Bill Text: MS SB2931 | 2010 | Regular Session | Introduced
Bill Title: Mississippi Pharmacy Practice Act; revise definitions and clarify permitting for nonresident pharmacists.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Failed) 2010-02-02 - Died In Committee [SB2931 Detail]
Download: Mississippi-2010-SB2931-Introduced.html
MISSISSIPPI LEGISLATURE
2010 Regular Session
To: Public Health and Welfare
By: Senator(s) Kirby, Gollott
Senate Bill 2931
AN ACT TO AMEND SECTION 73-21-73, MISSISSIPPI CODE OF 1972, TO REVISE CERTAIN DEFINITIONS UNDER THE MISSISSIPPI PHARMACY PRACTICE ACT; TO AMEND SECTION 73-21-106, MISSISSIPPI CODE OF 1972, TO CLARIFY PERMITTING REQUIREMENTS FOR NONRESIDENT PHARMACIES; AND FOR RELATED PURPOSES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. Section 73-21-73, Mississippi Code of 1972, is amended as follows:
73-21-73. As used in this chapter, unless the context requires otherwise:
(a) "Administer" means the direct application of a prescription drug pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion or any other means.
(b) "Board of Pharmacy," "Pharmacy Board," "MSBP" or "board" means the State Board of Pharmacy.
(c) "Compounding" means (i) the production, preparation, propagation, conversion or processing of a sterile or nonsterile drug or device either directly or indirectly by extraction from substances of natural origin or independently by means of chemical or biological synthesis or from bulk chemicals or the preparation, mixing, measuring, assembling, packaging or labeling of a drug or device as a result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or (ii) for the purpose of, as an incident to, research, teaching or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine regularly observed prescribing patterns.
(d) "Continuing Education Unit" means ten (10) clock hours of study or other * * * activity and shall include either of the following: (1) programs which have been approved by the American Council on Pharmaceutical Education (A.C.P.E.), or (2) programs which have been approved by the board prior to presentation.
(e) "Deliver" or "delivery" means the actual, constructive or attempted transfer in any manner of a drug or device from one person to another, whether or not for a consideration, including, but not limited to, delivery by mailing or shipping.
(f) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory which is required under federal or state law to be prescribed by a practitioner and dispensed by a pharmacist.
(g) "Dispense" or "dispensing" means the interpretation of a valid prescription of a practitioner by a pharmacist and the subsequent preparation of the drug or device for administration to or use by a patient or other individual entitled to receive the drug.
(h) "Distribute" means the delivery of a drug or device other than by administering or dispensing to persons other than the ultimate consumer.
(i) "Drug" means:
(i) Articles recognized as drugs in the official United States Pharmacopeia, official National Formulary, official Homeopathic Pharmacopeia, other drug compendium or any supplement to any of them;
(ii) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals;
(iii) Articles other than food intended to affect the structure or any function of the body of man or other animals; and
(iv) Articles intended for use as a component of any articles specified in subparagraph (i), (ii) or (iii) of this paragraph.
(j) "Drugroom" means a business, which does not require the services of a pharmacist, where prescription drugs or prescription devices are bought, sold, maintained or provided to consumers.
(k) "Extern" means a student in the professional program of a school of pharmacy accredited by the American Council on Pharmaceutical Education who is making normal progress toward completion of a professional degree in pharmacy.
(l) "Foreign pharmacy graduate" means a person whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside of the United States, the District of Columbia and Puerto Rico. Recognized schools of pharmacy are those colleges and universities listed in the World Health Organization's World Directory of Schools of Pharmacy, or otherwise approved by the Foreign Pharmacy Graduate Examination Committee (FPGEC) certification program as established by the National Association of Boards of Pharmacy.
(m) "Generic equivalent drug product" means a drug product which (i) contains the identical active chemical ingredient of the same strength, quantity and dosage form; (ii) is of the same generic drug name as determined by the United States Adoptive Names and accepted by the United States Food and Drug Administration; and (iii) conforms to such rules and regulations as may be adopted by the board for the protection of the public to assure that such drug product is therapeutically equivalent.
