reglab/statecodes huggingface dataset:
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 30 - Determination of Blood Alcohol by Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine › Section 19 CSR 25-30.050 - Approved Breath Analyzers

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment removes two instruments that
				  are no longer used for evidential testing in Missouri.
(1) Approved breath analyzers are-
NAME OR ITEM
MANUFACTURER OR SUPPLIER
Alco-Sensor IV with printer, Intox EC/IR II,
							 and
Intoximeters, Inc.
Intox DMT
Intoxilyzer, Model 8000
CMI/MPH, Operations of MPD, Inc.
(2)
				Breath analyzers are to be used within buildings or vehicles used for
				driving-while-intoxicated enforcement. These breath analyzers are not approved
				for mobile use in boats or in outside areas.
(3) Maintenance checks and breath tests
				performed on previously approved breath analyzers prior to the effective date
				of this rule shall be considered valid under this rule if such tests were
				completed in compliance with the rules in effect at the time the test was
				conducted.
*Original authority: 192.006, RSMo 1993, amended 1995;
					 306.114, RSMo 1993, amended 2004, 2005, 2008; 306.117, RSMo 1993, amended 2005,
					 2008; 577.020, RSMo 1977, amended 1982, 1983, 1996, 1998, 2001, 2006; 577.026,
					 RSMo 1982; and 577.037, RSMo 1982, amended 1983, 1988, 1993, 1996, 2001.
Eckhoff v. Director of Revenue
, 745 S.W.2d 815
					 (Mo. App. 1988);
Director of Revenue v. Martin
, 752 S.W.2d 453
					 (Mo. App. 1988). For purpose of breath analysis tests, the procedural
					 components of these tests include the testing techniques and methods, the
					 qualifications of the person administering the tests, and the nature and
					 description of the equipment and devices to be used. The designation of
					 approved suppliers of test ampoules for breathalyzer test was procedural only
					 and would be applied retrospectively.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 30 - Determination of Blood Alcohol by Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine › Section 19 CSR 25-30.051 - Breath Analyzer Calibration and Accuracy Verification Standards

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment further defines the required
				  certification of breath alcohol simulators, the reporting of simulator
				  certification on maintenance checks, adds a new supplier of compressed gas
				  mixtures, and removes a reference to restrictions that only applied to
				  instruments no longer used for evidential breath alcohol testing in
				  Missouri.
(1) Standards used
				for the purpose of verifying and calibrating breath analyzers shall consist of
				standard simulator solutions or compressed ethanol-gas standard
				mixtures.
(2) Standard simulator
				solutions, used to verify and calibrate evidential breath analyzers, shall be
				solutions from approved suppliers. The standard simulator solutions used shall
				have a vapor concentration within five percent (5%) of the following values:
(A) 0.10%;
(B) 0.08%; or
(C) 0.04%.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 30 - Determination of Blood Alcohol by Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine › Section 19 CSR 25-30.070 - Approval of Methods for the Analysis of Blood, Saliva, and Urine for the Determination of Blood Alcohol Content or the Presence of Drugs

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment combines two similar rules
				  and updates the statutory references and analytical methodologies that are now
				  applicable.
PURPOSE: This rule establishes the methods and
				  analytical principles approved for the determination of blood alcohol content
				  or the presence of drugs from samples of blood, urine, or
				  saliva.
(1) Samples of blood,
				saliva, or urine shall be collected in accordance with the provisions of
				sections 577.001-577.041, RSMo, and a sufficient volume of sample shall be
				collected to provide for duplicate testing.
(2) The laboratory in which these analyses
				are performed shall have a director who shall assume full responsibility for
				the accuracy of tests and reports.
(3) An individual shall have a valid Type I
				permit in order to perform analyses of blood, saliva, and urine for the
				presence of drugs.
(4) Methods
				based on the following analytical principles are approved for the determination
				of blood alcohol content from a sample of blood, saliva, or urine:
(A) Chromatography, in liquid or vapor
				phase;
(B)
				Spectrophotometry;
(C) Colorimetry;
				or
(D) The quantitative
				determination of the reduction of dichro-mate in acid solution by
				ethanol.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 30 - Determination of Blood Alcohol by Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine › Section 19 CSR 25-30.080

