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Rules of Department of Health Division 30—Division of Health Standards and Licensure Chapter 1—Controlled Substances

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19 CSR 30-1.010 Schedules of Controlled Substances ...... 3 19 CSR 30-1.020 List of Excepted Substances ...... 9 19 CSR 30-1.025 List of Exempt Anabolic Steroid Products ...... 9 19 CSR 30-1.030 Requirements for Controlled Substances Registration ...... 10 19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration ...... 20 19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances ...... 20 19 CSR 30-1.036 Disposing of Unwanted Controlled Substances ...... 21 19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations ...... 27

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 1 Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Title 19—DEPARTMENT OF G. Alpha-methylfentanyl (N-1- QQ. Para-fluorofentanyl (N-(4-fluoro- HEALTH (alphamethyl-beta-phenyl) phenyl)-N-(1-(2-phenethyl)-4- Division 30—Division of ethyl-4-piperidyl) propionanilide; piperidinyl) propanamide 9812 Health Standards and Licensure 1-(1-methyl-2-phenylethyl)-4 RR. Phenadoxone 9637 Chapter 1—Controlled Substances ((N-propanilido) piperidine) 9814 SS. Phenampromide 9638 H. Alpha-methylthiofentanyl (N-(1- TT. Phenomorphan 9647 19 CSR 30-1.010 Schedules of Controlled methyl-2-(2-thienyl)ethyl-4- UU. 9641 Substances piperidinyl)-N-phenylpro- VV. Piritramide 9642 panamide) 9832 WW. Proheptazine 9643 PURPOSE: Chapter 195, RSMo states in sec- I. Benzethidine 9606 XX. Properidine 9644 tion 195.230, RSMo that the Department of J. Betacetylmethadol 9607 YY. Propiram 9649 Health shall prepare a list of all drugs falling K. Beta-hydroxyfentanyl (N-(1- ZZ. Racemoramide 9645 within the purview of controlled substances. (2-hydroxy-2-phenethyl)-4- AAA. Tilidine 9750 Upon preparation, a copy of the list shall be piperidinyl)-N-phenylpro- BBB. Thiofentanyl (N-phenyl-N-(1- filed in the Office of the Secretary of State. It panamide) 9830 (2-thienyl)ethyl-4-piperidinyl)- also requires, in section 195.017.11, RSMo, L. Beta-hydroxy-3-methylfentanyl propanamide 9835 the Department of Health to revise and repub- (other name: N-(1-(2-hydroxy- CCC. Trimeperidine 9646 lish the schedules semiannually for two years 2-phenethyl)-3-methyl-4- 2. Opium derivatives. Unless specifical- from September 28, 1971, and annually after piperidinyl)-N-phenylpro- ly excepted or unless listed in another sched- that. panamide) 9831 ule, any of the following opium derivatives, M. Betameprodine 9608 its salts, isomers and salts of isomers when- PUBLISHER’S NOTE: The publication of the ever the existence of such salts, isomers and full text of the material that the adopting N. Betamethadol 9609 salts of isomers is possible within the specif- agency has incorporated by reference in this O. Betaprodine 9611 ic chemical designation: rule would be unduly cumbersome or expen- P. Clonitazene 9612 A. Acetorphine 9319 sive. Therefore, the full text of that material Q. Dextromoramide 9613 B. Acetyldihydrocodeine 9051 will be made available to any interested per- R. Diampromide 9615 C. Benzylmorphine 9052 son at both the Office of the Secretary of State S. 9616 D. Codeine methylbromide 9070 and the office of the adopting agency, pur- T. Difenoxin 9168 E. Codeine-N-Oxide 9053 suant to section 536.031.4, RSMo. Such U. Dimenoxadol 9617 F. 9054 material will be provided at the cost estab- V. Dimepheptanol 9618 G. Desomorphine 9055 lished by state law. W. Dimethylthiambutene 9619 H. Dihydromorphine 9145 X. Dioxaphetyl butyrate 9621 I. Drotebanol 9335 (1) Schedules of Controlled Substances. Y. Dipipanone 9622 J. Etorphine (except hydro- (A) Schedule I shall consist of the drugs Z. Ethylmethylthiambutene 9623 chloride salt) 9056 and other substances, by whatever official AA. Etonitazene 9624 name, common or usual name, chemical K. 9200 BB. Etoxeridine 9625 L. Hydromorphinol 9301 name or brand name designated, listed in this CC. Furethidine 9626 section. Each drug or substance has been M. Methyldesorphine 9302 DD. Hydroxypethidine 9627 N. Methyldihydromorphine 9304 assigned the Drug Enforcement Administra- EE. 9628 tion (DEA) Controlled Substances Code O. methylbromide 9305 FF. Levomoramide 9629 Number set forth opposite it. P. Morphine methylsulfonate 9306 GG. Levophenacylmorphan 9631 1. Opiates. Unless specifically excepted Q. Morphine-N-Oxide 9307 HH. 3-Methylfentanyl (N-(3-methyl-1- or unless listed in another schedule, any of R. Myrophine 9308 (2-phenylethyl)-4-piperidyl)- the following opiates, including their isomers, S. Nicocodeine 9309 N-phenylproanamide), its optical esters, , salts and salts of isomers, T. Nicomorphine 9312 esters and ethers, whenever the existence of and geometric isomers, salts U. Normorphine 9313 such isomers, esters, ethers and salts is pos- and salts of isomers 9813 V. Pholcodeine 9314 sible within the specific chemical designa- II. Morpheridine 9632 W. Thebacon 9315 tion: JJ. 3-Methylthiofentanyl (N-((3- 3. Hallucinogenic substances. Unless A. Acetyl--methylfentanyl methyl-1-(2-thienyl)ethyl-4- specifically excepted or unless listed in (N-(1-(1-methyl-2-phenethyl)-4- piperidinyl)-N-phenylpro- another schedule, any material, compound, piperidinyl)-N-phenylaceta- panamide) 9833 mixture or preparation, which contains any mide) 9815 KK. MPPP (1-methyl-4-phenyl-4- quantity of the following hallucinogenic sub- B. Acetylmethadol 9601 propionoxypiperidine) 9661 stances or which contains any of its salts, iso- C. Allylprodine 9602 LL. Noracymethadol 9633 mers and salts of isomers whenever the exis- D. Alphacetylmethadol (except levo- MM. Norlevorphanol 9634 tence of such salts, isomers and salts of iso- alphacetylmethadol also known as NN. Normethadone 9635 mers is possible within the specific chemical levo-alpha-acetylmethadol levo- OO. Norpipanone 9636 designation (For purposes of paragraph thadyl acetate or LAAM) 9603 PP. PEPAP (1-(-2-phenethyl)-4- (1)(A)3. of this rule only, the term isomer E. Alphameprodine 9604 phenyl-4-acetoxypi- includes the optical, position and geometric F. Alphamethadol 9605 peridine) 9663 isomers.):

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 3 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

A. 4-bromo-2,5-dimethoxyam- T. Peyote 7415 any material, compound, mixture or prepara- phetamine 7391 Meaning all parts of the plant presently clas- tion which contains any quantity of the fol- Some trade or other names: 4-bromo-2, 5- sified botanically as Lophophora williamsil lowing substances having a effect dimethoxy-a-methylphenethylamine; 4-bro- Lemaire, whether growing or not; the seeds on the central nervous system, including its mo-2,5-DMA; thereof; any extract from any part of such salts, isomers and salts of isomers: B. 2,5-dimethoxyamphetamine 7396 plant; and every compound, manufacture, A. (Some trade or other Some trade or other names: 2,5-dimethoxy-a- salt, derivative, mixture or preparation of names: 2-amino-1-phenyl-1- methylphenethylamine; 2,5-DMA; such plant, its seeds or extracts; propanone, alphaaminopropiophe- C. 2,5-dimethoxy-4-ethyl- U. N-ethyl-3-piperidyl benzilate 7482 none, 2-aminopropiophenone and 7399 V. N-methyl-3-piperidyl norephedrone) 1235 (Some trade or other names: DOET) 7399 benzilate 7484 B. 1503 D. 4-methoxyamphetamine 7411 W. 7437 C. (±)cis-4-methylaminorex Some trade or other names: 4-methoxy-a- X. Psilocyn 7438 ((±)cis-4,5-dihydro-4-methyl-5- methylphenethylamine; paramethoxyamphe- Y. 7370 phenyl-2-oxazolamine) 1590 tamine; PMA; Synthetic equivalents of the substances con- D. N-ethylamphetamine 1475 E. 5-methoxy-3,4-methylenedioxy tained in the plant or in the resinous extrac- E. N,N- (some amphetamine 7401 tives of Cannabis, sp, synthetic substances, other names: N,N-alpha-trimethyl- F. 4-methyl-2,5-dimethoxyam- derivatives and their isomers, or both, with benzeneethanamine; N,N-alpha- phetamine 7395 similar chemical structure and pharmacolog- trimethylphenethylamine), its salts, Some trade and other names: 4-methyl-2, 5- ical activity such as the following: optical isomers and salts of dimethoxy-a-methylphenethylamine; DOM; (I) , 1 cis or trans tetrahydro- optical isomers 1480 and STP; cannabinol and their optical isomers; 6. A temporary listing of substances G. 3,4-methylenedioxy ampheta- (II) , 6 cis or trans tetrahydro- subject to emergency scheduling under feder- mine 7400 cannabinol and their optical isomers; and al law shall include any material, compound, H. 3,4-methylenedioxymeth- (III) , 3, 4 cis or trans tetrahydro- mixture or preparation which contains any amphetamine (MDMA) 7405 cannabinol and its optical isomers (Since quantity of the following substances: I. 3,4-methylenedioxy-N-ethyl- nomenclature of these substances is not inter- A. N-(1-benzyl-4-piperidyl)-N-phenyl- amphetamine (also known as N- nationally standardized, compounds of these propanamide (benzylfentanyl), its ethyl-alpha-methyl-3,4 (methy- structures, regardless of numerical designa- optical isomers, salts and salts of lenedioxy) , tion of atomic positions are covered.); isomers 9818 N-ethyl MDA, MDE and Z. Ethylamine analog of phen- B. N-(1-(2-thienyl) methyl-4-piperidyl)- MDEA) 7404 cyclidine 7455 N-phenylpropanamide (thenylfen- J. N-hydroxy-3,4-methylenedioxy- Some trade or other names: N-ethyl-1- tanyl), its optical isomers, salts amphetamine (also known as phenylcyclohexylamine, (1-phenylcyclohexyl) and salts of isomers 9834 N-hydroxy-alpha-methyl-3,4- ethylamine, N-(1-phenylcyclohexyl)-ethy- C. (Some other (methylenedioxy) phenethyla- lamine, cyclohexamine, PCE; names: 2-methylamino-1-phenyl- mine and N-hydroxy MDA) 7402 AA. Pyrrolidine analog of phen- propan1-one; ephedrone; monome- K. 3,4,5-trimethoxy ampheta- cyclidine 7458 thylpropion UR 1431, its salts, mine 7390 Some trade or other names: 1(1-phenylcyclo- optical isomers and salts of L. Bufotenine 7433 hexyl)-pyrrolidine PCPy, PHP; optical isomers) 1237 Some trade and other names: 3->-Dimethy- BB. Thiophene analog of phency- D. (Some other names: laminoethyl)-5-hydroxyindole; 3-(2-dimethy- clidine 7470 aminoxaphen, 2-amino-5-phenyl-2- laminoethyl)-5-indolol; N, N-dimethylsero- Some trade or other names: 1-(1-(2-thienyl)- oxazoline or 4,5-dihydro-5-phenyl-2- tonin; 5-hydroxy-N,N-dimethyltryptamine; cyclohexyl)-piperidine, 2-thienyl analog of oxazolamine, its salts, optical mappine; , TPCP, TCP. isomers and salts of optical M. 7434 CC. 1-(1-(2-thienyl)cyclohexyl) isomers) 1585 Some trade and other names: N, N-Diethyl- pyrrolidine 7473 E. Alpha-ethyltryptamine, its opti- tryptamine; DET; Some other names: TCPy; and cal isomers, salts and salts of N. Dimethyltryptamine 7435 4. Depressants. Unless specifically isomers (Some other names: etrypta- Some trade or other names: DMT; excepted or unless listed in another schedule, mine; Alphaethyl-1H-indole-3- O. 7260 any material compound, mixture or prepara- ethanamine; 3-(2-aminobutyl) Some trade and other names: 7-Ethyl- tion which contains any quantity of the fol- indole) 7249 6,6>,7,8,9,10,12,13-octahydro-2-methoxy-6, lowing substances having a depressant effect (B) Schedule II shall consist of the drugs 9-methano-5H-pyrido (1',2':1,2) azepino (5, on the central nervous system, including its and other substances, by whatever official 4-b) indole; Tabernanthe iboga; salts, isomers and salts of isomers whenever name, common or usual name, chemical P. Lysergic acid diethylamide 7315 the existence of such salts, isomers and salts name or brand name designated, listed in this Q. Marihuana 7360 of isomers is possible within the specific section. Each drug or substance has been R. 7381 chemical designation: assigned the Controlled Substances Code S. 7374 A. Mecloqualone 2572 Number set forth opposite it. Some trade or other names: 3-Hexyl-1- B. Methaqualone 2565 1. Substances, vegetable origin or chem- Hydroxy-7,8,9,10-tetrahydro-6,6,9- 5. . Unless specifically ical synthesis. Unless specifically excepted or trimethyl-6H-dibenzo(b,d)pyran; Synhexyl; excepted or unless listed in another schedule, unless listed in another schedule, Schedule II

