of no more than thirty minutes during any contiguous eight-hour period. The pharmacist may leave the pharmacy area but may not leave the building during the break. When a pharmacist is on break, a pharmacy technician may continue to prepare prescriptions for the pharmacist’s verification. A prescription may not be delivered until the pharmacist has verified the accuracy of the prescription, and counseling, if required, has been provided to or refused by the patient.
A pharmacist may not compound or dispense any prescription order when he or she has knowledge that the prescription was issued by a practitioner without establishing an ongoing practitioner-patient relationship. An online or telephonic evaluation by questionnaire is inadequate to establish an appropriate practitioner-patient relationship: Provided, That this prohibition does not apply:
(e) After July 1, 2014, a previously registered pharmacist technician may renew his or her current registration without having successfully completed subdivision six, subsection (a), of section ten. The previously registered pharmacist may continue to renew his or her registration under this provision.
(a) There is a special volunteer pharmacist license for pharmacists retired or retiring from the active practice of pharmacist care who wish to donate their expertise for the pharmacist care and treatment of indigent and needy patients in the clinic setting of clinics organized, in whole or in part, for the delivery of health care services without charge. The special volunteer pharmacist license shall be issued by the board to pharmacists licensed or otherwise eligible for licensure under this article and the legislative rules promulgated hereunder without the payment of an application fee, license fee or renewal fee, and the initial license shall be issued for the remainder of the licensing period, and renewed consistent with the boards other licensing requirements. The board shall develop application forms for the special license provided in this subsection which shall contain the pharmacist’s acknowledgment that:
(2) The pharmacist may not receive any payment or compensation, either direct or indirect, or have the expectation of any payment or compensation, for any pharmacist care rendered under the special volunteer pharmacist license;
(b) Any pharmacist who renders any pharmaceutical service to indigent and needy patients of a clinic organized, in whole or in part, for the delivery of health care services without charge under a special volunteer pharmacist license authorized under subsection (a) of this section without payment or compensation or the expectation or promise of payment or compensation is immune from liability for any civil action arising out of any act or omission resulting from the rendering of the pharmacist care at the clinic unless the act or omission was the result of the pharmacist’s gross negligence or willful misconduct. In order for the immunity under this subsection to apply, there must be a written agreement between the pharmacist and the clinic pursuant to which the pharmacist provides voluntary uncompensated pharmacist care under the control of the clinic to patients of the clinic before the rendering of any services by the pharmacist at the clinic: Provided, That any clinic entering into such written agreement is required to maintain liability coverage of not less than $1 million per occurrence.
(d) For purposes of this section, “otherwise eligible for licensure” means the satisfaction of all the requirements for licensure as listed in section eight of this article and in the legislative rules promulgated thereunder, except the fee requirements of that section and of the legislative rules promulgated by the board relating to fees.
(f) Any policy or contract of liability insurance providing coverage for liability sold, issued or delivered in this state to any pharmacist covered under the provisions of this article shall be read so as to contain a provision or endorsement whereby the company issuing such policy waives or agrees not to assert as a defense on behalf of the policyholder or any beneficiary thereof, to any claim covered by the terms of such policy within the policy limits, the immunity from liability of the insured by reason of the care and treatment of needy and indigent patients by a pharmacist who holds a special volunteer pharmacist license.
(1) Earned a Certification from the Board of Pharmaceutical Specialties, is a Certified Geriatric Practitioner, or has completed an American Society of Health System Pharmacists(ASHP) accredited residency program, which includes two years of clinical experience approved by the boards;
(2) Successfully completed the course of study and holds the academic degree of Doctor of Pharmacy and has three years of clinical experience approved by the board and has completed an Accreditation Council for Pharmacy Education (ACPE) approved certificate program in the area of practice covered by the collaborative pharmacy practice agreement; or
(3) Successfully completed the course of study and hold the academic degree of Bachelor of Science in Pharmacy and has five years of clinical experience approved by the boards and has completed two ACPE approved certificate programs with at least one program in the area of practice covered by a collaborative pharmacy practice agreement.