Current through Register Vol. 49, No. 14, July 15, 2024
*Original authority: 192.006, RSMo 1993, amended 1995;
					 306.114, RSMo 1993, amended 2004, 2005, 2008; 306.117, RSMo 1993, amended 2005,
					 2008; 577.020, RSMo 1977, amended 1982, 1983, 1996, 1998, 2001, 2006; 577.026,
					 RSMo 1982; and 577.037, RSMo 1982, amended 1983, 1988, 1993, 1996,
					 2001.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 33 - Laboratories for Serologic Tests for Human Immunodeficiency Virus Antibodies › Section 19 CSR 25-33.010 - Approval of Laboratories for the Performance of Serologic Tests for Human Immunodeficiency Virus Antibodies

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes the procedures and
				  requirements for laboratories performing serologic tests on serum or plasma for
				  detection of antibodies to Human Immunodeficiency Virus in order to be approved
				  to conduct HIV tests by the Department of Health.
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) The director of
				a laboratory seeking Department of Health and Senior Services (DHSS) approval
				to perform serologic tests for detection of the Human Immunodeficiency Virus
				(HIV) antibodies shall make written application on form Lab 125, which is
				incorporated by reference, to the director, State Public Health Laboratory,
				DHSS.
(A) Hospitals licensed according to
				Chapter 197, RSMo shall be considered to be in compliance with departmental
				rules governing serologic tests for detection of HIV antibodies.
(B) In addition to applying for approval, the
				laboratory shall be in compliance with the Clinical Laboratory Improvement
				Amendments of 1988 (CLIA 88). A copy of the currently valid CLIA certificate
				shall be initially submitted to the director, State Public Health Laboratory,
				DHSS to obtain DHSS approval.
(C)
				All laboratory testing shall be conducted at the address given when application
				for the approval is made. Written notice of change of address shall be given to
				DHSS prior to actually moving the testing facilities.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 34 - Laboratories for Serologic Tests for Syphilis › Section 19 CSR 25-34.010 - Approval of Laboratories for the Performance of Serologic Tests for Syphilis on Prenatal Blood

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule deletes the requirement that test
				  procedures for syphilis must be from the manual of tests for syphilis and
				  allows for serologic testing by any method approved by the federal Food &
				  Drug Administration (FDA) through compliance with CLIA 88
				  regulations.
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) The director of
				a laboratory seeking Department of Health and Senior Services (DHSS) approval
				to perform serologic tests for syphilis on prenatal blood specimens shall make
				written application on form Lab 126, which is incorporated by reference, to the
				director, State Public Health Laboratory, DHSS.
(A) In addition to applying for approval, the
				laboratory shall be in compliance with the Clinical Laboratory Improvement
				Amendments of 1988 (CLIA 88). A copy of the currently valid CLIA certificate
				shall be initially submitted to the director, State Public Health Laboratory,
				DHSS to obtain DHSS approval.
(B)
				All laboratory testing shall be conducted at the address given when application
				for the approval is made. Written notice of change of address shall be given to
				the DHSS prior to actually moving the testing facilities.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 35 - Laboratories for Serologic Tests for Hepatitis B › Section 19 CSR 25-35.010 - Approval of Laboratories for the Performance of Serologic Tests for Hepatitis B on Prenatal Blood

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes uniform requirements
				  for all laboratory approvals relating serologic tests for Hepatitis B prenatal
				  blood.
(1) For a laboratory
				to be approved by the Missouri Department of Health to perform serologic tests
				for Hepatitis B on prenatal blood specimens, the laboratory shall have a
				current valid registration certificate showing compliance with the Clinical
				Laboratory Improvement Amendment of 1988 (CLIA 88).
*Original authority: 192.006.1., RSMo (1993); 192.020, RSMo
					 (1939), amended 1945, 1951; and 210.030, RSMo (1941), amended 1986,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 36 - Testing for Metabolic Diseases › Section 19 CSR 25-36.010 - Testing for Metabolic and Genetic Disorders