4 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

shall include any of the following substances B. Alphaprodine 9010 of isomers is possible within the specific whether produced directly or indirectly by C. 9020 chemical designation: extraction from substances of vegetable ori- D. Bezitramide 9800 A. Amobarbital 2125 gin or independently by means of chemical E. Bulk Dextropopoxyphene B. Glutethimide 2550 synthesis or by a combination of extraction (Non-dosage Forms) 9273 C. 2270 and chemical synthesis opium and opiate; and F. Butyl-nitrite no designated D. Phencyclidine 7471 any salt, compound, derivative or preparation number E. Secobarbital 2315 of opium or opiate, excluding , G. Carfentanil 9743 5. Hallucinogenic substances: thebaine-devied , , H. Dihydrocodeine 9120 A. Dronabinol (synthetic) in sesame oil , , naloxone and nal- I. Diphenoxylate 9170 and encapsulated in a soft gelatin capsule in a trexone and their respective salts, but includ- J. 9801 United States Food and Drug Administration ing the following: K. Isomethadone 9226 approved drug product 7369 A. Raw opium 9600 L. Levo-alphacetylmethadol 9220 (Some other names for dronabinol: (6aR- B. Opium extracts 9610 (Some other names: levo-alphaacetylmet- trans)-6a,7,8,10a-tetrahydro-6.6.9-trimethyl- C. Opium fluid 9620 hadol, levomethadyl acetate, LAAM) 9648 3-pentyl-6H-dibenzo (b,d) pyran-1-ol, or (-) D. Powdered opium 9639 M. 9210 -delta-9-(trans)-.); and E. Granulated opium 9640 N. 9220 B. 7379 F. Tincture of opium 9630 O. 9240 (Another name for nabilone: (±)trans-3-(1, G. Codeine 9050 P. 9250 1-dimethylheptyl)-6, 6a,7,8,10,10a-hexahy- H. Ethylmorphine 9190 Q. Methadone-Intermediate, 4-cyano- dro-1-hydroxy-6, 6-dimethyl-9H-dibenzo I. Etorphine hydrochloride 9059 2-dimethylamino-4,4-diphenyl (b,d) pyran-9-one.) J. Hydrocodone 9193 9254 6. Immediate precursors. Unless specif- K. Hydromorphone 9150 R Moramide-Intermediate, 2- ically excepted or unless listed in another L. Metopon 9260 methyl-3-morpholino-1,1-di- schedule, any material, compound, mixture M. Morphine 9300 phenylpropane-carboxylic or preparation which contains any quantity of N. 9143 acid 9802 the following substances: O. Oxymorphone 9652 S. (Meperidine) 9230 A. Immediate precursor to ampheta P. Thebaine 9333 T. Pethidine-Intermediate-A, 4-cyano- mine and : Any salt, compound, derivative or prepara- 1-methyl-4-phenylpiperidine 9232 (I) Phenylacetone 8501 tion thereof which is chemically equivalent or U. Pethidine-Intermediate-B, Some trade or other names: phenyl-2- identical with any of the substances referred ethyl-4-phenylpiperidine-4- propanone; P2P; benzyl methyl ketone; to in paragraph (1)(B)1. of this rule shall be carboxylate 9233 methyl benzyl ketone. included in Schedule II, except that these V. Pethidine-Intermediate-C, 1- B. Immediate precursors to phency- substances shall not include the isoquinoline methyl-4-phenylpiperidine-4- clidine (PCP): alkaloids of opium; opium poppy and poppy carboxylic acid 9234 (I) 1-phenylcyclohexylamine 7460 straw; leaves 9040 W. 9715 (II) 1-piperidinocyclohexane- and any salt, compound, derivative or prepa- X. Piminodine 9730 carbonitrile (PCC) 8603 ration of coca leaves including 9041 Y. Racemethorphan 9732 (C) Schedule III shall consist of the drugs and ecgonine 9180 Z. 9733 and other substances, by whatever official and their salts, isomers, derivatives and salts AA. 9740 name, common or usual name, chemical of isomers and derivatives and any salt, com- 3. Stimulants. Unless specifically name or brand name designated, listed in this pound, derivative or preparation thereof excepted or unless listed in another schedule, section. Each drug or substance has been which is chemically equivalent or identical any material, compound, mixture or prepara- assigned the DEA Controlled Substances with any of these substances, except that the tion which contains any quantity of the fol- Code Number set forth opposite it. substances shall not include decocainized lowing substances having a stimulant effect 1. Stimulants. Unless specifically ex- coca leaves or extraction of coca leaves, on the central nervous system: cepted or unless listed in another schedule, which extractions do not contain A. Amphetamine, its salts, optical any material, compound, mixture or prepara- cocaine 9041 isomers and salts of its optical tion which contains any quantity of the fol- or ecgonine 9180 isomers 1100 lowing substances having a stimulant effect and concentrate of poppy straw (the crude B. Methamphetamine, its salts, on the central nervous system, including its extract of poppy straw in either liquid, solid isomers and salts of its salts, isomers (whether optical, position or or powder form which contains the phenan- isomers 1105 geometric) and salts of such isomers whenev- threne alkaloids of the opium poppy) 9670 C. and its salts 1631 er the existence of such salts, isomers and 2. Opiates. Unless specifically excepted D. 1724 salts of isomers is possible within the specif- or unless in another schedule any of the fol- 4. Depressants. Unless specifically ic chemical designation: lowing opiates, including its isomers, esters, excepted or unless listed in another schedule, A. Those compounds, mixtures or ethers, salts and salts of isomers, esters and any material, compound, mixture or prepara- preparations in dosage unit form containing ethers whenever the existence of such iso- tion which contains any quantity of the fol- any stimulant substances listed in Schedule II mers, esters, ethers and salts is possible with- lowing substances having a depressant effect which compounds, mixtures or preparations in the specific chemical designation, dextror- on the central nervous system, including its were listed on August 25, 1971, as excepted phan and levopropoxyphene excepted: salts, isomers and salts of isomers whenever compounds under section 308.32 and any A. 9737 the existence of such salts, isomers and salts other drug of the quantitive composition

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 5 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

shown in that list for those drugs or which is B. Not more than 1.8 grams of G. Ethylestrenol the same except that it contains a lesser quan- codeine per one hundred milliliters (100 ml) H. Fluoxymesterone tity of controlled substances 1405 or not more than ninety milligrams (90 mg) I. Formebulone (Formebolone) B. Benzphetamine 1228 per dosage unit, with one (1) or more active, J. Mesterolone C. Chlorphentermine 1645 nonnarcotic ingredients in recognized thera- K .Methandienone D. Clortermine 1647 peutic amounts 9804 L. Methandranone E. 1615 C. Not more than three hundred mil- M. Methandriol 2. Depressants. Unless specifically ligrams (300 mg) of dihydrocodeinone per N. Methandrostenolone excepted or unless listed in another schedule, one hundred milliliters (100 ml) or not more O. Methenolone any material compound, mixture or prepara- than fifteen milligrams (15 mg) per dosage P. Methyltestosterone tion which contains any quantity of the fol- unit, with a fourfold or greater quantity of an Q. Mibolerone lowing substances having a depressant effect isoquinoline alkaloid of opium 9805 R. Nandrolone on the central nervous system: D. Not more than three hundred mil- S. Norethandrolone A. Any compound, mixture or prepa- ligrams (300 mg) of dihydrocodeinone per T. Oxandrolone ration containing: one hundred milliliters (100 ml) or not more U. Oxymesterone (I) Amobarbital 2126 than fifteen milligrams (15 mg) per dosage V. Oxymetholone (II) Secobarbital 2316 unit, with one (1) or more active nonnarcotic W. Stanolone (III) Pentobarbital 2271 ingredients in recognized therapeutic X. Stanozolol or any salt thereof and one (1) or more other amounts 9806 Y. Testolactone active medicinal ingredients which are not E. Not more than 1.8 grams of dihy- Z. Testosterone listed in any schedule; drocodeine per one hundred milliliters (100 AA. Trenbolone B. Any suppository dosage form con- ml) or not more than ninety milligrams (90 BB. Any salt, ester, or isomer of a drug taining: mg) per dosage unit, with one (1) or more or substance described or listed in this sub- (I) Amobarbital 2126 active, nonnarcotic ingredients in recognized paragraph, if that salt, ester or isomer pro- (II) Secobarbital 2316 therapeutic amounts 9807 motes muscle growth except an anabolic (III) Pentobarbital 2271 F. Not more than three hundred milli- steroid which is expressly intended for or any salt of any of these drugs and approved grams (300 mg) of ethylmorphine per one administration through implants to cattle or by the Food and Drug Administration for hundred milliliters (100 ml) or not more than other nonhuman species and which has been marketing only as a suppository; fifteen milligrams (15 mg) per dosage unit, approved by the secretary of Health and C. Any substance which contains any with one (1) or more active, nonnarcotic Human Services for that administration. quantity of a derivative of barbituric ingredients in recognized therapeutic (D) Schedule IV shall consist of the drugs acid or any salt thereof 2100 amounts 9808 and other substances, by whatever official D. Chlorexadol 2510 G. Not more than five hundred milli- name, common or usual name, chemical E. Lysergic acid 7300 grams (500 mg) of opium per one hundred name or brand name designated, listed in this F. Lysergic acid amide 7310 milliliters (100 ml) or per one hundred grams section. Each drug or substance has been G. Methyprylon 2575 (100 g) or not more than twenty-five mil- H. Sulfondiethylmethane 2600 ligrams (25 mg) per dosage unit, with one (1) assigned the DEA Controlled Substances I. Sulfonethylmethane 2605 or more active nonnarcotic ingredients in rec- Code Number set forth opposite it. J. 2610 ognized therapeutic amounts 9809 1. Narcotic drugs. Unless specifically K. Tiletamine and H. Not more than fifty milligrams (50 excepted or unless listed in another schedule, or any salt thereof 7295 mg) of morphine per one hundred milliliters any material, compound, mixture or prepara- Some trade or other names for a tiletamine- (100 ml) or per one hundred grams (100 g), tion containing limited quantities of any of zolazepam combination product: Telazol. with one (1) or more active, nonnarcotic the following narcotic drugs or any salts Some trade or other names for tiletamine: 2- ingredients in recognized therapeutic thereof: (ethylamino)-2-(2-thienyl)-cyclohexanone. amounts 9810 A. Not more than one milligram (1 Some trade or other names for zolazepam: 4- 5. Anabolic steroids. Unless specially mg) of difenoxin (DEA Drug Code (2-fluorophenyl)-6-8-dihydro-1,3,8- excepted or unless listed in another schedule, No. 9618) and not less than trimethylpyrazolo-(3,4-e) (1,4)-diazepin- any material, compound, mixture or prepara- twenty-five micrograms (25 :g) of 7(1H)-one, flupyrazapon. tion containing any quantity of the following sulfate per dosage unit; 3. 9400 substances, including its salts, isomers and B. Dextropopoxyphene (alpha-(+)-4- 4. Narcotics drugs. Unless specifically salts of isomers whenever the existence of dimethylamino-1,2-diphenyl-3- excepted or unless listed in another schedule, such salts of isomers is possible within the methyl-2-propionoxybutane) 9278 any material, compound, mixture or prepara- specific chemical designation. DEA has C. Narcotic drugs containing nonnarcot- tion containing limited quantities of any of assigned code 4000 for all anabolic steroids. ic active medicinal ingredients. Any com- the following narcotic drugs or any salts A. Boldenone pound, mixture or preparation containing any thereof: B. Chlorotestosterone (4-Chlortes- of the following limited quantities of narcotic A. Not more than 1.8 grams of tosterone) drugs or salts thereof, which shall include codeine per one hundred milliliters (100 ml) C. Clostebol one (1) or more nonnarcotic active medicinal or not more than ninety milligrams (90 mg) D. Dehydrochlormethyltestosterone ingredients in sufficient proportion to confer per dosage unit, with an equal or greater E. Dihydrotestosterone (4-Dihydro- upon the compound, mixture or preparation quantity of an isoquinoline alkaloid of testosterone) valuable medicinal qualities other than those opium 9803 F. Drostanolone possessed by the narcotic drug alone:

