reglab/statecodes huggingface dataset:
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.700 - Pharmacy Technician Registration

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines the requirements for
				  pharmacy technician registration.
(1) A pharmacy technician is defined as any
				person who assumes a supportive role under the direct supervision and
				responsibility of a pharmacist and who is utilized according to written
				standards of the employer or the pharmacist-in-charge to perform routine
				functions that do not require the use of professional judgement in connection
				with the receiving, preparing, compounding, distribution, or dispensing of
				medications.
(A) No person shall assume the
				role of a pharmacy technician without first registering with the board in
				accordance with the requirements in section
				338.013,
				RSMo and this rule. Nothing in this rule shall preclude the use of persons as
				pharmacy technicians on a temporary basis as long as the individual(s) is
				registered as or has applied to the board for registration as a technician in
				accordance with 338.013.1 and .2, RSMo.
(B) A person may be employed as a technician
				once a completed application and the required fee is received by the board. The
				board will provide either a registration certificate that shall be
				conspicuously displayed or a letter of disqualification preventing the
				applicant's employment within a pharmacy.
(C) Information required on the application
				shall include, but is not limited to-
1. The
				name, phone number, and residential address of the applicant;
2. Full-time and part-time addresses where
				the applicant will be employed as a technician;
3. Information concerning the applicant's
				compliance with state and federal laws, as well as any violations that could be
				considered grounds for discipline as outlined in section 338.013.5,
				RSMo;
4. One (1) two-inch by
				two-inch (2" x 2") frontal view portrait photograph of applicant; and
5. Proof of fingerprinting as required by
				20 CSR
				2220-2.450.
(D) A copy of the application must be
				maintained by the applicant at the site(s) of employment during and until
				notice of registration or disqualification is received by the applicant and
				must be readily retrievable for review by the board of pharmacy or the board's
				representatives.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.710 - Pharmacy Technician and Intern Pharmacist Supervision

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines the required supervision
				  for pharmacy technicians and intern pharmacists.
(1) Pharmacy technicians and intern
				pharmacists may assist a phar-macist in the practice of pharmacy as authorized
				by Chapter 338, RSMo, and the rules of the board, provided delegated tasks are
				per-formed under the direct supervision of a pharmacist. Direct supervi-sion
				means supervision by a Missouri licensed pharmacist who is readily and
				immediately available at all times the delegated tasks are being performed and
				who provides personal assistance, direction, and approval throughout the time
				the delegated tasks are being per-formed. "Readily and immediately available"
				means the pharmacist and pharmacy technician(s) or intern pharmacists are on
				the same physical premises, or if not, technology is used to communicate with
				and monitor the pharmacy technician and intern pharmacist, as authorized in
				section (2).
(2) Use of Technology.
				Except as otherwise provided by law or regulation, technology may be used to
				directly supervise a pharmacy technician and intern pharmacist, provided:
(A) Sufficient technology is available to
				allow communication between the pharmacist and the pharmacy technician or
				intern pharmacist in a manner that is sufficient to provide the personal
				assistance, direction, and approval required to verify and ensure delegated
				tasks are safely and properly performed. Technicians and intern pharmacists may
				not be supervised as authorized by this subsection if the required technology
				is not operating or available;
(B)
				All applicable state and federal laws are fully observed, including, but not
				limited to, all applicable privacy and confidentiality laws;
(C) The pharmacy technician or intern
				pharmacist has completed employer approved training in the activities performed
				and has an initial and annual documented assessment of competency.
				Documentation of the completed training and competency assessment must be
				maintained in the pharmacy's records for a minimum of two (2) years and
				provided to the board or the board's designee upon request; and
(D) The supervising pharmacist and the permit
				holder must maintain a sufficient audit trail of prescription/medication order
				data entry and modifications to a patient record performed by a pharmacy
				technician or intern pharmacist being supervised as authorized by this
				subsection. The record must include the identity of the pharmacy technician or
				intern pharmacist performing the data entry or modification and must be
				maintained in the pharmacy's records for a minimum of five (5) years.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.725 - Remote Data Entry

