reglab/statecodes huggingface dataset:
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 2220-6.100 - Pharmacy Standards for Dispensing Blood-Clotting Products

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule implements the provisions of section
				  338.400,
				  RSMo, and establishes pharmacy standards for dispensing blood-clotting
				  products.
(1) Definitions. The
				following definitions are hereby adopted and applicable to this rule:
(A) "Bleeding disorder," a medical condition
				characterized by a deficiency or absence of one (1) or more essential
				blood-clotting components in the human blood, including all forms of
				hemophilia, acquired hemophilia, von Willebrand's disease, and other bleeding
				disorders that result in uncontrollable bleeding or abnormal blood-clotting. As
				defined by section
				338.400,
				RSMo, "bleeding disorder" does not include a bleeding condition secondary to
				another medical condition or diagnosis, except for acquired
				hemophilia;
(B) "Blood-clotting
				product," a medicine approved for distribution by the federal Food and Drug
				Administration (FDA) that is used for the treatment and prevention of symptoms
				associated with bleeding disorders, including, but not limited to, recombinant
				and plasma derived factor products, von Willebrand factor products,
				antifibrinolytics, bypass products for patients with inhibitors, prothrombin
				complex concentrates, and activated pro-thrombin complex concentrates. Except
				as otherwise provided by section
				338.400,
				RSMo, a "blood-clotting product" does not include medical products approved
				solely for the treatment or prevention of side effects of a blood-clotting drug
				or medication;
(C) "Established
				patient," For purposes of section
				338.400,
				RSMo, and this rule, an "established patient" shall be defined as a bleeding
				disorder patient that has been dispensed a legend blood-clotting product by the
				pharmacy on more than three (3) occassions in a single calendar year;
				and
(D) "Pharmacy," an entity
				engaged in the practice of pharmacy as defined in section
				338.100,
				RSMo, that provides blood-clotting products and ancillary infusion equipment or
				supplies to patients with bleeding disorders.
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 2220-6.200 - Pharmacist Authority to Prescribe Pursuant to Section 338.665

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  pharmacists prescribing as authorized by section
				  338.665,
				  RSMo.
(1) Definitions.
(A) A nicotine replacement therapy product;
				as defined by section
				338.665,
				RSMo.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.010 - General Licensing Rules

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment modernizes rule language,
				  modifies the definition of an accredited pharmacy school/college, and revises
				  the timeframes for submitting a completed license application.
(1) Definitions.
(A) ACPE-Accreditation Council for Pharmacy
				Education.
(B) Accredited
				school/college of pharmacy-a school or college of pharmacy accredited by ACPE
				and located in a U.S. state or territory.
(C) Approved school/college of pharmacy-a
				Missouri school or college of pharmacy whose curriculum, physical equipment,
				course of instruction, and teaching personnel conform to ACPE standards and
				specifications and that has been recognized by the board as an approved
				school/college for pharmacy practice experience pursuant to
				20 CSR
				2220-7.027.
(D) Board-the Missouri State Board of
				Pharmacy.
(E) Foreign
				school/college-a school/college of pharmacy that is not located in the United
				States or a United States territory.
(F) MPJE-Multistate Pharmacy Jurisprudence
				Examination.
(G) NABP-National
				Association of Boards of Pharmacy.
(H) NAPLEX-North American Pharmacist
				Licensure Examination.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.025 - Intern Pharmacist Licensure

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment would remove the limit on the
				  number of intern pharmacist practice hours that may be earned per
				  week.
(1) The provisions of
				this rule shall be applicable to individuals seeking to earn pharmacy practice
				experience in Missouri.
(2)
				Requirements for Licensure. Every person who desires to gain pharmacy practice
				experience in Missouri shall first apply for an intern pharmacist license.
				Application for licensure shall be made on forms provided by the board and
				shall be accompanied by the application fee. To be eligible for licensure, the
				applicant shall submit proof of fingerprinting as required by
				20 CSR
				2220-7.090 and must be-
(A) Currently enrolled in or graduated from a
				school or college of pharmacy that is accredited by the Accreditation Council
				for Pharmacy Education (ACPE); or
(B) A graduate of an ACPE accredited school
				or college of pharmacy who is actively seeking to earn pharmacy practice
				experience to qualify for Missouri pharmacist licensure; or
(C) A graduate of a foreign school/college of
				pharmacy as defined by
				20 CSR
				2220-7.040 who has obtained Foreign Graduate
				Equivalency Certification from the National Association of Boards of Pharmacy
				and is actively seeking to earn pharmacy practice experience to qualify for
				Missouri licensure.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.027 - Approved Missouri Schools/Colleges of Pharmacy.