6 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(I) Not more than two hundred OO. 2285 portion to confer upon the compound, mix- milligrams (200 mg) of codeine per one hun- PP. Pinazepam 2883 ture or preparation valuable medicinal quali- dred milliliters (100 ml) or per one hundred QQ. Prazepam 2764 ties other than those possessed by the narcot- grams (100 g); RR. Quazepam 2881 ic drug alone: (II) Not more than one hundred SS. Temazepam 2925 A. Not more than two and five-tenths milligrams (100 mg) of dihydrocodeine per TT. Tetrazepam 2886 milligrams (2.5 mg) of diphenoxylate and not one hundred milliliters (100 ml) or per one UU. Triazolam 2887 less than twenty-five micrograms (25 :g) of hundred grams (100 g); or VV. 2783 atropine sulfate per dosage unit. (III) Not more than one hundred 3. . Any material, com- B. Not more than one hundred mil- milligrams (100 mg) of ethylmorphine per pound, mixture or preparation which con- ligrams (100 mg) of opium per one hundred one hundred milliliters (100 ml) or per one tains any quantity of the following sub- milliliters (100 ml) or per one hundred grams hundred grams (100 g). stances, including its salts, isomers (whether (100 g). 2. Depressants. Unless specifically optical, position or geometric) and salts of C. Not more than five tenths mil- excepted or unless listed in another schedule, such isomers, whenever the existence of such ligram (0.5 mg) of difenoxin (DEA Drug any material, compound, mixture or prepara- salts, isomers and salts of isomers is possible. Code No. 9618) and not less than twenty-five tion which contains any quantity of the fol- A. Fenfluramine 1670 micrograms (25 :g) of atropine sulfate per lowing substances, including its salts, isomers 4. Stimulants. Unless specifically ex- dosage unit. and salts of isomers whenever the existence cepted or unless listed in another schedule, 3. Stimulants. Unless specifically ex- of such salts, isomers and salts of isomers is any material, compound, mixture or prepara- empted or excluded or unless listed in anoth- possible within the specific chemical designa- tion which contains any quantity of the fol- er schedule, any material, compound, mix- tion: lowing substances having a stimulant effect ture or preparation which contains any quan- A. Alprazolam 2882 on the central nervous system, including its tity of the following substances having a stim- B. Barbital 2145 salts, isomers and salts of isomers: ulant effect on the central nervous system C. Bromazepam 2748 A. (±)—norpseudoephe- including its salts, isomers and salts of iso- D. Camazepam 2749 drine) 1230 mers: E. Chloral betaine 2460 B. Diethylpropion 1610 A. 1485 F. Chloral hydrate 2465 C. 1780 G. Chlordiazepoxide 2744 D. 1575 (2) Excluded Nonnarcotic Substances. The H. Clobazam 2751 E. 1605 following nonnarcotic substances which, I. Clonazepam 2737 F. 1580 under the Federal Food, Drug and Cosmetic J. Clorazepate 2768 G. (including organo- Act (21 U.S.C. 301), may be lawfully sold K. Clotiazepam 2752 metallic complexes and over the counter without a prescription are L. Cloxazolam 2753 chelates thereof) 1530 excluded from all schedules pursuant to sec- M. Delorazepam 2754 H. Phentermine 1640 tion 195.015(5), RSMo. N. Diazepam 2765 I. 1750 O. Estazolam 2756 J. SPA (-)-1-dimethyamino-1,2- P. Ethchlorvynol 2540 diphenylethane 1635 Q. Ethinamate 2545 5. Other substances. Unless specifically R. Ethyl loflazepate 2758 excepted or unless listed in another schedule, S. Fludiazepam 2759 any material, compound, mixture or prepara- T. Flunitrazepam 2763 tion which contains any quantity of the fol- U. Flurazepam 2767 lowing substances, including its salts: V. Halazepam 2762 A 9709 W. Haloxazolam 2771 (E) Schedule V shall consist of the drugs X. Ketazolam 2772 and other substances, by whatever official Y. Loprazolam 2773 name, common or usual name, chemical Z. Lorazepam 2885 name or brand name designated, listed in this AA. Lormetazepam 2774 subsection. BB. Mebutamate 2800 1. Narcotic drugs. Unless specifically CC. Medazepam 2836 excepted or unless listed in another schedule, DD. 2820 any material, compound, mixture or prepara- EE. 2264 tion containing any of the following narcotic FF. Methylphenobarbital drugs and their salts: (Mephobarbital) 2250 A. Buprenorphine 9064 GG. Midazolam 2884 2. Narcotic drugs containing nonnarcot- HH. Nimetazepam 2837 ic active medicinal ingredients. Any com- II. Nitrazepam 2834 pound, mixture or preparation containing any JJ. Nordiazepam 2838 of the following narcotic drugs, or their salts KK. Oxazepam 2835 calculated as the free anhydrous base or alka- LL. Oxazolam 2839 loid, in limited quantities as follows, which MM. Paraldehyde 2585 shall include one (1) or more nonnarcotic NN. Petrichloral 2591 active medicinal ingredients in sufficient pro-

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 7 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

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, Inc. Choate’s Leg Freeze LQ Chloral hydrate 246.67 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 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)

8 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

AUTHORITY: section 195.195, RSMo Supp. Amended: Filed April 3, 1991, effective Sept. will be made available to any interested per- 1993.* This rule was previously filed as 13 30, 1991. Amended: Filed May 1, 1991, son at both the Office of the Secretary of State CSR 50-130.010 and 19 CSR 10-130.010. effective Sept. 30, 1991. Amended: Filed and the office of the adopting agency, pur- Original rule filed Jan. 31, 1972, effective March 2, 1992, effective Aug. 6, 1992. suant to section 536.031.4, RSMo. Such April 1, 1972. Amended: Filed Oct. 4, 1972, Amended: Filed July 6, 1993, effective Dec. material will be provided at the cost estab- effective Oct. 14, 1972. Amended: Filed April 9, 1993. Emergency amendment filed Jan. 5, lished by state law. 4, 1973, effective April 14, 1973. Amended: 1994, effective Jan. 15, 1994, expired May Filed Sept. 28, 1973, effective Nov. 4, 1973. 14, 1994. Amended: Filed Jan. 5, 1994, (1) Excepted Stimulant or Depressant Com- Amended: Filed Jan. 3, 1974, effective Jan. effective July 30, 1994. pounds—Exempt Prescription Products. The 13, 1974. Amended: Filed Oct. 9, 1974, listed drugs in dosage unit form and any oth- effective Oct. 19, 1974. Amended: Filed July *Original authority 1957, amended 1971, 1989, 1993. er drug of the quantitative composition shown 17, 1975, effective July 27, 1975. Amended: State v. Miller, 588 SW2d 237 (Mo. App. in Part 1300 to end of Title 21, the Code of Filed Oct. 8, 1975, effective Oct. 18, 1975. 1979). Evidence of the presence of Federal Regulations, April 1990 or which is Refiled: March 24, 1976. Amended: Filed amphetamine is sufficient to support a con- the same except that it contains a lesser quan- Oct. 12, 1976, effective Jan. 13, 1977. trolled substances conviction; no quantitative tity of controlled substances or other sub- Amended: Filed March 15, 1977, effective analysis is necessary. Those rules refiled stances which do not have a stimulant, March 24, 1977. Amended: Filed Nov. 14, between January 1 and March 31, 1976 were depressant or hallucinogenic effect and which 1977, effective Nov. 6, 1977. Amended: Filed not required to be published under section are restricted by law to dispensing or pre- Sept. 28, 1977, effective Jan. 13, 1978. 536.021, RSMo. Also, courts must take judi- scription, are excepted from the provisions of Amended: Filed March 9, 1978, effective Feb. cial notice of the contents of the Code of sections 195.030, 195.040, 195.050 and 24, 1978. Amended: Filed Oct. 2, 1978, State Regulations. effective Sept. 27, 1978. Amended: Filed 195.100, RSMo as provided for in section Nov. 14, 1978, effective June 16, 1978. 195.017.6(5) and 8(3), RSMo. Selvey v. State, 578 SW2d 64 (Mo. App. Amended: Filed Nov. 14, 1978, effective Oct. 1979). Phenmetrazine, originally established (2) Excepted Chemical Preparations— 25, 1978. Amended: Filed Feb. 13, 1979, statutorily as a Schedule III controlled sub- Exempt Chemical Preparations. The listed effective Feb. 9, 1979. Amended: Filed Feb. stance, was rescheduled by the Division of 19, 1980, effective Feb. 11, 1980. Amended: preparations in unit form and any other Health to Schedule II. Such a rescheduling is Filed Oct. 14, 1980, effective July 24, 1980. preparation of the quantitative composition within the statutory power granted the Divi- Amended: Filed Oct. 14, 1980, effective Aug. shown in Part 1300 to end of Title 21, the sion of Health and does not usurp the leg- 21, 1980. Amended: Filed Oct. 14, 1981, Code of Federal Regulations, April 1990 islative power of the general assembly. effective Oct. 30, 1980. Amended: Filed Oct. which is the same except that it contains a lesser quantity of controlled substances or 14, 1981, effective May 8, 1981. Amended: State v. Davis, 450 SW2d 168 (Mo. App. other substances which do not have a stimu- Filed Oct. 14, 1981, effective Aug. 20, 1981. 1970). Statutes which direct the Division of lant, depressant or hallucinogenic effect are Amended: Filed Nov. 1, 1982, effective Dec. Health to prepare a list of drugs classified as excepted from the provisions of sections 11, 1982. Amended: Filed Jan. 12, 1983, and stimulants, the sale of which effective Feb. 11, 1983. Amended: Filed are made unlawful by statute, does not violate 195.030, 195.040, 195.050 and 195.110, March 11, 1983, effective April 1, 1983. the Missouri Constitution prohibition in Arti- RSMo as provided for in section Amended: Filed Sept. 2, 1983, effective Dec. cle I, section 31 against delegation of author- 195.017.6(5) and 8(3), RSMo. 11, 1983. Amended: Filed Nov. 7, 1983, ity to an agency to make a rule fixing a fine AUTHORITY: section 195.195, RSMo Supp. effective Dec. 11, 1983. Amended: Filed July or imprisonment as punishment for its viola- 12, 1984, effective Aug. 11, 1984. Amended: tion. 1989.* This rule was previously filed as 13 Filed Sept. 20, 1984, effective Nov. 11, 1984. CSR 50-130.020. Original rule filed Sept. 28, Amended: Filed Jan. 15, 1985, effective Feb. 1977, effective Jan. 13, 1978. Amended: 11, 1985. Amended: Filed May 29, 1985, 19 CSR 30-1.020 List of Excepted Sub- Filed Nov. 14, 1978, effective Dec. 11, 1978. effective June 27, 1985. Amended: Filed July stances Amended: Filed Oct. 12, 1979, effective Nov. 24, 1985, effective Aug. 26, 1985. Amended: 11, 1979. Amended: Filed Oct. 14, 1981, Filed Sept. 12, 1985, effective Oct. 11, 1985. PURPOSE: The Department of Health is effective Nov. 2, 1981. Amended: Filed Nov. Changed to 19 CSR 10-130.010, effective Oct. authorized to except by rule any compound, 1, 1982, effective Dec. 11, 1982. Amended: 11, 1985. Amended: Filed Jan. 3, 1986, mixture or preparation containing any stimu- Filed Nov. 7, 1983, effective Dec. 11, 1983. effective Jan. 16, 1986. Changed to 19 CSR lant or depressant substance if one or more Amended: Filed Oct. 2, 1991, effective Feb. 30-1.010, effective Aug. 11, 1986. Amended: active medicinal ingredients not having a 6, 1992. Filed April 17, 1987, effective May 14, 1987. stimulant or depressant effect on the central Amended: Filed July 3, 1987, effective Aug. nervous system is included to negate the *Original authority 1957, amended 1971, 1989. 27, 1987. Amended: Filed May 3, 1988, potential for abuse. The compounds, mixtures effective May 26, 1988. Amended: Filed Sept. and preparations excluded are listed in this 25, 1989, effective Oct. 27, 1989. Emergen- rule. 19 CSR 30-1.025 List of Exempt Anabolic cy amendment filed April 3, 1991, effective Steroid Products April 13, 1991, expired Aug. 10, 1991. Emer- PUBLISHER’S NOTE: The publication of the gency amendment filed May 1, 1991, effective full text of the material that the adopting PURPOSE: This rule maintains a list of May 11, 1991, expired Sept. 7, 1991. Emer- agency has incorporated by reference in this anabolic steroid products excluded from 19 gency amendment filed July 23, 1991, effec- rule would be unduly cumbersome or expen- CSR 30-1.010(1)(C)5. in conformance with tive Aug. 2, 1991, expired Nov. 28, 1991. sive. Therefore, the full text of that material federal law.