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment makes grammatical changes,
				  clarifies wording for consistency, and increases the fee ceiling for the
				  specimen screening.
(1) As
				used in this rule-
(A) Newborn screening
				means the testing of infants for metabolic and genetic disorders pursuant to
				sections
				191.331,
				191.332,
				and
				191.333,
				RSMo;
(B) Parent information sheet
				means the top sheet of the newborn screening specimen form that is to be
				detached and handed to the infant's parent or guardian at the time of specimen
				collection which explains the parent's or guardian's options and process for
				opting out of the specimen storage and/or release for anonymous research
				pursuant to section
				191.317,
				RSMo;
(C) Specimen storage means
				the five (5) year storage of the leftover newborn screening specimens at the
				Missouri State Public Health Laboratory after testing has been conducted
				pursuant to section
				191.317,
				RSMo; and
(D) Submitter(s) means a
				person or persons responsible for collecting specimens under section
				191.331,
				RSMo, for newborn screening tests.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 38 - Laboratory Fees › Section 19 CSR 25-38.010 - Laboratory Handling Fees

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes a charge for handling
				  samples and specimens submitted for testing to the State Public Health
				  Laboratory and defines those samples or specimens that are not subject to the
				  handling fee.
(1) There shall
				be a charge of ten dollars ($10) for each sample or specimen submitted to the
				State Public Health Laboratory upon which one (1) test or a series of tests are
				performed, except as otherwise provided in section (2) of this rule.
(2) The following samples or specimens
				submitted to the State Public Health Laboratory are not subject to the handling
				fee:
(A) As determined by the director of the
				Department of Health, samples or specimens that are submitted for testing which
				is of vital importance to the public health;
(B) Samples or specimens for test which are
				part of an epidemiologic investigation, study or ongoing Department of Health
				disease surveillance program;
(C)
				Samples or specimens submitted by authorized representatives of the Department
				of Health, local health departments or the federal government;
(D) Samples or specimens submitted as part of
				a contract or grant of which the Department of Health is a party;
(E) Specimens submitted for metabolic disease
				screening;
(F) Specimens submitted
				from other laboratories in Missouri for further testing and confirmation;
				and
(G) Specimens from patients who
				are unable to pay the handling fee as certified in writing by their
				physician.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 25 - Missouri State Public Health Laboratory › Chapter 38 - Laboratory Fees › Section 19 CSR 25-38.020 - Laboratory Fee for Tuberculosis Testing

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes a fee for testing
				  specimens for tuberculosis that are submitted to the State Public Health
				  Laboratory.
(1) A fee of
				forty-eight dollars ($48) shall be charged for each clinical specimen submitted
				to the State Public Health Laboratory for tuberculosis testing. Clinical
				specimens include raw sputum samples, gastric lavage samples, urine specimens
				or pleural, spinal, and joint fluids, other exudates or tissue
				samples.
(2) The Department of
				Health and Senior Services (DHSS) may waive the fee for testing clinical
				specimens that are submitted from local public health departments or when the
				director of DHSS determines the specimens are of critical importance for the
				protection of the public health and safety.
*Original authority: 701.322, RSMo 1993, amended
					 2001.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.004 - List of Excepted Substances

