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

Title Page

19 CSR 30-1.002 Schedules of Controlled Substances ...... 3 19 CSR 30-1.004 List of Excepted Substances...... 13 19 CSR 30-1.006 List of Exempt Products...... 13 19 CSR 30-1.008 List of Excluded Veterinary Anabolic Steroid Implant Products...... 14 19 CSR 30-1.010 Schedules of Controlled Substances (Rescinded November 30, 2000)...... 14 19 CSR 30-1.011 Definitions...... 15 19 CSR 30-1.013 Miscellaneous Fees ...... 16 19 CSR 30-1.015 Registrations and Fees...... 16 19 CSR 30-1.017 Registration Process ...... 16 19 CSR 30-1.019 Registration Location...... 19 19 CSR 30-1.020 List of Excepted Substances (Rescinded November 30, 2000)...... 19 19 CSR 30-1.023 Registration Changes ...... 19 19 CSR 30-1.025 List of Exempt Anabolic Steroid Products (Rescinded November 30, 2000)...... 20 19 CSR 30-1.026 Separate Registrations ...... 20 19 CSR 30-1.027 Investigative and Administrative Procedures ...... 21 19 CSR 30-1.030 Requirements for Controlled Substances Registration (Rescinded November 30, 2000) ...... 21 19 CSR 30-1.031 Physical Security Requirements...... 21 19 CSR 30-1.032 Security for Nonpractitioners ...... 21 19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration (Rescinded November 30, 2000) ...... 22

JOHN R. ASHCROFT (5/31/21) CODE OF STATE REGULATIONS 1 Secretary of State 19 CSR 30-1.034 Security for Practitioners ...... 22 19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances (Rescinded November 30, 2000) ...... 23 19 CSR 30-1.036 Disposing of Unwanted Controlled Substances (Rescinded November 30, 2000) ...... 23 19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations (Rescinded July 30, 2003) ...... 23 19 CSR 30-1.041 Records Requirements...... 23 19 CSR 30-1.042 Inventory Requirements ...... 23 19 CSR 30-1.044 Continuing Records General Requirements...... 25 19 CSR 30-1.046 Records for Manufacturers, Distributors, Importers and Exporters ...... 25 19 CSR 30-1.048 Records for Practitioners and Researchers...... 26 19 CSR 30-1.050 Records for Chemical Analysts ...... 27 19 CSR 30-1.052 Records for Long-Term Care Facilities (LTCF)...... 27 19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administering of Controlled Substances...... 28 19 CSR 30-1.062 Transmission of Prescriptions...... 28 19 CSR 30-1.064 Partial Filling of Prescriptions ...... 28 19 CSR 30-1.066 Dispensing by Individual Practitioners ...... 29 19 CSR 30-1.068 Administering In Emergency Rooms...... 29 19 CSR 30-1.070 Emergency Dispensing of Schedule II Substances...... 29 19 CSR 30-1.072 Dispensing of Schedule V Substances ...... 30 19 CSR 30-1.074 Dispensing Without a Prescription ...... 30 19 CSR 30-1.076 Emergency Distribution by a Pharmacy ...... 32 19 CSR 30-1.078 Disposing of Unwanted Controlled Substances ...... 32 19 CSR 30-1.080 Electronic Prescribing Waiver ...... 33

2 CODE OF STATE REGULATIONS (5/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Title 19—DEPARTMENT OF K. Alpha-methylthiofentanyl PP. 3-Methylfentanyl (N-(3- HEALTH AND SENIOR SERVICES (N-(1-methyl-2-(2-thienyl) methyl-1-(2-phenylethyl)- Division 30—Division of ethyl-4-piperidinyl)-N- 4-piperidyl)-N- Regulation and Licensure phenylpropanamide) 9832 phenylproanamide), its Chapter 1—Controlled Substances L. 9606 optical and geometric M. 9607 isomers, salts, and salts 19 CSR 30-1.002 Schedules of Controlled N. Beta-hydroxyfentanyl of isomers 9813 Substances (N-(1-(2-hydroxy-2- QQ. 3-Methylthiofentanyl (N- phenethyl)-4-piperidinyl)- (3-methyl-1-(2- PURPOSE: The Department of Health and N-phenylpropanamide) 9830 thienyl)ethyl-4-piperidinyl)- Nphenylpropanamide) 9833 Senior Services has prepared a list of all O. Beta-hydroxy-3- RR. 9632 falling within the purview of controlled sub- methylfentanyl (other name: SS. MPPP (1-methyl-4-phenyl- stances. N-(1-(2-hydroxy-2-phenethyl)- 4-propionoxypiperidine) 9661 3-methyl-4-piperidinyl)-N- TT. MT–45 (1-cyclohexyl- (1) Schedules of Controlled Substances. phenylpropanamide) 9831 (A) Schedule I shall consist of the drugs 4-(1,2-diphenylethyl) P. N-[1-[2-hydroxy-2-(thiophen- ) (9560) and other substances, by whatever official 2-yl) ethyl]piperidin-4-yl]- UU. 9633 name, common or usual name, chemical N-phenylpropionamide VV. 9634 name, or brand name designated, listed in (Other names: WW. 9635 this section. Each or substance has been beta-hydroxythiofentanyl) 9836 XX. 9636 assigned the Drug Enforcement Administra- Q. Betameprodine 9608 YY. N-(2-fluorophenyl)-2- tion (DEA) Controlled Substances Code R. 9609 methoxy-N- Number set forth opposite it. S. Betaprodine 9611 (1-phenethylpiperidin-4- 1. . Unless specifically excepted T. 9612 yl)acetamide, its isomers, or unless listed in another schedule, any of esters, , salts, and the following opiates, including their isomers, U. Cyclopropyl (N-(1- phenethylpiperidin-4-yl)-N- salts of isomers, esters, and esters, ethers, salts, and salts of isomers, ethers (Other name: esters, and ethers, whenever the existence of phenylcyclopropanecar- boxamide) 9845 ) 9838 such isomers, esters, ethers, and salts is pos- ZZ. ortho-Fluorofentanyl (N-(2- sible within the specific chemical designa- V. 9613 W. 9615 fluorophenyl)-N-(1- tion: phenethylpiperidin-4-yl) X. 9616 A. Acetyl--methylfentanyl propionamide); other name: Y. 9168 (N-(1-(1-methyl-2-phenethyl)- 2-fluorofentanyl) 9816 4-piperidinyl)-N- Z. 9617 AAA. para-Fluorobutyryl phenylacetamide) 9815 AA. 9618 fentanyl (N- B. 9601 BB. 9619 (4-fluorophenyl)-N-(1- C. Acetyl fentanyl (N-(1- CC. 9621 phenethylpiperidin-4- phenethylpiperidin-4-yl)- DD. 9622 yl)butyramide) 9823 N-phenylacetamide) 9821 EE. 9623 BBB. Para-fluorofentanyl(N- D. N-(1-phenethylpiperidin-4- FF. 9624 (4-fluorophenyl)-N- yl)-N-phenylacrylamide, GG. 9625 (1-(2-phenethyl)-4- its isomers, esters, ethers, HH. N-(4-fluorophenyl)-N- piperidinyl) salts, and salts of isomers, (1-phenethylpiperidin-4- propanamide 9812 esters, and ethers (Other yl)isobutyramide, its CCC. PEPAP (1-(-2-phenethyl)- names: acryl fentanyl, isomers, esters, ethers, 4-phenyl-4- acryloylfentanyl) 9811 salts, and salts of isomers, acetoxypiperidine) 9663 E. AH-7921(3,4-dichloro- esters, and ethers (Other DDD. 9637 N-[(1-dimethylamino) names: 4-fluoroisobutyryl EEE. 9638 cyclohexylmethyl] fentanyl, para- FFF. 9647 ) 9551 fluoroisobutyryl fentanyl) 9824 GGG. 9641 F. 9602 II. N-(1-phenethylpiperidin- HHH. 9642 G. (except III. 9643 4-yl)-N-phenylfuran-2- levoalphacetylmethadol JJJ. 9644 carboxamide (Other names: also known as levo-alpha- KKK. 9649 acetylmethadol levothadyl furanyl fentanyl) 9834 LLL. 9645 acetate or LAAM) 9603 JJ. 9626 MMM. N-(1-phenethylpiperidin- H. Alphameprodine 9604 KK. 9627 4-yl)-N- I. 9605 LL. 9628 phenyltetrahydrofuran-2- J. Alpha-methylfentanyl MM. Levomoramide 9629 carboxamide, its (N-1-(alphamethyl-beta- NN. 9631 isomers, esters, ethers, phenyl) ethyl-4-piperidyl) OO. Methoxyacetyl fentanyl salts, and salts of isomers, propionanilide; 1-(1-methyl-2- (2-methoxy-N-(1- esters, and ethers (Other phenylethyl)-4 phenethylpiperidin-4-yl)- name: tetrahydrofuranyl ((N-propanilido) ) 9814 N-phenylacetamide 9825 fentanyl) 9843

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 3 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