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 9 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

(1) Persons who in the course of legitimate 22. Testosterone Goldline Labs., 0182-3069 5. Conduct chemical analysis with con- Cypionate-Estra- Ft. Lauderdale, FL business handle products listed in the Table of diol Cypionate Injection trolled substances listed in any schedule, the Exempt Anabolic Steroid Products in this 23. Testosterone Goldline Labs., 0182-3073 registrant shall pay an annual fee of thirty section shall be exempt from the registration, Enanthate-Estra- Ft. Lauderdale, FL dollars ($30); and diol Valerate records, reports, prescriptions, physical secu- Injection 6. Import or export controlled sub- rity and import and export requirements asso- stances listed in any schedule, the registrant ciated with Schedule III substances. 24. Testosterone Schein Pharmaceuticals, 0364-6618 Enanthate-Estra- Port Washington, NY shall pay an annual fee of one hundred dollars diol Valerate ($100). Injection (B) Time and Method of Payment and (A) Trade Name Company NDC No. 25. Testosterone Steris Labs., Inc., 0402-0360 Refunds. Registration and reregistration fees 1. Androgyn LA Forest Pharmaceuticals, 0456-1005 Enanthate-Estra- Phoenix, AZ shall be paid at the time when the application St. Louis, MO diol Valerate 2. Andro-EEstro Rugby Laboratories, 0536-1605 Injection for registration or reregistration is submitted 90-4 Rockville Center, NY for filing. Payment should be made in the AUTHORITY: section 195.015.4, RSMo form of a personal, certified or cashier’s 3. depANDROGYN Forest Pharmaceuticals, 0456-1020 St. Louis, MO Supp. 1989.* Original rule filed July 6, check or money order made payable to 1993, effective Dec. 9, 1993. Department of Health. This is a nonrefund- 4. DEPO-T.E. Quality Research Pharma- 52765-257 able processing fee. Payments made in the ceuticals, Camel, IN *Original authority 195.95.4, RSMo 1971, amended form of stamps, foreign currency or third-par- 1989. 5. depTESTROGEN Martica Pharmaceuticals, 51698-257 ty endorsed checks will not be accepted. Phoenix, AZ (C) Persons Exempt From Fee. The 6. Duomone Wintec Pharmaceutical, 52047-360 Department of Health shall exempt the fol- Pacific, MO 19 CSR 30-1.030 Requirements for Con- lowing persons from payment of a fee for reg- 7. DURATESTRIN W.E. Hauck, Alpharetta, 43797-016 trolled Substances Registration istration or reregistration: GA 1. Any official or agency of the United 8. DUO-SPAN II Primedics Laboratories, 0684-0102 PURPOSE: These rules provide effective con- States Army, Navy, Marine Corps, Air Force, Gardena, CA trols on the manufacture, distribution, pre- Coast Guard, Veterans Administration or scribing, dispensing and administration of Public Health Service who is authorized to 9. Estratest Solvay Pharmaceuticals, 0032-1026 Marietta, GA narcotics and dangerous drugs in an effort to procure or purchase controlled substances for prevent them from being diverted from their official use; 10. Estratest HS Solvay Pharmaceuticals, 0032-1023 Marietta, GA intended uses to illicit markets, abuse and 2. Any official, employee or other civil misuse. officer or agency of the United States or state 11. PAN ESTRA Pan American Labs, 0525-0175 or any political subdivision or agency who is TEST Covington, LA PUBLISHER’S NOTE: The publication of the authorized to purchase controlled substances, 12. Premarin with Ayerst Labs., Inc., 0046-0879 full text of the material that the adopting to obtain these substances from official Methyltesto- New York, NY agency has incorporated by reference in this sterone stocks, to dispense or administer these sub- rule would be unduly cumbersome or expen- stances, to conduct research, instructional 13. Premarin with Ayerst Labs., Inc., 0046-0878 sive. Therefore, the full text of that material activities or chemical analysis with these sub- Methyltesto- New York, NY will be made available to any interested per- sterone stances, or any combination of them, in the son at both the Office of the Secretary of State course of his/her official duties or employ- 14. Synovex H Syntex Animal Health, and the office of the adopting agency, pur- ment; Pellets in process Palo Alto, CA suant to section 536.031.4, RSMo. Such 3. In order to claim exemption from material will be provided at the cost estab- 15. Synovex H Syntex Animal Health, payment of a registration or reregistration Pellets in process Palo Alto, CA lished by state law. granulation fee, the registrant shall apply for exemption by completing appropriate sections of the 16. Testagen Clint Pharmaceuticals, 55553-257 (1) Registration and Reregistration. Nashville, TN (A) Fee Amounts. For each registration or application; and reregistration to— 4. Exemption from payment of a regis- 17. TEST-ESTRO Rugby Laboratories, 0536-9470 tration or reregistration fee does not relieve Cypionates Rockville Centre, NY 1. Manufacture controlled substances, the registrant shall pay an annual fee of two the registrant of any other requirements or 18. Testosterone I.D.E.-Interstate, 0814-7737 duties prescribed by law. Cyp 50 Estradiol Amityville, NY hundred dollars ($200); Cyp 2 2. Distribute controlled substances, the (D) Period of Registration. registrant shall pay an annual fee of one hun- 1. At the time any person is first regis- 19. Testosterone Best Generics, No. 54274-530 tered, s/he shall be assigned to one (1) of Cypionate- Miami Beach, FL dred dollars ($100); Estradiol Cy- 3. Dispense controlled substances listed twelve (12) groups which shall correspond to pionate Injection in Schedules II—V or to conduct research or the months of the year. The expiration date of 20. Testosterone Schein Pharmaceuticals, 0364-6611 instructional activities with those substances, the registrations of all persons within any Cypionate-Estra- Port Washington, NY the registrant shall pay an annual fee of thir- group, will be the last day of the month des- diol Cypionate ty dollars ($30); ignated for that group. In assigning any per- Injection 4. Conduct research or instructional son to a group, the Department of Health 21. Testosterone Steris Labs., Inc., 0402-0257 activities with a controlled substance listed in may select a group, the expiration date of Cypionate-Estra- Phoenix, AZ diol Cypionate Schedule I, the registrant shall pay an annual which is more than one (1) year from the date Injection fee of thirty dollars ($30); the person was registered.

10 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

2. The preceding initial fee schedule neither contains these substances (other than on the certificate of registration. Any regis- does not apply to manufacturers or distribu- substances for display purposes or lawful dis- trant who ceases legal existence, discontinues tors. These registrants will be registered on tribution as samples only) nor serves as a dis- business or professional practice, or changes an annual basis only. tribution point for filling sales orders; and his/her name or address as shown on the cer- (E) Time for Application for Registration. C. An office used by a practitioner tificate of registration promptly shall notify 1. Any person who is required to be reg- (who is registered at another location) where the Department of Health of this fact. In the istered and who is not so registered may controlled substances are prescribed but nei- event of a change of name or address, the per- apply for registration at any time. No person ther administered nor otherwise dispensed as son may apply for a new certificate of regis- required to be registered shall engage in any a regular part of the professional practice of tration in advance of the effective date of the activity for which registration is required the practitioner at the office and where no change by filing an application and paying the until the application for registration is grant- supplies of controlled substances are main- appropriate fee in the same manner as an ed and certificate of registration is issued by tained. application for new registration. The applica- the Department of Health to that person. 2. A separate registration is not required tion shall be handled in the same manner as 2. Application forms may be requested for each separate practice location for an an application for registration. from—Missouri Department of Health, 1738 individual practitioner who holds a Missouri (K) Transfer of Registration. No registra- East Elm, Jefferson City, MO 65101. professional practice license; is registered tion or any authority conferred by registration 3. Forms for renewal of registration will with the federal Drug Enforcement Adminis- shall be assigned or otherwise transferred. be sent to each registrant sixty (60) days pri- tration (DEA); anticipates practicing in Mis- or to the expiration of the current registra- souri within the next twelve (12) months for (2) Requirements for the Physical Security of tion. no more than fourteen (14) days at more than Controlled Substances by Registrants. (F) Separate Registration for Independent one (1) location on a temporary basis and (A) Security Requirements Generally. Activities. The following eight (8) groups of provides a statement outlining the location(s) 1. All applicants and registrants shall activities are deemed to be independent of and date(s) of that practice activity at the time provide effective controls and procedures to each other and require separate registration: of application; maintains a record of the guard against theft and diversion of con- 1. Manufacturing controlled substances; date(s) and location(s) of all practice activity trolled substances. In order to determine 2. Distributing controlled substances; in Missouri and makes the record available to whether a registrant has provided effective 3. Dispensing narcotic and nonnarcotic the Bureau of Narcotics and Dangerous controls against diversion, the Department of and conducting research with nonnarcotic Drugs; and prescribes but does not dispense Health shall use the security requirement set and conducting instructional activities with or stock controlled substances at any Mis- forth in this section as standards for the phys- narcotic and nonnarcotic controlled sub- souri practice location. ical security controls and operating proce- stances listed in Schedules II—V; 3. A controlled substance registration dures necessary to prevent diversion. Sub- 4. Conducting research with narcotic shall be issued for a Missouri practice loca- stantial compliance with these standards may controlled substances listed in Schedules II— tion only. be deemed sufficient by the Department of V; (H) Application Information. All appli- Health after evaluation of the overall security 5. Conducting research and instruction- cants shall make full, true and complete system and needs of the applicant or regis- al activities with controlled substances listed answers on the application. The Department trant. in Schedule I; of Health may require an applicant to submit 2. Physical security controls shall be 6. Conducting chemical analysis with documents or written statements of fact rele- commensurate with the schedules and quality controlled substances listed in any schedule; vant to the application as considered neces- of controlled substances in the possession of 7. Importing controlled substances; and sary to determine whether the application the registrant in normal business operations. 8. Exporting controlled substances listed should be granted. The failure of the appli- If a controlled substance is transferred to a in Schedules I—IV. cant to provide these documents or state- different schedule, or a noncontrolled sub- (G) Separate Registration for Separate ments within a reasonable time after being stance is listed on any schedule, or the quan- Location. A separate registration is required requested to do so shall be considered to be a tity of controlled substances in the possession for each principal place of business or pro- waiver by the applicant of an opportunity to of the registrant in normal business opera- fessional practice at one (1) general physical present these documents or facts for consid- tions significantly increases, physical securi- location where controlled substances are eration in granting or denying the applica- ty controls shall be expanded and extended manufactured, distributed or dispensed by a tion. accordingly. person. (I) Modification in Registration. Any reg- 3. All registrants who receive or trans- 1. The following locations shall be istrant may apply to modify his/her registra- fer substantial quantities of controlled sub- deemed not to be places where controlled tion to authorize the handling of additional stances in normal business operations shall substances are manufactured, distributed or controlled substances by filing an application employ security procedures to guard against dispensed: in the same manner as an application for new in-transit losses. A. A warehouse where controlled registration. No fee shall be required to be (B) Security Controls for Nonpractitioners. substances are stored by or on behalf of a reg- paid for the modification. The application for 1. Before distributing a controlled sub- istered person, unless these substances are modification shall be handled in the same stance to any person who the registrant does distributed directly from the warehouse to manner as an application for registration. not know to be registered to possess the con- registrants other than the registered person or (J) Termination of Registration. The regis- trolled substance, the registrant shall make a to persons not required to register; tration of any person shall terminate if and good faith inquiry either with the federal B. An office used by agents of a reg- when the person dies, ceases legal existence, DEA or with the Department of Health to istrant where sales of controlled substances discontinues business or professional practice determine that the person is registered to pos- are solicited, made or supervised but which or changes his/her name or address as shown sess the controlled substance.