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule is being amended to clarify intern
				  pharmacist applicant requirements, establish limits for renewing an intern
				  pharmacist license, and recognize the board's discretion to limit the number of
				  hours earned at a special site or with a non-pharmacist
				  preceptor.
(1) Upon request,
				the board may approve a Missouri school/college of pharmacy for purposes of
				providing pharmacy practice experience to enrolled students. To be eligible for
				approval, the school/college of pharmacy must be located in Missouri and shall-
(A) Be accredited by the Accreditation
				Council for Pharmacy Education (ACPE) and comply with all applicable ACPE
				standards;
(B) Require as part of
				the school/college curriculum or training, a minimum of one thousand five
				hundred (1,500) hours of pharmacy practice experience in activities related to
				the practice of pharmacy as determined by the board or connected with
				pharmaceutical or patient-centered care through the interpretation and
				evaluation of prescription orders; the compounding, dispensing, and labeling of
				drugs and devices pursuant to prescription orders; the proper and safe storage
				of drugs and devices and the maintenance of proper records of them; the
				administration of immunizations; or consultation with patients and other health
				care practitioners about the safe and effective use of drugs and
				devices;
(C) Submit a list of all
				preceptors and sites that were used by the school/college curriculum for
				pharmacy practice experience within Page 834 Orders of Rulemaking the previous
				year. The list must be submitted to the board annually for review;
				and
(D) Submit the
				school's/college's policies and procedures for obtaining practice experience
				for board approval. The policies and procedures shall include
				policies/procedures for student training, approving sites/preceptors, and
				monitoring practice experience activities.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.030 - Pharmacist Licensure by Examination

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment modernizes rule language,
				  incorporates current application procedures from the National Association of
				  Boards of Pharmacy, and clarifies requirements/restrictions for taking and
				  passing the required licensure examinations.
(1) Examination Applications.
(A) Graduates of an accredited college/school
				of pharmacy may apply to the board for licensure as a Missouri pharmacist by
				examination. Applications shall be submitted on forms provided by the board
				with the examination application fee. The application must be notarized and
				include:
1. Satisfactory evidence that the
				applicant has graduated from an accredited school/college of pharmacy that
				meets the requirements of this rule;
2. Proof that the applicant has completed a
				state and federal criminal history background check, as required by
				20 CSR
				2220-7.090; and
3. Proof of one thousand five hundred (1,500)
				hours of pharmacy practice experience in activities related to the practice of
				pharmacy as approved by the board or connected with-
A. Patient-centered pharmaceutical care or
				pharmacist clinical services;
B.
				Evaluating or interpreting prescriptions or medication orders;
C. Compounding, dispensing, and labeling of
				drugs and devices;
D. The proper
				and safe storage of drugs and devices and appropriate record keeping for
				them;
E. Medication
				administration;
F. Medication
				therapy review/management; and
G.
				Consulting with patients and other health care practitioners about the safe and
				effective use of drugs and devices.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.040 - Foreign Graduates

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes licensure requirements
				  for pharmacist applicants who are graduates from a pharmacy school/college not
				  located in the United States or a United States territory.
(1) Definitions.
(A) Foreign school/college-For purposes of
				this rule, a foreign school/college shall be defined as a school/college of
				pharmacy that is not located in a United States (U.S.)
				state/territory.
(B) Preliminary
				evaluation application- The Application for Preliminary Evaluation of Foreign
				Pharmacy School Graduate provided by the board for graduates of a foreign
				school/college.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.050 - License Transfer/Reciprocity

