19c30-1—Division of Regulation and Licensure...phenethylamine, N-ethyl MDA, MDE and MDEA) 7404 N. N-hydroxy-3,4-methylenedioxyam-phetamine (also known as N-hydroxy-alpha-methyl-3,4-(methylenedioxy)

CODE OF STATE REGULATIONS 1ROBIN CARNAHAN (1/29/06)Secretary of State

Rules of

Department of Healthand Senior Services

Division 30�Division of Regulation and LicensureChapter 1�Controlled Substances

Title Page

19 CSR 30-1.002 Schedules of Controlled Substances .........................................................3

19 CSR 30-1.004 List of Excepted Substances ..................................................................8

19 CSR 30-1.006 List of Exempt Anabolic Steroid Products .................................................8

19 CSR 30-1.008 List of Excluded Veterinary Anabolic Steroid Implant Products .......................9

19 CSR 30-1.010 Schedules of Controlled Substances (Rescinded November 30, 2000) ................9

19 CSR 30-1.011 Definitions......................................................................................10

19 CSR 30-1.013 Miscellaneous Fees ...........................................................................11

19 CSR 30-1.015 Registrations and Fees........................................................................11

19 CSR 30-1.017 Registration Process ..........................................................................11

19 CSR 30-1.019 Registration Location.........................................................................12

19 CSR 30-1.020 List of Excepted Substances (Rescinded November 30, 2000) ........................13

19 CSR 30-1.023 Registration Changes .........................................................................13

19 CSR 30-1.025 List of Exempt Anabolic Steroid Products (Rescinded November 30, 2000).......13

19 CSR 30-1.026 Separate Registrations ........................................................................13

19 CSR 30-1.027 Investigative and Administrative Procedures .............................................14

19 CSR 30-1.030 Requirements for Controlled Substances Registration(Rescinded November 30, 2000) ..........................................................14

19 CSR 30-1.031 Physical Security Requirements.............................................................14

19 CSR 30-1.032 Security for Nonpractitioners ...............................................................14

19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration(Rescinded November 30, 2000) ..........................................................15

2 CODE OF STATE REGULATIONS (1/29/06) ROBIN CARNAHANSecretary of State

19 CSR 30-1.034 Security for Practitioners ....................................................................15

19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances (Rescinded November 30, 2000) ...............................16

19 CSR 30-1.036 Disposing of Unwanted Controlled Substances(Rescinded November 30, 2000) ..........................................................16

19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations(Rescinded July 30, 2003) ..................................................................16

19 CSR 30-1.041 Records Requirements........................................................................16

19 CSR 30-1.042 Inventory Requirements ......................................................................17

19 CSR 30-1.044 Continuing Records General Requirements...............................................18

19 CSR 30-1.046 Records for Manufacturers, Distributors, Importers and Exporters ..................18

19 CSR 30-1.048 Records for Practitioners and Researchers................................................20

19 CSR 30-1.050 Records for Chemical Analysts .............................................................20

19 CSR 30-1.052 Records for Long-Term Care Facilities (LTCF)..........................................21

19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administeringof Controlled Substances....................................................................21

19 CSR 30-1.062 Transmission of Prescriptions ...............................................................21

19 CSR 30-1.064 Partial Filling of Schedule II Prescriptions ...............................................22

19 CSR 30-1.066 Dispensing by Individual Practitioners ....................................................22

19 CSR 30-1.068 Administering In Emergency Rooms.......................................................22

19 CSR 30-1.070 Emergency Dispensing of Schedule II Substances.......................................23

19 CSR 30-1.072 Dispensing of Schedule V Substances .....................................................23

19 CSR 30-1.074 Dispensing Without a Prescription .........................................................23

19 CSR 30-1.076 Emergency Distribution by a Pharmacy ...................................................24

19 CSR 30-1.078 Disposing of Unwanted Controlled Substances ..........................................24

Title 19�DEPARTMENT OFHEALTH AND SENIOR SERVICES

Division 30�Division ofRegulation and Licensure

Chapter 1�Controlled Substances

19 CSR 30-1.002 Schedules of ControlledSubstances

PURPOSE: Chapter 195, RSMo states in sec-tion 195.230, RSMo that the Department ofHealth shall prepare a list of all drugs fallingwithin the purview of controlled substances.Upon preparation, a copy of the list shall befiled in the Office of the Secretary of State. Italso requires, in section 195.017.11, RSMo,the Department of Health to revise and repub-lish the schedules semiannually for two yearsfrom September 28, 1971, and annually afterthat.

(1) Schedules of Controlled Substances.(A) Schedule I shall consist of the drugs

and other substances, by whatever officialname, common or usual name, chemicalname or brand name designated, listed in thissection. Each drug or substance has beenassigned the Drug Enforcement Administra-tion (DEA) Controlled Substances CodeNumber set forth opposite it.

1. Opiates. Unless specifically exceptedor unless listed in another schedule, any ofthe following opiates, including their isomers,esters, ethers, salts and salts of isomers,esters and ethers, whenever the existence ofsuch isomers, esters, ethers and salts is pos-sible within the specific chemical designa-tion:

A. Acetyl-alpha-methylfentanyl (N-(1-(1-methyl-2-phenethyl)-4-piperidinyl)-N-phenylace-tamide) 9815

B. Acetylmethadol 9601C. Allylprodine 9602D. Alphacetylmethadol (except levo-

alphacetylmethadol also knownas levo-alpha-acetylmethadol levo-thadyl acetate or LAAM) 9603

E. Alphameprodine 9604F. Alphamethadol 9605G. Alpha-methylfentanyl (N-1-

(alphamethyl-beta-phenyl) ethyl-4-piperidyl) propionanilide; 1-(1-methyl-2-phenylethyl)-4 ((N-pro-panilido) piperidine) 9814

H. Alpha-methylthiofentanyl (N-(1-methyl-2-(2-thienyl) ethyl-4-piperidinyl)-N-phenylpropan-amide) 9832

I. Benzethidine 9606J. Betacetylmethadol 9607

K. Beta-hydroxyfentanyl (N-(1-(2-hydroxy-2-phenethyl)-4-piperi-dinyl)-N-phenylpropan-amide) 9830

L. Beta-hydroxy-3-methylfentanyl (other name: N-(1-(2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl)-N-phenylpropan-amide) 9831

M. Betameprodine 9608N. Betamethadol 9609O. Betaprodine 9611P. Clonitazene 9612Q. Dextromoramide 9613R. Diampromide 9615S. Diethylthiambutene 9616T. Difenoxin 9168U. Dimenoxadol 9617V. Dimepheptanol 9618W. Dimethylthiambutene 9619X. Dioxaphetyl butyrate 9621Y. Dipipanone 9622Z. Ethylmethylthiambutene 9623AA. Etonitazene 9624BB. Etoxeridine 9625CC. Furethidine 9626DD. Hydroxypethidine 9627EE. Ketobemidone 9628FF. Levomoramide 9629GG. Levophenacylmorphan 9631HH. 3-Methylfentanyl (N-(3-methyl-

1-(2-phenylethyl)-4-piperidyl)-N-phenylproan-amide), its optical and geometric isomers, salts and salts of isomers 9813

II. 3-Methylthiofentanyl (N-((3-methyl-1-(2-thienyl)ethyl-4-piperidinyl)-N-phenylpropanamide) 9833

JJ. Morpheridine 9632KK. MPPP (1-methyl-4-phenyl-

4-propionoxypiperidine) 9661LL. Noracymethadol 9633MM. Norlevorphanol 9634NN. Normethadone 9635OO. Norpipanone 9636PP. Para-fluorofentanyl

(N-(4-fluorophenyl)-N-(1-(2-phenethyl)-4-piperidinyl) propana-mide 9812

QQ. PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypi-peridine) 9663

RR. Phenadoxone 9637SS. Phenampromide 9638TT. Phenomorphan 9647UU. Phenoperidine 9641VV. Piritramide 9642WW. Proheptazine 9643XX. Properidine 9644

YY. Propiram 9649ZZ. Racemoramide 9645AAA. Thiofentanyl

(N-phenyl-N-(1-(2-thienyl)ethyl-4-piperidinyl)-propanamide 9835

BBB. Tilidine 9750CCC. Trimeperidine 9646

2. Opium derivatives. Unless specifical-ly excepted or unless listed in another sched-ule, any of the following opium derivatives,its salts, isomers and salts of isomers when-ever the existence of such salts, isomers andsalts of isomers is possible within the specif-ic chemical designation:

A. Acetorphine 9319B. Acetyldihydrocodeine 9051C. Benzylmorphine 9052D. Codeine methylbromide 9070E. Codeine-N-Oxide 9053F. Cyprenorphine 9054G. Desomorphine 9055H. Dihydromorphine 9145I. Drotebanol 9335J. Etorphine (except hydro-

chloride salt) 9056K. Heroin 9200L. Hydromorphinol 9301M. Methyldesorphine 9302N. Methyldihydromorphine 9304O. Morphine methylbromide 9305P. Morphine methylsulfonate 9306Q. Morphine-N-Oxide 9307R. Myrophine 9308S. Nicocodeine 9309T. Nicomorphine 9312U. Normorphine 9313V. Pholcodeine 9314W. Thebacon 9315

3. Hallucinogenic substances. Unlessspecifically excepted or unless listed inanother schedule, any material, compound,mixture or preparation, which contains anyquantity of the following hallucinogenic sub-stances or which contains any of its salts, iso-mers and salts of isomers whenever the exis-tence of such salts, isomers and salts ofisomers is possible within the specific chem-ical designation (For purposes of paragraph(1)(A)3. of this rule only, the term isomerincludes the optical, position and geometricisomers.):

A. Alpha-ethyltryptamine 7249Some trade or other names: etryptamine;Monase; alpha-ethyl-1H-indole-3-ethen-amine; 3-(2-aminobutyl)indole; alpha-ETand AET;

B. Benzylpiperazine or othername BZP 7493

C. 4-bromo-2,5-dimethoxyampheta-mine 7391


Chapter 1�Controlled Substances 19 CSR 30-1

Some trade or other names: 4-bromo-2, 5-dimethoxy-a-methylphenethylamine; 4-bro-mo-2,5-DMA;

D. 4-bromo-2,5-dimethoxyphene-thylamine 7392

E. 2,5-dimethoxyamphetamine 7396Some trade or other names: 2,5-dimethoxy-a-methylphenethylamine; 2,5-DMA;

F. 2,5-dimethoxy-4-ethylampheta-mine 7399

Some trade or other names: DOETG. 2,5-dimethoxy-4-(n)-pro-

pylthiophenethylamineH. 4-methoxyamphetamine 7411

Some trade or other names: 4-methoxy-a-methylphenethylamine; paramethoxyam-phetamine; PMA;

I. 5-methoxy-3,4-methylenedioxy-amphetamine 7401

J. 4-methyl-2,5-dimethoxyamphe-tamine 7395

Some trade and other names: 4-methyl-2, 5-dimethoxy-a-methylphenethylamine; DOM;and STP;

K. 3,4-methylenedioxy amphe-tamine 7400

L. 3,4-methylenedioxymethampheta- mine (MDMA) 7405

M. 3,4-methylenedioxy-N-ethylam-phetamine (also known as N-ethyl-alpha-methyl-3,4 (methylenedioxy)phenethylamine, N-ethyl MDA, MDE and MDEA) 7404

N. N-hydroxy-3,4-methylenedioxyam-phetamine (also known as N-hydroxy-alpha-methyl-3,4-(methylenedioxy) phenethylamineand N-hydroxy MDA) 7402

O. 3,4,5-trimethoxy ampheta-mine 7390

P. Bufotenine 7433Some trade and other names: 3-(b-Dimethy-laminoethyl)-5-hydroxyindole; 3-(2-dimethyl-aminoethyl)-5-indolol; N, N-dimethylsero-tonin; 5-hydroxy-N,N-dimethyltryptamine;mappine;

Q. Diethyltryptamine 7434Some trade and other names: N, N-Diethyl-tryptamine; DET;

R. Dimethyltryptamine 7435Some trade or other names: DMT;

S. Ibogaine 7260Some trade and other names: 7-Ethyl-6,6b,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido (1',2':1,2) azepino (5,4-b) indole; Tabernanthe iboga;

T. Lysergic acid diethylamide 7315U. Marihuana 7360

Some trade or other names: marijuana;V. Mescaline 7381W. Parahexyl 7374

Some trade or other names: 3-Hexyl-1-Hydroxy-7,8 ,9 ,10- t e t rahydro-6 ,6 ,9 -trimethyl-6H-dibenzo(b,d)pyran; Synhexyl;

X. Peyote 7415Meaning all parts of the plant presently clas-sified botanically as Lophophora williamsilLemaire, whether growing or not; the seedsthereof; any extract from any part of suchplant; and every compound, manufacture,salt, derivative, mixture or preparation ofsuch plant, its seeds or extracts;

Y. N-ethyl-3-piperidyl benzi-late 7482

Z. N-methyl-3-piperidyl benzi-late 7484

AA. Psilocybin 7437BB. Psilocyn 7438CC. Tetrahydrocannabinols 7370

Synthetic equivalents of the substances con-tained in the plant or in the resinous extrac-tives of Cannabis, sp, synthetic substances,derivatives and their isomers, or both, withsimilar chemical structure and pharmacolog-ical activity such as the following:

(I) D 1 cis or trans tetrahydro-cannabinol and their optical isomers;

(II) D 6 cis or trans tetrahydro-cannabinol and their optical isomers; and

(III) D 3, 4 cis or trans tetrahydro-cannabinol and its optical isomers (Sincenomenclature of these substances is not inter-nationally standardized, compounds of thesestructures, regardless of numerical designa-tion of atomic positions are covered.);

DD. Ethylamine analog of phencycli-dine 7455

Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)-ethy-lamine, cyclohexamine, PCE;

EE. Pyrrolidine analog of phencycli-dine 7458

Some trade or other names: 1(1-phenylcyclo-hexyl)-pyrrolidine PCPy, PHP;

FF. Thiophene analog of phencycli-dine 7470

Some trade or other names: 1-(1-(2-thienyl)-cyclohexyl)-piperidine, 2-thienyl analog ofphencyclidine, TPCP, TCP;

GG. Triflouromethylphenyl-piperazine or other nameTFMPP;

HH. 1-(1-(2-thienyl)cyclohexyl) pyrrolidine 7473

Some other names: TCPy.4. Depressants. Unless specifically

excepted or unless listed in another schedule,any material compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system, including itssalts, isomers and salts of isomers whenever

the existence of such salts, isomers and saltsof isomers is possible within the specificchemical designation:

A. Gamma-hydroxybutyric acid andother names GHB; gamma-hydroxybutyrate;4-hydroxybutyrate; 4-hydroxybutonic acid;sodium oxybate; sodium oxybutryrate;

B. Mecloqualone 2572C. Methaqualone 2565

5. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers and salts of isomers:

A. Aminorex 1585Some trade or other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; 4,5-dihydro-5-phenyl-2-oxazolamine;

B. Cathinone (Some trade or othernames: 2-amino-1-phenyl-1-propanone, alphaamino-propiophenone, 2-aminopropio-phenone and norephedrone) 1235

C. Fenethylline 1503D. Methcathinone 1585

Some trade or other names: 2-(methyl-amino)-propiophenone; alpha-(methyla-mino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one; alpha-N-methylamino-propiophenone; monomethylpropion; ephe-drone; N-methylcathinone; methylcathinine;AL-464; AL-422; AL-463 and URI 432; itssalts, optical isomers and salts of optical iso-mers;

E. (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) 1590

F. N-ethylamphetamine 1475G. N,N-dimethylamphetamine 1480

(some other names: N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethyl-phenethylamine), its salts, optical isomersand salts of optical isomers.

