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 2220-2.083 - Electronic Record-Keeping Systems

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The purpose of this rule is to establish
				  requirements and guidelines for maintaining prescription hard copies in an
				  electronic record-keeping system.
(1) In lieu of maintaining the original
				prescription hard copy or a hard copy representation as required by
				20 CSR
				2220-2.018 or
				20 CSR
				2220-2.080, a pharmacy shall be authorized to maintain
				an exact digitized image of the prescription in an electronic record-keeping
				system (ERS). For purposes of this rule, an electronic record-keeping system is
				defined as a system maintained by the pharmacy that provides input, storage,
				processing, communications, output, and control functions for digitized images
				of original prescriptions. Any alterations to the digitized original
				prescription shall be documented as required by
				20 CSR
				2220-2.018 or
				20 CSR
				2220-2.080, as applicable.
(2) Controlled substance hard copy
				prescriptions shall be maintained as required by applicable state and federal
				law.
(3) Digitized prescription
				images shall be readily retrievable by the pharmacy. Readily retrievable shall
				be defined as providing records immediately or within two (2) hours of a
				request of the inspector or by making a computer terminal available to the
				inspector for immediate use. An ERS system shall be capable of printing and
				retrieving the digitized prescription image at the time of inspection,
				including the reverse side of the prescription if applicable. Any printout of a
				digitized prescription image provided by a licensee/registrant to the patient
				or the patient's representative shall be conspicuously marked with the
				statement "Copy Only - Not Valid for Dispensing Purposes."
(4) Pharmacies maintaining an ERS shall
				establish written policies and procedures for the use of the ERS which shall
				include policies and procedures for reviewing compliance with the requirements
				of this rule and for storing, retrieving, and recovering digitized images. The
				policy and procedure manual shall be reviewed annually and shall be available
				to representatives of the board upon request.
(5) All digitized images in the ERS shall be
				stored, copied, or saved onto secure storage media on a regular basis in a
				manner that will allow image recovery in the event of a disaster, system
				interruption, or system failure.
*Original authority: 338.100, RSMo 1939, amended 1971,
					 1990, 1997, 1999, 2010 and 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011
					 .
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 2220-2.085 - Electronic Prescriptions and Medication Orders

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates and clarifies
				  requirements for electronic prescriptions.
PURPOSE: This rule establishes guidelines for
				  electronic prescriptions and medication orders.
(1) Definitions.
(A) Electronic image transmission-An exact
				visual image of a paper prescription or medication order that is electronically
				received by a pharmacy from a licensed prescriber or the prescriber's
				authorized agent (e.g., a facsimile/scan).
(B) Electronic prescription-Any prescription or
				medication order, other than an electronic image transmission , which is
				electronically transmitted from a licensed prescriber or the prescriber's
				authorized agent to a pharmacy.
(C) Electronic signature An exact electronic replica
				of the prescriber's signature or a confidential digital key code, number, or
				other identifier attached to or logically associated with a record that is
				executed or adopted by a prescriber with the intent to sign the
				record.
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 2220-2.090 - Pharmacist-in-Charge

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates compliance
				  requirements and responsibilities for the designated pharmacist-in-charge of a
				  board licensed pharmacy.
(1)
				Except as otherwise authorized by law, each pharmacy shall designate a
				pharmacist-in-charge who is responsible for managing pharmacy compliance and
				supervising pharmacy staff. At a minimum, the pharmacist-in-charge shall assist
				the permit holder in ensuring pharmacy operations and clinical activities
				comply with the rules of the board and all applicable state and federal law
				governing pharmacy practice.
(A) The
				pharmacist-in-charge must be regularly involved in, and engaged with, pharmacy
				operations and monitoring pharmacy compliance. Except in the event of an
				emergency or other urgent need, the pharmacist-in-charge must be consulted and
				given an opportunity to provide input prior to implementation of any pharmacy
				policy, procedure, system, or practice that will modify or expand the delivery
				of pharmacy services.
(B) The
				pharmacist-in-charge must be physically present at the pharmacy for a
				sufficient amount of time as needed to effectively supervise pharmacy
				activities and ensure pharmacy compliance. Additionally, the permit holder must
				provide the pharmacist-in-charge designated time to review pharmacy compliance
				on a regular basis while not engaged in medication dispensing or providing
				patient services.
(C) The
				pharmacist-in-charge must have authority to temporarily suspend or restrict
				pharmacy operations or the activity of licensees/registrants, if deemed
				reasonably necessary or appropriate to ensure pharmacy compliance or the safe
				provision of pharmacy services, pending final direction or approval from the
				permit holder.
(D) The permit
				holder must have policies and procedures in place for regularly reviewing
				staffing and resource needs with the pharmacist-in-charge, including policies
				and procedures for requesting additional staff or staffing
				modifications.
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 2220-2.095 - Resource Eligibility Standards for Title XIX Under the Poverty Level