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 11 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

2. The registrant shall design and oper- trative, civil or criminal action resulting from include a pharmacist, a pharmacy or an insti- ate a system to disclose to the registrant sus- an investigation of the individual’s handling tutional practitioner; picious orders of controlled substances. The of controlled substances. 5. The term institutional practitioner registrant shall inform the Department of A. A registrant may apply in writing means a hospital or other person (other than Health of suspicious orders when discovered to the Department of Health for a waiver of an individual) licensed, registered or other- by the registrant. Suspicious orders include paragraph (2)(D)1. of this rule for a specific wise permitted by the United States or Mis- orders of unusual size, orders deviating sub- employee. souri to dispense a controlled substance in the stantially from a normal pattern and orders of B. The Department of Health may course of professional practice, but does not unusual frequency. issue a written waiver to any registrant upon include a pharmacy; 3. The registrant shall notify the Depart- determination that a waiver would be consis- 6. The term name means the official ment of Health of any theft or significant loss tent with the public health and safety. In mak- name, common or usual name, chemical of any controlled substances upon discovery ing this determination, the Department of name or brand name of a substance; of this theft or loss. Health shall consider—the duties of the 7. The term long-term care facility 4. The registrant shall not distribute any employee, the circumstances surrounding the means a nursing home, retirement care, men- controlled substance as a complimentary conviction, the length of time since the con- tal care, or other facility or institution which sample to any potential or current customer viction was entered, whether a waiver has provides extended health care to resident without the prior written request of the cus- been granted by the federal DEA to 21 CFR patients; tomer, to be used only for satisfying the legit- 1301.76, the security measures taken by the 8. The term pharmacist means any phar- imate medical needs of patients of the cus- employer to prevent the theft and diversion of macist licensed in Missouri to dispense con- tomer and only in reasonable quantities. The controlled substances, and any other factors trolled substances and shall include any other request must contain the name, address and consistent with public health and safety. person (for example, pharmacist intern) registration number of the customer and the 2. The registrant shall notify the Depart- authorized to dispense controlled substances name of the specific controlled substance ment of Health of the loss or theft of any con- under the supervision of a pharmacist desired. The request shall be preserved by the trolled substances upon discovery of the loss licensed in Missouri; registrant with other records of distribution of or theft. 9. The term prescription means an order controlled substances. In addition, the for medication which is dispensed to or for an requirements for order forms shall be com- (3) Recordkeeping Requirements for Regis- ultimate user but does not include an order plied with for any distribution of a controlled trants. for medication which is dispensed for imme- substance listed in Schedule I or II. (A) Definitions. As used in this rule, the diate administration to the ultimate user. (For (C) Physical Security Controls for Practi- following terms shall have the meanings spec- example, an order to dispense a drug to a bed tioners. ified: patient for immediate administration in a hos- 1. Controlled substances listed in Sched- 1. The term commercial container pital is not a prescription.); ules I and II shall be stored in a securely means any bottle, jar, tube, ampule or other 10. The term readily retrievable means locked, substantially constructed cabinet. receptacle in which a substance is held for that certain records are kept by automatic 2. Controlled substances listed in Sched- distribution or dispensing to an ultimate user data processing systems or other electronic or ules III, IV and V shall be stored in a secure- and, in addition, any box or package in which mechanized recordkeeping systems in a man- ly locked, substantially constructed cabinet. the receptacle is held for distribution or dis- ner that they can be separated out from all However, pharmacies may disperse these sub- pensing to an ultimate user. The term com- other records in a reasonable time, records stances throughout the stock of noncontrolled mercial container does not include any pack- are kept on which certain items are aster- substances in such a manner as to obstruct age liner, package insert of other material isked, redlined or in some other manner visu- the theft or diversion of the controlled sub- kept with or within a commercial container, ally identifiable apart from other items stances. nor any carton, crate, drug or other package appearing on the records or a combination of 3. Subsection (2)(C) of this rule also in which commercial containers are stored or these methods; and shall apply to nonpractitioners authorized to are used for shipment of controlled sub- 11. Any term not defined in this section conduct research or chemical analysis under stances; shall have the definition set forth in Chapter another registration. 2. The term dispenser means an individ- 195, RSMo. (D) Other Security Controls for Practition- ual practitioner, institutional practitioner, (B) Persons Required to Keep Records. ers. pharmacy or pharmacist who dispenses a 1. Each registrant shall maintain the 1. The registrant shall not employ as an controlled substance; records and inventory required by section (3) agent or employee who has access to con- 3. The term home infusion pharmacy of this rule except as exempted by section (3) trolled substances any person who has been means a pharmacy which compounds solu- of this rule. found guilty or entered a plea of guilty or tions for direct administration to a patient in 2. Registered individual practitioners nolo contendere in a criminal prosecution a private residence, long-term care facility or and institutional practitioners are required to under the laws of any state or of the United hospice setting by means of parenteral, intra- keep records with respect to controlled sub- States for any offense related to controlled venous, intramuscular, subcutaneous or stances listed in Schedule II which are pre- substances or who has had an application for intraspinal infusion; scribed and Schedules II—V controlled sub- a state or federal controlled substance regis- 4. The term individual practitioner stances which are administered or dispensed. tration denied or has had his/her registration means a physician, dentist, veterinarian or 3. A registered person using any con- revoked or surrendered for cause at any time. other individual licensed, registered or other- trolled substance in research conducted in For purposes of this subsection, the term for wise permitted by the United States or Mis- conformity with an exemption granted under cause means a surrender in place of or as a souri to dispense a controlled substance in the Section 505(i) or 512(j) of the federal Food, consequence of any federal or state adminis- course of professional practice, but does not Drug and Cosmetic Act (21 U.S.C. 355(i) or

12 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

360(j)) at a registered establishment which shall comply with the requirement that all not yet invoiced, substances stored in a ware- maintains records in accordance with either records be kept at the registered location. house on behalf of the registrant and sub- of those sections is not required to keep (D) Each registered manufacturer, distrib- stances in the possession of employees of the records if s/he notifies the Department of utor, importer and exporter shall maintain registrant and intended for distribution as Health of the name, address and registration inventories and records of controlled sub- complimentary samples. number of the establishment maintaining stances as follows: 2. A separate inventory shall be made by these records. 1. Inventories and records of controlled a registrant for each registered location in the 4. A registered person using any con- substances listed in Schedules I and II shall event controlled substances are in the posses- trolled substance in preclinical research or in be maintained separately from all of the sion or under the control of the registrant at a teaching at a registered establishment which records of the registrant; and location for which s/he is not registered, the maintains records with respect to these sub- 2. Inventories and records of controlled substances shall be included in the inventory stances is not required to keep records if s/he substances listed in Schedules III, IV and V of the registered location to which they are notifies the Department of Health of the shall be maintained either separately from all subject to control or to which the person pos- name, address and registration number of the other records of the registrant or in a form sessing the substance is responsible. Each establishment maintaining the records. that the information required is readily inventory for a registered location shall be 5. Notice required by paragraphs retrievable from the ordinary business kept at the registered location. (3)(B)4. and 5. of this rule shall be given at records of the registrant. 3. A separate inventory shall be made by the time the person applies for registration or (E) Each registered individual practitioner a registrant for each independent activity for reregistration and shall be made in the form required to keep records and institutional which s/he is registered. of an attachment to the application, which practitioner shall maintain inventories and 4. A registrant may take an inventory on shall be filed with the application. records of controlled substances in the man- a date that is within four (4) days of his/her (C) Maintenance of Records and Invento- ner prescribed in subsection (3)(D) of this biennial inventory date if, in advance, s/he ries. Every inventory and other record rule. notifies the Department of Health of the date required to be kept under section (3) of this (F) Each registered pharmacy shall main- on which s/he will take the inventory. A reg- rule, shall be kept by the registrant and be tain the inventories and records of controlled istrant may take an inventory either as of the available, for at least two (2) years from the substances as follows: opening of business or as of the close of busi- 1. Inventories and records of all con- ness on the inventory date. The registrant date of the inventory or record, for inspecting trolled substances listed in Schedules I and II shall indicate on the inventory records and copying by authorized employees of the shall be maintained separately from all other whether the inventory is taken as of the open- Department of Health, except that financial records of the pharmacy and prescriptions for ing or as of the close of business and the date and shipping records (such as invoices and these substances shall be maintained in a sep- the inventory is taken. packing slips, but not executed order forms) arate prescription file; and 5. An inventory must be maintained in a may be kept at a central location rather than 2. Inventories and records of controlled written, typewritten or printed form. An at the registered location if the registrant substances listed in Schedules III, IV and V inventory taken by use of an oral recording obtains from the Department of Health shall be maintained either separately from all device must be transcribed promptly. approval of his/her central recordkeeping sys- other records of the pharmacy or in a form (H) Initial Inventory Date. tem and permit to keep central records. The that the information required is readily 1. Every person required to keep permit to keep central records shall be subject retrievable from ordinary business records of records who is registered with the Depart- to the following conditions: the pharmacy and prescriptions for those sub- ment of Health after May 1, 1971 and who 1. The permit shall specify the nature of stances shall be maintained either in separate was not registered previously shall take an the records to be kept centrally and the exact prescription files for controlled substances inventory of all stocks of controlled sub- location where the records will be kept; listed in Schedules III, IV and V only or in a stances on hand on the date s/he first engages 2. The registrant agrees to deliver all or form that they are readily retrievable from the in the manufacture, distribution or dispensing any part of these records to the registered other prescription records of the pharmacy. of controlled substances. location within forty-eight (48) hours of Prescriptions will be deemed readily retriev- 2. Compliance with federal initial inven- receipt of a written request from the Depart- able if, at the time they are initially filed, the tory date requirements is deemed satisfactory. ment of Health for these records and if the face of the prescription is stamped in red ink Duplicate inventories are not required. Department of Health chooses to do so in lieu in the lower right corner with the letter C no (I) Biennial Inventory Date. Every two (2) of requiring delivery of records to the regis- less than one inch (1") high and filed either years following the date on which the initial tered location, to allow authorized employees in the prescription file for controlled sub- inventory is taken by a registrant, the regis- of the Department of Health to inspect the stances listed in Schedules I and II or in the trant shall take a new inventory of all stocks records at the central location upon request usual consecutively numbered prescription of controlled substances on hand. The bien- by the employees without a warrant of any file for noncontrolled substances. nial inventory may be taken on the date of the kind; and (G) General Requirements for Inventories. year on which the initial inventory was taken, 3. The failure of the registrant to per- 1. Each inventory shall contain a com- on the registrant’s regular general physical form his/her agreements under the permit plete and accurate record of all controlled inventory date, if any, which is nearest to and shall revoke, without further action, the per- substances on hand on the date the inventory does not vary by more than six (6) months mit and all other such permits held by the was taken. Controlled substances shall be from the biennial date that would otherwise registrant under other registrations. In the deemed to be on hand if they are in the pos- apply or any other fixed date which does not event of a revocation of other permits under session of or under the control of the regis- vary by more than six (6) months from the paragraph (3)(C)3. of this rule, the registrant, trant, including substances returned by a cus- biennial date that would otherwise apply. If within thirty (30) days after the revocation, tomer, substances ordered by a customer but the registrant elects to take the biennial

