Rules of Department of Health and Senior Services Division 30—Division of Regulation and Licensure Chapter 1—Controlled Substances

Title Page

19 CSR 30-1.002 Schedules of Controlled Substances ...... 3 19 CSR 30-1.004 List of Excepted Substances ...... 8 19 CSR 30-1.006 List of Exempt Anabolic Steroid Products ...... 8 19 CSR 30-1.008 List of Excluded Veterinary Anabolic Steroid Implant Products ...... 9 19 CSR 30-1.010 Schedules of Controlled Substances (Rescinded November 30, 2000) ...... 9 19 CSR 30-1.011 Definitions...... 10 19 CSR 30-1.013 Miscellaneous Fees ...... 11 19 CSR 30-1.015 Registrations and Fees...... 11 19 CSR 30-1.017 Registration Process ...... 11 19 CSR 30-1.019 Registration Location...... 14 19 CSR 30-1.020 List of Excepted Substances (Rescinded November 30, 2000)...... 14 19 CSR 30-1.023 Registration Changes ...... 14 19 CSR 30-1.025 List of Exempt Anabolic Steroid Products (Rescinded November 30, 2000)...... 15 19 CSR 30-1.026 Separate Registrations ...... 15 19 CSR 30-1.027 Investigative and Administrative Procedures ...... 15 19 CSR 30-1.030 Requirements for Controlled Substances Registration (Rescinded November 30, 2000) ...... 16 19 CSR 30-1.031 Physical Security Requirements...... 16 19 CSR 30-1.032 Security for Nonpractitioners ...... 16 19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration (Rescinded November 30, 2000) ...... 17

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 1 Secretary of State 19 CSR 30-1.034 Security for Practitioners ...... 17 19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances (Rescinded November 30, 2000) ...... 18 19 CSR 30-1.036 Disposing of Unwanted Controlled Substances (Rescinded November 30, 2000) ...... 18 19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations (Rescinded July 30, 2003) ...... 18 19 CSR 30-1.041 Records Requirements...... 18 19 CSR 30-1.042 Inventory Requirements ...... 18 19 CSR 30-1.044 Continuing Records General Requirements...... 20 19 CSR 30-1.046 Records for Manufacturers, Distributors, Importers and Exporters ...... 20 19 CSR 30-1.048 Records for Practitioners and Researchers...... 21 19 CSR 30-1.050 Records for Chemical Analysts ...... 22 19 CSR 30-1.052 Records for Long-Term Care Facilities (LTCF)...... 22 19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administering of Controlled Substances...... 23 19 CSR 30-1.062 Transmission of Prescriptions...... 23 19 CSR 30-1.064 Partial Filling of Schedule II Prescriptions ...... 23 19 CSR 30-1.066 Dispensing by Individual Practitioners ...... 24 19 CSR 30-1.068 Administering In Emergency Rooms...... 24 19 CSR 30-1.070 Emergency Dispensing of Schedule II Substances...... 24 19 CSR 30-1.072 Dispensing of Schedule V Substances ...... 25 19 CSR 30-1.074 Dispensing Without a Prescription ...... 25 19 CSR 30-1.076 Emergency Distribution by a Pharmacy ...... 27 19 CSR 30-1.078 Disposing of Unwanted Controlled Substances ...... 27

2 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Title 19—DEPARTMENT OF K. Beta-hydroxyfentanyl (N-(1-(2- YY. Propiram 9649 HEALTH AND SENIOR SERVICES hydroxy-2-phenethyl)-4-piperi- ZZ. Racemoramide 9645 Division 30—Division of dinyl)-N-phenylpropan- AAA. Thiofentanyl Regulation and Licensure amide) 9830 (N-phenyl-N-(1-(2- Chapter 1—Controlled Substances L. Beta-hydroxy-3-methylfentanyl thienyl)ethyl-4-piperidinyl)- (other name: N-(1-(2-hydroxy- propanamide 9835 19 CSR 30-1.002 Schedules of Controlled 2-phenethyl)-3-methyl-4- BBB. Tilidine 9750 Substances piperidinyl)-N-phenylpropan- CCC. Trimeperidine 9646 amide) 9831 2. Opium derivatives. Unless specifical- PURPOSE: Chapter 195, RSMo states in sec- M. Betameprodine 9608 ly excepted or unless listed in another sched- tion 195.230, RSMo that the Department of N. Betamethadol 9609 ule, any of the following opium derivatives, Health shall prepare a list of all drugs falling O. Betaprodine 9611 its salts, isomers and salts of isomers when- within the purview of controlled substances. P. Clonitazene 9612 ever the existence of such salts, isomers and Upon preparation, a copy of the list shall be Q. Dextromoramide 9613 salts of isomers is possible within the specif- filed in the Office of the Secretary of State. It R. Diampromide 9615 ic chemical designation: also requires, in section 195.017.11, RSMo, S. Diethylthiambutene 9616 A. Acetorphine 9319 the Department of Health to revise and repub- T. Difenoxin 9168 B. Acetyldihydrocodeine 9051 lish the schedules semiannually for two years U. Dimenoxadol 9617 C. Benzylmorphine 9052 from September 28, 1971, and annually after V. Dimepheptanol 9618 D. Codeine methylbromide 9070 that. W. Dimethylthiambutene 9619 E. Codeine-N-Oxide 9053 X. Dioxaphetyl butyrate 9621 F. Cyprenorphine 9054 (1) Schedules of Controlled Substances. Y. Dipipanone 9622 G. Desomorphine 9055 (A) Schedule I shall consist of the drugs Z. Ethylmethylthiambutene 9623 H. Dihydromorphine 9145 and other substances, by whatever official AA. Etonitazene 9624 I. Drotebanol 9335 name, common or usual name, chemical BB. Etoxeridine 9625 J. Etorphine (except hydro- name or brand name designated, listed in this CC. Furethidine 9626 chloride salt) 9056 DD. Hydroxypethidine 9627 section. Each drug or substance has been K. Heroin 9200 EE. Ketobemidone 9628 assigned the Drug Enforcement Administra- L. Hydromorphinol 9301 FF. Levomoramide 9629 tion (DEA) Controlled Substances Code M. Methyldesorphine 9302 GG. Levophenacylmorphan 9631 Number set forth opposite it. N. Methyldihydromorphine 9304 HH. 3-Methylfentanyl (N-(3-methyl- 1. Opiates. Unless specifically excepted O. Morphine methylbromide 9305 1-(2-phenylethyl)-4- or unless listed in another schedule, any of P. Morphine methylsulfonate 9306 piperidyl)-N-phenylproan- the following opiates, including their isomers, Q. Morphine-N-Oxide 9307 amide), its optical and esters, ethers, salts and salts of isomers, R. Myrophine 9308 geometric isomers, salts and esters and ethers, whenever the existence of S. Nicocodeine 9309 salts of isomers 9813 such isomers, esters, ethers and salts is pos- II. 3-Methylthiofentanyl (N-((3- T. Nicomorphine 9312 sible within the specific chemical designa- methyl-1-(2-thienyl) U. Normorphine 9313 tion: ethyl-4-piperidinyl)-N- V. Pholcodeine 9314 A. Acetyl-alpha-methylfentanyl (N- phenylpropanamide) 9833 W. Thebacon 9315 (1-(1-methyl-2-phenethyl)- JJ. Morpheridine 9632 3. Hallucinogenic substances. Unless 4-piperidinyl)-N-phenylace- KK. MPPP (1-methyl-4-phenyl- specifically excepted or unless listed in tamide) 9815 4-propionoxypiperidine) 9661 another schedule, any material, compound, B. Acetylmethadol 9601 LL. Noracymethadol 9633 mixture or preparation, which contains any C. Allylprodine 9602 MM. Norlevorphanol 9634 quantity of the following hallucinogenic sub- D. Alphacetylmethadol (except levo- NN. Normethadone 9635 stances or which contains any of its salts, iso- alphacetylmethadol also known OO. Norpipanone 9636 mers and salts of isomers whenever the exis- as levo-alpha-acetylmethadol levo- PP. Para-fluorofentanyl tence of such salts, isomers and salts of thadyl acetate or LAAM) 9603 (N-(4-fluorophenyl)- isomers is possible within the specific chem- E. Alphameprodine 9604 N-(1-(2-phenethyl)-4- ical designation (For purposes of paragraph F. Alphamethadol 9605 piperidinyl) propana- (1)(A)3. of this rule only, the term isomer G. Alpha-methylfentanyl (N-1- mide 9812 includes the optical, position and geometric (alphamethyl-beta-phenyl) ethyl- QQ. PEPAP (1-(-2-phenethyl)-4- isomers.): 4-piperidyl) propionanilide; 1-(1- phenyl-4-acetoxypi- A. Alpha-ethyltryptamine 7249 methyl-2-phenylethyl)-4 ((N-pro- peridine) 9663 Some trade or other names: etryptamine; panilido) piperidine) 9814 RR. Phenadoxone 9637 Monase; alpha-ethyl-1H-indole-3-ethen- H. Alpha-methylthiofentanyl (N-(1- SS. Phenampromide 9638 amine; 3-(2-aminobutyl)indole; alpha-ET methyl-2-(2-thienyl) ethyl-4- TT. Phenomorphan 9647 and AET; piperidinyl)-N-phenylpropan- UU. Phenoperidine 9641 B. Benzylpiperazine or other amide) 9832 VV. Piritramide 9642 name BZP 7493 I. Benzethidine 9606 WW. Proheptazine 9643 C. 4-bromo-2,5-dimethoxyampheta- J. Betacetylmethadol 9607 XX. Properidine 9644 mine 7391

ROBIN CARNAHAN (1/29/06) CODE OF STATE REGULATIONS 3 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Some trade or other names: 4-bromo-2, 5- Some trade or other names: 3-Hexyl-1- the existence of such salts, isomers and salts dimethoxy-a-methylphenethylamine; 4-bro- Hydroxy-7,8,9,10-tetrahydro-6,6,9- of isomers is possible within the specific mo-2,5-DMA; trimethyl-6H-dibenzo(b,d)pyran; Synhexyl; chemical designation: D. 4-bromo-2,5-dimethoxyphene- X. Peyote 7415 A. Gamma-hydroxybutyric acid and thylamine 7392 Meaning all parts of the plant presently clas- other names GHB; gamma-hydroxybutyrate; E. 2,5-dimethoxyamphetamine 7396 sified botanically as Lophophora williamsil 4-hydroxybutyrate; 4-hydroxybutonic acid; Some trade or other names: 2,5-dimethoxy-a- Lemaire, whether growing or not; the seeds sodium oxybate; sodium oxybutryrate; methylphenethylamine; 2,5-DMA; thereof; any extract from any part of such B. Mecloqualone 2572 F. 2,5-dimethoxy-4-ethylampheta- plant; and every compound, manufacture, C. Methaqualone 2565 mine 7399 salt, derivative, mixture or preparation of 5. Stimulants. Unless specifically Some trade or other names: DOET such plant, its seeds or extracts; excepted or unless listed in another schedule, G. 2,5-dimethoxy-4-(n)-pro- Y. N-ethyl-3-piperidyl benzi- any material, compound, mixture or prepara- pylthiophenethylamine late 7482 tion which contains any quantity of the fol- H. 4-methoxyamphetamine 7411 Z. N-methyl-3-piperidyl benzi- lowing substances having a stimulant effect Some trade or other names: 4-methoxy-a- late 7484 on the central nervous system, including its methylphenethylamine; paramethoxyam- AA. Psilocybin 7437 salts, isomers and salts of isomers: phetamine; PMA; BB. Psilocyn 7438 A. Aminorex 1585 I. 5-methoxy-3,4-methylenedioxy- CC. Tetrahydrocannabinols 7370 Some trade or other names: aminoxaphen; 2- amphetamine 7401 Synthetic equivalents of the substances con- amino-5-phenyl-2-oxazoline; 4,5-dihydro-5- J. 4-methyl-2,5-dimethoxyamphe- tained in the plant or in the resinous extrac- phenyl-2-oxazolamine; tamine 7395 tives of Cannabis, sp, synthetic substances, B. Cathinone (Some trade or other Some trade and other names: 4-methyl-2, 5- derivatives and their isomers, or both, with names: 2-amino-1-phenyl-1- dimethoxy-a-methylphenethylamine; DOM; similar chemical structure and pharmacolog- propanone, alphaamino- and STP; ical activity such as the following: propiophenone, 2-aminopropio- K. 3,4-methylenedioxy amphe- (I) D 1 cis or trans tetrahydro- phenone and norephedrone) 1235 tamine 7400 cannabinol and their optical isomers; C. Fenethylline 1503 (II) D 6 cis or trans tetrahydro- D. Methcathinone 1585 L. 3,4-methylenedioxymethampheta- cannabinol and their optical isomers; and Some trade or other names: 2-(methyl- mine (MDMA) 7405 (III) D 3, 4 cis or trans tetrahydro- amino)-propiophenone; alpha-(methyla- M. 3,4-methylenedioxy-N-ethylam- cannabinol and its optical isomers (Since mino)propiophenone; 2-(methylamino)-1- phetamine (also known as N-ethyl- nomenclature of these substances is not inter- phenylpropan-1-one; alpha-N-methylamino- alpha-methyl-3,4 (methylenedioxy) nationally standardized, compounds of these propiophenone; monomethylpropion; ephe- phenethylamine, N-ethyl MDA, structures, regardless of numerical designa- drone; N-methylcathinone; methylcathinine; MDE and MDEA) 7404 tion of atomic positions are covered.); AL-464; AL-422; AL-463 and URI 432; its N. N-hydroxy-3,4-methylenedioxyam- DD. Ethylamine analog of phencycli- salts, optical isomers and salts of optical iso- phetamine (also known as N- dine 7455 mers; hydroxy-alpha-methyl-3,4- Some trade or other names: N-ethyl-1- E. (±)cis-4-methylaminorex ((±)cis- (methylenedioxy) phenethylamine phenylcyclohexylamine, (1-phenylcyclohexyl) 4,5-dihydro-4-methyl-5-phenyl- and N-hydroxy MDA) 7402 ethylamine, N-(1-phenylcyclohexyl)-ethy- 2-oxazolamine) 1590 O. 3,4,5-trimethoxy ampheta- lamine, cyclohexamine, PCE; F. N-ethylamphetamine 1475 mine 7390 EE. Pyrrolidine analog of phencycli- G. N,N-dimethylamphetamine 1480 P. Bufotenine 7433 dine 7458 (some other names: N,N-alpha-trimethyl- Some trade and other names: 3-(b-Dimethy- Some trade or other names: 1(1-phenylcyclo- benzeneethanamine; N,N-alpha-trimethyl- laminoethyl)-5-hydroxyindole; 3-(2-dimethyl- hexyl)-pyrrolidine PCPy, PHP; phenethylamine), its salts, optical isomers aminoethyl)-5-indolol; N, N-dimethylsero- FF. Thiophene analog of phencycli- and salts of optical isomers. tonin; 5-hydroxy-N,N-dimethyltryptamine; dine 7470 6. A temporary listing of substances mappine; Some trade or other names: 1-(1-(2-thienyl)- subject to emergency scheduling under feder- Q. Diethyltryptamine 7434 cyclohexyl)-piperidine, 2-thienyl analog of al law shall include any material, compound, Some trade and other names: N, N-Diethyl- phencyclidine, TPCP, TCP; mixture or preparation which contains any tryptamine; DET; GG. Triflouromethylphenyl- quantity of the following substances: R. Dimethyltryptamine 7435 piperazine or other name A. N-(1-benzyl-4-piperidyl)-N-phe- Some trade or other names: DMT; TFMPP; nylpropanamide (benzyl- S. Ibogaine 7260 HH. 1-(1-(2-thienyl)cyclohexyl) fentanyl), its optical isomers, salts Some trade and other names: 7-Ethyl- pyrrolidine 7473 and salts of isomers 9818 6,6b,7,8,9,10,12,13-octahydro-2-methoxy-6, Some other names: TCPy. B. N-(1-(2-thienyl) methyl-4-piper- 9-methano-5H-pyrido (1',2':1,2) azepino (5, 4. Depressants. Unless specifically idyl)-N-phenylpropanamide 4-b) indole; Tabernanthe iboga; excepted or unless listed in another schedule, (thenylfentanyl), its optical T. Lysergic acid diethylamide 7315 any material compound, mixture or prepara- isomers, salts and salts U. Marihuana 7360 tion which contains any quantity of the fol- of isomers 9834 Some trade or other names: marijuana; lowing substances having a depressant effect (B) Schedule II shall consist of the drugs V. Mescaline 7381 on the central nervous system, including its and other substances, by whatever official W. Parahexyl 7374 salts, isomers and salts of isomers whenever name, common or usual name, chemical