NNN. Thiofentany (N-phenyl-N- isomers.): U. 3,4-methylenedioxy-N- (1-(2-thienyl)ethyl-4- A. Alpha-ethyltryptamine 7249 ethylamphetamine (also piperidinyl)- Some trade or other names: etryptamine; known as N-ethylalpha- propanamide 9835 Monase; alpha-ethyl-1H-indole-3-ethenamine; methyl-3,4 (methylenedioxy) OOO. 9750 3-(2-aminobutyl)indole; alpha-ET; and AET; , N-ethyl PPP. 9646 B. 4-bromo-2,5- MDA, MDE, and MDEA) 7404 2. derivatives. Unless specifical- 7391 V. N-hydroxy-3,4- ly excepted or unless listed in another sched- Some trade or other names: 4-bromo-2, 5- methylenedioxyamphetamine ule, any of the following opium derivatives, dimethoxy-a-methylphenethylamine; 4-bromo- (also known as N-hydroxy- its salts, isomers, and salts of isomers when- alpha-methyl-3,4 2, 5-DMA; ever the existence of such salts, isomers, and (methylenedioxy) C. 4-bromo-2,5- salts of isomers is possible within the specif- phenethylamine and N- dimethoxyphenethylamine 7392 ic chemical designation: hydroxy MDA) 7402 A. 9319 D. 2,5-dimethoxyamphetamine 7396 W. 3,4,5- B. 9051 Some trade or other names: 2,5-dimethoxy- 7390 C. 9052 amethylphenethylamine; 2,5-DMA; X. 5-MeO-DMT or 5-methoxy- D. methylbromide 9070 E. 2,5-dimethoxy-4- N,N-dimethyltryptamine 7431 E. Codeine-N-Oxide 9053 ethylamphetamine 7399 Y. Alpha-methyltryptamine 7432 F. 9054 Some trade or other names: DOET; Z. Bufotenine 7433 G. 9055 F. 2,5-dimethoxy-4-(n)- Some trade and other names: 3-(b-Dimethy- H. 9145 propylthiophenethylamine laminoethyl)-5-hydroxyindole; 3-(2-dimethy- I. 9335 (other name: -T-7) 7348 laminoethyl)-5-indolol; N, N-dimethylsero- J. (except G. 2-(2,5-Dimethoxy-4-(n)- tonin; 5-hydroxy-N, N-dimethyltryptamine; hydrochloride salt) 9056 propylphenyl) ethanamine mappine; K. 9200 (2C-P) 7524 AA. 7434 L. 9301 H. 2-(2,5-Dimethoxy-4- Some trade and other names: N, N-Diethyl- M. 9302 ethylphenyl) ethanamine ; DET; N. 9304 (2C-E ) 7509 BB. Dimethyltryptamine 7435 O. methylbromide 9305 I. 2-(2,5-Dimethoxy-4- Some trade or other names: DMT; CC. 5-methoxy-N,N- P. Morphine methylsulfonate 9306 methylphenyl) ethanamine Q. Morphine-N-Oxide 9307 (2C-D) 7508 R. 9308 (other name: 5- J. 2-(2,5-Dimethoxy-4-nitro- S. 9309 MeODIPT) 7439 phenyl) ethanamine (2C-N) 7521 T. 9312 DD. 7260 U. 9313 K. 2-(2,5-Dimethoxyphenyl) Some trade and other names: 7-Ethyl- V. 9314 ethanamine (2C-H) 7517 6,6ß,7,8,9,10,12,13-octahydro-2-methoxy-6, W. 9315 L. 2-(4-Chloro-2,5- 9-methano-5H-pyrido [1’,2’:1,2] azepino[5,4- 3. Similar Synthetic Substances. dimethoxyphenyl) b] indole; Tabernanthe iboga; Substances scheduled by the United States ethanamine (2C-C) 7519 EE. Lysergic acid diethylamide 7315 Drug Enforcement Administration as sub- M. 2-(4-Ethylthio-2,5- FF. Marihuana 7360 stances that share a pharmacological profile dimethoxyphenyl) Some trade or other names: marijuana; similar to fentanyl, morphine, and other syn- ethanamine (2C-T-2) 7385 GG. 7381 thetic , unless specifically excepted or N. 2-(4-Iodo-2,5- HH. 7374 unless listed in another schedule. These sub- dimethoxyphenyl) Some trade or other names: 3-Hexyl-1- stances are— ethanamine (2C-I) 7518 hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl- A. Butyryl fentanyl (N- O. 2-(4-Isopropylthio)-2,5- 6H-dibenzo[b,d]pyran; Synhexyl; (1-phenethylpiperidin-4-yl)- dimethoxyphenyl) II. Peyote 7415 N-phenylbutyramide) 9822 ethanamine (2C-T-4) 7532 Meaning all parts of the plant presently clas- B. U–47700 (3,4-Dichloro- P. 4-methoxyamphetamine 7411 sified botanically as Lophophora williamsii N-[2-(dimethylamino) Some trade or other names: 4-methoxy- Lemaire, whether growing or not; the seeds cyclohexyl]-N- amethylphenethylamine; paramethoxyam- thereof; any extract from any part of such methylbenzamide) 9547 phetamine; PMA; plant; and every compound, manufacture, 4. Hallucinogenic substances. Unless salt, derivative, mixture, or preparation of Q. 5-methoxy-3,4- specifically excepted or unless listed in such plant, its seeds, or extracts; methylenedioxyamphetamine 7401 another schedule, any material, compound, JJ. N-ethyl-3-piperidyl mixture or preparation, which contains any R. 4-methyl-2,5- benzilate 7482 quantity of the following hallucinogenic sub- dimethoxyamphetamine 7395 KK. N-methyl-3-piperidyl stances or which contains any of its salts, iso- Some trade and other names: 4-methyl-2, 5- benzilate 7484 mers, and salts of isomers whenever the exis- dimethoxy-a-methylphenethylamine; DOM; LL. 7437 tence of such salts, isomers, and salts of and STP; MM. Psilocyn 7438 isomers is possible within the specific chem- S. 3,4- NN. naturally ical designation (For purposes of paragraph methylenedioxyamphetamine 7400 contained in a plant of the genus (1)(A)4. of this rule only, the term isomer T. 3,4-methylenedioxymetham- (cannabis 7370 plant), as well as synthetic includes the optical, position, and geometric phetamine(MDMA) 7405 equivalents of the substances contained in the

4 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

cannabis plant or in the resinous extractives DDD. (1-pentyl-1H-indol-3- NNN. of such plant, and/or synthetic substances, yl)(2,2,3,3- (Other names: α- derivatives, and their isomers, or both, with tetramethylcyclopropyl) methylaminovalerophenone; similar chemical structure and pharmacolog- methanone 2-(methylamino)-1- ical activity to those substances contained in (Other names: UR- phenylpentan-1-one) 1246 the plant, such as the following: 144, 1-pentyl-3-(2,2,3,3- OOO. (I) 1 cis or trans tetrahydrocannabi- tetramethylcyclopro- (Other names: bk- nol and their optical isomers; poyl)indole) 7144 MBDP; 1-(1,3- (II) 6 cis or trans tetrahydro- EEE. [1-(5-fluoro-pentyl)- benzodioxol- cannabinol and their optical isomers; 1Hindol-3-yl](2,2,3,3- 5-yl)-2- (III) 3,4 cis or trans tetrahydro- tetramethylcyclopropyl) (methylamino)pentan- cannabinol and its optical isomers; and methanone (Other names: 1-one) 7542 (IV) Since nomenclature of these 5-fluoro-UR-144, 5-F-UR- PPP. substances is not internationally standard- 144, XLR11, 1-(5-fluo- (Other names: ropentyl)-3-(2,2,3,3- ized, compounds of these structures, regard- naphthylpyrovalerone; 1- tetramethylcyclopro- less of numerical designation of atomic posi- (naphthalen-2-yl)-2- tions are covered; poyl)indole) 7011 FFF. N-(1-adamantyl)-1-pentyl- (pyrrolidin-1-yl)pentan- OO. Ethylamine analog of 1-one) 1258 7455 1Hindazole-3-carboxamide QQQ. alpha-pyrrolidinobutio- Some trade or other names: N-ethyl-1- (Other names: APINACA, phenone phenylcyclohexylamine, (1-phenylcyclohexyl) AKB48) 7048 (Other names: ethylamine, N-(1-phenylcyclohexyl)-ethy- GGG. 2-(4-iodo-2,5- α-PBP; 1-phenyl-2- lamine, cyclohexamine, PCE; dimethoxyphenyl)-N-(2- PP. analog of methoxybenzyl)ethanamine (pyrrolidin- phencyclidine 7458 (Other names: 251- 1-yl)butan-1-one) 7546 Some trade or other names: 1-(1-phenylcy- NBOMe; 2C-I-NBOMe; RRR. N-(1-amino-3-methyl-1- clohexyl)-pyrrolidine PCPy, PHP; 25I; Cimbi-5) 7538 oxobutan-2-yl)-1- QQ. Thiophene analog of HHH. 2-(4-chloro-2,5- (cyclohexylmethyl)- phencyclidine 7470 dimethoxyphenyl)-N-(2- 1H-indazole- Some trade or other names: 1-(1-(2-thienyl)- methoxybenzyl)ethanamine 3-carboxamide cyclohexyl)-piperidine, 2-thienyl analog of (Other names: 25C- (Other names: AB- phencyclidine, TPCP, TCP; NBOMe; 2C-C-NBOMe; CHMINACA) 7031 RR. 1-(1-(2-thienyl)cyclohexyl) 25C; Cimbi-82) 7537 SSS. N-(1-amino-3-methyl-1- pyrrolidine 7473 III. 2-(4-bromo-2,5- oxobutan-2-yl)-1-pentyl- Some other names: TCPy; dimethoxyphenyl)-N-(2- 1Hindazole-3-carboxamide SS. methoxybenzyl)ethanamine (Other names: TT. (Other names: 25B- AB-PINACA) 7023 UU. 3-Fluoromethcathinone 1233 NBOMe; 2C-B-NBOMe; TTT. [1-(5-fluoropentyl)- VV. 4-Fluoromethcathinone 1238 25B; Cimbi-36) 7536 1H-indazol-3-yl](naphthalen- WW. , or 4- JJJ. 4-methyl-N-ethylcathinone 1-yl)methanone methylmethcathinone 1248 (Other names: 4-MEC; 2- (Other names: XX. Methylenedioxy- (ethylamino)-1-(4- THJ-2201) 7024 , MDPV, or methylphenyl)propan- UUU. N-(1-amino-3,3-dimethyl- (1-(1,3-Benzodioxol-5-yl)- 1-one) 1249 1-oxobutan-2-yl)-1- KKK. 4-methyl-alphapyrrolid- 2-(1-pyrrolidinyl)-1- (cyclohexylmethyl)- inopropiophenone, pentanone 7535 1H-indazole-3-carboxamide (Other names: 4-MePPP; YY. , or 3,4- (Other names: MAB- Methylenedioxy- MePPP; 4-methyl- α CHMINACA; 7540 -pyrrolidinopropiophenone; 1-(4-methylphenyl)-2- ADB-CHMINACA) 7032 ZZ. Quinolin-8-yl 1-pentyl- VVV. methyl 2-(1-(5- 1Hindole-3-carboxylate (pyrrolidin-1-yl)-propan- 1-one) 7498 fluoropentyl)- (PB-22; QUPIC) 7222 1H-indazole-3- AAA. Quinolin-8-yl 1-(5- LLL. alphapyrrolidinopentio- carboxamido)-3,3- fluoropentyl)-1H-indole- phenone α α dimethylbutanoate 3-carboxylate (5-fluoro- (Other names: -PVP; - PB-22; 5F-PB-22) 7225 pyrrolidinovalerophenone; (Other names: BBB. N-(1-amino-3-methyl-1- 1-phenyl-2-(pyrrolidin-1- 5F–ADB; 5F–MDMB– oxobutan-2-yl)-1- yl)pentan-1-one) 7545 PINACA) 7034 (4-fluorobenzyl)-1Hindazole- MMM. WWW. methyl 2-(1-(5- 3-carboxamide (AB- (Other names: bk- fluoropentyl)- FUBINACA) 7012 MBDB; 1-(1,3- 1H-indazole-3- CCC. N-(1-amino-3, 3-dimethyl-1- benzodioxol-5- carboxamido)-3- oxobutan-2-yl)-1-pentyl- yl)-2- methylbutanoate 1H-indazole-3-carboxamide (methylamino)butan-1- (Other names: 5F– (ADB-PINACA) 7035 one) 7541 AMB) 7033