(c) All activities performed by the pharmacist in conjunction with the protocol shall be documented in the patient's medical record. The pharmacists shall report at least every thirty days to the physician regarding the patient's drug therapy management. The collaborative pharmacy practice agreement and protocols shall be available for inspection by the board, the West Virginia Board of Medicine, or the West Virginia Board of Osteopathy, depending on the licensing board of the participating physician. A copy of the protocol shall be filed in the patient's medical record.
(b) Except as provided in section twenty-one of this article, the following acts shall be prohibited:
(a) A pharmacist who receives a prescription for a brand name drug or drug product shall substitute the least expensive therapeutic equivalent generic drug or drug product based on the cash retail sales price of the respective products at the time it is dispensed unless otherwise required by a third party payor, the patient or in the exercise of his or her professional judgment the pharmacist affirmatively indicates that the least expensive therapeutic equivalent drug is not suitable for the particular patient: Provided, That no substitution may be made by the pharmacist where the prescribing practitioner indicates that, in his or her professional judgment, a specific brand name drug is medically necessary for a particular patient.
(b) A written prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner has indicated in his or her own handwriting, the words “Brand Necessary” or "Brand Medically Necessary". The following sentence shall be printed on the prescription form. "This prescription may be filled with a generically equivalent drug product unless the words ‘Brand Necessary’ or 'Brand Medically Necessary' are written, in the practitioner's own handwriting, indicated by the prescribing practitioner on this prescription form."
(c) A verbal prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner shall indicate to the pharmacist that the prescription is "Brand Necessary" or "Brand Medically Necessary". The pharmacist shall note the instructions on the file copy of the prescription or electronic chart.
(d) An electronic prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner shall indicate to the pharmacist that the prescription is "Brand Necessary" or "Brand Medically Necessary". The pharmacist shall note the instructions on the file copy of the prescription or electronic chart.
(e) No person may by trade rule, work rule, contract or in any other way prohibit, restrict, limit or attempt to prohibit, restrict or limit the making of a generic name drug or other product substitution under the provisions of this section. No employer or his or her agent may use coercion or other means to interfere with the professional judgment of the pharmacist in deciding which generic name drugs or drug products shall be stocked or substituted: Provided, That this section may not be construed to permit the pharmacist to generally refuse to substitute less expensive therapeutically equivalent generic drugs for brand name drugs and that any pharmacist so refusing shall be subject to the penalties prescribed in this article.
(f) A pharmacist may substitute a drug pursuant to the provisions of this section only if the drug is a lower cash retail sales price than the prescribed drug. Where substitution is proper, pursuant to this section, or where the practitioner prescribes the drug by generic name, the pharmacist shall, consistent with his or her professional judgment, dispense an equivalent generic drug product with the lowest cash retail sales price which is available in the pharmacy at the time of dispensing: Provided, That all savings in the retail price of the prescription shall be passed on to the purchaser and shall be equal to the difference between the retail price of the brand name product and the customary and usual costs of the generic product substituted therefor: Provided, however, That in no event shall such savings be less than the difference in acquisition cost of the brand name product prescribed and the acquisition cost of the substituted product.
(g) Each pharmacy shall maintain a record of any substitution of an equivalent generic name drug product for a prescribed brand name drug product on the file copy of a written, electronic or verbal prescription or chart order. The record shall include the manufacturer and generic name of the drug product selected.
(k) A pharmacist may not substitute a generic-named therapeutically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type is listed on the formulary established by the board pursuant to this article or is found to be in violation of the requirements of the FDA.
(l) A pharmacist who substitutes any drug shall, either personally or through his or her agent, assistant or employee, notify the person presenting the prescription of the substitution. The person presenting the prescription shall have the right to refuse the substitution. Upon request the pharmacist shall relate the cash retail sales price difference between the brand name and the drug substituted for it.
(m) A pharmacist complying with the provisions of this section may not be liable in any way for the dispensing of a generic-named therapeutically equivalent drug, substituted under the provisions of this section, unless the generic-named therapeutically equivalent drug was incorrectly substituted.
(n) In no event, where the pharmacist substitutes a drug under the provisions of this section, shall the prescribing physician be liable in any action for loss, damage, injury or death of any person occasioned by or arising from the use of the substitute drug unless the original drug was incorrectly prescribed.
(a) A pharmacy shall be under the direction and supervision of a licensed pharmacist who shall be designated by the owner of the pharmacy as the pharmacist-in-charge. This designation shall be filed with the board within thirty days of the designation.