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment removes geographic
				  restrictions on remote data entry sites and allows Missouri licensed or
				  registered pharmacy technicians and intern pharmacists to perform remote data
				  entry from a site located in a U.S. state or territory.
(1) Definitions.
(A) "Remote Data Entry Sites"-A remote site
				located in a U.S. state or territory that is operated by a Missouri licensed
				pharmacy and used by a Missouri licensed or registered pharmacy technician or
				intern pharmacist to electronically perform non-dispensing data entry
				functions, including, but not limited to, obtaining, entering, validating, or
				processing patient information or data.
(B) "Supervising Pharmacy"-A Missouri
				licensed pharmacy that is physically located in Missouri and responsible for
				operating a remote data entry site.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.800 - Vacuum Tube Drug Delivery System

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule is being amended pursuant to
				  Executive Order 17-03 to remove unnecessary/duplicative rule language and to
				  correct a rule citation.
(1)
				Vacuum tube systems are for use in the delivery of drugs to the patient or
				his/her agent.
(A) Any drug delivery system
				that utilizes a vacuum tube to deliver drugs outside of a licensed pharmacy
				must be designed and engineered in such a way as to ensure security of all
				drugs and that drugs are delivered correctly and efficiently to the intended
				recipient.
(B) Only systems that
				are dedicated for the delivery of drugs from a location within a licensed
				pharmacy to another location specific for drug delivery and are not connected,
				combined or attached to other systems shall be used. Multiple or switchable
				stations where the delivery of drugs could occur at more than one destination
				outside of the pharmacy are prohibited.
1.
				When the pharmacy is closed or there is no pharmacist on duty, the vacuum tube
				system must be turned off and no drugs shall be delivered to consumers during
				these time periods.
(C)
				Any pharmacy, which cannot maintain a direct and identifiable line of sight
				with the consumer, must maintain a video camera and audio system to provide for
				effective communication between pharmacy personnel and consumers. It must be a
				system that will allow for the appropriate exchange of oral as well as written
				communications to facilitate patient counseling and other matters involved in
				the correct transaction or provision of drugs.
1. Video monitors used for the proper
				identification of persons receiving prescription drugs shall be a minimum of
				twelve inches (12") wide.
2. Both
				the video monitor and the audio system must be in good working order or
				operations utilizing the vacuum tube system shall cease until appropriate
				corrections or repairs are made to the system(s).
3. Backlighting or other factors that may
				inhibit video or audio performance must be taken into account when using such
				systems to identify recipients of prescription drugs. Positive identification
				of recipients must be made before any drug is delivered.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.900 - Class N: Health Care Facility Automated Dispensing Systems

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment clarifies and updates
				  supervision, technology, and operational requirements for Class N Health Care
				  facility automated dispensing systems.
PURPOSE: This rule establishes licensing standards
				  and requirements for the use of Class N automated dispensing systems (Health
				  Care Facility).
(1)
				Definitions.
(A) "Class N: Automated
				dispensing system" (ADS)-An automated system located within a licensed health
				care facility used to dispense medication for resident patients of the facility
				pursuant to a patient-specific prescription or a medication order as defined by
				Chapter 338, RSMo, or a prescription drug order as defined by 20 CSR 22202.140.
				An automated dispensing system does not include an automated system used for
				compounding medication, a Class O automated dispensing system, or an automated
				filling system governed by
				20 CSR
				2220-2.950.
(B) "Electronic verification system"-An
				electronic verification, bar code verification, weight verification, radio
				frequency identification (RFID), or similar electronic process or system
				process used to verify and ensure medication has been properly stocked,
				restocked, loaded, filled, dispensed, or labeled.
(C) "Licensed health care facility"-A health
				care facility licensed by or operated by the state of Missouri, or otherwise
				authorized by the state, to administer health care to resident patients in the
				ordinary course of business or professional practice.
(D) "Med pak"-A patient med pak as defined by
				20 CSR
				2220-2.145.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.910 - Class O: Automated Dispensing Systems (Ambulatory Care)