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 5 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

XXX. N-(adamantan-1-yl)-1-(5- (c) JWH-015, or 1-propyl- (b) JWH-203, or 1-pentyl- fluoropentyl)-1H-indazole- 2-methyl-3-(1- 3-(2- 3-carboxamide naphthoyl)indole chloropheny- (Other names: 5F– (d) JWH-018, or 1-pentyl- lacetyl)indole 7203 APINACA, 5F–AKB48) 7049 3-(1-naphthoyl)indole 7118 (c) JWH-250, or 1-pentyl- YYY. N-(1-amino-3,3-dimethyl- (e) JWH-019, or 1-hexyl- 3-(2- 1-oxobutan-2-yl)-1-(4- 3-(1-naphthoyl)indole 7019 methoxypheny- fluorobenzyl)-1H-indazole- (f) JWH-073, or 1-butyl- lacetyl)indole 6250 3-carboxamide 3-(1-naphthoyl)indole 7173 (d) JWH-251, or 1-pentyl- (Other names: (g) JWH-081, or 1-pentyl- 3-(2- ADB–FUBINACA) 7010 3-(4-methoxy-1- methylphenylacetyl)indole ZZZ. methyl 2-(1- naphthoyl)indole 7081 (e) RCS-8, or 1-(2- (cyclohexylmethyl)- (h) JWH-098, or 1-pentyl- cyclohexylethyl)-3-(2- 1H-indole- 2-methyl-3-(4- methoxypheny- lacetyl)indole 7008 3-carboxamido)-3,3- methoxy-1- (V) Any compound structurally dimethylbutanoate naphthoyl)indole derived from 2-(3-hydroxycyclohexyl) (Other names: (i) JWH-122, or 1-pentyl- by substitution at the 5-position of the pheno- MDMB–CHMICA, 3-(4-methyl-1- lic ring by alkyl, haloalkyl, alkenyl, MMB–CHMINACA) 7042 naphthoyl)indole 7122 cycloalkylmethyl, cycloalkylethyl, 1-(N- AAAA. methyl 2-(1-(4- (j) JWH-164, or 1-pentyl- methyl-2-piperidinyl)methyl or 2-(4-mor- fluorobenzyl)- 3-(7-methoxy-1- pholinyl)ethyl group, whether or not substi- 1H-indazole- naphthoyl)indole tuted in the cyclohexyl ring to any extent. 3-carboxamido)-3,3- (k) JWH-200, or 1-(2-(4- Including, but not limited to: dimethylbutanoate (morpholinyl)ethyl))-3- (a) CP 47,497 & homologues, or (Other names: (1-naphthoyl)indole 7200 2-[(1R,3S)-3-hydroxycyclohexyl]-5-(2-methy- MDMB–FUBINACA) 7020 (l) JWH-210, or 1-pentyl- loctan-2-yl)phenol), where side chain n=5, BBBB. methyl 2-(1-(4- 3-(4-ethyl-1- and homologues where side chain n-4, 6, or fluorobenzyl)-1H- naphthoyl)indole 7 7297, 7298 indazole- (m) JWH-398, or 1-pentyl- (VI) Any compound containing a 3- 3-carboxamido)-3- 3-(4-chloro-1- (benzoyl)indole structure with substitution at methylbutanoate naphthoyl)indole 7398 the atom of the indole ring by alkyl, (Other names: (II) Any compound structurally haloalkyl, alkenyl, cycloalkylmethyl, FUB–AMB, MMB– derived from 3-(1-naphthoyl)pyrrole by sub- cycloalkylethyl, 1-(N-methyl-2- FUBINACA, AMB– stitution at the nitrogen atom of the pyrrole piperidinyl)methyl or 2-(4-morpholinyl)ethyl FUBINACA) (7021) ring by alkyl, haloalkyl, alkenyl, cycloalkyl- group, whether or not further substituted in CCCC. Synthetic : methyl, cycloalkylethyl, 1-(N-methyl-2- the indole ring to any extent and whether or Unless specifically exempted or unless listed piperidinyl)methyl or 2-(4-morpholinyl)ethyl not substituted in the phenyl ring to any in another schedule, any material, com- group, whether or not further substituted in extent. Including, but not limited to: pound, mixture, or preparation which con- the pyrrole ring to any extent, whether or not (a) AM-694, or 1-(5- tains any quantity of the following sub- substituted in the naphthyl ring to any extent; fluoropentyl)-3-(2- stances, or which contains their salts, (III) Any compound structurally iodobenzoyl)indole 7694 isomers, and salts of isomers whenever the derived from 1-(1-naphthylmethyl)indene by (b) RCS-4, or 1-pentyl-3-(4- existence of such salts, isomers, and salts of substitution at the 3-position of the indene methoxybenzoyl)indole isomers is possible within the specific chem- ring by alkyl, haloalkyl, alkenyl, cycloalkyl- (SR-19 and RCS-4) 7104 ical designation: methyl, cycloalkylethyl, 1-(N-methyl-2- (VII) CP 50,556-1, or [(6S,6aR,9R,10aR)-9-hydroxy-6-methyl-3- (I) Any compound structurally piperidinyl)methyl or 2-(4-morpholinyl)ethyl [(2R)-5-phenylpentan-2-yl]oxy- derived from 3-(1-naphthoyl)indole or 1Hin- group, whether or not further substituted in 5,6,6a,7,8,9,10,10a-octahydrophenanthridin- dol- 3-yl-(1-naphthyl)methane by substitution the indene ring to any extent, whether or not 1-yl] acetate; at the nitrogen atom of the indole ring by substituted in the naphthyl ring to any extent; (VIII) HU-210, or (6aR,10aR)-9- alkyl, haloalkyl, alkenyl, cycloalkylmethyl, (IV) Any compound structurally (hydroxymethyl)-6,6-dimethyl-3-(2-methy- cycloalkylethyl, 1-(N-methyl-2- derived from 3-phenylacetylindole by substi- loctan-2-yl)-6a , 7, 10, 10a-tetrahydroben- piperidinyl)methyl or 2-(4-morpholinyl)ethyl tution at the nitrogen atom of the indole ring zo[c]chromen-1-ol; group, whether or not further substituted in with alkyl, haloalkyl, alkenyl, cycloalkyl- (IX) HU-211, or the indole ring to any extent, whether or not methyl, cycloalkylethyl, 1-(N-methyl-2- ,(6aS,10aS)-9-(hydroxymethyl)- substituted in the naphthyl ring to any extent. piperidinyl)methyl or 2-(4-morpholinyl)ethyl 6,6-dimethyl-3-(2-methyloctan-2-yl)- Including, but not limited to: group, whether or not further substituted in 6a,7,10,10a-tetrahydrobenzo[c]chromen-1- (a) AM2201, or 1-(5- the indole ring to any extent, whether or not ol; fluoropentyl)-3- substituted in the phenyl ring to any extent. (X) , or (1-naphthoyl)indole 7201 Including, but not limited to: DMHP. (b) JWH-007, or 1- (a) JWH-201, or 1-pentyl- 5. . Unless specifically pentyl-2-methyl- 3-(4- excepted or unless listed in another sched- 3-(1-naphthoyl)indole methoxyphenylacetyl)indole ule, any material compound, mixture or