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 13 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

inventory on his/her regular general physical impure substances awaiting disposal, sub- listed in Schedule I (other than lysergic acid inventory date or another fixed date, s/he stances held for quality control purposes or diethylamide) or less than point five gram shall notify the Department of Health of this substances maintained for extemporaneous (0.5 g) of lysergic acid diethylamide, is on election and of the date on which the bienni- compoundings), the name of the substance; hand at the time of inventory, those sub- al inventory will be taken. the total quantity of the substance to the near- stances need not be included in the inventory. (J) Inventory Date for Newly Controlled est metric unit weight or the total number of Laboratories of the division may process up Substances. On the effective date of a rule by units of finished form; the reason for the sub- to one hundred fifty grams (150 g) of any hal- the Department of Health adding a substance stance being maintained by the registrant and lucinogenic substance in Schedule I without to any schedule of controlled substances, whether the substance is capable of use in the regard to a need for an inventory of those which substance was not listed immediately manufacture of any controlled substance in substances. prior to that date in any such schedule, every finished form. (P) General Requirements for Continuing registrant required to keep records who is (L) Inventories of Distributors. Each regis- Records. manufacturing, distributing or dispensing that tered distributor shall include in his/her 1. Every registrant required to keep substance shall take inventory of all stocks of inventory the same information required of records shall maintain on a current basis a the substance on hand. After that, this sub- manufacturers in paragraphs (3)(K)3. and 4. complete and accurate record of each such stance shall be included in each inventory of this rule. substance manufactured, imported, received, made by the registrant. (M) Inventories of Dispensers and Re- sold, delivered, exported or otherwise dis- (K) Inventories of Manufacturers. Each searchers. Each person registered to dispense posed of by him/her, except that no registrant registered manufacturer shall include the fol- or conduct research with controlled sub- shall be required to maintain a perpetual lowing information in his/her inventory: stances and required to keep records shall inventory. 1. For each controlled substance in bulk include in his/her inventory the same infor- 2. Separate records shall be maintained form to be used in (or capable of use in) the mation required of manufacturers in para- by a registrant for each registered location manufacture of the same or other controlled graphs (3)(K)3. and 4. of this rule. In deter- except as provided in subsection (3)(C) of this or noncontrolled substances in finished form, mining the number of units of each finished rule. In the event controlled substances are in the name of the substance and the total quan- form of a controlled substance in a commer- the possession or under the control of a reg- tity of the substance to the nearest metric unit cial container which has been opened, the istrant at a location for which s/he is not reg- weight consistent with unit size (except that dispenser shall do as follows: istered, the substance shall be included in the for inventories made in 1971, avoirdupois 1. If the substance is listed in Schedule records of the registered location to which weights may be utilized where metric weights I or II, s/he shall make an exact count or they are subject to control or to which the are not readily available); measure of the contents; and person possessing the substance is responsi- 2. For each controlled substance in the 2. If the substance is listed in Schedule ble. process of manufacture on the inventory date III, IV or V, s/he shall make an estimated 3. Separate records shall be maintained the name of the substance, the quantity of the count or measure of the contents, unless the by a registrant for each independent activity substance in each batch, stage of manufac- container holds more than one thousand for which s/he is registered. ture, or both, identified by the batch number (1000) tablets or capsules in which case s/he 4. In recording dates of receipt, impor- or other appropriate identifying number and must make an exact count of the contents. tation, distribution, exportation or other the physical form which the substance is to (N) Inventories of Importers and Ex- transfers, the date on which the controlled take upon completion of the manufacturing porters. Each registered importer or exporter substances are actually received, imported, process (for example, granulations, tablets, shall include in his/her inventory the same distributed, exported or otherwise transferred capsules or solutions), identified by the batch information required of manufacturers in shall be used as the date of receipt or distri- number or other appropriate identifying num- paragraphs (3)(K)1., 3. and 4. of this rule. bution of any documents of transfer (for ber and if possible the finished form of the Each registered importer and exporter who example, invoices or packing slips). substance (for example, ten milligram (10 also is registered as a manufacturer or as a (Q) Records of Manufacturers. Each regis- mg) tablet or ten milligram (10 mg) concen- distributor shall include in his/her inventory tered manufacturer shall maintain records tration per fluid ounce or milliliter) and the as an importer or exporter only those stocks with the following information: number or volume; of controlled substances that actually are sep- 1. For each controlled substance in bulk 3. For each controlled substance in fin- arated from his/her stocks as a manufacturer form to be used in or capable of use in or ished form, the name of the substance; each or as a distributor (for example, in-transit or being used in the manufacture of the same or finished form of the substance (for example, in storage for shipment). other controlled or noncontrolled substances ten milligram (10 mg) tablet or ten milligram (O) Inventories for Chemical Analysts. in finished form— (10 mg) concentration per fluid ounce or Each analytical laboratory registered to con- A. The name of the substance; milliliter); the number of units or volume of duct chemical analysis with controlled sub- B. The quantity manufactured in bulk each finished form in each commercial con- stances shall include in its inventory the same form by the registrant, including the date, tainer (for example, four (4) one hundred information required of manufacturers in quantity and batch or other identifying num- (100) tablet bottles or three milliliter (3 ml) paragraphs (3)(K)1., 3. and 4. of this rule as ber of each batch manufactured; vials); the number of commercial containers to substances which have been manufactured, C. The quantity received from other of each finished form (for example, four (4) imported or received by the laboratory con- persons including the date and quantity of one hundred (100) tablet bottles or six (6) ducting the inventory. If less than one kilo- each receipt and the name, address and regis- three milliliter (3 ml) vials); and gram (1 kg) of any controlled substance (oth- tration number of the other person from 4. For each controlled substance not er than a hallucinogenic controlled substance whom the substance was received; included in paragraphs (3)(K)1.—3. of this listed in Schedule I) or less than twenty D. The quantity imported directly by rule (for example, damaged, defective or grams (20 g) of a hallucinogenic substance the registrant (under a registration as an

14 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

importer) for use in manufacture by him/her, name, address and registration number of the 4. The number of commercial contain- including the date, quantity and import per- person from whom the units were received; ers of each finished form imported directly by mit or declaration number for each importa- E. The number of units of finished the registrant including the date of and the tion; form, commercial containers, or both, number of containers in each importation; E. The quantity used to manufacture imported directly by the registrant, including 5. The number of commercial contain- the same substance in finished form including the date of and the number of units, commer- ers of each finished form distributed to other the date and batch or other identifying num- cial containers, or both, in each importation; persons, including the date of and number of ber of each manufacture; the quantity used in F. The number of units, commercial containers in each distribution and the name, the manufacture; the finished form (for exam- containers, or both, manufactured by the reg- address and registration number of the person ple, ten milligram (10 mg) tablets or ten mil- istrant from units in finished form received to whom the containers were distributed; ligram (10 mg) concentration per fluid ounce from others or imported including: the date 6. The number of commercial contain- or milliliter); the number of units of finished and batch or other identifying number of each ers of the finished form exported directly by form manufactured; the quantity used in qual- manufacture; the operation performed (for the registrant, including the date of and the ity control; the quantity lost during manufac- example, repackaging or relabeling); the number of containers in each exportation; turing and the causes for the loss, if known; number of units of finished form used in the and the total quantity of the substance contained manufacture, the number manufactured and 7. The number of units or volume of fin- in the finished form; the theoretical and actu- the number lost during the manufacture, with ished forms, commercial containers, or both, al yields and other information as is neces- the causes for these losses, if known, and oth- distributed or disposed of in any other man- sary to account for all controlled substances er information as is necessary to account for ner by the registrant (for example, by distri- used in the manufacturing process; all controlled substances used in the manu- bution as complimentary samples) including F. The quantity used to manufacture facturing process; the date and manner of distribution or dis- other controlled and noncontrolled sub- G. The number of commercial con- posal, the name, address and registration stances, including the name of each substance tainers distributed to other persons including number of the person to whom distributed manufactured and the information required in the date of and number of containers in each and the quantity of the substance in finished subparagraph (3)(Q)1.E. of this rule; distribution and the name, address and regis- form distributed or disposed. G. The quantity distributed in bulk tration number of the person to whom the (S) Records for Practitioners and form to other persons, including the date and containers were distributed; Researchers. quantity of each distribution and the name, H. The number of commercial con- 1. Each individual practitioner, institu- address and registration number of each per- tainers exported directly by the registrant, tional practitioner and pharmacy shall main- son to whom a distribution was made; including the date, number of containers and tain records with the following information H. The quantity exported directly by export permit or declaration number for each for each controlled substance received, main- the registrant, including the date, quantity exportation; and tained, dispensed or disposed: and export permit or declaration number of I. The number of units of finished A. The name of the substance; each exportation; and forms, commercial containers, or both, dis- B. Each finished form (for example, I. The quantity distributed or dis- tributed or disposed of in any other manner ten milligram (10 mg) tablet or ten milligram posed of in any other manner by the registrant by the registrant (for example, by distribution (10 mg) concentration per fluid ounce or (for example, distribution of complimentary of complimentary samples or by destruction), milliliter) and the number of units or volume samples or by destruction) including the date including the date and manner of distribution of finished form in each commercial contain- and manner of distribution or disposal, the or disposal, the name, address and registra- er (for example, one hundred (100) tablet bot- name, address and registration number of the tion number of the person to whom distribut- tle or three milliliter (3 ml) vial); person to whom distributed and the quantity ed and the quantity in finished form dis- distributed or disposed; and tributed or disposed. C. The number of commercial con- 2. For each controlled substance in fin- tainers of each finished form received from ished form— (R) Records for Distributors. Each registered other persons, including the date of and num- A. The name of the substance; distributor shall maintain records with the ber of containers in each receipt and the B. Each finished form (for example, following information for each controlled name, address and registration number of the ten milligram (10 mg) tablet or ten milligram substance: person from whom the containers were (10 mg) concentration per fluid ounce or 1. The name of the substance; received; milliliter) and the number of units or volume 2. Each finished form (for example, ten D. The number of units or volume of of finished form in each commercial contain- milligram (10 mg) tablet or ten milligram (10 the finished form dispensed including the er (for example, one hundred (100) tablet bot- mg) concentration per fluid ounce or name and address of the person to whom it tle or three milliliter (3 ml) vial); milliliter) and the number of units or volume was dispensed, the date of dispensing, the C. The number of containers of each of finished form in each commercial contain- number of units or volume dispensed and the such commercial finished form manufactured er (for example, one hundred (100) tablet bot- written or typewritten name or initials of the from bulk form by the registrant, including tle or three milliliter (3 ml) vial); individual who dispensed or administered the the information required in subparagraph 3. The number of commercial contain- substance; and (3)(Q)1.E. of this rule; ers of each such finished form received from E. The number of units or volume of D. The number of units of finished other persons, including the date of and num- the finished forms, commercial containers, or forms, commercial containers, or both, ber of containers in each receipt and the both, disposed of in any other manner by the received from other persons, including the name, address and registration number of the registrant, including the date and manner of date of and number of units, commercial con- person from whom the containers were disposal and the quantity of the substance in tainers, or both, in each receipt and the received; finished form disposed.

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 15 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

2. Each individual practitioner shall by electronic computer transmission shall (V) Records for Chemical Analysts. maintain a record of the date, full name and verify with each practitioner on a regular 1. Each person registered to conduct address of the patient, the drug name, basis that the prescription was authorized by chemical analysis with controlled substances strength, dosage form and quantity for all the practitioner. If verification is made by shall maintain records with the following Schedule II controlled substances prescribed telephone, the pharmacist shall document the information (to the extent known and reason- and for all Schedule II—V controlled sub- verification on the reverse of the prescription ably ascertainable by him/her) for each con- stances administered. This record may be or in the computer. If verification is made by trolled substance: maintained in the patient’s medical record. sending the practitioner a copy of a computer A. The name of the substance; 3. Individual practitioners shall maintain printout, the practitioner shall verify, sign B. The form(s) in which the substance the records listed in subparagraphs and return the printout to the pharmacy. The is received, imported or manufactured by the (3)(S)1.A.—E. of this rule separately from pharmaccy shall maintain the verified print- registrant (for example, powder, granulation, patient medical records. out in a separate file. tablet, capsule or solution) and the concen- 4. A registrant who transfers a con- (T) Records for Importers. Each registered tration of the substance in that form (for trolled substance to or receives a controlled importer shall maintain records with the fol- example, Chemically Pure (CP), United substance from another registrant shall main- lowing information for each controlled sub- States Pharmacopeia (USP), National For- tain a written record of the transfer which stance: mulary (NF), ten milligram (10 mg) tablet or contains the following information: the date 1. The name of the substance; ten milligram (10 mg) concentration per of transfer, drug name, strength, dosage 2. The quantity (or number of units or milliliter); form, quantity, name, address and registra- volume in finished form) imported, including C. The total number of the forms tion number of the transferring registrant and the date, quantity (or number of units or vol- received, imported or manufactured (for the name, address and registration number of ume) and import permit or declaration num- example one hundred (100) tablets, thirty the receiving registrant. ber for each importation; (30) one milliliter (1 ml) vials or ten grams 5. DEA Official Order Forms shall be 3. The quantity (or number of units or (10 g) powder), including the date and quan- used for transfers of Schedule II controlled volume in finished form) distributed to other tity of each receipt, importation or manufac- substances. persons, including the date, quantity (or num- ture and the name, address and registration 6. A prescription may not be issued for ber of units or volume) of each distribution number, if any, of the person from whom the an individual practitioner to obtain controlled and the name, address and registration num- substance was received; and substances for dispensing or administering to ber of each person to whom a distribution D. The quantity distributed, exported patients. was made; and or destroyed in any manner by the registrant 7. Prescriptions which are transmitted 4. The quantity disposed of in any other (except quantities used in chemical analysis by facsimile to a pharmacy for dispensing manner by the registrant except quantities or other laboratory work), including the date shall include the telephone number of the fac- used in manufacturing by an importer under and manner of distribution, exportation or simile machine or computer from which it is a registration as a manufacture, which quan- destruction and the name, address and regis- sent and the date and time of transmission. tities are to be recorded, including the date tration number, if any, of each person to Immediately after a Schedule III, IV or V and manner of disposal and the quantity dis- whom the substance was distributed or prescription or a Schedule II prescription for posed. a long-term care facility patient or home hos- (U) Records of Exporters. Each registered exported. pice patient is transmitted to a pharmacy by exporter shall maintain records with the fol- 2. Order forms, import and export per- facsimile equipment, the practitioner or the lowing information for each controlled sub- mits, import invoices and export declarations practitioner’s agent shall sign and date the stance: relating to controlled substances shall be face of the prescription. The prescriptions 1. The name of the substance; maintained separately from all other records shall be maintained in chronological order 2. The quantity (or number of units or of the registrant. separately from patient files in a manner so volume in finished form) received from other 3. Records of controlled substances used each prescription is readily retrievable for persons, including the date and quantity (or in chemical analysis or other laboratory work inspection at the transmitting practitioner’s number of units or volume) of each receipt are not required. office. and the name, address and registration num- 4. Records relating to known or suspect- 8. Any pharmacy receiving a controlled ber of each person from whom the substance ed controlled substances received as samples substance prescription transmitted by facsim- was received; for analysis are not required under paragraph ile equipment shall maintain the facsimile 3. The quantity (or number of units or (3)(V)1. of this rule. copy of the prescription along with the date volume in finished form) exported, including (W) Records for Long-Term Care Facility and time of transmission and the number of the date, quantity (or number of units or vol- (LTCF) Emergency Kits. LTCFs and their the facsimile machine from which it originat- ume) and the export permit or declaration suppliers shall maintain written records of ed, as a part of its original prescription number for each exportation, but excluding transfers of controlled substances from the records. all quantities (and numbers of units and vol- supplier to the LTCF emergency kit. 9. Any practitioner who transmits a con- umes) manufactured by an exporter under a 1. The records shall include the date of trolled substance prescription by electronic registration as a manufacture, which quanti- transfer; the name of each controlled sub- computer transmission shall maintain a print- ties (and numbers of units and volumes) are stance, the strength, dosage form and quanti- out of each day’s transmissions. The practi- to be recorded; and ty; the name, address and controlled sub- tioner shall verify that the information in the 4. The quantity disposed of in any other stance registration number of the supplier and printout is correct and shall sign the printout. manner by the registrant including the date the name, address and controlled substance 10. Each pharmacist who dispenses con- and manner of disposal and the quantity dis- registration number of the LTCF. Federal trolled substances under a prescription sent posed. DEA Official Order Forms shall not be used