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes licensing standards
				  and requirements for Class O: Automated Dispensing Systems (Ambulatory
				  Care).
(1) Definitions.
(A) "Ambulatory prescription dispensing
				system"-A Class O automated dispensing system (Class O ADS) used to process,
				verify, fill, label, and dispense a completed prescription/medication order for
				patient retrieval from the system using an electronic verification
				system.
(B) "Class O automated
				dispensing system"- A pharmacy license classification which allows the use of
				an ambulatory prescription dispensing system or a prescription pick-up system
				as defined by this rule at a specific location. A Class O ADS does not include
				an automated system used for compounding medication, a Class N automated
				dispensing system, or an automated filling system governed by
				20 CSR
				2220-2.950.
(C) "Electronic verification system"-An
				electronic verification, bar code verification, weight verification, radio
				frequency identification (RFID), or similar electronic process or system
				process used to verify and ensure medication/prescriptions have been properly
				stocked, restocked, loaded, filled, dispensed, or labeled.
(D) "Prescription pick-up system"-A Class O
				ADS that allows a patient to obtain a filled, labeled, and pharmacist-verified
				prescription/medication order placed in the system by or on behalf of a
				Missouri-licensed pharmacy for patient retrieval. A prescription pick-up system
				does not include a vacuum tube drug delivery system identified in
				20 CSR
				2220-2.800.
(E) "Supervising pharmacist"-A
				Missouri-licensed pharmacist designated to supervise a Class O ADS while the
				system is in operation.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.950 - Automated Filling Systems

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes standards for
				  automated filling systems.
(1) Definitions. The following definitions
				shall be applicable for purposes of this rule:
(A) "Automated filling system"-An automated
				system used by a pharmacy to assist in filling a prescription drug order by
				selecting, labeling, filling, or sealing medication for dispensing. An
				"automated filling system" shall not include automated devices used solely to
				count medication, vacuum tube drug delivery systems governed by
				20 CSR
				2220-2.800, or automated dispensing and storage
				systems governed by
				20 CSR
				2220-2.900 used to dispense medication directly to a
				patient or to an authorized health care practitioner for immediate distribution
				or administration to the patient;
(B) "Electronic verification system"-An
				electronic verification, bar code verification, weight verification, radio
				frequency identification (RFID), or similar electronic process or system that
				accurately verifies medication has been properly dispensed and labeled by, or
				loaded into, an automated filling system;
(C) "Manufacturer unit of use package"- A
				drug dispensed in the manufacturer's original and sealed packaging, or in the
				original and sealed packaging of a repackager, without additional manipulation
				or preparation by the pharmacy, except for application of the pharmacy
				label;
(D) "Repackager"-A
				repackager registered with the United States Food and Drug Administration;
				and
(E) "Repacked"-Any drug that
				has been removed from the original packaging of the manufacturer or a
				repackager's packaging and is placed in a container for use in an automated
				filling system.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.990 - Rx Cares For Missouri Program

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes the Missouri Board of
				  Pharmacy's medication disposal program as part of the Rx Cares for Missouri
				  Program created by section
				  338.710,
				  RSMo and establishes standards/criteria for Program operation and
				  participation.
(1) Section
				338.710,
				RSMo, established the "Rx Cares for Missouri Program" within the Board of
				Pharmacy to promote medication safety and to prevent prescription drug abuse,
				misuse, and diversion in Missouri. As part of the Rx Cares for Missouri
				Program, the board is hereby establishing a medication destruction and disposal
				program (the "Program") for the purposes of collecting unused or unwanted
				medication from the public for disposal in accordance with state and federal
				law. Operation of the Program may be delegated to a board approved vendor or
				third-party.
(2) Eligible
				Participants. To be eligible for participation, applicants must be physically
				located in Missouri and currently registered to collect unwanted controlled
				substances with the United States Drug Enforcement Administration ("DEA") and
				the Missouri Bureau of Narcotics and Dangerous Drugs ("BNDD") unless exempt
				from registration by state or federal law. Additionally, the applicant must be-
(A) A licensed Missouri pharmacy or drug
				distributor;
(B) A licensed
				healthcare provider authorized to prescribe controlled substances;
(C) A hospital, office, clinic, or other
				medical institution that provides health care services;
(D) A federal, state, local, or municipal
				public health, law enforcement, or other governmental agency, or
(E) A higher education institution located in
				Missouri that is accredited by a national or regional accrediting body
				recognized by the United States Secretary of Education.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.995 - Board Approved Pilot and Research Projects