6 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

preparation which contains any quantity of B. N-(1-phenethylpiperidin-4- monocycle; and/or the following substances having a yl)-N-phenylpentanamide, (e) Replacement of the N-propi- effect on the , includ- its isomers, esters, ethers, onyl group by another acyl group. ing its salts, isomers, and salts of isomers salts and salts of isomers, H. Naphthalen-1-yl 1-(5- whenever the existence of such salts, isomers, esters, and ethers (Other fluoropentyl)-1H-indole- and salts of isomers is possible within the name: valeryl fentanyl) 9840 3-carboxylate, its optical, specific chemical designation: C. N-(4-methoxyphenyl)-N- positional, and geometric A. Gamma-hydroxybutyric acid and (1-phenethylpiperidin-4- isomers, salts, and salts of other names GHB; gamma-hydroxybutyrate; yl)butyramide, its isomers, isomers (Other names: 4-hydroxybutyrate; 4-hydroxybutonic acid; esters, ethers, salts, and NM2201; CBL2201) (7221) ; sodium oxybutryrate 2010 salts of isomers, esters, and I. N-(1-amino-3-methyl-1- B. 2572 ethers (Other name: para- oxobutan-2-yl)-1- C. 2565 methoxybutyryl fentanyl) (9837) (5-fluoropentyl)-1H- 6. . Unless specifically D. N-(4-chlorophenyl)-N-(1- indazole-3-carboxamide, excepted or unless listed in another schedule, phenethylpiperidin- its optical, positional, and any material, compound, mixture, or prepa- 4-yl)isobutyramide, its geometric isomers, ration which contains any quantity of the fol- isomers, esters, ethers, salts, and salts of isomers lowing substances having a effect salts, and salts of isomers, (Other names: on the central nervous system, including its esters, and ethers (Other 5F-AB-PINACA) (7025) salts, isomers, and salts of isomers: name: para-chloroisobutyryl J. 1-(4-cyanobutyl)-N-(2- A. 1585 fentanyl) (9826) phenylpropan-2-yl)-1H- Some trade or other names: aminoxaphen; 2- E. N-(1-phenethylpiperidin-4- indazole-3-carboxamide, amino-5-phenyl-2-; 4,5-dihydro-5- yl)-N-phenylisobutyramide, its optical, positional, and phenyl-2-oxazolamine; its isomers, esters, ethers, geometric isomers, salts, B. N- (some salts, and salts of isomers, and salts of isomers (Other other names: BZP, 1- esters, and ethers (Other names: 4-CN- benzylpiperzaine) 7493 name: isobutyryl CUMYLBUTINACA; C. (Some trade or fentanyl) (9827) 4-cyano-CUMYL-BUTINACA; other names: 2-amino-1- F. N-(1-phenethylpiperidin-4- 4-CN-CUMYLBINACA; phenyl-1-propanone, yl)-N- CUMYL-4CNBINACA; alphaaminopropiophenone, phenylcyclopentanecarboxamide, SGT-78) (7089) 2-aminopropiophenone and its isomers, esters, ethers, K. methyl 2-(1- norephedrone) 1235 salts, and salts of isomers, D. 1503 (cyclohexylmethyl)-1H- esters, and ethers (Other E. Methcathinone 1237 indole-3-carboxamido)- name: cyclopentyl Some trade or other names: 2-(methylamino)- 3-methylbutanoate, its fentanyl) (9847) ; alpha-(methylamino) propio- optical, positional, and G. Fentanyl-related substances, phenone; 2-(methylamino)-1-phenylpropan-1- geometric isomers, salts, one; alpha-N-methylaminopropiophenone; their isomers, esters, ethers, and salts of isomers (Other monomethylpropion; ephedrone; N-methyl- salts, and salts of isomers, names: MMB-CHMICA, cathinone; methylcathinine; AL-464; AL-422; esters, and ethers. 9850 AMB-CHMICA) (7044) AL-463 and URI 432; (I) Fentanyl-related substance L. 1-(5-fluoropentyl)-N-(2- F. 4-methoxymethcathinone means any substance not otherwise listed phenylpropan-2-yl)-1H- G. cis-4-methylaminorex under another Administration Controlled pyrrolo[2,3-b]pyridine-3- (cis-4,5-dihydro-4-methyl- Substance Code Number, and for which no carboxamide, its optical, 5-phenyl-2-oxazolamine) 1590 exemption or approval is in effect under sec- positional, and geometric H. 4-Methyl-alpha- tion 505 of the Federal Food, Drug, and Cos- isomers, salts, and salts of pyrrolidinobutiophenone, metic Act 21 U.S.C. 355, that is structurally isomers (Other names: or MPBP related to fentanyl by one (1) or more of the 5F-CUMYL-P7AICA) (7085) I. N-ethylamphetamine 1475 following modifications: M. N-Ethylpentylone, its J. N,N- 1480 (a) Replacement of the phenyl optical, positional, and (some other names: N,N-alpha-trimethylben- portion of the phenethyl group by any mono- geometric isomers, salts, and zeneethanamine; N,N-alpha- cycle, whether or not further substituted in or salts of isomers (Other trimethylphenethylamine) on the monocycle; names: ephylone, 1-(1,3- 7. A temporary listing of substances (b) Substitution in or on the benzodioxol-5-yl)-2- subject to emergency scheduling under feder- phenethyl group with alkyl, alkenyl, alkoxyl, (ethylamino)-pentan-1- al law shall include any material, compound, hydroxyl, halo, haloalkyl, amino, or nitro one) (7543) mixture, or preparation which contains any groups; N. ethyl 2-(1-(5-fluoropentyl)- quantity of the following substances: (c) Substitution in or on the 1H-indazole-3-carboxamido)- A. N-(1-phenethylpiperidin-4- piperidine ring with alkyl, alkenyl, alkoxyl, 3,3-dimethylbutanoate, its yl)-N-phenylacetamide, its ester, , hydroxyl, halo, haloalkyl, optical, positional, and optical, positional, and amino, or nitro groups; geometric isomers, salts, and geometric isomers, salts, and (d) Replacement of the aniline salts of isomers (trivial salts of isomers (Other ring with any aromatic monocycle whether or name: 5F-EDMB- names: acetyl fentanyl) 9821 not further substituted in or on the aromatic PINACA) 7036

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 7 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