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The Department of Health is authorized to
				  except by rule any compound, mixture or preparation containing any stimulant or
				  depressant substance if one or more active medicinal ingredients not having a
				  stimulant or depressant effect on the central nervous system is included to
				  negate the potential for abuse. The compounds, mixtures and preparations
				  excluded are listed in this rule.
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) Excepted
				Stimulant or Depressant Compounds-Exempt Prescription Products. The listed
				drugs in dosage unit form and any other drug of the quantitative composition
				shown in Part 1300 to end of Title 21, the
Code of Federal
				Regulations
, April 1998 or which is the same except that it contains a
				lesser quantity of controlled substances or other substances which do not have
				a stimulant, depressant or hallucinogenic effect and which are restricted by
				law to dispensing or prescription, are excepted from the provisions of sections
				195.030,
				195.040,
				195.050
				and 195.100, RSMo as provided for in section 195.017.6(5) and .8(3), RSMo. The
				rules of the Drug Enforcement Administration, 21 CFR Part 1300 to the end of
				Title 21, are hereby incorporated by reference and made a part of this
				rule.
(2) Excepted Chemical
				Preparations- Exempt Chemical Preparations. The listed preparations in unit
				form and any other preparation of the quantitative composition shown in Part
				1300 to end of Title 21, the
Code of Federal Regulations
,
				April 1998 which is the same except that it contains a lesser quantity of
				controlled substances or other substances which do not have a stimulant,
				depressant or hallucinogenic effect are excepted from the provisions of
				sections
				195.030,
				195.040,
				195.050
				and 195.110, RSMo as provided for in section 195.017.6(5) and .8(3), RSMo. The
				rules of the Drug Enforcement Administration, 21 CFR Part 1300 to the end of
				Title 21, are hereby incorporated by reference and made a part of this
				rule.
*Original authority: 195.195, RSMo 1957, amended 1971,
					 1989, 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.008 - List of Excluded Veterinary Anabolic Steroid Implant Products

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule maintains a list of veterinary
				  anabolic steroid products excluded from
				  19 CSR
				  30-1.002(1)(C) 5. in conformance with
				  federal law.
(1) The
				following products containing an anabolic steroid that are expressly intended
				for administration through implants to cattle or other nonhuman species and
				which have been approved by the Secretary of Health and Human Services for such
				administration and are excluded from all schedules pursuant to section
				195.017.5, RSMo.
Trade Name
Company
NDC or DIN No.
(A) Component E-H
Vetlife, Inc., Norcross, GA
021641-002
(B) Component E-H
Elanco, Scarborough, ON
01968327
(C) Component TE-S Vetlife, Inc., Norcross, GA
021641-004
(D) Component T-H
Vetlife, Inc., Norcross, GA
021641-006
(E) Component T-S
Vetlife, Inc., Norcross, GA
021641-005
(F) F-TO
Animal Health, Upjohn Internationa Kalamazoo, MI
00093351 l,
(G) Finaplix-H
Hoechst Roussel Vet, Somerville, NJ
12799-807-10
(H) Finaplix-S
Hoechst Roussel Vet, Somerville, NJ
12799-807-07
(I) Heifer-oid
Anchor Division, Boehringer Ingelheim, St. Joseph, MO
(J) Heifer-oid
Bio-Ceutic Division Boehringer Ingelheim, St. Joseph, MO
(K) Heifer-oid
Ivy Laboratories, Inc., Overland Park, KS
(L) Implus-H
The Upjohn Co., Kalamazoo, MI
0009-0434-01
(M) Implus-H
Upjohn Co., Animal Health Division, Orangeville, ON
06-0434-01 01968327
(N) Revalor-G
Hoechst Roussel Vet, Somerville, NJ
12799-811
(O) Revalor-H
Hoechst Roussel Vet, Somerville, NJ
12799-810
(P) Revalor-S
Hoechst Roussel Vet, Somerville, NJ
12799-809
(Q) Synovex H
Fort Dodge Labs, Fort Dodge, IA
0856-3901
(R) Synovex H
Syntex Laboratories, Palo Alto, CA
(S) Synovex Plus
Fort Dodge Labs, Fort Dodge, IA
0856-3904
*Original authority: 195.017, RSMo 1971, amended 1987,
					 1989, 1994, 1996, 1997, 1998 and 195.195, RSMo 1957, amended 1971, 1989,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.010 - Schedules of Controlled Substances