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  applicants for pharmacist licensure by license
				  transfer/reciprocity.
(1) The
				provisions of this rule shall be applicable to applicants for pharmacist
				licensure that are currently registered or licensed as a pharmacist in another
				United States (U.S.) state/territory who desire to be licensed by reciprocity
				or license transfer.
(2) Foreign
				Graduates. Graduates of a school/college of pharmacy not located in a U.S.
				state/territory shall first comply with
				20 CSR
				2220-7.040.
(3) Individuals seeking licensure by license
				transfer/reciprocity shall first file a preliminary application for license
				transfer with the National Association of Boards of Pharmacy (NABP). Potential
				applicants shall pay all NABP required fees and comply with all applicable NABP
				requirements.
(A) After NABP's review of the
				preliminary application, NABP will forward the official application for license
				transfer/reciprocity to the applicant which shall be completed and filed with
				the board along with the application fee. The official application shall be
				notarized and shall be accompanied by proof of fingerprinting as required by
				20 CSR
				2220-7.090.
(B) The NABP official application shall be
				submitted to the board no more than three (3) months from the issue date of the
				official application as designated by NABP. If the official application is not
				submitted to the board within the required three (3) months, the applicant
				shall be required to apply to NABP for reevaluation of their application and
				for an extension of the NABP issuance date. Applicants shall complete all
				reevalua-tion/extension requirements and pay all applicable fees required by
				NABP.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.060 - Score Transfer

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines requirements for
				  transferring North American Pharmacist Licensure Examination scores to
				  Missouri.
(1) An applicant
				applying to take the North American Pharmacist Licensure Examination (NAPLEX)
				in another jurisdiction may have the score transferred to Missouri by
				completing the NAPLEX score transfer form supplied by the National Association
				of Boards of Pharmacy (NABP). To be eligible for score transfer, the applicant
				must have achieved a minimum passing score of seventy-five (75) on the NAPLEX.
				The applicant shall complete all required score transfer forms and pay any
				applicable fees as established by NABP.
(2) A score transfer applicant shall apply
				for and shall be required to comply with all applicable licensing/application
				requirements as otherwise established by Chapter 338, RSMo, and
				20 CSR
				2220-7.010 through
				20 CSR
				2220-7.090.
(3) A NAPLEX score transferred to Missouri
				shall only be deemed valid for a period of five (5) years.
*Original authority: 338.020, RSMo 1939, amended 1947,
					 1949, 1981, 1990; 338.040, RSMo 1939, amended 1961, 1969, 1981, 1990; 338.070,
					 RSMo 1939, amended 1947, 1953, 1961, 1969, 1981, 1985, 1997; 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 7 - Licensing › Section 20 CSR 2220-7.070 - Temporary Pharmacist License (Post-Graduate Training)

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  obtaining a temporary pharmacist license to practice pharmacy for pharmacists
				  completing post-graduate training programs.
(1) Applicants for Post-Graduate Training.
				Pursuant to section
				338.043,
				RSMo, a pharmacist licensed or registered in another state may apply for a
				temporary pharmacist license to complete a post-graduate pharmacy training
				program in the state of Missouri.
(2) Applicants for a temporary pharmacist
				license shall file an application on a form provided by the board with the
				application fee. The application will not be considered unless it is fully
				completed and properly attested. The application shall include:
(A) The name and signature of a
				Missouri-licensed pharmacist who will be supervising the applicant. The
				supervising pharmacist's license shall be active in Missouri and shall not be
				under discipline with the board;
(B) The name and address of all locations
				where the applicant will be practicing and a description of the applicant's
				proposed duties;
(C) A portrait
				photograph which measures two inches by two inches (2" x 2"); and
(D) A protocol which outlines the applicant's
				duties. At a minimum, the protocol shall define and include:
1. The type of practice to be performed and a
				specific job description of professional duties and functions to be
				completed;
2. The identity of the
				supervising pharmacist which includes a statement attesting to the ability and
				understanding of responsibilities involved;
3. A complete listing of all affiliations to
				be utilized during the licensure period; and
4. A complete listing of all locations where
				professional services will occur.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.075 - Temporary Pharmacist License for Non-Resident Military Spouses

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for
				  obtaining a temporary pharmacist license for non-resident military spouses as
				  authorized by section
				  324.008,
				  RSMo.
(1) A non-resident
				spouse of an active duty member of the Armed Forces of the United States who
				has been transferred or is scheduled to be transferred to the state of
				Missouri, is domiciled in the state of Missouri, or who has moved to the state
				of Missouri on a permanent change-of-station basis, may apply for a temporary
				Missouri pharmacist license to practice in this state. To be eligible for a
				temporary pharmacist license under this rule, the nonresident military spouse
				must meet the requirements of section
				324.008,
				RSMo. No application fee shall apply.
(2) Applicants for a temporary pharmacist
				license must file an application on a form provided by the board that includes:
(A) The applicant's name and
				address;
(B) The name and address
				of all locations where the applicant will be practicing, if known;
(C) A portrait photograph which measures two
				inches by two inches (2" x 2");
(D)
				Official verification from a state or territory of the United States showing
				that the applicant holds a current and active pharmacist license in the
				applicable state or territory;
(E)
				Evidence that the applicant meets the practice requirements of section
				324.008.3, RSMo; and
(F) An
				attestation that the temporary pharmacist agrees to comply with all state and
				federal laws applicable to the practice of pharmacy, including, but not limited
				to, Chapter 338, RSMo, the rules of the board and all controlled substance
				laws.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.080 - Pharmacist License Renewal and Continuing Pharmacy Education