O. methyl 2-(1-(5-fluoropentyl)- W. alpha-Pyrrolidinohepta- (VI) Tincture of opium 9630 1H-indole-3-carboxamido)-3,3- phenone, its optical, (VII) Codeine 9050 dimethylbutanoate, its optical, positional, and geometric (VIII) 9334 positional, and geometric isomers, salts, and salts of (IX) 9190 isomers, salts, and salts of isomers (Other names: (X) Etorphine hydrochloride 9059 isomers (trivial name: PV8; 1-phenyl-2- (XI) 9193 5F-MDMB-PICA) 7041 (pyrrolidin-1-yl)heptan-1- (XII) 9150 P. N-(adamantan-1-yl)-1-(4- one) 7548 (XIII) 9260 fluorobenzyl)-1H-indazole-3- X. 4'-Chloro-alpha- (XIV) Morphine 9300 carboxamide, its optical, pyrrolidinovalerophenone, its (XV) 9330 positional, and geometric optical, positional, and (XVI) 9143 isomers, salts, and salts geometric isomers, salts, and (XVII) 9652 of isomers (trivial names: salts of isomers (Other (XVIII) 9333 α FUB-AKB48; FUB- names: 4-chloro- -PVP; 4'- B. Any salt, compound, derivative, or APINACA; AKB48 N-(4- chloro-alpha- preparation thereof which is chemically FLUOROBENZYL)) 7047 pyrrolidinopentiophenone; 1- equivalent or identical with any of the sub- Q. 1-(5-fluoropentyl)-N-(2- (4-chlorophenyl)-2-(pyrrolidin- stances referred to in subparagraph 1-yl) pentan-1-one) 7443 phenylpropan-2-yl)-1H- (1)(B)1.A. of this rule shall be included in Y. N,N-diethyl-2-(2-(4 indazole-3-carboxamide, its Schedule II, except that these substances shall isopropoxybenzyl)-5-nitro- optical, positional, and not include the of 1H-benzimidazol-1-yl)ethan- geometric isomers, salts, and opium; salts of isomers (trivial names: 1-amine, its isomers, esters, ethers, salts, and salts C. Opium poppy and poppy 5F-CUMYL-PINACA; straw 9650 SGT-25) 7083 of isomers, esters, and ethers (Other names: ; D. leaves (9040) and any salt, R. (1-(4-fluorobenzyl)-1H- compound, derivative, or preparation of coca indol-3-yl)(2,2,3,3- N,N-diethyl-2-[[4- (1- methylethoxy) leaves (including (9041) and ecgo- tetramethylcyclopropyl) nine (9180) and their salts, isomers, deriva- methanone, its optical, phenyl]methyl]-5-nitro-1H- benzimidazole-1- tives, and salts of isomers and derivatives), positional, and geometric and any salt, compound, derivative, or prepa- isomers, salts, and salts of ethanamine) 9614 ration thereof which is chemically equivalent isomers (trivial name: 8. , to include all parts of the plant or identical with any of these substances, FUB-144) 7014 presently classified botanically as catha except that the substances shall not include: S. N-Ethylhexedrone, its optical, edulis, whether growing or not; the seeds (I) Decocainized coca leaves or positional, and geometric thereof; any extract from any part of such extraction of coca leaves, which extractions isomers, salts, and salts of plant; and every compound, manufacture, do not contain cocaine or ecgonine; or isomers (Other name: 2- salt, derivative, mixture, or preparation of the (ethylamino)-1- plant, its seed, or extracts. 7032 (II) ; phenylhexan-1-one) 7246 (B) Schedule II shall consist of the drugs E. Concentrate of (the T. alpha-Pyrrolidinohexano- and other substances, by whatever official crude extract of poppy straw in either liquid, phenone, its optical, positional, name, common or usual name, chemical solid, or powder form which contains and geometric isomers, salts, name, or brand name designated, listed in the alkaloids of the opium and salts of isomers (Other this section. Each drug or substance has been poppy) 9670 names: α-PHP; alpha- assigned the Controlled Substances Code 2. Opiates. Unless specifically excepted pyrrolidinohexiophenone; 1- Number set forth opposite it. or unless in another schedule any of the fol- phenyl-2-(pyrrolidin-1- 1. Substances, vegetable origin, or lowing opiates, including its isomers, esters, yl)hexan-1-one) 7544 chemical synthesis. Unless specifically ethers, salts, and salts of isomers, esters, and U. 4-Methyl-alpha- excepted or unless listed in another schedule, ethers whenever the existence of such iso- ethylaminopentiophenone, Schedule II shall include any of the following mers, esters, ethers, and salts is possible its optical, positional, and substances whether produced directly or indi- within the specific chemical designation, dex- geometric isomers, salts, and rectly by extraction from substances of veg- trorphan, and levopropoxyphene excepted: salts of isomers (Other etable origin or independently by means of A. 9737 names: 4-MEAP; 2- chemical synthesis or by a combination of B. Alphaprodine 9010 (ethylamino)-1- extraction and chemical synthesis: C. 9020 (4-methylphenyl)pentan-1- A. Opium and opiate; and any salt, D. 9800 one) 7245 compound, derivative, or preparation of E. Bulk V. 4'-Methyl-alpha- opium or opiate, excluding , (Non-dosage Forms) 9273 pyrrolidinohexiophenone, thebaine-derived , , F. 9743 its optical, positional, and , , , , G. 9120 geometric isomers, salts, and and and their respective salts, but H. 9170 salts of isomers (Other including the following: I. Fentanyl 9801 names: MPHP; 4'-methyl- (I) Raw opium 9600 J. 9226 alpha-pyrrolidinohexano- (II) Opium extracts 9610 K. Levo-alphacetylmethadol phenone; 1-(4- (III) Opium fluid 9620 Some other names: levo-alphaacetyl- methylphenyl)-2-(pyrrolidin-1- (IV) Powdered opium 9639 methadol, levomethadyl acetate, yl)hexan-1-one) 7446 (V) Granulated opium 9640 LAAM 9648

8 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

L. 9210 dimethylheptyl)-6, 6a,7,8,10,10a-hexahydro- B. 1228 M. 9220 1-hydroxy-6, 6-dimethyl-9H-dibenzo(b,d) C. 1645 N. 9240 pyran-9-one. D. 1647 O. 9250 B. Dronabinol [(-)-delta-9-trans E. 1615 P. Methadone-Intermediate, ] in an oral solution in a 2. Depressants. Unless specifically 4-cyano-2-dimethylamino- drug product approved for marketing by the excepted or unless listed in another schedule, 4,4-diphenyl 9254 United States Food and Drug Administra- any material compound, mixture, or prepara- Q. Moramide-Intermediate, 2- tion. (7365) tion which contains any quantity of the fol- methyl-3-morpholino-1, 6. Immediate precursors. Unless specif- lowing substances having a depressant effect 1-diphenylpropane-carboxylic ically excepted or unless listed in another on the central nervous system: acid 9802 schedule, any material, compound, mixture, A. Any compound, mixture, or R. (Meperidine) 9230 or preparation which contains any quantity of preparation containing— S. Pethidine-Intermediate-A, 4- the following substances: (I) 2126 cyano-1-methyl-4- A. Immediate precursor to (II) 2316 phenylpiperidine 9232 and : (III) 2271 T. Pethidine-Intermediate-B, (I) Phenylacetone 8501 or any salt thereof and one (1) or more other ethyl-4-phenylpiperidine-4- Some trade or other names: phenyl-2- active medicinal ingredients which are not carboxylate 9233 propanone; P2P; benzyl methyl ketone; listed in any schedule; U. Pethidine-Intermediate-C, 1- methyl benzyl ketone; B. Any suppository dosage form con- methyl-4-phenylpiperidine- B. Immediate precursors to phencycli- taining— 4-carboxylic acid 9234 dine (PCP): (I) Amobarbital 2126 V. 9715 (I) 1-phenylcyclohexylamine 7460 (II) Secobarbital 2316 W. 9730 (II) 1-piperidinocyclo- (III) Pentobarbital 2271 X. Racemethorphan 9732 hexanecarbonitrile or any salt of any of these drugs and approved Y. 9733 (PCC) 8603 by the Food and Drug Administration for Z. 9739 C. Immediate precursor to fentanyl: marketing only as a suppository; AA. 9740 (I) 4-anilino-N-phenethyl-4- C. Any substance which contains any BB. 9780 piperidine (ANPP) 8333 quantity of a derivative of barbituric acid or CC. 9729 (II) N-phenyl-N-(piperidin- any salt thereof 2100 3. Stimulants. Unless specifically 4-yl)propionamide D. Chlorhexadol 2510 excepted or unless listed in another schedule, (norfentanyl) 8366 E. 2020 any material, compound, mixture, or prepa- 7. Any material, compound, mixture, or F. Any drug product containing ration which contains any quantity of the fol- preparation which contains any quantity of gamma hydroxybutyric acid, including its lowing substances having a stimulant effect the following alkyl nitrites: salts, isomers, and salts of isomer, for which on the central nervous system: A. Amyl nitrite; an application is approved under section 505 A. Amphetamine, its salts, B. Butyl nitrite. of the Federal Food, Drug, and Cosmetic optical isomers, and salts (C) Schedule III shall consist of the drugs Act; 2012 of its optical isomers 1100 and other substances, by whatever official G. , its salts, isomer, B. , its salts, name, common or usual name, chemical and salts of isomers (some isomers, and salts of its name, or brand name designated, listed in other names for ketamine: isomers 1205 this section. Each drug or substance has been (±)-2-(2-chlorophenyl)-2- C. Methamphetamine, its salts, assigned the DEA Controlled Substances (methylamino)- isomers, and salts of its Code Number set forth opposite it. cyclohexanone) 7285 isomers 1105 1. Stimulants. Unless specifically H. Lysergic acid 7300 D. and its salts 1631 excepted or unless listed in another schedule, I. Lysergic acid amide 7310 E. 1724 any material, compound, mixture, or prepa- J. 2575 4. Depressants. Unless specifically ration which contains any quantity of the fol- K. Perampanel, and its salts, excepted or unless listed in another schedule, lowing substances having a stimulant effect isomers, and salts of any material, compound, mixture, or prepa- on the central nervous system, including its isomers 2261 ration which contains any quantity of the fol- salts, isomers (whether optical, position, or L. Sulfondiethylmethane 2600 lowing substances having a depressant effect geometric), and salts of such isomers when- M. Sulfonethylmethane 2605 on the central nervous system, including its ever the existence of such salts, isomers, and N. 2610 salts, isomers, and salts of isomers whenever salts of isomers is possible within the specif- O. and the existence of such salts, isomers, and salts ic chemical designation: or any salt thereof 7295 of isomers is possible within the specific A. Those compounds, mixtures, or Some trade or other names for a tiletamine- chemical designation: preparations in dosage unit form containing zolazepam combination product: Telazol. A. Amobarbital 2125 any stimulant substances listed in Schedule II Some trade or other names for tiletamine: 2- B. 2550 which compounds, mixtures, or preparations (ethylamino)-2-(2-thienyl)-cyclohexanone. C. Pentobarbital 2270 were listed on August 25, 1971, as excepted Some trade or other names for zolazepam: 4- D. Phencyclidine 7471 compounds under 21 CFR 308.32 and any (2-fluorophenyl)-6-8-dihydro-1,3,8- E. Secobarbital 2315 other drug of the quantitive composition trimethylpyrazolo-(3,4-e) (1,4)-diazepin- 5. Hallucinogenic substances: shown in that list for those drugs or which is 7(1H)-one, flupyrazapon. A. 7379 the same except that it contains a lesser quan- 3. 9400 Another name for nabilone: (±)trans-3-(1, 1- tity of controlled substances 1405 4. drugs. Unless specifically

