reglab/statecodes huggingface dataset:
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.8 - Pharmacies › Rule 24.174.841 - STERILE PRODUCTS

Current through Register Vol. 13, July 5, 2024
(1) Policies and
				procedures must be prepared for the compounding, dispensing, delivery,
				administration, storage, and use of sterile pharmaceutical products. The
				policiesmust include a quality assurance program for monitoring personnel
				qualifications and training in sterile technique, product storage, stability
				standards, and infection control. Policies and procedures mustbe current and
				available for inspection by a designee of the Board of Pharmacy.
(2) An institutional pharmacy compounding
				sterile products must have an isolated area designed to avoid unnecessary
				traffic and airflow disturbances.
(3) An institutional pharmacy compounding
				sterile products must utilize an appropriate aseptic environmental control
				device such as a laminar flow biological safety cabinet capable of maintaining
				Class 100 conditions during normal activity, or have policies and procedures in
				place limiting the pharmacy's scope of sterile product preparation.
(4) An institution preparing cytotoxic drugs
				must have a vertical flow Class II biological safety cabinet. Cytotoxic drugs
				must be prepared in a vertical flow Class II biological safety cabinet.
(a) Protective apparel including nonvinyl
				gloves, gowns and masks must be available, and gloves must be worn at all
				times.
(b) Appropriate containment
				techniques must be used in addition to aseptic techniques required for sterile
				product preparation.
(c) Prepared
				doses of cytotoxic drugs must be clearly identified, labeled with proper
				precautions, and dispensed in a manner to minimize risk of cytotoxic
				spills.
(d) Disposal of cytotoxic
				waste must comply with all applicable local, state, and federal laws.
(e) Written procedures for handling cytotoxic
				spills must be included in the policies and procedures manual.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.8 - Pharmacies › Rule 24.174.842 - POSITIVE IDENTIFICATION FOR CONTROLLED SUBSTANCE PRESCRIPTIONS

Current through Register Vol. 13, July 5, 2024
(1) The board authorizes the following
				allowable identifications in addition to those listed in 37-7-410, MCA:
(a) a valid government-issued photo
				identification, including but not limited to passport, military, or
				state-issued identification.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.9 - Patient Counseling › Rule 24.174.901 - PATIENT RECORDS

Current through Register Vol. 13, July 5, 2024
(1) A patient
				record system shall be maintained by all pharmacies for patients for whom
				prescription drug orders are dispensed. The patient record system shall provide
				for the immediate retrieval of information necessary for the dispensing
				pharmacist to identify previously dispensed drugs at the time a prescription
				drug order is presented for dispensing. The pharmacist or pharmacy technician
				under a board-approved utilization plan, shall make a reasonable effort to
				obtain, record, and maintain the following information:
(a) full name of the patient for whom the
				drug is intended;
(b) address and
				telephone number of the patient;
(c) patient's age or date of birth;
(d) patient's gender;
(e) pharmacist comments relevant to the
				individual's drug therapy, including any other information peculiar to the
				specific patient or drug.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.9 - Patient Counseling › Rule 24.174.902 - PROSPECTIVE DRUG REVIEW

Current through Register Vol. 13, July 5, 2024
(1) A pharmacist
				shall review the patient record and each prescription drug order presented for
				dispensing for purposes of promoting therapeutic appropriateness by
				identifying:
(a) over-utilization or
				under-utilization;
(b) therapeutic
				duplication;
(c) drug-disease
				contraindications;
(d) drug-drug
				interactions;
(e) incorrect drug
				dosage or duration of drug treatment;
(f) drug-allergy interactions;
(g) clinical abuse/misuse.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.9 - Patient Counseling › Rule 24.174.903 - PATIENT COUNSELING

Current through Register Vol. 13, July 5, 2024
(1) Upon receipt of
				a new prescription drug order or refill prescription drug order if deemed
				necessary by the pharmacist, and following a review of the patient's record, a
				pharmacist shall personally offer to discuss matters which will enhance or
				optimize drug therapy with each patient or caregiver of such patient. Such
				discussion shall be in person, whenever practicable, or by telephone, and shall
				include appropriate elements of patient counseling. Such elements may include
				the following:
(a) the name and description
				of the drug;
(b) the dosage form,
				dose, route of administration, and duration of drug therapy;
(c) intended use of the drug and expected
				action;
(d) special directions and
				precautions for preparation, administration, and use by the patient;
(e) common severe side or adverse effects or
				interactions and therapeutic contraindications that may be encountered,
				including their avoidance, and the action required if they occur;
(f) techniques for self-monitoring drug
				therapy;
(g) proper storage;
(h) prescription refill
				information;
(i) action to be
				taken in the event of a missed dose; and
(j) pharmacist comments relevant to the
				individual's drug therapy, including any other information peculiar to the
				specific patient or drug.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1001 - REGISTRATION OF OUT-OF-STATE MAIL SERVICE PHARMACIES