4 CODE OF STATE REGULATIONS (1/29/06) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

name or brand name designated, listed in this lowing opiates, including its isomers, esters, 4. Depressants. Unless specifically section. Each drug or substance has been ethers, salts and salts of isomers, esters and excepted or unless listed in another schedule, assigned the Controlled Substances Code ethers whenever the existence of such iso- any material, compound, mixture or prepara- Number set forth opposite it. mers, esters, ethers and salts is possible with- tion which contains any quantity of the fol- 1. Substances, vegetable origin or chem- in the specific chemical designation, dextror- lowing substances having a depressant effect ical synthesis. Unless specifically excepted or phan and levopropoxyphene excepted: on the central nervous system, including its unless listed in another schedule, Schedule II A. Alfentanil 9737 salts, isomers and salts of isomers whenever shall include any of the following substances B. Alphaprodine 9010 the existence of such salts, isomers and salts whether produced directly or indirectly by C. Anileridine 9020 of isomers is possible within the specific extraction from substances of vegetable ori- D. Bezitramide 9800 chemical designation: gin or independently by means of chemical E. Bulk Dextropropoxyphene A. Amobarbital 2125 synthesis or by a combination of extraction (Non-dosage Forms) 9273 B. Glutethimide 2550 and chemical synthesis opium and opiate; and F. Butyl- C. Pentobarbital 2270 any salt, compound, derivative or preparation nitrite no designated number D. Phencyclidine 7471 of opium or opiate, excluding apomorphine, G. Carfentanil 9743 E. Secobarbital 2315 thebaine-devied butorphanol, dextrorphan, H. Dihydrocodeine 9120 5. Hallucinogenic substances: nalbuphine, nalmefene, naloxone and nal- I. Diphenoxylate 9170 A. Nabilone 7379 trexone and their respective salts, but includ- J. Fentanyl 9801 Another name for nabilone: (±)trans-3-(1, 1- ing the following: K. Isomethadone 9226 dimethylheptyl)-6, 6a,7,8,10,10a-hexahydro- A. Raw opium 9600 L. Levo-alphacetylmethadol 9220 1-hydroxy-6, 6-dimethyl-9H-dibenzo(b,d) B. Opium extracts 9610 Some other names: levo-alphaacetylmetha- pyran-9-one. C. Opium fluid 9620 dol, levomethadyl acetate, LAAM 9648 6. Immediate precursors. Unless specif- D. Powdered opium 9639 M. Levomethorphan 9210 ically excepted or unless listed in another E. Granulated opium 9640 N. Levorphanol 9220 schedule, any material, compound, mixture F. Tincture of opium 9630 O. Metazocine 9240 or preparation which contains any quantity of G. Codeine 9050 P. Methadone 9250 the following substances: H. Ethylmorphine 9190 Q. Methadone-Intermediate, 4-cyano- A. Immediate precursor to amphe- I. Etorphine hydrochloride 9059 2-dimethylamino-4,4-diphenyl tamine and methamphetamine: J. Hydrocodone 9193 butane 9254 (I) Phenylacetone 8501 K. Hydromorphone 9150 R. Moramide-Intermediate, 2-methyl- Some trade or other names: phenyl-2- L. Metopon 9260 3-morpholino-1,1-diphenylpro- propanone; P2P; benzyl methyl ketone; M. Morphine 9300 pane-carboxylic acid 9802 methyl benzyl ketone; N. Oxycodone 9143 S. Pethidine (Meperidine) 9230 B. Immediate precursors to phencycli- O. Oxymorphone 9652 T. Pethidine-Intermediate-A, 4-cyano- dine (PCP): P. Thebaine 9333 1-methyl-4-phenylpiperi- (I) 1-phenylcyclohexylamine 7460 Any salt, compound, derivative or prepara- dine 9232 (II) 1-piperidinocyclohexane- tion thereof which is chemically equivalent or U. Pethidine-Intermediate-B, ethyl-4- carbonitrile (PCC) 8603 identical with any of the substances referred phenylpiperidine-4-carboxy- (C) Schedule III shall consist of the drugs to in paragraph (1)(B)1. of this rule shall be late 9233 and other substances, by whatever official included in Schedule II, except that these V. Pethidine-Intermediate-C, 1-me- name, common or usual name, chemical substances shall not include the isoquinoline thyl-4-phenylpiperidine-4- name or brand name designated, listed in this alkaloids of opium; opium poppy and poppy carboxylic acid 9234 section. Each drug or substance has been straw; coca leaves 9040 W. Phenazocine 9715 assigned the DEA Controlled Substances and any salt, compound, derivative or prepa- X. Piminodine 9730 Code Number set forth opposite it. ration of coca leaves including cocaine 9041 Y. Racemethorphan 9732 1. Stimulants. Unless specifically and ecgonine 9180 Z. Racemorphan 9733 excepted or unless listed in another schedule, any material, compound, mixture or prepara- and their salts, isomers, derivatives and salts AA. Remifentanil 9739 tion which contains any quantity of the fol- of isomers and derivatives and any salt, com- BB. Sufentanil 9740 lowing substances having a stimulant effect pound, derivative or preparation thereof 3. Stimulants. Unless specifically on the central nervous system, including its which is chemically equivalent or identical excepted or unless listed in another schedule, salts, isomers (whether optical, position or with any of these substances, except that the any material, compound, mixture or prepara- geometric) and salts of such isomers whenev- substances shall not include decocainized tion which contains any quantity of the fol- er the existence of such salts, isomers and coca leaves or extraction of coca leaves, lowing substances having a stimulant effect salts of isomers is possible within the specif- which extractions do not contain on the central nervous system: ic chemical designation: cocaine 9041 A. Amphetamine, its salts, optical A. Those compounds, mixtures or or ecgonine 9180 isomers and salts of its optical preparations in dosage unit form containing and concentrate of poppy straw (the crude isomers 1100 any stimulant substances listed in Schedule II extract of poppy straw in either liquid, solid B. Methamphetamine, its salts, which compounds, mixtures or preparations or powder form which contains the phenan- isomers and salts of its were listed on August 25, 1971, as excepted threne alkaloids of the opium poppy) 9670 isomers 1105 compounds under section 308.32 and any 2. Opiates. Unless specifically excepted C. Phenmetrazine and its salts 1631 other drug of the quantitive composition or unless in another schedule any of the fol- D. Methylphenidate 1724 shown in that list for those drugs or which is

ROBIN CARNAHAN (1/29/06) CODE OF STATE REGULATIONS 5 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

the same except that it contains a lesser quan- or not more than ninety milligrams (90 mg) D. Dehydrochlormethyltestosterone tity of controlled substances 1405 per dosage unit, with an equal or greater E. Dihydrotestosterone (4-Dihydro- B. Benzphetamine 1228 quantity of an isoquinoline alkaloid of testosterone) C. Chlorphentermine 1645 opium 9803 F. Drostanolone D. Clortermine 1647 B. Not more than 1.8 grams of G. Ethylestrenol E. Phendimetrazine 1615 codeine per one hundred milliliters (100 ml) H. Fluoxymesterone 2. Depressants. Unless specifically or not more than ninety milligrams (90 mg) I. Formebulone (Formebolone) excepted or unless listed in another schedule, per dosage unit, with one (1) or more active, J. Mesterolone any material compound, mixture or prepara- nonnarcotic ingredients in recognized thera- tion which contains any quantity of the fol- K. Methandienone peutic amounts 9804 L. Methandranone lowing substances having a depressant effect C. Not more than three hundred mil- on the central nervous system: M. Methandriol A. Any compound, mixture or prepa- ligrams (300 mg) of hydrocodone per one N. Methandrostenolone ration containing: hundred milliliters (100 ml) or not more than O. Methenolone fifteen milligrams (15 mg) per dosage unit, (I) Amobarbital 2126 P. Methyltestosterone with a fourfold or greater quantity of an iso- (II) Secobarbital 2316 Q. Mibolerone quinoline alkaloid of opium 9805 (III) Pentobarbital 2271 R. Nandrolone D. Not more than three hundred mil- or any salt thereof and one (1) or more other S. Norethandrolone active medicinal ingredients which are not ligrams (300 mg) of hydrocodone per one hundred milliliters (100 ml) or not more than T. Oxandrolone listed in any schedule; U. Oxymesterone B. Any suppository dosage form con- fifteen milligrams (15 mg) per dosage unit, with one (1) or more active nonnarcotic V. Oxymetholone taining: W. Stanolone (I) Amobarbital 2126 ingredients in recognized therapeutic X. Stanozolol (II) Secobarbital 2316 amounts 9806 Y. Testolactone (III) Pentobarbital 2271 E. Not more than 1.8 grams of dihy- Z. Testosterone or any salt of any of these drugs and approved drocodeine per one hundred milliliters (100 AA. Trenbolone by the Food and Drug Administration for ml) or not more than ninety milligrams (90 marketing only as a suppository; mg) per dosage unit, with one (1) or more BB. Any salt, ester, or isomer of a C. Any substance which contains any active, nonnarcotic ingredients in recognized drug or substance described or listed in this quantity of a derivative of barbituric acid or therapeutic amounts 9807 subparagraph, if that salt, ester or isomer any salt thereof 2100 F. Not more than three hundred mil- promotes muscle growth except an anabolic D. Chlorhexadol 2510 ligrams (300 mg) of ethylmorphine per one steroid which is expressly intended for E. Any drug product containing hundred milliliters (100 ml) or not more than administration through implants to cattle or gamma hydroxybutric acid, including its fifteen milligrams (15 mg) per dosage unit, other nonhuman species and which has been salts, isomers and salts of isomer, for which with one (1) or more active, nonnarcotic approved by the secretary of Health and an application is approved under section 505 ingredients in recognized therapeutic Human Services for that administration. of the Federal Food, Drug and Cosmetic Act; amounts 9808 6. Dronabinol (synthetic) in sesame oil F. Ketamine 7285 G. Not more than five hundred mil- and encapsulated in a soft gelatin capsule in a G. Lysergic acid 7300 ligrams (500 mg) of opium per one hundred United States Food and Drug Administration H. Lysergic acid amide 7310 milliliters (100 ml) or per one hundred grams approved drug product 7369 I. Methyprylon 2575 (100 g) or not more than twenty-five mil- (Some other names for dronabinol: (6aR- J. Sulfondiethylmethane 2600 ligrams (25 mg) per dosage unit, with one (1) trans)-6a,7,8,10a-tetrahydro-6.6.9-trimethyl- K. Sulfonethylmethane 2605 or more active nonnarcotic ingredients in rec- 3-pentyl-6H-dibenzo (b,d) pyran-1-ol, or (-) L. Sulfonmethane 2610 ognized therapeutic amounts 9809 -delta-9-(trans)-tetrahydrocannabinol.) M. Tiletamine and zolazepam H. Not more than fifty milligrams (50 (D) Schedule IV shall consist of the drugs mg) of morphine per one hundred milliliters or any salt thereof 7295 and other substances, by whatever official (100 ml) or per one hundred grams (100 g), Some trade or other names for a tiletamine- name, common or usual name, chemical with one (1) or more active, nonnarcotic zolazepam combination product: Telazol. name or brand name designated, listed in this Some trade or other names for tiletamine: 2- ingredients in recognized therapeutic section. Each drug or substance has been (ethylamino)-2-(2-thienyl)-cyclohexanone. amounts 9810 assigned the DEA Controlled Substances Some trade or other names for zolazepam: 5. Anabolic steroids. Unless specially Code Number set forth opposite it. 4-(2-fluorophenyl)-6-8-dihydro-1,3,8- excepted or unless listed in another schedule, trimethylpyrazolo-(3,4-e) (1,4)-diazepin- any material, compound, mixture or prepara- 1. Narcotic drugs. Unless specifically 7(1H)-one, flupyrazapon. tion containing any quantity of the following excepted or unless listed in another schedule, 3. Nalorphine 9400 substances, including its salts, isomers and any material, compound, mixture or prepara- 4. Narcotics drugs. Unless specifically salts of isomers whenever the existence of tion containing limited quantities of any of excepted or unless listed in another schedule, such salts of isomers is possible within the the following narcotic drugs or any salts any material, compound, mixture or prepara- specific chemical designation. DEA has thereof: tion containing limited quantities of any of assigned code 4000 for all anabolic steroids. A. Not more than one milligram (1 the following narcotic drugs or any salts A. Boldenone mg) of difenoxin (DEA Drug Code No. thereof: B. Chlorotestosterone (4-Chlortestos- 9618) and not less than twenty-five micro- A. Not more than 1.8 grams of terone) grams (25 mcg) of atropine sulfate per dosage codeine per one hundred milliliters (100 ml) C. Clostebol unit;

6 CODE OF STATE REGULATIONS (1/29/06) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

B. Dextropropoxyphene (alpha-(+)- CC. Mebutamate 2800 6. Ephedrine. Any material, compound, 4-dimethylamino-1,2-diphenyl-3-methyl-2- DD. Medazepam 2836 mixture or preparation which contains any propionoxybutane) 9278 EE. Meprobamate 2820 quantity of the following substances having a C. Narcotic drugs containing nonnar- FF. Methohexital 2264 stimulant effect on the central nervous system cotic active medicinal ingredients. Any com- GG. Methylphenobarbital including their salts, isomers and salts of iso- pound, mixture or preparation containing any (Mephobarbital) 2250 mers: of the following limited quantities of narcotic HH. Midazolam 2884 A. Ephedrine or its salts, optical iso- drugs or salts thereof, which shall include II. Nimetazepam 2837 mers or salts of optical isomers as the only one (1) or more nonnarcotic active medicinal JJ. Nitrazepam 2834 active medicinal ingredient or contains ingredients in sufficient proportion to confer KK. Nordiazepam 2838 ephedrine or its salts, optical isomers, or salts upon the compound, mixture or preparation LL. Oxazepam 2835 of optical isomers and therapeutically valuable medicinal qualities other than those MM. Oxazolam 2839 insignificant quantities of another active possessed by the narcotic drug alone: NN. Paraldehyde 2585 medicinal ingredient. (I) Not more than two hundred mil- OO. Petrichloral 2591 (E) Schedule V shall consist of the drugs ligrams (200 mg) of codeine per one hundred PP. Phenobarbital 2285 and other substances, by whatever official milliliters (100 ml) or per one hundred grams QQ. Pinazepam 2883 name, common or usual name, chemical (100 g); RR. Prazepam 2764 name or brand name designated, listed in this (II) Not more than one hundred SS. Quazepam 2881 subsection. milligrams (100 mg) of dihydrocodeine per TT. Temazepam 2925 1. Narcotic drugs. Unless specifically one hundred milliliters (100 ml) or per one UU. Tetrazepam 2886 excepted or unless listed in another schedule, hundred grams (100 g); or VV. Triazolam 2887 any material, compound, mixture or prepara- (III) Not more than one hundred WW. Zaleplon 2781 tion containing any of the following narcotic milligrams (100 mg) of ethylmorphine per XX. Zolpidem 2783 drugs and their salts: one hundred milliliters (100 ml) or per one 3. Fenfluramine. Any material, com- A. Buprenorphine 9064 hundred grams (100 g). pound, mixture or preparation which con- 2. Narcotic drugs containing nonnarcot- 2. Depressants. Unless specifically tains any quantity of the following sub- ic active medicinal ingredients. Any com- excepted or unless listed in another schedule, stances, including its salts, isomers (whether pound, mixture or preparation containing any any material, compound, mixture or prepara- optical, position or geometric) and salts of of the following narcotic drugs, or their salts tion which contains any quantity of the fol- such isomers, whenever the existence of such calculated as the free anhydrous base or alka- lowing substances, including its salts, isomers salts, isomers and salts of isomers is possible: loid, in limited quantities as follows, which and salts of isomers whenever the existence A. Fenfluramine 1670 shall include one (1) or more nonnarcotic of such salts, isomers and salts of isomers is 4. Stimulants. Unless specifically active medicinal ingredients in sufficient pro- possible within the specific chemical designa- excepted or unless listed in another schedule, portion to confer upon the compound, mix- tion: any material, compound, mixture or prepara- ture or preparation valuable medicinal quali- A. Alprazolam 2882 tion which contains any quantity of the fol- ties other than those possessed by the narcotic B. Barbital 2145 lowing substances having a stimulant effect drug alone: C. Bromazepam 2748 on the central nervous system, including its A. Not more than two and five-tenths D. Camazepam 2749 salts, isomers and salts of isomers: milligrams (2.5 mg) of diphenoxylate and not E. Chloral betaine 2460 A. Cathine ((+)-norpseudoephed- less than twenty-five micrograms (25 mcg) of F. Chloral hydrate 2465 rine) 1230 atropine sulfate per dosage unit. G. Chlordiazepoxide 2744 B. Diethylpropion 1610 B. Not more than one hundred mil- H. Clobazam 2751 C. Fencamfamin 1780 ligrams (100 mg) of opium per one hundred I. Clonazepam 2737 D. Fenproporex 1575 milliliters (100 ml) or per one hundred grams J. Clorazepate 2768 E. Mazindol 1605 (100 g). K. Clotiazepam 2752 F. Mefenorex 1580 C. Not more than five-tenths mil- L. Cloxazolam 2753 G. Modafinil 1680 ligram (0.5 mg) of difenoxin (DEA Drug M. Delorazepam 2754 H. Pemoline (including organometal- Code No. 9618) and not less than twenty-five N. Diazepam 2765 lic complexes and chelates micrograms (25 mcg) of atropine sulfate per O. Dichloralphenazone 2467 thereof) 1530 dosage unit. P. Estazolam 2756 I. Phentermine 1640 3. Stimulants. Unless specifically Q. Ethchlorvynol 2540 J. Pipradrol 1750 exempted or excluded or unless listed in R. Ethinamate 2545 K. Sibutramine 1675 another schedule, any material, compound, S. Ethyl loflazepate 2758 L. SPA (-)-1-dimethyamino- mixture or preparation which contains any T. Fludiazepam 2759 1,2-diphenylethane 1635 quantity of the following substances having a U. Flunitrazepam 2763 5. Other substances. Unless specifically stimulant effect on the central nervous system V. Flurazepam 2767 excepted or unless listed in another schedule, including its salts, isomers and salts of iso- W. Halazepam 2762 any material, compound, mixture or prepara- mers: X. Haloxazolam 2771 tion which contains any quantity of the fol- A. Pyrovalerone 1485 Y. Ketazolam 2772 lowing substances, including its salts: Z. Loprazolam 2773 A. Pentazocine 9709 (2) Excluded Nonnarcotic Substances. The AA. Lorazepam 2885 B. Butorphanol (including its optical following nonnarcotic substances which, BB. Lormetazepam 2774 isomers) 9720 under the Federal Food, Drug and Cosmetic

ROBIN CARNAHAN (1/29/06) CODE OF STATE REGULATIONS 7 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Act (21 U.S.C. 301), may be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to sec- tion 195.015(5), RSMo. Excluded Nonnarcotic Products mg or Company Trade Name NDC Code Form Controlled Substance mg/ml

Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00 Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00 Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00 Hawthorne Products, Choate’s Leg Freeze LQ Chloral hydrate 246.67 Inc. Parke-Davis & Co. Tedral 00071-0230 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Elixir 00071-0242 EX Phenobarbital 40.00 Parke-Davis & Co. Tedral S.A. 00071-0231 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Suspension 00071-0237 SU Phenobarbital 80.00 Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10 Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00 Smith Kline Consumer Benzedrex 49692-0928 IN Propylhexedrine 250.00 Sterling Drug, Inc. Bronkolixir 00057-1004 EL Phenobarbital 0.80 Sterling Drug, Inc. Bronkotabs 00057-1005 TB Phenobarbital 8.00 Vicks Chemical Co. Vicks Inhaler 23900-0010 IN I-Desoxyephedrine 113.00 White Hall Labs Primatene 00573-2940 TB Phenobarbital 8.00 (P-tablets)

AUTHORITY: sections 195.015 and 195.195, of the Secretary of State at a cost not to lant, depressant or hallucinogenic effect are RSMo 2000.* Material found in this rule pre- exceed actual cost of copy reproduction. The excepted from the provisions of sections viously filed as 19 CSR 30-1.010. Original entire text of the rule is printed here. This 195.030, 195.040, 195.050 and 195.110, rule filed April 14, 2000, effective Nov. 30, note refers only to the incorporated by refer- RSMo as provided for in section 2000. Amended: Filed Jan. 31, 2003, effec- ence material. 195.017.6(5) and .8(3), RSMo. The rules of tive July 30, 2003. the Drug Enforcement Administration, 21 (1) Excepted Stimulant or Depressant Com- CFR Part 1300 to the end of Title 21, are *Original authority: 115.015, RSMo 1971, amended 1989 pounds—Exempt Prescription Products. The hereby incorporated by reference and made a and 195.195, RSMo 1957, amended 1971, 1989, 1993. listed drugs in dosage unit form and any other part of this rule. drug of the quantitative composition shown in Part 1300 to end of Title 21, the Code of Fed- AUTHORITY: section 195.195, RSMo 1994.* 19 CSR 30-1.004 List of Excepted Sub- eral Regulations, April 1998 or which is the Material found in this rule previously filed as stances same except that it contains a lesser quantity 19 CSR 30-1.020. Original rule filed April 14, 2000, effective Nov. 30, 2000. PURPOSE: The Department of Health is of controlled substances or other substances authorized to except by rule any compound, which do not have a stimulant, depressant or *Original authority: 195.195, RSMo 1957, amended mixture or preparation containing any stimu- hallucinogenic effect and which are restricted 1971, 1989, 1993. lant or depressant substance if one or more by law to dispensing or prescription, are active medicinal ingredients not having a excepted from the provisions of sections stimulant or depressant effect on the central 195.030, 195.040, 195.050 and 195.100, nervous system is included to negate the RSMo as provided for in section potential for abuse. The compounds, mixtures 195.017.6(5) and .8(3), RSMo. The rules of 19 CSR 30-1.006 List of Exempt Anabolic and preparations excluded are listed in this the Drug Enforcement Administration, 21 Steroid Products rule. CFR Part 1300 to the end of Title 21, are hereby incorporated by reference and made a PURPOSE: This rule maintains a list of anabolic steroid products excluded from 19 PUBLISHER’S NOTE: The secretary of state part of this rule. CSR 30-1.002(1)(C)5. in conformance with has determined that the publication of the federal law. entire text of the material which is incorpo- (2) Excepted Chemical Preparations— rated by reference as a portion of this rule Exempt Chemical Preparations. The listed would be unduly cumbersome or expensive. preparations in unit form and any other (1) Persons who in the course of legitimate Therefore, the material which is so incorpo- preparation of the quantitative composition business handle products listed in the Table of rated is on file with the agency who filed this shown in Part 1300 to end of Title 21, the Exempt Anabolic Steroid Products in this rule, and with the Office of the Secretary of Code of Federal Regulations, April 1998 section shall be exempt from the registration, State. Any interested person may view this which is the same except that it contains a records, reports, prescriptions, physical secu- material at either agency’s headquarters or lesser quantity of controlled substances or rity and import and export requirements asso- the same will be made available at the Office other substances which do not have a stimu- ciated with Schedule III substances.