(n) "Internet" means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.
(o) "Interested directly" means being employed by, having full or partial ownership of, or control of, any facility permitted or licensed by the Mississippi State Board of Pharmacy.
(p) "Interested indirectly" means having a spouse who is employed by any facility permitted or licensed by the Mississippi State Board of Pharmacy.
(q) "Intern" means a person who has graduated from a school of pharmacy but has not yet become licensed as a pharmacist.
(r) "Manufacturer" means a person, business or other entity engaged in the production, preparation, propagation, conversion or processing of a prescription drug or device, if such actions are associated with promotion and marketing of such drugs or devices.
(s) "Manufacturer's distributor" means any person or business who is not an employee of a manufacturer, but who distributes sample drugs or devices, as defined under subsection (i) of this section, under contract or business arrangement for a manufacturer to practitioners.
(t) "Manufacturing" of prescription products means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances from natural origin or independently by means of chemical or biological synthesis, or from bulk chemicals and includes any packaging or repackaging of the substance(s) or labeling or relabeling of its container, if such actions are associated with promotion and marketing of such drug or devices.
(u) "Misappropriation of a prescription drug" means to illegally or unlawfully convert a drug, as defined in subsection (i) of this section, to one's own use or to the use of another.
(v) "Nonprescription drugs" means nonnarcotic medicines or drugs that may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government.
(w) "Person" means an individual, corporation, partnership, association or any other legal entity.
(x) "Pharmacist" means an individual health care provider licensed by this state to engage in the practice of pharmacy. This recognizes a pharmacist as a learned professional who is authorized to provide patient services.
(y) "Pharmacy" means any location for which a pharmacy permit is required and in which prescription drugs are maintained, compounded and dispensed for patients by a pharmacist. This definition includes any location where pharmacy-related services are provided by a pharmacist.
(z) "Prepackaging" means the act of placing small precounted quantities of drug products in containers suitable for dispensing or administering in anticipation of prescriptions or orders.
(aa) Unlawful or unauthorized "possession" means physical holding or control by a pharmacist of a controlled substance outside the usual and lawful course of employment.
(bb) "Practice of pharmacy" means a health care service that includes, but is not limited to, the compounding, dispensing, and labeling of drugs or devices; interpreting and evaluating prescriptions; administering and distributing drugs and devices; the compounding, dispensing and labeling of drugs and devices; maintaining prescription drug records; advising and consulting concerning therapeutic values, content, hazards and uses of drugs and devices; prescribing legend drugs within the regulations as set forth by the Board; providing comprehensive drug therapy management and comprehensive patient management as set forth by the Board; initiating or modifying of drug therapy in accordance with written guidelines or protocols * * * approved by the board; selecting drugs; participating in drug utilization reviews; storing prescription drugs and devices; ordering lab work in accordance with written guidelines or protocols as defined by paragraph (ll) of this section; providing pharmacotherapeutic consultations; supervising supportive personnel and such other acts, services, operations or transactions necessary or incidental to the conduct of the foregoing.
(cc) "Practitioner" means a physician, dentist, veterinarian, pharmacist, or other health care provider authorized by law to diagnose and prescribe drugs.
(dd) "Prescribing Pharmacist" means a licensed pharmacist who has been granted prescriptive authority by the Board.
(ee) "Prescription" means a written, verbal or electronically transmitted order issued by a practitioner for a drug or device to be dispensed for a patient by a pharmacist.
(ff) "Prescription drug" or "legend drug" means a drug which is required under federal law or state law to be dispensed by prescription on order of a licensed physician, dentist, veterinarian or any other healthcare provider so authorized and is required to bear the statement, "Caution: Federal law prohibits dispensing without a prescription," "Rx only" or similar wording indicating that such drug may be sold or dispensed only upon the prescription of a licensed healthcare provider.
* * *
(gg) "Product selection" means the dispensing of a generic equivalent drug product in lieu of the drug product ordered by the prescriber.