Current through Register Vol. 13, July 5, 2024
(1) No out-of-state pharmacy shall ship, mail
				or deliver prescription drugs and/or devices to a patient in this state unless
				registered by the Montana Board of Pharmacy.
37-7-712,
					 MCA; IMP,
					 37-7-703,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1002 - CONDITIONS OF REGISTRATION

Current through Register Vol. 13, July 5, 2024
(1) As
				conditions of registration, the out-of-state mail service pharmacy must comply
				with the following:
(a) be a legal entity
				registered and in good standing with the Montana Secretary of State with a
				registered agent in Montana for service of process designated;
(b) be registered and in good standing with
				the National Association of Boards of Pharmacy verified internet pharmacy
				practice sites (VIPPS) if registered after June 1, 2001;
(c) maintain, in readily retrievable form,
				records of legend drugs and/or devices dispensed to Montana patients;
(d) supply upon request, all information
				needed by the Montana Board of Pharmacy to carry out the board's
				responsibilities under the statutes and regulations pertaining to out-of-state
				mail service pharmacies;
(e)
				maintain pharmacy hours that permit the timely dispensing of drugs to Montana
				patients and provide reasonable access for the Montana patients to consult with
				a licensed pharmacist about such patients' medications;
(f) provide toll-free telephone communication
				consultation between a Montana patient and a pharmacist at the pharmacy who has
				access to the patient's records, and ensure that said telephone number(s) will
				be placed upon the label affixed to each legend drug container. A toll-free
				telephone number shall also be provided to the board to allow for compliance
				with all information requests by the board.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1003 - IDENTIFICATION OF PHARMACIST-IN-CHARGE OF DISPENSING TO MONTANA

Current through Register Vol. 13, July 5, 2024
(1) Each out-of-state mail service pharmacy
				that ships, mails, delivers prescription drugs and/or devices and oversees the
				pharmacy services provided to patients in Montana shall identify a
				pharmacist-in-charge of dispensing prescriptions for shipment to Montana and
				oversee the pharmacy services provided. Each pharmacist so identified shall
				meet the following requirements:
(a) be
				licensed in good standing in the state in which the out-of-state mail service
				pharmacy is located;
(b) be
				properly listed on the application form prescribed by the board;
(c) comply with all applicable Montana laws
				and rules; and
(d) notify the
				Montana board promptly in writing of any changes in the licensure status of the
				pharmacist-in-charge and any disciplinary actions initiated and/or finalized
				against the pharmacist's license.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1004 - CHANGE IN LOCATION

Current through Register Vol. 13, July 5, 2024
(1) Whenever a mail
				service pharmacy changes its physical location outside of its then existing
				business location, its original license becomes void and must be surrendered.
				The mail service pharmacy shall submit a new license application for the new
				location at least 30 days before such change occurs.
37-7-201,
					 37-7-712,
					 MCA; IMP,
					 37-7-701,
					 37-7-702,
					 37-7-703,
					 37-7-704,
					 37-7-706,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1005 - CHANGE IN OWNERSHIP

Current through Register Vol. 13, July 5, 2024
(1) When a mail
				service pharmacy changes ownership, the original license becomes void and must
				be surrendered to the board, and a new license obtained by the new owner. The
				owner shall submit a new license application at least 30 days prior to the
				change in ownership.
(2) A change
				in ownership for the purposes of this rule shall be deemed to occur when more
				than 50 percent of the equitable ownership of a business is transferred in a
				single transaction or in a related series of transactions to one or more
				persons or any other legal entity.
(3) The board must be notified in writing
				when five to 50 percent of the equitable ownership of a business is transferred
				in a single transaction or in a related series of transactions to one or more
				persons or any other legal entity.
37-7-201,
					 37-7-712,
					 MCA; IMP,
					 37-7-701,
					 37-7-702,
					 37-7-703,
					 37-7-704,
					 37-7-706,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1007 - AGENT OF RECORD (REPEALED)

Current through Register Vol. 13, July 5, 2024
37-7-712,
					 MCA; IMP,
					 37-7-703,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1008 - USE OF PHARMACY TECHNICIANS BY OUT-OF-STATE MAIL SERVICE PHARMACIES

Current through Register Vol. 13, July 5, 2024
(1) Any application for out-of-state mail
				service pharmacy registration from a facility located in a state which does not
				regulate the use of pharmacy technicians may not allow a pharmacist to
				supervise more than one supportive person at any one time in the compounding or
				dispensing of prescription drugs, unless approved by the board.
(2) Any application for out-of-state mail
				service pharmacy licensure from a facility located in a state which does
				regulate the use of pharmacy technicians shall provide information on the
				supervisor to technician ratio allowed in the resident state, and submit a
				utilization plan for the employment of pharmacy technicians.
37-7-712,
					 MCA; IMP,
					 37-7-703,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1009 - COMPLIANCE

