HOME    SEARCH    ABOUT US    CONTACT US    HELP   
           
Montana Administrative Register Notice 24-174-60 No. 18   09/23/2010    
Prev Next

 

BEFORE THE BOARD OF PHARMACY

DEPARTMENT OF LABOR AND INDUSTRY

STATE OF MONTANA

 

In the matter of the amendment of ARM 24.174.401 fee schedule, 24.174.403 change in address, 24.174.805 change of pharmacist-in-charge, 24.174.813 class IV facility, 24.174.1003 identification of pharmacist-in-charge, 24.174.1201 wholesale drug distributor, 24.174.1302 telepharmacy operations, 24.174.1412 dangerous drugs, and the adoption of NEW RULES I through X cancer drug repository, and NEW RULES XI through XIV clinical pharmacist practitioner

)

)

)

)

)

)

)

)

)

)

)

)

)

NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT AND ADOPTION

 

TO:  All Concerned Persons

 

            1.  On October 14, 2010, at 9:00 a.m., a public hearing will be held in room B-07, 301 South Park Avenue, Helena, Montana, to consider the proposed amendment and adoption of the above-stated rules.

 

            2.  The Department of Labor and Industry (department) will make reasonable accommodations for persons with disabilities who wish to participate in this public hearing or need an alternative accessible format of this notice.  If you require an accommodation, contact the Board of Pharmacy (board) no later than 5:00 p.m., on October 8, 2010, to advise us of the nature of the accommodation that you need.  Please contact Ronald Klein, RPh, Board of Pharmacy, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513; telephone (406) 841-2371; Montana Relay 1 (800) 253-4091; TDD (406) 444-2978; facsimile (406) 841-2305; e-mail dlibsdpha@mt.gov.

 

            3.  The rules proposed to be amended provide as follows, stricken matter interlined, new matter underlined:

 

 

            24.174.401  FEE SCHEDULE

            (1) through (3) remain the same.

            (4)  Original registration for clinical pharmacist practitioner     25

            (5)  Clinical pharmacist practitioner annual renewal fee     25

            (4) and (5) remain the same, but are renumbered (6) and (7).

            (6) (8)  Class IV Family planning limited pharmacy facility,

certified pharmacy license, (original and renewal)     75

            (7) through (21) remain the same, but are renumbered (9) through (23).

 

            AUTH:  37-1-134, 37-7-201, 50-32-314, MCA

            IMP:     37-1-134, 37-7-201, 37-7-302, 37-7-306, 37-7-321, 37-7-604, 37-7-605, 37-7-703, 50-32-314, MCA

 

REASON:  In conjunction with the adoption of New Rules XI through XIV to implement Senate Bill 174, the board is amending this rule to establish application and renewal fees for the newly created class of clinical pharmacist practitioner.  The board estimates the original and renewal registration fees will affect ten clinical pharmacist practitioners a year and generate approximately $250 in annual revenue.  The board is amending renumbered (8) to rename class IV pharmacies to mirror proposed amendments to ARM 24.174.813 within this notice.

 

            24.174.403  CHANGE IN ADDRESS AND/OR EMPLOYMENT  (1)  All licensees shall notify the board in writing within ten 30 days of any change in employment and/or any change of business or personal address.

 

            AUTH:  37-7-201, MCA

            IMP:     37-7-201, MCA

 

REASON:  The board is amending this rule to expand licensees' notice period from ten days to thirty days to afford licensees ample time to report updates to the board and for consistency among similar rules with reporting requirements.

 

            24.174.805  CHANGE OF PHARMACIST-IN-CHARGE  (1)  When the pharmacist-in-charge of a pharmacy leaves the employment of such pharmacy ceases to be the pharmacist-in-charge, the pharmacist will be held responsible for the proper notification to notifying the board in writing of such termination of services.

            (2)  Within 72 hours of termination of services of the pharmacist-in-charge, a new pharmacist-in-charge must be designated and an affidavit in writing on the appropriate board-approved form and filed with the board.  The license will then be updated to indicate the name of the new pharmacist-in-charge.

 

            AUTH:  37-7-201, MCA

            IMP:     37-7-201, 37-7-321, MCA

 

REASON:  The board determined it is reasonably necessary to amend this rule to address a situation that came before the board's screening panel.  The panel discovered that the current language of (1) does not require someone who ceases to be the pharmacist-in-charge, but remains a pharmacist at the same pharmacy, to report such a change to the board, but only requires the reporting of someone who leaves the pharmacy entirely.  The board is amending this rule because it is in the public's best interest for the board to know of every pharmacist-in-charge change as there is no reason for this distinction.  The board is also clarifying that such notification must be in writing for consistency with other reporting requirements. 