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes application
				  requirements and criteria for pilot projects authorized by section
				  338.143,
				  RSMo.
(1) This rule
				establishes requirements for the approval and operation of pharmacy pilot or
				demonstration research projects related to technology assisted verification or
				remote medication dispensing that are designed to enhance patient care or
				safety, improve patient outcomes, or expand access to pharmacy services, as
				authorized by section
				338.143,
				RSMo.
(2) Applicants to operate a
				pilot program pursuant to this rule shall file an application on a form
				provided by the board. To be eligible, the applicant must hold a current and
				active license, registration, or permit from the board that is not under
				discipline.
(3) Proposal
				Requirements. Proposed pilot projects must be submit-ted to the board in
				writing and include-
(A) A one (1) page
				abstract of the project that includes the project's goals, purpose, scope, and
				proposed timelines;
(B) A narrative
				description of the following:
1. Activities
				that will be undertaken as part of the pilot project, including, the intended
				audience;
2. The goals and
				objectives of the project. Services and antici-pated outcomes must be clearly
				described and align with section
				338.143,
				RSMo;
3. A description of the
				capacity and structure the applicant has in place to operate the proposed pilot
				program, including, staff and personnel who will be monitoring, supervising, or
				participating in the pilot project and their relevant education, experience, or
				qualifi-cations;
4. Procedures for
				training staff on project operations;
5. An explanation of how the proposal will
				enhance patient care or safety, improve patient outcomes, or expand access to
				pharmacy services for Missouri citizens;
6. A projected timeline for implementation
				and completion of the proposed pilot project. The proposed pilot project must
				be eligi-ble for completion within eighteen (18) months of approval, unless
				otherwise authorized by the board;
7. Evaluation measures for assessing impact
				and effectiveness; and
8. A plan
				for pilot project termination
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 3 - Negative Generic Drug Formulary › Section 20 CSR 2220-3.010 - Generic Drug Formulary

Current through Register Vol. 49, No. 14, July 15, 2024
This rule originally filed as 4 CSR 220-3.010.
				  Emergency rule filed Dec. 28, 1978, effective Jan. 7, 1979, expired April 30,
				  1979. Moved to
				  20 CSR
				  2220-3.010, effective Aug. 28,
				  2006.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 3 - Negative Generic Drug Formulary › Section 20 CSR 2220-3.011 - Generic Drug Substitution

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule is being amended pursuant to
				  Executive Order 17-03 to remove unnecessary/duplicate rule
				  language.
PURPOSE: The purpose of this rule is to establish
				  requirements for generic drug substitution.
(1) Except as otherwise provided by Chapter
				338, RSMo, a pharmacist who receives a prescription for a brand name drug or
				biological product may select a less expensive generically equivalent or
				inter-changeable biological product unless the patient requests a brand named
				drug or biological product or the prescribing practitioner indicates that
				substitution is prohibited or displays "brand medically necessary", "dispense
				as written", "do not substitute", "DAW", or words of similar import on the
				prescription.
(2) All pharmacists
				and dispensing physicians should be warned that any drug product not holding an
				approved New Drug Application or Abbreviated New Drug Application may not be
				used as a substitute in the state of Missouri without the dispenser assuming
				some personal liability.
(3) A
				pharmacist shall not substitute drug products that are rated as therapeutically
				in equivalent to other pharmaceutically equivalent products as listed in the
				latest edition or cumulative supplement of The Approved Drug Products with
				Therapeutic Equivalence Evaluations published by the United States Government,
				Department of Health and Human Services.
*Original authority: 338.056, RSMo 1978; 338.057, RSMo
					 1978; and 338.140, RSMo 1939, amended 1981,
					 1989.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 3 - Negative Generic Drug Formulary › Section 20 CSR 2220-3.040 - Return and Reuse of Drugs and Devices

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The board is amending section (3) of this
				  rule to address return and reuse of medication to an automated filling
				  system.
(1) Pharmacists and
				pharmacies shall not accept from patients or their agents for reuse or resale
				any drugs, prescribed medications, chemicals, poisons or medical devices unless
				otherwise provided for in this regulation.
(2) A pharmacist or pharmacy may receive and
				reuse drugs from long-term care facilities, hospitals, and hospice facilities
				(as regulated by the Department of Health and Senior Services, in
				19 CSR
				30-35.020 Hospices Providing Direct Care in a Hospice
				Facility), provided that the following conditions are met:
(A) The pharmacist has assurance from a
				person in responsible charge of the drugs at a facility delineated in this
				section that the drugs being returned have been stored in accordance with the
				manufacturer's recommendations and meet U.S.P. standards;
(B) The drugs were originally dispensed by
				the pharmacist or pharmacy to the facility delineated in section (2);
(C) There is an established mechanism to
				trace the expiration date and the manufacturer's lot number of the drugs being
				returned;
(D) Only drug products
				dispensed by a licensed pharmacy utilizing one (1) of the following sources may
				be reused and no drug products for reuse shall be in any way subject to further
				repackaging:
1. Drug products in the original
				manufacturer's packaging that remains sealed in tamper-evident
				packaging;
2. Drug products
				repackaged by facilities that are federally registered as a repackager of
				medications and the packaging remains sealed in tamper-evident
				packaging;
3. Drug products that
				have been repackaged by a licensed pharmacy and are returned unused by the
				facility and remain sealed in tamper-evident packaging;
4. Drug products that have been repackaged by
				a licensed pharmacy and are provided in unit of use packaging whereby unused
				portions can be separated and reused without any further repackaging processes
				necessary on the returned product; and
(E) Any products that are accepted for return
				and can be reused based on standards provided in this rule shall be re-labeled
				to provide accurate information concerning patient and prescription
				information. Original lot numbers, expiration or beyond-use-dates assigned to a
				product that is reused by a pharmacy shall not be altered or in any way
				updated.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.010 - Drug Distributor Advisory Committee