Current through Register Vol. 13, July 5, 2024
(1) Each out-of-state mail service pharmacy
				shall comply with the following:
(a) all
				statutory and regulatory requirements of the state of Montana for controlled
				substances, including those that are different from federal law or regulation,
				unless compliance would violate the pharmacy drug laws or regulations of the
				state in which the pharmacy is located;
(b) all statutory and regulatory requirements
				of the state of Montana regarding drug product selection laws, unless
				compliance would violate the laws or regulations of the state in which the
				pharmacy is located;
(c) labeling
				of all prescriptions dispensed, to include but not be limited to identification
				of the product and quantity dispensed;
(d) all the statutory and regulatory
				requirements of the state of Montana for dispensing prescriptions in accordance
				with the quantities indicated by the prescriber, unless compliance would
				violate laws or regulations of the state in which the pharmacy is
				located.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.10 - Out-of-State Mail Service Pharmacies › Rule 24.174.1010 - DISCIPLINARY ACTION (REPEALED)

Current through Register Vol. 13, July 5, 2024
37-7-712,
					 MCA; IMP,
					 37-7-703,
					 37-7-704,
					 37-7-711,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1101 - PERSONNEL

Current through Register Vol. 13, July 5, 2024
(1) Each
				institutional pharmacy must be directed by a pharmacist-in-charge who is
				licensed to engage in the practice of pharmacy in Montana and who is
				responsible for the storage, compounding, repackaging, dispensing, and
				distribution of drugs within the facility. Depending upon the needs of the
				facility, pharmacy services may be provided on a full or part-time basis, with
				a mechanism for emergency service provided at all times. Contractual providers
				of pharmacy services shall meet the same requirements as pharmacies located
				within the institution.
(2)
				Registered pharmacy technicians or technicians-in-training may be utilized
				pursuant to the written policies and procedures of the institutional pharmacy.
				Exemptions to established ratios as defined in ARM
				24.174.711 may be granted with
				board approval.
(3) Personnel
				shall be provided with appropriate training before beginning to prepare sterile
				and nonsterile compounded pharmaceuticals, including training in the
				theoretical principles and practical skills of aseptic manipulations when
				performing compounded sterile preparation (CSP). The pharmacist-in-charge shall
				establish pharmacy policies and procedures that contain protocols in accordance
				with the guidelines in the United States Pharmacopeia (USP) Chapter 797
				"Pharmaceutical Compounding - Sterile Preparations" for the initial training
				and testing of all personnel and for annual retesting in aseptic manipulative
				skills for those personnel involved in low- and medium-risk
				compounding.
(4) Personnel involved
				in high-risk compounding must be retested in aseptic manipulative skills at
				least semi-annually.
AUTH:
					 37-7-201,
					 MCA; IMP:
					 37-7-201,
					 37-7-307,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1104 - INSTITUTIONAL PHARMACIST AND PHARMACIST-IN-CHARGE RESPONSIBILITY

Current through Register Vol. 13, July 5, 2024
(1) The pharmacy
				director/pharmacist-in-charge shall provide forapplicable policies and
				procedures to ensure:
(a) mechanisms for
				receiving and verifying drug orders from prescribers and evaluating them for
				safety and therapeutic appropriateness based on patient parameters and dosing
				guidelines;
(b) appropriate filling
				and proper labeling of all containers from which drugs are to be dispensed or
				administered on an inpatient or outpatient basis;
(c) a system for the admixture of parenteral
				products accomplished within the pharmacy, and verification that the facility's
				department of nursing willprovideeducation and training of nursing personnel
				regarding sterile technique, stability and compatibility of parenteral products
				not mixed within the pharmacy;
(d)
				appropriate clinical services and monitoring of outcomes, and the development
				of new areas of pharmaceutical care appropriate for that institution;
(e) a policy by which an offer is made to
				convey the discharge medication regimen to a patient's pharmacies;
(f) maintaining and distributing a list of
				emergency drugs, antidotes, and their doses throughout the
				institution;
(g) pharmacy
				participation in formulary development;
(h) participation in drug utilization review
				and monitoring of adverse drug reactionsand development of procedures to avoid
				problems identified;
(i) evaluation
				of reported medication errors and development of procedures to prevent those
				errors;
(j) proper acquisition and
				secure, temperature-controlledstorage of all prescription drugs;
(k) quality control of sterile and nonsterile
				pharmaceutical products, including procedures for identifying, removing and
				destroying outdated products;
(l)
				pharmacy safety and security;
(m)
				utilization of registered technicians or technicians in training;
(n) accurate distribution systems and
				secure,temperature-controlled storage of pharmaceutical products throughout the
				institution;
(o) unit-dosing of
				bulk pharmaceuticals, compounding and sterilization of drug products if
				applicable;
(p) the appropriate
				use, security and accountability of controlled substances;
(q) staff development and competency
				evaluation;
(r) maintenance of all
				required records; and
(s)
				compliance with all other requirements of the Montana Board of
				Pharmacy.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1107 - ABSENCE OF PHARMACIST IN INSTITUTIONAL SETTINGS