            The board is amending (2) to require that the designation of a new pharmacist-in-charge must be in writing on a board-approved form and removing the requirement of an affidavit.  The board determined that an affidavit is not necessary for the reporting and written notice is sufficient for the board's record keeping.  The board is also striking the unnecessary statement that the license will be updated, as it is standard practice for board staff to update licenses upon receipt of current information from licensees.  Implementation cites are being amended to accurately reflect all statutes implemented through the rule.

 

            24.174.813  CLASS IV FAMILY PLANNING LIMITED PHARMACY FACILITY  (1)  A Class IV family planning limited pharmacy facility shall be administered in compliance with the following standards:

            (a)  that any  Any legend drugs, controlled by federal law and required to bear the legend "federal law prohibits dispensing without a prescription," dispensed shall first have been packaged, labeled, and otherwise prepared by a registered pharmacist holding a current license in Montana.  The pharmacist is to be recorded with the board and the board shall be notified of any change of the pharmacist in charge.

            (i)  a legend drug is defined as one that is controlled by federal law and carries the legend "Federal Law Prohibits Dispensing Without a Prescription".

            (b)  The pharmacist-in-charge serving at a family planning limited pharmacy must be identified to the board and the family planning limited pharmacy shall, within 30 days, notify the board of any change of the pharmacist-in-charge.

            (b) (c)  that the The registered pharmacist-in-charge shall provide this service to said facility at regular periods and that these periods be posted at said the facility.

            (c) (d)  that adequate Adequate locked storage must be provided for all drugs referred to in these rules.  Only the pharmacist may have access to the legend drug stock.  However, the person in charge, or his or her designee, may obtain a product that has been properly prepared by the pharmacist for delivery to the recipient.

            (e)  Only the pharmacist may have access to the legend drug stock; however an authorized person may obtain a product that has been properly prepared by the pharmacist for delivery to the recipient.

            (d)  that records for all legend drugs dispensed and to whom be kept at the facility for the purpose of accounting for these drugs.  These records would include present stock and all shipments received thereafter.

            (f)  All appropriate records shall be maintained onsite at the facility.

            (e)  that these drugs be delivered to the recipient at no cost for the drug.

            (g)  The facility may not charge the recipient for the cost of the drug.

            (f) (h)  that the dispensing Dispensing of drugs by M.D.'s medical practitioners may not be restricted, except as defined in 37-2-104 and 37-7-103, MCA.

            (g) (i)  that nothing  Nothing in these rules authorizes the dispensing of any drugs and devices other than the following:

            (i)  oral contraceptives,; injectable long-term contraceptives,; progestational drugs,; diaphragms,; contraceptive jellies,; creams,; and foams,; IUD's,; condoms,; vaginal creams,; ointments,; and suppositories used in the routine treatment of vaginal disorders.;

            (ii)  oral antibiotics used to treat Chlamydia, both patient and partner; and

            (iii)  oral antibiotics used to treat Gonorrhea, both patient and partner.

            (h)  that all nonlegend contraceptive devices and products be dispensed in accordance with the contraceptive drug or device law, Title 45, chapter 8, 45-8-204, MCA.

            (i) (j)  that each  Each family planning center must apply for a license from the board and submit the required fee for a Class IV family planning limited pharmacy facility.  This license is to be displayed in a conspicuous place at the facility.

            (k)  Each family planning limited pharmacy facility will be inspected on a routine basis by the pharmacy inspector/compliance officer or other individuals appointed by the Board of Pharmacy and also may be inspected as necessary for cause.

 

            AUTH:  37-7-201, MCA

            IMP:     37-7-201, 37-7-321, MCA

 

REASON:  It is reasonable and necessary to amend this rule throughout for clarity, ease of use, and to comply with ARM numbering and formatting standards.  The board is amending the facility name for clarity and to align with previous rule amendments that eliminated facility classes I through III, leaving only class IV.

            The board is amending (1)(e) to use the term "authorized person" and avoid confusion between the use of "person in charge" in ARM 24.174.1202, regarding wholesale drug distributors.  The board is amending (1)(h) to address additional medical practitioners with prescriptive authority, as defined at 37-2-101, MCA.

            It is reasonably necessary to amend (1)(i) to allow a family planning limited pharmacy to dispense oral antibiotic medication to better provide for the timely treatment of patients with certain sexually transmitted diseases.  Montana's chief medical officer requested that the board amend the rules to address this serious public health concern.