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes operating guidelines
				  for the drug distributor advisory committee.
(1) As authorized in section 338.140.4.,
				RSMo, an advisory committee, composed of five (5) members, one (1) of whom
				shall be a representative of pharmacy, but who shall not be a member of the
				pharmacy board, three (3) of whom shall be representatives of wholesale drug
				distributors, as defined in section
				338.330, RSMo, and
				one (1) of whom shall be a representative of drug manufacturers, shall be
				appointed by the State Board of Pharmacy.
(2) Appointments to the advisory committee
				shall be made by the president of the board.
(A) Except for the initial committee
				appointments, each appointment shall be for a term of five (5) years. Beginning
				with the first committee appointments, the terms will be staggered so that one
				(1) term will expire each year after that.
(B) No appointment shall become effective
				until approved by the board. Each candidate shall meet with the board prior to
				any decision by the board to confirm. This meeting will be held in order for
				the board to review the candidate's credentials and to familiarize him/her with
				board personnel and advisory committee responsibilities.
(C) Terms of new committee members shall
				commence on July 1, unless the appointment is to fill an unexpired
				term.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.025 - Termination of Business as a Drug Distributor

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This establishes guidelines for the
				  termination of business as a drug distributor.
(1) A licensed drug distributor who plans to
				terminate business activities shall file a written notice with the State Board
				of Pharmacy. The written notice shall be submitted to the State Board of
				Pharmacy in person or by registered or certified mail within (15) days after
				the date of termination. This notice shall be made on a form provided by the
				board or in letter form from the license and shall include the following
				information:
(A) The name, address, license
				number and effective date of closure;
(B) The name, address and license number of
				the entity to which any of the stock/inventory will be transferred;
				and
(C) The name and address of the
				location to which records, required to be maintained by law, have been
				transferred;
1. Any records that are
				transferred to an unlicensed location must be retrievable for board review
				within seven (7) working days of a request made by an authorized official of
				the board;
2. Any records that are
				transferred to a licensed drug distributor or pharmacy must be maintained in
				accordance with record requirements as set forth in 4 CSR 220-5.030.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.030 - Definitions and Standards for Drug Wholesale and Pharmacy Distributors