6. A temporary listing of substancessubject to emergency scheduling under feder-al law shall include any material, compound,mixture or preparation which contains anyquantity of the following substances:

A. N-(1-benzyl-4-piperidyl)-N-phe-nylpropanamide (benzyl-fentanyl), its optical isomers, saltsand salts of isomers 9818

B. N-(1-(2-thienyl) methyl-4-piper-idyl)-N-phenylpropanamide(thenylfentanyl), its optical isomers, salts and saltsof isomers 9834

(B) Schedule II shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemical


19 CSR 30-1�DEPARTMENT OF HEALTHAND SENIOR SERVICES Division 30�Division of Regulation and Licensure

name or brand name designated, listed in thissection. Each drug or substance has beenassigned the Controlled Substances CodeNumber set forth opposite it.

1. Substances, vegetable origin or chem-ical synthesis. Unless specifically excepted orunless listed in another schedule, Schedule IIshall include any of the following substanceswhether produced directly or indirectly byextraction from substances of vegetable ori-gin or independently by means of chemicalsynthesis or by a combination of extractionand chemical synthesis opium and opiate; andany salt, compound, derivative or preparationof opium or opiate, excluding apomorphine,thebaine-devied butorphanol, dextrorphan,nalbuphine, nalmefene, naloxone and nal-trexone and their respective salts, but includ-ing the following:

A. Raw opium 9600B. Opium extracts 9610C. Opium fluid 9620D. Powdered opium 9639E. Granulated opium 9640F. Tincture of opium 9630G. Codeine 9050H. Ethylmorphine 9190I. Etorphine hydrochloride 9059J. Hydrocodone 9193K. Hydromorphone 9150L. Metopon 9260M. Morphine 9300N. Oxycodone 9143O. Oxymorphone 9652P. Thebaine 9333

Any salt, compound, derivative or prepara-tion thereof which is chemically equivalent oridentical with any of the substances referredto in paragraph (1)(B)1. of this rule shall beincluded in Schedule II, except that thesesubstances shall not include the isoquinolinealkaloids of opium; opium poppy and poppystraw; coca leaves 9040and any salt, compound, derivative or prepa-ration of coca leaves including cocaine 9041and ecgonine 9180and their salts, isomers, derivatives and saltsof isomers and derivatives and any salt, com-pound, derivative or preparation thereofwhich is chemically equivalent or identicalwith any of these substances, except that thesubstances shall not include decocainizedcoca leaves or extraction of coca leaves,which extractions do not contain cocaine 9041or ecgonine 9180and concentrate of poppy straw (the crudeextract of poppy straw in either liquid, solidor powder form which contains the phenan-threne alkaloids of the opium poppy) 9670

2. Opiates. Unless specifically exceptedor unless in another schedule any of the fol-

lowing opiates, including its isomers, esters,ethers, salts and salts of isomers, esters andethers whenever the existence of such iso-mers, esters, ethers and salts is possible with-in the specific chemical designation, dextror-phan and levopropoxyphene excepted:

A. Alfentanil 9737B. Alphaprodine 9010C. Anileridine 9020D. Bezitramide 9800E. Bulk Dextropropoxyphene

(Non-dosage Forms) 9273F. Butyl-

nitrite no designated numberG. Carfentanil 9743H. Dihydrocodeine 9120I. Diphenoxylate 9170J. Fentanyl 9801K. Isomethadone 9226L. Levo-alphacetylmethadol 9220

Some other names: levo-alphaacetylmetha-dol, levomethadyl acetate, LAAM 9648

M. Levomethorphan 9210N. Levorphanol 9220O. Metazocine 9240P. Methadone 9250Q. Methadone-Intermediate, 4-cyano-

2-dimethylamino-4,4-diphenylbutane 9254

R. Moramide-Intermediate, 2-methyl-3-morpholino-1,1-diphenylpro-pane-carboxylic acid 9802

S. Pethidine (Meperidine) 9230T. Pethidine-Intermediate-A, 4-cyano-

1-methyl-4-phenylpiperi-dine 9232

U. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxy-late 9233

V. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid 9234

W. Phenazocine 9715X. Piminodine 9730Y. Racemethorphan 9732Z. Racemorphan 9733AA. Remifentanil 9739BB. Sufentanil 9740

3. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system:

A. Amphetamine, its salts, optical isomers and salts of its opticalisomers 1100

B. Methamphetamine, its salts,isomers and salts of itsisomers 1105

C. Phenmetrazine and its salts 1631D. Methylphenidate 1724

4. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system, including itssalts, isomers and salts of isomers wheneverthe existence of such salts, isomers and saltsof isomers is possible within the specificchemical designation:

A. Amobarbital 2125B. Glutethimide 2550C. Pentobarbital 2270D. Phencyclidine 7471E. Secobarbital 2315

5. Hallucinogenic substances:A. Nabilone 7379

Another name for nabilone: (±)trans-3-(1, 1-dimethylheptyl)-6, 6a,7,8,10,10a-hexahydro-1-hydroxy-6, 6-dimethyl-9H-dibenzo(b,d)pyran-9-one.

6. Immediate precursors. Unless specif-ically excepted or unless listed in anotherschedule, any material, compound, mixtureor preparation which contains any quantity ofthe following substances:

A. Immediate precursor to amphe-tamine and methamphetamine:

(I) Phenylacetone 8501Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone;methyl benzyl ketone;

B. Immediate precursors to phencycli-dine (PCP):

(I) 1-phenylcyclohexylamine 7460(II) 1-piperidinocyclohexane-

carbonitrile (PCC) 8603(C) Schedule III shall consist of the drugs

and other substances, by whatever officialname, common or usual name, chemicalname or brand name designated, listed in thissection. Each drug or substance has beenassigned the DEA Controlled SubstancesCode Number set forth opposite it.

1. Stimulants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers (whether optical, position orgeometric) and salts of such isomers whenev-er the existence of such salts, isomers andsalts of isomers is possible within the specif-ic chemical designation:

A. Those compounds, mixtures orpreparations in dosage unit form containingany stimulant substances listed in Schedule IIwhich compounds, mixtures or preparationswere listed on August 25, 1971, as exceptedcompounds under section 308.32 and anyother drug of the quantitive compositionshown in that list for those drugs or which is



the same except that it contains a lesser quan-tity of controlled substances 1405

B. Benzphetamine 1228C. Chlorphentermine 1645D. Clortermine 1647E. Phendimetrazine 1615

2. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a depressant effecton the central nervous system:

A. Any compound, mixture or prepa-ration containing:

(I) Amobarbital 2126(II) Secobarbital 2316(III) Pentobarbital 2271

or any salt thereof and one (1) or more otheractive medicinal ingredients which are notlisted in any schedule;

B. Any suppository dosage form con-taining:

(I) Amobarbital 2126(II) Secobarbital 2316(III) Pentobarbital 2271

or any salt of any of these drugs and approvedby the Food and Drug Administration formarketing only as a suppository;

C. Any substance which contains anyquantity of a derivative of barbituric acid orany salt thereof 2100

D. Chlorhexadol 2510E. Any drug product containing

gamma hydroxybutric acid, including itssalts, isomers and salts of isomer, for whichan application is approved under section 505of the Federal Food, Drug and Cosmetic Act;

F. Ketamine 7285G. Lysergic acid 7300H. Lysergic acid amide 7310I. Methyprylon 2575J. Sulfondiethylmethane 2600K. Sulfonethylmethane 2605L. Sulfonmethane 2610M. Tiletamine and zolazepam

or any salt thereof 7295Some trade or other names for a tiletamine-zolazepam combination product: Telazol. Some trade or other names for tiletamine: 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.Some trade or other names for zolazepam:4-(2-fluorophenyl)-6-8-dihydro-1,3,8-trimethylpyrazolo-(3,4-e) (1,4)-diazepin-7(1H)-one, flupyrazapon.

3. Nalorphine 94004. Narcotics drugs. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture or prepara-tion containing limited quantities of any ofthe following narcotic drugs or any saltsthereof:

A. Not more than 1.8 grams ofcodeine per one hundred milliliters (100 ml)

or not more than ninety milligrams (90 mg)per dosage unit, with an equal or greaterquantity of an isoquinoline alkaloid ofopium 9803

B. Not more than 1.8 grams ofcodeine per one hundred milliliters (100 ml)or not more than ninety milligrams (90 mg)per dosage unit, with one (1) or more active,nonnarcotic ingredients in recognized thera-peutic amounts 9804

C. Not more than three hundred mil-ligrams (300 mg) of hydrocodone per onehundred milliliters (100 ml) or not more thanfifteen milligrams (15 mg) per dosage unit,with a fourfold or greater quantity of an iso-quinoline alkaloid of opium 9805

D. Not more than three hundred mil-ligrams (300 mg) of hydrocodone per onehundred milliliters (100 ml) or not more thanfifteen milligrams (15 mg) per dosage unit,with one (1) or more active nonnarcoticingredients in recognized therapeuticamounts 9806

E. Not more than 1.8 grams of dihy-drocodeine per one hundred milliliters (100ml) or not more than ninety milligrams (90mg) per dosage unit, with one (1) or moreactive, nonnarcotic ingredients in recognizedtherapeutic amounts 9807

F. Not more than three hundred mil-ligrams (300 mg) of ethylmorphine per onehundred milliliters (100 ml) or not more thanfifteen milligrams (15 mg) per dosage unit,with one (1) or more active, nonnarcoticingredients in recognized therapeuticamounts 9808

G. Not more than five hundred mil-ligrams (500 mg) of opium per one hundredmilliliters (100 ml) or per one hundred grams(100 g) or not more than twenty-five mil-ligrams (25 mg) per dosage unit, with one (1)or more active nonnarcotic ingredients in rec-ognized therapeutic amounts 9809

H. Not more than fifty milligrams (50mg) of morphine per one hundred milliliters(100 ml) or per one hundred grams (100 g),with one (1) or more active, nonnarcoticingredients in recognized therapeuticamounts 9810

5. Anabolic steroids. Unless speciallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion containing any quantity of the followingsubstances, including its salts, isomers andsalts of isomers whenever the existence ofsuch salts of isomers is possible within thespecific chemical designation. DEA hasassigned code 4000 for all anabolic steroids.

A. BoldenoneB. Chlorotestosterone (4-Chlortestos-

terone) C. Clostebol

D. Dehydrochlormethyltestosterone E. Dihydrotestosterone (4-Dihydro-

testosterone) F. Drostanolone G. EthylestrenolH. FluoxymesteroneI. Formebulone (Formebolone)J. MesteroloneK. MethandienoneL. MethandranoneM. MethandriolN. MethandrostenoloneO. Methenolone P. MethyltestosteroneQ. MiboleroneR. NandroloneS. NorethandroloneT. OxandroloneU. OxymesteroneV. OxymetholoneW. StanoloneX. StanozololY. TestolactoneZ. TestosteroneAA. TrenboloneBB. Any salt, ester, or isomer of a

drug or substance described or listed in thissubparagraph, if that salt, ester or isomerpromotes muscle growth except an anabolicsteroid which is expressly intended foradministration through implants to cattle orother nonhuman species and which has beenapproved by the secretary of Health andHuman Services for that administration.

6. Dronabinol (synthetic) in sesame oiland encapsulated in a soft gelatin capsule in aUnited States Food and Drug Administrationapproved drug product 7369(Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-6.6.9-trimethyl-3-pentyl-6H-dibenzo (b,d) pyran-1-ol, or (-)-delta-9-(trans)-tetrahydrocannabinol.)

(D) Schedule IV shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname or brand name designated, listed in thissection. Each drug or substance has beenassigned the DEA Controlled SubstancesCode Number set forth opposite it.

1. Narcotic drugs. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion containing limited quantities of any ofthe following narcotic drugs or any saltsthereof:

A. Not more than one milligram (1mg) of difenoxin (DEA Drug Code No.9618) and not less than twenty-five micro-grams (25 mcg) of atropine sulfate per dosageunit;



B. Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane) 9278

C. Narcotic drugs containing nonnar-cotic active medicinal ingredients. Any com-pound, mixture or preparation containing anyof the following limited quantities of narcoticdrugs or salts thereof, which shall includeone (1) or more nonnarcotic active medicinalingredients in sufficient proportion to conferupon the compound, mixture or preparationvaluable medicinal qualities other than thosepossessed by the narcotic drug alone:

(I) Not more than two hundred mil-ligrams (200 mg) of codeine per one hundredmilliliters (100 ml) or per one hundred grams(100 g);

(II) Not more than one hundredmilligrams (100 mg) of dihydrocodeine perone hundred milliliters (100 ml) or per onehundred grams (100 g); or

(III) Not more than one hundredmilligrams (100 mg) of ethylmorphine perone hundred milliliters (100 ml) or per onehundred grams (100 g).

2. Depressants. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances, including its salts, isomersand salts of isomers whenever the existenceof such salts, isomers and salts of isomers ispossible within the specific chemical designa-tion:

A. Alprazolam 2882B. Barbital 2145C. Bromazepam 2748D. Camazepam 2749E. Chloral betaine 2460F. Chloral hydrate 2465G. Chlordiazepoxide 2744H. Clobazam 2751I. Clonazepam 2737J. Clorazepate 2768K. Clotiazepam 2752L. Cloxazolam 2753M. Delorazepam 2754N. Diazepam 2765O. Dichloralphenazone 2467P. Estazolam 2756Q. Ethchlorvynol 2540R. Ethinamate 2545S. Ethyl loflazepate 2758T. Fludiazepam 2759U. Flunitrazepam 2763V. Flurazepam 2767W. Halazepam 2762X. Haloxazolam 2771Y. Ketazolam 2772Z. Loprazolam 2773AA. Lorazepam 2885BB. Lormetazepam 2774

CC. Mebutamate 2800DD. Medazepam 2836EE. Meprobamate 2820FF. Methohexital 2264GG. Methylphenobarbital

(Mephobarbital) 2250HH. Midazolam 2884II. Nimetazepam 2837JJ. Nitrazepam 2834KK. Nordiazepam 2838LL. Oxazepam 2835MM. Oxazolam 2839NN. Paraldehyde 2585OO. Petrichloral 2591PP. Phenobarbital 2285QQ. Pinazepam 2883RR. Prazepam 2764SS. Quazepam 2881TT. Temazepam 2925UU. Tetrazepam 2886VV. Triazolam 2887WW. Zaleplon 2781XX. Zolpidem 2783

3. Fenfluramine. Any material, com-pound, mixture or preparation which con-tains any quantity of the following sub-stances, including its salts, isomers (whetheroptical, position or geometric) and salts ofsuch isomers, whenever the existence of suchsalts, isomers and salts of isomers is possible:

A. Fenfluramine 16704. Stimulants. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances having a stimulant effecton the central nervous system, including itssalts, isomers and salts of isomers:

A. Cathine ((+)-norpseudoephed-rine) 1230

B. Diethylpropion 1610C. Fencamfamin 1780D. Fenproporex 1575E. Mazindol 1605F. Mefenorex 1580G. Modafinil 1680H. Pemoline (including organometal-

lic complexes and chelatesthereof) 1530

I. Phentermine 1640J. Pipradrol 1750K. Sibutramine 1675L. SPA (-)-1-dimethyamino-

1,2-diphenylethane 16355. Other substances. Unless specifically

excepted or unless listed in another schedule,any material, compound, mixture or prepara-tion which contains any quantity of the fol-lowing substances, including its salts:

A. Pentazocine 9709B. Butorphanol (including its optical

isomers) 9720

6. Ephedrine. Any material, compound,mixture or preparation which contains anyquantity of the following substances having astimulant effect on the central nervous systemincluding their salts, isomers and salts of iso-mers:

A. Ephedrine or its salts, optical iso-mers or salts of optical isomers as the onlyactive medicinal ingredient or containsephedrine or its salts, optical isomers, or saltsof optical isomers and therapeuticallyinsignificant quantities of another activemedicinal ingredient.

(E) Schedule V shall consist of the drugsand other substances, by whatever officialname, common or usual name, chemicalname or brand name designated, listed in thissubsection.