8 CODE OF STATE REGULATIONS (1/29/06) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(A) Trade Name Company NDC or DIN No. Trade Name Company NDC or DIN No. (M) Implus-H Upjohn Co., Animal 06-0434-01 1. Androgyn L.A. Forest Pharmaceuticals, 0456-1005 33. Testosterone Goldline Labs., 0182-3073 Health Division, 01968327 St. Louis, MO Enanthate-Estra- Ft. Lauderdale, FL Orangeville, ON 2. Andro-Estro Rugby Laboratories, 0536-1605 diol Valerate (N) Revalor-G Hoechst Roussel Vet, 12799-811 90-4 Rockville Center, NY Injection Somerville, NJ 3. depANDROGYN Forest Pharmaceuticals, 0456-1020 34. Testosterone Schein Pharmaceuticals, 0364-6618 (O) Revalor-H Hoechst Roussel Vet, 12799-810 St. Louis, MO Enanthate-Estra- Port Washington, NY Somerville, NJ 4. DEPO-T.E. Quality Research Pharma- 52765-257 diol Valerate (P) Revalor-S Hoechst Roussel Vet, 12799-809 ceuticals, Camel, IN Injection Somerville, NJ 5. depTESTROGEN Martica Pharmaceuticals, 51698-257 35. Testosterone Steris Labs., Inc., 0402-0360 (Q) Synovex H Fort Dodge Labs, 0856-3901 Phoenix, AZ Enanthate-Estra- Phoenix, AZ Fort Dodge, IA 6. Duomone Wintec Pharmaceutical, 52047-360 diol Valerate (R) Synovex H Syntex Laboratories, Pacific, MO Injection Palo Alto, CA 7. DURATESTRIN W.E. Hauck, Alpharetta, 43797-016 36. Tilapia Sex Rangen, Inc., (S) Synovex Plus Fort Dodge Labs, 0856-3904 GA Reversal Feed Buhl, ID Fort Dodge, IA 8. DUO-SPAN II Primedics Laboratories, 0684-0102 (Investigational) Gardena, CA 37. Tilapia Sex Ziegler Brothers, Inc. AUTHORITY: section 195.195, RSMo 1994 9. Estratest Solvay Pharmaceuticals, 0032-1026 Reversal Feed Gardners, PA Marietta, GA (Investigational) and 195.017, RSMo Supp. 1999.* Original 10. Estratest HS Solvay Pharmaceuticals, 0032-1023 rule filed April 14, 2000, effective Nov. 30, Marietta, GA 11. Menogen Sage Pharmaceuticals, 59243-570 AUTHORITY: section 195.195, RSMo 1994.* 2000. Shreveport, LA Material found in this rule previouly filed as 12. Menogen HS Sage Pharmaceuticals, 59243-560 19 CSR 30-1.025. Original rule filed April *Original authority: 195.017, RSMo 1971, amended 1987, Shreveport, LA 1989, 1994, 1996, 1997, 1998 and 195.195, RSMo 1957, 13. PAN ESTRA Pan American Labs, 0525-0175 14, 2000, effective Nov. 30, 2000. amended 1971, 1989, 1993. TEST Covington, LA 14. Premarin with Ayerst Labs., Inc. 0046-0879 *Original authority: 195.195, RSMo 1957, amended Methyltestos- New York, NY 1971, 1989, 1993. terone 19 CSR 30-1.010 Schedules of Controlled 15. Premarin with Ayerst Labs., Inc., 0046-0878 Substances Methyltestos- New York, NY terone 19 CSR 30-1.008 List of Excluded Veteri- (Rescinded November 30, 2000) 16. Synovex H Syntex Animal Health, nary Anabolic Steroid Implant Products Pellets in Palo Alto, CA AUTHORITY: section 195.195, RSMo Supp. process 17. Synovex H Syntex Animal Health, PURPOSE: This rule maintains a list of vet- 1993. This rule was previously filed as 13 Pellets in Palo Alto, CA CSR 50-130.010 and 19 CSR 10-130.010. process erinary anabolic steroid products excluded granulation from 19 CSR 30-1.002(1)(C)5. in confor- Original rule filed Jan. 31, 1972, effective 18. Synovex Plus Fort Dodge Animal mance with federal law. April 1, 1972. Amended: Filed Oct. 4, 1972, in-process Health, effective Oct. 14, 1972. Amended: Filed April granulation Fort Dodge, IA 19. Synovex Plus Fort Dodge Animal (1) The following products containing an 4, 1973, effective April 14, 1973. Amended: in-process Health, anabolic steroid that are expressly intended Filed Sept. 28, 1973, effective Nov. 4, 1973. bulk pellets Fort Dodge, IA Amended: Filed Jan. 3, 1974, effective Jan. 20. Testagen Clint Pharmaceuticals, 55553-257 for administration through implants to cattle Nashville, TN or other nonhuman species and which have 13, 1974. Amended: Filed Oct. 9, 1974, 21. TEST-ESTRO Rugby Laboratories, 0536-9470 been approved by the Secretary of Health and effective Oct. 19, 1974. Amended: Filed July Cypionates Rockville Centre, NY 22. Testoderm Alza Corp., 17314-4608 Human Services for such administration and 17, 1975, effective July 27, 1975. Amended: 4 mg/d Palo Alto, CA are excluded from all schedules pursuant to Filed Oct. 8, 1975, effective Oct. 18, 1975. 23. Testoderm Alza Corp., 17314-4609 section 195.017.5, RSMo. Refiled: March 24, 1976. Amended: Filed 6 mg/d Palo Alto, CA 24. Testoderm Alza Corp., 17314-2836 Oct. 12, 1976, effective Jan. 13, 1977. with Adhesive Palo Alto, CA Trade Name Company NDC or DIN No. Amended: Filed March 15, 1977, effective (A) Component E-H Vetlife, Inc., 021641-002 6 mg/d March 24, 1977. Amended: Filed Nov. 14, 25. Testoderm Alza Corp., Norcross, GA in-process film Palo Alto, CA (B) Component E-H Elanco, 01968327 1977, effective Nov. 6, 1977. Amended: Filed 26. Testoderm Alza Corp., Scarborough, ON Sept. 28, 1977, effective Jan. 13, 1978. with Adhesive Palo Alto, CA (C) Component TE-S Vetlife, Inc., 021641-004 in-process film Norcross, GA Amended: Filed March 9, 1978, effective Feb. 27. Testosterone I.D.E.-Interstate, 0814-7737 (D) Component T-H Vetlife, Inc., 021641-006 24, 1978. Amended: Filed Oct. 2, 1978, Cyp 50 Estradiol Amityville, NY Norcross, GA effective Sept. 27, 1978. Amended: Filed Cyp 2 (E) Component T-S Vetlife, Inc., 021641-005 28. Testosterone Best Generics, No. 54274-530 Norcross, GA Nov. 14, 1978, effective June 16, 1978. Cypionate- Miami Beach, FL (F) F-TO Animal Health, 00093351 Amended: Filed Nov. 14, 1978, effective Oct. Estradiol Cypionate Upjohn International, 25, 1978. Amended: Filed Feb. 13, 1979, Injection Kalamazoo, MI 29. Testosterone Schein Pharmaceuticals, 0364-6611 (G) Finaplix-H Hoechst Roussel effective Feb. 9, 1979. Amended: Filed Feb. Cypionate- Port Washington, NY Vet, 12799-807-10 19, 1980, effective Feb. 11, 1980. Amended: Estradiol Cypionate Somerville, NJ Injection (H) Finaplix-S Hoechst Roussel Filed Oct. 14, 1980, effective July 24, 1980. 30. Testosterone Steris Labs., Inc., 0402-0257 Vet, 12799-807-07 Amended: Filed Oct. 14, 1980, effective Aug. Cypionate-Estra- Phoenix, AZ Somerville, NJ 21, 1980. Amended: Filed Oct. 14, 1981, diol Cypionate (I) Heifer-oid Anchor Division, Injection Boehringer Ingelheim, effective Oct. 30, 1980. Amended: Filed Oct. 31. Testosterone Goldline Labs, 0182-3069 St. Joseph, MO 14, 1981, effective May 8, 1981. Amended: Cypionate-Estra- Ft. Lauderdale, FL (J) Heifer-oid Bio-Ceutic Division, Filed Oct. 14, 1981, effective Aug. 20, 1981. diol Cypionate Boehringer Ingelheim, Injection St. Joseph, MO Amended: Filed Nov. 1, 1982, effective Dec. 32. Testosterone The Upjohn Co., 0009-0253 (K) Heifer-oid Ivy Laboratories, Inc., 11, 1982. Amended: Filed Jan. 12, 1983, Cypionate-Estra- Kalamazoo, MI Overland Park, KS diol Cypionate (L) Implus-H The Upjohn Co., 0009-0434-01 effective Feb. 11, 1983. Amended: Filed Injection Kalamazoo, MI March 11, 1983, effective April 1, 1983.

ROBIN CARNAHAN (1/29/06) CODE OF STATE REGULATIONS 9 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Amended: Filed Sept. 2, 1983, effective Dec. cle I, section 31 against delegation of author- other facility or institution which provides 11, 1983. Amended: Filed Nov. 7, 1983, ity to an agency to make a rule fixing a fine extended health care to resident patients; effective Dec. 11, 1983. Amended: Filed July or imprisonment as punishment for its viola- (I) Name means the official name, com- 12, 1984, effective Aug. 11, 1984. Amended: tion. mon or usual name, chemical name or brand Filed Sept. 20, 1984, effective Nov. 11, 1984. name of a substance; Amended: Filed Jan. 15, 1985, effective Feb. (J) Nurse means a registered or licensed 11, 1985. Amended: Filed May 29, 1985, 19 CSR 30-1.011 Definitions practical nurse licensed under Chapter 335, effective June 27, 1985. Amended: Filed July RSMo; 24, 1985, effective Aug. 26, 1985. Amended: PURPOSE: This rule contains definitions (K) Patient care areas means any area of a Filed Sept. 12, 1985, effective Oct. 11, 1985. which establish the intended meaning of cer- hospital where medical attention is rendered Changed to 19 CSR 10-130.010, effective Oct. tain terms used throughout this chapter. to a patient; 11, 1985. Amended: Filed Jan. 3, 1986, (L) Pre-hospital emergency medical ser- effective Jan. 16, 1986. Changed to 19 CSR (1) As used in this chapter, the following vice means an emergency medical services 30-1.010, effective Aug. 11, 1986. Amended: terms shall have the meanings specified: system as defined in Chapter 190, RSMo pro- Filed April 17, 1987, effective May 14, 1987. (A) Commercial container means any bot- viding services to persons prior to admission Amended: Filed July 3, 1987, effective Aug. tle, jar, tube, ampule or other receptacle in to a hospital; 27, 1987. Amended: Filed May 3, 1988, which a substance is held for distribution or (M) Prescription means an order for med- effective May 26, 1988. Amended: Filed Sept. dispensing to an ultimate user and, in addi- ication which is dispensed to or for an ulti- 25, 1989, effective Oct. 27, 1989. Emergen- tion, any box or package in which the recep- mate user but does not include an order for cy amendment filed April 3, 1991, effective tacle is held for distribution or dispensing to medication which is dispensed for immediate April 13, 1991, expired Aug. 10, 1991. Emer- an ultimate user. The term commercial con- administration to the ultimate user. (For gency amendment filed May 1, 1991, effective tainer does not include any package liner, example, an order to dispense a drug to a bed May 11, 1991, expired Sept. 7, 1991. Emer- package insert of other material kept with or patient for immediate administration in a hos- gency amendment filed July 23, 1991, effec- within a commercial container, nor any car- pital is not a prescription.); tive Aug. 2, 1991, expired Nov. 28, 1991. ton, crate, drug or other package in which (N) Readily retrievable means that certain Amended: Filed April 3, 1991, effective Sept. commercial containers are stored or are used records are kept by automatic data processing 30, 1991. Amended: Filed May 1, 1991, for shipment of controlled substances; systems or other electronic or mechanized effective Sept. 30, 1991. Amended: Filed (B) Controlled substances administration record keeping systems in a manner that they March 2, 1992, effective Aug. 6, 1992. record means the form used to record infor- can be separated out from all other records; Amended: Filed July 6, 1993, effective Dec. mation when administering individual drug and/or records are kept on which certain 9, 1993. Emergency amendment filed Jan. 5, doses to patients; items are asterisked, redlined, highlighted or 1994, effective Jan. 15, 1994, expired May (C) Dispenser means an individual practi- in some other manner visually identifiable 14, 1994. Amended: Filed Jan. 5, 1994, tioner, institutional practitioner, pharmacy or apart from other items appearing on the effective July 30, 1994. Rescinded: Filed pharmacist who dispenses a controlled sub- records; and records are provided within April 14, 2000, effective Nov. 30, 2000. stance; three working days of a request; (D) Hospice means a public agency or pri- (O) Registration means a Missouri con- State v. Miller, 588 SW2d 237 (Mo. App. vate organization or subdivision of either of trolled substances registration; (P) Reregistration means a registration 1979). Evidence of the presence of these that is primarily engaged in providing issued to a person who was previously regis- amphetamine is sufficient to support a con- care to dying persons and their families and trolled substances conviction; no quantitative tered and whose application for reregistration meets the standards specified in 19 CSR 30- analysis is necessary. Those rules refiled was received by the Department of Health 35; between January 1 and March 31, 1976 were prior to the expiration of the previous regis- (E) Hospital employee means a nurse, not required to be published under section tration; physician, pharmacist or other responsible 536.021, RSMo. Also, courts must take judi- (Q) Temporary location registration means patient-care employee; cial notice of the contents of the Code of a registration issued to an individual practi- (F) Individual practitioner means a physi- State Regulations. tioner who: cian, dentist, veterinarian, optometrist or 1. Has a current Missouri professional Selvey v. State, 578 SW2d 64 (Mo. App. other individual licensed, registered or other- license to practice and is registered with the 1979). Phenmetrazine, originally established wise permitted by the United States or Mis- Department of Health at the address listed on statutorily as a Schedule III controlled sub- souri to dispense a controlled substance in the his/her professional license; stance, was rescheduled by the Division of course of professional practice, but does not 2. Has a federal Drug Enforcement Health to Schedule II. Such a rescheduling is include a pharmacist, a pharmacy or an insti- Administration registration that is valid in within the statutory power granted the Divi- tutional practitioner; Missouri; sion of Health and does not usurp the leg- (G) Institutional practitioner means a hos- 3. Anticipates practicing in Missouri islative power of the general assembly. pital or other person (other than an individu- within the next 12 months; al) licensed, registered or otherwise permit- 4. Does not practice for more than 90 State v. Davis, 450 SW2d 168 (Mo. App. ted by the United States or Missouri to consecutive calendar days at any location; 1970). Statutes which direct the Division of dispense a controlled substance in the course 5. Maintains a record of the date(s) and Health to prepare a list of drugs classified as of professional practice, but does not include location(s) of all practice activity in Missouri barbiturates and stimulants, the sale of which a pharmacy; and makes the record available to the Bureau are made unlawful by statute, does not violate (H) Long-term care facility means a nurs- of Narcotics and Dangerous Drugs. This the Missouri Constitution prohibition in Arti- ing home, retirement care, mental care, or record shall be retained for two years;