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The purpose of this rule is to authorize
				  pharmacies to collect medication for purposes of destruction and to establish
				  requirements for medication collection programs.
(1) Missouri licensed pharmacies may collect
				medication from the public for destruction in compliance with this rule.
				Pharmacies collecting controlled substances shall comply with all applicable
				state and federal controlled substance laws. Pharmacies collecting non-
				controlled substances shall comply with sections (2) to (9) of this rule.
				Participation in a medication return or destruction program is voluntary. This
				rule shall not be construed to require that a licensee or permit holder
				participate in or establish a return/destruction program.
(2) Definitions. The following definitions
				shall apply for purposes of this rule:
(A)
				"Mail"- Mail shall include mailing via the United States Postal Service or
				shipping via a common carrier; and
(B) "Nonretrievable"- For the purposes of
				destruction, a condition or state to which medication is rendered after
				undergoing a process that permanently alters the medication's physical
				condition or state through irreversible means and thereby renders the
				medication unavailable and unusable for all practical purposes.
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 2220-2.110 - PRN Refills

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule clarifies the board's requirements
				  for refills as needed so that the practicing pharmacists in Missouri will have
				  adequate guidelines in this area.
(1) A pharmacist shall not fill or refill any
				prescription which was written more than one (1) year before being presented to
				the pharmacist, unless the pharmacist consults with the prescriber and
				confirms-
(A) That the person for whom the
				drugs or medicines were prescribed is still under the prescriber's care or
				treatment;
(B) That the prescriber
				desires for the person to continue receiving the drugs or medicines;
				or
(C) If the prescriber answers
				negatively in either case listed in subsection (1)(A) or (B), the pharmacist
				shall not fill or refill the prescription, even if the prescription authorizes
				refills as needed (PRN).
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 2220-2.120 - Transfer of Prescription or Medication Order Information

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment would grant board licensees
				  additional time to fulfill prescription transfer requests received from
				  parties/entities other than the patient, provided the transfer is completed in
				  timely manner and a pharmacist ensures no interruption in patient therapy will
				  occur.
(1) Prescription
				information shall be transferred for the purposes of refill between licensed
				pharmacies, provided the prescription information to be transferred meets all
				of the following criteria:
(A) The
				prescription information indicates authorization by the prescriber for
				refilling;
(B) The drug on the
				prescription information is not a Schedule II controlled substance;
(C) The number of lawfully allowable refills
				has not been exceeded or the maximum allowable time limit has not been
				exceeded;
(D) If the transfer
				involves a controlled substance, all information must be transferred directly
				between two (2) licensed pharmacists; and
(E) The transfer of original prescription
				information for a controlled substance listed in Schedules III, IV or V for the
				purpose of refill dispensing is permissible between pharmacies on a one
				(1)-time basis only. However, pharmacies electronically sharing a realtime,
				online database may transfer up to the maximum refills permitted by law and the
				prescriber's authorization.
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 2220-2.130 - Drug Repackaging