            The board is striking former (1)(h) as the referenced contraceptive drug or device law was repealed in 1989.  The board is adding (1)(k) to provide for the timely inspection of such facilities by the pharmacy inspector/compliance officer.  The board concluded that inspection is necessary to ensure the public's safety as these facilities maintain legend drugs and may be located in remote areas of the state.

 

            24.174.1003  IDENTIFICATION OF PHARMACIST-IN-CHARGE OF DISPENSING TO MONTANA  (1) through (1)(b) remain the same.

            (c)  comply with all applicable Montana laws and rules; and

            (d)  notify the Montana board promptly in writing of any relevant changes in employment or address, etc.; the licensure status of the pharmacist-in-charge and any disciplinary actions initiated and/or finalized against the pharmacist's license.

            (e)  notify the Montana board promptly of any disciplinary actions initiated and/or finalized against the pharmacist's license.

(2)  When the pharmacist-in-charge of an out-of-state mail service pharmacy ceases to be the pharmacist-in-charge, the pharmacist will be held responsible for notifying the board in writing of such termination of services.

            (3)  Within 72 hours of termination of services of the pharmacist-in-charge, a new pharmacist-in-charge must be designated in writing on the appropriate board-approved form and filed with the board.

 

            AUTH:  37-7-712, MCA

            IMP:     37-7-703, MCA

 

REASON:  The board is amending this rule to set forth the specific changes that must be reported to the board regarding pharmacists-in-charge to address a recent increase in the number of mail service pharmacies that failed to notify the board when there was a change in their pharmacist-in-charge.  The board concluded that it is in the public's best interest for the board to know of every pharmacist-in-charge change, and that such notification must be in writing.  The board determined these amendments are also necessary to remain consistent with requirements for in-state pharmacies in ARM 24.174.805.

 

            24.174.1201  WHOLESALE DRUG DISTRIBUTOR LICENSING  (1)  Every person engaged in manufacturing, wholesale distribution, which includes reverse wholesale distribution, or selling of drugs, medicines, chemicals, poisons for medicinal purposes, medical gases, or legend devices other than to the consuming public or patient, in the state of Montana, shall be licensed annually by the board.  Each applicant shall:

            (a) through (6) remain the same.

 

            AUTH:  37-7-201, 37-7-610, MCA

            IMP:     37-7-603, 37-7-604, 37-7-605, 37-7-606, MCA

 

REASON:  The board determined it is reasonably necessary to amend this rule to specify that wholesale drug distribution includes a relatively new business practice of reverse distribution of prescription drugs.  The board notes that wholesale distributors remove outdated and unusable drugs from inventory for proper disposal and has concluded that this process is included in the regulated practice of wholesale drug distribution.

 

            24.174.1302  TELEPHARMACY OPERATIONS  (1) through (4)(b)(ii) remain the same.

            (iii)  have at least six months of active experience as a pharmacy technician or experience deemed as equivalent by the board.

            (c) through (z) remain the same.

 

            AUTH:  37-7-201, MCA

            IMP:     37-7-101, 37-7-201, 37-7-321, MCA

 

REASON:  It is reasonable and necessary to amend this rule to allow the board discretion in the operation of a telepharmacy.  This rule change will allow the board to examine the credentials of a pharmacy technician and deem those credentials sufficient.  This rule will allow telepharmacy operations to hire qualified and experienced individuals in a timely and cost effective manner.

 

            24.174.1412  ADDITIONS, DELETIONS, AND RESCHEDULING OF DANGEROUS DRUGS  (1)  The Board of Pharmacy hereby adopts the most current schedule of dangerous drugs as defined in 21 CFR 1308, et. seq. April 1, 1999 2009.  Copies are available from the Board of Pharmacy, 301 South Park Avenue, P.O. Box 200513, Helena, MT 59620-0513.

 

            AUTH:  50-32-103, 50-32-203, MCA

            IMP:     50-32-103, 50-32-202, 50-32-203, 50-32-209, 50-32-222, 50-32-223, 50-32-224, 50-32-225, 50-32-226, 50-32-228, 50-32-229, 50-32-231, 50-32-232, MCA

 

REASON:  It is reasonable and necessary to amend this rule to reflect the most current and applicable federal regulations.