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment eliminates the mandatory
				  delinquent fee and incorporates a graduated delinquent fee
				  schedule.
(1) All pharmacist
				licensees shall apply to renew their Missouri pharmacist license on or before
				October 31 of every even-numbered year. Applicants shall file a renewal
				application on a form provided by the board and pay the renewal fee. The
				renewal application must be completed correctly and in its entirety in order
				for it to be processed and the license renewed. Any portion of the application
				that is incomplete or inaccurate shall result in the rejection of the renewal
				application and require its return to the applicant for correction.
(A) No active pharmacist license will be
				renewed by the board unless the applicant has fulfilled the continuing
				education requirements as set forth in section
				338.060,
				RSMo, and the provisions of this rule. At the time of renewal, a licensee shall
				truthfully attest he/she has completed the continuing education requirements
				required by this rule. The attestation shall be submitted with the renewal
				application and shall truthfully affirm that the licensee has completed all
				continuing education requirements and that proof of continuing education
				completion has been maintained by the pharmacist as required by section (2) of
				this rule. The required continuing education must be completed by the date the
				renewal is signed or submitted to the board.
(B) A Missouri pharmacist license that has
				not been renewed by the board on or before October 31 of each even-numbered
				year shall be deemed expired. Upon expiration, the holder of an expired license
				shall be deemed no longer licensed and shall not practice pharmacy in the state
				of Missouri until the license has been renewed by the board. To renew an
				expired license, the holder shall file a renewal application with the board and
				shall pay all delinquent fees. A delinquent fee shall not be required if the
				renewal application was postmarked or submitted via the board's electronic
				renewal system on or before October 31 of each even-numbered year. Renewal
				applications received prior to October 31 that are returned to the applicant
				for correction will not be considered late and subject to the delinquent fee if
				the corrected application is returned to the board within thirty (30) days
				after receipt.
(C) Any person who
				fails to renew his/her pharmacist license within two (2) years of its
				expiration shall be treated in the same manner as a person who has never been
				licensed and shall be required to file a new pharmacist license application
				with the board.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 7 - Licensing › Section 20 CSR 2220-7.090 - Fingerprint Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes guidelines for the
				  submission of fingerprints by applicants.
(1) Applicants for licensure or registration
				required to provide fingerprints to the board shall include:
(A) All pharmacist applicants, including,
				applicants by examination, score transfer, reciprocity/transfer, and foreign
				graduates;
(B) Drug distributor
				license manager-in-charge (unless currently licensed as a pharmacist in the
				state of Missouri);
(C) Pharmacy
				technician applicants;
(D) Owners
				with a ten percent (10%) or more interest in a drug distributor applicant
				(non-publicly held companies only); and
(E) Intern pharmacist applicants.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.010 - Definitions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule adopts definitions for purposes of
				  20 CSR Chapter 8 governing drug outsourcers and third-party logistics
				  providers.
(1) Definitions.
				The following definitions are applicable to 20 CSR 2220 Chapter 8:
(A) "Drug outsourcer" or "Drug outsourcer
				facility"- An entity registered with the United States Food and Drug
				Administration pursuant to section 503(B) of the federal Food, Drug and
				Cosmetic Act, as amended by the Drug Quality and Security Act (21 section USC
				353b);
(B) "Drug related device"-An
				article that is not considered a prescription drug under federal law, but which
				meets the definition of a device as provided in 21 U.S.C. 321(h) and 21 U.S.C.
				360j(e);
(C) "Drug" or
				"Prescription drug"-A legend drug as defined by section
				338.330, RSMo;
				and
(D) "Third-party logistics
				provider" or "3PL"-An entity that provides or coordinates warehousing, or other
				logistics services of a prescription drug or drug-related device on behalf of a
				manufacturer, wholesale distributor, or dispenser of such a product, but does
				not take ownership of the product, nor has responsibility to direct the sale or
				disposition of the product. A third-party logistics provider license is
				required for entities conducting 3PL activities that are physically located in
				this state or shipping drug products into Missouri.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.020 - Licensing Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes licensing requirements
				  and procedures for drug outsourcers and third-party logistics
				  providers.
(1) No person or
				entity may act as a third-party logistics provider (3PL) or a drug outsourcer
				unless the person/entity has obtained the applicable 3PL or drug outsourcer
				license from the board. A separate license is required for each facility owned
				or operated as a 3PL or drug outsourcer.
(A)
				Applicants must submit a completed application to the board with the applicable
				fee along with the following information:
1.
				The name, full business address, e-mail address, and telephone number of the
				applicant and the facility where third-party logistics provider services or
				drug outsourcer activities will be provided, if different;
2. All trade or business names used by the
				licensee;
3. For 3PL applicants,
				the name, address, telephone number, and e-mail address of a manager-in-charge
				that meets the requirements of 20 CSR 2220-8.030 along with his/her employment
				history for the previous seven (7) years and a notarized manager-in-charge
				affidavit;
4. For drug outsourcer
				applicants, the name, address, telephone number, and e-mail address of a
				pharmacist responsible for supervising the facility who holds a current and
				active pharmacist license issued by a U.S. state or territory. If the
				designated pharmacist does not have a current and active Missouri pharmacist
				license, official verification must be submitted from the board of pharmacy or
				equivalent pharmacist governmental licensing agency verifying that the
				designated pharmacist holds a current and active pharmacist license issued by
				such state/territory;
5. The type
				of ownership or legal structure; and
6. The name(s) of the owner, operator, or
				both, of the licensed entity, including:
A.
				If a sole proprietorship, the full name of the sole proprietor and the name of
				the business entity. The sole proprietor must sign the application;
B. If a partnership or limited liability
				partnerships, the name of each partner and the name of the partnership. A
				partner or general partner must sign the application; or
C. If a corporation, the name of the
				corporate president, vice president, secretary, treasurer, chief executive
				officer, board of directors, and senior vice presidents, or their equivalents,
				the corporate name(s), and the name of the state of incorporation. An officer
				of the corporation must sign the application.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.030 - Nonresident Third-Party Logistics Providers/Drug Outsourcer Facilities