Current through Register Vol. 13, July 5, 2024
(1) During times that an institutional
				pharmacy does not have a pharmacist in attendance, arrangements must be made in
				advance by the pharmacist-in-charge for provision of drugs to the medical staff
				and other authorized personnel by use of night cabinets, floor stock and, in
				emergency circumstances, by access to the pharmacy. A mechanism for providers
				and nursing to obtain pharmacy consultation must be available at all times in
				accordance with ARM
				24.174.1101.
(2) If night cabinets are used to store drugs
				in the absence of a pharmacist, they must be locked and sufficiently secure to
				deny access to unauthorized persons, and must be located outside of the
				pharmacy area. Contents of night cabinets must be prepackaged. Only
				specifically authorized personnel may obtain access by key or combination,
				pursuant to a valid prescription order. The pharmacist-in-charge shall, in
				conjunction with the appropriate committee of the facility, develop inventory
				listings of drugs included in these cabinets and determine who may have
				access.
(3) A complete verification
				audit of all inpatient orders and activity concerning the night cabinet or
				after-hours pharmacy entry must be conducted by a pharmacist, pharmacy
				technician, or other licensed designee of that pharmacist within 72 hours of
				the drugs having been removed from the night cabinet or pharmacy.
(4) Whenever any drug is not available from
				floor stock or night cabinets, and that drug is required to treat the immediate
				needs of a patient whose health would otherwise be jeopardized, the drug may be
				obtained from the pharmacy by an authorized registered nurse or licensed
				practical nurse in accordance with established policies and procedures. The
				responsible nurse shall be designated by the appropriate committee of the
				institutional facility.
(a) Removal of any
				drug from the pharmacy, floor stock, or night cabinet by an authorized nurse
				must be recorded on a suitable form showing the following information:
(i) patient name;
(ii) the patient's room number if
				applicable;
(iii) the name,
				strength, and quantity of drug removed;
(iv) the date and time the drug was
				removed;
(v) the signature of the
				nurse removing the drug; and
(vi)
				documentation of pharmacy review.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1111 - DRUG DISTRIBUTION AND CONTROL IN AN INSTITUTIONAL OR CORRECTIONAL FACILITY

Current through Register Vol. 13, July 5, 2024
(1) The
				pharmacist-in-charge shall establish written policies and procedures for the
				safe and efficient distribution of drugs and provision of pharmaceutical care,
				including the mechanism by which drug review will be accomplished and
				documented. A current copy of such procedures must be on hand for inspection by
				the Board of Pharmacy.
(2)
				Automated dispensing devices must be stocked with drugs only by or under the
				supervision of a registered pharmacist. At the time of removal of any drug, the
				device must automatically make an electronic record indicating the date of
				removal, the name, strength, and quantity of drug removed, name of the patient
				for whom the drug was ordered, and the name or other identification of the
				person removing the drug. These records must be maintained for a period of two
				years.
(3) Drugs or
				herbal/alternative food supplement products brought into an institutional
				facility by a patient must not be administered, unless they can be identified
				and their quality assured by a pharmacist and their use has been authorized by
				the attending physician. If such drugs are not to be administered, the
				pharmacist-in-charge shall develop policies and procedures for storing them for
				return to the patient upon discharge or transferring them to an adult member of
				the patient's immediate family.
(4) Investigational drugs must be stored in
				and dispensed from the pharmacy only pursuant to written policies and
				procedures.
(a) Complete information regarding
				these drugs and their disposition must be maintained in the facility prior to
				their initial dispensing.
(b) The
				drug monograph and a signed patient consent form must be obtained and made
				available in accordance with state and federal guidelines.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1114 - USE OF DRUG KITS IN CERTAIN INSTITUTIONAL FACILITIES