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for drug
				  repackaging.
PUBLISHER'S NOTE: The secretary of state has
				  determined that the publication of the entire text of the material which is
				  incorporated by reference as a portion of this rule would be unduly cumbersome
				  or expensive. Therefore, the material which is so incorporated is on file with
				  the agency who filed this rule, and with the Office of the Secretary of State.
				  Any interested person may view this material at either agency's headquarters or
				  the same will be made available at the Office of the Secretary of State at a
				  cost not to exceed actual cost of copy reproduction. The entire text of the
				  rule is printed here. This note refers only to the incorporated by reference
				  material.
(1) A pharmacist or
				pharmacy may prepackage drugs for other than immediate dispensing purposes
				provided that the following conditions are met:
(A) Only products which will be directly
				provided to the patient may be prepackaged;
(B) Containers utilized for prepackaging
				shall meet, as a minimum requirement, that of Class B container standards as
				referenced by the
United States Pharmacopoeia
(USP), which has
				been incorporated herein by reference. Where applicable, light sensitive
				containers shall be used;
(C) The
				maximum expiration date allowed for prepacked drugs shall be the manufacturer's
				expiration date or twelve (12) months, whichever is less; and
(D) Any prepacked drug must have a label
				affixed to it which contains, at a minimum, the name and strength of the drug,
				the name of the manufacturer or distributor, an expiration date as defined in
				subsection (1)(C) and lot number. Pharmacies that store drugs within an
				automated counting device may, in place of the required label, maintain records
				for lot numbers and expiration dates that are required on the label as long as
				it is fully traceable and is readily retrievable during an
				inspection.
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 2220-2.140 - Prescription Services by Pharmacists/Pharmacies for Residents in Long-Term Care Facilities

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes standards for
				  pharmacists providing prescription services to residents in long-term care
				  facilities. The standards are directed to licensed pharmacists and pharmacies,
				  and not to long-term care facilities.
PUBLISHER'S NOTE: The secretary of state has
				  determined that the publication of the entire text of the material which is
				  incorporated by reference as a portion of this rule would be unduly cumbersome
				  or expensive. Therefore, the material which is so incorporated is on file with
				  the agency who filed this rule, and with the Office of the Secretary of State.
				  Any interested person may view this material at either agency's headquarters or
				  the same will be made available at the Office of the Secretary of State at a
				  cost not to exceed actual cost of copy reproduction. The entire text of the
				  rule is printed here. This note refers only to the incorporated by reference
				  material.
(1) Licensure. A
				pharmacist who or pharmacy which provides prescription services to a long-term
				care facility must be licensed to practice pharmacy in this state. A long-term
				care facility means a nursing home, retirement care, mental care or other
				facility or institution which provides extended health care to resident
				patients.
(2) Medication Services.
(A) Policies and procedures shall be
				formulated to cover all packaging and dispensing responsibilities of the
				pharmacist/pharmacy to the residents of the long-term care facility and shall
				include, at a minimum:
1. Methods used to
				dispense medications in a timely fashion to the facility;
2. Proper notification to the facility when a
				medication is not readily available;
3. Proper labeling requirements to meet the
				needs of the facility and which are consistent with state and federal laws;
				and
4. Appropriate medication
				destruction, return of unused medication, or both, which is consistent with
				state and federal laws.
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 2220-2.145 - Minimum Standards for Multi-Med Dispensing

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment would expand the authorized
				  beyond-use date for patient med paks and would authorize inclusion of
				  controlled substances as allowed by state and federal controlled substance
				  laws.
(1) In lieu of
				dispensing two (2) or more prescribed drug products in separate containers, a
				pharmacist may, with the consent of the patient, the patient's caregiver, or a
				prescriber, provide a customized patient medication package (patient med
				pak).
(2) A patient med pak is a
				package prepared by a pharmacist for a specific patient comprising one (1) or
				more containers and containing two (2) or more prescribed solid oral dosage
				forms. The patient med pak is so designed or each container is so labeled as to
				indicate the day and time, or period of time, that the contents within each
				container are to be taken.
(A) The patient med
				pak shall bear a label stating-
1. The name of
				the patient;
2. A serial number for
				the patient med pak itself and a separate identifying serial number for each of
				the prescription orders for each of the drug products contained
				therein;
3. The name, strength,
				physical description or identification and total quantity of each drug product
				contained therein;
4. The
				directions for use and cautionary statements if any, contained in the
				prescription order for each drug product therein;
5. Any storage instructions or cautionary
				statements required by the official compendia;
6. The name of the prescriber of each drug
				product;
7. The date of preparation
				of the patient med pak and the beyond-use date assigned to the patient med pak
				(such beyond-use date shall be not later than ninety (90) days from the date of
				preparation);
8. The name, address,
				and telephone number of the dispenser; and
9. Any other information, statements, or
				warnings required for any of the drug products.
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 2220-2.150 - Mandatory Reporting Rule