16 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

to record transfers of controlled substances to LTCF emergency kits. 2. No physician’s order or prescription shall be used for initial stocking or replace- ment of controlled substances in the emer- gency kit. Controlled substances contained in the kit shall be obtained from a pharmacy, hospital or practitioner who holds a con- trolled substances registration. 3. The administration and medical staff of the LTCF, in conjunction with the primary supplier, shall designate in written protocols and procedures who may have access to the emergency kit, who may administer con- trolled substances from the emergency kit and under what circumstances and a list of the controlled substances it intends to maintain in the emergency kit. These protocols and pro- cedures shall be subject to review and approval by the Department of Health. 4. Each administration of controlled substances from the emergency kit shall be based upon a practitioner’s order and shall be recorded in an administration record separate from the patient’s medical record. This administration record shall include: the date, patient’s name, drug name, drug strength, dosage, ordering practitioner’s name and name of the person administering the con- trolled substance. 5. For the purpose of this subsection, the term LTCF means a nursing care, resi- dential care, retirement care, mental care or other facility or institution which provides extended health care to resident patients and is licensed under Chapter 197 or 198, RSMo or operated by a state agency.

AUTHORITY: section 195.195, RSMo 1994.* This rule was previously filed as 13 CSR 50- 131.010. Original rule filed Jan. 31, 1972, effective April 1, 1972. Amended: Filed April 12, 1983, effective July 11, 1983. Amended: Filed May 31, 1989, effective Oct. 1, 1989. Amended: Filed Nov. 26, 1991, effective April 9, 1992. Amended: Filed Aug. 26, 1992, effective April 8, 1993. Amended: Filed Nov. 1, 1994, effective June 30, 1995.

*Original authority 1957, amended 1971, 1989, 1993.

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 17 Secretary of State

19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

19 CSR 30-1.033 Hearing Procedures on order to show cause why a controlled sub- intramuscular, subcutaneous or intraspinal Controlled Substances Registration stances registration should not be denied, infusion; suspended or revoked. (B) Long-term care facility means a nurs- PURPOSE: This rule provides procedures for ing home, retirement care, mental care or Department of Health hearings to show cause (7) At any hearing on the denial, suspension other facility or institution which provides or revocation of a controlled substances reg- why a controlled substances registration extended health care to resident patients; and should not be denied, suspended or revoked. istration, the registrant or applicant shall have (C) Prescription means an order for medi- the burden of proving that the requirements cation which is dispensed to or for an ulti- (1) When the Department of Health holds a for registration have been satisfied. hearing under an order to appear for a hear- mate user but does not include an order for ing and show cause why a controlled sub- (8) As soon as practicable after the hearing, medication which is dispensed for immediate stances registration should not be denied, the hearing officer shall issue a decision on administration to the ultimate user. (For suspended or revoked, the procedures of this the granting, denial, revocation or suspension example, an order to dispense a drug to a bed rule shall be followed. of registration. If a registration is denied, patient for immediate administration in a hos- revoked or suspended, the decision shall pital is not a prescription.) (2) Any person entitled to appear in a hearing include the findings of fact and conclusions of may appear in person or by representative. law upon which the order is based. The deci- (2) When determining if controlled sub- sion shall specify the date on which it shall stances are being lawfully prescribed, dis- (3) Hearings shall be conducted in an infor- take effect. The hearing officer shall give one pensed and administered by practitioners, the mal but orderly manner under the direction of (1) copy of the decision to each party in the Department of Health shall enforce Chapter the presiding officer. Evidentiary rules do not hearing. 195, RSMo, the Department of Health rules apply. in 19 CSR 30 pertaining to controlled sub- (9) Hearings shall be recorded. Copies of the stances, and the federal Controlled Sub- (4) Participants in any hearing and their rep- hearing record shall be made available to both stances Act 21 U.S.C. 801–966, and its reg- resentatives shall conduct themselves in parties upon request. accordance with the directions of the presid- ulations, 21 CFR 1300–1399. In determining ing officer. Refusal to comply with this sec- AUTHORITY: sections 195.040.11 and lawful prescribing, dispensing and adminis- tion shall constitute grounds for immediate 195.195, RSMo Supp. 1989.* Original rule tering of controlled substances, the Depart- exclusion from any hearing. filed Aug. 26, 1992, effective April 8, 1993. ment of Health also shall consider the provi- sions of Chapters 330, 332, 334, 336, 338 (5) A presiding officer, designated by the *Original authority: 195.040.11, RSMo 1939, amended and 340, RSMo, the rules in 4 CSR 110, 4 Department of Health, shall preside over the 1971, 1978, 1987, 1989 and 195.195, RSMo 1957, amended 1971, 1989. CSR 150, 4 CSR 210, 4 CSR 220, 4 CSR hearing. The functions of a presiding officer 230 and 4 CSR 270, and protocols relating to shall begin upon his/her designation and ter- the respective practitioners established and on minate upon certification of the record of the file at the respective licensing boards. hearing to the Administrative Hearing Com- 19 CSR 30-1.035 Requirements for Pre- mission. The presiding officer shall conduct a scribing, Dispensing and Administering (3) An individual practitioner who dispenses fair and impartial hearing and take all neces- Controlled Substances controlled substances shall— sary action to avoid delay and maintain order. (A) Provide direct supervision to employ- The presiding officer shall have the authority PURPOSE: This rule provides effective con- ees or agents who assist in the dispensing of to— trols for the prescribing, dispensing and controlled substances. Controlled substances (A) Arrange and change the date, time and administering of controlled substances to pre- place of a hearing and issue notice of the vent diversion from lawful usage. shall not be dispensed from an individual change; practitioner’s inventory unless a practitioner (B) Require parties to state their position in PUBLISHER’S NOTE: The publication of the is physically in the registered location except writing regarding issues in the hearing and to full text of the material that the adopting when a registered professional nurse is dis- exchange statements with all other parties; agency has incorporated by reference in this pensing under a collaborative practice agree- (C) Examine witnesses and direct witness- rule would be unduly cumbersome or expen- ment; es to testify; sive. Therefore, the full text of that material (B) Package all controlled substances dis- (D) Receive, rule on, exclude or limit evi- will be made available to any interested per- pensed from an individual practitioner’s dence; and son at both the Office of the Secretary of State inventory in compliance with the Poison Pre- (E) Rule on procedural issues. and the office of the adopting agency, pur- vention Packaging Act of 1970, 15 U.S.C. suant to section 536.031.4, RSMo. Such 1471—1476; (6) Any person entitled to a hearing who material will be provided at the cost estab- (C) Permanently affix a label to the exteri- receives proper notice of the date, time and lished by state law. place of the hearing and fails to appear shall or of the drug container which includes: the be considered to have waived his/her oppor- (1) As used in this rule, the following terms date, the name and address of the dispensing tunity for the hearing, unless s/he shows a shall have the meanings specified: practitioner, the name of the patient, direc- good reason for failing to appear. The presid- (A) Home infusion pharmacy means a tions for use, and the exact name and strength ing officer assigned to the case may issue a pharmacy which compounds solutions for of the drug dispensed for all controlled sub- decision—without a hearing—on the basis of direct administration to a patient in a private stances dispensed; and information in the investigative files and the residence, long-term care facility or hospice (D) Dispense only to individuals with allegations in the Department of Health’s setting by means of parenteral, intravenous, whom the practitioner has established and

20 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

documented a practitioner/patient relation- ing practitioner to a pharmacy by facsimile level of controlled substances in the pharma- ship. An individual practitioner shall not dis- equipment or electronic computer transmis- cy; pense under the order of another practitioner sion, provided the original written, signed (E) Nurse—registered or licensed practical not practicing at that location. prescription is presented to the pharmacist nurse licensed under Chapter 335, RSMo; for review prior to the actual dispensing of and (4) Controlled substances may be adminis- the controlled substance, except that— (F) Patient care areas—any area of a hospi- tered to a hospital emergency room patient (A) A prescription written for a Schedule tal where medical attention is rendered to a under a verbal order of a registered practi- II narcotic substance to be compounded for patient. tioner who is not physically present if— the direct administration to a patient by par- (A) The order is for a legitimate medical enteral, intravenous, intramuscular, subcuta- (2) A registrant in possession of any con- purpose and the practitioner who orders the neous or intraspinal infusion may be trans- trolled substances and desiring or required to administration of a controlled substance is mitted by the practitioner or the practitioner’s destroy the controlled substances beyond acting in the usual course of his/her medical agent to the home infusion pharmacy by fac- reclamation shall notify the Bureau of Nar- simile. The facsimile shall serve as and shall practice, after sufficient examination and cotics and Dangerous Drugs (BNDD), the be maintained in the same manner as an orig- establishment of a practitioner/patient rela- Drug Enforcement Administration (DEA) or tionship; inal written prescription. other persons authorized by state or federal (B) The practitioner who orders the admin- (B) A prescription written for a Schedule II law or regulation to destroy controlled sub- istration of a controlled substance is a medi- substance for a resident of a long-term care stances. If notification is to DEA, the federal cal staff member of the hospital; facility may be transmitted by the practition- procedures are to be followed. If notification (C) The administration of a controlled sub- er or the practitioner’s agent to the dispens- stance is documented in a formal medical ing pharmacy by facsimile. The facsimile is to the BNDD, the following procedures record for the patient; shall serve as and shall be maintained in the shall be used: (D) The patient is assessed in the hospital same manner as an original written prescrip- (A) Notification by the registrant shall con- by a practitioner, when available, or a regis- tion. sist of the name and address of registrant; tered nurse. If the patient is not assessed by a registrant’s BNDD and DEA number; the practitioner in the hospital, a registered nurse (7) All written controlled substance prescrip- drug name, strength and amount to be shall assess the patient and confirm and doc- tions shall be signed by the prescribing prac- destroyed; and ument in the patient’s medical record the titioner on the date prescribed. No controlled (B) The BNDD shall instruct the registrant substance prescription shall be signed prior existence of a preestablished practi- to dispose of the controlled substance in one to the actual date it is issued. tioner/patient relationship with the practition- (1) of the following ways: 1. By delivery in person or registered er who ordered administration of a controlled AUTHORITY: sections 195.040.3(2), substance; and 195.050.6 and 195.195, RSMo 1994.* Orig- mail to the BNDD office closest to the regis- (E) The order is written in the patient’s inal rule filed Nov. 14, 1988, effective Feb. trant; medical record and within seventy-two (72) 24, 1989. Amended: Filed Aug. 26, 1992, 2. By destruction at the registrant’s hours, is authenticated by the ordering practi- effective April 8, 1993. Amended: Filed Nov. work address by a BNDD employee or tioner. 1, 1994, effective June 30, 1995. designee; or 3. By other means as the BNDD shall (5) A pharmacist may dispense directly a *Original authority: 195.040.3(2), RSMo 1939, amended determine is sufficient to ensure that the sub- controlled substance in Schedule III, IV or V 1971, 1978, 1987, 1989, 1994; 195.050.6, RSMo 1939, amended 1971, 1989; and 195.195, RSMo 1957, amend- stance will not become available to unautho- only under a written prescription signed by a rized personnel. practitioner or a facsimile of a written, signed ed 1971, 1989, 1993. prescription transmitted by the practitioner or (3) In the event the registrant is a hospital, his/her authorized agent or under an oral pre- 19 CSR 30-1.036 Disposing of Unwanted the following procedures are to be used for scription made by an individual practitioner Controlled Substances the destruction of controlled substances: whether communicated by the practictioner (A) When disposal of controlled sub- or his/her authorized agent a prescription PURPOSE: This rule establishes procedures stances is in patient care areas— transmitted by electronic computer transmis- for disposing of unwanted controlled sub- 1. Controlled substances which are con- sion by the authorizing practitioner or the stances. taminated by patient body fluids are to be practitioner’s agent to the pharmacy. All oral destroyed by a physician, nurse or a pharma- prescriptions and prescriptions transmitted by (1) The following definitions shall be used in cist in the presence of another hospital electronic computer transmission shall be administering this rule: employee; promptly reduced to writing by the pharma- (A) Controlled substances administration 2. An excess volume of a controlled sub- cist containing all information required in record—the form used to record information section 195.060, RSMo, except for the signa- when administering individual drug doses to stance which must be discarded from a ture of the practitioner. patients; dosage unit just prior to use shall be (B) Hospital—as defined in section destroyed by a nurse, pharmacist or physician (6) A pharmacist may dispense a controlled 195.010(17), RSMo; in the presence of another hospital employee; substance in Schedule II only under a written (C) Hospital employee—a nurse, physi- 3. The remaining contents of opened prescription signed by the practitioner, except cian, pharmacist or other responsible patient- glass ampules of controlled substances shall as provided in section 195.060.3, RSMo. A care employee; be destroyed by a nurse, pharmacist or physi- prescription for a Schedule II controlled sub- (D) Inventory record—the pharmacy cian in the presence of another hospital stance may be transmitted from the prescrib- record that documents the current inventory employee;