Current through Register Vol. 13, July 5, 2024
(1) In an institutional facility , drugs may
				be provided for use by authorized personnel through drug kits prepared by the
				registered pharmacist providing pharmaceutical services to the facility. Such
				drug kits must meet all of the following requirements:
(a) a registered pharmacist shall prepare and
				seal the drug kit for a supplying pharmacy;
(b) the supplying pharmacy and the designated
				practitioner or appropriate committee of the institutional facility shall
				jointly determine the identity and quantity of drugs to be included in the drug
				kit;
(c) the drug kit must be
				locked and stored in a secure area to prevent unauthorized access and to ensure
				a proper storage environment for the drugs contained therein;
(d) all drugs in the drug kit must be
				properly labeled, including lot number and expiration date, and shall possess
				any additional information that may be required to prevent risk of harm to the
				patient;
(e) the exterior of the
				drug kit must be clearly labeled to indicate:
(i) expiration date of the drug kit. The
				expiration date of a drug kit must be the earliest date of expiration of any
				drug supplied in the drug kit. On or before the expiration date, the supplying
				pharmacy shall replace the expired drug;
(ii) the name, address, and telephone number
				of the supplying pharmacy; and
(iii) a statement indicating that the drug
				kit is to be used in situations only pursuant to a valid drug order;
(f) if a drug kit is being
				utilized for an emergency drug cart or crash cart in an inpatient setting, as
				defined in ARM
				24.174.301(15):
(i) the pharmacist-in-charge must maintain
				policies and procedures for access to the cart; and
(ii) a pharmacist must review access to the
				cart within 72 hours of drug removal.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1115 - USE OF CONTINGENCY KITS IN CERTAIN INSTITUTIONAL FACILITIES (Repealed)

Current through Register Vol. 13, July 5, 2024
AUTH:
					 37-7-201,
					 MCA IMP:
					 37-7-201,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1121 - STERILE PRODUCTS [Renumbered]

Current through Register Vol. 13, July 5, 2024
37-7-201,
					 MCA; IMP,
					 37-7-201,
					 37-7-307,
					 37-7-308,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1122 - OUTPATIENT CENTERS FOR SURGICAL SERVICES

Current through Register Vol. 13, July 5, 2024
(1) The board shall annually register and
				inspect all outpatient centers for surgical services in Montana, regardless of
				pharmacy status.
(2) In an
				outpatient center for surgical services without an on-site pharmacy, drug
				distribution must be directed by a physician or consulting pharmacist licensed
				to practice in Montana and who is responsible for the security, storage, and
				distribution of drugs within the facility.
(3) The physician director or consulting
				pharmacist shall provide for applicable policies and procedures to ensure:
(a) proper acquisition and secure,
				temperature-controlled storage of all pharmaceuticals;
(b) security and accountability of controlled
				substances;
(c) quality control of
				sterile and nonsterile pharmaceutical products including procedures for
				identifying, removing, and destroying outdated products;
(d) evaluation of reported medication errors
				and development of procedures to prevent those errors;
(e) maintenance of all required records;
				and
(f) compliance with all
				requirements of the board.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.11 - Institutional Pharmacies › Rule 24.174.1141 - RETURN OF MEDICATION FROM LONG TERM CARE FACILITIES - DONATED DRUG PROGRAM

Current through Register Vol. 13, July 5, 2024
(1) In facilities
				licensed by the Montana Department of Public Health and Human Services where
				United States pharmacopeia storage requirements are assured, unit-dosed legend
				drugs, with the exception of controlled substances, no longer needed by the
				patient for whom they were prescribed, may be transferred to a provisional
				permitted pharmacy for relabeling and dispensing free of charge to patients who
				are uninsured, indigent or have insufficient funds to obtain needed
				prescription drugs. Prescription medications may be dispensed pursuant to a
				valid prescription order. A usual and customary dispensing fee may be charged
				at the pharmacist's discretion.
(2)
				The pharmacist-in-charge of the provisional permitted pharmacy shall be
				responsible for determining the suitability of the legend drug for use.
				Medications must be unopened in sealed, unaltered unit dose containers that
				meet USP standards for light, moisture and air permeation. No product in which
				drug integrity cannot be assured shall be accepted for redispensing by the
				pharmacist.
(3) A redispensed
				prescription medication must be assigned the expiration date stated on the unit
				dose packaging. Medications packaged in unit dose form within a pharmacy must
				be given an expiration date of one year or actual date of expiration of the
				medication, whichever comes first, and must not be repackaged.
(4) No medication can be redistributed more
				than once.
(5) Only authorized
				personnel shall carry out the physical transfer of medication in either
				facility, pursuant to established policies and procedures.
(6) The patient's name and other identifying
				marks must be obliterated from packaging prior to transfer. The drug name,
				strength, lot number and expiration date must remain clearly visible on the
				packaging.
(7) An inventory list of
				drugs transferred, including expiration dates, must accompany the drugs, and
				must be maintained in the provisional permitted pharmacy for a period of two
				years.
(8) Policies and procedures
				to document safe storage and transfer of unneeded medications must be written
				and adhered to by the facilities involved, and must be available for inspection
				by an authorized representative of the Montana Board of Pharmacy or Department
				of Public Health and Human Services.
37-7-201,
					 37-7-1401,
					 MCA; IMP,
					 37-7-201,
					 37-7-1401,
					 37-7-1402,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1201 - WHOLESALE DISTRIBUTOR AND THIRD-PARTY LOGISTICS PROVIDER LICENSING