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.
(1) Reports to the
				board from a hospital or ambulatory surgical center concerning any disciplinary
				action against a licensed pharmacist or the voluntary resignation of any
				licensed pharmacist against whom any complaints or reports have been made which
				might have led to final disciplinary action shall comply with section
				383.133,
				RSMo and this rule and include at a minimum:
(A) The name, address and telephone number of
				the person making the report;
(B)
				The name, address and telephone number of the person who is the subject of the
				report;
(C) A brief description of
				the facts which gave rise to the issuance of the report, including the dates of
				occurrence deemed to necessitate the filing of the report;
(D) If court action is involved and known to
				the reporting agent, the identity of the court, including the date of filing
				and the docket number of the action;
(E) A statement as to what final action was
				taken by the institution; and
(F)
				That the report is being submitted in order to comply with the reporting
				provisions of Chapter 383, RSMo.
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 2220-2.160 - Definition of Disciplinary Actions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines disciplinary actions which
				  may be imposed by the Missouri Board of Pharmacy.
(1) The Missouri Board of Pharmacy may
				publish or cause to be published all disciplines of certificates of
				registration or licenses or both, including the name of the licensee, the
				license number, the terms of discipline and a summary of the Findings of Fact
				and Conclusions of Law of the Administrative Hearing Commission, in any
				professional journal or newsletter read by licensed pharmacists practicing in
				Missouri or in any newspaper of general circulation or both.
(2) The Missouri Board of Pharmacy may
				publicize the terms of disciplinary agreements, including the name of the
				licensee, the license number and a summary of the complaint, in any
				professional journal or newsletter read by licensed pharmacists practicing in
				Missouri or in any newspaper of general circulation.
(3) Any licensee whose certificate of
				registration, license to practice pharmacy, or both, has been revoked or
				suspended shall-
(A) Surrender his/her
				certificate of registration or license, or both, to the Missouri Board of
				Pharmacy to be held by the Missouri Board of Pharmacy for the duration of the
				suspension period;
(B) Refrain from
				misrepresenting the status of his/her license to practice pharmacy to any
				patient or to the general public; and
(C) Refrain from maintaining a physical
				presence in any location which is licensed as a pharmacy in Missouri during the
				period of suspension, except as a customer.
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 2220-2.165 - Licensure Disciplinary Agreements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes guidelines to be used
				  by the board for licensure disciplinary agreements.
(1) The board may elect to enter into an
				agreement for discipline with the holder of a pharmacist or pharmacy license
				for the purpose of informally resolving a complaint which the board has
				prepared.
(2) The use of licensure
				disciplinary agreements shall be subject to the following:
(A) Agreements of this type will be used at
				the option of the board and shall not bar the board from filing any complaints
				with the Administrative Hearing Commission in order to seek disciplinary action
				for any violation of Chapter 338, RSMo;
(B) All licensure disciplinary agreements
				shall contain a public notice clause which provides that the board will publish
				the licensing action in its quarterly newsletter and shall treat the
				information contained in the agreement as public information;
(C) When entering into a licensure
				disciplinary agreement, the board and the licensee shall waive any rights
				attendant to a hearing before the Administrative Hearing Commission and will
				consent that the licensure disciplinary agreement is in lieu of proceedings
				before the Administrative Hearing Commission; and
(D) If the board determines that a licensee
				has violated a term or condition of the agreement, or has otherwise failed to
				comply with the provisions of Chapter 338, RSMo, which violation would be
				actionable in a proceeding before the State Board of Pharmacy, the
				Administrative Hearing Commission, or in a circuit court, the board may elect
				to pursue any lawful remedies or procedures afforded to it.
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 2220-2.170 - Procedure for Impaired Pharmacist

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes an efficient and
				  timely process for the disposition of information and tentative board action
				  concerning impaired pharmacists to the attorney general's office for purposes
				  of preparing a complaint and streamlines the procedure utilized in interviewing
				  pharmacists who are chemically impaired.
(1) The executive director shall receive
				information concerning the impairment of licensees and coordinate any
				investigations that seek to substantiate information concerning a possible
				impairment.
(2) Investigations by
				board inspectors or division investigators concerning chemically impaired
				licensees will be collected and reviewed by the executive director. Cases will
				be divided into two (2) categories.
(A)
				Category A. Chemically impaired licensees where additional information is
				evident that known distribution of controlled substances or legend drugs to
				other individuals has taken place.
(B) Category B. Chemical impairment of a
				licensee where controlled substances, legend drugs or alcohol have been
				acquired for personal use only.
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 2220-2.175 - Well-Being Program