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 9 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

excepted or unless listed in another schedule, expressly intended for administration through Y. 1 3 β-ethyl-17β-hydroxygon-4-en-3- any material, compound, mixture, or prepa- implants to cattle or other nonhuman species one ration containing limited quantities of any of and which has been approved by the Secre- Z. 4-hydroxytestosterone (4,17β- the following drugs or any salts tary of Health and Human Services for that dihydroxy-androst-4-en-3-one) thereof: administration. If any person prescribes, dis- AA. 4-hydroxy-19-nortestosterone A. Not more than one and eight tenths penses, or distributes such steroid for human (4,17β-dihydroxy-estr-4-en-3-one) grams (1.8gm) of codeine per one hundred use, such person shall be considered to have BB. Mestanolone (17α-methyl-17β- milliliters (100 mL) or not more than ninety prescribed, dispensed, or distributed an hydroxy-5α-androstan-3-one) milligrams (90 mg) per dosage unit, with an anabolic steroid within the meaning of this CC. Mesterolone (1α-methyl-17β- equal or greater quantity of an isoquinoline paragraph. Unless specifically excepted or hydroxy-[5α]-androstan-3-one) of opium 9803 unless listed in another schedule, any materi- DD. Methandienone (17α-methyl- B. Not more than one and eight tenths al, compound, mixture, or preparation con- 17β-hydroxyandrost-1,4-dien-3-one) grams (1.8gm) of codeine per one hundred taining any quantity of the following sub- EE. Methandriol (17α-methyl- milliliters (100 mL) or not more than ninety stances, including its salts, esters, and ethers: 3β,17β-dihydroxyandrost-5-ene) milligrams (90 mg) per dosage unit, with one A. 3β,17β-dihydroxy-5α-androstane FF. Methasterone (2α,17α-dimethyl- (1) or more active, nonnarcotic ingredients in B. 3α,17β-dihydroxy-5α-androstane 5α-androstan-17β-ol-3-one) α recognized therapeutic amounts 9804 C. 5 -androstan-3,17-dione GG. Methenolone (1-methyl-17β- β β C. Not more than one and eight D. 1-androstenediol (3 ,17 -dihy- hydroxy-5α-androst-1-en-3-one) α tenths grams (1.8gm) of dihydrocodeine per droxy-5 -androst-1-ene) HH. 17α-methyl-3β,17β-dihydroxy- α β one hundred milliliters (100 mL) or not more E. 1-androstenediol (3 ,17 -dihy- 5α-androstane α than ninety milligrams (90 mg) per dosage droxy-5 -androst-1-ene) II. 17α-methyl-3α,17β-dihydroxy-5α- β β unit, with one (1) or more active, nonnarcot- F. 4-androstenediol (3 ,17 -dihy- androstane ic ingredients in recognized therapeutic droxy-androst-4-ene) JJ. 17α-methyl-3β,17β-dihydroxyan- β β amounts 9807 G. 5-androstenediol (3 ,17 -dihy- drost-4-ene D. Not more than three hundred mil- droxy-androst-5-ene) α α KK. 17 -methyl-4-hydroxynan- ligrams (300 mg) of ethylmorphine per one H. 1-androstenedione ([5 ]-androst- drolone (17α-methyl-4-hydroxy-17β-hydrox- hundred milliliters (100 mL) or not more 1-en-3,17-dione) yestr-4- en-3-one) than fifteen milligrams (15 mg) per dosage I. 4-androstenedione (androst-4-en- LL. Methyldienolone (17α-methyl- unit, with one (1) or more active, nonnar- 3,17-dione) 17β-hydroxyestra-4,9(10)-dien-3-one) cotic ingredients in recognized therapeutic J. 5-androstenedione (androst-5-en- MM. Methyltrienolone (17α-methyl- amounts 9808 3,17-dione) 17β-hydroxyestra-4,9,11-trien-3-one) E. Not more than five hundred mil- K. Bolasterone (7α,17α-dimethyl- NN. Methyltestosterone (17α-methyl- ligrams (500 mg) of opium per one hundred 17β-hydroxyandrost-4-en-3-one) 17-hydroxyandrost-4-en-3-one) milliliters (100 mL) or per one hundred L. Boldenone (17β-hydroxyandrost-1, OO. Mibolerone (7α,17α-dimethyl- grams (100 gm) or not more than twenty-five 4-diene-3-one) 17β-hydroxyestr-4-en-3-one) milligrams (25 mg) per dosage unit, with one M. Boldione (androstra-1,4-diene- α Δ (1) or more active nonnarcotic ingredients in 3,17-dione) PP. 17 -methyl- 1-dihydrotestos- β α terone (17β-hydroxy-17α-methyl-5α-androst- recognized therapeutic amounts 9809 N. Calusterone (7 ,17 -dimethyl- α F. Not more than fifty milligrams (50 17β-hydroxyandrost-4-en-3-one) 1-en-3-one) (a.k.a. 17- -methyl-1-testos- β terone) mg) of morphine per one hundred milliliters O. Clostebol (4-chloro-17 -hydrox- β (100 mL) or per one hundred grams (100 yandrost-4-en-3-one) QQ. Nandrolone (17 -hydroxyestr-4- gm), with one (1) or more active, nonnarcot- P. Dehydrochloromethyltestosterone ene-3-one) ic ingredients in recognized therapeutic (4-chloro-17β-hydroxy-17α-methyl-androst- RR. 19-nor-4-androstenediol β β amounts 9810 1, 4-dien-3-one) (3 ,17 -dihydroxyestr-4-ene) 5. Any material, compound, mixture, or Q. Desoxymethyltestosterone (17α- SS. 19-nor-4-andro stenediol α β preparation containing any of the following methyl-5α-androst-2-en-17β-ol) (a.k.a. (3 ,17 -dihydroxyestr-4-ene) narcotic drugs or their salts, as set forth madol) TT. 19-nor-4,9(10)-androstadiene- below: R. Δ1- (a.k.a.’1- dione (estra-4,9(10)-diene-3,17-dione) A. 9064 ’) (17β-hydroxy-5α-androst-1-en- UU. 19-nor-5-androstenediol (3β,17β- 6. Anabolic steroids. Unless specially 3-one) dihydroxyestr-5-ene) excepted or unless listed in another schedule, S. 4-dihydrotestosterone (17β- VV. 19-nor-5-androstenediol any material, compound, mixture, or prepa- hydroxy-androstan-3-one) (3α,17β-dihydroxyestr-5-ene) ration containing any quantity of the follow- T. Drostanolone (17β-hydroxy-2α- WW. 19-nor-4-androstenedione (estr- ing substances, including its salts, isomers, methyl-5α-androstan-3-one) 4-en-3,17-dione) and salts of isomers whenever the existence U. Ethylestrenol (17α-ethyl-17β- XX. 19-nor-5-androstenedione (estr- of such salts of isomers is possible within the hydroxyestr-4-ene) 5-en-3,17-dione) specific chemical designation. DEA has V. Fluoxymesterone (9-fluoro-17α- YY. Norbolethone (13β,17α-diethyl- assigned code 4000 for all anabolic steroids. methyl-11β,17β-dihydroxyandrost-4-en-3- 17β-hydroxygon-4-en-3-one) Anabolic steroids. Any drug or hormonal one) ZZ. Norclostebol (4-chloro-17β- substance, chemically and pharmacologically W. Formebulone (Formebolone) (2- hydroxyestr-4-en-3-one) related to testosterone (other than estrogens, formyl-17α-methyl-11α,17β-dihydroxyan- AAA. Norethandrolone (17α-ethyl- progestins, corticosteroids, and dehy- drost-1,4-dien-3-one) 17β-hydroxyestr-4-en-3-one) droepiandrosterone) that promotes muscle X. Furazabol (17α-methyl-17β- BBB. Normethandrolone (17α- growth, except an anabolic steroid which is hydroxyandrostano[2,3-c]-furazan) methyl-17β-hydroxyestr-4-en-3-one)