 

            4.  The proposed new rules provide as follows:

 

            NEW RULE I  PARTICIPATION  (1)  A pharmacy or facility may fully participate in the cancer drug repository program by accepting, storing and dispensing, or administering donated drugs and supplies, or may limit its participation to only accepting and storing donated drugs and supplies.  If a pharmacy or facility chooses to limit its participation, the pharmacy or facility shall distribute any donated drugs to a fully participating repository.

            (2)  A pharmacy or facility may withdraw from participation in the cancer drug repository program at any time, upon notification to the board.  A notice to withdraw shall be in writing.

            (3)  Any patient who is diagnosed with cancer is eligible to receive drugs or supplies under the cancer drug repository program.

            (4)  Cancer drugs may be donated to a pharmacy or facility.

            (5)  Participation in the program is voluntary.

            (6)  There is no limitation on the number of doses that can be donated to the program as long as the donated drugs meet the requirements of these regulations.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1403, MCA

 

REASON:  The 2009 Montana Legislature enacted Chapter 299, Laws of 2009 (House Bill 409), an act establishing a cancer drug repository program and participant registry.  The bill was signed by the Governor on April 18, 2009, and became effective October 1, 2009.  The board is adopting New Rules I through X to establish the repository program and further implement the legislation.

 

            NEW RULE II  DONATION OF CANCER DRUGS  (1)  Any person or entity may donate cancer drugs to the program.  Any person or entity who donates to the program must contact a pharmacy or facility to obtain a form on which the donor must specify the cancer drug to be donated.  The board will supply the form to be used which will include:

            (a)  name of the cancer drug;

            (b)  quantity of the cancer drug;

            (c)  the name of the person to whom the cancer drug was originally prescribed;

            (d)  the relationship between the person or entity donating the cancer drug and the person to whom the drug was prescribed;

            (e)  signature of the person donating the cancer drug; and

            (f)  date the form was signed.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1403, MCA

 

            NEW RULE III  ACCEPTABLE CANCER DRUGS  (1)  The following categories of drugs are acceptable for dispensing or distribution under the program:

            (a)  a cancer drug that is in its original, unopened, sealed, and tamper-evident packaging;

            (b)  a cancer drug packaged in single unit doses if the outside packaging is opened, but the single unit dose packaging is unopened;

            (c)  a cancer drug that does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; and

            (d)  an injectable cancer drug if it does not have temperature requirements other than controlled room temperature.

            (2) Any cancer drug donated to the program must have at least six months remaining before its expiration date occurs.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1404, 37-7-1405, MCA

 

            NEW RULE IV  NONACCEPTABLE CANCER DRUGS  (1)  The following categories of drugs are not acceptable for dispensing or distribution under the program, because the effectiveness and safety of the cancer drug cannot be ensured or is otherwise prohibited:

            (a)  a cancer drug that is adulterated or misbranded;

            (b)  a cancer drug in packaging that has been opened, unsealed, or tampered with, or that is no longer in its original container;

            (c)  a cancer drug packaged in single unit doses if the outside packaging is opened and the single unit dose packaging is also opened;

            (d)  a cancer drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature;

            (e)  controlled substances; and

            (f)  a cancer drug that has expired before dispensing to the patient.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1404, 37-7-1405, MCA

 

            NEW RULE V  DISPENSING AND DISTRIBUTION OF CANCER DRUGS

            (1)  A pharmacy or facility must comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of donated cancer drugs.

            (2)  A pharmacy or facility must inspect all such drugs prior to dispensing or distributing to determine if they are adulterated, misbranded, or expired.

            (3)  The following are authorized to dispense drugs:

            (a)  practitioners with prescriptive authority; and

            (b)  licensed pharmacists.

            (4)  Cancer drugs may only be dispensed pursuant to a prescription issued by a prescribing practitioner.  Cancer drugs may be:

            (a)  dispensed to an ultimate user of the cancer drug; or

            (b)  distributed to another pharmacy or facility for dispensing.

            (5)  Cancer drugs donated under the program may not be resold.

            (6)  Patients for whom cancer drugs are dispensed under the program must be notified by the prescribing practitioner that the cancer drugs they received were originally dispensed to another patient and were returned for redispensing through the program.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1405, MCA

 

            NEW RULE VI  STORAGE REQUIREMENTS  (1)  The pharmacy or facility that receives donated cancer drugs for dispensing or distribution must:

            (a)  provide equipment for the storage of cancer drugs donated to the program at controlled room temperature;

            (b)  maintain the inventory of donated cancer drugs separate from all other drug inventory of the pharmacy or facility; and

            (c)  establish a secure location for the storage of the donated cancer drugs.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1404, MCA

 

            NEW RULE VII  RECORD-KEEPING REQUIREMENTS  (1)  A pharmacy or facility must maintain a perpetual inventory log book of all cancer drugs received, dispensed, or distributed.