10 CODE OF STATE REGULATIONS (1/29/06) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

6. Maintains all required controlled sub- research or instructional activities with those cation; stance records at each location; substances, the registrant shall pay a fee of (D) Exemption from payment of a registra- 7. Does not receive or stock controlled thirty dollars ($30); tion or re-registration fee does not relieve the substances at any location; (D) Conduct research or instructional registrant of any other requirements or duties activities with a controlled substance listed in prescribed by law; and (2) Any term not defined in this rule shall Schedule I, the registrant shall pay a fee of (E) Any registration that is exempt from have the definition set forth in Chapter 195, thirty dollars ($30); payment pursuant to this section shall be valid RSMo. (E) Conduct chemical analysis with con- only when authorized persons are conducting trolled substances listed in any schedule, the activities in the course of their official duties AUTHORITY: section 195.195, RSMo 2000.* registrant shall pay a fee of thirty dollars or employment at their government practice Original rule filed April 14, 2000, effective ($30); and location. If the person conducts controlled Nov. 30, 2000. Amended: Filed Jan. 31, (F) Import or export controlled substances substance activities away from his or her gov- 2003, effective July 30, 2003. listed in any schedule, the registrant shall pay ernment practice location, the person shall *Original authority: 195.195, RSMo 1957, amended a fee of sixty-six dollars ($66). apply and submit the required fee for a non- 1971, 1989, 1993. exempt registration. (2) Lapsed Registration Fee. A late charge of ten dollars ($10) must be submitted with the AUTHORITY: sections 195.030 and 195.195, 19 CSR 30-1.013 Miscellaneous Fees original registration fee if an application is RSMo 2000.* Original rule filed April 14, submitted more than fifteen (15) days after a 2000, effective Nov. 30, 2000. Amended: PURPOSE: This rule establishes and fixes previous registration has expired. Filed Jan. 31, 2003, effective July 30, 2003. certain fees and charges statutorily autho- Amended: Filed April 29, 2011, effective Nov. rized to be made by the Department of Health (3) Time and Method of Payment and 30, 2011. in provisions codified in Chapters 195 and Refunds. Registration and re-registration fees 610, RSMo. shall be paid at the time when the application *Original authority: 195.030, RSMo 1939, amended 1971, for registration or re-registration is submitted 1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, amended 1971, 1989, 1993. (1) Fees for copies of public records or other for filing. This is a nonrefundable processing documents: fee. Payment should be made in the form of a (A) Copy, per page $ 0.25 personal, certified, or cashier’s check or 19 CSR 30-1.017 Registration Process (B) Research fee, per hour $15.00 money order made payable to Department of Health and Senior Services. Payments made PURPOSE: This rule establishes the period (2) Payment of fee may be required in in the form of stamps, foreign currency, or and expiration of registration, the process of advance. third-party endorsed checks will not be applying for registration, and information (3) Fees are nonrefundable. accepted. Applications and fees submitted required to complete an application for regis- electronically online shall use a credit card tration. AUTHORITY: section 195.030, RSMo Supp. and use the online payment system provided 1999 and 195.195, RSMo 1994.* Original on the department’s website. (1) Database and Survey Process. rule filed April 14, 2000, effective Nov. 30, (A) Applicants may apply for and receive a 2000. (4) Persons Exempt From Fee. The Depart- registration that is effective for up to twelve ment of Health and Senior Services shall (12) months. *Original authority: 195.030, RSMo 1939, amended 1971, exempt the following persons from payment (B) Applicants may apply with either a 1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, of a fee for registration or re-registration: paper application or through the department’s amended 1971, 1989, 1993. (A) Any official or agency of the United electronic online system. States Army, Navy, Marine Corps, Air Force, (C) Simultaneously with completing an 19 CSR 30-1.015 Registrations and Fees Coast Guard, Veterans Administration, or application for a controlled substances regis- Public Health Service who is authorized to tration, practitioners may also complete an PURPOSE: This rule establishes fees for var- procure or purchase controlled substances for annual voluntary census to assist the depart- ious types of registration, a late registration official use; ment in determining practitioner shortages fee, manner of payment, and exemption from (B) Any official, employee or other civil and underserved regions of the state. the registration fee. officer, or agency of the United States or state Required questions and fields for controlled or any political subdivision or agency who is substance registrations are marked with an (1) For each registration or re-registration authorized to purchase controlled substances, asterisk (*) in the electronic online system to— to obtain these substances from official and on paper applications. (A) Manufacture controlled substances, the stocks, to dispense or administer these sub- registrant shall pay a fee of sixty-six dollars stances, to conduct research, instructional (2) Period of Registration. ($66); activities, or chemical analysis with these (A) Any registration shall be current and (B) Distribute controlled substances, the substances, or any combination of them, in effective for twelve (12) months from the date registrant shall pay a fee of sixty-six dollars the course of his/her official duties or issued or until the expiration date assigned at ($66); employment; the time the registration is issued. No person (C) Dispense controlled substances listed (C) In order to claim exemption from pay- who is required to be registered shall conduct in Schedules II–V including dispensing of ment of a registration or re-registration fee, any activity for which registration is required controlled substances by individual practi- the registrant shall apply for exemption by without a current registration. No controlled tioners in training programs or to conduct completing appropriate sections of the appli- substance activities shall take place after a

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 11 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

registration expires until a new registration Schedules II, III, IV, and V, as authorized by fax number, email address, federal controlled has been issued. statute, unless a registration is restricted as to substances registration number, if applicable; (B) At the time any registration is issued, schedules or activities because of a settlement professional degree, if applicable; and pro- the registration shall be assigned to one of agreement, probation, or other disciplinary fessional license number, if applicable. If the twelve (12) groups which shall correspond to action taken by the Department of Health and applicant has an application pending for a the months of the year. The expiration date of Senior Services, the Drug Enforcement federal controlled substances registration all registrations within any group shall be the Administration, or a professional licensing number, the applicant shall indicate the appli- last day of the month designated for that board. Authority to conduct activities with cation is pending; group. controlled substances in Schedule I requires a (G) Whether the applicant, or any officer (C) Registrations for manufacturers and separate application and registration. of a corporate applicant, or individual distributors may be assigned to a single employed by any applicant having access to group, and the expiration date may be less (4) All applicants shall make full, true, and controlled substances, has ever entered a plea than twelve (12) months from the date the complete answers on the application. The of guilty, no contest, nolo contendere, or oth- registration was issued. Department of Health and Senior Services erwise been convicted of any violation of any (D) Training program registrations may be may require an applicant to submit docu- state or federal law related to the possession, assigned to a single group, and the expiration ments or written statements of fact relevant to manufacture, distribution, dispensing, or pre- date may be less than twelve (12) months the application as considered necessary to scribing of controlled substances. If the from the date the registration was issued. determine whether the application should be answer is yes, the applicant shall provide an (E) A certificate of registration shall be granted. The failure of the applicant to pro- explanation; made available online and printable to the vide these documents or statements within (H) If the applicant is an individual or a registrant which shall include the name and sixty (60) days after being requested to do so registrant that holds a professional license, address of the registrant, the expiration date shall be considered to be a waiver by the whether he or she is currently licensed and of the registration, and a registration number applicant of an opportunity to present these registered to practice his or her profession for the convenience of identifying a registra- documents or facts for consideration in grant- under the laws of this state; tion or a registrant. The same registration ing or denying the application. (I) If the applicant is not an individual or number may be used for a new registration registrant that holds a professional license, for the same person. (5) Applications for Individual Practitioner the applicant shall answer yes or no to Registrations. Applications by physicians, vet- whether the applicant is currently authorized (3) Requirements for All Applicants. erinarians, optometrists, podiatrists, and to conduct business under the laws of this (A) Any person who is required to be reg- researchers for Missouri Controlled Substance state; istered and who is not so registered may Registrations shall include: (J) Previous Discipline. If the applicant cur- apply for registration at any time. No person (A) The applicant’s full legal name (first rently holds or has previously held a state or required to be registered shall engage in any name, middle name, and last name), includ- federal controlled substance registration or activity for which registration is required ing any suffixes such as junior, senior, or III, state professional license or registration, the until the application for registration is pro- gender, race, and ethnicity; applicant shall answer yes or no to whether the cessed and the registration is issued. All (B) A listing of all addresses and practice applicant’s license, registration, or application applications are for new registrations. locations where controlled substance activi- or renewal thereof has ever been surrendered, (B) Applications for registration shall be ties will be taking place. The applicant’s revoked, suspended, denied, restricted, or made on forms designated by the Department street addresses, cities, zip codes, counties, placed on probation and if any such action is of Health and Senior Services. Application and state. The number of hours worked per pending. If the answer is yes, the applicant forms may be requested from the Missouri week for each location shall be provided for shall provide an explanation; Department of Health and Senior Services, performing direct patient care (non-hospital), (K) Whether the applicant is abusing or has PO Box 570, Jefferson City, MO 65102-0570 administration, research, teaching, in-patient abused or been treated for or diagnosed with or may be completed online and submitted hospital care, and other. The applicant shall addiction regarding controlled substances dur- electronically via the Missouri Department of also identify his or her primary, principle ing the past year. For purposes of this subsec- Health and Senior Services’ website at practice location, where he or she spends the tion, “abusing” or “abused” means using or www.health.mo.gov along with the required most time. This will be the principle practice having used a controlled substance in a man- fee. address that appears on the controlled sub- ner not authorized under Chapter 195, (C) A written application in paper form stances registration. A physical street address RSMo; shall contain the signature of the applicant is required and post office box addresses shall (L) Copies and attachments of any guilty and shall be provided to the Department of not be accepted; pleas, convictions, or disciplinary actions Health and Senior Services with any required (C) Whether the application is for a physi- identified in subsections (G) and (J) of this fee. This is a nonrefundable processing fee. cian, veterinarian, optometrist, podiatrist, or section, if the department does not already (D) An application which does not contain researcher; have them on file; or is not accompanied by the required infor- (D) His or her anticipated drug activities (M) The original signature of the individu- mation or fee may be denied sixty (60) days such as administering, prescribing, or dis- al applicant, if the application is submitted on after notifying the applicant of the deficiency. pensing; paper; (E) An application may be withdrawn by (E) The required fee and fee information. (N) His or her Social Security number and making a written request to the Department If claiming an exemption from a fee, the date of birth (MM/DD/YYYY); of Health and Senior Services. applicant shall identify the name of the gov- (O) The date the application is signed; (F) A person who is registered may con- ernment agency that employs him or her; (P) What drug schedules the applicant is duct activities with controlled substances in (F) His or her business telephone number, requesting authority in; and

12 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(Q) A listing of mid-level practitioners by claiming an exemption from a fee, the appli- hospital care, and other; name and license number with whom appli- cant must identify the name of the govern- (K) The applicant’s business phone num- cant has agreements pursuant to Chapter 334, ment agency; ber and fax number; RSMo. (L) Copies and attachments of any guilty (L) The applicant’s criminal history infor- pleas, convictions, or disciplinary actions mation as it pertains to controlled substance (6) Applications for Pharmacies and Busi- identified in subsections (I) and (J) of this laws. The applicant shall answer yes or no as nesses. Applications for retail pharmacies section, if the department does not already to whether the applicant or any employees and ambulance services, ambulatory surgery have them on file; with access to controlled drugs have ever pled centers, analytical laboratories, correctional (M) If the applicant is a retail business, the guilty, no contest, nolo contendere, or ever centers, distributors, exporters, hospices, applicant shall provide a letter from the Mis- been convicted of any violation of state or hospitals, importers, manufacturers, narcotic souri Department of Revenue that documents federal law relating to controlled substances; treatment programs, long-term care facility that no Missouri taxes are due and the appli- (M) Information regarding any previous or E-kits, teaching institutions, researchers, or cant is in good standing; and pending disciplinary actions regarding the other applicants not listed in sections (5)–(8), (N) The applicant shall sign and date an applicant’s professional license or any con- shall include: application submitted on paper and may use trolled substance registration, as to whether (A) The applicant’s full legal name, and if the electronic process if applying online. An the applicant’s privileges or authority have applicable, d/b/a name; application may be signed by the owner, chief been revoked, surrendered, suspended, (B) The applicant’s tax ID number, if executive officer or administrator, corporate restricted, or placed on probation, or if any applicable; officer, medical director, or pharmacist in application for a state license or any drug (C) The applicant’s facility license num- charge. registration has ever been denied; ber, if applicable, and federal controlled sub- (N) Whether the applicant is abusing or has stances registration number. If the applicant (7) Applications for Dentists. Applications abused or been treated for or diagnosed with has an application pending for a federal con- for dentists with the degrees of D.D.S. or addiction regarding controlled substances dur- trolled substances registration number, the D.M.D. shall include: ing the past year. For purposes of this subsec- applicant shall indicate an application is (A) The applicant’s full legal name (first tion, “abusing” or “abused” means using or pending; name, middle name, and last name), includ- having used a controlled substance in a man- (D) The applicant’s email address; ing any suffixes such as junior, senior, or III; ner not authorized under Chapter 195, (E) The applicant’s principle Missouri (B) His or her Social Security number and RSMo; business street address, city, state, county, date of birth (MM/DD/YYYY); (O) The application shall be submitted and zip code as it will appear on the con- (C) The applicant’s federal controlled sub- with the required fee and fee information. If trolled substances registration certificate. stances registration number. If the applicant claiming an exemption from a fee, the appli- Post office box numbers shall not be accept- has an application pending for a federal con- cant shall identify the name of the govern- ed. A separate mailing address may also be trolled substances registration number, the provided; applicant shall indicate the application is ment agency that employs him or her; (F) The applicant’s business telephone pending; (P) The applicant shall provide copies and number and fax number; (D) The applicant’s gender, race, and eth- attachments of any guilty pleas, convictions, (G) The applicant’s type of business activ- nicity; or disciplinary actions identified in subsec- ity, licensure type, licensure agency, and (E) The applicant’s email address; tions (L) and (M) of this section, if the license number; (F) The applicant’s primary specialty and department does not already have them on (H) What controlled substance schedules any board certification; file; and the applicant is requesting authority in; (G) Whether the applicant is licensed to (Q) The applicant shall sign and date an (I) The applicant’s criminal history infor- practice and conduct activities and the appli- application submitted on paper and may use mation as it pertains to controlled substance cant’s licensure type, license number, and the electronic process if applying online. laws. The applicant shall answer yes or no as name of licensing agency; to whether the owner, CEO or administrator, (H) What drug schedules the applicant is (8) Applications for Mid-Level Practitioners. corporate officer, medical director, pharma- requesting to conduct activities in; Applications for mid-level practitioners as cist in charge, or any employee with access to (I) The applicant’s anticipated drug activi- defined by 21 CFR 1300.01(b)(28) such as controlled drugs has ever pled guilty, no con- ties such as administering, prescribing, or advanced practice nurses and physician assis- test, nolo contendere, or ever been convicted dispensing; tants shall include: of any violation of state or federal law relat- (J) The applicant’s street addresses, city, (A) The applicant’s full legal name (first ing to controlled substances; zip code, county, and state of their primary, name, middle name, and last name), includ- (J) Whether there are any previous or principle practice location, where they spend ing any suffixes such as junior, senior, or III; pending disciplinary actions regarding the the most time. This will be the address that (B) The applicant’s social security number applicant’s professional license or any con- appears on the controlled substances registra- and date of birth (MM/DD/YYYY); trolled substance registration, whether the tion. Post office box numbers shall not be (C) The applicant’s federal controlled sub- applicant’s privileges or authority have been accepted. Applicants shall also provide any stances registration number. If the applicant revoked, surrendered, suspended, restricted, secondary practice locations and the number has an application pending for a federal con- or placed on probation, or if any application of chair-side work hours per week at each trolled substances registration number, the for a state license or any drug registration has location. The number of hours worked per applicant shall indicate the application is ever been denied; week for each location shall be provided for pending; (K) The application shall be submitted performing direct patient care (non-hospital), (D) The applicant’s gender, race, and eth- with the required fee and fee information. If administration, research, teaching, in-patient nicity;

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 13 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

(E) The applicant’s email address; tions (L) and (M) of this section, if the PURPOSE: This rule establishes procedures (F) Whether the applicant is licensed to department does not already have them on for modifying an existing registration, practice and conduct activities and the appli- file; and describes the conditions under which a regis- cant’s licensure type, license number, and (Q) The applicant shall sign and date an tration automatically terminates, and pro- name of licensing agency; application submitted on paper and may use hibits the transfer of a registration. (G) What controlled substance schedules the electronic process if applying online. (III, IV, or V) the applicant is requesting to (1) Modification of Registration. conduct activities in; AUTHORITY: section 195.195, RSMo 2000.* (A) Any registrant may apply to modify (H) Which physicians the applicant has Original rule filed April 14, 2000, effective his/her registration to authorize the handling collaborative or supervision agreements with; Nov. 30, 2000. Amended: Filed Jan. 31, of controlled substances in additional sched- (I) A copy of the applicant’s collaborative 2003, effective July 30, 2003. Amended: ules by submitting a request in writing to the or supervision agreements with physicians, Filed April 29, 2011, effective Nov. 30, 2011. department. No fee shall be required to be and a list of controlled substances from each paid for the modification. The application for physician that the mid-level practitioner is *Original authority: 195.195, RSMo 1957, amended modification shall be handled in the same authorized to conduct activities with, in that 1971, 1989, 1993. manner as an application for registration. agreement; (B) Any registrant may request to modify (J) The applicant’s street address, city, zip his or her name or address as shown on the 19 CSR 30-1.019 Registration Location code, county, and state of the applicant’s pri- registration provided that such a modification does not constitute a change of ownership or mary, principle practice location. This will be PURPOSE: This rule establishes require- location. The request shall be made in writing, the principle address that appears on the con- ments for the physical location of a registra- trolled substances registration. Post office and no fee shall be required to be paid for the tion. boxes shall not be accepted. Applicants shall modification. The request for changes may be also provide any secondary practice location (1) A controlled substance registration shall submitted electronically using the depart- addresses and the number of hours worked be issued at a U.S. Postal Service street ment’s online database system. Requests sub- per week for each location for performing address. mitted in paper form shall contain the regis- direct patient care (non-hospital), administra- trant’s signature. tion, research, teaching, in-patient hospital (2) A controlled substance registration shall (C) When the registrant’s name or address care, and other; be issued to an individual practitioner at a as shown on the registration changes, the reg- (K) The applicant’s business phone num- Missouri practice location where controlled istrant shall notify the Department of Health ber and fax number; substance and other patient care activities and Senior Services in writing, including the (L) The applicant’s criminal history infor- occur. registrant’s signature, prior to or within thir- mation as it pertains to controlled substance ty (30) days subsequent to the effective date laws. The applicant shall answer yes or no as AUTHORITY: section 195.195, RSMo 2000.* of the change. No fee shall be required to be to whether the applicant or any employee Original rule filed April 14, 2000, effective paid for the modification. with access to controlled drugs has ever pled Nov. 30, 2000. Amended: Filed Jan. 31, (2) Termination of Registration. guilty, no contest, nolo contendere, or ever 2003, effective July 30, 2003. Amended: (A) The registration of any person shall been convicted of any violation of state or Filed April 29, 2011, effective Nov. 30, 2011. federal law relating to controlled substances; terminate— (M) Information regarding any previous or *Original authority: 195.195, RSMo 1957, amended 1. On the expiration date assigned to the pending disciplinary actions regarding the 1971, 1989, 1993. registration at the time the registration was applicant’s professional license or any con- issued; trolled substance registration, as to whether 2. If and when the person dies; the applicant’s privileges or authority have 19 CSR 30-1.020 List of Excepted Sub- 3. If and when the person ceases legal been revoked, surrendered, suspended, stances existence; restricted, or placed on probation, or if any (Rescinded November 30, 2000) 4. If and when a business changes own- application for a state license or any drug ership, except— registration has ever been denied; AUTHORITY: section 195.195, RSMo Supp. A. The registration shall not termi- (N) Whether the applicant has abused or 1989. This rule was previously filed as 13 nate for thirty (30) days from the effective been treated for or diagnosed with addiction CSR 50-130.020. Original rule filed Sept. 28, date of the change if the new owner applies regarding controlled substances during the 1977, effective Jan. 13, 1978. Amended: for a registration within the thirty (30)-day past year. For purposes of this subsection, Filed Nov. 14, 1978, effective Dec. 11, 1978. period and the corresponding Drug Enforce- “abusing” or “abused” means using or having Amended: Filed Oct. 12, 1979, effective Nov. ment Administration registration remains used a controlled substance in a manner not 11, 1979. Amended: Filed Oct. 14, 1981, effective as provided for by the Drug authorized under Chapter 195, RSMo; effective Nov. 2, 1981. Amended: Filed Nov. Enforcement Administration; (O) The application shall be submitted 1, 1982, effective Dec. 11, 1982. Amended: 5. If and when the person discontinues with the required fee and fee information. If Filed Nov. 7, 1983, effective Dec. 11, 1983. business or changes business location, claiming an exemption from a fee, the appli- Amended: Filed Oct. 2, 1991, effective Feb. except— cant shall identify the name of the govern- 6, 1992. Rescinded: Filed April 14, 2000, A. The registration shall not termi- ment agency that employs the applicant; effective Nov. 30, 2000. nate for thirty (30) days from the effective (P) The applicant shall provide copies and date of the change if the person applies for a attachments of any guilty pleas, convictions, new registration or modification within the or disciplinary actions identified in subsec- 19 CSR 30-1.023 Registration Changes thirty (30)-day period; or