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.013 - Miscellaneous Fees

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes and fixes certain fees
				  and charges statutorily authorized to be made by the Department of Health in
				  provisions codified in Chapters 195 and 610, RSMo.
(1) Fees for copies of public records or
				other documents:
(A) Copy, per page
$0.25
(B) Research fee, per hour
$15.00
(2)
				Payment of fee may be required in advance.
(3) Fees are nonrefundable.
*Original authority: 195.030, RSMo 1939, amended 1971,
					 1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, amended 1971, 1989,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.015 - Registrations and Fees

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment changes the method for paying
				  registration fees by requiring applicants to pay registration fees by credit
				  card rather than in the form of personal, certified, or cashier's
				  checks.
(1) For each
				registration or re-registration to-
(A)
				Manufacture controlled substances, the registrant shall pay a fee of sixty-six
				dollars ($66);
(B) Distribute
				controlled substances, the registrant shall pay a fee of sixty-six dollars
				($66);
(C) Dispense controlled
				substances listed in Schedules II-V including dispensing of controlled
				substances by individual practitioners in training programs or to conduct
				research or instructional activities with those substances, the registrant
				shall pay a fee of thirty dollars ($30);
(D) Conduct research or instructional
				activities with a controlled substance listed in Schedule I, the registrant
				shall pay a fee of thirty dollars ($30);
(E) Conduct chemical analysis with controlled
				substances listed in any schedule, the registrant shall pay a fee of thirty
				dollars ($30); and
(F) Import or
				export controlled substances listed in any schedule, the registrant shall pay a
				fee of sixty-six dollars ($66).
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.017 - Registration Process

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment requires applicants to apply
				  for registrations through an electronic online system and eliminates the paper
				  application process.
(1)
				Database and Survey Process.
(A) Applicants
				may apply for and receive a registration that is effective for up to twelve
				(12) months.
(B) Applicants shall
				apply through the department's electronic online system.
(C) Simultaneously with completing an
				application for a controlled substances registration, practitioners may also
				complete an annual voluntary census to assist the department in determining
				practitioner shortages and underserved regions of the state. Required questions
				and fields for controlled substance registrations are marked with an asterisk
				(*) in the electronic online system.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.019 - Registration Location

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes requirements for the
				  physical location of a registration.
(1) A controlled substance registration shall
				be issued at a U.S. Postal Service street address.
(2) A controlled substance registration shall
				be issued to an individual practitioner at a Missouri practice location where
				controlled substance and other patient care activities occur.
*Original authority: 195.195, RSMo 1957, amended 1971,
					 1989, 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.020 - List of Excepted Substances

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.025 - List of Exempt Anabolic Steroid Products

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.026 - Separate Registrations

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment changes requirements related
				  to controlled substance registrations for separate locations of emergency
				  medical services vehicles to comply with the Protecting Patient Access to
				  Emergency Medications Act, which amended
				  21 U.S.C. section
				  823(j), effective November
				  17, 2017.
(1) Independent
				Activities. The following eight groups of activities are deemed to be
				independent of each other and require separate registration:
(A) Manufacturing controlled
				substances;
(B) Distributing
				controlled substances, except:
1. A dispenser
				distributing less than 5% of the total combined dosage units of controlled
				substances distributed and dispensed in a calendar year shall be exempt from
				obtaining a separate registration for distributing;
2. A dispenser distributing more than 5% of
				the total combined dosage units of controlled substances distributed and
				dispensed in a calendar year must obtain a separate registration as a
				distributor but shall be exempt from maintaining separate inventories under
				19 CSR
				30-1.042;
(C) Dispensing controlled substances listed
				in Schedules II-V;
(D) Conducting
				research and instructional activities with controlled substances listed in
				Schedule I;
(E) Conducting research
				with controlled substances listed in Schedules II-V;
(F) Conducting a narcotic treatment program
				with narcotic controlled substances listed in Schedules II-V;
(G) Conducting instructional activities with
				controlled substances listed in Schedules II-V;
(H) Importing controlled substances;
(I) Exporting controlled
				substances;
(J) Conducting chemical
				analysis with controlled substances listed in any schedule.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.027 - Investigative and Administrative Procedures