1. Narcotic drugs. Unless specificallyexcepted or unless listed in another schedule,any material, compound, mixture or prepara-tion containing any of the following narcoticdrugs and their salts:

A. Buprenorphine 90642. Narcotic drugs containing nonnarcot-

ic active medicinal ingredients. Any com-pound, mixture or preparation containing anyof the following narcotic drugs, or their saltscalculated as the free anhydrous base or alka-loid, in limited quantities as follows, whichshall include one (1) or more nonnarcoticactive medicinal ingredients in sufficient pro-portion to confer upon the compound, mix-ture or preparation valuable medicinal quali-ties other than those possessed by the narcoticdrug alone:

A. Not more than two and five-tenthsmilligrams (2.5 mg) of diphenoxylate and notless than twenty-five micrograms (25 mcg) ofatropine sulfate per dosage unit.

B. Not more than one hundred mil-ligrams (100 mg) of opium per one hundredmilliliters (100 ml) or per one hundred grams(100 g).

C. Not more than five-tenths mil-ligram (0.5 mg) of difenoxin (DEA DrugCode No. 9618) and not less than twenty-fivemicrograms (25 mcg) of atropine sulfate perdosage unit.

3. Stimulants. Unless specificallyexempted or excluded or unless listed inanother schedule, any material, compound,mixture or preparation which contains anyquantity of the following substances having astimulant effect on the central nervous systemincluding its salts, isomers and salts of iso-mers:

A. Pyrovalerone 1485

(2) Excluded Nonnarcotic Substances. Thefollowing nonnarcotic substances which,under the Federal Food, Drug and Cosmetic



Act (21 U.S.C. 301), may be lawfully soldover the counter without a prescription, areexcluded from all schedules pursuant to sec-tion 195.015(5), RSMo.

AUTHORITY: sections 195.015 and 195.195,RSMo 2000.* Material found in this rule pre-viously filed as 19 CSR 30-1.010. Originalrule filed April 14, 2000, effective Nov. 30,2000. Amended: Filed Jan. 31, 2003, effec-tive July 30, 2003.

*Original authority: 115.015, RSMo 1971, amended 1989and 195.195, RSMo 1957, amended 1971, 1989, 1993.

19 CSR 30-1.004 List of Excepted Sub-stances

PURPOSE: The Department of Health isauthorized to except by rule any compound,mixture or preparation containing any stimu-lant or depressant substance if one or moreactive medicinal ingredients not having astimulant or depressant effect on the centralnervous system is included to negate thepotential for abuse. The compounds, mixturesand preparations excluded are listed in thisrule.

PUBLISHER�S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.Therefore, the material which is so incorpo-rated is on file with the agency who filed thisrule, and with the Office of the Secretary ofState. Any interested person may view thismaterial at either agency�s headquarters orthe same will be made available at the Office

of the Secretary of State at a cost not toexceed actual cost of copy reproduction. Theentire text of the rule is printed here. Thisnote refers only to the incorporated by refer-ence material.

(1) Excepted Stimulant or Depressant Com-pounds�Exempt Prescription Products. Thelisted drugs in dosage unit form and any otherdrug of the quantitative composition shown inPart 1300 to end of Title 21, the Code of Fed-eral Regulations, April 1998 or which is thesame except that it contains a lesser quantity of controlled substances or other substanceswhich do not have a stimulant, depressant orhallucinogenic effect and which are restricted by law to dispensing or prescription, areexcepted from the provisions of sections195.030, 195.040, 195.050 and 195.100,RSMo as provided for in section195.017.6(5) and .8(3), RSMo. The rules ofthe Drug Enforcement Administration, 21CFR Part 1300 to the end of Title 21, arehereby incorporated by reference and made apart of this rule.

(2) Excepted Chemical Preparations�Exempt Chemical Preparations. The listedpreparations in unit form and any otherpreparation of the quantitative compositionshown in Part 1300 to end of Title 21, theCode of Federal Regulations, April 1998which is the same except that it contains alesser quantity of controlled substances orother substances which do not have a stimu-

lant, depressant or hallucinogenic effect areexcepted from the provisions of sections195.030, 195.040, 195.050 and 195.110,RSMo as provided for in section195.017.6(5) and .8(3), RSMo. The rules ofthe Drug Enforcement Administration, 21CFR Part 1300 to the end of Title 21, arehereby incorporated by reference and made apart of this rule.

AUTHORITY: section 195.195, RSMo 1994.*Material found in this rule previously filed as19 CSR 30-1.020. Original rule filed April14, 2000, effective Nov. 30, 2000.

*Original authority: 195.195, RSMo 1957, amended1971, 1989, 1993.

19 CSR 30-1.006 List of Exempt AnabolicSteroid Products

PURPOSE: This rule maintains a list ofanabolic steroid products excluded from 19CSR 30-1.002(1)(C)5. in conformance withfederal law.

(1) Persons who in the course of legitimatebusiness handle products listed in the Table ofExempt Anabolic Steroid Products in thissection shall be exempt from the registration,records, reports, prescriptions, physical secu-rity and import and export requirements asso-ciated with Schedule III substances.



Excluded Nonnarcotic Productsmg or

Company Trade Name NDC Code Form Controlled Substance mg/ml

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

(P-tablets)

(A) Trade Name Company NDC or DIN No.1. Androgyn L.A. Forest Pharmaceuticals, 0456-1005

St. Louis, MO2. Andro-Estro Rugby Laboratories, 0536-1605

90-4 Rockville Center, NY3. depANDROGYN Forest Pharmaceuticals, 0456-1020

St. Louis, MO4. DEPO-T.E. Quality Research Pharma- 52765-257

ceuticals, Camel, IN5. depTESTROGEN Martica Pharmaceuticals, 51698-257

Phoenix, AZ6. Duomone Wintec Pharmaceutical, 52047-360

Pacific, MO7. DURATESTRIN W.E. Hauck, Alpharetta, 43797-016

GA8. DUO-SPAN II Primedics Laboratories, 0684-0102

Gardena, CA9. Estratest Solvay Pharmaceuticals, 0032-1026

Marietta, GA 10. Estratest HS Solvay Pharmaceuticals, 0032-1023

Marietta, GA 11. Menogen Sage Pharmaceuticals, 59243-570

Shreveport, LA 12. Menogen HS Sage Pharmaceuticals, 59243-560

Shreveport, LA13. PAN ESTRA Pan American Labs, 0525-0175

TEST Covington, LA14. Premarin with Ayerst Labs., Inc. 0046-0879

Methyltestos- New York, NYterone

15. Premarin with Ayerst Labs., Inc., 0046-0878 Methyltestos- New York, NYterone

16. Synovex H Syntex Animal Health, Pellets in Palo Alto, CAprocess

17. Synovex H Syntex Animal Health,Pellets in Palo Alto, CAprocess granulation

18. Synovex Plus Fort Dodge Animalin-process Health,granulation Fort Dodge, IA

19. Synovex Plus Fort Dodge Animalin-process Health,bulk pellets Fort Dodge, IA

20. Testagen Clint Pharmaceuticals, 55553-257Nashville, TN

21. TEST-ESTRO Rugby Laboratories, 0536-9470 Cypionates Rockville Centre, NY

22. Testoderm Alza Corp., 17314-46084 mg/d Palo Alto, CA

23. Testoderm Alza Corp., 17314-46096 mg/d Palo Alto, CA

24. Testoderm Alza Corp., 17314-2836with Adhesive Palo Alto, CA6 mg/d

25. Testoderm Alza Corp., in-process film Palo Alto, CA

26. Testoderm Alza Corp.,with Adhesive Palo Alto, CAin-process film

27. Testosterone I.D.E.-Interstate, 0814-7737 Cyp 50 Estradiol Amityville, NYCyp 2

28. Testosterone Best Generics, No. 54274-530 Cypionate- Miami Beach, FL Estradiol CypionateInjection

29. Testosterone Schein Pharmaceuticals, 0364-6611 Cypionate- Port Washington, NYEstradiol CypionateInjection

30. Testosterone Steris Labs., Inc., 0402-0257 Cypionate-Estra- Phoenix, AZ diol CypionateInjection

31. Testosterone Goldline Labs, 0182-3069Cypionate-Estra- Ft. Lauderdale, FLdiol CypionateInjection

32. Testosterone The Upjohn Co., 0009-0253Cypionate-Estra- Kalamazoo, MIdiol CypionateInjection

Trade Name Company NDC or DIN No.33. Testosterone Goldline Labs., 0182-3073

Enanthate-Estra- Ft. Lauderdale, FLdiol ValerateInjection

34. Testosterone Schein Pharmaceuticals, 0364-6618 Enanthate-Estra- Port Washington, NYdiol Valerate Injection

35. Testosterone Steris Labs., Inc., 0402-0360Enanthate-Estra- Phoenix, AZdiol ValerateInjection

36. Tilapia Sex Rangen, Inc., Reversal Feed Buhl, ID(Investigational)

37. Tilapia Sex Ziegler Brothers, Inc.Reversal Feed Gardners, PA(Investigational)

AUTHORITY: section 195.195, RSMo 1994.*Material found in this rule previouly filed as19 CSR 30-1.025. Original rule filed April14, 2000, effective Nov. 30, 2000.


19 CSR 30-1.008 List of Excluded Veteri-nary Anabolic Steroid Implant Products

PURPOSE: This rule maintains a list of vet-erinary anabolic steroid products excludedfrom 19 CSR 30-1.002(1)(C)5. in confor-mance with federal law.

(1) The following products containing ananabolic steroid that are expressly intendedfor administration through implants to cattleor other nonhuman species and which havebeen approved by the Secretary of Health andHuman Services for such administration andare excluded from all schedules pursuant tosection 195.017.5, RSMo.

Trade Name Company NDC or DIN No.(A) Component E-H Vetlife, Inc., 021641-002

Norcross, GA(B) Component E-H Elanco, 01968327

Scarborough, ON(C) Component TE-S Vetlife, Inc., 021641-004

Norcross, GA(D) Component T-H Vetlife, Inc., 021641-006

Norcross, GA(E) Component T-S Vetlife, Inc., 021641-005

Norcross, GA(F) F-TO Animal Health, 00093351

Upjohn International,Kalamazoo, MI

(G) Finaplix-H Hoechst RousselVet, 12799-807-10Somerville, NJ

(H) Finaplix-S Hoechst RousselVet, 12799-807-07Somerville, NJ

(I) Heifer-oid Anchor Division,Boehringer Ingelheim,St. Joseph, MO

(J) Heifer-oid Bio-Ceutic Division,Boehringer Ingelheim, St. Joseph, MO

(K) Heifer-oid Ivy Laboratories, Inc.,Overland Park, KS

(L) Implus-H The Upjohn Co., 0009-0434-01Kalamazoo, MI

(M) Implus-H Upjohn Co., Animal 06-0434-01Health Division, 01968327Orangeville, ON

(N) Revalor-G Hoechst Roussel Vet, 12799-811Somerville, NJ

(O) Revalor-H Hoechst Roussel Vet, 12799-810Somerville, NJ

(P) Revalor-S Hoechst Roussel Vet, 12799-809Somerville, NJ

(Q) Synovex H Fort Dodge Labs, 0856-3901Fort Dodge, IA

(R) Synovex H Syntex Laboratories,Palo Alto, CA

(S) Synovex Plus Fort Dodge Labs, 0856-3904Fort Dodge, IA

AUTHORITY: section 195.195, RSMo 1994and 195.017, RSMo Supp. 1999.* Originalrule filed April 14, 2000, effective Nov. 30,2000.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998 and 195.195, RSMo 1957,amended 1971, 1989, 1993.

19 CSR 30-1.010 Schedules of ControlledSubstances(Rescinded November 30, 2000)

AUTHORITY: section 195.195, RSMo Supp.1993. This rule was previously filed as 13CSR 50-130.010 and 19 CSR 10-130.010.Original rule filed Jan. 31, 1972, effectiveApril 1, 1972. Amended: Filed Oct. 4, 1972,effective Oct. 14, 1972. Amended: Filed April4, 1973, effective April 14, 1973. Amended:Filed Sept. 28, 1973, effective Nov. 4, 1973.Amended: Filed Jan. 3, 1974, effective Jan.13, 1974. Amended: Filed Oct. 9, 1974,effective Oct. 19, 1974. Amended: Filed July17, 1975, effective July 27, 1975. Amended:Filed Oct. 8, 1975, effective Oct. 18, 1975.Refiled: March 24, 1976. Amended: FiledOct. 12, 1976, effective Jan. 13, 1977.Amended: Filed March 15, 1977, effectiveMarch 24, 1977. Amended: Filed Nov. 14,1977, effective Nov. 6, 1977. Amended: FiledSept. 28, 1977, effective Jan. 13, 1978.Amended: Filed March 9, 1978, effective Feb.24, 1978. Amended: Filed Oct. 2, 1978,effective Sept. 27, 1978. Amended: FiledNov. 14, 1978, effective June 16, 1978.Amended: Filed Nov. 14, 1978, effective Oct.25, 1978. Amended: Filed Feb. 13, 1979,effective Feb. 9, 1979. Amended: Filed Feb.19, 1980, effective Feb. 11, 1980. Amended:Filed Oct. 14, 1980, effective July 24, 1980.Amended: Filed Oct. 14, 1980, effective Aug.21, 1980. Amended: Filed Oct. 14, 1981,effective Oct. 30, 1980. Amended: Filed Oct.14, 1981, effective May 8, 1981. Amended:Filed Oct. 14, 1981, effective Aug. 20, 1981.Amended: Filed Nov. 1, 1982, effective Dec.11, 1982. Amended: Filed Jan. 12, 1983,effective Feb. 11, 1983. Amended: FiledMarch 11, 1983, effective April 1, 1983.



Amended: Filed Sept. 2, 1983, effective Dec.11, 1983. Amended: Filed Nov. 7, 1983,effective Dec. 11, 1983. Amended: Filed July12, 1984, effective Aug. 11, 1984. Amended:Filed Sept. 20, 1984, effective Nov. 11, 1984.Amended: Filed Jan. 15, 1985, effective Feb.11, 1985. Amended: Filed May 29, 1985,effective June 27, 1985. Amended: Filed July24, 1985, effective Aug. 26, 1985. Amended:Filed Sept. 12, 1985, effective Oct. 11, 1985.Changed to 19 CSR 10-130.010, effective Oct.11, 1985. Amended: Filed Jan. 3, 1986,effective Jan. 16, 1986. Changed to 19 CSR30-1.010, effective Aug. 11, 1986. Amended:Filed April 17, 1987, effective May 14, 1987.Amended: Filed July 3, 1987, effective Aug.27, 1987. Amended: Filed May 3, 1988,effective May 26, 1988. Amended: Filed Sept.25, 1989, effective Oct. 27, 1989. Emergen-cy amendment filed April 3, 1991, effectiveApril 13, 1991, expired Aug. 10, 1991. Emer-gency amendment filed May 1, 1991, effectiveMay 11, 1991, expired Sept. 7, 1991. Emer-gency amendment filed July 23, 1991, effec-tive Aug. 2, 1991, expired Nov. 28, 1991.Amended: Filed April 3, 1991, effective Sept.30, 1991. Amended: Filed May 1, 1991,effective Sept. 30, 1991. Amended: FiledMarch 2, 1992, effective Aug. 6, 1992.Amended: Filed July 6, 1993, effective Dec.9, 1993. Emergency amendment filed Jan. 5,1994, effective Jan. 15, 1994, expired May14, 1994. Amended: Filed Jan. 5, 1994,effective July 30, 1994. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

State v. Miller, 588 SW2d 237 (Mo. App.1979). Evidence of the presence ofamphetamine is sufficient to support a con-trolled substances conviction; no quantitativeanalysis is necessary. Those rules refiledbetween January 1 and March 31, 1976 werenot required to be published under section536.021, RSMo. Also, courts must take judi-cial notice of the contents of the Code ofState Regulations.

Selvey v. State, 578 SW2d 64 (Mo. App.1979). Phenmetrazine, originally establishedstatutorily as a Schedule III controlled sub-stance, was rescheduled by the Division ofHealth to Schedule II. Such a rescheduling iswithin the statutory power granted the Divi-sion of Health and does not usurp the leg-islative power of the general assembly.

State v. Davis, 450 SW2d 168 (Mo. App.1970). Statutes which direct the Division ofHealth to prepare a list of drugs classified asbarbiturates and stimulants, the sale of whichare made unlawful by statute, does not violatethe Missouri Constitution prohibition in Arti-

cle I, section 31 against delegation of author-ity to an agency to make a rule fixing a fineor imprisonment as punishment for its viola-tion.