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides standards for the proper
				  storage, maintenance, labeling and distribution of drugs by drug wholesale and
				  pharmacy distributors, and further defines methods of inspections and quality
				  assurance used by the Board of Pharmacy to ensure the public's safety in these
				  areas. For purposes of this rule, the term drug distributor will be used to
				  define all entities that are licensed under section
				  338.330, RSMo and are
				  subject to this rule.
(1)
				Drug distributors must maintain standards of practice that will ensure that
				only drugs of appropriate quality will be distributed to practitioners for
				further compounding and dispensing to the public. These standards shall be
				subject to periodic reviews through the board's inspection process.
(A) This process will include on-site
				inspections for drug distributors who are located in this state and may include
				border states or by requesting information on licensure and inspections
				conducted by other states or the federal government through the board
				office.
(B) For purposes of this
				rule, the term drug distributor, when used, defines anyone engaged in any
				activity as defined in section
				338.330,
				RSMo.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.040 - Drug Distributor Inspection Exemptions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines requirements for Board of
				  Pharmacy inspection exemption of wholesale drug and pharmacy
				  distributors.
(1) Inspections
				of drug distribution facilities shall be conducted by the board in accordance
				with the provisions as outlined in section
				338.360,
				RSMo. Any drug distributor facility which has been inspected by the Food and
				Drug Administration (FDA) over a period of less than two (2) years and
				candemonstrate that all inspections resulted in a satisfactory rating shall be
				exempt from further inspection by the board until and upon the time that any
				inspection of the premises of the facility results in a less than satisfactory
				rating or the last full inspection by the FDA is two (2) years old or greater.
(A) For purposes of this rule, the results of
				federal inspections that are deemed to be less than satisfactory shall include,
				but not be limited to, any documentation as to deficiencies in any drug
				distribution, repackaging, labeling, quality control or environmental policies
				or procedures, or both. Deficiencies may be defined as any statement which is a
				part of a compliance report recorded by federal inspection with or without
				sanctions, penalties, fines or discipline imposed.
1. For purposes of further definition, an
				inspection that is conducted by the FDA that is used for exemption purposes
				must be a full inspection of all operations and procedures of the facility.
				Abbreviated inspectional options as defined in federal policy guidelines may
				not be considered to fulfill the exemption requirements as provided in section
				338.360,
				RSMo and this rule.
2. Any drug
				distribution facility which has been granted an exemption from inspection must
				notify the board at any time of an inspection conducted by the FDA or the Drug
				Enforcement Administration that results in less than a satisfactory rating as
				defined in subsection (1)(A) of this rule.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.050 - Out-of-State Distributor License/Registration Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes guidelines for
				  license/registration procedures for out-of-state drug
				  distributors.
(1)
				Out-of-state wholesale drug distributors or out-of-state pharmacy distributors
				may be licensed, as required by sections 338.210- 338.370, RSMo, by reciprocity
				if they-
(A) Possess a valid license in good
				standing in the state or foreign jurisdiction in which they are located
				pursuant to legal standards comparable to those which must be met by a
				distributor of this state as prerequisites for obtaining a license under the
				laws of this state; and
(B) Are
				located in a state or foreign jurisdiction which extends reciprocal treatment
				under its own laws to a wholesale distributor of this state.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.060 - Controlled Substance Reporting

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines requirements for reporting
				  the distribution of controlled substances from drug and pharmacy distributors
				  to persons and facilities that are registered with the Federal Drug Enforcement
				  Administration.
(1) Wholesale
				drug and pharmacy distributors that distribute Schedule II products and
				Schedule III narcotics Automation of Reports and Consolidated Orders (ARCOS
				products) shall provide a listing of those products distributed within the
				state to the board on a quarterly basis when requested to do so by the board.
				In addition, wholesale drug and pharmacy distributors that distribute
				controlled substances within the state shall provide up to a twenty-four (24)
				month retrospective listing of all controlled substances (Schedule II through
				Schedule IV) distributed within the state or to a specific location to the
				board when requested to do so by the board. The board shall submit the request
				thirty (30) days in advance of the information requested. Reports must be
				submitted to the board either on hard copy in typewritten form or by electronic
				media. If electronic media is used in providing the reports, it shall be
				provided in one (1) of the following formats.
(A) If an electronic tape is used, it shall
				be an IBM 9-track, labeled or nonlabeled, 1600 or 6250 bits per inch
				(bpi);
(B) If a diskette is used,
				it shall be either a MacIntosh 400K or 800K; MS-DOS 5 1/4" 360K or 1.2 meg;
				MS-DOS 3 1/2" 720K or 1.44 meg; or an IBM 8" diskette; or
(C) If a cartridge is used, it shall be a
				1/2" tape, 3480 Compatible.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.070 - Standards of Operation for Medical Gas Distributors