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates requirements for the
				  Well-Being Committee providers and Well-Being Committee
				  participants.
(1)
				Definitions.
(A) Board-State Board of
				Pharmacy.
(B) Impairment-An
				illness, substance abuse, or physical or mental condition suffered by a
				licensee that is reasonably related to the ability to practice
				pharmacy.
(C) Licensee-Pharmacist,
				intern pharmacist, or technician licensed or registered in the state of
				Missouri or who has applied for licensure or registration in the state of
				Missouri.
(D) Well-Being
				Committee-The committee established pursuant to section
				338.380, RSMo, authorized to
				create, operate, and maintain the Well-Being Program.
(E) Well-Being Program- The program operated by the
				Well-Being Committee for purposes of early identification, intervention,
				treatment, and rehabilitation of pharmacists, intern pharmacists, and pharmacy
				technicians who may be impaired by reasons of illness, substance abuse, or as a
				result of any physical or mental condition.
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 2220-2.180 - Public Records

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)
				All public records of the State Board of Pharmacy will be open for inspection
				and copying by any member of the general public during normal business hours,
				holidays excepted, except for those records closed pursuant to section
				610.021,
				RSMo. All public meetings of the Board of Pharmacy not closed pursuant to the
				provisions of section
				610.021,
				RSMo will be open to any member of the public.
(2) The Board of Pharmacy establishes the
				executive director of the board as the custodian of its records as required by
				section
				610.023,
				RSMo. The executive director is responsible for the maintenance of the board's
				records and is responsible for responding to requests for access to public
				records.
(3) When a request for
				inspection of public records is made and the individual inspecting the records
				requests copies of the records, the board will collect the appropriate fee for
				costs for inspecting and copying of the records, as outlined in the board's fee
				rule, 20 CSR 2220-4.100. The board may require payment of the fees prior to
				making available any public records.
(4) Written requests for access to records
				and responses to the requests will be maintained by the board as a public
				record for two (2) years. Such records will be open for inspection by any
				member of the general public during regular business hours, as required by
				state law.
*Original authority: 338.140, RSMo 1939, amended 1981, 1989
					 and 338.280, RSMo 1951, amended 1971, 1981. For Chapters 610 and 620, please
					 consult the Missouri Revised Statutes.
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 2220-2.190 - Patient Counseling

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes minimum standards for
				  patient counseling to comply with the federal Omnibus Budget Reconciliation Act
				  of 1990 which requires that all states establish standards by January 1,
				  1993.
(1) Upon receipt of a
				prescription drug order and following a review of the available patient
				information, a pharmacist or his/her designee shall personally offer to discuss
				matters which will enhance or optimize drug therapy with each patient or
				caregiver of each patient. Counseling shall be conducted by the pharmacist or a
				pharmacy extern under the pharmacist's immediate supervision to allow the
				patient to safely and appropriately utilize the medication so that maximum
				therapeutic outcomes can be obtained. If the patient or care-giver is not
				available, then a written offer to counsel with a telephone number of the
				dispensing pharmacy at no cost to the patient must be supplied with the
				medication so that the patient or caregiver may contact the pharmacist for
				counseling when necessary. In situations where automated pick-up systems are
				used for providing refill prescriptions to patients, the offer to counsel may
				be provided within the information provided by the kiosk to the patient during
				the processing phase prior to release of the medication to the patient. The
				elements of counseling shall include matters which the pharmacist deems
				significant in the exercise of his/her professional judgment and is consistent
				with applicable state laws.
(2)
				Pharmacies shall maintain appropriate patient information to facilitate
				counseling. This may include, but shall not be limited to, the patient's name,
				address, telephone number, age, gender, clinical information, disease states,
				allergies and a listing of other drugs prescribed.
(3) Alternative forms of patient information
				shall be used to supplement patient counseling when appropriate. Examples may
				include, but shall not be limited to, written information leaflets, pictogram
				labels, video programs, and the like.
(4) Patient counseling, as described in this
				rule, shall not be required for inpatients of a hospital, institution or other
				setting where other licensed or certified health care professionals are
				authorized to administer medications.
(5) A pharmacist shall not be required to
				counsel a patient or caregiver when the patient or caregiver refuses
				consultation.
*Original authority: 338.140, RSMo 1939, amended 1981,
					 1989, 1997 and 338.280, RSMo 1951, amended 1971, 1981
					 .
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 2220-2.195 - Prospective Drug Utilization Review