19 CSR 30-1.011 Definitions

PURPOSE: This rule contains definitionswhich establish the intended meaning of cer-tain terms used throughout this chapter.

(1) As used in this chapter, the followingterms shall have the meanings specified:

(A) Commercial container means any bot-tle, jar, tube, ampule or other receptacle inwhich a substance is held for distribution ordispensing to an ultimate user and, in addi-tion, any box or package in which the recep-tacle is held for distribution or dispensing toan ultimate user. The term commercial con-tainer does not include any package liner,package insert of other material kept with orwithin a commercial container, nor any car-ton, crate, drug or other package in whichcommercial containers are stored or are usedfor shipment of controlled substances;

(B) Controlled substances administrationrecord means the form used to record infor-mation when administering individual drugdoses to patients;

(C) Dispenser means an individual practi-tioner, institutional practitioner, pharmacy orpharmacist who dispenses a controlled sub-stance;

(D) Hospice means a public agency or pri-vate organization or subdivision of either ofthese that is primarily engaged in providingcare to dying persons and their families andmeets the standards specified in 19 CSR 30-35;

(E) Hospital employee means a nurse,physician, pharmacist or other responsiblepatient-care employee;

(F) Individual practitioner means a physi-cian, dentist, veterinarian, optometrist orother individual licensed, registered or other-wise permitted by the United States or Mis-souri to dispense a controlled substance in thecourse of professional practice, but does notinclude a pharmacist, a pharmacy or an insti-tutional practitioner;

(G) Institutional practitioner means a hos-pital or other person (other than an individu-al) licensed, registered or otherwise permit-ted by the United States or Missouri todispense a controlled substance in the courseof professional practice, but does not includea pharmacy;

(H) Long-term care facility means a nurs-ing home, retirement care, mental care, or

other facility or institution which providesextended health care to resident patients;

(I) Name means the official name, com-mon or usual name, chemical name or brandname of a substance;

(J) Nurse means a registered or licensedpractical nurse licensed under Chapter 335,RSMo;

(K) Patient care areas means any area of ahospital where medical attention is renderedto a patient;

(L) Pre-hospital emergency medical ser-vice means an emergency medical servicessystem as defined in Chapter 190, RSMo pro-viding services to persons prior to admissionto a hospital;

(M) Prescription means an order for med-ication which is dispensed to or for an ulti-mate user but does not include an order formedication which is dispensed for immediateadministration to the ultimate user. (Forexample, an order to dispense a drug to a bedpatient for immediate administration in a hos-pital is not a prescription.);

(N) Readily retrievable means that certainrecords are kept by automatic data processingsystems or other electronic or mechanizedrecord keeping systems in a manner that theycan be separated out from all other records;and/or records are kept on which certainitems are asterisked, redlined, highlighted orin some other manner visually identifiableapart from other items appearing on therecords; and records are provided withinthree working days of a request;

(O) Registration means a Missouri con-trolled substances registration;

(P) Reregistration means a registrationissued to a person who was previously regis-tered and whose application for reregistrationwas received by the Department of Healthprior to the expiration of the previous regis-tration;

(Q) Temporary location registration meansa registration issued to an individual practi-tioner who:

1. Has a current Missouri professionallicense to practice and is registered with theDepartment of Health at the address listed onhis/her professional license;

2. Has a federal Drug EnforcementAdministration registration that is valid inMissouri;

3. Anticipates practicing in Missouriwithin the next 12 months;

4. Does not practice for more than 90consecutive calendar days at any location;

5. Maintains a record of the date(s) andlocation(s) of all practice activity in Missouriand makes the record available to the Bureauof Narcotics and Dangerous Drugs. Thisrecord shall be retained for two years;



6. Maintains all required controlled sub-stance records at each location;

7. Does not receive or stock controlledsubstances at any location;

(2) Any term not defined in this rule shallhave the definition set forth in Chapter 195,RSMo.

AUTHORITY: section 195.195, RSMo 2000.*Original rule filed April 14, 2000, effectiveNov. 30, 2000. Amended: Filed Jan. 31,2003, effective July 30, 2003.


19 CSR 30-1.013 Miscellaneous Fees

PURPOSE: This rule establishes and fixescertain fees and charges statutorily autho-rized to be made by the Department of Healthin provisions codified in Chapters 195 and610, RSMo.

(1) Fees for copies of public records or otherdocuments:

(A) Copy, per page $ 0.25(B) Research fee, per hour $15.00

(2) Payment of fee may be required inadvance.

(3) Fees are nonrefundable.

AUTHORITY: section 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov. 30,2000.


19 CSR 30-1.015 Registrations and Fees

PURPOSE: This rule establishes fees for var-ious types of registration, a late registrationfee, manner of payment, and exemption fromthe registration fee, and implements a con-version for registrations to last 36 months.

(1) For each registration or re-registrationto�

(A) Manufacture controlled substances, theregistrant shall pay a fee of two hundred dol-lars ($200);

(B) Distribute controlled substances, theregistrant shall pay a fee of two hundred dol-lars ($200);

(C) Dispense controlled substances listedin Schedules II�V including dispensing ofcontrolled substances by individual practi-

tioners in training programs or to conductresearch or instructional activities with thosesubstances, the registrant shall pay a fee ofninety dollars ($90);

(D) Conduct research or instructionalactivities with a controlled substance listed inSchedule I, the registrant shall pay a fee ofninety dollars ($90);

(E) Conduct chemical analysis with con-trolled substances listed in any schedule, theregistrant shall pay a fee of ninety dollars($90);

(F) Import or export controlled substanceslisted in any schedule, the registrant shall paya fee of two hundred dollars ($200);

(G) Dispense controlled substances listedin Schedules II�V by an individual practi-tioner who has a temporary location registra-tion, the registrant shall pay an annual fee ofthirty dollars ($30).

(2) Lapsed Registration Fee. A late charge often dollars ($10) must be submitted with theoriginal registration fee if an application issubmitted more than fifteen (15) days after aprevious registration has expired.

(3) Time and Method of Payment andRefunds. Registration and re-registration feesshall be paid at the time when the applicationfor registration or re-registration is submittedfor filing. Payment should be made in theform of a personal, certified or cashier�scheck or money order made payable toDepartment of Health and Senior Services.This is a nonrefundable processing fee. Pay-ments made in the form of stamps, foreigncurrency or third-party endorsed checks willnot be accepted.

(4) Persons Exempt From Fee. The Depart-ment of Health and Senior Services shallexempt the following persons from paymentof a fee for registration or re-registration:

(A) Any official or agency of the UnitedStates Army, Navy, Marine Corps, Air Force,Coast Guard, Veterans Administration orPublic Health Service who is authorized toprocure or purchase controlled substances forofficial use;

(B) Any official, employee or other civilofficer or agency of the United States or stateor any political subdivision or agency who isauthorized to purchase controlled substances,to obtain these substances from officialstocks, to dispense or administer these sub-stances, to conduct research, instructionalactivities or chemical analysis with these sub-stances, or any combination of them, in thecourse of his/her official duties or employ-ment;

(C) In order to claim exemption from pay-ment of a registration or re-registration fee,the registrant shall apply for exemption bycompleting appropriate sections of the appli-cation;

(D) Exemption from payment of a registra-tion or re-registration fee does not relieve theregistrant of any other requirements or dutiesprescribed by law;

(E) Any registration that is exempt frompayment pursuant to this section shall be validonly when authorized persons are conductingactivities in the course of their official dutiesor employment.

AUTHORITY: sections 195.030 and 195.195,RSMo 2000.* Original rule filed April 14,2000, effective Nov. 30, 2000. Amended:Filed Jan. 31, 2003, effective July 30, 2003.


19 CSR 30-1.017 Registration Process

PURPOSE: This rule establishes the periodand expiration of registration, the process ofapplying for registration, and informationrequired to complete an application for regis-tration.

(1) Period of Registration.(A) Any registration, except a re-registra-

tion, shall be current and effective for 36months from the date issued or until the expi-ration date assigned at the time the registra-tion is issued. A re-registration shall be cur-rent and effective for 36 months from theexpiration date of the previous registration,provided that the application for re-registra-tion was received prior to the expiration ofthe previous registration. No person who isrequired to be registered shall conduct anyactivity for which registration is requiredwithout a current registration.

(B) At the time any registration is issued,the registration shall be assigned to one of 12groups which shall correspond to the monthsof the year. The expiration date of all regis-trations within any group shall be the last dayof the month designated for that group.

(C) Registrations for manufacturers anddistributors may be assigned to a singlegroup, and the expiration date may be lessthan 36 months from the date the registrationwas issued.

(D) Temporary location registrations andtraining program registrations may beassigned to a single group, and the expiration



date may be less than 12 months from thedate the registration was issued.

(E) A certificate of registration shall beprovided to the registrant which shall includethe name and address of the registrant, theexpiration date of the registration and a regis-tration number for the convenience of identi-fying a registration or a registrant. The sameregistration number may be used for a newregistration for the same person.

(2) Application for Registration. (A) Any person who is required to be reg-

istered and who is not so registered mayapply for registration at any time. No personrequired to be registered shall engage in anyactivity for which registration is requireduntil the application for registration is pro-cessed and the registration is issued.

(B) Applications for registration shall beon forms designated by the Department ofHealth and Senior Services. Applicationforms may be requested from the MissouriDepartment of Health and Senior Services,PO Box 570, Jefferson City, MO 65102-0570.

(C) An application form containing theoriginal signature of the applicant must beprovided to the Department of Health andSenior Services with any required fee. This isa nonrefundable processing fee.

(D) An application which does not containor is not accompanied by the required infor-mation or fee may be denied sixty (60) daysafter notifying the applicant of the deficiency.

(E) An application may be withdrawn bymaking a written request to the Departmentof Health and Senior Services.

(F) A person who is registered may con-duct activities with controlled substances inSchedules II, III, IV and V, as authorized bystatute, unless a registration is restricted as toschedules or activities because of a settlementagreement, probation, or other disciplinaryaction taken by the Department of Health andSenior Services, the Drug EnforcementAdministration or a professional licensingboard. Authority to conduct activities withcontrolled substances in Schedule I requires aseparate application and registration.

(3) All applicants shall make full, true andcomplete answers on the application. TheDepartment of Health and Senior Servicesmay require an applicant to submit docu-ments or written statements of fact relevant tothe application as considered necessary todetermine whether the application should begranted. The failure of the applicant to pro-vide these documents or statements withinsixty (60) days after being requested to do soshall be considered to be a waiver by the

applicant of an opportunity to present thesedocuments or facts for consideration in grant-ing or denying the application.

(4) Information Required on Applications.The information required on all applicationsfor a Missouri Controlled Substance Regis-tration includes:

(A) Type of Application. The applicantmust identify whether the application is for anew registration, a name change, a change ofaddress or a change of ownership;

(B) Applicant Information. The applicantmust provide his or her full legal name andpractice location that is not a post office box;

(C) Registration Type. The applicant mustidentify whether the application is for a fullthree (3)-year registration or a one (1)-yearlocum tenens registration;

(D) Type of Business Activity. The appli-cant must identify whether the application isfor a pharmacy, hospital, practitioner, nursinghome kit, emergency medical service, narcot-ic treatment program, teaching institution,manufacturer, distributor, researcher, analyti-cal lab, importer, exporter, registered nurse(may not prescribe controlled substances), orother;

(E) Appropriate Fee. The applicant mustidentify whether the application is for a gov-ernment entity that is fee exempt along withthe title of the governing unit;

(F) General Information. The applicantmust provide his or her business telephonenumber; Drug Enforcement Administration(DEA) number, if applicable; professionaldegree, if applicable and professional licensenumber, if applicable;

(G) The applicant must answer yes or no towhether the applicant, or any officer of acorporate applicant, or individual employedby any applicant having access to controlledsubstances, has ever entered a plea of guilty,no contest, nolo contendere, or otherwisebeen convicted of any violation of any stateor federal law related to the possession, man-ufacture, distribution, dispensing or prescrib-ing of controlled substances. If the answer isyes, the applicant must provide an explana-tion;

(H) If the applicant is an individual or aregistrant that holds a professional license,the applicant must answer yes or no towhether they are currently licensed and reg-istered to practice their profession under thelaws of this state;

(I) If the applicant is not an individual or aregistrant that holds a professional license,the applicant shall answer yes or no towhether they are currently authorized to con-duct business under the laws of this state;

(J) Previous Discipline. If the applicantcurrently holds or has previously held a stateor federal controlled substance registration orstate professional license or registration, theapplicant must answer yes or no to whethertheir license, registration or application orrenewal thereof has ever been surrendered,revoked, suspended, denied, restricted orplaced on probation and if any such action ispending. If the answer is yes, the applicantmust provide an explanation;

(K) The original signature of the individu-al applicant, corporate officer or hospitaladministrator and the official title of theapplicant if the applicant is other than anindividual;

(L) If the applicant is an individual, theapplicant must provide his or her SocialSecurity number and date of birth;

(M) The date the application is signed;(N) The county of business activity; and(O) The applicant must indicate what drug

schedules they request authority in.



19 CSR 30-1.019 Registration Location

PURPOSE: This rule establishes require-ments for the physical location of a registra-tion.

(1) A controlled substance registration shallbe issued at a U.S. Postal Service streetaddress.

(2) A controlled substance registration shallbe issued to an individual practitioner at aMissouri practice location where controlledsubstance and other patient care activitiesoccur, except:

(A) When an individual practitioner has atemporary location registration, the registra-tion shall be issued to the address where thepractitioner�s professional license to practicein Missouri is issued. A practitioner with atemporary location registration shall:

1. Have a current Missouri professionallicense to practice and be registered with theDepartment of Health and Senior Services atthe address listed on his/her professionallicense;

2. Have a federal Drug EnforcementAdministration registration that is valid inMissouri;



3. Anticipate practicing in Missouriwithin the next twelve (12) months;

4. Not practice for more than ninety(90) consecutive calendar days at any loca-tion;

5. Maintain a record of the date(s) andlocation(s) of all practice activity in Missouriand make the record available to the Bureauof Narcotics and Dangerous Drugs. Thisrecord shall be retained for two (2) years;

6. Maintain all required controlled sub-stance records at each location;

7. Not receive or stock controlled sub-stances at any location.



19 CSR 30-1.020 List of Excepted Sub-stances(Rescinded November 30, 2000)

AUTHORITY: section 195.195, RSMo Supp.1989. This rule was previously filed as 13CSR 50-130.020. Original rule filed Sept. 28,1977, effective Jan. 13, 1978. Amended:Filed Nov. 14, 1978, effective Dec. 11, 1978.Amended: Filed Oct. 12, 1979, effective Nov.11, 1979. Amended: Filed Oct. 14, 1981,effective Nov. 2, 1981. Amended: Filed Nov.1, 1982, effective Dec. 11, 1982. Amended:Filed Nov. 7, 1983, effective Dec. 11, 1983.Amended: Filed Oct. 2, 1991, effective Feb.6, 1992. Rescinded: Filed April 14, 2000,effective Nov. 30, 2000.

19 CSR 30-1.023 Registration Changes

PURPOSE: This rule establishes proceduresfor modifying an existing registration,describes the conditions under which a regis-tration automatically terminates, and pro-hibits the transfer of a registration.

(1) Modification of Registration.(A) Any registrant may apply to modify

his/her registration to authorize the handlingof controlled substances in additional sched-ules by filing an application in the same man-ner as an application for new registration. Nofee shall be required to be paid for the modi-fication. The application for modificationshall be handled in the same manner as anapplication for registration.

(B) Any registrant may request to modifyhis or her name or address as shown on the

registration provided that such a modificationdoes not constitute a change of ownership orlocation. The request shall be made in writ-ing and no fee shall be required to be paid forthe modification.

(C) When the registrant�s name or addressas shown on the registration changes the reg-istrant shall notify the Department of Healthin writing, including the registrant�s signa-ture, prior to or within 30 days subsequent tothe effective date of the change. No fee shallbe required to be paid for the modification.