14 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

6. Upon the written request of the regis- (1) Independent Activities. The following ther contains these substances (other than trant. eight groups of activities are deemed to be substances for display purposes or lawful dis- (B) A mid-level practitioner’s registration independent of each other and require sepa- tribution as samples only) nor serves as a dis- shall be contingent upon the physician with rate registration: tribution point for filling sales orders; whom he or she has entered into an agree- (A) Manufacturing controlled substances; 3. An office used by a practitioner (who ment pursuant to Chapter 334, RSMo, having (B) Distributing controlled substances, is registered at another location) where con- a current and valid registration. When such except: trolled substances are prescribed but neither physician’s registration expires, closes, or is 1. A dispenser distributing less than administered nor otherwise dispensed as a no longer valid, any mid-level practitioner(s) 5% of the total combined dosage units of con- regular part of the professional practice of the with whom he or she has entered into an trolled substances distributed and dispensed practitioner at the office and where no sup- agreement shall no longer have controlled in a calendar year shall be exempt from plies of controlled substances are maintained; substance authority. The mid-level practition- obtaining a separate registration for distribut- 4. A location on the immediate or con- er(s) shall cease controlled drug activities ing; tiguous property of a hospital, provided that until the physician has obtained a new regis- 2. A dispenser distributing more than the location is owned and operated by the tration or the mid-level practitioner(s) 5% of the total combined dosage units of con- hospital and controlled substances are not obtain(s) another agreement with another trolled substances distributed and dispensed dispensed for use away from the location; physician pursuant to Chapter 334, RSMo. in a calendar year must obtain a separate reg- 5. A separate location from a registered Mid-level practitioners and any physician istration as a distributor but shall be exempt pre-hospital emergency medical service loca- with whom he or she has entered into an from maintaining separate inventories under tion where an emergency vehicle is housed agreement pursuant to Chapter 334, RSMo, 19 CSR 30-1.042; that does not have a permanent location of shall notify the Department of Health and (C) Dispensing controlled substances listed operation and which rotates between loca- Senior Services of the termination of any in Schedules II–V; tions at least every 30 days for operational such agreement. (D) Conducting research and instructional reasons other than controlled substance regis- (C) Any registrant who ceases legal exis- activities with controlled substances listed in tration; tence or discontinues business or profession- Schedule I; 6. A pre-hospital emergency medical al practice shall notify the Department of (E) Conducting research with controlled service located outside the state of Missouri Health and Senior Services of the effective substances listed in Schedules II–V; that renders assistance to a pre-hospital emer- (F) Conducting a narcotic treatment pro- date of this action and promptly return gency medical service located in the state of gram with narcotic controlled substances list- his/her registration certificate to the Depart- Missouri under a mutual aid contract in the ed in Schedules II–V; ment of Health and Senior Services. case of an emergency, major catastrophe or (G) Conducting instructional activities other unforeseen event that jeopardizes the with controlled substances listed in Schedules (3) Transfer of Registration. No registration ability of the local Missouri pre-hospital II–V; or any authority conferred by registration emergency medical service to promptly (H) Importing controlled substances; shall be assigned or otherwise transferred. respond. (I) Exporting controlled substances; (B) A separate registration is not required (J) Conducting chemical analysis with con- AUTHORITY: section 195.195, RSMo 2000.* for each separate practice location for an trolled substances listed in any schedule. Original rule filed April 14, 2000, effective individual practitioner who has a temporary Nov. 30, 2000. Amended: Filed Jan. 31, (2) No activity shall be conducted with any location registration. 2003, effective July 30, 2003. Amended: controlled substance in any schedule not Filed April 29, 2011, effective Nov. 30, 2011. requested for and shown on the current regis- AUTHORITY: section 195.195, RSMo 1994.* tration. Original rule filed April 14, 2000, effective *Original authority: 195.195, RSMo 1957, amended Nov. 30, 2000. 1971, 1989, 1993. (3) Separate Locations. A separate registra- *Original authority: 195.195, RSMo 1957, amended tion is required for each principal place of 1971, 1989, 1993. 19 CSR 30-1.025 List of Exempt Anabolic business or professional practice at one gen- Steroid Products eral physical location where controlled sub- (Rescinded November 30, 2000) stances are manufactured, distributed or dis- 19 CSR 30-1.027 Investigative and Admin- pensed by a person. istrative Procedures AUTHORITY: section 195.015.4, RSMo (A) For purposes of registration only, the Supp. 1989. Original rule filed July 6, 1993, following locations shall be deemed not to be PURPOSE: This rule establishes procedures effective Dec. 9, 1993. Rescinded: Filed places where controlled substances are man- for the handling and disposition of informa- April 14, 2000, effective Nov. 30, 2000. ufactured, distributed or dispensed: tion indicating violations of Chapter 195, 1. A warehouse where controlled sub- RSMo by the Department of Health, pursuant stances are stored by or on behalf of a reg- to the mandates of section 195.040. 19 CSR 30-1.026 Separate Registrations istered person, unless these substances are distributed directly from the warehouse to (1) The Department of Health may allow offi- PURPOSE: This rule defines the require- registrants other than the registered person or cers of state and federal administrative agen- ments for controlled substance registrations to persons not required to register; cies to attend and participate in informal con- for separate activities and for separate sites, 2. An office used by agents of a regis- ferences conducted with Missouri controlled and defines when a separate registration is trant where sales of controlled substances are substances registrants, Missouri regulated not required. solicited, made or supervised but which nei- chemical registrants or applicants in order to

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 15 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

assist the Department of Health in its delib- trols shall be expanded and extended accord- (A) The registrant shall complete and sub- erations. ingly. mit a Report of Loss, Theft or Diversion of Controlled Substances or Regulated Chemi- AUTHORITY: section 195.195, RSMo 1994.* (3) All registrants who receive or transfer cals to the Department of Health and Senior Original rule filed April 14, 2000, effective substantial quantities of controlled substances Services no later than seven (7) business days Nov. 30, 2000. in normal business operations shall employ after the discovery of such a loss. If the extent security procedures to guard against in-tran- of the loss cannot be fully determined in that *Original authority: 195.195, RSMo 1957, amended sit losses. time frame, the registrant shall contact the 1971, 1989, 1993. Department of Health and Senior Services to AUTHORITY: section 195.195, RSMo 1994.* request permission to submit an interim 19 CSR 30-1.030 Requirements for Con- Original rule filed April 14, 2000, effective report and arrange for a complete report to be trolled Substances Registration Nov. 30, 2000. completed and submitted. The registrant may (Rescinded November 30, 2000) attach a copy of a completed Drug Enforce- *Original authority: 195.195, RSMo 1957, amended ment Administration Loss Form in lieu of 1971, 1989, 1993. AUTHORITY: section 195.195, RSMo 1994. completing the back or second page of a This rule was previously filed as 13 CSR 50- Report of Loss, Theft or Diversion of Con- trolled Substances or Regulated Chemicals 131.010. Original rule filed Jan. 31, 1972, 19 CSR 30-1.032 Security for Nonpracti- form. In the event of theft, diversion or sus- effective April 1, 1972. Amended: Filed April tioners pected theft or diversion, the report submit- 12, 1983, effective July 11, 1983. Amended: ted to the Department of Health and Senior Filed May 31, 1989, effective Oct. 1, 1989. PURPOSE: This rule describes specific Services shall be accompanied by or followed Amended: Filed Nov. 26, 1991, effective April actions required of nonpractitioner regis- by a summary of the internal investigation 9, 1992. Amended: Filed Aug. 26, 1992, trants to maintain effective security. performed, the outcome of the investigation, effective April 8, 1993. Amended: Filed Nov. PUBLISHER’S NOTE: The secretary of state and a copy of any law enforcement agency 1, 1994, effective June 30, 1995. Rescinded: report completed if applicable. has determined that the publication of the Filed April 14, 2000, effective Nov. 30, 2000. (B) If an insignificant amount of a con- entire text of the material which is incorpo- trolled substance is lost during lawful activi- rated by reference as a portion of this rule ties authorized under Chapter 195, RSMo, 19 CSR 30-1.031 Physical Security Re- would be unduly cumbersome or expensive. the reason for the loss or a description of quirements This material as incorporated by reference in what occurred, the name of the drug and the this rule shall be maintained by the agency at amount lost shall be documented in writing, PURPOSE: This rule requires applicants and its headquarters and shall be made available signed by the registrant and attached or filed registrants to maintain security controls and to the public for inspection and copying at no with the last completed annual inventory. procedures to prevent theft and diversion of more than the actual cost of reproduction. controlled substances. This note applies only to the reference mate- (4) The registrant shall not distribute any rial. The entire text of the rule is printed controlled substance as a complimentary (1) All applicants and registrants shall pro- here. sample to any potential or current customer vide effective controls and procedures to without the prior written request of the cus- guard against theft and diversion of con- (1) Before distributing a controlled substance tomer, to be used only for satisfying the legit- trolled substances. In order to determine to any person who the registrant does not imate medical needs of patients of the cus- whether a registrant has provided effective know to be registered to possess the con- tomer and only in reasonable quantities. The controls against diversion, the Department of trolled substance, the registrant shall make a request must contain the name, address and Health shall use the security requirement set good faith inquiry either with the federal registration number of the customer and the forth in 19 CSR 30-1.032–19 CSR 30-1.034 Drug Enforcement Administration (DEA) or name of the specific controlled substance as standards for the physical security controls with the Department of Health and Senior desired. The request shall be preserved by the and operating procedures necessary to pre- Services to determine that the person is reg- registrant with other records of distribution of vent diversion. Substantial compliance with istered to possess the controlled substance. controlled substances. In addition, the these standards may be deemed sufficient by requirements for order forms shall be com- the Department of Health after evaluation of (2) The registrant shall design and operate a plied with for any distribution of a controlled the overall security system and needs of the system to disclose to the registrant suspicious substance listed in Schedule I or II. applicant or registrant. orders of controlled substances. The regis- trant shall inform the Department of Health (5) Entities registered with the Department of (2) Physical security controls shall be com- and Senior Services of suspicious orders Health and Senior Services as distributors mensurate with the schedules and quantity of when discovered by the registrant. Suspicious shall be deemed to have met security require- controlled substances in the possession of the orders include orders of unusual size, orders ments for storage of Schedule V controlled registrant in normal business operations. If a deviating substantially from a normal pattern substance drug products containing ephedrine controlled substance is transferred to a dif- and orders of unusual frequency. or pseudoephedrine if those products are ferent schedule, or a noncontrolled substance stored in compliance and consistent with the is listed on any schedule, or the quantity of (3) The registrant shall notify the Department regulated chemicals requirements set forth by controlled substances in the possession of the of Health and Senior Services of any theft or the United States Drug Enforcement Admin- registrant in normal business operations sig- significant loss of any controlled substances istration and 21 CFR 1309.71 which is here- nificantly increases, physical security con- upon discovery of this theft or loss. by incorporated by reference in this rule, as

16 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

published on April 1, 2005 by the U.S. Gov- trolled substances any person who has been agency reported to; the number of losses or ernment Printing Office, U.S. Superinten- found guilty or entered a plea of guilty or thefts the registrant has experienced in the dent of Documents, Washington, DC 20402- nolo contendere in a criminal prosecution past twenty-four (24) months; the type of loss 001; www.gpoaccess.gov/cfr/retrieve.html. under the laws of any state or of the United or diversion such as, break in/burglary, rob- This rule does not incorporate any subse- States for any offense related to controlled bery, employee theft, forged or falsified quent amendments or additions. Distributors substances or who has had an application for records, lost in transit, or other explained will be required to conduct background a state or federal controlled substance regis- type of loss; if lost in transit, the name of the checks on employees with access to these tration denied or has had his/her registration common carrier and name of consignee; the substances and to report losses of controlled revoked or surrendered for cause at any time. name(s) of the individual diverting controlled substances as required in 19 CSR 30-1.034. For purposes of this subsection, the term for cause means a surrender in place of or as a substances who was responsible for the theft AUTHORITY: sections 195.017, RSMo Supp. consequence of any federal or state adminis- or loss; copy of registrant’s internal inves- 2005 and 195.195, RSMo 2000.* Original trative, civil or criminal action resulting from tigative report involving the loss or theft; the rule filed April 14, 2000, effective Nov. 30, an investigation of the individual’s handling full name, date of birth and Social Security 2000. Emergency amendment filed Aug. 18, of controlled substances. number of the individual(s) responsible for 2005, effective Aug. 28, 2005, expired Feb. 1. A registrant may apply in writing to the theft or diversion, if known; a copy of the 23, 2006. Amended: Filed Sept. 1, 2005, the Department of Health and Senior Ser- police report if law enforcement was notified; effective Feb. 28, 2006. vices for a waiver of subsection (2)(A) of this if the loss or diversion was in transit, identi- rule for a specific employee. fy the origin of the delivery, the name of the *Original authority: 195.017, RSMo 1971, amended 1987, 1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195, 2. The Department of Health and Senior carrier(s) used and the name of the con- RSMo 1957, amended 1971, 1989, 1993. Services may issue a written waiver to any signee; a list of all controlled substances lost, registrant upon determination that a waiver stolen or diverted by their generic name, would be consistent with the public health trade name, the dosage strength, dosage form 19 CSR 30-1.033 Hearing Procedures on and safety. In making this determination, the and quantity; the signature of the person Controlled Substances Registration Department of Health and Senior Services completing the loss report and their title and (Rescinded November 30, 2000) shall consider—the duties of the employee, the date of their signature. If the extent of the the circumstances surrounding the convic- AUTHORITY: sections 195.040.11 and tion, the length of time since the conviction loss cannot be fully determined in that time 195.195, RSMo Supp. 1989. Original rule was entered, whether a waiver has been frame, the registrant shall contact the Depart- filed Aug. 26, 1992, effective April 8, 1993. granted by the federal Drug Enforcement ment of Health and Senior Services to request Rescinded: Filed April 14, 2000, effective Administration (DEA) pursuant to 21 CFR permission to submit an interim report and Nov. 30, 2000. 1301.76, the security measures taken by the arrange for a complete report to be complet- employer to prevent the theft and diversion of ed and submitted. The registrant may attach a controlled substances, and any other factors copy of a completed Drug Enforcement 19 CSR 30-1.034 Security for Practitioners consistent with public health and safety. Administration Loss Form in lieu of complet- PURPOSE: This rule describes specific (B) A registrant shall notify the Depart- ing the back or second page of a loss report actions required of practitioner registrants to ment of Health and Senior Services of the form provided by the Department of Health maintain effective security. This rule also cre- theft, diversion or significant loss of any con- and Senior Services. In the event of theft, ates and defines the form which must be used trolled substances or regulated chemicals diversion or suspected theft or diversion, the by a registrant to report any theft or loss of upon discovery. report submitted to the Department of Health 1. The registrant shall complete and controlled substances to the Department of and Senior Services shall be accompanied by submit a report of the loss or diversion of Health. or followed by a summary of the internal controlled substances to the Department of investigation performed, the outcome of the (1) Physical Security. Health and Senior Services no later than investigation, and a copy of any law enforce- (A) Controlled substances listed in Sched- seven (7) business days after the discovery of ment agency report completed if applicable. ules I and II shall be stored in a securely such a loss. The loss report form shall con- locked, substantially constructed cabinet. tain the following information: name and 2. If an insignificant amount of a con- (B) Controlled substances listed in Sched- address of registrant, business phone num- trolled substance is lost during lawful activi- ules III, IV and V shall be stored in a secure- ber; Missouri Controlled Substance Registra- ties authorized under Chapter 195, RSMo, ly locked, substantially constructed cabinet. tion Number; federal Drug Enforcement the reason for the loss or a description of However, pharmacies may disperse these sub- Administration Registration number; date of what occurred, the name of the drug and the stances throughout the stock of noncontrolled theft or loss; date of discovery of theft or amount lost shall be documented in writing, substances in such a manner as to obstruct loss; county of location; principal type of signed by the registrant and attached or filed the theft or diversion of the controlled sub- registration such as M.D., D.O., D.P.M., with the last completed annual inventory. stances. O.D., D.V.M., D.D.S., D.M.D., A.N.P., (C) This rule also shall apply to nonpracti- emergency medical service, pharmacy, hospi- AUTHORITY: section 195.195, RSMo 2000.* tioners authorized to conduct research or tal, manufacturer, nursing home kit, narcotic Original rule filed April 14, 2000, effective chemical analysis under another registration. treatment program, teaching institution, dis- Nov. 30, 2000. Amended: Filed Jan. 31, tributor, importer, exporter, or other speci- 2003, effective July 30, 2003. (2) Other Security. fied business; whether or not the loss or theft (A) The registrant shall not employ as an was reported to law enforcement; the name *Original authority: 195.195, RSMo 1957, amended agent or employee who has access to con- and phone number of the law enforcement 1971, 1989, 1993.