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  prospective drug utilization review prior to dispensing a prescription or
				  medication order.
(1)
				Prospective Drug Review.
(A) Prior to
				dispensing or otherwise approving medication for patient use, pharmacists shall
				use their professional judgment to review available patient records to assess
				therapeutic appropriateness.
(B)
				The pharmacist shall take appropriate steps within their professional judgment
				to address or resolve identified therapeutic appropriateness issues.
				Prospective drug review may only be performed by a pharmacist or an intern
				pharmacist working under the supervision of a Missouri licensed
				pharmacist.
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 2220-2.300 - Record Confidentiality and Disclosure

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
				  authorize disclosure of confidential records as allowed by state and federal
				  law.
(1) Prescription
				records, physician orders and other records related to any patient care or
				medical condition(s) of a patient that are maintained by a pharmacy in
				accordance with section
				338.100,
				RSMo shall be considered confidential. Adequate security shall be maintained
				over such records in order to prevent any indiscriminate or unauthorized use of
				any written, electronic or verbal communications of confidential
				information.
(2) Confidential
				records may only be released to-
(A) The
				patient;
(B) A health care provider
				involved in treatment activities of the patient;
(C) Lawful requests from a court or grand
				jury;
(D) A person authorized by a
				court order;
(E) Any other person
				or entity authorized by a patient to receive such information;
(F) For the transfer of medical or
				prescription information between pharmacists as provided by law;
(G) Government agencies acting within the
				scope of their statutory authority; or
(H) A person or entity to whom such
				information may be disclosed under 45 CFR Parts 160, 164 and 165 (the Privacy
				Standards of the Health Insurance Portability and Accountability Act of 1996)
				or other applicable state/federal law.
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 2220-2.410 - Class B Hospital Pharmacy Compounding for Drug Shortages

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for Class
				  B hospital pharmacies compounding medication in the event of a drug
				  shortage.
(1) Class B
				hospital pharmacies may compound and provide medications that are in shortage
				to patients without a patient-specific prescription, provided-
(A) The pharmacy has confirmed and documented
				the product is not available despite due diligence;
(B) The medication is compounded for
				administration to patients in a hospital clinic or facility or in another
				hospital that is under common control, management, or ownership of the same
				hospital or hospital system, as defined by section
				338.165, RSMo;
(C) The preparation compounded is the same
				dosage form and strength that is in shortage;
(D) The quantity distributed at one time does
				not exceed the amount needed to meet the anticipated healthcare practitioner
				need for seven (7) days based on the hospital's or hospital clinic's/facility's
				usage;
(E) The pharmacy must stop
				compounding and distribution once the product is available;
(F) The pharmacy must label the preparation
				container with-
1. Pharmacy name, address, and
				telephone number;
2. Date of
				distribution;
3. Preparation name,
				strength, dosage form, and quantity;
4. Name of each active or therapeutic
				ingredient included in the preparation;
5. Preparation lot/batch number;
6. Preparation beyond-use date; and
7. Statement: "Pharmacy Compounded
				Preparation";
(G) The
				pharmacy maintains a record of the distribution that is readily available on
				request of the board or the board's authorized designee and can be retrieved by
				specific hospital or hospital clinic or facility, if requested;
(H) In lieu of recording an identifying
				prescription number or a readily retrievable unique identifier, the hospital or
				hospital clinic or facility name must be recorded on the compounding
				log;
(I) The pharmacy must comply
				with all applicable provisions of
				20 CSR
				2220-2.400. A Class H license and compliance with
				20 CSR
				2220-2.200 is required for any sterile preparation;
				and
(J) The pharmacy complies with
				all applicable controlled substance laws and regulations.
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 2220-2.425 - Required Pharmacy Reporting