(2) Termination of Registration.(A) The registration of any person shall

terminate:1. On the expiration date assigned to the

registration at the time the registration wasissued;

2. If and when the person dies;3. If and when the person ceases legal

existence;4. If and when a business changes own-

ership, except;A. The registration shall not termi-

nate for thirty (30) days from the effectivedate of the change if the new owner appliesfor a registration within the thirty (30)-dayperiod and the corresponding Drug Enforce-ment Administration registration remainseffective as provided for by the DrugEnforcement Administration;

5. If and when the person discontinuesbusiness or changes business location,except:

A. The registration shall not termi-nate for thirty (30) days from the effectivedate of the change if the person applies for anew registration or modification within thethirty (30)-day period;

B. The registration shall not terminateif it is a temporary location registration;

6. Upon the written request of the regis-trant.

(B) Any registrant who ceases legal exis-tence or discontinues business or profession-al practice shall notify the Department ofHealth and Senior Services of the effectivedate of this action and promptly returnhis/her registration certificate to the Depart-ment of Health and Senior Services.

(3) Transfer of Registration. No registrationor any authority conferred by registrationshall be assigned or otherwise transferred.



19 CSR 30-1.025 List of Exempt AnabolicSteroid Products (Rescinded November 30, 2000)

AUTHORITY: section 195.015.4, RSMoSupp. 1989. Original rule filed July 6, 1993,effective Dec. 9, 1993. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.026 Separate Registrations

PURPOSE: This rule defines the require-ments for controlled substance registrationsfor separate activities and for separate sites,and defines when a separate registration isnot required.

(1) Independent Activities. The followingeight groups of activities are deemed to beindependent of each other and require sepa-rate registration:

(A) Manufacturing controlled substances; (B) Distributing controlled substances,

except:1. A dispenser distributing less than

5% of the total combined dosage units of con-trolled substances distributed and dispensedin a calendar year shall be exempt fromobtaining a separate registration for distribut-ing;

2. A dispenser distributing more than5% of the total combined dosage units of con-trolled substances distributed and dispensedin a calendar year must obtain a separate reg-istration as a distributor but shall be exemptfrom maintaining separate inventories under19 CSR 30-1.042;

(C) Dispensing controlled substances listedin Schedules II�V;

(D) Conducting research and instructionalactivities with controlled substances listed inSchedule I;

(E) Conducting research with controlledsubstances listed in Schedules II�V;

(F) Conducting a narcotic treatment pro-gram with narcotic controlled substances list-ed in Schedules II�V;

(G) Conducting instructional activitieswith controlled substances listed in SchedulesII�V;

(H) Importing controlled substances; (I) Exporting controlled substances;(J) Conducting chemical analysis with con-

trolled substances listed in any schedule.

(2) No activity shall be conducted with anycontrolled substance in any schedule notrequested for and shown on the current regis-tration.

(3) Separate Locations. A separate registra-tion is required for each principal place of



business or professional practice at one gen-eral physical location where controlled sub-stances are manufactured, distributed or dis-pensed by a person.

(A) For purposes of registration only, thefollowing locations shall be deemed not to beplaces where controlled substances are man-ufactured, distributed or dispensed:

1. A warehouse where controlled sub-stances are stored by or on behalf of a reg-istered person, unless these substances aredistributed directly from the warehouse toregistrants other than the registered person orto persons not required to register;

2. An office used by agents of a regis-trant where sales of controlled substances aresolicited, made or supervised but which nei-ther contains these substances (other thansubstances for display purposes or lawful dis-tribution as samples only) nor serves as a dis-tribution point for filling sales orders;

3. An office used by a practitioner (whois registered at another location) where con-trolled substances are prescribed but neitheradministered nor otherwise dispensed as aregular part of the professional practice of thepractitioner at the office and where no sup-plies of controlled substances are maintained;

4. A location on the immediate or con-tiguous property of a hospital, provided thatthe location is owned and operated by thehospital and controlled substances are notdispensed for use away from the location;

5. A separate location from a registeredpre-hospital emergency medical service loca-tion where an emergency vehicle is housedthat does not have a permanent location ofoperation and which rotates between loca-tions at least every 30 days for operationalreasons other than controlled substance regis-tration;

6. A pre-hospital emergency medicalservice located outside the state of Missourithat renders assistance to a pre-hospital emer-gency medical service located in the state ofMissouri under a mutual aid contract in thecase of an emergency, major catastrophe orother unforeseen event that jeopardizes theability of the local Missouri pre-hospitalemergency medical service to promptlyrespond.

(B) A separate registration is not requiredfor each separate practice location for anindividual practitioner who has a temporarylocation registration.

AUTHORITY: section 195.195, RSMo 1994.*Original rule filed April 14, 2000, effectiveNov. 30, 2000.


19 CSR 30-1.027 Investigative and Admin-istrative Procedures

PURPOSE: This rule establishes proceduresfor the handling and disposition of informa-tion indicating violations of Chapter 195,RSMo by the Department of Health, pursuantto the mandates of section 195.040.

(1) The Department of Health may allowofficers of state and federal administrativeagencies to attend and participate in informalconferences conducted with Missouri con-trolled substances registrants, Missouri regu-lated chemical registrants or applicants inorder to assist the Department of Health in itsdeliberations.



19 CSR 30-1.030 Requirements for Con-trolled Substances Registration(Rescinded November 30, 2000)

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 April12, 1983, effective July 11, 1983. Amended:Filed May 31, 1989, effective Oct. 1, 1989.Amended: Filed Nov. 26, 1991, effective April9, 1992. Amended: Filed Aug. 26, 1992,effective April 8, 1993. Amended: Filed Nov.1, 1994, effective June 30, 1995. Rescinded:Filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.031 Physical Security Re-quirements

PURPOSE: This rule requires applicants andregistrants to maintain security controls andprocedures to prevent theft and diversion ofcontrolled substances.

(1) All applicants and registrants shall pro-vide effective controls and procedures toguard against theft and diversion of con-trolled substances. In order to determinewhether a registrant has provided effectivecontrols against diversion, the Department ofHealth shall use the security requirement setforth in 19 CSR 30-1.032�19 CSR 30-1.034as standards for the physical security controls

and operating procedures necessary to pre-vent diversion. Substantial compliance withthese standards may be deemed sufficient bythe Department of Health after evaluation ofthe overall security system and needs of theapplicant or registrant.

(2) Physical security controls shall be com-mensurate with the schedules and quantity ofcontrolled substances in the possession of theregistrant in normal business operations. If acontrolled substance is transferred to a dif-ferent schedule, or a noncontrolled substanceis listed on any schedule, or the quantity ofcontrolled substances in the possession of theregistrant in normal business operations sig-nificantly increases, physical security con-trols shall be expanded and extended accord-ingly.

(3) All registrants who receive or transfersubstantial quantities of controlled substancesin normal business operations shall employsecurity procedures to guard against in-tran-sit losses.



19 CSR 30-1.032 Security for Nonpracti-tioners

PURPOSE: This rule describes specificactions required of nonpractitioner regis-trants to maintain effective security.

PUBLISHER�S NOTE: The secretary of statehas determined that the publication of theentire text of the material which is incorpo-rated by reference as a portion of this rulewould be unduly cumbersome or expensive.This material as incorporated by reference inthis rule shall be maintained by the agency atits headquarters and shall be made availableto the public for inspection and copying at nomore than the actual cost of reproduction.This note applies only to the reference mate-rial. The entire text of the rule is printedhere.

(1) Before distributing a controlled substanceto any person who the registrant does notknow to be registered to possess the con-trolled substance, the registrant shall make agood faith inquiry either with the federalDrug Enforcement Administration (DEA) orwith the Department of Health and SeniorServices to determine that the person is reg-istered to possess the controlled substance.





(2) The registrant shall design and operate asystem to disclose to the registrant suspiciousorders of controlled substances. The regis-trant shall inform the Department of Healthand Senior Services of suspicious orderswhen discovered by the registrant. Suspiciousorders include orders of unusual size, ordersdeviating substantially from a normal patternand orders of unusual frequency.

(3) The registrant shall notify the Departmentof Health and Senior Services of any theft orsignificant loss of any controlled substancesupon discovery of this theft or loss.

(A) The registrant shall complete and sub-mit a Report of Loss, Theft or Diversion ofControlled Substances or Regulated Chemi-cals to the Department of Health and SeniorServices no later than seven (7) business daysafter the discovery of such a loss. If the extentof the loss cannot be fully determined in thattime frame, the registrant shall contact theDepartment of Health and Senior Services torequest permission to submit an interimreport and arrange for a complete report to becompleted and submitted. The registrant mayattach a copy of a completed Drug Enforce-ment Administration Loss Form in lieu ofcompleting the back or second page of aReport of Loss, Theft or Diversion of Con-trolled Substances or Regulated Chemicalsform. In the event of theft, diversion or sus-pected theft or diversion, the report submit-ted to the Department of Health and SeniorServices shall be accompanied by or followedby a summary of the internal investigationperformed, the outcome of the investigation,and a copy of any law enforcement agencyreport completed if applicable.

(B) If an insignificant amount of a con-trolled substance is lost during lawful activi-ties authorized under Chapter 195, RSMo,the reason for the loss or a description ofwhat occurred, the name of the drug and theamount lost shall be documented in writing,signed by the registrant and attached or filedwith the last completed annual inventory.

(4) The registrant shall not distribute anycontrolled substance as a complimentarysample to any potential or current customerwithout the prior written request of the cus-tomer, to be used only for satisfying the legit-imate medical needs of patients of the cus-tomer and only in reasonable quantities. Therequest must contain the name, address andregistration number of the customer and thename of the specific controlled substancedesired. The request shall be preserved by theregistrant with other records of distributionof controlled substances. In addition, therequirements for order forms shall be com-

plied with for any distribution of a controlledsubstance listed in Schedule I or II.

(5) Entities registered with the Department ofHealth and Senior Services as distributorsshall be deemed to have met security require-ments for storage of Schedule V controlledsubstance drug products containing ephedrineor pseudoephedrine if those products arestored in compliance and consistent with theregulated chemicals requirements set forth bythe United States Drug Enforcement Admin-istration and 21 CFR 1309.71 which is here-by incorporated by reference in this rule, aspublished on April 1, 2005 by the U.S. Gov-ernment Printing Office, U.S. Superinten-dent of Documents, Washington, DC 20402-001; www.gpoaccess.gov/cfr/retrieve.html.This rule does not incorporate any subse-quent amendments or additions. Distributorswill be required to conduct backgroundchecks on employees with access to thesesubstances and to report losses of controlledsubstances as required in 19 CSR 30-1.034.

AUTHORITY: sections 195.017, RSMo Supp.2005 and 195.195, RSMo 2000.* Originalrule filed April 14, 2000, effective Nov. 30,2000. Emergency amendment filed Aug. 18,2005, effective Aug. 28, 2005, expired Feb.23, 2006. Amended: Filed Sept. 1, 2005,effective Feb. 28, 2006.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195,RSMo 1957, amended 1971, 1989, 1993.

19 CSR 30-1.033 Hearing Procedures onControlled Substances Registration (Rescinded November 30, 2000)

AUTHORITY: sections 195.040.11 and195.195, RSMo Supp. 1989. Original rulefiled Aug. 26, 1992, effective April 8, 1993.Rescinded: Filed April 14, 2000, effectiveNov. 30, 2000.

19 CSR 30-1.034 Security for Practitioners

PURPOSE: This rule describes specificactions required of practitioner registrants tomaintain effective security. This rule also cre-ates and defines the form which must be usedby a registrant to report any theft or loss ofcontrolled substances to the Department ofHealth.

(1) Physical Security.(A) Controlled substances listed in Sched-

ules I and II shall be stored in a securelylocked, substantially constructed cabinet.

(B) Controlled substances listed in Sched-ules III, IV and V shall be stored in a secure-ly locked, substantially constructed cabinet.However, pharmacies may disperse these sub-stances throughout the stock of noncontrolledsubstances in such a manner as to obstructthe theft or diversion of the controlled sub-stances.

(C) This rule also shall apply to nonpracti-tioners authorized to conduct research orchemical analysis under another registration.

(2) Other Security. (A) The registrant shall not employ as an

agent or employee who has access to con-trolled substances any person who has beenfound guilty or entered a plea of guilty ornolo contendere in a criminal prosecutionunder the laws of any state or of the UnitedStates for any offense related to controlledsubstances or who has had an application fora state or federal controlled substance regis-tration denied or has had his/her registrationrevoked or surrendered for cause at any time.For purposes of this subsection, the term forcause means a surrender in place of or as aconsequence of any federal or state adminis-trative, civil or criminal action resulting froman investigation of the individual�s handlingof controlled substances.

1. A registrant may apply in writing tothe Department of Health and Senior Ser-vices for a waiver of subsection (2)(A) of thisrule for a specific employee.

2. The Department of Health and SeniorServices may issue a written waiver to anyregistrant upon determination that a waiverwould be consistent with the public healthand safety. In making this determination, theDepartment of Health and Senior Servicesshall consider�the duties of the employee,the circumstances surrounding the convic-tion, the length of time since the convictionwas entered, whether a waiver has beengranted by the federal Drug EnforcementAdministration (DEA) pursuant to 21 CFR1301.76, the security measures taken by theemployer to prevent the theft and diversion ofcontrolled substances, and any other factorsconsistent with public health and safety.

(B) A registrant shall notify the Depart-ment of Health and Senior Services of thetheft, diversion or significant loss of any con-trolled substances or regulated chemicalsupon discovery.

1. The registrant shall complete andsubmit a report of the loss or diversion ofcontrolled substances to the Department ofHealth and Senior Services no later thanseven (7) business days after the discovery ofsuch a loss. The loss report form shall con-tain the following information: name and



address of registrant, business phone num-ber; Missouri Controlled Substance Registra-tion Number; federal Drug EnforcementAdministration Registration number; date oftheft or loss; date of discovery of theft orloss; county of location; principal type ofregistration such as M.D., D.O., D.P.M.,O.D., D.V.M., D.D.S., D.M.D., A.N.P.,emergency medical service, pharmacy, hospi-tal, manufacturer, nursing home kit, narcotictreatment program, teaching institution, dis-tributor, importer, exporter, or other speci-fied business; whether or not the loss or theftwas reported to law enforcement; the nameand phone number of the law enforcementagency reported to; the number of losses orthefts the registrant has experienced in thepast twenty-four (24) months; the type of lossor diversion such as, break in/burglary, rob-bery, employee theft, forged or falsifiedrecords, lost in transit, or other explainedtype of loss; if lost in transit, the name of thecommon carrier and name of consignee; thename(s) of the individual diverting controlledsubstances who was responsible for the theftor loss; copy of registrant�s internal inves-tigative report involving the loss or theft; thefull name, date of birth and Social Securitynumber of the individual(s) responsible forthe theft or diversion, if known; a copy of thepolice report if law enforcement was notified;if the loss or diversion was in transit, identi-fy the origin of the delivery, the name of thecarrier(s) used and the name of the con-signee; a list of all controlled substances lost,stolen or diverted by their generic name,trade name, the dosage strength, dosage formand quantity; the signature of the personcompleting the loss report and their title andthe date of their signature. If the extent of theloss cannot be fully determined in that timeframe, the registrant shall contact the Depart-ment of Health and Senior Services to requestpermission to submit an interim report andarrange for a complete report to be complet-ed and submitted. The registrant may attach acopy of a completed Drug EnforcementAdministration Loss Form in lieu of complet-ing the back or second page of a loss reportform provided by the Department of Healthand Senior Services. In the event of theft,diversion or suspected theft or diversion, thereport submitted to the Department of Healthand Senior Services shall be accompanied byor followed by a summary of the internalinvestigation performed, the outcome of theinvestigation, and a copy of any law enforce-ment agency report completed if applicable.

2. If an insignificant amount of a con-trolled substance is lost during lawful activi-ties authorized under Chapter 195, RSMo,the reason for the loss or a description of

what occurred, the name of the drug and theamount lost shall be documented in writing,signed by the registrant and attached or filedwith the last completed annual inventory.