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule establishes procedures for the
				  handling and disposition of information indicating violations of Chapter 195,
				  RSMo by the Department of Health, pursuant to the mandates of section
				  195.040.
(1) The Department of Health may allow
				officers of state and federal administrative agencies to attend and participate
				in informal conferences conducted with Missouri controlled substances
				registrants, Missouri regulated chemical registrants or applicants in order to
				assist the Department of Health in its deliberations.
*Original authority: 195.195, RSMo 1957, amended 1971,
					 1989, 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.030 - Requirements for Controlled Substances Registration

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.031 - Physical Security Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule requires applicants and
				  registrants to maintain security controls and procedures to prevent theft and
				  diversion of controlled substances.
(1) All applicants and registrants shall
				provide effective controls and procedures to guard against theft and diversion
				of controlled substances. In order to determine whether a registrant has
				provided effective controls against diversion, the Department of Health shall
				use the security requirement set forth in
				19 CSR
				30-1.032-19 CSR
				30-1.034 as standards for the physical security
				controls and operating procedures necessary to prevent diversion. Substantial
				compliance with these standards may be deemed sufficient by the Department of
				Health after evaluation of the overall security system and needs of the
				applicant or registrant.
(2)
				Physical security controls shall be commensurate with the schedules and
				quantity of controlled substances in the possession of the registrant in normal
				business operations. If a controlled substance is transferred to a different
				schedule, or a noncontrolled substance is listed on any schedule, or the
				quantity of controlled substances in the possession of the registrant in normal
				business operations significantly increases, physical security controls shall
				be expanded and extended accordingly.
(3) All registrants who receive or transfer
				substantial quantities of controlled substances in normal business operations
				shall employ security procedures to guard against in-transit losses.
*Original authority: 195.195, RSMo 1957, amended 1971,
					 1989, 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.033 - Hearing Procedures on Controlled Substances Registration

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.034 - Security for Practitioners

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule describes specific actions
				  required of practitioner registrants to maintain effective security. This rule
				  also creates and defines the form which must be used by a registrant to report
				  any theft or loss of controlled substances to the Department of
				  Health.
(1) Physical
				Security.
(A) Controlled substances listed in
				Schedules I and II shall be stored in a securely locked, substantially
				constructed cabinet.
(B) Controlled
				substances listed in Schedules III, IV and V shall be stored in a securely
				locked, substantially constructed cabinet. However, pharmacies may disperse
				these substances throughout the stock of noncontrolled substances in such a
				manner as to obstruct the theft or diversion of the controlled
				substances.
(C) This rule also
				shall apply to nonpractitioners authorized to conduct research or chemical
				analysis under another registration.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.035 - Requirements for Prescribing, Dispensing and Administering Controlled Substances

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.036 - Disposing of Unwanted Controlled Substances

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded November 30, 2000)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.040 - Dispensing and Distribution of Controlled Substances in Certain Situations