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes additional guidelines
				  for non-resident third-party logistics providers and drug outsourcer
				  applicants.
(1) Nonresident
				third-party logistics (3PL) providers or drug out-sourcer facilities may not
				act as a third-party logistics provider or a drug outsourcer or ship, mail, or
				deliver legend drugs, or for drug outsourcers, compounded drugs into Missouri
				without first obtaining the applicable license from the board. Nonresident
				third-party logistics providers or drug outsourcers may be licensed by
				reciprocity if they-
(A) Possess a valid 3PL
				or drug outsourcer license or an equivalent license that is in good standing in
				the state or foreign jurisdiction in which they are located that was issued
				pursuant to legal standards comparable to those which must be met by a Missouri
				third-party logistics provider or drug outsourcer; and
(B) Are located in a state or foreign
				jurisdiction which extends reciprocal treatment to a third-party logistics
				provider of this state or, for drug outsourcer applicants, a drug outsourcer of
				this state.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.040 - Standards of Operation (Drug Outsourcers)

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides standards of operation
				  for drug outsourcers licensed by the board.
(1) Drug outsourcers shall comply with all
				applicable state and federal laws governing drug outsourcing activities,
				including, but not limited to, controlled substance laws and the federal Food,
				Drug and Cosmetics Act, as amended by the Drug Quality and Security Act.
(A) Except as otherwise required by federal
				law, drug outsourcers must comply with all applicable current good
				manufacturing practices (cGMPs) required by federal law and the United States
				Food and Drug Administration.
(B) A
				separate Missouri drug distributor license is required if a drug outsourcer is
				engaged in any additional drug distribution activities as defined by Chapter
				338, RSMo, other than drug outsourcing. A pharmacy license is required if
				medication will be dispensed pursuant to a patient-specific
				prescription.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.045 - Standards of Operation (Third-Party Logistics Providers)