19 CSR 30-1.035 Requirements for Pre-scribing, Dispensing and AdministeringControlled Substances(Rescinded November 30, 2000)

AUTHORITY: sections 195.040.3(2),195.050.6 and 195.195, RSMo 1994. Origi-nal rule filed Nov. 14, 1988, effective Feb.24, 1989. Amended: Filed Aug. 26, 1992,effective April 8, 1993. Amended: Filed Nov.1, 1994, effective June 30, 1995. Rescinded:Filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.036 Disposing of UnwantedControlled Substances (Rescinded November 30, 2000)

AUTHORITY: section 195.050.6, RSMo1986. Original rule filed Jan. 18, 1989,effective April 27, 1989. Rescinded: FiledApril 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.040 Dispensing and Distribu-tion of Controlled Substances in CertainSituations(Rescinded July 30, 2003)

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. Rescinded: Filed Jan.31, 2003, effective July 30, 2003.

19 CSR 30-1.041 Records Requirements

PURPOSE: This rule defines the record keep-ing and inventory requirements for variousclasses of registrants.

(1) Persons Required to Keep Records. (A) Each registrant shall maintain the

records and inventory required by 19 CSR30-1.041�19 CSR 30-1.052, except asexempted by 19 CSR 30-1.041�19 CSR 30-1.052.

(B) Registered individual practitioners andinstitutional practitioners are required to keep

records with respect to controlled substanceswhich are prescribed, administered or dis-pensed.

(C) A registered person using any con-trolled substance in research conducted inconformity with an exemption granted undersection 505(i) or 512(j) of the federal Food,Drug and Cosmetic Act (21 U.S.C. 355(i) or360(j)) at a registered establishment whichmaintains records in accordance with eitherof those sections is not required to keeprecords if s/he notifies the Department ofHealth of the name, address and registrationnumber of the establishment maintainingthese records.

(D) A registered person using any con-trolled substance in preclinical research or inteaching at a registered establishment whichmaintains records with respect to these sub-stances is not required to keep records if s/henotifies the Department of Health of thename, address and registration number of theestablishment maintaining the records.

(E) Notice required by subsection (1)(D) ofthis rule shall be given at the time the personapplies for registration or re-registration andshall be made in the form of an attachment tothe application, which shall be filed with theapplication.

(2) Maintenance of Records and Inventories.Every inventory and other record required tobe kept under 19 CSR 30-1.041�19 CSR 30-1.052, shall be kept by the registrant and beavailable, for at least two years from the dateof the inventory or record, for inspecting andcopying by authorized employees of theDepartment of Health, except that financialand shipping records (such as invoices andpacking slips, but not executed order forms)may be kept at a central location rather thanat the registered location if the registrantobtains from the Department of Healthapproval of his/her central record keepingsystem and a permit to keep central records.The permit to keep central records shall besubject to the following conditions:

(A) The permit shall specify the nature ofthe records to be kept centrally and the exactlocation where the records will be kept;

(B) The registrant agrees to deliver all orany part of these records to the registeredlocation within three working days of receiptof a written request from the Department ofHealth for these records and if the Depart-ment of Health chooses to do so in lieu ofrequiring delivery of records to the registeredlocation, to allow authorized employees ofthe Department of Health to inspect therecords at the central location upon requestby the employees without a warrant of anykind;



(C) The failure of the registrant to performhis/her agreements under the permit shallrevoke, without further action, the permit andall other such permits held by the registrantunder other registrations. In the event of arevocation of other permits under subsection(2)(C) of this rule, the registrant, within 30days after the revocation, shall comply withthe requirement that all records be kept at theregistered location.

(3) Each registered individual practitioner,institutional practitioner, manufacturer, dis-tributor, importer and exporter shall maintaininventories and records of controlled sub-stances as follows:

(A) Inventories and records of controlledsubstances listed in Schedules I and II shallbe maintained separately from all of therecords of the registrant;

(B) Inventories and records of controlledsubstances listed in Schedules III, IV and Vshall be maintained either separately from allother records of the registrant or in a formthat the information required is readilyretrievable from the ordinary businessrecords of the registrant.

(4) Each registered pharmacy shall maintainthe inventories and records of controlled sub-stances as follows:

(A) Inventories and records of all con-trolled substances listed in Schedules I and IIshall be maintained separately from all otherrecords of the pharmacy and prescriptions forthese substances shall be maintained in a sep-arate prescription file;

(B) Inventories and records of controlledsubstances listed in Schedules III, IV and Vshall be maintained either separately from allother records of the pharmacy or in a formthat the information required is readilyretrievable from ordinary business records ofthe pharmacy and prescriptions for those sub-stances shall be maintained in a separate pre-scription file.

AUTHORITY: sections 195.050 and 195.195,RSMo 1994 and 195.030, RSMo Supp.1999.* Original rule filed April 14, 2000,effective Nov. 30, 2000.

*Original authority: 195.030, RSMo 1939, amended 1971,1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended1971, 1989; and 195.195, RSMo 1957, amended 1971,1989, 1993.

19 CSR 30-1.042 Inventory Requirements

PURPOSE: This rule defines requirementsfor the form and maintenance of controlledsubstance inventories.

(1) General Requirements.(A) Each inventory shall contain a com-

plete and accurate record of all controlledsubstances on hand on the date the inventorywas taken. Controlled substances shall bedeemed to be on hand if they are in the pos-session of or under the control of the regis-trant, including substances returned by a cus-tomer, substances ordered by a customer butnot yet invoiced, substances stored in a ware-house on behalf of the registrant and sub-stances in the possession of employees of theregistrant and intended for distribution ascomplimentary samples.

(B) A separate inventory shall be made bya registrant for each registered location. Inthe event controlled substances are in the pos-session or under the control of the registrantat a location for which s/he is not registered,the substances shall be included in the inven-tory of the registered location to which theyare subject to control or to which the personpossessing the substance is responsible. Eachinventory for a registered location shall bekept at the registered location.

(C) A separate inventory shall be made bya registrant for each independent activity forwhich s/he is registered.

(D) A registrant may take an inventoryeither as of the opening of business or as ofthe close of business on the inventory date.The registrant shall indicate on the inventoryrecords whether the inventory is taken as ofthe opening or as of the close of business andthe date the inventory is taken.

(E) An inventory must be maintained in apermanent written, typewritten or printedform. An inventory taken by use of an oralrecording device must be transcribed prompt-ly.

(2) Initial Inventory Date. (A) Every person required to keep records

who is registered with the Department ofHealth after May 1, 1971 and who was notregistered previously shall take an inventoryof all stocks of controlled substances on handon the date s/he first engages in the manufac-ture, distribution or dispensing of controlledsubstances.

(B) Compliance with federal initial inven-tory date requirements is deemed satisfactory.Duplicate inventories are not required.

(3) Annual Inventory Date. After the initialinventory is taken, the registrant shall take anew inventory of all stocks of controlled sub-stances on hand at least once a year. Theannual inventory may be taken on any datethat is within one year of the previous annu-al inventory date.

(4) Inventory Date for Newly ControlledSubstances. On the effective date of a rule bythe Department of Health adding a substanceto any schedule of controlled substances,which substance was not listed immediatelyprior to that date in any such schedule, everyregistrant required to keep records who ismanufacturing, distributing or dispensing thatsubstance shall take inventory of all stocks ofthe substance on hand. After that, this sub-stance shall be included in each inventorymade by the registrant.

(5) Inventories of Manufacturers. Each regis-tered manufacturer shall include the follow-ing information in his/her inventory:

(A) For each controlled substance in bulkform to be used in (or capable of use in) themanufacture of the same or other controlledor noncontrolled substances in finished form,the name of the substance and the total quan-tity of the substance to the nearest metric unitweight consistent with unit size (except thatfor inventories made in 1971, avoirdupoisweights may be utilized where metric weightsare not readily available);

(B) For each controlled substance in theprocess of manufacture on the inventory datethe name of the substance, the quantity of thesubstance in each batch, stage of manufac-ture, or both, identified by the batch numberor other appropriate identifying number andthe physical form which the substance is totake upon completion of the manufacturingprocess (for example, granulations, tablets,capsules or solutions), identified by the batchnumber or other appropriate identifying num-ber and if possible the finished form of thesubstance (for example, ten milligram (10mg) tablet or ten milligram (10 mg) concen-tration per fluid ounce or milliliter) and thenumber or volume;

(C) For each controlled substance in fin-ished form, the name of the substance; eachfinished form of the substance (for example,ten milligram (10 mg) tablet or ten milligram(10 mg) concentration per fluid ounce ormilliliter); the number of units or volume ofeach finished form in each commercial con-tainer (for example, four 100 tablet bottles orthree milliliter (3 ml) vials); the number ofcommercial containers of each finished form(for example, four 100 tablet bottles or sixthree milliliter (3 ml) vials);

(D) For each controlled substance notincluded in subsections (5)(A)�(C) of thisrule (for example, damaged, defective orimpure substances awaiting disposal, sub-stances held for quality control purposes orsubstances maintained for extemporaneouscompoundings), the name of the substance;

the total quantity of the substance to the near-est metric unit weight or the total number ofunits of finished form; the reason for the sub-stance being maintained by the registrant andwhether the substance is capable of use in themanufacture of any controlled substance infinished form.

(6) Inventories of Distributors. Each regis-tered distributor shall include in his/herinventory the same information required ofmanufacturers in subsections (5)(C) and (D)of this rule.

(7) Inventories of Dispensers andResearchers. Each person registered to dis-pense or conduct research with controlledsubstances and required to keep records shallinclude in his/her inventory the same infor-mation required of manufacturers in subsec-tions (5)(C) and (D) of this rule. In deter-mining the number of units of each finishedform of a controlled substance in a commer-cial container which has been opened, thedispenser shall do as follows:

(A) If the substance is listed in Schedule Ior II, s/he shall make an exact count or mea-sure of the contents;

(B) If the substance is listed in ScheduleIII, IV or V, s/he shall make an estimatedcount or measure of the contents, unless thecontainer holds more than 1,000 tablets orcapsules in which case s/he must make anexact count of the contents.

(8) Inventories of Importers and Exporters.Each registered importer or exporter shallinclude in his/her inventory the same infor-mation required of manufacturers in subsec-tions (5)(A), (C) and (D) of this rule. Eachregistered importer and exporter who also isregistered as a manufacturer or as a distribu-tor shall include in his/her inventory as animporter or exporter only those stocks ofcontrolled substances that actually are sepa-rated from his/her stocks as a manufactureror as a distributor (for example, in-transit orin storage for shipment).

(9) Inventories for Chemical Analysts. Eachanalytical laboratory registered to conductchemical analysis with controlled substancesshall include in its inventory the same infor-mation required of manufacturers in subsec-tions (5)(A), (C) and (D) of this rule as tosubstances which have been manufactured,imported or received by the laboratory con-ducting the inventory. If less than one kilo-gram (1 kg) of any controlled substance(other than a hallucinogenic controlled sub-stance listed in Schedule I) or less than twen-ty grams (20 g) of a hallucinogenic substancelisted in Schedule I (other than lysergic acid

diethylamide) or less than point five gram(0.5 g) of lysergic acid diethylamide, is onhand at the time of inventory, those sub-stances need not be included in the inventory.Laboratories of the division may process upto one hundred fifty grams (150 g) of any hal-lucinogenic substance in Schedule I withoutregard to a need for an inventory of thosesubstances.

AUTHORITY: sections 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov. 30,2000.


19 CSR 30-1.044 Continuing Records Gen-eral Requirements

PURPOSE: This rule sets requirements forthe maintenance of ongoing controlled sub-stance records.

(1) Every registrant required to keep recordsshall maintain on a current basis a completeand accurate record of each such substancemanufactured, imported, received, sold,delivered, exported or otherwise disposed ofby him/her.

(2) Separate records shall be maintained by aregistrant for each registered location exceptas provided in 19 CSR 30-1.041(2). In theevent controlled substances are in the posses-sion or under the control of a registrant at alocation for which s/he is not registered, thesubstance shall be included in the records ofthe registered location to which they are sub-ject to control or to which the person pos-sessing the substance is responsible.

(3) Separate records shall be maintained by aregistrant for each independent activity forwhich s/he is registered.

(4) In recording dates of receipt, importation,distribution, exportation or other transfers,the date on which the controlled substancesare actually received, imported, distributed,exported or otherwise transferred shall beused as the date of receipt or distribution ofany documents of transfer (for example,invoices or packing slips).

(5) Records must be provided to the Depart-ment of Health within three working daysupon request.

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

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

19 CSR 30-1.046 Records for Manufac-turers, Distributors, Importers andExporters

PURPOSE: This rule sets requirements forrecord keeping by manufacturers, distribu-tors, importers and exporters of controlledsubstances.

(1) Records for Manufacturers. Each regis-tered manufacturer shall maintain recordswith the following information:

(A) For each controlled substance in bulkform to be used in or capable of use in orbeing used in the manufacture of the same orother controlled or noncontrolled substancesin finished form�

1. The name of the substance; 2. The quantity manufactured in bulk

form by the registrant, including the date,quantity and batch or other identifying num-ber of each batch manufactured;

3. The quantity received from other per-sons including the date and quantity of eachreceipt and the name, address and registrationnumber of the other person from whom thesubstance was received;

4. The quantity imported directly by theregistrant (under a registration as animporter) for use in manufacture by him/her,including the date, quantity and import per-mit or declaration number for each importa-tion;

5. The quantity used to manufacture thesame substance in finished form including thedate and batch or other identifying number ofeach manufacture; the quantity used in themanufacture; the finished form (for example,ten milligram (10 mg) tablets or ten mil-ligram (10 mg) concentration per fluid ounceor milliliter); the number of units of finishedform manufactured; the quantity used in qual-ity control; the quantity lost during manufac-turing and the causes for the loss, if known;the total quantity of the substance containedin the finished form; the theoretical and actu-al yields and other information as is neces-sary to account for all controlled substancesused in the manufacturing process;

6. The quantity used to manufactureother controlled and noncontrolled sub-stances, including the name of each substancemanufactured and the information required inparagraph (1)(A)5. of this rule;



7. The quantity distributed in bulk formto other persons, including the date and quan-tity of each distribution and the name,address and registration number of each per-son to whom a distribution was made;

8. The quantity exported directly by theregistrant, including the date, quantity andexport permit or declaration number of eachexportation;

9. The quantity distributed or disposedof in any other manner by the registrant (forexample, distribution of complimentary sam-ples or by destruction) including the date andmanner of distribution or disposal, the name,address and registration number of the personto whom distributed and the quantity dis-tributed or disposed;

(B) For each controlled substance in fin-ished form�

1. The name of the substance; 2. Each finished form (for example, ten

milligram (10 mg) tablet or ten milligram (10mg) concentration per fluid ounce ormilliliter) and the number of units or volumeof finished form in each commercial contain-er (for example, 100 tablet bottle or threemilliliter (3 ml) vial);

3. The number of containers of eachsuch commercial finished form manufacturedfrom bulk form by the registrant, includingthe information required in paragraph(1)(A)5. of this rule;

4. The number of units of finishedforms, commercial containers, or both,received from other persons, including thedate of and number of units, commercial con-tainers, or both, in each receipt and thename, address and registration number of theperson from whom the units were received;

5. The number of units of finished form,commercial containers, or both, importeddirectly by the registrant, including the dateof and the number of units, commercial con-tainers, or both, in each importation;

6. The number of units, commercialcontainers, or both, manufactured by the reg-istrant from units in finished form receivedfrom others or imported including: the dateand batch or other identifying number of eachmanufacture; the operation performed (forexample, repackaging or relabeling); thenumber of units of finished form used in themanufacture, the number manufactured andthe number lost during the manufacture, withthe causes for these losses, if known, andother information as is necessary to accountfor all controlled substances used in the man-ufacturing process;

7. The number of commercial contain-ers distributed to other persons including thedate of and number of containers in each dis-tribution and the name, address and registra-

tion number of the person to whom the con-tainers were distributed;

8. The number of commercial contain-ers exported directly by the registrant, includ-ing the date, number of containers and exportpermit or declaration number for each expor-tation;

9. The number of units of finishedforms, commercial containers, or both, dis-tributed or disposed of in any other mannerby the registrant (for example, by distributionof complimentary samples or by destruction),including the date and manner of distributionor disposal, the name, address and registra-tion number of the person to whom distribut-ed and the quantity in finished form dis-tributed or disposed.