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The purpose of this rule is to establish
				  requirements for reporting compounding information to the Missouri Board of
				  Pharmacy to ensure compliance with state and federal law.
(1) Pharmacies located in Missouri that have
				distributed or dispensed compounded human drug preparations/products pursuant
				to prescriptions or medication orders in the previous calendar year, shall
				annually report the following information on a form provided by the board:
(A) The number of prescriptions or medication
				orders for compounded human drug preparations/products that the pharmacy
				distributed or dispensed interstate during the previous calendar
				year;
(B) The number of
				prescriptions or medication orders for compounded human drug
				preparations/products that the pharmacy dispensed (or caused to be dispensed)
				from the facility in which the drug preparations/products were compounded
				during the previous calendar year (e.g., not picked up on-site by the patient
				or the patient's designee);
(C) The
				number of prescription or medication orders for compounded human drug
				preparations/products dispensed on-site at the pharmacy during the previous
				calendar year (e.g., picked up by the patient or the patient's
				designee);
(D) The sum of the
				figures from subsections (1)(B) and (1)(C) above; and
(E) The quotient from dividing the figure in
				subsection (1)(A) by the figure from subsection (1)(D).
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 2220-2.650 - Standards of Operation for a Class J: Shared Services Pharmacy

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates licensing and
				  policy/procedure requirements for Class J Shared Services
				  pharmacies.
(1) Class J
				Shared Services. A Class J Shared Services permit is required if two (2) or
				more pharmacies are engaged in, or have an arrangement to provide, functions
				related to the practice of pharmacy for or on behalf of the other pharmacy.
				These functions may include, but are not limited to, prescription/order
				receipt, prescription/order clarification or modification, obtaining prescriber
				authorization, data entry, compounding, dispensing, pharmacist verification,
				patient counseling, patient profile maintenance, medication therapy services,
				medication administration, drug utilization review (DUR), and obtaining refill
				authorization. All pharmacies participating in the shared services arrangement
				must have a Class J permit.
(A) Pharmacies may
				perform Class J Shared Services provided the parties-
1. Have the same owner or have a written
				contract outlining the services to be provided and the responsibilities of each
				party in fulfilling the terms of said contract in compliance with federal and
				state laws and regulations;
2.
				Maintain a separate Class J classification for each location involved in
				providing shared services; and
3.
				Either share a common database or have access to each pharmacy's prescription
				records and patient profiles and records, as needed to safely and properly
				perform the shared services activities.
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 2220-2.675 - Standards of Operation/Licensure for Class L Veterinary Pharmacies

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines standards for a Class L
				  veterinary pharmacy.
(1) A
				Class A or a Class L pharmacy permit shall be required for any entity engaged
				in the sale, dispensing, or filling of a legend drug for use in animals that
				must only be dispensed by prescription under state or federal law. For purposes
				of this rule, a legend drug shall be defined as provided by 21 USC section
				353.
(2) Class A Pharmacies. Class
				A permit holders shall comply with all laws/rules applicable to Class A
				pharmacies, provided a Class A pharmacy shall comply with sections (7) and (8)
				of this rule when legend drugs are dispensed for animal use.
(3) Class L Pharmacies. A Class L pharmacy
				shall dispense, sell, or provide legend drugs only for animal use. Except as
				otherwise provided in this rule, a Class L pharmacy shall comply with all
				applicable state and federal pharmacy and controlled substance laws/rules
				including, but not limited to, all applicable provisions of Chapter 338, RSMo,
				and the rules of the board.
(4)
				Pharmacy Operations. A Class L pharmacy shall comply with
				20 CSR
				2220-2.010, with the following allowed modifications:
(A) The pharmacy permit shall be displayed in
				plain view at the pharmacy location;
(B) The pharmacy shall maintain sufficient
				space, equipment, and storage capabilities as necessary to carry out its
				operations;
(C) Legend drugs shall
				be properly identified and stored in a defined area within the
				pharmacy;
(D) Legend drugs shall be
				stored in a clean and sanitary designated area and within temperature
				requirements as provided for by the manufacturer or the latest edition of the
				United States Pharmacopoeia (USP);
(E) The pharmacy shall maintain a current
				reference manual related to veterinary drugs that complies with
				20 CSR
				2220-2.010(1)(D);
(F) Appropriate sewage disposal must be
				available within the pharmacy and a hot and cold water supply shall be
				accessible to pharmacy staff. If compounding is performed, the hot and cold
				water supply shall be located within the pharmacy;
(G) Pharmacy compounding shall comply with
				20 CSR
				2220-2.200,
				20 CSR
				2220-2.400, and all other applicable provisions of
				state/federal law;
(H) All
				dispensing errors shall be documented in the pharmacy's records;
(I) Animals shall not be allowed in the
				designated area where legend drugs are stored or maintained; and
(J) The pharmacist-in-charge shall be
				notified within twenty-four (24) hours after a dispensing error is learned by
				pharmacy staff. Documentation of notification shall be maintained in the
				pharmacy's prescription records.
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 2220-2.680 - Class R-Remote Dispensing Site Pharmacy