            (2)  The perpetual inventory log book must contain the following information regarding all cancer drugs received, dispensed, or distributed:

            (a)  name of the cancer drug;

            (b)  quantity of the cancer drug;

            (c)  expiration date of the cancer drug;

            (d)  lot number of the cancer drug;

            (e)  name of pharmacy or facility;

            (f)  name of person who donated the cancer drug;

            (g)  name of the person to whom the cancer drug was dispensed;

            (h)  date the cancer drug was dispensed;

            (i)  name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the program;

            (j)  name of the pharmacy or facility which the cancer drug was distributed;

            (k)  date the cancer drug was distributed to another pharmacy or facility;

            (l)  date of destruction of the expired cancer drug; and

            (m)  the amount of the handling fee charged, if any.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1405, MCA

 

            NEW RULE VIII  HANDLING FEE  (1)  A pharmacy or facility that receives donated cancer drugs may charge a handling fee to the patient for dispensing or distribution of cancer drugs under the program.

            (2)  The handling fee must not exceed the applicable Medicaid dispensing fee.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1405, MCA

 

            NEW RULE IX  PHARMACY OR FACILITY REGISTRY  (1)  The board shall establish and maintain a pharmacy or facility registry for the program.

            (2)  The pharmacy or facility registry shall include:

            (a)  pharmacy's or facility's name;

            (b)  pharmacy's or facility's address;

            (c)  pharmacy's or facility's telephone number; and

            (d)  whether the pharmacy or facility is in a practitioner's office, a pharmacy, a clinic, or a hospital.

            (3)  It is the responsibility of the pharmacy or facility to:

            (a)  notify the board of the desire to participate in the program; and

            (b)  provide the required registry information to the board.

            (4)  Any pharmacy or facility in the program will be entered on the pharmacy or facility registry by the board.

            (5)  It is the responsibility of the pharmacy or facility to notify the board:

            (a)  of any change of name, address, telephone number; and

            (b)  when it no longer wants to participate in the program.

            (6)  The board will make the pharmacy or facility registry information available to any person or entity wishing to donate cancer drugs to the program.

            (7)  The board will provide public access to the pharmacy or facility registry information on the board web site, or by contacting the board office.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, 37-7-1403, MCA

 

            NEW RULE X  INSPECTIONS AND TERMINATION FROM PROGRAM

            (1)  The board may, in its discretion, inspect pharmacy or facilities in the program for compliance with the storage and record-keeping requirements of this subchapter.

            (2)  In the event of noncompliance with the storage and record-keeping requirements of this subchapter, the board may terminate the pharmacy's or facility's participation in the program.

 

AUTH:  37-7-1401, MCA

            IMP:     37-7-1401, MCA

 

            NEW RULE XI  DEFINITIONS  (1)  "Board of Pharmaceutical Specialties" (BPS) means an independent nongovernmental certification body that provides recognition of persons involved in the advanced practice of pharmacy specialties through development and administration, a certification process that is consistent with public policy regarding the credentialing of healthcare professionals.

            (2)  "Clinical practice experience" means working in a pharmacy practice setting which includes at least 50 percent of time spent in:

            (a)  communication with healthcare professionals and patients regarding drug therapy, wellness, and health promotion;

            (b)  designing, implementing, monitoring, evaluating, and modifying or recommending modifications in drug therapy to optimize patient care;

            (c)  identifying, assessing, and solving medication-related problems and providing a clinical judgment as to the continuing effectiveness of the therapeutic plan;

            (d)  conducting physical assessment applicable to the area of practice, evaluating patient problems, ordering and monitoring medications, and/or laboratory tests in accordance with established standards of practice;

            (e)  referring patients to other healthcare professionals as appropriate;

            (f)  integrating relevant diet, exercise, and other non-drug therapy with pharmaceutical care;

            (g)  retrieving, evaluating, utilizing, and managing data and professional resources;

            (h)  documenting interventions and evaluating outcomes; and

            (i)  integrating national standards for the quality of healthcare.

            (3)  "Collaborative practice agreement" is defined as set forth in ARM 24.174.524.