Current through Register Vol. 49, No. 14, July 15, 2024
(Rescinded July 30, 2003)
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.041 - Records Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines the record keeping and
				  inventory requirements for various classes of registrants.
(1) Persons Required to Keep Records.
(A) Each registrant shall maintain the
				records and inventory required by
				19 CSR
				30-1.041-19 CSR
				30-1.052, except as exempted by
				19 CSR
				30-1.041-19 CSR
				30-1.052.
(B) Registered individual practitioners and
				institutional practitioners are required to keep records with respect to
				controlled substances which are prescribed, administered or
				dispensed.
(C) A registered person
				using any controlled substance in research conducted in conformity with an
				exemption granted under section 505(i) or 512(j) of the federal Food, Drug and
				Cosmetic Act (
				21
				U.S.C. 355(i) or
				360(j)
				) at a registered establishment which maintains records in accordance with
				either of those sections is not required to keep records if s/he notifies the
				Department of Health of the name, address and registration number of the
				establishment maintaining these records.
(D) A registered person using any controlled
				substance in preclinical research or in teaching at a registered establishment
				which maintains records with respect to these substances is not required to
				keep records if s/he notifies the Department of Health of the name, address and
				registration number of the establishment maintaining the records.
(E) Notice required by subsection (1)(D) of
				this rule shall be given at the time the person applies for registration or
				re-registration and shall be made in the form of an attachment to the
				application, which shall be filed with the application.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.042 - Inventory Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule defines requirements for the form
				  and maintenance of controlled substance inventories.
(1) General Requirements.
(A) Each inventory shall contain a complete
				and accurate record of all controlled substances on hand on the date the
				inventory was taken. Controlled substances shall be deemed to be on hand if
				they are in the possession of or under the control of the registrant, including
				substances returned by a customer, substances ordered by a customer but not yet
				invoiced, substances stored in a warehouse on behalf of the registrant and
				substances in the possession of employees of the registrant and intended for
				distribution as complimentary samples.
(B) A separate inventory shall be made by a
				registrant for each registered location. In the event controlled substances are
				in the possession or under the control of the registrant at a location for
				which s/he is not registered, the substances shall be included in the inventory
				of the registered location to which they are subject to control or to which the
				person possessing the substance is responsible. Each inventory for a registered
				location shall be kept at the registered location.
(C) A separate inventory shall be made by a
				registrant for each independent activity for which s/he is
				registered.
(D) A registrant may
				take an inventory either as of the opening of business or as of the close of
				business on the inventory date. The registrant shall indicate on the inventory
				records whether the inventory is taken as of the opening or as of the close of
				business and the date the inventory is taken.
(E) An inventory must be maintained in a
				permanent written, typewritten or printed form. An inventory taken by use of an
				oral recording device must be transcribed promptly.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.044 - Continuing Records General Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for the
				  maintenance of ongoing controlled substance records.
(1) Every registrant required to keep records
				shall maintain on a current basis a complete and accurate record of each such
				substance manufactured, imported, received, sold, delivered, exported or
				otherwise disposed of by him/her.
(2) Separate records shall be maintained by a
				registrant for each registered location except as provided in
				19 CSR
				30-1.041(2). In the event controlled
				substances are in the possession or under the control of a registrant at a
				location for which s/he is not registered, the substance shall be included in
				the records of the registered location to which they are subject to control or
				to which the person possessing the substance is responsible.
(3) Separate records shall be maintained by a
				registrant for each independent activity for which s/he is
				registered.
(4) In recording dates
				of receipt, importation, distribution, exportation or other transfers, the date
				on which the controlled substances are actually received, imported,
				distributed, exported or otherwise transferred shall be used as the date of
				receipt or distribution of any documents of transfer (for example, invoices or
				packing slips).
(5) Records must be
				provided to the Department of Health within three working days upon
				request.
*Original authority: 195.050, RSMo 1939, amended 1971, 1989
					 and 195.195, RSMo 1957, amended 1971, 1989,
					 1993.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.046 - Records for Manufacturers, Distributors, Importers and Exporters