(2) Records for Distributors. Each registereddistributor shall maintain records with thefollowing information for each controlledsubstance:

(A) The name of the substance; (B) Each finished form (for example, ten


(C) The number of commercial containersof each such finished form received fromother persons, including the date of and num-ber of containers in each receipt and thename, address and registration number of theperson from whom the containers werereceived;

(D) The number of commercial containersof each finished form imported directly bythe registrant including the date of and thenumber of containers in each importation;

(E) The number of commercial containersof each finished form distributed to other per-sons, including the date of and number ofcontainers in each distribution and the name,address and registration number of the personto whom the containers were distributed;

(F) The number of commercial containersof the finished form exported directly by theregistrant, including the date of and the num-ber of containers in each exportation;

(G) The number of units or volume of fin-ished forms, commercial containers, or both,distributed or disposed of in any other man-ner by the registrant (for example, by distri-bution as complimentary samples) includingthe date and manner of distribution or dis-posal, the name, address and registrationnumber of the person to whom distributedand the quantity of the substance in finishedform distributed or disposed.

(3) Records for Importers. Each registeredimporter shall maintain records with the fol-lowing information for each controlled sub-stance:

(A) The name of the substance; (B) The quantity (or number of units or

volume in finished form) imported, includingthe date, quantity (or number of units or vol-ume) and import permit or declaration num-ber for each importation;

(C) The quantity (or number of units orvolume in finished form) distributed to otherpersons, including the date, quantity (or num-ber of units or volume) of each distributionand the name, address and registration num-ber of each person to whom a distributionwas made;

(D) The quantity disposed of in any othermanner by the registrant except quantitiesused in manufacturing by an importer undera registration as a manufacture, which quan-tities are to be recorded, including the dateand manner of disposal and the quantity dis-posed.

(4) Records for Exporters. Each registeredexporter shall maintain records with the fol-lowing information for each controlled sub-stance:

(A) The name of the substance; (B) The quantity (or number of units or

volume in finished form) received from otherpersons, including the date and quantity (ornumber of units or volume) of each receiptand the name, address and registration num-ber of each person from whom the substancewas received;

(C) The quantity (or number of units orvolume in finished form) exported, includingthe date, quantity (or number of units or vol-ume) and the export permit or declarationnumber for each exportation, but excludingall quantities (and numbers of units and vol-umes) manufactured by an exporter under aregistration as a manufacture, which quanti-ties (and numbers of units and volumes) areto be recorded;

(D) The quantity disposed of in any othermanner by the registrant including the dateand manner of disposal and the quantity dis-posed.





19 CSR 30-1.048 Records for Practitionersand Researchers

PURPOSE: This rule sets requirements forrecord keeping for individual practitionersand researchers. It also sets requirements forthe use of facsimile and electronic computertransmission of controlled substance pre-scriptions.

(1) Each individual practitioner, institutionalpractitioner and pharmacy shall maintainrecords with the following information foreach controlled substance received, main-tained, dispensed or disposed:

(A) The name of the substance; (B) Each finished form (for example, ten


(C) The number of commercial containersof each finished form received from otherpersons, including the date of and number ofcontainers in each receipt and the name,address and registration number of the personfrom whom the containers were received;

(D) The number of units or volume of thefinished form dispensed including the nameand address of the person to whom it was dis-pensed, the date of dispensing, the number ofunits or volume dispensed and the written ortypewritten name or initials of the individualwho dispensed or administered the substance;

(E) The number of units or volume of thefinished forms, commercial containers, orboth, disposed of in any other manner by theregistrant, including the date and manner ofdisposal and the quantity of the substance infinished form disposed.

(2) Each individual practitioner shall main-tain a record of the date, full name andaddress of the patient, the drug name,strength, dosage form and quantity for allcontrolled substances prescribed or adminis-tered. This record may be maintained in thepatient�s medical record. When the controlledsubstance record is maintained in thepatient�s medical record and the practitioneris not the custodian of the medical record, thepractitioner shall make the controlled sub-stance record available as required in 19 CSR30-1.041 and 19 CSR 30-1.044.

(3) Individual practitioners shall maintain therecords listed in subsections (1)(A)�(E) ofthis rule separately from patient medicalrecords.

(4) A registrant who transfers a controlledsubstance to or receives a controlled sub-stance from another registrant shall maintaina written record of the transfer which con-tains the following information: the date oftransfer, drug name, strength, dosage form,quantity, name, address and registration num-ber of the transferring registrant and thename, address and registration number of thereceiving registrant.

(5) Drug Enforcement Administration officialorder forms shall be used for transfers ofSchedule II controlled substances.

(6) A prescription may not be issued for anindividual practitioner to obtain controlledsubstances for dispensing or administering topatients.

(7) Prescriptions which are transmitted byfacsimile to a pharmacy for dispensing shallinclude the telephone number of the facsimi-le machine or computer from which it is sentand the date and time of transmission. Imme-diately after a Schedule III, IV or V pre-scription or a Schedule II prescription for along-term care facility patient or hospicepatient or for a Schedule II narcotic substanceto be compounded for the direct administra-tion to a patient by parenteral, intravenous,intramuscular, subcutaneous or intraspinalinfusion is transmitted to a pharmacy by fac-simile equipment, the practitioner or thepractitioner�s agent shall sign and date theface of the prescription. The prescriptionsshall be maintained in chronological orderseparately from patient medical records in amanner so each prescription is readilyretrievable for inspection at the transmittingpractitioner�s office. In the event the facsimi-le is transmitted from a long-term care facil-ity or hospital, the prescription shall be main-tained at the long-term care facility orhospital in chronological order separatelyfrom the patient medical records in a mannerso each prescription is readily retrievable, ormaintained in the patient medical records.

(8) Any pharmacy receiving a controlled sub-stance prescription transmitted by facsimileequipment shall maintain the facsimile copyof the prescription along with the date andtime of transmission and the telephone num-ber of the facsimile machine from which itoriginated, as a part of its original prescrip-tion records.

(9) Any practitioner or practitioner�s agentwho transmits a controlled substance pre-scription by electronic computer transmissionshall maintain a printout of each day�s trans-missions. The practitioner or practitioner�s

agent shall verify that the information in theprintout is correct and shall sign the printout.

(10) Each pharmacist who dispenses con-trolled substances under a prescriptiontransmitted by electronic computer trans-mission, shall verify with the practitionerwithin 30 days of the filling such prescrip-tion that the prescription was authorized bythe practitioner. If verification is made bytelephone, the pharmacist shall documentthe verification on the reverse of the pre-scription or in the computer. If verificationis made by sending the practitioner a copyof a computer printout, the practitionershall verify, sign and return the printout tothe pharmacy. The pharmacy shall maintainthe verified printout in a separate file.



19 CSR 30-1.050 Records for ChemicalAnalysts

PURPOSE: This rule sets requirements forrecord keeping for chemical analyst regis-trants.

(1) Each person registered to conduct chemi-cal analysis with controlled substances shallmaintain records with the following informa-tion (to the extent known and reasonablyascertainable by him/her) for each controlledsubstance:

(A) The name of the substance; (B) The form(s) in which the substance is

received, imported or manufactured by theregistrant (for example, powder, granulation,tablet, capsule or solution) and the concen-tration of the substance in that form (forexample, Chemically Pure (CP), UnitedStates Pharmacopeia (USP), National Formu-lary (NF), ten milligram (10 mg) tablet or tenmilligram (10 mg) concentration permilliliter);

(C) The total number of the formsreceived, imported or manufactured (forexample 100 tablets, 30 one milliliter (1 ml)vials or ten grams (10 g) powder), includingthe date and quantity of each receipt, impor-tation or manufacture and the name, addressand registration number, if any, of the personfrom whom the substance was received; and

(D) The quantity distributed, exported ordestroyed in any manner by the registrant(except quantities used in chemical analysis



or other laboratory work), including the dateand manner of distribution, exportation ordestruction and the name, address and regis-tration number, if any, of each person towhom the substance was distributed orexported.

(2) Order forms, import and export permits,import invoices and export declarations relat-ing to controlled substances shall be main-tained separately from all other records of theregistrant.

(3) Records of controlled substances used inchemical analysis or other laboratory workare not required.

(4) Records relating to known or suspectedcontrolled substances received as samples foranalysis are not required under section (1) ofthis rule.



19 CSR 30-1.052 Records for Long-TermCare Facilities (LTCF)

PURPOSE: This rule sets requirements forrecord keeping by long-term care facility reg-istrants.

(1) Long-term care facilities (LTCFs) andtheir suppliers shall maintain written recordsof transfers of controlled substances from thesupplier to the LTCF emergency kit.

(2) The records shall include the date oftransfer; the name of each controlled sub-stance, the strength, dosage form and quanti-ty; the name, address and controlled sub-stance registration number of the supplier andthe name, address and controlled substanceregistration number of the LTCF. FederalDrug Enforcement Administration (DEA)official order forms shall not be used torecord transfers of controlled substances toLTCF emergency kits.

(3) No physician�s order or prescription shallbe used for initial stocking or replacement ofcontrolled substances in the emergency kit.Controlled substances contained in the kitshall be obtained from a pharmacy, hospitalor practitioner who holds a controlled sub-stances registration.

(4) The administration and medical staff ofthe LTCF, in conjunction with the primarysupplier, shall designate in written protocolsand procedures who may have access to theemergency kit, who may administer con-trolled substances from the emergency kit andunder what circumstances and a list of thecontrolled substances it intends to maintain inthe emergency kit. These protocols and pro-cedures shall be subject to review andapproval by the Department of Health. Onlythose individuals designated in the LTCF�swritten policies and procedures shall haveaccess to or administer controlled substancesfrom the emergency kit.

(5) Each administration of controlled sub-stances from the emergency kit shall be basedupon a practitioner�s order and shall berecorded in an administration record separatefrom the patient�s medical record. Thisadministration record shall include: the date,patient�s name, drug name, drug strength,dosage, ordering practitioner�s name andname of the person administering the con-trolled substance.



19 CSR 30-1.060 Determining Lawful Pre-scribing, Dispensing and Administering ofControlled Substances

PURPOSE: This rule defines the statutoryand regulatory basis for determining what islawful prescribing, dispensing and adminis-tering of controlled substances.

When determining if controlled substancesare being lawfully prescribed, dispensed andadministered by practitioners, the Depart-ment of Health shall enforce Chapter 195,RSMo, the Department of Health rules in 19CSR 30 pertaining to controlled substances,and the federal Controlled Substances Act 21U.S.C. 801�966, and its regulations, 21 CFR1300�1399. In determining lawful prescrib-ing, dispensing and administering of con-trolled substances, the Department of Healthalso shall consider the provisions of Chapters330, 332, 334, 335, 336, 338 and 340,RSMo, the rules in 4 CSR 110, 4 CSR 150,4 CSR 200, 4 CSR 210, 4 CSR 220, 4 CSR230 and 4 CSR 270, and protocols relating tothe respective practitioners established and onfile at the respective licensing boards.

AUTHORITY: sections 195.030, RSMo Supp.1999 and 195.195, RSMo 1994.* Originalrule filed April 14, 2000, effective Nov 30,2000.

*Original authority: 195.030, RSMo 1939, amended 1971,1989, 1993, 1995, 1999 and 195.195, RSMo 1957,amended 1971, 1989, 1993.

19 CSR 30-1.062 Transmission of Prescrip-tions

PURPOSE: This rule sets requirements gov-erning the transmission of prescription infor-mation.

(1) Prescriptions in Schedule II. A pharma-cist may dispense a controlled substance inSchedule II only under a written prescriptionsigned by the practitioner, except as providedin section 195.060.3, RSMo. A prescriptionfor a Schedule II controlled substance may betransmitted from the prescribing practitionerto a pharmacy by facsimile equipment orelectronic computer transmission, providedthe original written, signed prescription ispresented to the pharmacist for review priorto the actual dispensing of the controlled sub-stance, except that�

(A) A prescription written for a ScheduleII narcotic substance to be compounded forthe direct administration to a patient by par-enteral, intravenous, intramuscular, subcuta-neous or intraspinal infusion may be trans-mitted by the practitioner or the practitioner�sagent to the pharmacy by facsimile or by elec-tronic computer transmission. The facsimileor the computer transmission which has beenreduced to writing shall serve as and shall bemaintained in the same manner as an originalwritten prescription.

(B) A prescription written for a Schedule IIsubstance for a resident of a long-term carefacility may be transmitted by the practition-er or the practitioner�s agent to the pharmacyby facsimile or by electronic computer trans-mission. The facsimile or the computer trans-mission which has been reduced to writingshall serve as and shall be maintained in thesame manner as an original written prescrip-tion.

(C) A prescription written for a ScheduleII substance for a patient of a hospice may betransmitted by the practitioner or the practi-tioner�s agent to the pharmacy by facsimile orby electronic computer transmission. Thepractitioner or the practitioner�s agent shallnote on the prescription that the patient is ahospice patient. The facsimile or the comput-er transmission which has been reduced towriting shall serve as and shall be maintained





in the same manner as an original writtenprescription.

(2) Prescriptions in Schedule III, IV or V. Apharmacist may dispense directly a controlledsubstance in Schedule III, IV or V only undera written prescription signed by a practition-er or a facsimile of a written, signed pre-scription transmitted by the practitioner orhis/her authorized agent or under an oral pre-scription made by an individual practitionerwhether communicated by the practitioner orhis/her authorized agent or a prescriptiontransmitted by electronic computer transmis-sion by the authorizing practitioner or thepractitioner�s agent to the pharmacy. All oralprescriptions and prescriptions transmitted byelectronic computer transmission shall bepromptly reduced to writing by the pharma-cist containing all information required insection 195.060, RSMo, except for the signa-ture of the practitioner.

(3) Written Prescriptions. All written con-trolled substance prescriptions shall be signedby the prescribing practitioner on the dateprescribed. No controlled substance prescrip-tion shall be signed prior to the actual date itis issued.



19 CSR 30-1.064 Partial Filling of Sched-ule II Prescriptions

PURPOSE: This rule sets requirements forthe partial filling of Schedule II prescriptions.

(1) The partial filling of a prescription for acontrolled substance listed in Schedule II ispermissible, if the pharmacist is unable tosupply the full quantity called for in a writtenor emergency oral prescription and s/hemakes a notation of the quantity supplied onthe face of the written prescription (or writ-ten record of the emergency oral prescrip-tion). The remaining portion of the prescrip-tion may be filled within 72 hours of the firstpartial filling; however, if the remaining por-tion is not or cannot be filled within the 72-hour period, the pharmacist shall so notifythe prescribing individual practitioner. Nofurther quantity may be supplied beyond 72hours without a new prescription.

(2) A prescription for a Schedule II con-trolled substance written for a patient in along-term care facility (LTCF) or for a patient

with a medical diagnosis documenting a ter-minal illness may be filled in partial quanti-ties to include individual dosage units. Ifthere is any question whether a patient maybe classified as having a terminal illness, thepharmacist must contact the practitioner priorto partially filling the prescription. Both thepharmacist and the prescribing practitionerhave a corresponding responsibility to assurethat the controlled substance is for a termi-nally ill patient. The pharmacist must recordon the prescription whether the patient is�terminally ill� or an �LTCF patient.� A pre-scription that is partially filled and does notcontain the notation �terminally ill� or�LTCF patient� shall be deemed to have beenfilled in violation of Chapter 195, RSMo. Foreach partial filling, the dispensing pharmacistshall record on the back of the prescription(or on another appropriate record, uniformlymaintained and readily retrievable) the dateof the partial filling, quantity dispensed,remaining quantity authorized to be dis-pensed, and the identification of the dispens-ing pharmacist. The total quantity of Sched-ule II controlled substances dispensed in allpartial fillings must not exceed the total quan-tity prescribed. Schedule II prescriptions forpatients in a LTCF or patients with a medicaldiagnosis documenting a terminal illnessshall be valid for a period not to exceed 60days from the issue date unless sooner termi-nated by the discontinuance of medication.