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 17 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

19 CSR 30-1.035 Requirements for Pre- number of the establishment maintaining tributor, importer and exporter shall maintain scribing, Dispensing and Administering these records. inventories and records of controlled sub- Controlled Substances (D) A registered person using any con- stances as follows: (Rescinded November 30, 2000) trolled substance in preclinical research or in (A) Inventories and records of controlled teaching at a registered establishment which substances listed in Schedules I and II shall AUTHORITY: sections 195.040.3(2), maintains records with respect to these sub- be maintained separately from all of the 195.050.6 and 195.195, RSMo 1994. Origi- stances is not required to keep records if s/he records of the registrant; nal rule filed Nov. 14, 1988, effective Feb. notifies the Department of Health of the (B) Inventories and records of controlled 24, 1989. Amended: Filed Aug. 26, 1992, name, address and registration number of the substances listed in Schedules III, IV and V effective April 8, 1993. Amended: Filed Nov. establishment maintaining the records. shall be maintained either separately from all 1, 1994, effective June 30, 1995. Rescinded: (E) Notice required by subsection (1)(D) of other records of the registrant or in a form Filed April 14, 2000, effective Nov. 30, 2000. this rule shall be given at the time the person that the information required is readily applies for registration or re-registration and retrievable from the ordinary business shall be made in the form of an attachment to records of the registrant. 19 CSR 30-1.036 Disposing of Unwanted the application, which shall be filed with the Controlled Substances application. (4) Each registered pharmacy shall maintain (Rescinded November 30, 2000) the inventories and records of controlled sub- (2) Maintenance of Records and Inventories. stances as follows: AUTHORITY: section 195.050.6, RSMo Every inventory and other record required to (A) Inventories and records of all con- 1986. Original rule filed Jan. 18, 1989, be kept under 19 CSR 30-1.041–19 CSR 30- trolled substances listed in Schedules I and II effective April 27, 1989. Rescinded: Filed 1.052, shall be kept by the registrant and be shall be maintained separately from all other April 14, 2000, effective Nov. 30, 2000. available, for at least two years from the date records of the pharmacy and prescriptions for of the inventory or record, for inspecting and these substances shall be maintained in a sep- copying by authorized employees of the arate prescription file; 19 CSR 30-1.040 Dispensing and Distribu- Department of Health, except that financial (B) Inventories and records of controlled tion of Controlled Substances in Certain and shipping records (such as invoices and substances listed in Schedules III, IV and V Situations packing slips, but not executed order forms) (Rescinded July 30, 2003) shall be maintained either separately from all may be kept at a central location rather than other records of the pharmacy or in a form at the registered location if the registrant AUTHORITY: section 195.195, RSMo 1986. that the information required is readily obtains from the Department of Health This rule was previously filed as 13 CSR 50- retrievable from ordinary business records of approval of his/her central record keeping 132.010. Original rule filed Jan. 31, 1972, the pharmacy and prescriptions for those sub- system and a permit to keep central records. effective April 1, 1972. Rescinded: Filed Jan. stances shall be maintained in a separate pre- The permit to keep central records shall be 31, 2003, effective July 30, 2003. scription file. subject to the following conditions: (A) The permit shall specify the nature of AUTHORITY: sections 195.050 and 195.195, 19 CSR 30-1.041 Records Requirements the records to be kept centrally and the exact RSMo 1994 and 195.030, RSMo Supp. location where the records will be kept; 1999.* Original rule filed April 14, 2000, PURPOSE: This rule defines the record keep- (B) The registrant agrees to deliver all or effective Nov. 30, 2000. ing and inventory requirements for various any part of these records to the registered classes of registrants. location within three working days of receipt *Original authority: 195.030, RSMo 1939, amended 1971, of a written request from the Department of 1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended 1971, 1989; and 195.195, RSMo 1957, amended 1971, (1) Persons Required to Keep Records. Health for these records and if the Depart- 1989, 1993. (A) Each registrant shall maintain the ment of Health chooses to do so in lieu of records and inventory required by 19 CSR requiring delivery of records to the registered 30-1.041–19 CSR 30-1.052, except as location, to allow authorized employees of 19 CSR 30-1.042 Inventory Requirements exempted by 19 CSR 30-1.041–19 CSR 30- the Department of Health to inspect the 1.052. records at the central location upon request PURPOSE: This rule defines requirements (B) Registered individual practitioners and by the employees without a warrant of any for the form and maintenance of controlled institutional practitioners are required to keep kind; substance inventories. records with respect to controlled substances (C) The failure of the registrant to perform which are prescribed, administered or dis- his/her agreements under the permit shall (1) General Requirements. pensed. revoke, without further action, the permit and (A) Each inventory shall contain a com- (C) A registered person using any con- all other such permits held by the registrant plete and accurate record of all controlled trolled substance in research conducted in under other registrations. In the event of a substances on hand on the date the inventory conformity with an exemption granted under revocation of other permits under subsection was taken. Controlled substances shall be section 505(i) or 512(j) of the federal Food, (2)(C) of this rule, the registrant, within 30 deemed to be on hand if they are in the pos- Drug and Cosmetic Act (21 U.S.C. 355(i) or days after the revocation, shall comply with session of or under the control of the regis- 360(j)) at a registered establishment which the requirement that all records be kept at the trant, including substances returned by a cus- maintains records in accordance with either registered location. tomer, substances ordered by a customer but of those sections is not required to keep not yet invoiced, substances stored in a ware- records if s/he notifies the Department of (3) Each registered individual practitioner, house on behalf of the registrant and sub- Health of the name, address and registration institutional practitioner, manufacturer, dis- stances in the possession of employees of the

18 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

registrant and intended for distribution as (5) Inventories of Manufacturers. Each regis- (7) Inventories of Dispensers and complimentary samples. tered manufacturer shall include the follow- Researchers. Each person registered to dis- (B) A separate inventory shall be made by ing information in his/her inventory: pense or conduct research with controlled a registrant for each registered location. In (A) For each controlled substance in bulk substances and required to keep records shall the event controlled substances are in the pos- form to be used in (or capable of use in) the include in his/her inventory the same infor- session or under the control of the registrant manufacture of the same or other controlled mation required of manufacturers in subsec- at a location for which s/he is not registered, or noncontrolled substances in finished form, tions (5)(C) and (D) of this rule. In deter- the substances shall be included in the inven- the name of the substance and the total quan- mining the number of units of each finished tory of the registered location to which they tity of the substance to the nearest metric unit form of a controlled substance in a commer- are subject to control or to which the person weight consistent with unit size (except that cial container which has been opened, the possessing the substance is responsible. Each for inventories made in 1971, avoirdupois dispenser shall do as follows: inventory for a registered location shall be weights may be utilized where metric weights (A) If the substance is listed in Schedule I kept at the registered location. are not readily available); or II, s/he shall make an exact count or mea- (C) A separate inventory shall be made by (B) For each controlled substance in the sure of the contents; a registrant for each independent activity for process of manufacture on the inventory date (B) If the substance is listed in Schedule which s/he is registered. the name of the substance, the quantity of the III, IV or V, s/he shall make an estimated (D) A registrant may take an inventory substance in each batch, stage of manufac- count or measure of the contents, unless the either as of the opening of business or as of ture, or both, identified by the batch number container holds more than 1,000 tablets or the close of business on the inventory date. or other appropriate identifying number and capsules in which case s/he must make an The registrant shall indicate on the inventory the physical form which the substance is to exact count of the contents. records whether the inventory is taken as of take upon completion of the manufacturing the opening or as of the close of business and process (for example, granulations, tablets, (8) Inventories of Importers and Exporters. the date the inventory is taken. capsules or solutions), identified by the batch Each registered importer or exporter shall (E) An inventory must be maintained in a number or other appropriate identifying num- include in his/her inventory the same infor- permanent written, typewritten or printed ber and if possible the finished form of the mation required of manufacturers in subsec- form. An inventory taken by use of an oral substance (for example, ten milligram (10 tions (5)(A), (C) and (D) of this rule. Each recording device must be transcribed prompt- mg) tablet or ten milligram (10 mg) concen- registered importer and exporter who also is ly. tration per fluid ounce or milliliter) and the registered as a manufacturer or as a distribu- number or volume; tor shall include in his/her inventory as an (2) Initial Inventory Date. (C) For each controlled substance in fin- importer or exporter only those stocks of (A) Every person required to keep records ished form, the name of the substance; each controlled substances that actually are sepa- who is registered with the Department of finished form of the substance (for example, rated from his/her stocks as a manufacturer Health after May 1, 1971 and who was not ten milligram (10 mg) tablet or ten milligram or as a distributor (for example, in-transit or registered previously shall take an inventory (10 mg) concentration per fluid ounce or in storage for shipment). of all stocks of controlled substances on hand milliliter); the number of units or volume of on the date s/he first engages in the manufac- each finished form in each commercial con- (9) Inventories for Chemical Analysts. Each ture, distribution or dispensing of controlled analytical laboratory registered to conduct substances. tainer (for example, four 100 tablet bottles or chemical analysis with controlled substances (B) Compliance with federal initial inven- three milliliter (3 ml) vials); the number of shall include in its inventory the same infor- tory date requirements is deemed satisfactory. commercial containers of each finished form mation required of manufacturers in subsec- Duplicate inventories are not required. (for example, four 100 tablet bottles or six three milliliter (3 ml) vials); tions (5)(A), (C) and (D) of this rule as to (3) Annual Inventory Date. After the initial (D) For each controlled substance not substances which have been manufactured, inventory is taken, the registrant shall take a included in subsections (5)(A)–(C) of this imported or received by the laboratory con- new inventory of all stocks of controlled sub- rule (for example, damaged, defective or ducting the inventory. If less than one kilo- stances on hand at least once a year. The impure substances awaiting disposal, sub- gram (1 kg) of any controlled substance annual inventory may be taken on any date stances held for quality control purposes or (other than a hallucinogenic controlled sub- that is within one year of the previous annu- substances maintained for extemporaneous stance listed in Schedule I) or less than twen- al inventory date. compoundings), the name of the substance; ty grams (20 g) of a hallucinogenic substance the total quantity of the substance to the near- listed in Schedule I (other than lysergic acid (4) Inventory Date for Newly Controlled est metric unit weight or the total number of diethylamide) or less than point five gram Substances. On the effective date of a rule by units of finished form; the reason for the sub- (0.5 g) of lysergic acid diethylamide, is on the Department of Health adding a substance stance being maintained by the registrant and hand at the time of inventory, those sub- to any schedule of controlled substances, whether the substance is capable of use in the stances need not be included in the inventory. which substance was not listed immediately manufacture of any controlled substance in Laboratories of the division may process up prior to that date in any such schedule, every finished form. to one hundred fifty grams (150 g) of any hal- registrant required to keep records who is lucinogenic substance in Schedule I without manufacturing, distributing or dispensing that (6) Inventories of Distributors. Each regis- regard to a need for an inventory of those substance shall take inventory of all stocks of tered distributor shall include in his/her substances. the substance on hand. After that, this sub- inventory the same information required of stance shall be included in each inventory manufacturers in subsections (5)(C) and (D) AUTHORITY: sections 195.030, RSMo Supp. made by the registrant. of this rule. 1999 and 195.195, RSMo 1994.* Original

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 19 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

rule filed April 14, 2000, effective Nov. 30, tors, importers and exporters of controlled address and registration number of the person 2000. substances. to whom distributed and the quantity dis- tributed or disposed; *Original authority: 195.030, RSMo 1939, amended 1971, (1) Records for Manufacturers. Each regis- (B) For each controlled substance in fin- 1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, tered manufacturer shall maintain records amended 1971, 1989, 1993. ished form— with the following information: 1. The name of the substance; (A) For each controlled substance in bulk 2. Each finished form (for example, ten 19 CSR 30-1.044 Continuing Records Gen- form to be used in or capable of use in or milligram (10 mg) tablet or ten milligram (10 eral Requirements being used in the manufacture of the same or mg) concentration per fluid ounce or other controlled or noncontrolled substances milliliter) and the number of units or volume PURPOSE: This rule sets requirements for in finished form— of finished form in each commercial contain- the maintenance of ongoing controlled sub- 1. The name of the substance; er (for example, 100 tablet bottle or three stance records. 2. The quantity manufactured in bulk milliliter (3 ml) vial); form by the registrant, including the date, 3. The number of containers of each (1) Every registrant required to keep records quantity and batch or other identifying num- such commercial finished form manufactured shall maintain on a current basis a complete ber of each batch manufactured; from bulk form by the registrant, including and accurate record of each such substance 3. The quantity received from other per- the information required in paragraph manufactured, imported, received, sold, sons including the date and quantity of each (1)(A)5. of this rule; delivered, exported or otherwise disposed of receipt and the name, address and registration 4. The number of units of finished by him/her. number of the other person from whom the forms, commercial containers, or both, substance was received; received from other persons, including the (2) Separate records shall be maintained by a 4. The quantity imported directly by the date of and number of units, commercial con- registrant for each registered location except registrant (under a registration as an tainers, or both, in each receipt and the as provided in 19 CSR 30-1.041(2). In the importer) for use in manufacture by him/her, name, address and registration number of the event controlled substances are in the posses- including the date, quantity and import per- person from whom the units were received; sion or under the control of a registrant at a mit or declaration number for each importa- 5. The number of units of finished form, location for which s/he is not registered, the tion; commercial containers, or both, imported substance shall be included in the records of 5. The quantity used to manufacture the directly by the registrant, including the date the registered location to which they are sub- same substance in finished form including the of and the number of units, commercial con- ject to control or to which the person pos- date and batch or other identifying number of tainers, or both, in each importation; sessing the substance is responsible. each manufacture; the quantity used in the 6. The number of units, commercial manufacture; the finished form (for example, containers, or both, manufactured by the reg- (3) Separate records shall be maintained by a ten milligram (10 mg) tablets or ten mil- registrant for each independent activity for istrant from units in finished form received ligram (10 mg) concentration per fluid ounce which s/he is registered. from others or imported including: the date or milliliter); the number of units of finished and batch or other identifying number of each (4) In recording dates of receipt, importation, form manufactured; the quantity used in qual- manufacture; the operation performed (for distribution, exportation or other transfers, ity control; the quantity lost during manufac- example, repackaging or relabeling); the the date on which the controlled substances turing and the causes for the loss, if known; number of units of finished form used in the are actually received, imported, distributed, the total quantity of the substance contained manufacture, the number manufactured and exported or otherwise transferred shall be in the finished form; the theoretical and actu- the number lost during the manufacture, with used as the date of receipt or distribution of al yields and other information as is neces- the causes for these losses, if known, and any documents of transfer (for example, sary to account for all controlled substances other information as is necessary to account invoices or packing slips). used in the manufacturing process; for all controlled substances used in the man- 6. The quantity used to manufacture ufacturing process; (5) Records must be provided to the Depart- other controlled and noncontrolled sub- 7. The number of commercial contain- ment of Health within three working days stances, including the name of each substance ers distributed to other persons including the upon request. manufactured and the information required in date of and number of containers in each dis- paragraph (1)(A)5. of this rule; tribution and the name, address and registra- AUTHORITY: sections 195.050 and 195.195, 7. The quantity distributed in bulk form tion number of the person to whom the con- RSMo 1994.* Original rule filed April 14, to other persons, including the date and quan- tainers were distributed; 2000, effective Nov. 30, 2000. tity of each distribution and the name, 8. The number of commercial contain- address and registration number of each per- ers exported directly by the registrant, includ- *Original authority: 195.050, RSMo 1939, amended 1971, son to whom a distribution was made; ing the date, number of containers and export 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993. 8. The quantity exported directly by the permit or declaration number for each expor- registrant, including the date, quantity and tation; export permit or declaration number of each 9. The number of units of finished forms, 19 CSR 30-1.046 Records for Manufac- exportation; commercial containers, or both, distributed or turers, Distributors, Importers and 9. The quantity distributed or disposed disposed of in any other manner by the regis- Exporters of in any other manner by the registrant (for trant (for example, by distribution of compli- example, distribution of complimentary sam- mentary samples or by destruction), including PURPOSE: This rule sets requirements for ples or by destruction) including the date and the date and manner of distribution or dispos- record keeping by manufacturers, distribu- manner of distribution or disposal, the name, al, the name, address and registration number

20 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

of the person to whom distributed and the and the name, address and registration num- (B) Each finished form (for example, ten quantity in finished form distributed or dis- ber of each person to whom a distribution milligram (10 mg) tablet or ten milligram (10 posed. was made; mg) concentration per fluid ounce or (D) The quantity disposed of in any other milliliter) and the number of units or volume (2) Records for Distributors. Each registered manner by the registrant except quantities of finished form in each commercial contain- distributor shall maintain records with the used in manufacturing by an importer under er (for example, 100 tablet bottle or three following information for each controlled a registration as a manufacture, which quan- milliliter (3 ml) vial); substance: tities are to be recorded, including the date (C) The number of commercial containers (A) The name of the substance; and manner of disposal and the quantity dis- of each finished form received from other (B) Each finished form (for example, ten posed. persons, including the date of and number of milligram (10 mg) tablet or ten milligram (10 containers in each receipt and the name, mg) concentration per fluid ounce or (4) Records for Exporters. Each registered address and registration number of the person milliliter) and the number of units or volume exporter shall maintain records with the fol- from whom the containers were received; of finished form in each commercial contain- lowing information for each controlled sub- (D) The number of units or volume of the er (for example, 100 tablet bottle or three stance: finished form dispensed including the name milliliter (3 ml) vial); (A) The name of the substance; and address of the person to whom it was dis- (C) The number of commercial containers (B) The quantity (or number of units or pensed, the date of dispensing, the number of of each such finished form received from volume in finished form) received from other units or volume dispensed and the written or other persons, including the date of and num- persons, including the date and quantity (or typewritten name or initials of the individual ber of containers in each receipt and the number of units or volume) of each receipt who dispensed or administered the substance; name, address and registration number of the and the name, address and registration num- (E) The number of units or volume of the person from whom the containers were ber of each person from whom the substance finished forms, commercial containers, or received; was received; both, disposed of in any other manner by the (D) The number of commercial containers (C) The quantity (or number of units or registrant, including the date and manner of of each finished form imported directly by volume in finished form) exported, including disposal and the quantity of the substance in the registrant including the date of and the the date, quantity (or number of units or vol- finished form disposed. number of containers in each importation; ume) and the export permit or declaration (2) Each individual practitioner shall main- (E) The number of commercial containers number for each exportation, but excluding tain a record of the date, full name and of each finished form distributed to other per- all quantities (and numbers of units and vol- address of the patient, the drug name, sons, including the date of and number of umes) manufactured by an exporter under a strength, dosage form and quantity for all containers in each distribution and the name, registration as a manufacture, which quanti- address and registration number of the person controlled substances prescribed or adminis- ties (and numbers of units and volumes) are tered. This record may be maintained in the to whom the containers were distributed; to be recorded; (F) The number of commercial containers patient’s medical record. When the controlled (D) The quantity disposed of in any other substance record is maintained in the of the finished form exported directly by the manner by the registrant including the date registrant, including the date of and the num- patient’s medical record and the practitioner and manner of disposal and the quantity dis- is not the custodian of the medical record, the ber of containers in each exportation; posed. (G) The number of units or volume of fin- practitioner shall make the controlled sub- ished forms, commercial containers, or both, stance record available as required in 19 CSR AUTHORITY: sections 195.050 and 195.195, 30-1.041 and 19 CSR 30-1.044. distributed or disposed of in any other man- RSMo 1994.* Original rule filed April 14, ner by the registrant (for example, by distri- 2000, effective Nov. 30, 2000. (3) Individual practitioners shall maintain the bution as complimentary samples) including records listed in subsections (1)(A)–(E) of the date and manner of distribution or dis- *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, this rule separately from patient medical posal, the name, address and registration records. number of the person to whom distributed 1993. and the quantity of the substance in finished (4) A registrant who transfers a controlled form distributed or disposed. 19 CSR 30-1.048 Records for Practitioners substance to or receives a controlled sub- and Researchers stance from another registrant shall maintain (3) Records for Importers. Each registered a written record of the transfer which con- importer shall maintain records with the fol- PURPOSE: This rule sets requirements for tains the following information: the date of lowing information for each controlled sub- record keeping for individual practitioners transfer, drug name, strength, dosage form, stance: and researchers. It also sets requirements for quantity, name, address and registration num- (A) The name of the substance; the use of facsimile and electronic computer ber of the transferring registrant and the (B) The quantity (or number of units or transmission of controlled substance pre- name, address and registration number of the volume in finished form) imported, including scriptions. receiving registrant. the date, quantity (or number of units or vol- ume) and import permit or declaration num- (1) Each individual practitioner, institutional (5) Drug Enforcement Administration official ber for each importation; practitioner and pharmacy shall maintain order forms shall be used for transfers of (C) The quantity (or number of units or records with the following information for Schedule II controlled substances. volume in finished form) distributed to other each controlled substance received, main- persons, including the date, quantity (or num- tained, dispensed or disposed: (6) A prescription may not be issued for an ber of units or volume) of each distribution (A) The name of the substance; individual practitioner to obtain controlled