(hh) "Provider" or "primary health care provider" includes a pharmacist who provides health care services within his or her scope of practice pursuant to state law and regulation.
(ii) "Registrant" means a pharmacy or other entity which is registered with the Mississippi State Board of Pharmacy to buy, sell or maintain controlled substances.
(jj) "Repackager" means a person registered by the Federal Food and Drug Administration as a repackager who removes a prescription drug product from its marketed container and places it into another, usually of smaller size, to be distributed to persons other than the consumer.
(kk) "Reverse distributor" means a business operator that is responsible for the receipt and appropriate return or disposal of unwanted, unneeded or outdated stocks of controlled or uncontrolled drugs from a pharmacy.
(ll) "Supportive personnel" or "pharmacist technician" means those individuals utilized in pharmacies whose responsibilities are to provide nonjudgmental technical services concerned with the preparation and distribution of drugs under the direct supervision and responsibility of a pharmacist.
(mm) "Written guideline or protocol" means an agreement in which any practitioner authorized to prescribe drugs delegates to a pharmacist authority to conduct specific prescribing functions in an institutional setting, or with individual patients, provided that a specific protocol agreement is signed on each patient and is filed as required by law or by rule or regulation of the board.
(nn) "Wholesaler" means a person who buys or otherwise acquires prescription drugs or prescription devices for resale or distribution, or for repackaging for resale or distribution, to persons other than consumers.
SECTION 2. Section 73-21-106, Mississippi Code of 1972, is amended as follows:
73-21-106. (1) Any pharmacy located outside this state that ships, mails or delivers, in any manner, controlled substances or prescription or legend drugs or devices into this state shall be considered a nonresident pharmacy, shall be permitted by the board, and shall:
(a) Disclose to the board the location, names, and titles of all principal corporate officers and all pharmacists-in-charge. A report containing this information shall be made on an annual basis and within thirty (30) days after any change of office, corporate officer or pharmacist-in-charge;
(b) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. The nonresident pharmacy shall maintain at all times a valid unexpired license, permit or registration to conduct the pharmacy in compliance with the laws of the state in which it is a resident. As a prerequisite to permitting by the board, the nonresident pharmacy shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located; * * *
(c) Maintain its records of controlled substances and prescription or legend drugs or devices dispensed to patients in this state so that the records are readily retrievable from the records of other drugs dispensed; and
(d) Shall be subject to all rules and regulations of the board in the same manner as pharmacies permitted by the board.
(2) Any pharmacy subject to this section shall provide 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, a toll-free telephone service to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state.
(3) The permit fee for nonresident pharmacies shall be the same as the fee as set by subsection (4) of Section 73-21-105.
(4) The permit requirements of this section shall apply to any nonresident pharmacy that dispenses, distributes, ships, mails or delivers controlled substances or prescription or legend drugs and devices into this state directly to a consumer.
(5) The board may deny, revoke or suspend a nonresident pharmacy permit * * * for:
(a) Failure to comply with any requirement of this section or the board's regulations;
(b) Conduct that causes serious bodily or serious psychological injury to a resident of this state if the board has referred the matter to the regulatory or licensing agency in the state in which the pharmacy is located and the regulatory or licensing agency fails to initiate an investigation within forty-five (45) days of the referral; or
(c) Violation of the Uniform Controlled Substances Law.
(6) It is unlawful for any nonresident pharmacy that is not permitted under this section to advertise its services in this state, or for any person who is a resident of this state to advertise the pharmacy services of a nonresident pharmacy that is not permitted by the board, with the knowledge that the advertisement will or is likely to induce members of the public in this state to use the pharmacy to fill prescriptions.
(7) When requested to do so by the board or the Mississippi Bureau of Narcotics, each nonresident pharmacy shall supply any inspection reports, controlled substances dispensing records, warning notices, notice of deficiency reports or any other related reports from the state in which it is located concerning the operation of a nonresident pharmacy for review of compliance with state and federal drug laws.
SECTION 3. This act shall take effect and be in force from and after July 1, 2010.