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule provides standards of operation
				  for third-party logistic providers licensed by the board.
(1) Third-party logistics providers (3PL)
				shall comply with all applicable state and federal law governing 3PL
				activities, controlled substances and drug distribution/handling, including,
				but not limited to, the federal Food, Drug and Cosmetics Act, as amended by the
				federal Drug Supply Chain Security Act ( 20 USC section 351 et seq).
(2) Manager-In-Charge. No third-party
				logistics provider license will be issued unless the facility is under the
				direct supervision of a man-ager-in-charge who has been designated with the
				board and who will be responsible for facility operations and ensuring
				compliance with state and federal law. The designated manager-in-charge must
				have appropriate education or experience to perform the duties assigned. At a
				minimum, the manager-in-charge must have at least two (2) years of
				education/experience in third-party logistics provider or drug distribution
				standards of operation or legal/compliance requirements. Education beyond a
				high school diploma or its equivalent may be used to meet these minimum
				requirements.
(A) 3PL activities must be
				conducted under the supervision of the designated manager-in-charge. The
				manager-in-charge must be actively involved and aware of the daily operations
				of the third-party logistics provider and must be physically present at the
				third-party logistics provider facility during normal business hours, except
				for absences due to illness, scheduled vacations, or other authorized absence.
				The manager-in-charge must ensure that policies and procedures governing the
				third-party logistics provider's operations are current and accurate.
(B) In the event the manager-in-charge
				designated with the board changes, the third-party logistics provider may not
				continue operations until a new manager-in-charge is named. A change of
				manag-er-in-charge application must be submitted to the board with the
				applicable fee within fifteen (15) calendar days after the new
				manag-er-in-charge is designated.
(C) In addition to the manager-in-charge, all
				individuals employed or engaged in third-party logistics operations must have
				sufficient education, training, or experience to perform the duties assigned. A
				list must be maintained of all managers or other individuals in charge of 3PL
				activities or drug distribution, storage and handling, and a description of the
				individual's duties.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.050 - Inspection Exemptions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines requirements for
				  inspection standards for drug outsourcers and third-party logistics providers
				  and standards for inspection exemptions for third-party logistic
				  providers.
(1) Board
				inspections of third-party logistics providers and drug out-sourcers will be
				conducted in accordance with Chapter 338, RSMo. At the discretion of the board,
				a third-party logistics provider facility that has been inspected by the United
				States Food and Drug Administration (FDA) within the previous two (2) years may
				be exempt from inspection by the board if the FDA inspection(s) resulted in a
				satisfactory rating. The FDA inspection must be a full inspection of all
				facility operations and procedures.
(2) The board may terminate an exemption
				under this section if deemed necessary or appropriate, if the last full FDA
				inspection is two (2) years old or greater or if any subsequent facility
				inspection by a state or federal entity results in less than a satisfactory
				rating.
(A) For purposes of this rule, a less
				than satisfactory rating includes, but is not limited to, any documented
				deficiency related to third-party logistic provider operations, drug
				distribution, repackaging, labeling, quality control, environmental
				policies/procedures, or controlled substances. Deficiencies include any
				statement that is a part of a federal compliance, inspection or observational
				report with or without sanctions, penalties, fines, or discipline
				imposed.
(B) Licensees granted an
				inspection exemption under this section shall notify the board if any
				inspection conducted by the FDA or the Drug Enforcement Administration results
				in less than a satisfactory rating as defined in subsection (2)(A).
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 8 - Third-Party Logistic Providers and Drug Outsourcer Facilities › Section 20 CSR 2220-8.060 - Termination of Business

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes guidelines for
				  terminating business as a third-party logistics provider or drug
				  outsourcer.
(1) A licensed
				third-party logistics provider or drug outsourcer must notify the board within
				fifteen (15) days after terminating business in Missouri. Notification must be
				in writing or on a form provided by the board and 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 where records required to be maintained by law will be
				transferred.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 1 - Organization and Description of Board › Section 20 CSR 2230-1.010 - General Organization