Current through Register Vol. 13, July 5, 2024
(1) Every person engaged in wholesale
				distribution of drugs or prescription devices, which includes reverse wholesale
				distribution, medical gases, or as a third-party logistics provider (3PL), as
				defined in
				37-7-602,
				MCA, shall be licensed annually by the board. Each applicant shall:
(a) be a legal entity registered and in good
				standing with the Montana Secretary of State;
(b) file an application on a form prescribed
				by the board;
(c) pay the
				appropriate licensing and registration fees;
(d) meet the requirements of
				37-7-604,
				MCA; and
(e) designate a
				person-in-charge of the facility and for purposes of meeting requirements of
				37-7-611,
				MCA, regarding a criminal background check at time of initial licensure or any
				change in person-in-charge, complete the requirements included on a form
				prescribed by the board.
(i) The
				person-in-charge must notify the board of any changes or termination of
				services.
(ii) Within 72 hours of
				termination of services, a new person-in-charge must be designated in writing
				on the appropriate board-approved forms and filed with the board.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1202 - MANUFACTURER AND REPACKAGER LICENSING

Current through Register Vol. 13, July 5, 2024
(1) Every person seeking licensure or renewal
				as a manufacturer or repackager, as defined in
				37-7-602,
				MCA, shall:
(a) be a legal entity registered
				and in good standing with the Montana Secretary of State;
(b) file an application on a form prescribed
				by the board;
(c) pay the
				appropriate licensing and registration fees;
(d) meet the requirements of
				37-7-604,
				MCA; and
(e) designate a
				person-in-charge of the facility.
(i) The
				person-in-charge must notify the board of any changes or termination of
				services.
(ii) Within 72 hours of
				termination of services, a new person-in-charge must be designated in writing
				on the appropriate board-approved forms and filed with the board.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1203 - PERSONNEL

Current through Register Vol. 13, July 5, 2024
(1) Each licensee under this subchapter shall
				require each person employed in any prescription drug wholesale activity to
				have sufficient education, training, and experience in any combination,
				sufficient for that person to:
(a) complete
				assigned work in a manner which maintains the quality, safety, and security of
				the drug or device products in accordance with Title 37, MCA;
(b) assume responsibility for compliance with
				the licensing requirements of Title 37, MCA.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1204 - MEDICAL GAS DISTRIBUTOR

Current through Register Vol. 13, July 5, 2024
(1) Every person
				engaged in the manufacture or distribution of medical gases other than to the
				consuming public or a patient, in the state of Montana, shall register annually
				with the board. Each applicant shall:
(a)
				provide proof of registration with the Food and Drug Administration (FDA) as a
				medical gas manufacturer and comply with all FDA requirements;
(b) register with the board as a wholesale
				drug distributor;
(c) file an
				application to register as a medical gas distributor on a form prescribed by
				the board; and
(d) pay the
				appropriate registration fee.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1205 - MEDICAL GAS SUPPLIER

Current through Register Vol. 13, July 5, 2024
(1) Every person
				engaged in supplying medical gases to the consuming public, or to a patient or
				a patient's agent, in the state of Montana that is not a licensed pharmacy
				shall register annually with the board. Each applicant shall:
(a) register with the board as a wholesale
				drug distributor;
(b) file an
				application to register as a medical gas supplier on a form prescribed by the
				board; and
(c) pay the appropriate
				registration fee.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1206 - MEDICAL GAS FEE SCHEDULE

Current through Register Vol. 13, July 5, 2024
(1) The fees for
				registration to manufacture, distribute, or supply medical gases shall be
				assessed according to the following schedule:
REGISTRATION
ANNUAL FEE
(a) medical gas distributor
$75
(b) medical gas supplier
75
37-1-134,
					 37-7-201,
					 37-7-610,
					 MCA; IMP,
					 37-7-604,
					 37-7-605,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1207 - CHANGE IN LOCATION

Current through Register Vol. 13, July 5, 2024
(1) Whenever a
				facility licensed under this subchapter changes its physical location outside
				of its then existing business location, its original license becomes void and
				must be surrendered. The facility shall submit a new license application for
				the new location at least 30 days before such change occurs.
AUTH:
					 37-7-201,
					 37-7-610,
					 MCA; IMP:
					 37-7-604,
					 37-7-605,
					 37-7-610,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1208 - CHANGE IN OWNERSHIP