 

AUTH:  37-7-201, MCA

            IMP:     37-7-201, 37-7-306, MCA

 

REASON:  The 2009 Montana Legislature enacted Chapter 293, Laws of 2009 (Senate Bill 174), an act creating the professional classification of clinical pharmacist practitioner.  The bill was signed by the Governor on April 17, 2009, and became effective October 1, 2009.  The board is adopting New Rules XI through XIV to establish definitions, qualifications, and requirements for clinical pharmacist practitioners and further implement the legislation.

 

            NEW RULE xII  Requirements to become a Clinical Pharmacist Practitioner  (1)  An applicant for a clinical pharmacist practitioner registration shall:

            (a)  submit an application on a form prescribed by the board;

            (b)  pay a registration fee as prescribed by the board;

            (c)  hold an active, unrestricted Montana pharmacist license;

            (d)  have completed five years of clinical practice experience or have completed a pharmacy residency and two years clinical practice experience and hold one of the following active certifications:

            (i)  BPS certification; or

            (ii)  nationally recognized certification in an area of practice as approved by the board and Board of Medical Examiners (BME).

            (e)  submit a signed collaborative practice agreement to the board that includes a description of the type of supervision the collaborating physician will exercise over the clinical pharmacist practitioner;

            (f)  following approval of the board, submit the application and collaborative practice agreement to the BME for approval; and

            (g)  appear before the board and/or BME if requested.

            (2)  Within ten days of discontinuing work under an approved collaborative drug therapy agreement, the pharmacist shall notify the board and the clinical pharmacist practitioner's registration shall be inactive, until such time as a new application is approved.

 

AUTH:  37-7-201, MCA

            IMP:     37-7-201, 37-7-306, MCA

 

            NEW RULE xIIi  Requirements to maintain Clinical Pharmacist Practitioner Registration  (1)  In addition to completing the annual renewal requirements for a pharmacist's license, a clinical pharmacist practitioner must pay a clinical pharmacist practitioner annual renewal fee to the board.

            (2)  The board shall randomly select renewal notice forms of clinical pharmacist practitioners for audit of current certification and requirements for continued registration.

 

AUTH:  37-7-201, MCA

            IMP:     37-7-201, 37-7-306, MCA

 

            NEW RULE xIV  Unprofessional Conduct  (1)  A clinical pharmacist practitioner's registration may be disciplined by the board for unprofessional conduct as defined by the board in ARM 24.174.2301.

            (2)  The BME may take appropriate action for the unlicensed practice of medicine under 37-3-101 and 37-1-317, MCA, if a clinical pharmacist practitioner exceeds the scope of practice as defined in 37-7-306, MCA.

 

AUTH:  37-1-319, 37-7-201, MCA

            IMP:     37-1-316, 37-7-306, MCA

 

            5.  Concerned persons may present their data, views, or arguments either orally or in writing at the hearing.  Written data, views, or arguments may also be submitted to the Board of Pharmacy, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513, by facsimile to (406) 841-2305, or by e-mail to dlibsdpha@mt.gov, and must be received no later than 5:00 p.m., October 22, 2010.

 

            6.  An electronic copy of this Notice of Public Hearing is available through the department and board's site on the World Wide Web at www.pharmacy.mt.gov.  The department strives to make the electronic copy of this notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the department strives to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems, and that technical difficulties in accessing or posting to the e-mail address do not excuse late submission of comments.

 

            7.  The board maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this board.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies the person wishes to receive notices regarding all board administrative rulemaking proceedings or other administrative proceedings.  The request must indicate whether e-mail or standard mail is preferred.  Such written request may be sent or delivered to the Board of Pharmacy, 301 South Park Avenue, P.O. Box 200513, Helena, Montana 59620-0513; faxed to the office at (406) 841-2305; e-mailed to dlibsdpha@mt.gov; or made by completing a request form at any rules hearing held by the agency.

 

            8.  The bill sponsor contact requirements of 2-4-302, MCA, apply and have been fulfilled.  The primary bill sponsor was contacted on February 24, 2010, by electronic mail.

 

            9.  Mike Fanning, attorney, has been designated to preside over and conduct this hearing.

 

                                                                     BOARD OF PHARMACY

                                                                     WILLIAM BURTON, RPH, PRESIDENT

 

 

 

/s/ DARCEE L. MOE                                 /s/ KEITH KELLY

Darcee L. Moe                                           Keith Kelly, Commissioner

Alternate Rule Reviewer                            DEPARTMENT OF LABOR AND INDUSTRY

 

 

 

            Certified to the Secretary of State September 13, 2010

 

Home  |   Search  |   About Us  |   Contact Us  |   Help  |   Disclaimer  |   Privacy & Security