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes standards of operation
				  for medical gas distributors. This proposed rule has been reviewed by the Drug
				  Distributor Advisory Committee as required by section 338.140.4,
				  RSMo.
(1) Medical gases are
				defined as compressed gases and liquid gases that a distributor or manufacturer
				has labeled for medical use in compliance with federal law.
(2) Medical gas distributor is defined as an
				entity which is licensed by the board as a drug distributor and is involved in
				the distribution of medical gases and related medical devices pursuant to a
				medical gas order to medical gas suppliers and other entities that are
				registered, licensed or permitted to use, administer or distribute medical
				gases.
(3) Medical gas distributors
				that are not involved in the storage or transfer of any other federal legend
				drugs and only store, transfer or transfill medical grade gas products other
				than nitrous oxide are exempt from the following regulation sections:
				20
				CSR 2220-5.030(3)(B); (3)(C)4., 9.,
				12., and 13.; (3)(E); and (3)(M)4. Medical gas distributors that store,
				transfer or transfill nitrous oxide are exempt from
				20
				CSR 2220-5.030(3)(B); (3)(C)4. and
				9.; (3)(E) and (3)(M)4. All other drug distributor requirements contained
				within the board's regulations shall be considered applicable to medical gas
				distributors.
(4) A medical gas
				distributor that is involved in the manufacture/transfilling of medical gases
				must register with the Food and Drug Administration (FDA) as a medical gas
				manufacturer and comply with the drug listing requirements of the federal act.
				In addition, all current good manufacturing practice requirements as set forth
				in 21 CFR 210 through 211 must be complied with.
*Original authority: 338.050, RSMo 1939, amended 1949,
					 1961, 1971, 1981; 338.333, RSMo 1989; 338.335, RSMo 1998; 338.337, RSMo 1989;
					 and 338.340, RSMo 1989.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 6 - Pharmaceutical Care Standards › Section 20 CSR 2220-6.030

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 338.280, RSMo 1951, amended 1971,
					 1981; 338.010, RSMo 1939, amended 1951, 1989, 1990; and 334.104.4. and 338.095,
					 RSMo 1993.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 6 - Pharmaceutical Care Standards › Section 20 CSR 2220-6.050 - Administration of Vaccines

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment implements 2023 legislative
				  revisions to section 338.010, RSMo, and establishes
				  pharmacist immunization procedures under revised section
				  338.010.1(4), 
				  RSMo.
PURPOSE: This rule establishes procedures for
				  pharmacists administering vaccines as authorized by section
				  338.010.1, RSMo.
(1) A Missouri licensed pharmacist may order
				and administer vaccines as authorized by section
				338.010.1, RSMo. Pharmacists
				must be competent to perform the services provided and maintain ongoing/
				continued competency. Except as otherwise authorized by law, for purposes of
				section 338.010.1(4),
				RSMo, pharmacists may administer reformulated
				or updated versions of vaccines authorized by the U.S. Food and Drug
				Administration (FDA) after January 1, 2023, provided the initial vaccine was
				approved by the FDA prior to January 1, 2023.
(A) Vaccines must be administered in
				accordance with current treatment guidelines established by the Centers for
				Disease Control (CDC) and the manufacturer's guidelines, provided CDC
				guidelines shall control in the event of a conflict. Vaccines may not be
				administered to persons under seven (7) years of age unless otherwise
				authorized by law.
(B) Pharmacists
				shall ensure compliance with all state and federal laws and regulations
				pertaining to Vaccine Information Statements and informed consent
				requirements.
(C) Vaccines must be
				stored in accordance with CDC guidelines/recommendations and within the
				manufacturer's labeled requirements, including, when vaccinating outside of a
				pharmacy.
(D) A pharmacist may only
				delegate vaccine administration to an intern pharmacist or qualified pharmacy
				technician who has met the qualifications of subsections (3)(B) and (C) of this
				rule and is working under the direct supervision of a pharmacist qualified to
				administer vaccines. Proof of an intern's or qualified pharmacy technician's
				compliance with subsections (3)(B) and (C) must be maintained by both the
				supervising pharmacist and the intern pharmacist/qualifying pharmacy technician
				for a minimum of two (2) years.
(E)
				For purposes of this rule, a "qualified pharmacy technician" is defined as a
				currently registered Missouri pharmacy technician who-
1. Holds an active pharmacy technician
				certification issued by a certification entity accredited by the National
				Commission for Certifying Agencies;
2. Has an initial and, if applicable, annual
				documented assessment of competency in vaccine administration; and
3. Has assisted in the practice of pharmacy
				as a registered/licensed pharmacy technician in the state of Missouri or
				another U.S. state or territory for a minimum of one (1) year.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 6 - Pharmaceutical Care Standards › Section 20 CSR 2220-6.055 - Non-Dispensing Activities