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 21 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

substances for dispensing or administering to the verified printout in a separate file. controlled substances received as samples for patients. analysis are not required under section (1) of AUTHORITY: sections 195.050 and 195.195, this rule. (7) Prescriptions which are transmitted by RSMo 1994.* Original rule filed April 14, facsimile to a pharmacy for dispensing shall 2000, effective Nov. 30, 2000. AUTHORITY: sections 195.050 and 195.195, include the telephone number of the facsimi- RSMo 1994.* Original rule filed April 14, le machine or computer from which it is sent *Original authority: 195.050, RSMo 1939, amended 1971, 2000, effective Nov. 30, 2000. 1989 and 195.195, RSMo 1957, amended 1971, 1989, and the date and time of transmission. Imme- 1993. diately after a Schedule III, IV or V pre- *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, scription or a Schedule II prescription for a 1993. long-term care facility patient or hospice 19 CSR 30-1.050 Records for Chemical patient or for a Schedule II narcotic substance Analysts to be compounded for the direct administra- 19 CSR 30-1.052 Records for Long-Term tion to a patient by parenteral, intravenous, PURPOSE: This rule sets requirements for Care Facilities (LTCF) intramuscular, subcutaneous or intraspinal record keeping for chemical analyst regis- infusion is transmitted to a pharmacy by fac- trants. PURPOSE: This rule sets requirements for simile equipment, the practitioner or the record keeping by long-term care facility reg- practitioner’s agent shall sign and date the (1) Each person registered to conduct chemi- istrants. face of the prescription. The prescriptions cal analysis with controlled substances shall shall be maintained in chronological order maintain records with the following informa- (1) Long-term care facilities (LTCFs) and separately from patient medical records in a tion (to the extent known and reasonably their suppliers shall maintain written records manner so each prescription is readily ascertainable by him/her) for each controlled of transfers of controlled substances from the retrievable for inspection at the transmitting substance: supplier to the LTCF emergency kit. practitioner’s office. In the event the facsimi- (A) The name of the substance; le is transmitted from a long-term care facil- (B) The form(s) in which the substance is (2) The records shall include the date of ity or hospital, the prescription shall be main- received, imported or manufactured by the transfer; the name of each controlled sub- tained at the long-term care facility or registrant (for example, powder, granulation, stance, the strength, dosage form and quanti- hospital in chronological order separately tablet, capsule or solution) and the concen- ty; the name, address and controlled sub- from the patient medical records in a manner tration of the substance in that form (for stance registration number of the supplier and so each prescription is readily retrievable, or example, Chemically Pure (CP), United the name, address and controlled substance maintained in the patient medical records. States Pharmacopeia (USP), National Formu- registration number of the LTCF. Federal lary (NF), ten milligram (10 mg) tablet or ten Drug Enforcement Administration (DEA) (8) Any pharmacy receiving a controlled sub- milligram (10 mg) concentration per official order forms shall not be used to stance prescription transmitted by facsimile milliliter); record transfers of controlled substances to equipment shall maintain the facsimile copy (C) The total number of the forms LTCF emergency kits. of the prescription along with the date and received, imported or manufactured (for time of transmission and the telephone num- example 100 tablets, 30 one milliliter (1 ml) (3) No physician’s order or prescription shall ber of the facsimile machine from which it vials or ten grams (10 g) powder), including be used for initial stocking or replacement of originated, as a part of its original prescrip- the date and quantity of each receipt, impor- controlled substances in the emergency kit. tion records. tation or manufacture and the name, address Controlled substances contained in the kit and registration number, if any, of the person shall be obtained from a pharmacy, hospital (9) Any practitioner or practitioner’s agent from whom the substance was received; and or practitioner who holds a controlled sub- who transmits a controlled substance pre- (D) The quantity distributed, exported or stances registration. scription by electronic computer transmission destroyed in any manner by the registrant shall maintain a printout of each day’s trans- (except quantities used in chemical analysis (4) The administration and medical staff of missions. The practitioner or practitioner’s or other laboratory work), including the date the LTCF, in conjunction with the primary agent shall verify that the information in the and manner of distribution, exportation or supplier, shall designate in written protocols printout is correct and shall sign the printout. destruction and the name, address and regis- and procedures who may have access to the tration number, if any, of each person to emergency kit, who may administer con- (10) Each pharmacist who dispenses con- whom the substance was distributed or trolled substances from the emergency kit and trolled substances under a prescription exported. under what circumstances and a list of the transmitted by electronic computer trans- controlled substances it intends to maintain in mission, shall verify with the practitioner (2) Order forms, import and export permits, the emergency kit. These protocols and pro- within 30 days of the filling such prescrip- import invoices and export declarations relat- cedures shall be subject to review and tion that the prescription was authorized by ing to controlled substances shall be main- approval by the Department of Health. Only the practitioner. If verification is made by tained separately from all other records of the those individuals designated in the LTCF’s telephone, the pharmacist shall document registrant. written policies and procedures shall have the verification on the reverse of the pre- access to or administer controlled substances scription or in the computer. If verification (3) Records of controlled substances used in from the emergency kit. is made by sending the practitioner a copy chemical analysis or other laboratory work of a computer printout, the practitioner are not required. (5) Each administration of controlled sub- shall verify, sign and return the printout to stances from the emergency kit shall be based the pharmacy. The pharmacy shall maintain (4) Records relating to known or suspected upon a practitioner’s order and shall be

22 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

recorded in an administration record separate signed by the practitioner, except as provided section 195.060, RSMo, except for the signa- from the patient’s medical record. This in section 195.060.3, RSMo. A prescription ture of the practitioner. administration record shall include: the date, for a Schedule II controlled substance may be patient’s name, drug name, drug strength, transmitted from the prescribing practitioner (3) Written Prescriptions. All written con- dosage, ordering practitioner’s name and to a pharmacy by facsimile equipment or trolled substance prescriptions shall be signed name of the person administering the con- electronic computer transmission, provided by the prescribing practitioner on the date trolled substance. the original written, signed prescription is prescribed. No controlled substance prescrip- presented to the pharmacist for review prior tion shall be signed prior to the actual date it AUTHORITY: sections 195.050 and 195.195, to the actual dispensing of the controlled sub- is issued. RSMo 1994.* Original rule filed April 14, stance, except that— 2000, effective Nov. 30, 2000. (A) A prescription written for a Schedule AUTHORITY: section 195.195, RSMo 1994.* II narcotic substance to be compounded for Original rule filed April 14, 2000, effective *Original authority: 195.050, RSMo 1939, amended 1971, Nov. 30, 2000. 1989 and 195.195, RSMo 1957, amended 1971, 1989, the direct administration to a patient by par- 1993. enteral, intravenous, intramuscular, subcuta- *Original authority: 195.195, RSMo 1957, amended neous or intraspinal infusion may be trans- 1971, 1989, 1993. mitted by the practitioner or the practitioner’s 19 CSR 30-1.060 Determining Lawful Pre- agent to the pharmacy by facsimile or by elec- scribing, Dispensing and Administering of tronic computer transmission. The facsimile 19 CSR 30-1.064 Partial Filling of Sched- Controlled Substances or the computer transmission which has been ule II Prescriptions reduced to writing shall serve as and shall be PURPOSE: This rule defines the statutory maintained in the same manner as an original PURPOSE: This rule sets requirements for and regulatory basis for determining what is written prescription. the partial filling of Schedule II prescriptions. lawful prescribing, dispensing and adminis- (B) A prescription written for a Schedule II tering of controlled substances. substance for a resident of a long-term care (1) The partial filling of a prescription for a facility may be transmitted by the practition- controlled substance listed in Schedule II is When determining if controlled substances permissible, if the pharmacist is unable to are being lawfully prescribed, dispensed and er or the practitioner’s agent to the pharmacy supply the full quantity called for in a written administered by practitioners, the Depart- by facsimile or by electronic computer trans- ment of Health shall enforce Chapter 195, mission. The facsimile or the computer trans- or emergency oral prescription and s/he RSMo, the Department of Health rules in 19 mission which has been reduced to writing makes a notation of the quantity supplied on CSR 30 pertaining to controlled substances, shall serve as and shall be maintained in the the face of the written prescription (or writ- and the federal Controlled Substances Act 21 same manner as an original written prescrip- ten record of the emergency oral prescrip- U.S.C. 801–966, and its regulations, 21 CFR tion. tion). The remaining portion of the prescrip- 1300–1399. In determining lawful prescrib- (C) A prescription written for a Schedule tion may be filled within 72 hours of the first ing, dispensing and administering of con- II substance for a patient of a hospice may be partial filling; however, if the remaining por- trolled substances, the Department of Health transmitted by the practitioner or the practi- tion is not or cannot be filled within the 72- also shall consider the provisions of Chapters tioner’s agent to the pharmacy by facsimile or hour period, the pharmacist shall so notify 330, 332, 334, 335, 336, 338 and 340, by electronic computer transmission. The the prescribing individual practitioner. No RSMo, the rules in 4 CSR 110, 4 CSR 150, practitioner or the practitioner’s agent shall further quantity may be supplied beyond 72 4 CSR 200, 4 CSR 210, 4 CSR 220, 4 CSR note on the prescription that the patient is a hours without a new prescription. 230 and 4 CSR 270, and protocols relating to hospice patient. The facsimile or the comput- the respective practitioners established and on er transmission which has been reduced to (2) A prescription for a Schedule II con- file at the respective licensing boards. writing shall serve as and shall be maintained trolled substance written for a patient in a in the same manner as an original written long-term care facility (LTCF) or for a patient AUTHORITY: sections 195.030, RSMo Supp. prescription. with a medical diagnosis documenting a ter- 1999 and 195.195, RSMo 1994.* Original minal illness may be filled in partial quanti- rule filed April 14, 2000, effective Nov 30, (2) Prescriptions in Schedule III, IV or V. A ties to include individual dosage units. If 2000. pharmacist may dispense directly a controlled there is any question whether a patient may substance in Schedule III, IV or V only under be classified as having a terminal illness, the *Original authority: 195.030, RSMo 1939, amended 1971, a written prescription signed by a practition- pharmacist must contact the practitioner prior 1989, 1993, 1995, 1999 and 195.195, RSMo 1957, er or a facsimile of a written, signed pre- to partially filling the prescription. Both the amended 1971, 1989, 1993. scription transmitted by the practitioner or pharmacist and the prescribing practitioner his/her authorized agent or under an oral pre- have a corresponding responsibility to assure 19 CSR 30-1.062 Transmission of Prescrip- scription made by an individual practitioner that the controlled substance is for a termi- tions whether communicated by the practitioner or nally ill patient. The pharmacist must record his/her authorized agent or a prescription on the prescription whether the patient is PURPOSE: This rule sets requirements gov- transmitted by electronic computer transmis- “terminally ill” or an “LTCF patient.” A pre- erning the transmission of prescription infor- sion by the authorizing practitioner or the scription that is partially filled and does not mation. practitioner’s agent to the pharmacy. All oral contain the notation “terminally ill” or prescriptions and prescriptions transmitted by “LTCF patient” shall be deemed to have been (1) Prescriptions in Schedule II. A pharma- electronic computer transmission shall be filled in violation of Chapter 195, RSMo. For cist may dispense a controlled substance in promptly reduced to writing by the pharma- each partial filling, the dispensing pharmacist Schedule II only under a written prescription cist containing all information required in shall record on the back of the prescription

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 23 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

(or on another appropriate record, uniformly from an individual practitioner’s inventory by 19 CSR 30-1.070 Emergency Dispensing of maintained and readily retrievable) the date a mid-level practitioner with whom he or she Schedule II Substances of the partial filling, quantity dispensed, has entered into an agreement pursuant to remaining quantity authorized to be dis- Chapter 334, RSMo, when the practitioner is PURPOSE: This rule provides for the pre- pensed, and the identification of the dispens- not present at the registered location. scribing and dispensing of Schedule II drugs ing pharmacist. The total quantity of Sched- in an emergency situation. ule II controlled substances dispensed in all AUTHORITY: section 195.195, RSMo 2000.* partial fillings must not exceed the total quan- Original rule filed April 14, 2000, effective (1) In the case of a bona fide emergency sit- tity prescribed. Schedule II prescriptions for Nov. 30, 2000. Amended: Filed April 29, uation, as defined by the Department of patients in a LTCF or patients with a medical 2011, effective Nov. 30, 2011. Health, a pharmacist may dispense a Sched- diagnosis documenting a terminal illness ule II controlled substance upon receiving *Original authority: 195.195, RSMo 1957, amended shall be valid for a period not to exceed 60 oral authorization of a prescribing practition- 1971, 1989, 1993. days from the issue date unless sooner termi- er; provided, that— nated by the discontinuance of medication. (A) The quantity prescribed and dispensed 19 CSR 30-1.068 Administering In Emer- is limited to the amount adequate to treat the AUTHORITY: section 195.195, RSMo 1994.* gency Rooms patient during the emergency period. Pre- Original rule filed April 14, 2000, effective scribing or dispensing beyond the emergency Nov. 30, 2000. PURPOSE: This rule sets requirements for period must be pursuant to a written pre- administering controlled substances in hospi- scription; *Original authority: 195.195, RSMo 1957, amended tal emergency rooms. (B) The prescription immediately shall be 1971, 1989, 1993. reduced to writing by the pharmacist and (1) Controlled substances may be adminis- shall contain all information, except for the tered to a hospital emergency room patient prescribing practitioner’s signature; 19 CSR 30-1.066 Dispensing by Individual under a verbal order of a registered practi- (C) If the prescribing practitioner is not Practitioners tioner who is not physically present if— known to the pharmacist, s/he must make (A) The order is for a legitimate medical reasonable effort to determine that the oral PURPOSE: This rule sets requirements for purpose and the practitioner who orders the authorization came from a practitioner, by individual practitioners who dispense con- administration of a controlled substance is verifying his/her phone number against that trolled substances. acting in the usual course of his/her medical listed in the directory and other good faith efforts to insure his/her identity; (1) An individual practitioner who dispenses practice, after sufficient examination and establishment of a practitioner/patient rela- (D) Within seven days after authorizing an controlled substances shall— emergency oral prescription, the prescribing tionship; (A) Provide direct supervision to employ- practitioner must cause a written prescription (B) The practitioner who orders the admin- ees or agents who assist in the administering for the emergency quantity prescribed to be or dispensing of controlled substances. Con- istration of a controlled substance is a medi- delivered to the dispensing pharmacist. The trolled substances shall not be dispensed from cal staff member of the hospital; prescription shall have written on its face an individual practitioner’s inventory unless a (C) The administration of a controlled sub- authorization for emergency dispensing. The practitioner is physically in the registered stance is documented in a formal medical written prescription may be delivered to the location except pursuant to the provisions of record for the patient; pharmacist in person or by mail, but if deliv- section (2) of this rule; (D) The patient is assessed in the hospital ered by mail it must be postmarked within the (B) Package all controlled substances dis- by a practitioner, when available, or a regis- seven-day period. Upon receipt, the dispens- pensed from an individual practitioner’s tered nurse. If the patient is not assessed by a ing pharmacist shall attach this prescription inventory in compliance with the Poison Pre- practitioner in the hospital, a registered nurse to the oral emergency prescription which had vention Packaging Act of 1970, 15 U.S.C. shall assess the patient and confirm and doc- earlier been reduced to writing. The pharma- 1471–1476; ument in the patient’s medical record the cist shall notify the Department of Health if (C) Permanently affix a label to the exteri- existence of a preestablished pract- the prescribing practitioner fails to deliver a or of the drug container which includes: the itioner/patient relationship with the practi- written prescription to him/her; failure of the date, the name and address of the dispensing tioner who ordered administration of a con- pharmacist to do so shall void the authority practitioner, the name of the patient, direc- trolled substance; conferred by this section to dispense without tions for use, and the exact name and strength (E) The order is written in the patient’s a written prescription of a prescribing practi- tioner. of the drug dispensed for all controlled sub- medical record and is authenticated by the stances dispensed; ordering practitioner within a time frame and (2) Definition of Emergency Situation. For (D) Dispense only to individuals with manner as defined by the medical staff in the purpose of authorizing an oral prescrip- whom the practitioner has established and cooperation with nursing and administration. tion of a controlled substance listed in Sched- documented a practitioner/patient relation- This policy shall be included in the hospital’s ule II of the controlled substances law (sec- ship. An individual practitioner shall not dis- written policies and procedures. tions 195.010–195.320, RSMo), the term pense under the order of another practitioner emergency situation means those situations in not practicing at that location. AUTHORITY: section 195.195, RSMo 1994.* which the prescribing practitioner determines Original rule filed April 14, 2000, effective that— (2) Mid-level practitioners shall not indepen- Nov. 30, 2000. (A) Immediate administration of a con- dently purchase, stock, administer, and dis- trolled substance is necessary for proper pense controlled substances. Controlled sub- *Original authority: 195.195, RSMo 1957, amended treatment of the intended ultimate user; stances may be administered or dispensed 1971, 1989, 1993. (B) No appropriate alternative treatment is