Current through Register Vol. 13, July 5, 2024
(1) When a facility
				licensed under this subchapter changes ownership, the original license becomes
				void and must be surrendered to the board, and a new license obtained by the
				new owner. The owner shall submit a new license application at least 30 days
				prior to the change in ownership.
(2) A change in ownership for the purposes of
				this rule shall be deemed to occur when more than 50 percent of the equitable
				ownership of a business is transferred in a single transaction or in a related
				series of transactions to one or more persons or any other legal
				entity.
(3) The board must be
				notified in writing when five to 50 percent of the equitable ownership of a
				business is transferred in a single transaction or in a related series of
				transactions to one or more persons or any other legal entity.
AUTH:
					 37-7-201,
					 37-7-610,
					 MCA; IMP:
					 37-7-604,
					 37-7-605,
					 37-7-610,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1211 - MINIMUM FACILITY REQUIREMENTS

Current through Register Vol. 13, July 5, 2024
(1) All
				facilities licensed under this subchapter shall:
(a) establish, maintain, and adhere to
				written policies and procedures for receipt, recordkeeping, security, storage,
				inventory control, and distribution of drugs or devices;
(b) comply with state and federal law
				requirements including, but not limited to:
(i)
											37-7-602,
				37-7-604,
				37-7-609,
				and
				37-7-610,
				MCA; and
(ii) 21 CFR - 205 as
				established by the Food and Drug Administration (FDA); and
(c) comply with product track and trace
				transaction requirements established by the FDA.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1212 - MINIMUM REQUIREMENTS FOR ESTABLISHMENT AND MAINTENANCE OF DRUG DISTRIBUTION RECORDS (REPEALED)

Current through Register Vol. 13, July 5, 2024
AUTH:
					 37-7-201,
					 37-7-610,
					 MCA; IMP:
					 37-7-604,
					 37-7-609,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.12 - Wholesale Drug Distributors Licensing › Rule 24.174.1213 - NATIONAL CLEARINGHOUSE FOR WHOLESALE DRUG DISTRIBUTOR LICENSING (REPEALED)

Current through Register Vol. 13, July 5, 2024
AUTH:
					 37-7-201,
					 37-7-610,
					 MCA; IMP:
					 37-7-604,
					 37-7-605,
					 37-7-606,
					 37-7-607,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.13 - Telepharmacy › Rule 24.174.1303 - REMOTE TELEPHARMACY DISPENSING MACHINE SITES

Current through Register Vol. 13, July 5, 2024
(1) Remote telepharmacy dispensing machine
				sites contain prescription inventory which is secured in an automated
				dispensing device connected to the central processing unit at the parent
				pharmacy.
(2) A site cannot be
				licensed as a remote telepharmacy dispensing machine site if it is located
				within a ten mile radius of an existing pharmacy.
(3) A pharmacist must approve all outpatient
				prescriptions before they are dispensed, unless the prescription is directly
				dispensed by a person authorized to prescribe.
(4) All filled prescriptions must have a
				label that meets the requirements of ARM
				24.174.511 attached to the final
				drug container.
(5) A licensed
				pharmacist at the parent site shall perform counseling and professional
				consultation via audio and video link as required by ARM
				24.174.903, unless the
				prescription is directly dispensed by a person authorized to
				prescribe.
(6) Registered
				technicians involved in stocking and removal of prescription medications under
				this rule must have at least 80 hours of pretraining in bar coding technology.
				All requirements of ARM
				24.174.701 through
				24.174.714 will apply, excluding
				the technician certification requirement of ARM
				24.174.702.
(7) Policies and procedures of the parent
				pharmacy and the remote telepharmacy dispensing machine site must address all
				aspects of the telepharmacy operation, including stocking procedures and
				removal of outdated prescription medications.
(8) The pharmacist at the parent pharmacy
				shall perform an ongoing analysis of incident reports and outcomes, with
				appropriate corrective action taken when necessary to ensure patient
				safety.
(9) The
				pharmacist-in-charge of the parent pharmacy or that person's designee shall
				conduct and complete monthly inspections of the remote telepharmacy dispensing
				machine site. Inspection criteria must be included in the policies and
				procedures for the site. The inspection reports must be available for review at
				the next board inspection.
(10)
				Remote telepharmacy dispensing machine sites must be licensed with the board by
				November 30 of each year, and will be subject to random inspection by board
				inspectors.
(11) This rule does not
				apply to institutional satellite pharmacies as defined in ARM
				24.174.301.
37-7-201,
					 MCA; IMP,
					 37-7-101,
					 37-7-201,
					 37-7-321,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1401 - REQUIREMENTS FOR REGISTRATION