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule is being amended to update
				  information relating to the board.
(1) Whenever used in this division, the word
				board means the State Board of Podiatric Medicine.
(2) The State Board of Chiropody was created
				by an act of the 63rd General Assembly. The name of the State Board of
				Chiropody was changed to the State Board of Podiatry by an act of the 75th
				General Assembly. The name of the State Board of Podiatry was changed to the
				State Board of Podiatric Medicine by an act of the 88th General
				Assembly.
(3) The board consists of
				four (4) Missouri-licensed doctors of podiatric medicine and one (1) public
				member. The governor appoints the members of the board with the advice and
				consent of the senate, from nominees submitted by the director of the Division
				of Professional Registration. The term of office of each member is four (4)
				years.
(4) The board is authorized
				by section
				330.140,
				RSMo to adopt rules necessary to administer and enforce the provisions of
				Chapter 330, RSMo.
(5) The board
				has superintending control over the practice of podiatric medicine within this
				state. The board's primary duties consist of:
(A) Examining and licensing
				applicants;
(B) Approving colleges
				of podiatric medicine;
(C)
				Approving continuing education programs;
(D) Issuing temporary licenses for
				internship/residencies; and
(E)
				Disciplining licenses of doctors found guilty of violating the provisions of
				Chapter 330, RSMo.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 1 - Organization and Description of Board › Section 20 CSR 2230-1.020 - Board Member Compensation

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule fixes the compensation for the
				  members of the State Board of Podiatric Medicine in compliance with the
				  mandates of section 330.110.1, RSMo.
(1) Each member of the State Board of
				Podiatric Medicine shall receive the sum of seventy dollars ($70) as
				compensation for each day that member devotes to the affairs of the
				board.
(2) In addition to the
				compensation fixed herein, each member is entitled to reimbursement of his/her
				expenses necessarily incurred in the discharge of his/her official
				duties.
(3) No request for
				compensation provided herein shall be processed for payment unless sufficient
				funds are available for that purpose within the appropriations for this
				board.
*Original authority: 330.110, RSMo 1945, amended 1965,
					 1980, 1981, 1988, 1995, 1999, 2005 and 330.140, RSMo 1945, amended 1981, 1993,
					 1995, 1998.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 1 - Organization and Description of Board › Section 20 CSR 2230-1.030 - Definitions

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines terms used in 20 CSR
				  2230.
(1) Board-whenever used
				in these rules, unless stated otherwise, the term board means the State Board
				of Podiatric Medicine in the state of Missouri.
(2) Certificate of Registration-as referred
				to in Chapter 330, RSMo and these rules means license to practice podiatric
				medicine in the state of Missouri.
(3) Postgraduate clinical residency-a formal,
				structured postgraduate training program of at least twelve (12) months which
				is approved by the Council on Podiatric Medical Education of the American
				Podiatric Medical Association. Postgraduate clinical residency programs must be
				sponsored by and conducted in an institution such as a hospital, or conducted
				by a college of podiatric medicine accredited by the Council on Podiatric
				Medical Education of the American Podiatric Medical Association.
(4) Missouri Law Examination-Missouri Law
				Examination covers knowledge of Chapter 330, RSMo and the rules governing the
				practice of podiatric medicine in the state of Missouri.
(5) National Board Examination-Part 1, Part
				2, Part 3 (formally known as the Podiatric Medical Licensing Examination for
				States, PMLexis) developed and administered by the National Board of Podiatric
				Medical Examiners (NBPME), or designee of the board.
(6) Reporting period for continuing medical
				education requirements-the twenty-four (24)-month period immediately preceding
				the biennial licensure renewal date, which is February 28 of each even-numbered
				year.
*Original authority: 330.010, RSMo 1939, amended 1945,
					 1961, 1969, 1976, 1995, 1998, 2005; 330.040, RSMo 1939, amended 1981, 2005;
					 330.050, 1945, amended 1981, 2005; 330.070, RSMo 1945, amended 1947, 1971,
					 1981, 1999, 2005; and 330.140, RSMo 1945, amended 1981, 1993, 1995,
					 1998.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 2 - General Rules › Section 20 CSR 2230-2.015 - Military Training to Meet Requirements for Licensure

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule requires the board to accept
				  evidence of military education, training, or service to be applied toward the
				  requirements for licensure.
(1) Any applicant for licensure may, as part
				of the evidence of meeting the requisite educational and/or training
				requirements for licensure, submit evidence of military experience as a member
				of the military.
(2) The board
				shall review the evidence submitted and, if appropriate, make additional
				inquiry of the applicant to determine the scope and duties of the military
				experience to determine whether the military experience shall be counted
				towards the qualifications for licensure.
(3) In its review of the military experience,
				the board shall evaluate the content and nature of the military experience to
				determine whether that military experience shall count towards the education,
				training, or service requirements for licensure. The board shall construe
				liberally the military experience in determining whether it will count towards
				the education, training, or service requirements for licensure.
(4) "Military experience" shall mean
				education, training, or service completed by an applicant while a member of the
				United States armed forces or reserves, the national guard of any state, the
				military reserves of any state, or the naval militia of any state.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 2 - General Rules › Section 20 CSR 2230-2.020 - Professional Conduct Rules