10 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

CCC. Oxandrolone (17α-methyl-17β- C. 2-[(dimethylamino)methyl]-1-(3- CC. 2772 hydroxy-2-oxa-[5α]-androstan-3-one) methoxyphenyl)cyclohexanol, its salts, opti- DD. 2245 DDD. Oxymesterone (17α-methyl- cal and geometric isomers, and salts of these EE. 2773 4,17β-dihydroxyandrost-4-en-3-one) isomers (including ) 9752 FF. 2885 EEE. Oxymetholone (17α-methyl-2- D. Narcotic drugs containing nonnar- GG. 2774 hydroxymethylene-17β-hydroxy-[5α]- cotic active medicinal ingredients. Any com- HH. 2800 androstan-3-one) pound, mixture, or preparation containing II. 2836 FFF. Prostanozol (17β-hydroxy-5α- any of the following limited quantities of nar- JJ. 2820 androstano[3,2-c]pyrazole) cotic drugs or salts thereof, which shall KK. 2264 GGG. Stanolone (Δ1-dihydrotestos- include one (1) or more nonnarcotic active LL. terone (a.k.a. 1-testosterone)(17β-hydroxy- medicinal ingredients in sufficient proportion (Mephobarbital) 2250 5α-androst-1-en-3-one)) to confer upon the compound, mixture, or MM. 2884 HHH. Stanozolol (17α-methyl-17β- preparation valuable medicinal qualities other NN. 2837 hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole) than those possessed by the narcotic drug OO. 2834 III. Stenbolone (17β-hydroxy-2- alone: PP. Nordiazepam 2838 methyl-[5α]-androst-1-en-3-one) (I) Not more than two hundred mil- QQ. 2835 JJJ. Testolactone(13-hydroxy-3-oxo- ligrams (200 mg) of codeine per one hundred RR. 2839 13,17-secoandrosta-1,4-dien-17-oic acid lac- milliliters (100 mL) or per one hundred SS. 2585 tone) grams (100 gm); TT. 2591 KKK. Testosterone(17β-hydroxyan- (II) Not more than one hundred UU. 2285 drost-4-en-3-one); milligrams (100 mg) of dihydrocodeine per VV. 2883 LLL. Tetrahydrogestrinone (13β,17α- one hundred milliliters (100 mL) or per one WW. 2764 diethyl-17β-hydroxygon-4,9, 11-trien-3-one) hundred grams (100 gm); or XX. 2881 MMM. Trenbolone (17β-hydroxyestr- (III) Not more than one hundred YY. 2223 4,9,11-trien-3-one) milligrams (100 mg) of ethylmorphine per ZZ. 2925 NNN. Any salt, ester, or isomer of a one hundred milliliters (100 mL) or per one AAA. 2886 drug or substance described or listed in this hundred grams (100 gm). BBB. 2887 subparagraph, if that salt, ester, or isomer 2. Depressants. Unless specifically CCC. 2781 promotes muscle growth except an anabolic excepted or unless listed in another schedule, DDD. 2783 steroid which is expressly intended for any material, compound, mixture, or prepa- EEE. 2784 administration through implants to cattle or ration which contains any quantity of the fol- 3. . Any material, com- other nonhuman species and which has been lowing substances, including its salts, iso- pound, mixture, or preparation which con- approved by the secretary of Health and mers, and salts of isomers whenever the tains any quantity of the following sub- Human Services for that administration. existence of such salts, isomers, and salts of stances, including its salts, isomers (whether 7. Dronabinol (synthetic) in sesame isomers is possible within the specific chem- optical, position, or geometric), and salts of oil and encapsulated in a soft gelatin capsule ical designation: such isomers, whenever the existence of such in a United States Food and Drug Adminis- A. 2731 salts, isomers, and salts of isomers is possi- tration approved drug product 7369 B. 2882 ble: (Some other names for dronabinol: C. 2145 A. Fenfluramine 1670 (6aRtrans)- 6a,7,8,10a-tetrahydro-6.6.9- D. Brexanolone 2400 4. . Any material, compound, trimethyl-3-pentyl-6H-dibenzo (b,d) pyran-1- E. 2748 mixture, or preparation which contains any ol, or (-) -delta-9-(trans)-tetrahydrocannabi- F. 2749 quantity of the following substances, includ- nol.) G. 8192 ing its salts, isomers, and salts of isomers, (D) Schedule IV shall consist of the drugs H. betaine 2460 whenever the existence of such salts, isomers, and other substances, by whatever official I. 2465 and salts of isomers is possible: name, common or usual name, chemical J. 2744 A. Lorcaserin 1625 name, or brand name designated, listed in K. 2751 5. Stimulants. Unless specifically this section. Each drug or substance has been L. 2737 excepted or unless listed in another schedule, assigned the DEA Controlled Substances M. 2768 any material, compound, mixture, or prepa- Code Number set forth opposite it. N. 2752 ration which contains any quantity of the fol- 1. Narcotic drugs. Unless specifically O. 2753 lowing substances having a stimulant effect excepted or unless listed in another schedule, P. 2754 on the central nervous system, including its any material, compound, mixture, or prepa- Q. 2765 salts, isomers, and salts of isomers: ration containing limited quantities of any of R. 2467 A. ((+)- the following narcotic drugs or any salts S. 2756 norpseudoephedrine) 1230 thereof: T. 2540 B. Diethylpropion 1610 A. Not more than one milligram (1 U. 2545 C. 1760 mg) of difenoxin (DEA Drug Code No. V. 2758 D. 1575 9168) and not less than twenty-five micro- W. 2759 E. 1605 grams (25 mcg) of sulfate per dosage X. 2763 F. 1580 unit 9167 Y. 2767 G. 1680 B. Dextropropoxyphene (alpha-(+)- Z. 2138 H. (including 4-dimethylamino-1,2-diphenyl-3-methyl-2- AA. 2762 organometallic complexes propionoxybutane) 9278 BB. 2771 and chelates thereof) 1530

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 11 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

I. 1640 dred grams (100 gm); E. [2,4,6- J. 1750 C. Not more than one hundred mil- trifluoro-N-(6-(1- K. 1675 ligrams (100 mg) of ethylmorphine per one methylpiperidine-4- L. (2-amino-3- hundred milliliters (100 mL) or per one hun- carbonyl) pyridine-2- phenylpropyl ; dred grams (100 gm); yl-benzamide] 2790 benzenepropanol, beta- D. Not more than two and five-tenths F. Cenobamate ([(1R)-1-(2- amino-, carbamate (ester)) 1650 milligrams (2.5 mg) of diphenoxylate and not chlorophenyl)-2-(tetrazol- M. SPA (-)-1-dimethylamino- less than twenty-five micrograms (25 mcg) of 2-yl)ethyl] carbamate; 2H- 1,2-diphenylethane 1635 atropine sulfate per dosage unit; tetrazole-2-, alpha-(2- 6. Other substances. Unless specifically E. Not more than one hundred mil- chlorophenyl)-, carbamate excepted or unless listed in another schedule, ligrams (100 mg) of opium per one hundred (ester), (alphaR)-; carbamic any material, compound, mixture, or prepa- milliliters (100 mL) or per one hundred acid (R)-(+)-1-(2- ration which contains any quantity of the fol- grams (100 gm); and chlorophenyl)-2-(2H-tetrazol- lowing substances, including its salts: F. Not more than five-tenths mil- 2-yl)ethyl ester) 2720 A. 9709 ligram (0.5 mg) of difenoxin (DEA Drug B. Butorphanol (including its Code No. 9168) and not less than twenty-five (2) Excluded Nonnarcotic Substances. The optical isomers) 9720 micrograms (25 mcg) of atropine sulfate per following nonnarcotic substances which, C. (5-[[[(2S)-2- dosage unit. under the Federal Food, Drug, and Cosmetic amino-3-[4-aminocarbonyl)- 2. Stimulants. Unless specifically Act (21 U.S.C. 301) and section 201(g)(1) of 2,6-dimethylphenyl]-1- exempted or excluded or unless listed in the federal Controlled Substances Act (21 oxopropyl] [(1S)-1-(4-phenyl- another schedule, any material, compound, U.S.C. 811(g)(1)), may be lawfully sold over 1 H-imidazol-2- mixture, or preparation which contains any the counter without a prescription, are yl)ethyl]amino]methyl]-2- quantity of the following substances having a excluded from all schedules pursuant to sec- methoxybenzoic acid) stimulant effect on the central nervous system tion 195.015(5), RSMo. (including its optical isomers) including its salts, isomers, and salts of iso- and its salts, isomers, and mers: salts of isomers 9725 A. Pyrovalerone 1485 7. . Any material, compound, 3. Any compound, mixture, or prepara- mixture, or preparation which contains any tion containing any detectable quantity of quantity of the following substances having a or its salts or optical stimulant effect on the central nervous system isomers, or salts of optical isomers or any including their salts, isomers, and salts of iso- compound, mixture, or preparation contain- mers: ing any detectable quantity of ephedrine or its A. Ephedrine or its salts, optical iso- salts or optical isomers, or salts of optical mers, or salts of optical isomers as the only isomers if the drug preparations are starch- active medicinal ingredient or contains based solid dose forms, if such preparations ephedrine or its salts, optical isomers, or salts are sold over the counter without a prescrip- of optical isomers and therapeutically tion. The following drug preparations con- insignificant quantities of another active taining ephedrine and pseudoephedrine are medicinal ingredient. not scheduled controlled substances: (E) Schedule V shall consist of the drugs A. Drug preparations in liquid form; and other substances, by whatever official B. Drug preparations that require a name, common or usual name, chemical prescription in order to be dispensed. name, or brand name designated, listed in 4. Unless specifically exempted or this subsection. excluded or unless listed in another schedule, 1. Narcotic drugs containing nonnarcot- any material, compound, mixture, or prepa- ic active medicinal ingredients. Any com- ration which contains any quantity of the fol- pound, mixture, or preparation containing lowing substances having a depressant effect any of the following narcotic drugs, or their on the central nervous system, including its salts calculated as the free anhydrous base or salts: alkaloid, in limited quantities as follows, A. Ezogabine [N-[2-amino-4(4- which shall include one (1) or more nonnar- fluorobenzylamino)-phenyl]- cotic active medicinal ingredients in suffi- carbamic acid ethyl ester] 2779 cient proportion to confer upon the com- B. [(R)-2- pound, mixture, or preparation valuable acetoamido-N-benzyl- medicinal qualities other than those pos- 3-methoxy-propionamide] 2746 sessed by the narcotic drug alone: C. [(S)-3- A. Not more than two hundred mil- (aminomethyl)-5- ligrams (200 mg) of codeine per one hundred methylhexanoic acid] 2782 milliliters (100 mL) or per one hundred D. Brivaracetam ((25)-2-[(4R)- grams (100 gm); 2-oxo-4-propylpyrrolidin-1- B. Not more than one hundred mil- yl]butanamide) (also referred ligrams (100 mg) of dihydrocodeine per one to as BRV; UCB-34714; hundred milliliters (100 mL) or per one hun- Briviact) 2710

