Senate Bill No. 702

(By Senators Prezioso and Love)


[Introduced February 19, 2007; referred to the Committee on Health and Human Resources; and then to the Committee on the Judiciary.]


A BILL to amend and reenact §30-5-1b and §30-5-3 of the Code of West Virginia, 1931, as amended; and to amend said code by adding thereto a new section, designated §30-5-6b, all relating to out-of-state sales of pharmaceuticals; defining terms; providing for licensure and permits of pharmacies, mail order pharmacies and out-of-state pharmacies; and setting forth the authority of the West Virginia Board of Pharmacy.

Be it enacted by the Legislature of West Virginia:
That §30-5-1b and §30-5-3 of the Code of West Virginia, 1931, as amended, be amended and reenacted; and that said code be amended by adding thereto a new section, designated §30-5-6b, all to read as follows:
§30-5-1b. Definitions.The following words and phrases, as used in this article, have the following meanings, unless the context otherwise requires:
(1) "Administer" means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means.
(2) "Board of pharmacy" or "board" means the West Virginia State Board of Pharmacy.
(3) "Collaborative pharmacy practice" is that practice of pharmacy where one or more pharmacists have jointly agreed, on a voluntary basis, to work in conjunction with one or more physicians under written protocol where the pharmacist or pharmacists may perform certain patient care functions authorized by the physician or physicians under certain specified conditions and limitations.
(4) "Collaborative pharmacy practice agreement" is a written and signed agreement between a pharmacist, a physician, and the individual patient or the patients' authorized representative who has granted his or her informed consent, that provides for collaborative pharmacy practice for the purpose of drug therapy management of a patient, which has been approved by the Board of Pharmacy, the Board of Medicine in the case of an allopathic physician or the West Virginia Board of Osteopathy in the case of an osteopathic physician.
(5) "Compounding" means:
(A) The preparation, mixing, assembling, packaging or labeling of a drug or device:
(i) As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice for sale or dispensing; or
(ii) For the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing; and
(B) The preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
(6) "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 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.
(7) "Deliver" or "delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another, whether or not for a consideration.
(8) "Device" means an instrument, apparatus, implement or machine, contrivance, implant or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, "Caution: Federal or state law requires dispensing by or on the order of a physician."
(9) "Dispense" or "dispensing" means the preparation and delivery of a drug or device in an appropriately labeled and suitable container to a patient or patient's representative or surrogate pursuant to a lawful order of a practitioner for subsequent administration to, or use by, a patient.
(10) "Distribute" means the delivery of a drug or device other than by administering or dispensing.
(11) "Drug" means:
(A) Articles recognized as drugs in the USP-DI, facts and comparisons, physicians desk reference or supplements thereto, for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human or other animals;
(B) Articles, other than food, intended to affect the structure or any function of the body of human or other animals; and
(C) Articles intended for use as a component of any articles specified in paragraphs (A) or (B) of this subdivision.
(12) "Drug regimen review" includes, but is not limited to, the following activities:
(A) Evaluation of the prescription drug orders and patient records for:
(i) Known allergies;
(ii) Rational therapy-contraindications;
(iii) Reasonable dose and route of administration; and
(iv) Reasonable directions for use.
(B) Evaluation of the prescription drug orders and patient records for duplication of therapy.
(C) Evaluation of the prescription drug for interactions and/or adverse effects which may include, but are not limited to, any of the following:
(i) Drug-drug;
(ii) Drug-food;
(iii) Drug-disease; and
(iv) Adverse drug reactions.
(D) Evaluation of the prescription drug orders and patient records for proper use, including over use and under use and optimum therapeutic outcomes.
(13) "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:
(A) Implementing, modifying, and managing drug therapy according to the terms of the collaborative pharmacy practice agreement;
(B) Collecting and reviewing patient histories;
(C) Obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration;
(D) Ordering screening laboratory tests that are dose related and specific to the patient's medication or are protocol driven and are also specifically set out in the collaborative pharmacy practice agreement between the pharmacist and physician.
(14) "Good faith prior examination" means an in-person medical examination of the patient, arising from a complaint by the patient, without regard to whether portions of the examination are conducted by other practitioners, when the patient is physically examined and a medical history of the patient is obtained.
(14)(15) "Intern" means an individual who is:
(A) Currently registered by this state to engage in the practice of pharmacy while under the supervision of a licensed pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; or