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule ensures that licensed podiatrists
				  and their affiliated firms are registered correctly with the secretary of state
				  and with the State Board of Podiatric Medicine and also ensures that a licensee
				  with this board files a list of assumed trade names or any other names the
				  licensee shall use, other than what is registered with the
				  board.
(1) The practice of
				podiatric medicine under a trade name or assumed name is prohibited, unless the
				trade name or assumed name is properly registered with the secretary of state
				pursuant to the provisions of sections 417.200-417.230, RSMo, or
				otherwise.
(2) Every person
				licensed to engage in the practice of podiatric medicine in this state shall
				file with the board a list of assumed names, trade names, or any names other
				than the name under which a license to practice has been issued by the board,
				that is used in his or her practice, before using such name.
(3) A person engaged in the practice of
				podiatric medicine under any assumed name, trade name, or any name other than
				the name under which a license to practice has been issued by the board, shall
				immediately disclose to any person, upon request and without condition, the
				licensed name of each and every person involved in the practice of podiatric
				medicine under the assumed name, trade name, or any other name.
(4) A person engaged in the practice of
				podiatric medicine shall require any subordinate to immediately disclose to any
				person, upon request and without condition, the licensed name of each and every
				person involved in the practice of podiatric medicine under an assumed name,
				trade name, or any other name.
*Original authority: 330.140, RSMo 1945, amended 1981,
					 1993, 1995, 1998 and 330.160, RSMo 1939, amended 1951, 1981, 1999,
					 2005.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 2 - General Rules › Section 20 CSR 2230-2.021 - Advertising Regulation

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets forth the content and methods
				  that podiatrists who are licensed by the State Board of Podiatric Medicine
				  shall follow if they advertise their services to the public in
				  Missouri.
(1) Nothing in
				these rules shall be construed as allowing any advertisement or solicitation
				which is false, misleading or deceptive. Any advertisement or solicitation
				which is false, misleading or deceptive is prohibited.
(2) Any podiatrist whose office or practice
				is the subject of any advertisement or solicitation is responsible for the form
				and content of that advertisement or solicitation.
(3) Definitions. The following words and
				terms when used in this rule shall have the following meaning:
(A) Advertisement shall mean any attempt,
				directly or indirectly, by publication, dissemination or circulation in print,
				or electronic media which, directly or indirectly, induces or attempts to
				induce any person or entity to purchase or enter into an agreement to purchase
				services, treatment or related goods from a podiatrist;
(B) Electronic media shall include radio,
				television, email and Internet;
(C)
				Print media shall include, but not be limited to, newspapers, magazines,
				periodicals, professional journals, telephone directories, circulars,
				handbills, flyers, billboards, signs, matchcovers, Internet, email, and other
				items, documents or comparable publications, the content of which is
				disseminated by means of the printed word;
(D) Range of fees shall refer to an expressly
				stated upper and lower limit on the fees charged for services or goods offered
				by a podiatrist; and
(E)
				Solicitation shall mean any conduct other than that which has been defined as
				advertising which occurs outside the podiatrist's office and which, directly or
				indirectly, induces or attempts to induce any person or entity to purchase or
				enter into an agreement to purchase services, treatment or related goods from a
				podiatrist.
Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2230 - State Board of Podiatric Medicine › Chapter 2 - General Rules › Section 20 CSR 2230-2.022 - Podiatric Titles

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule clarifies that no person other
				  than a licensed podiatrist may use the podiatric medical titles defined in this
				  rule.
(1) Only persons who
				hold a license to practice podiatric medicine in this state may use the words
				podiatric medicine, podiatry, podiatric, podiatrist, foot specialist, chiropody
				or chiropodist, or variations of these words in connection with his/her
				practice. Any person who holds a license to practice podiatric medicine in this
				state may also use the abbreviation DPM in connection with his/her practice. No
				other person shall assume any title or use any abbreviation or other words
				including, but not limited to, the words and abbreviation listed in this rule,
				letters, signs or devices to indicate the person using the same is a licensed
				podiatrist.
*Original authority: 330.140, RSMo 1945, amended 1981,
					 1993, 1995, 1998 and 330.200, RSMo 1939, amended
					 1981.