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 21 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

4. Single units of single dose packages the hospital for two (2) years with other con- of controlled substances which are contami- trolled substances records. nated other than by patient body fluids and are not an infectious hazard, or have been (4) If the registrant administers controlled removed from their original or security pack- substances and is not a hospital, the following aging, or are partially used, or are otherwise procedures are to be used for the destruction rendered unsuitable for patient use shall be of controlled substances: destroyed by a nurse, pharmacist or physician (A) Controlled substances which are con- in the presence of another hospital employee taminated by patient body fluids are to be or returned to the pharmacy for destruction; destroyed, in the presence of another employ- 5. The following shall be entered in the ee, by the registrant or designee authorized to controlled substance administration record or administer; a separate controlled substance destruction (B) An excess volume of a controlled sub- record when the controlled substance is stance which must be discarded from a destroyed in the patient care area: the date dosage unit just prior to use is to be and hour of destruction, the drug name and destroyed, in the presence of another employ- strength, the amount destroyed, the reason ee, by the registrant or designee authorized to for destruction and the patient’s name and administer; room number. The nurse, pharmacist or (C) The remaining contents of opened physician and the witnessing hospital employ- glass ampules of controlled substances which ee shall sign the entry. The drug shall be are not patient contaminated are to be destroyed so that it is beyond reclamation. destroyed, in the presence of another employ- The controlled substance administration or ee, by the registrant or designee authorized to destruction records are to be retained for two administer; (2) years and available for inspection by (D) When the controlled substance is Department of Health investigators; and destroyed by the registrant or designee autho- 6. All other controlled substances which rized to administer, the following shall be are not patient contaminated but which are to entered in the controlled substances adminis- be destroyed shall be returned to the pharma- tration records or a separate controlled sub- cy for destruction; and stances destruction record: the date and (B) When disposal of controlled substances amount destroyed, the reason for destruction is in the pharmacy— and the registrant’s name and address. The 1. Single units of controlled substances registrant or designee doing the destruction which are contaminated other than by patient and the witnessing employee shall sign the body fluids and are not an infectious hazard, entry. The drug shall be destroyed so that it is or have been removed from their original or beyond reclamation. The controlled sub- security packaging, or are partially used, or stances administration or destruction records are otherwise rendered unsuitable for patient are to be retained for two (2) years and avail- use shall be destroyed by a pharmacist in the able for inspection by Department of Health presence of another hospital employee or held investigators; and for later destruction; and (E) All other controlled substances which 2. In the presence of the director or are not patient-contaminated but are to be assistant director of security, or the director destroyed shall be placed in a suitable con- or assistant director of nursing, or the hospi- tainer for storage, and the BNDD notified of tal administrator or assistant administrator, the need for destruction. the director of pharmacy or designated phar- macist may destroy beyond reclamation any AUTHORITY: section 195.050.6, RSMo other unwanted controlled substances provid- 1986.* Original rule filed Jan. 18, 1989, ed—the BNDD of the Department of Health effective April 27, 1989. is notified in writing by certified mail fifteen *Original authority 1939, amended 1971, 1989. (15) calendar days prior to the proposed destruction date using the registrant’s inven- tory of drugs destroyed or surrendered (Form NDD 12) stating the drug name and strength, the amount to be destroyed and the proposed destruction date and method of destruction. If the BNDD does not object, destruction shall occur on the proposed date. The pharmacist shall destroy the previously identified drugs, complete Form NDD 12 with the signature of the witness included and return a copy to the BNDD. The original shall be maintained at

22 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State

Chapter 1—Controlled Substances 19 CSR 30-1

19 CSR 30-1.040 Dispensing and Distribu- tions 195.010–195.320, RSMo), the term his/her professional practice without a pre- tion of Controlled Substances in Certain emergency situation means those situations in scription. Situations which the prescribing practitioner determines (C) An institutional practitioner may that— administer or dispense directly (but not pre- PURPOSE: These rules provide for the dis- (A) Immediate administration of a con- scribe) a controlled substance listed in Sched- pensing of Schedule V controlled substances, trolled substance is necessary for proper ule V only pursuant to a written prescription for the dispensing of Schedule II controlled treatment of the intended ultimate user; signed by the prescribing individual practi- substances in emergency situations and for (B) No appropriate alternative treatment is tioner or pursuant to an oral prescription the emergency distribution of a controlled available, including administration of a drug made by a prescribing individual practitioner substance. which is not a controlled substance under and promptly reduced to writing by the phar- Schedule II; and macist (containing all information required (1) Emergency Dispensing of Schedule II (C) It is not reasonably possible for the except for the signature of the prescribing Controlled Substances. In the case of a bona prescribing practitioner to provide a written individual practitioner) or pursuant to an fide emergency situation, as defined by the prescription to be presented to the person dis- order for medication made by an individual Department of Health, a pharmacist may dis- pensing the substance prior to the dispensing. practitioner which is dispensed for immediate pense a Schedule II controlled substance administration to the ultimate user. upon receiving oral authorization of a pre- (3) Emergency Controlled Substance Distri- scribing practitioner; provided, that— bution by a Pharmacy. An emergency means (5) Dispensing Without Prescription. A con- (A) The quantity prescribed and dispensed a situation where a quantity of a controlled trolled substance listed in Schedule V which is limited to the amount adequate to treat the substance must be dispensed by a pharmacy is not a prescription drug and determined patient during the emergency period. Pre- to a patient who does not have an alternative under the federal Food, Drug and Cosmetic scribing or dispensing beyond the emergency source for that substance reasonably available Act may be dispensed by a pharmacist with- period must be pursuant to a written pre- to him/her and the pharmacy cannot obtain out a prescription to a purchaser at retail; scription; that substance through its normal distribution provided, that— (B) The prescription immediately shall be channels within the time required to meet the (A) Dispensing is made only by a pharma- reduced to writing by the pharmacist and immediate needs of the patient for that sub- cist and not by a nonpharmacist employee shall contain all information, except for the stance. In the event of an emergency, a phar- even if under the supervision of a pharmacist prescribing practitioner’s signature; macy may distribute (without being registered (although after the pharmacist has fulfilled (C) If the prescribing practitioner is not as a distributor) a controlled substance in his/her professional and legal responsibili- known to the pharmacist, s/he must make Schedule III, IV or V to a second pharmacy ties, the actual cash transaction, credit trans- reasonable effort to determine that the oral in order for that pharmacy to dispense the action or delivery may be completed by a authorization came from a practitioner, by substance; provided, that— nonpharmacist); verifying his/her phone number against that (A) The amount distributed does not (B) Not more than two hundred forty cubic listed in the directory and other good faith exceed the amount required by the second centimeters (240 cc) eight ounces (8 oz.) of efforts to insure his/her identity; and pharmacy for his/her immediate dispensing; any controlled substance containing opium, (D) Within seventy-two (72) hours after (B) The distribution is recorded as being nor more than one hundred twenty cubic cen- authorizing an emergency oral prescription, dispensed by the first pharmacy and the sec- timeters (120 cc) four ounces (4 oz.) of any the prescribing practitioner must cause a ond pharmacy records the substance as being other controlled substance nor more than written prescription for the emergency quan- received. Each pharmacy will retain a signed forty-eight (48) dosage units of any controlled tity prescribed to be delivered to the dispens- receipt of the distribution; substance containing opium, nor more than ing pharmacist. The prescription shall have (C) The second pharmacy is registered to written on its face authorization for emergen- dispense the controlled substance to be dis- twenty-four (24) dosage units of any other cy dispensing. The written prescription may tributed to him/her; and controlled substance may be dispensed at be delivered to the pharmacist in person or by (D) If the substance is a Schedule II con- retail to the same purchaser in any given mail, but if delivered by mail it must be post- trolled substance, an order form is required. forty-eight (48)-hour period; marked within the seventy-two (72)-hour (C) The purchaser is at least eighteen (18) period. Upon receipt, the dispensing pharma- (4) Dispensing of Schedule V Substances, years of age; cist shall attach this prescription to the oral Requirement of Prescription. (D) The pharmacist requires every pur- emergency prescription which had earlier (A) A pharmacist directly may dispense a chaser of a Schedule V controlled substance been reduced to writing. The pharmacist controlled substance listed in Schedule V not known to him/her to furnish suitable shall notify the Department of Health if the pursuant to a prescription. A prescription for identification (including proof of age where prescribing practitioner fails to deliver a writ- a controlled substance listed in Schedule V appropriate); ten prescription to him/her; failure of the may be refilled only as expressly authorized (E) A bound record book for dispensing of pharmacist to do so shall void the authority by the prescribing individual practitioner on Schedule V controlled substances is main- conferred by this section to dispense without the prescription. If this authorization is giv- tained by the pharmacist. The book shall con- a written prescription of a prescribing practi- en, the prescription may not be refilled. A tain the name and address of the purchaser, tioner. pharmacist dispensing those substances pur- the name and quantity of controlled substance suant to a prescription shall label the sub- purchased, the date of each purchase and the (2) Definition of Emergency Situation. For stance and file the prescription. name or initials of the pharmacist who dis- the purpose of authorizing an oral prescrip- (B) An individual practitioner may admin- pensed the substance to the purchaser (the tion of a controlled substance listed in Sched- ister or dispense directly a controlled sub- book shall be maintained in accordance with ule II of the controlled substances law (sec- stance listed in Schedule V in the course of recordkeeping requirements); and

Rebecca McDowell Cook (6/30/98) CODE OF STATE REGULATIONS 27 Secretary of State 19 CSR 30-1—HEALTH Division 30—Division of Health Standards and Licensure

(F) A prescription is not required for dis- tribution or dispensing of the substance pur- suant to any other federal, state or local law.

AUTHORITY: section 195.195, RSMo 1986.* This rule was previously filed as 13 CSR 50- 132.010. Original rule filed Jan. 31, 1972, effective April 1, 1972.

*Original authority 1957, amended 1971, 1989.

28 CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook Secretary of State