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for record
				  keeping by manufacturers, distributors, importers and exporters of controlled
				  substances.-
(1) Records for
				Manufacturers. Each registered manufacturer shall maintain records with the
				following information:
(A) For each controlled
				substance in bulk form to be used in or capable of use in or being used in the
				manufacture of the same or other controlled or noncontrolled substances in
				finished form-
1. The name of the
				substance;
2. The quantity
				manufactured in bulk form by the registrant, including the date, quantity and
				batch or other identifying number of each batch manufactured;
3. The quantity received from other persons
				including the date and quantity of each receipt and the name, address and
				registration number of the other person from whom the substance was
				received;
4. The quantity imported
				directly by the registrant (under a registration as an importer) for use in
				manufacture by him/her, including the date, quantity and import permit or
				declaration number for each importation;
5. The quantity used to manufacture the same
				substance in finished form including the date and batch or other identifying
				number of each manufacture; the quantity used in the manufacture; the finished
				form (for example, ten milligram (10 mg) tablets or ten milligram (10 mg)
				concentration per fluid ounce or milliliter); the number of units of finished
				form manufactured; the quantity used in quality control; the quantity lost
				during manufacturing and the causes for the loss, if known; the total quantity
				of the substance contained in the finished form; the theoretical and actual
				yields and other information as is necessary to account for all controlled
				substances used in the manufacturing process;
6. The quantity used to manufacture other
				controlled and noncontrolled substances, including the name of each substance
				manufactured and the information required in paragraph (1)(A)5. of this
				rule;
7. The quantity distributed
				in bulk form to other persons, including the date and quantity of each
				distribution and the name, address and registration number of each person to
				whom a distribution was made;
8.
				The quantity exported directly by the registrant, including the date, quantity
				and export permit or declaration number of each exportation;
9. The quantity distributed or disposed of in
				any other manner by the registrant (for example, distribution of complimentary
				samples or by destruction) including the date and manner of distribution or
				disposal, the name, address and registration number of the person to whom
				distributed and the quantity distributed or disposed;
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.048 - Records for Practitioners and Researchers

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment will allow prescriptions for
				  controlled substances to be transmitted electronically provided federal laws
				  relating to electronic prescribing of controlled substances are
				  followed.
PURPOSE: This rule sets requirements for record
				  keeping for practitioners and researchers. It also sets requirements for the
				  use of facsimile and electronic prescriptions.
(1) Each individual practitioner,
				institutional practitioner and pharmacy shall maintain records with the
				following information for each controlled substance received, maintained,
				dispensed or disposed:
(A) The name of the
				substance;
(B) Each finished form
				(for example, ten milligram (10 mg) tablet or ten milligram (10 mg)
				concentration per fluid ounce or milliliter) and the number of units or volume
				of finished form in each commercial container (for example, 100 tablet bottle
				or three milliliter (3 ml) vial);
(C) The number of commercial containers of
				each finished form received from other persons, including the date of and
				number of containers in each receipt and the name, address and registration
				number of the person from whom the containers were received;
(D) The number of units or volume of the
				finished form dispensed including the name and address of the person to whom it
				was dispensed, the date of dispensing, the number of units or volume dispensed
				and the written or typewritten name or initials of the individual who dispensed
				or administered the substance;
(E)
				The number of units or volume of the finished forms, commercial containers, or
				both, disposed of in any other manner by the registrant, including the date and
				manner of disposal and the quantity of the substance in finished form
				disposed.
Missouri Code of State Regulations › Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES › Division 30 - Division of Regulation and Licensure › Chapter 1 - Controlled Substances › Section 19 CSR 30-1.050 - Records for Chemical Analysts

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This rule sets requirements for record
				  keeping for chemical analyst registrants.
(1) Each person registered to conduct
				chemical analysis with controlled substances shall maintain records with the
				following information (to the extent known and reasonably ascertainable by
				him/her) for each controlled substance:
(A)
				The name of the substance;
(B) The
				form(s) in which the substance is received, imported or manufactured by the
				registrant (for example, powder, granulation, tablet, capsule or solution) and
				the concentration of the substance in that form (for example, Chemically Pure
				(CP), United States Pharmacopeia (USP), National Formulary (NF), ten milligram
				(10 mg) tablet or ten milligram (10 mg) concentration per
				milliliter);
(C) The total number
				of the forms received, imported or manufactured (for example 100 tablets, 30
				one milliliter (1 ml) vials or ten grams (10 g) powder), including the date and
				quantity of each receipt, importation or manufacture and the name, address and
				registration number, if any, of the person from whom the substance was
				received; and
(D) The quantity
				distributed, exported or destroyed in any manner by the registrant (except
				quantities used in chemical analysis or other laboratory work), including the
				date and manner of distribution, exportation or destruction and the name,
				address and registration number, if any, of each person to whom the substance
				was distributed or exported.