(B) A graduate of an approved college of pharmacy or a graduate who has established educational equivalency by obtaining a foreign pharmacy graduate examination committee (FPGEC) certificate, who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or
(C) A qualified applicant awaiting examination for licensure; or
(D) An individual participating in a residency or fellowship program.
(15)(16) "Labeling" means the process of preparing and affixing a label to a drug container exclusive, however, of a labeling by a manufacturer, packer or distributor of a nonprescription drug or commercially packaged legend drug or device. Any label shall include all information required by federal law or regulation and state law or rule.
(17)"Legitimate medical purpose" means any medical purpose that arises from a documented practitioner-patient relationship.
(16)(18) "Mail-order pharmacy" means a pharmacy, regardless of its location, which dispenses greater than ten percent prescription drugs via the mail.
(17)(19)"Manufacturer" means a person engaged in the manufacture of drugs or devices.
(18)(20)"Manufacturing" means the production, preparation, propagation or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of the substance or substances or labeling or relabeling of its contents and the promotion and marketing of the drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners or other persons.
(19)(21)"Nonprescription drug" means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
(22)"Out-of-state pharmacy" means any pharmacy which dispenses drugs or medicines or conducts business using internet, electronic communications, facsimile, or telephone, or otherwise from any point outside the state of West Virginia to any point within the state of West Virginia.
(20)(23)"Patient counseling" means the oral communication by the pharmacist of information, as defined in the rules of the board, to the patient to improve therapy by aiding in the proper use of drugs and devices.
(21)(24)"Person" means an individual, corporation, partnership, association or any other legal entity, including government.
(22)(25)"Pharmaceutical care" is the provision of drug therapy and other pharmaceutical patient care services 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 as defined in the rules of the board.
(23)(26)"Pharmacist" or "registered pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy and pharmaceutical care.
(24)(27)"Pharmacist-in-charge" means a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs and who is personally in full and actual charge of the pharmacy and personnel.
(25)(28)"Pharmacist's scope of practice pursuant to the collaborative pharmacy practice agreement" means those duties and limitations of duties placed upon the pharmacist by the collaborating physician, as jointly approved by the Board of Pharmacy and the Board of Medicine or the Board of Osteopathy.
(26)(29)"Pharmacy" means any drugstore, apothecary or place within this state where drugs are dispensed and sold at retail or displayed for sale at retail and pharmaceutical care is provided and any place outside of this state where drugs are dispensed and pharmaceutical care is provided to residents of this state.
(27)(30)"Physician" means an individual currently licensed, in good standing and without restrictions, as an allopathic physician by the West Virginia Board of Medicine, or an osteopathic physician by the West Virginia Board of Osteopathy.
(28)(31)"Pharmacy technician" means registered supportive personnel who work under the direct supervision of a pharmacist who have passed an approved training program as described in this article.
(29)(32)"Practitioner" means an individual currently licensed, registered or otherwise authorized by any state, territory or district of the United States to prescribe and administer drugs in the course of professional practices, including allopathic and osteopathic physicians, dentists, physician's assistants, optometrists, veterinarians, podiatrists and nurse practitioners as allowed by law.
(33)"Practitioner-patient relationship" means a medical relationship that exists between a patient, a practitioner or practitioner's designee, after the practitioner, or his or her designee, has conducted at least one prior examination.
(30)(34)"Preceptor" means an individual who is currently licensed as a pharmacist by the board, meets the qualifications as a preceptor under the rules of the Board and participates in the instructional training of pharmacy interns.
(31)(35)"Prescription drug" or "legend drug" means a drug which, under federal law, is required, prior to being dispensed or delivered, to be labeled with either of the following statements:
(A) "Caution: Federal law prohibits dispensing without prescription"; or
(B) "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.
(32)(36)"Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient.
(33)(37)"Prospective drug use review" means a review of the patients' drug therapy and prescription drug order, as defined in the rules of the Board, prior to dispensing the drug as part of a drug regimen review.
(34)(38)"USP-DI" means the United States pharmacopeia- dispensing information.
(35)(39)"Wholesale distributor" means any person engaged in wholesale distribution of drugs, including, but not limited to, manufacturers' and distributors' warehouses, chain drug warehouses and wholesale drug warehouses, independent wholesale drug trader and retail pharmacies that conduct wholesale distributions.
§30-5-3. When licensed pharmacist required; person not licensed pharmacist, pharmacy technician or licensed intern not to compound prescriptions or dispense poisons or narcotics; licensure of interns; prohibiting the dispensing of prescription orders in absence of practitioner-patient relationship.