Current through Register Vol. 13, July 5, 2024
(1) The
				board shall register a person to manufacture dangerous drugs (as defined in
				50-32-101,
				MCA) included in Schedules I through V upon the following conditions:
(a) applicant is registered for such purposes
				pursuant to the Federal Controlled Substances Act of 1970;
(b) the applicant has made proper application
				and has paid the applicable fee; and
(c) the category of manufacturer as
				above-stated shall include only those applicants who are engaged in the
				manufacturing of dangerous drugs within the state of Montana.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1402 - RENEWALS

Current through Register Vol. 13, July 5, 2024
(1) All applications for registration shall
				be made on forms provided by the board and shall be filed with the
				board.
(2) Renewal notices will be
				sent as specified in ARM
				24.101.414.
(3) The provisions of ARM
				24.101.408 apply.
(4) The registrant shall prominently display
				the certificate of registration to be visible to the public.
50-32-103,
					 MCA; IMP,
					 37-1-141,
					 50-32-301,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1403 - APPLICATION FORMS

Current through Register Vol. 13, July 5, 2024
(1) If any person
				is required to be registered and is not so registered and is applying for
				registration to manufacture or distribute dangerous drugs in Schedules I
				through V, the person shall apply on a form prescribed by the board.
(2) If any person is required to be
				registered and is not so registered and is applying for registration to
				dispense dangerous drugs in Schedules II through V, the person shall apply on a
				form prescribed by the board.
(3)
				If any person is required to be registered and is not so registered and is
				applying for registration to analyze or conduct research with dangerous drugs
				in Schedules I through V, the person shall apply on a form prescribed by the
				board.
(4) Any licensee applying
				for renewal of registration to manufacture or distribute dangerous drugs in
				Schedules I through V, the licensee shall apply on a form prescribed by the
				board.
(5) Any licensee applying
				for renewal to dispense dangerous drugs in Schedules II through V, the licensee
				shall apply on a form prescribed by the board.
50-32-103,
					 MCA; IMP,
					 50-32-306,
					 50-32-308,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1404 - REQUIRED RECORDS

Current through Register Vol. 13, July 5, 2024
(1) As used in this
				subchapter, the term "records" means:
(a)
				those records and inventories maintained by persons registered to manufacture,
				distribute, analyze or dispense dangerous drugs or samples thereof in
				conformance with record keeping and inventory requirements of federal statute
				and regulation, ( 21 CFR 304 ), and as they may be amended from
				time-to-time.
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1411 - SECURITY REQUIREMENTS

Current through Register Vol. 13, July 5, 2024
(1) All
				applicants and registrants shall establish and maintain effective written
				controls and procedures to guard against theft and diversion of dangerous drugs
				into other than legitimate medical, scientific or industrial
				channels.
(2) The registrant shall
				not employ as an agent or employee any person who has access to dangerous
				drugs, who has had a federal or state application for registration denied or
				his registration revoked at any time, or has been convicted of a felony offense
				under any state or federal law relating to dangerous drugs or convicted of any
				other felony.
(3) The registrant
				shall notify the Board of Pharmacy in writing by forwarding a copy of the
				applicable DEA form reporting the theft or loss of any dangerous drugs upon
				discovery of such theft or loss. The notification shall contain a list of all
				dangerous drugs stolen or lost.
(4)
				The registrant shall notify law enforcement officials of any theft or loss of
				any dangerous drug promptly upon discovery of such theft or loss.
50-32-103,
					 MCA; IMP,
					 50-32-106,
					 MCA;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1412 - ADDITIONS, DELETIONS, AND RESCHEDULING OF DANGEROUS DRUGS

Current through Register Vol. 13, July 5, 2024
(1) In addition to those dangerous drugs
				scheduled in
				50-32-222,
				50-32-224,
				50-32-226,
				50-32-229,
				and
				50-32-232,
				MCA, the board adds the following to dangerous drug schedules after considering
				federal regulations and/or the criteria enumerated in Title 50, chapter 32,
				part 2, MCA:
(a) Schedule I:
(i) none at this time;
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1420

Current through Register Vol. 13, July 5, 2024
AUTH:
					 50-32-103,
					 MCA; IMP:
					 50-32-103,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1421

Current through Register Vol. 13, July 5, 2024
AUTH:
					 50-32-103,
					 MCA; IMP:
					 50-32-103,
					 MCA
Administrative Rules of Montana › Department 24 - LABOR AND INDUSTRY › Chapter 24.174 - BOARD OF PHARMACY › Subchapter 24.174.14 - Dangerous Drug Act › Rule 24.174.1422

Current through Register Vol. 13, July 5, 2024
AUTH:
					 50-32-103,
					 MCA; IMP:
					 50-32-103,
					 MCA