(c) A pharmacist-in-charge may not hold the designated position at more than one pharmacy, whether within or outside the state, except as provided by legislative rule.
(c) A person, who offers for sale, sells, offers for sale through the method of distribution any legend drugs is subject to this article.
(a) As used in this section, “long-term care facility” or “LTCF” means any nursing home, personal care home, or residential board and care home as defined in section two, article five-c, chapter sixteen of this code which provides extended health care to resident patients: Provided, That the care or treatment in a household, whether for compensation or not, of any person related by blood or marriage, within the degree of consanguinity of second cousin to the head of the household, or his or her spouse, may not be deemed to constitute a nursing home, personal care home or residential board and care home within the meaning of this article. This section does not apply to:
(e) The pharmacist shall record on the prescription that the patient is “terminally ill” or a “LTCF patient”. A prescription that is partially filled and does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been filled in violation of section three hundred eight, article three, chapter sixty-a of this code.
(19) Agree to participate in a legend drug product conversion program promoted or offered by a manufacturer, wholesaler or distributor of such product for which the pharmacist or pharmacy received any form of financial remuneration, or agreed to participate in a legend drug program in which the pharmacist or pharmacy is promoted or offered as the exclusive provider of legend drug products or whereby in any way the public is denied, limited or influenced in selecting pharmaceutical service or counseling;
(j) The board may defer disciplinary action with regard to an impaired licensee or registrant who voluntarily signs an agreement, in a form satisfactory to the board, agreeing not to practice pharmacist care and to enter an approved treatment and monitoring program in accordance with the board’s legislative rule. This subsection, provided that this section should not apply to a licensee or registrant who has been convicted of, pleads guilty to, or enters a plea of nolo contendere or a conviction relating to a controlled substance in any jurisdiction.
(k) Nothing shall be construed as barring criminal prosecutions for violations of this article.
(l) A person authorized to practice under this article, who reports or otherwise provides evidence of the negligence, impairment or incompetence of another member of this profession to the board or to any peer review organization, is not liable to any person for making such a report if such report is made without actual malice and in the reasonable belief that such report is warranted by the facts known to him or her at the time.
(b) Any person, who violates any of the provisions of this article is guilty of a misdemeanor, and, upon conviction, shall be fined not to exceed $50 for the first offense, and upon conviction of a second offense shall be fined not less than $50 nor more than $500, or shall be imprisoned in the county jail not to exceed thirty days, or both fined and imprisoned. Each and every day that the violation continues shall constitute a separate offense.
(b) “Designated precursor” means any drug product made subject to the requirements of this article by the provisions of section seven of this article.
(d) "Drug product" means a pharmaceutical product that contains as its single active ingredient ephedrine, pseudoephedrine or phenylpropanolamine or a substance identified on the supplemental list provided in section seven of this article which may be sold without a prescription and which is labeled for use by a consumer in accordance with the requirements of the laws and rules of this state and the federal government.
(e) "Ephedrine" means ephedrine, its salts or optical isomers or salts of optical isomers.
(j) "Pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy and pharmaceutical care pharmacist care as defined in subsection (t), section one-b, article fifty five, chapter thirty of this code.
(l) "Pharmacy" means any drugstore, apothecary or place within this state where drugs are dispensed and sold at retail or display for sale at retail and pharmaceutical pharmacist care is provided outside of this state where drugs are dispensed and pharmaceutical pharmacist care is provided to residents of this state.
(n) "Pharmacy technician" means a registered technician who meets the requirements for registration as set forth in article five, chapter thirty of this code.
(o) "Retail establishment" means any entity or person within this state who sells, transfers or distributes goods, including over-the-counter drug products, to an ultimate consumer.
(p) "Schedule V" means the schedule of controlled substances set out in section two hundred twelve, section two of this chapter.
(r) "Superintendent of the State Police" or "Superintendent" means the Superintendent of the West Virginia State Police as set forth in section five, article two, chapter fifteen of this code.
(s) "Wholesaler" means any person within this state or another state, other than a manufacturer, who sells, transfers or in any manner furnishes a drug product to any other person in this state for the purpose of being resold.
Article five, chapter 30 has been completely rewritten; therefore, the entire article is underscored.
§60A-10-3 Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.