24 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

available, including administration of a drug PURPOSE: This rule provides for dispensing may be sold, dispensed, distributed, or oth- which is not a controlled substance under Schedule V controlled substances without a erwise provided only as follows: Schedule II; prescription in certain situations. (A) Products that are designated Schedule (C) It is not reasonably possible for the V controlled substances which contain any prescribing practitioner to provide a written (1) Definitions. For the purposes of this rule, detectable amount of pseudoephedrine, prescription to be presented to the person dis- the following terms shall apply: ephedrine, phenylpropanolamine, their salts pensing the substance prior to the dispensing. (A) “Dispenser” means a pharmacist, or optical isomers, or salts of their optical intern pharmacist, or registered pharmacy isomers may be sold, distributed, or other- AUTHORITY: section 195.195, RSMo 1994.* technician who sells, dispenses, or otherwise wise provided only by a pharmacist or phar- Original rule filed April 14, 2000, effective provides methamphetamine precursor prod- Nov. 30, 2000. macy ancillary personnel as authorized by the ucts to purchasers. Missouri State Board of Pharmacy; *Original authority: 195.195, RSMo 1957, amended (B)“Methamphetamine precursor prod- (B) Dispensers of methamphetamine pre- 1971, 1989, 1993. ucts” means both Schedule V pseu- cursor products shall exercise reasonable care doephedrine products and any other drug in assuring that the purchaser has not exceed- product containing any detectable amount of ed the three and six-tenths (3.6)-gram limit 19 CSR 30-1.072 Dispensing of Schedule V ephedrine, pseudoephedrine, or phenyl- Substances per day or the nine (9)-gram limit per thirty propanolamine, including the salts or optical (30)-day period; PURPOSE: This rule provides for the pre- isomers or salts of optical isomers or (C) Dispensers shall utilize the real-time scribing, administering and dispensing of ephedrine, its salts or optical isomers, or salts electronic pseudoephedrine tracking system Schedule V drugs. of optical isomers of ephedrine, pseu- established and maintained by the Missouri doephedrine, or phenylpropanolamine. Department of Health and Senior Services (1) A pharmacist may dispense directly a (C) “Valid photo identification” means a (DHSS); controlled substance listed in Schedule V photo identification that is issued by a state or (D) Methamphetamine precursor products pursuant to a prescription. A prescription for the federal government or a document that, regulated by Missouri law as controlled sub- a controlled substance listed in Schedule V with respect to identification, is considered stances shall only be sold to customers eigh- may be refilled only as expressly authorized acceptable and showing the date of birth of teen (18) years of age or older who present a by the prescribing individual practitioner. If the person, including forms of identification valid photo identification; this authorization is not given, the prescrip- acceptable under federal regulations 8 CFR (E) Any dispenser who sells, dispenses, or tion may not be refilled. A pharmacist dis- 274a.2(b)(1)(v)(A) and (B). pensing those substances pursuant to a pre- otherwise provides any methamphetamine precursor product shall submit the following scription shall label the substance and file the (2) Dispensing Without a Prescription. A information to the DHSS electronic database prescription. controlled substance listed in Schedule V which is not a prescription drug under the at the time of purchase: (2) An individual practitioner may administer federal Food, Drug and Cosmetic Act, and is 1. Date and time of transaction; or dispense directly a controlled substance not a methamphetamine precursor product, 2. Pharmacy identification information, listed in Schedule V in the course of his/her may be dispensed by a pharmacist without a including: professional practice without a prescription. prescription to a purchaser at retail; provid- A. National Council for Prescription ed, that— Drug Programs identification number; or (3) An institutional practitioner may adminis- (A) Dispensing is made only by a pharma- B. National Association of Boards of ter or dispense directly (but not prescribe) a cist and not by a non-pharmacist employee Pharmacy identification number; or controlled substance listed in Schedule V even if under the supervision of a pharmacist C. Vendor assigned site and/or phar- only pursuant to a written prescription signed (although after the pharmacist has fulfilled macy identifier; by the prescribing individual practitioner or his/her professional and legal responsibili- 3. Purchaser information, including the pursuant to an oral prescription made by a ties, the actual cash transaction, credit trans- following fields: prescribing individual practitioner and action, or delivery may be completed by a A. Purchaser’s given or first name; promptly reduced to writing by the pharma- non-pharmacist); and B. Purchaser’s middle name (if any); cist (containing all information required (B) Dispensing, sale, distribution, or oth- C. Purchaser’s surname or last name; except for the signature of the prescribing erwise providing is limited to not more than D. The purchaser’s full name shall be individual practitioner) or pursuant to an two hundred forty cubic centimeters (240 cc) entered into the database without the use of order for medication made by an individual or eight ounces (8 oz.) of any controlled sub- initials or nicknames; practitioner which is dispensed for immediate stance containing opium, nor more than one E. Purchaser’s date of birth; and administration to the ultimate user. hundred twenty cubic centimeters (120 cc) or F. Purchaser’s address, including number, street, city, state, and zip code; AUTHORITY: section 195.195, RSMo 1994.* four ounces (4 oz.) of any other controlled 4. Identification of the form of valid Original rule filed April 14, 2000, effective substance, nor more than forty-eight (48) photo identification presented by the purchas- Nov. 30, 2000. dosage units of any controlled substance con- taining opium, nor more than twenty-four er; including issuing agency of the photo *Original authority: 195.195, RSMo 1957, amended (24) dosage units of any other controlled sub- identification and identification number 1971, 1989, 1993. stance may be dispensed at retail to the same appearing on the photo identification; purchaser in any given forty-eight (48)-hour 5. Purchaser’s signature; period. 6. Dispenser identification, including: 19 CSR 30-1.074 Dispensing Without a A. The name of the individual per- Prescription (3) Methamphetamine precursor products forming the transaction; or

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 25 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

B. The initials of the individual per- entered into the database where it may be actions in the database. forming the transaction; held pending until the system comes back on 1. Pharmacy employees shall only use 7. Transaction number, assigned by the line, or all of the required information for their own passwords for their own transac- database provider/vendor; transactions occurring during the time the tions and shall not dispense or make a sale 8. Purchase transaction information, DHSS electronic database is unavailable must under the password of another person. including the following: be recorded manually and entered into the 2. The database computer shall not be A. Product Universal Product Code DHSS electronic database by the registrant as left on and unattended so that another person (UPC); soon as is practicable, but within no more can use the previous user’s password. Users B. Product National Drug Code than forty-eight (48) hours following the shall close out their personal access when (NDC) (optional); resumption of operability. Documentation their activities are completed. C. Unique product description; and shall also identify the reason for the late entry 3. The pharmacist-in-charge shall be D. Purchase quantity, in grams as— into the DHSS electronic database; responsible for insuring pharmacy employees (I) Product grams per box and (J) At least once each month, the pharma- have adequate password privileges. The phar- number of boxes in transaction; cist-in-charge shall review the logbook of macist-in-charge shall insure that new (II) Product grams per dosage form changes and the changes captured by the employees have their own personal passwords such as tablet, capsule, or milliliter, and database to see what changes and alterations and also insure that ex-employees have their number of dosages per transaction; or pharmacy employees have entered regarding passwords removed from the system; (III) Other mechanism identified by sales of methamphetamine precursors. The (N) Access to Database by Law Enforce- the database provider/vendor; and date and time that the pharmacist-in-charge ment and Regulatory Agencies. 9. Form of pseudoephedrine in a manner conducts this monthly review shall be docu- 1. Access to the database and controlled defined by the database provider/vendor, mented in the bound logbook maintained by substance records shall be made available to including but not limited to: the pharmacy in addition to the electronic those agencies with authority under Chapter A. Tablet; system; 195 and Chapter 338, RSMo. B. Capsule; (K) Documentation in the bound logbook 2. Law enforcement agencies and regu- C. Liquid-filled gelcap; or shall be maintained in a readily retrievable latory agencies shall only have the ability to D. Liquid; manner for two (2) years from the date of the read and review and shall not be able to enter (F) Purchaser information provided and transaction and available for inspection and data or change records. entered into the DHSS electronic database copying by authorized DHSS employees and 3. It shall be the responsibility of each shall be the same as that on the presented law enforcement; agency’s administrator, chief, sheriff, or identification. Full names shall be used and (L) Denials of Sales and Dispensings. other chief executive officer to insure— not merely initials or a nickname; 1. Except as provided in subsection (D) A. Only authorized employees have (G) If the DHSS electronic database is not of this section, if an individual attempts to access to the database; available at the time of the sale of the purchase a methamphetamine precursor prod- B. Employees only use their own methamphetamine precursor product, the uct in violation of the three and six-tenths passwords and passwords are not shared; information to be provided in subsection (3.6) gram per day or nine (9) gram per C. Each employee adheres to all state (3)(E) above shall be recorded manually and month quantity restrictions or age restriction and federal laws regarding confidentiality; entered into the DHSS electronic database as established by sections 195.017 and 195.417, and soon as practicable after the system is back RSMo, the dispenser shall refuse to make the D. As employees change, that new online, as specified in subsection (3)(I). Sig- sale. The purchaser must be at least eighteen passwords are assigned to new employees and natures shall be captured on paper and then (18) years of age. passwords of ex-employees or transferred may be scanned to the database; 2. Sales of methamphetamine precursor employees are removed. The chief, sheriff, (H) Every dispenser who sells, dispenses products shall be denied to purchasers who or chief executive officer of the law enforce- or otherwise provides any methamphetamine are not able to produce a valid government ment or regulatory agency shall notify the precursor product shall maintain a bound log- issued identification card with the required DHSS in writing when an employee’s access book in addition to the electronic database information displayed on it. is to be added or removed; and system. The logbook shall be used for docu- 3. In the event that the dispenser per- (O) Method for Enforcement Agencies to menting a clear audit trail of any alterations, ceives that refusal of the purchase may place Gain or Alter Access to the Database. changes, or deletions to the original transac- him or her in imminent physical harm, then 1. Requests submitted to the DHSS to tion record, and sales that occurred during the dispenser may use the database safety add or remove an employee from access to system failures, including date and time of override function to proceed with the transac- the database shall— entry into the database, justification, and tion, provided that— A. Be submitted in writing on the resultant contacts with law enforcement A. When jeopardy is no longer per- agency’s letterhead; because the override button was used; ceived, the dispenser shall immediately con- B. State whether this is a request for (I) In the event that the DHSS electronic tact local law enforcement to report the pur- an employee to be granted access to the database is unavailable for five (5) minutes or chase; and database or a request to remove an employ- more due to a failure on the DHSS network B. The dispenser shall document in ee’s access; or because of a failure attributable to systems their manual log, the circumstance, the indi- C. Provide the employee’s full name other than the DHSS, the dispenser may con- vidual contacted at the local law enforcement and title; tinue with the transaction until the system is agency, and the date and time of that contact; D. Provide the employee’s Missouri available. All information required to be cap- (M) Pharmacy Employees. Employees in a POST certification number if the employee is tured with each transaction shall be retained pharmacy shall be assigned individual per- a sworn law enforcement officer; and and documented. The information may be sonal passwords to identify their own trans- E. Be signed by the chief, sheriff, or

26 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

chief executive officer of the requesting agen- receipt of the distribution; glass ampules of controlled substances shall cy. (C) The second pharmacy is registered to be destroyed by a nurse, pharmacist or physi- 2. Multiple requests for multiple dispense the controlled substance to be dis- cian in the presence of another hospital employees and actions may be submitted on tributed to him/her; employee; one (1) letter. (D) If the substance is a Schedule II con- 4. Single units of single dose packages 3. The DHSS shall notify the provider of trolled substance, the official order form des- of controlled substances which are contami- the database in writing of persons who are ignated by the federal Drug Enforcement nated other than by patient body fluids and given access or have access removed. Administration must be used to document the are not an infectious hazard, or have been 4. The DHSS may restrict access to the transfer. removed from their original or security pack- database to a limited number of people in aging, or are partially used, or are otherwise each agency, depending on the size of the AUTHORITY: section 195.195, RSMo 1994.* rendered unsuitable for patient use shall be agency, their locations, and number of sworn Original rule filed April 14, 2000, effective destroyed by a nurse, pharmacist or physician officers engaged in the actual enforcement of Nov. 30, 2000. in the presence of another hospital employee controlled substance laws. or returned to the pharmacy for destruction; *Original authority: 195.195, RSMo 1957, amended 5. The following shall be entered in the 1971, 1989, 1993. AUTHORITY: sections 195.017 and 195.417, controlled substance administration record or RSMo Supp. 2010 and sections 195.030, a separate controlled substance destruction 195.050, and 195.195, RSMo 2000.* Origi- record when the controlled substance is 19 CSR 30-1.078 Disposing of Unwanted nal rule filed April 14, 2000, effective Nov. destroyed in the patient care area: the date Controlled Substances 30, 2000. Emergency amendment filed Aug. and hour of destruction, the drug name and 18, 2005, effective Aug. 28, 2005, expired PURPOSE: This rule establishes procedures strength, the amount destroyed, the reason Feb. 23, 2006. Amended: Filed Sept. 1, 2005, for disposing of unwanted controlled sub- for destruction and the patient’s name and effective Feb. 28, 2006. Emergency amend- stances. room number. The nurse, pharmacist or ment filed July 9, 2010, effective Sept. 28, physician and the witnessing hospital employ- 2010, expired March 26, 2011. Amended: (1) A registrant in possession of any con- ee shall sign the entry. The drug shall be Filed June 29, 2010, effective Jan. 30, 2011. trolled substance(s) and desiring or required destroyed so that it is beyond reclamation. to dispose of such substance(s) shall: The controlled substance administration or *Original authority: 195.017, RSMo 1971, amended 1987, destruction records are to be retained for two 1989, 1994, 1996, 1997, 1998, 2001, 2005, 2006, 2008; (A) Return the controlled substances to the 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, original supplier; years and available for inspection by Depart- 1997, 1999; 195.050, RSMo 1939, amended 1971, 1989; (B) Transfer the controlled substances to a ment of Health investigators; 195.195, RSMo 1957, amended 1971, 1989, 1993; and distributor authorized to accept controlled 6. All other controlled substances which 195.417, RSMo 2001, amended 2003, 2005, 2008. substances for the purpose of disposal; are not patient contaminated but which are to (C) Submit a DEA Form 41 to the federal be disposed of shall be returned to the phar- 19 CSR 30-1.076 Emergency Distribution Drug Enforcement Administration requesting macy for disposal; by a Pharmacy authorization to dispose of the controlled sub- (B) When disposal of controlled substances stances in compliance with federal regula- is in the pharmacy— PURPOSE: This rule provides for dispensing tions; 1. Single units of controlled substances of controlled substances by a pharmacy in (D) Contact the Bureau of Narcotics and which are contaminated other than by patient emergency situations. Dangerous Drugs (BNDD), Department of body fluids and are not an infectious hazard, Health for information pertaining to subsec- or have been removed from their original or (1) An emergency means a situation where a tions (1)(A), (B) or (C). security packaging, or are partially used, or quantity of a controlled substance must be are otherwise rendered unsuitable for patient dispensed by a pharmacy to a patient who (2) The return, transfer or disposal of any use shall be destroyed by a pharmacist in the does not have an alternative source for that controlled substance shall be documented in presence of another hospital employee or held substance reasonably available to him/her and accordance with 19 CSR 30-1.044. for later destruction; the pharmacy cannot obtain that substance 2. All other controlled substances which through its normal distribution channels (3) In the event the registrant is a hospital, are not patient contaminated but are to be dis- within the time required to meet the immedi- the following procedures are to be used for posed of shall be placed in a suitable con- ate needs of the patient for that substance. In the destruction of controlled substances: tainer for storage and disposed of as the event of an emergency, a pharmacy may (A) When disposal of controlled sub- described in section (1) of this rule. distribute (without being registered as a dis- stances is in patient care areas— tributor) a controlled substance in Schedule 1. Controlled substances which are con- (4) If the registrant administers controlled III, IV or V to a second pharmacy in order taminated by patient body fluids are to be substances and is not a hospital, the following for that pharmacy to dispense the substance; destroyed by a physician, nurse or a pharma- procedures are to be used for the destruction provided, that— cist in the presence of another hospital of controlled substances: (A) The amount distributed does not employee; (A) Controlled substances which are con- exceed the amount required by the second 2. An excess volume of a controlled sub- taminated by patient body fluids are to be pharmacy for his/her immediate dispensing; stance which must be discarded from a destroyed, in the presence of another employ- (B) The distribution is recorded as being dosage unit just prior to use shall be ee, by the registrant or designee authorized to dispensed by the first pharmacy and the sec- destroyed by a nurse, pharmacist or physician administer; ond pharmacy records the substance as being in the presence of another hospital employee; (B) An excess volume of a controlled sub- received. Each pharmacy will retain a signed 3. The remaining contents of opened stance which must be discarded from a

ROBIN CARNAHAN (10/31/11) CODE OF STATE REGULATIONS 27 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

dosage unit just prior to use is to be destroyed, in the presence of another employ- ee, by the registrant or designee authorized to administer; (C) The remaining contents of opened glass ampules of controlled substances which are not patient contaminated are to be destroyed, in the presence of another employ- ee, by the registrant or designee authorized to administer; (D) When the controlled substance is destroyed by the registrant or designee autho- rized to administer, the following shall be entered in the controlled substances adminis- tration records or a separate controlled sub- stances destruction record: the date and amount destroyed, the reason for destruction and the registrant’s name and address. The registrant or designee doing the destruction and the witnessing employee shall sign the entry. The drug shall be destroyed so that it is beyond reclamation. The controlled sub- stances administration or destruction records are to be retained for two years and available for inspection by Department of Health inves- tigators; (E) All other controlled substances which are not patient-contaminated but are to be disposed of shall be placed in a suitable con- tainer for storage and disposed of as described in section (1) of this rule.

AUTHORITY: sections 195.050 and 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000.

*Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.

28 CODE OF STATE REGULATIONS (10/31/11) ROBIN CARNAHAN Secretary of State