19 CSR 30-1.066 Dispensing by IndividualPractitioners

PURPOSE: This rule sets requirements forindividual practitioners who dispense con-trolled substances.

(1) An individual practitioner who dispensescontrolled substances shall�

(A) Provide direct supervision to employ-ees or agents who assist in the administeringor dispensing of controlled substances. Con-trolled substances shall not be dispensed froman individual practitioner�s inventory unless apractitioner is physically in the registeredlocation except pursuant to the provisions ofsection (2) of this rule;

(B) Package all controlled substances dis-pensed from an individual practitioner�sinventory in compliance with the Poison Pre-vention Packaging Act of 1970, 15 U.S.C.1471�1476;

(C) Permanently affix a label to the exteri-or of the drug container which includes: thedate, the name and address of the dispensingpractitioner, the name of the patient, direc-tions for use, and the exact name and strengthof the drug dispensed for all controlled sub-stances dispensed;

(D) Dispense only to individuals withwhom the practitioner has established anddocumented a practitioner/patient relation-ship. An individual practitioner shall not dis-pense under the order of another practitionernot practicing at that location.

(2) Controlled substances may be adminis-tered or dispensed from an individual practi-tioner�s inventory by an authorized employeeor agent when the practitioner is not presentat the registered location when�

(A) The administration or dispensing isauthorized by the individual practitionerunder a written agreement pursuant to anarrangement established and implemented inaccordance with Missouri statutes;

(B) The person who administers or dis-penses the controlled substance is authorizedby statute to administer or dispense con-trolled substances;

(C) The person who administers or dis-penses the controlled substance is registeredwith the Department of Health to administeror dispense controlled substances;

(D) The person who administers or dis-penses the controlled substance does so incompliance with all provisions of Chapter195, RSMo and subsections (1)(B), (C) and(D) of this rule.



19 CSR 30-1.068 Administering In Emer-gency Rooms

PURPOSE: This rule sets requirements foradministering controlled substances in hospi-tal emergency rooms.

(1) Controlled substances may be adminis-tered to a hospital emergency room patientunder a verbal order of a registered practi-tioner who is not physically present if�

(A) The order is for a legitimate medicalpurpose and the practitioner who orders theadministration of a controlled substance isacting in the usual course of his/her medicalpractice, after sufficient examination andestablishment of a practitioner/patient rela-tionship;

(B) The practitioner who orders the admin-istration of a controlled substance is a medi-cal staff member of the hospital;

(C) The administration of a controlled sub-stance is documented in a formal medicalrecord for the patient;

(D) The patient is assessed in the hospitalby a practitioner, when available, or a regis-tered nurse. If the patient is not assessed by apractitioner in the hospital, a registered nurseshall assess the patient and confirm and doc-ument in the patient�s medical record theexistence of a preestablished pract-itioner/patient relationship with the practi-tioner who ordered administration of a con-trolled substance;

(E) The order is written in the patient�smedical record and is authenticated by theordering practitioner within a time frame andmanner as defined by the medical staff incooperation with nursing and administration.This policy shall be included in the hospital�swritten policies and procedures.



19 CSR 30-1.070 Emergency Dispensing ofSchedule II Substances

PURPOSE: This rule provides for the pre-scribing and dispensing of Schedule II drugsin an emergency situation.

(1) In the case of a bona fide emergency sit-uation, as defined by the Department ofHealth, a pharmacist may dispense a Sched-ule II controlled substance upon receivingoral authorization of a prescribing practition-er; provided, that�

(A) The quantity prescribed and dispensedis limited to the amount adequate to treat thepatient during the emergency period. Pre-scribing or dispensing beyond the emergencyperiod must be pursuant to a written pre-scription;

(B) The prescription immediately shall bereduced to writing by the pharmacist andshall contain all information, except for theprescribing practitioner�s signature;

(C) If the prescribing practitioner is notknown to the pharmacist, s/he must makereasonable effort to determine that the oralauthorization came from a practitioner, byverifying his/her phone number against thatlisted in the directory and other good faithefforts to insure his/her identity;

(D) Within seven days after authorizing anemergency oral prescription, the prescribingpractitioner must cause a written prescriptionfor the emergency quantity prescribed to bedelivered to the dispensing pharmacist. Theprescription shall have written on its faceauthorization for emergency dispensing. Thewritten prescription may be delivered to thepharmacist in person or by mail, but if deliv-ered by mail it must be postmarked within theseven-day period. Upon receipt, the dispens-ing pharmacist shall attach this prescriptionto the oral emergency prescription which hadearlier been reduced to writing. The pharma-cist shall notify the Department of Health ifthe prescribing practitioner fails to deliver awritten prescription to him/her; failure of thepharmacist to do so shall void the authorityconferred by this section to dispense withouta written prescription of a prescribing practi-tioner.

(2) Definition of Emergency Situation. Forthe purpose of authorizing an oral prescrip-tion of a controlled substance listed in Sched-ule II of the controlled substances law (sec-tions 195.010�195.320, RSMo), the termemergency situation means those situations inwhich the prescribing practitioner determinesthat�

(A) Immediate administration of a con-trolled substance is necessary for propertreatment of the intended ultimate user;

(B) No appropriate alternative treatment isavailable, including administration of a drugwhich is not a controlled substance underSchedule II;

(C) It is not reasonably possible for theprescribing practitioner to provide a writtenprescription to be presented to the person dis-pensing the substance prior to the dispensing.

AUTHORITY: section 195.195, RSMo 1994.*Original rule filed April 14, 2000, effectiveNov. 30, 2000.*Original authority: 195.195, RSMo 1957, amended1971, 1989, 1993.

19 CSR 30-1.072 Dispensing of Schedule VSubstances

PURPOSE: This rule provides for the pre-scribing, administering and dispensing ofSchedule V drugs.

(1) A pharmacist may dispense directly acontrolled substance listed in Schedule Vpursuant to a prescription. A prescription fora controlled substance listed in Schedule Vmay be refilled only as expressly authorizedby the prescribing individual practitioner. Ifthis authorization is not given, the prescrip-tion may not be refilled. A pharmacist dis-pensing those substances pursuant to a pre-

scription shall label the substance and file theprescription.

(2) An individual practitioner may administeror dispense directly a controlled substancelisted in Schedule V in the course of his/herprofessional practice without a prescription.

(3) An institutional practitioner may adminis-ter or dispense directly (but not prescribe) acontrolled substance listed in Schedule Vonly pursuant to a written prescription signedby the prescribing individual practitioner orpursuant to an oral prescription made by aprescribing individual practitioner andpromptly reduced to writing by the pharma-cist (containing all information requiredexcept for the signature of the prescribingindividual practitioner) or pursuant to anorder for medication made by an individualpractitioner which is dispensed for immediateadministration to the ultimate user.



19 CSR 30-1.074 Dispensing Without aPrescription

PURPOSE: This rule provides for dispensingSchedule V controlled substances without aprescription in certain situations.

(1) A controlled substance listed in ScheduleV which is not a prescription drug and deter-mined under the federal Food, Drug and Cos-metic Act may be dispensed by a pharmacistwithout a prescription to a purchaser at retail;provided, that�

(A) Products that are designated ScheduleV controlled substances which contain anydetectable amount of pseudoephedrine, itssalts or optical isomers, or salts of opticalisomers or ephedrine, its salts or optical iso-mers, or salts of optical isomers may be sold,distributed or otherwise provided only by apharmacist or pharmacy ancillary personnelas authorized by the Missouri State Board ofPharmacy;

(B) Dispensing of any other substance list-ed in Schedule V is made only by a pharma-cist and not by a nonpharmacist employeeeven if under the supervision of a pharmacist(although after the pharmacist has fulfilledhis/her professional and legal responsibili-ties, the actual cash transaction, credit trans-action or delivery may be completed by anonpharmacist);



(C) Dispensing, sale, distribution or other-wise providing is limited to:

1. Not more than two hundred fortycubic centimeters (240 cc) eight ounces (8oz.) of any controlled substance containingopium, nor more than one hundred twentycubic centimeters (120 cc) four ounces (4oz.) of any other controlled substance normore than forty-eight (48) dosage units of anycontrolled substance containing opium, normore than twenty-four (24) dosage units ofany other controlled substance may be dis-pensed at retail to the same purchaser in anygiven forty-eight (48)-hour period;

2. Within any thirty (30)-day period, notmore than any number of packages of anydrug product containing any detectableamount of ephedrine or pseudoephedrine inany total amount greater than nine (9) grams,or any of their salts or optical isomers, orsalts of optical isomers, either as:

A. The sole active ingredient; orB. One of the active ingredients of a

combination drug; orC. A combination of any of the prod-

ucts specified in subsections (A) and (B) ofthis section;

(D) The purchaser is at least eighteen (18)years of age;

(E) The pharmacist requires every pur-chaser of a Schedule V controlled substancenot known to him/her to furnish suitablephoto identification (including proof of agewhere appropriate);

(F) Pharmacists and registered pharmacytechnicians shall implement and maintain awritten or electronic log of each transaction.

1. Such log shall include the followinginformation:

A. The name and address of the pur-chaser;

B. The amount of the compound,mixture, or preparation purchased;

C. The date of each purchase; andD. The name or initials of the phar-

macist or registered pharmacy technicianwho dispensed, sold, distributed, or other-wise provided the compound, mixture, orpreparation to the purchaser.

2. An auxiliary written log shall beestablished for the documentation of Sched-ule V substances dispensed, sold, distributedor otherwise provided if the electronic log isinoperative for any reason.

3. Any electronic log described in sub-section (F) must be capable of providing alisting of utilization of any Schedule V sub-stance for a minimum of the preceding twelve(12)-month period. Utilization informationshall be available by both specific Schedule Vproduct and purchaser name;

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

AUTHORITY: sections 195.017, RSMo Supp.2005 and 195.050 and 195.195, RSMo2000.* Original rule filed April 14, 2000,effective Nov. 30, 2000. Emergency amend-ment filed Aug. 18, 2005, effective Aug. 28,2005, expired Feb. 23, 2006. Amended: FiledSept. 1, 2005, effective Feb. 28, 2006.

*Original authority: 195.017, RSMo 1971, amended 1987,1989, 1994, 1996, 1997, 1998, 2001, 2005; 195.050,RSMo 1939, amended 1971, 1989; and 195.195, RSMo1957, amended 1971, 1989, 1993.

19 CSR 30-1.076 Emergency Distributionby a Pharmacy

PURPOSE: This rule provides for dispensingof controlled substances by a pharmacy inemergency situations.

(1) An emergency means a situation where aquantity of a controlled substance must bedispensed by a pharmacy to a patient whodoes not have an alternative source for thatsubstance reasonably available to him/her andthe pharmacy cannot obtain that substancethrough its normal distribution channelswithin the time required to meet the immedi-ate needs of the patient for that substance. Inthe event of an emergency, a pharmacy maydistribute (without being registered as a dis-tributor) a controlled substance in ScheduleIII, IV or V to a second pharmacy in orderfor that pharmacy to dispense the substance;provided, that�

(A) The amount distributed does notexceed the amount required by the secondpharmacy for his/her immediate dispensing;

(B) The distribution is recorded as beingdispensed by the first pharmacy and the sec-ond pharmacy records the substance as beingreceived. Each pharmacy will retain a signedreceipt of the distribution;

(C) The second pharmacy is registered todispense the controlled substance to be dis-tributed to him/her;

(D) If the substance is a Schedule II con-trolled substance, the official order form des-ignated by the federal Drug EnforcementAdministration must be used to document thetransfer.



19 CSR 30-1.078 Disposing of UnwantedControlled Substances

PURPOSE: This rule establishes proceduresfor disposing of unwanted controlled sub-stances.

(1) A registrant in possession of any con-trolled substance(s) and desiring or requiredto dispose of such substance(s) shall:

(A) Return the controlled substances to theoriginal supplier;

(B) Transfer the controlled substances to adistributor authorized to accept controlledsubstances for the purpose of disposal;

(C) Submit a DEA Form 41 to the federalDrug Enforcement Administration requestingauthorization to dispose of the controlled sub-stances in compliance with federal regula-tions;

(D) Contact the Bureau of Narcotics andDangerous Drugs (BNDD), Department ofHealth for information pertaining to subsec-tions (1)(A), (B) or (C).

(2) The return, transfer or disposal of anycontrolled substance shall be documented inaccordance with 19 CSR 30-1.044.

(3) In the event the registrant is a hospital,the following procedures are to be used forthe destruction of controlled substances:

(A) When disposal of controlled sub-stances is in patient care areas�

1. Controlled substances which are con-taminated by patient body fluids are to bedestroyed by a physician, nurse or a pharma-cist in the presence of another hospitalemployee;

2. An excess volume of a controlled sub-stance which must be discarded from adosage unit just prior to use shall bedestroyed by a nurse, pharmacist or physicianin the presence of another hospital employee;

3. The remaining contents of openedglass ampules of controlled substances shallbe destroyed by a nurse, pharmacist or physi-cian in the presence of another hospitalemployee;

4. Single units of single dose packagesof controlled substances which are contami-nated other than by patient body fluids andare not an infectious hazard, or have beenremoved from their original or security pack-aging, or are partially used, or are otherwiserendered unsuitable for patient use shall bedestroyed by a nurse, pharmacist or physicianin the presence of another hospital employeeor returned to the pharmacy for destruction;

5. The following shall be entered in thecontrolled substance administration record ora separate controlled substance destructionrecord when the controlled substance is



destroyed in the patient care area: the dateand hour of destruction, the drug name andstrength, the amount destroyed, the reasonfor destruction and the patient�s name androom number. The nurse, pharmacist orphysician and the witnessing hospital employ-ee shall sign the entry. The drug shall bedestroyed so that it is beyond reclamation.The controlled substance administration ordestruction records are to be retained for twoyears and available for inspection by Depart-ment of Health investigators;

6. All other controlled substances whichare not patient contaminated but which are tobe disposed of shall be returned to the phar-macy for disposal;

(B) When disposal of controlled substancesis in the pharmacy�

1. Single units of controlled substanceswhich are contaminated other than by patientbody fluids and are not an infectious hazard,or have been removed from their original orsecurity packaging, or are partially used, orare otherwise rendered unsuitable for patientuse shall be destroyed by a pharmacist in thepresence of another hospital employee or heldfor later destruction;

2. All other controlled substances whichare not patient contaminated but are to be dis-posed of shall be placed in a suitable con-tainer for storage and disposed of asdescribed in section (1) of this rule.

(4) If the registrant administers controlledsubstances and is not a hospital, the followingprocedures are to be used for the destructionof controlled substances:

(A) Controlled substances which are con-taminated by patient body fluids are to bedestroyed, in the presence of another employ-ee, by the registrant or designee authorized toadminister;

(B) An excess volume of a controlled sub-stance which must be discarded from adosage unit just prior to use is to bedestroyed, in the presence of another employ-ee, by the registrant or designee authorized toadminister;

(C) The remaining contents of openedglass ampules of controlled substances whichare not patient contaminated are to bedestroyed, in the presence of another employ-ee, by the registrant or designee authorized toadminister;

(D) When the controlled substance isdestroyed by the registrant or designee autho-rized to administer, the following shall beentered in the controlled substances adminis-tration records or a separate controlled sub-stances destruction record: the date andamount destroyed, the reason for destructionand the registrant�s name and address. The

registrant or designee doing the destructionand the witnessing employee shall sign theentry. The drug shall be destroyed so that it isbeyond reclamation. The controlled sub-stances administration or destruction recordsare to be retained for two years and availablefor inspection by Department of Health inves-tigators;

(E) All other controlled substances whichare not patient-contaminated but are to bedisposed of shall be placed in a suitable con-tainer for storage and disposed of asdescribed in section (1) of this rule.


*Original authority: 195.050, RSMo 1939, amended1971, 1989 and 195.195, RSMo 1957, amended 1971,1989, 1993.