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment establishes requirements for
				  pharmacy technicians assisting pharmacists with non-dispensing activities
				  authorized by the rule outside of a Missouri licensed pharmacy.
(1) Pursuant to section
				338.220,
				RSMo, a pharmacist may perform the following non-dispensing activities outside
				of a licensed pharmacy:
(A) Patient
				counseling/education, as authorized by Missouri law, provided the pharmacist
				shall be obligated to comply with
				20 CSR
				2220-2.190, when applicable;
(B) Obtain patient
				history/information;
(C) Review
				patient records/medical histories;
(D) Patient assessment/evaluation, as
				authorized by Missouri law;
(E)
				Billing and insurance claim submissions/review;
(F) Drug utilization review;
(G) Assess health plan and medication
				eligibility/coverage;
(H) Pharmacy
				compliance audits/evaluations;
(I)
				Administer drugs, vaccines, or biologicals, as authorized by law and the rules
				of the board;
(J) Peer review/peer
				consultations;
(K) Review, select,
				and develop formularies or plan/practice guidelines;
(L) Review compliance with benefit
				guidelines;
(M) Manage inventory,
				including purchasing and ordering;
(N) Manage/review information
				systems;
(O) Patient medication
				review;
(P) Consultation with other
				health care professionals;
(Q)
				Patient referrals;
(R) Prescription
				orderentry/review, provided that a pharmacist shall only be authorized to
				accept a prescription on the premises of a Missouri licensed pharmacy, as
				required by section 338.095.5, RSMo; and
(S) Medication therapy management, pursuant
				to and as authorized by Chapter 338, RSMo, and the rules of the
				board.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 6 - Pharmaceutical Care Standards › Section 20 CSR 2220-6.070 - Certificate of Medication Therapeutic Plan Authority

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes procedures for
				  obtaining a certificate of medication therapeutic plan authority, as authorized
				  by section
				  338.010,
				  RSMo.
(1) A pharmacist shall
				obtain a certificate of medication therapeutic authority from the Missouri
				State Board of Pharmacy to provide medication therapy services that include
				initiating or implementing a modification of a patient's medication therapy or
				device usage. Pharmacists with a certificate of medication therapeutic
				authority shall enter into a written protocol with a Missouri-licensed
				physician that complies with the requirements of
				20 CSR
				2220-6.080, prior to performing medication therapy
				services.
(2) Applicants for
				certification shall hold an active Missouri pharmacist license. Applications
				shall be submitted on forms provided by the Missouri State Board of Pharmacy
				and shall be accompanied by the certificate of medication therapeutic plan
				authority fee and proof the applicant-
(A)
				Holds a doctor of pharmacy (PharmD) degree earned from a school, accredited by
				the Accreditation Council for Pharmacy Education (ACPE); or
(B) Has successfully completed a postgraduate
				medication therapy certificate course or program accredited or granted by the
				APCE, American Society of Health-System Pharmacists, American Society of
				Consultant Pharmacists, or the American Pharmacists Association; or
(C) Holds a current certification from the
				Board of Pharmaceutical Specialties, the Commission for Certification in
				Geriatric Pharmacy, or the National Certification Board for Diabetes Educators;
				or
(D) Has completed a
				post-graduate medication therapy certificate course that, at a minimum,
				included training in the following areas:
1.
				Assessing patient specific data and issues;
2. Establishing medication therapeutic goals
				or medication related action plans for identified medication conditions and
				medication related concerns;
3.
				Assessing and addressing adverse reactions and adverse drug events;
4. Modifying and monitoring medication
				regimens;
5. Improving patient care
				and outcomes through medication therapy services;
6. Evaluating treatment progress;
7. Assessing and monitoring pharma-cokinetic
				and pharmacodynamic changes in medication regimen reviews;
8. Medication reconciliation;
9. Drug utilization review;
10. Applicable state or federal
				law;
11. Formulating and
				documenting personal medication records;
12. Documenting clinical outcomes;
13. Interpreting, monitoring, ordering, and
				assessing patient test results; and
14. Patient education and
				counseling.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 6 - Pharmaceutical Care Standards › Section 20 CSR 2220-6.080 - Medication Therapy Services By Protocol

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes procedures for the
				  provision of medication therapy services by protocol, as authorized by section
				  338.010,
				  RSMo.
(1) Except as otherwise
				provided herein, a pharmacist who holds a certificate of medication therapeutic
				plan authority from the Missouri State Board of Pharmacy shall be authorized to
				provide medication therapy services in Missouri if the pharmacist-
(A) Holds a current Missouri pharmacist
				license that is not under discipline with the Missouri State Board of Pharmacy;
				and
(B) Has entered into a written
				protocol with a Missouri licensed physician that complies with the requirements
				of this rule.