(a) It is unlawful for any person not a pharmacist, or who does not employ a pharmacist, to conduct any pharmacy or store for the purpose of retailing, compounding or dispensing prescription drugs or prescription devices.
(b) It is unlawful for the proprietor of any store or pharmacy to permit any person not a pharmacist to compound or dispense prescriptions or prescription refills or to retail or dispense the poisons and narcotic drugs named in sections two, three and six, article eight, chapter sixteen of this code: Provided, That a licensed intern may compound and dispense prescriptions or prescription refills under the direct supervision of a pharmacist: Provided, however, That registered pharmacy technicians may assist in the preparation and dispensing of prescriptions or prescription refills including, but not limited to, reconstitution of liquid medications, typing and affixing labels under the direct supervision of a licensed pharmacist.
(c) It is the duty of a pharmacist or employer who employs an intern to license the intern with the board within ninety days after employment. The board shall furnish proper forms for this purpose and shall issue a certificate to the intern upon licensure.
(d) The experience requirement for licensure as a pharmacist shall be computed from the date certified by the supervising pharmacist as the date of entering the internship. If the internship is not registered with the board of pharmacy, then the intern shall receive no credit for such experience when he or she makes application for examination for licensure as a pharmacist: Provided, That credit may be given for such unregistered experience if an appeal is made and evidence produced showing experience was obtained but not registered and that failure to register the internship experience was not the fault of the intern.
(e) An intern having served part or all of his or her internship in a pharmacy in another state or foreign country shall be given credit for the same when the affidavit of his or her internship is signed by the pharmacist under whom he or she served, and it shows the dates and number of hours served in the internship and when the affidavit is attested by the secretary of the state board of pharmacy of the state or country where the internship was served.
(f) Up to one third of the experience requirement for licensure as a pharmacist may be fulfilled by an internship in a foreign country.

(g) No pharmacist, while practicing at any pharmacy licensed by the board, in-state or out-of-state, may compound or dispense to a resident of West Virginia any prescription order when he or she has knowledge that the prescription was issued by a practitioner without establishing an ongoing or legitimate 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:
(1) In a documented emergency;
(2) In an on-call or cross-coverage situation; or
(3) Where patient care is rendered in consultation with another practitioner who as an ongoing relationship with the patient and who has agreed to supervise the patient's treatment, including the use of any prescribed medications.
(h)An indication ongoing or legitimate practitioner-patient relationship has been established when:
(1) A patient has a medical complaint;
(2) A medical history has been taken;
(3) A physical examination has been performed; and
(4) Some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.
A patient completing a questionnaire that is reviewed by a physician hired or working on behalf of an internet pharmacy shall not establish an ongoing or legitimate practitioner-patient relationship. This provision is not intended to limit the ability of practitioners to engage in legitimate telemedicine where health care is provided using telecommunication networks to transmit and receive information including voice communications, images, and patient records.
(i) No person shall obtain or attempt to obtain a prescription for a controlled substance without having formed a legitimate practitioner-patient relationship with the practitioner from whom the person seeks the prescription.
(j) No person shall assist a person to obtain a prescription in violation of this chapter by any means, including but not limited to, electronic communications, facsimile, internet, or telephone, by facilitating the communication between a person and the pharmacy or practitioner, or both, to complete any drug transaction.