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines licensing requirements and
				  compliance standards for Class-R Remote Dispensing Site
				  pharmacies.
(1) Definitions.
(A) "Community Mental Health Center"-A
				community mental health center as defined by
				42
				CFR section 410.2, section 205.975, RSMo, or
				the Missouri Department of Mental Health.
(B) "Federally qualified health center"- A
				federally qualified health center as defined by
				42
				U.S.C. section
				1396d(l)(2)(B), as
				amended.
(C) "Intern Pharmacist"-An
				individual who holds a current and active Missouri intern pharmacist license
				and has completed employer approved training in the activities to be performed
				at the Class R pharmacy and has an initial and annual documented assessment of
				competency.
(D) "Outpatient
				Clinic"-A facility where healthcare services are provided by a licensed
				healthcare provider on the facility's premises to patients who are not
				hospitalized or admitted to the outpatient clinic for greater than twenty-three
				(23) hours.
(E) "Qualified Pharmacy
				Technician"-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 completed employer approved training
				in the activities to be performed at the Class R pharmacy and has an initial
				and annual documented assessment of competency; and
3. Has assisted in the practice of pharmacy
				as a registered pharmacy technician in the state of Missouri for a minimum of
				one (1) year.
(F)
				"Remote Dispensing Site Pharmacy"-Any location in this state where the practice
				of pharmacy occurs that is staffed by one (1) or more qualified pharmacy
				technicians or intern pharmacists whose activities are supervised by a
				pharmacist at a supervising pharmacy that is under common ownership through a
				continuous real-time audio and video link. A remote dispensing site pharmacy
				does not include a dispensing prescriber's office or an automated
				device.
(G) "Retail Pharmacy"-A
				pharmacy licensed by the board that is open to, and offers pharmacy services
				to, the general public.
(H) "Rural
				Health Clinic"- A rural health clinic as defined by the federal Rural Health
				Clinic Services Act, PL. 95-210, as amended.
(I) "Supervising pharmacy"-A Missouri
				licensed pharmacy located in this state or approved by the board that oversees
				the dispensing activities of a Class R pharmacy.
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 2220-2.685 - Standards of Operation for a Class Q: Charitable Pharmacy

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment establishes licensure
				  exemptions for pharmacies engaged in sharing services with a Class Q Charitable
				  Pharmacy.
(1) Definitions.
(A) "Charitable organization"-An organization
				qualified as a charitable organization pursuant to section 501(c)(3) of the
				Internal Revenue Code.
(B)
				"Charitable pharmacy"-A site in Missouri that is owned or operated by a
				charitable organization for purposes of providing pharmacy services to
				appropriately screened and qualified indigent patients. Class Q pharmacies may
				only provide services to or for qualified indigent patients.
(C) "Health care entity"-A hospital owned by
				the State of Missouri or any entity or organization that is licensed or
				certified by the state or federal government as a hospital, hospice facility,
				ambulatory surgical center, nursing home, long-term care facility, residential
				care facility, skilled nursing facility, mental/behavioral health care
				facility, or a habilitation center as defined by Chapter 630, RSMo, and that is
				required to maintain patient records by state or federal law.
(D) "Qualified indigent patient"-A patient of
				a charitable pharmacy that has been screened and approved by a charitable
				organization and deemed not to have sufficient funds to obtain needed
				medication based on the charitable organization's pre-established
				criteria.
(E) "Qualified intern
				pharmacist"-A currently licensed Missouri intern pharmacist who has completed
				employer approved training in the activities to be performed at a Class Q
				pharmacy and has an initial and, if applicable, annual documented assessment of
				competency.
(F) "Qualified pharmacy
				technician"-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 completed employer approved training
				in the activities to be performed at a Class Q pharmacy and has an initial and,
				if applicable, annual documented assessment of competency; and
3. Has assisted in the practice of pharmacy
				as a registered pharmacy technician in the state of Missouri for a minimum of
				one (1) year.