§30-5-6b. Permits for out-of-state pharmacies; requests for information by consumer; information disclosure by out-of- state pharmacies, internet and electronic communications related to out-of-state pharmacies.

(a) Every out-of-state pharmacy which dispenses drugs or medicines or conducts business using internet, electronic communications, facsimile, or telephone, or otherwise from any point within the state of West Virginia to any point outside of the state of West Virginia shall be registered as a pharmacy or drugstore pursuant to the provisions of section fourteen of this article. Prior to being qualified and authorized to transact business in the state of West Virginia, every out-of-state pharmacy shall register annually with the Board of Pharmacy to conduct such business in this state. Such registration shall include fees for licensing and meeting all renewal and licensing qualifications.
(b) Every out-of-state pharmacy granted an permit by the board shall disclose to the board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescription drugs to residents of the state. A report containing this information shall be made to the board on an annual basis and within thirty (30) days of any change of office, corporate officer, or pharmacist.
(c) Every out-of-state pharmacy granted an permit shall comply with all statutorily authorized directions and requests for information from any regulatory agency of the state and from the board in accordance with the provisions of this section. The out- of-state pharmacy shall maintain at all times a valid unexpired permit, license, or regular registration to conduct the pharmacy in compliance with the laws of the jurisdiction in which it is a resident. The out-of-state pharmacy shall also submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located: Provided, that the out-of-state pharmacy granted a permit shall submit to the West Virginia Board of Pharmacy a copy of any subsequent inspection report on the pharmacy conducted by the regulatory or licensing body of the jurisdiction in which it is located.
(d) Every out-of-state pharmacy granted an permit by the board shall maintain complete and accurate records of any prescription drugs dispensed to patients in West Virginia. These records are to be readily retrievable from the records of other drugs dispensed.
(e) Records for all prescriptions delivered into West Virginia shall be readily retrievable from the other prescription records of the out-of-state pharmacy.
(f) Every out-of-state pharmacy shall have a pharmacist in charge who is licensed to engage in the practice of pharmacy by West Virginia that shall be responsible for compliance by the pharmacy with the provisions of this section.
(g) Every out-of-state pharmacy shall during its regular hours of operation, but not less than six (6) days per week and for a minimum of forty (40) hours per week, provide a toll-free telephone service directly to the pharmacist in charge of the out-of-state pharmacy. The pharmacist shall be available to both the patient and each licensed and practicing in-state pharmacist for the purpose of facilitating communication between the patient and the West Virginia pharmacists with access to the patient's prescription records. The toll-free number shall be placed on a label affixed to each container of drugs dispensed to patients within this state.
(h) Every out-of-state pharmacy, when doing business in West Virginia through means including, but not limited to, electronic communications, facsimile, internet, or telephone shall:
(1) Comply with all requirements set forth in article nine, chapter sixty-a of this code.
(2) Prior to obtaining an permit to operate through the internet, receive and display in every medium in which it advertises itself a seal of approval from the National Associations of Boards of Pharmacy certifying that it is a Verified Internet Pharmacy Practice Site. The Verified Internet Pharmacy Practice Site approval and accreditation shall be maintained and remain current.
(3) Certify to the board the percentage of its annual business conducted via the internet and submit such supporting documentation as requested by the board, and in a form or application required by the board, when it applies for permit or renewal.
(4) Use the address on file with the West Virginia board of pharmacy as the return address on the labels of any package shipped into or within the state. The return address shall be placed on the package in a clear and prominent manner.

NOTE: The purpose of this bill is to add and refine definitions of out-of-state pharmacy, patient-practitioner relationship, and legitimate medical purpose. The bill also provides clarification for certain licensures and permits issued by the Board of Pharmacy and establishes guidelines for issuance of permits for out-of-state pharmacies.

Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.