12 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Excluded Nonnarcotic Products mg or Company Trade Name NDC Code Form Controlled Substance mg/mL

Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00 Aphena Pharma Nasal decongestant/ Levometamfetamine 50.00 Solutions—New York, LLC inhaler/vapor (l-desoxyephedrine) Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00 Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00 Hawthorne Products, Inc. Choate’s Leg Freeze LQ Chloral hydrate 246.67 Parke-Davis & Co. Tedral 00071-0230 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Elixir 00071-0242 EX Phenobarbital 40.00 Parke-Davis & Co. Tedral S.A. 00071-0231 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Suspension 00071-0237 SU Phenobarbital 80.00 Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10 Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00 Smith Kline Consumer Benzedrex 49692-0928 IN 250.00 Sterling Drug, Inc. Bronkolixir 00057-1004 EL Phenobarbital 0.80 Sterling Drug, Inc. Bronkotabs 00057-1005 TB Phenobarbital 8.00 Vicks Chemical Co. Vicks Inhaler 23900-0010 IN I-Desoxyephedrine 113.00 White Hall Labs Primatene 00573-2940 TB Phenobarbital 8.00 (P-tablets)

AUTHORITY: section 195.015, RSMo Supp. interested person may view this material at 195.017.6(5) and .8(3), RSMo. The rules of 2020, and section 195.195, RSMo 2016.* either agency’s headquarters or the same will the Drug Enforcement Administration, 21 Material found in this rule previously filed as be made available at the Office of the Secre- CFR Part 1300 to the end of Title 21, are 19 CSR 30-1.010. Original rule filed April 14, tary of State at a cost not to exceed actual cost hereby incorporated by reference and made a 2000, effective Nov. 30, 2000. Amended: Filed of copy reproduction. The entire text of the part of this rule. Jan. 31, 2003, effective July 30, 2003. Amend- rule is printed here. This note refers only to ed: Filed Sept. 30, 2016, effective May 30, the incorporated by reference material. AUTHORITY: section 195.195, RSMo 1994.* 2017. Emergency amendment filed Oct. 25, Material found in this rule previously filed as 2018, effective Nov. 4, 2018, expired May 2, (1) Excepted Stimulant or Depressant Com- 19 CSR 30-1.020. Original rule filed April 2019. Amended: Filed Oct. 25, 2018, effective pounds—Exempt Prescription Products. The 14, 2000, effective Nov. 30, 2000. April 30, 2019. Emergency amendment filed listed drugs in dosage unit form and any other Oct. 30, 2020, effective Nov. 16, 2020, drug of the quantitative composition shown in *Original authority: 195.195, RSMo 1957, amended Part 1300 to end of Title 21, the Code of Fed- 1971, 1989, 1993. expired May 14, 2021. Amended: Filed Oct. 30, 2020, effective April 30, 2021. eral Regulations, April 1998 or which is the same except that it contains a lesser quantity 19 CSR 30-1.006 List of Exempt Anabolic *Original authority: 195.015, RSMo 1971, amended 1989, of controlled substances or other substances 2014, 2020 and 195.195, RSMo 1957, amended 1971, which do not have a stimulant, depressant or Steroid Products 1989, 1993, 2014. hallucinogenic effect and which are restricted by law to dispensing or prescription, are PURPOSE: This rule maintains a list of excepted from the provisions of sections anabolic steroid products excluded from 19 19 CSR 30-1.004 List of Excepted Sub- 195.030, 195.040, 195.050 and 195.100, CSR 30-1.002(1)(C)5. in conformance with stances RSMo as provided for in section federal law. 195.017.6(5) and .8(3), RSMo. The rules of PURPOSE: The Department of Health is the Drug Enforcement Administration, 21 (1) Persons who in the course of legitimate authorized to except by rule any compound, CFR Part 1300 to the end of Title 21, are business handle products listed in the Table of mixture or preparation containing any stimu- hereby incorporated by reference and made a Exempt Anabolic Steroid Products in this lant or depressant substance if one or more part of this rule. section shall be exempt from the registration, active medicinal ingredients not having a stim- records, reports, prescriptions, physical secu- ulant or depressant effect on the central ner- (2) Excepted Chemical Preparations— rity and import and export requirements asso- vous system is included to negate the potential Exempt Chemical Preparations. The listed ciated with Schedule III substances. for abuse. The compounds, mixtures and preparations in unit form and any other preparations excluded are listed in this rule. preparation of the quantitative composition (A) Trade Name Company NDC or DIN No. shown in Part 1300 to end of Title 21, the 1. Androgyn L.A. Forest Pharmaceuticals, 0456-1005 St. Louis, MO PUBLISHER’S NOTE: The secretary of state Code of Federal Regulations, April 1998 2. Andro-Estro Rugby Laboratories, 0536-1605 has determined that the publication of the which is the same except that it contains a 90-4 Rockville Center, NY entire text of the material which is incorporat- lesser quantity of controlled substances or 3. depANDROGYN Forest Pharmaceuticals, 0456-1020 St. Louis, MO ed by reference as a portion of this rule would other substances which do not have a stimu- 4. DEPO-T.E. Quality Research Pharma- 52765-257 be unduly cumbersome or expensive. There- lant, depressant or hallucinogenic effect are ceuticals, Camel, IN fore, the material which is so incorporated is excepted from the provisions of sections 5. depTESTROGEN Martica Pharmaceuticals, 51698-257 Phoenix, AZ on file with the agency who filed this rule, and 195.030, 195.040, 195.050 and 195.110, 6. Duomone Wintec Pharmaceutical, 52047-360 with the Office of the Secretary of State. Any RSMo as provided for in section Pacific, MO

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 13 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Trade Name Company NDC or DIN No. Trade Name Company NDC or DIN No. (R) Synovex H Syntex Laboratories, 7. DURATESTRIN W.E. Hauck, Alpharetta, 43797-016 36. Tilapia Sex Rangen, Inc., Palo Alto, CA GA Reversal Feed Buhl, ID (S) Synovex Plus Fort Dodge Labs, 0856-3904 8. DUO-SPAN II Primedics Laboratories, 0684-0102 (Investigational) Fort Dodge, IA Gardena, CA 37. Tilapia Sex Ziegler Brothers, Inc. 9. Estratest Solvay Pharmaceuticals, 0032-1026 Reversal Feed Gardners, PA AUTHORITY: section 195.195, RSMo 1994 Marietta, GA (Investigational) 10. Estratest HS Solvay Pharmaceuticals, 0032-1023 and 195.017, RSMo Supp. 1999.* Original Marietta, GA rule filed April 14, 2000, effective Nov. 30, 11. Menogen Sage Pharmaceuticals, 59243-570 AUTHORITY: section 195.195, RSMo 1994.* Shreveport, LA Material found in this rule previouly filed as 2000. 12. Menogen HS Sage Pharmaceuticals, 59243-560 19 CSR 30-1.025. Original rule filed April Shreveport, LA *Original authority: 195.017, RSMo 1971, amended 1987, 13. PAN ESTRA Pan American Labs, 0525-0175 14, 2000, effective Nov. 30, 2000. 1989, 1994, 1996, 1997, 1998 and 195.195, RSMo 1957, TEST Covington, LA amended 1971, 1989, 1993. 14. Premarin with Ayerst Labs., Inc. 0046-0879 *Original authority: 195.195, RSMo 1957, amended Methyltestos- New York, NY 1971, 1989, 1993. terone 15. Premarin with Ayerst Labs., Inc., 0046-0878 19 CSR 30-1.010 Schedules of Controlled Methyltestos- New York, NY Substances terone 19 CSR 30-1.008 List of Excluded Veteri- 16. Synovex H Syntex Animal Health, (Rescinded November 30, 2000) Pellets in Palo Alto, CA nary Anabolic Steroid Implant Products process AUTHORITY: section 195.195, RSMo Supp. 17. Synovex H Syntex Animal Health, PURPOSE: This rule maintains a list of vet- Pellets in Palo Alto, CA 1993. This rule was previously filed as 13 process erinary anabolic steroid products excluded CSR 50-130.010 and 19 CSR 10-130.010. granulation from 19 CSR 30-1.002(1)(C)5. in confor- Original rule filed Jan. 31, 1972, effective 18. Synovex Plus Fort Dodge Animal mance with federal law. in-process Health, April 1, 1972. Amended: Filed Oct. 4, 1972, granulation Fort Dodge, IA effective Oct. 14, 1972. Amended: Filed April 19. Synovex Plus Fort Dodge Animal (1) The following products containing an 4, 1973, effective April 14, 1973. Amended: in-process Health, anabolic steroid that are expressly intended bulk pellets Fort Dodge, IA Filed Sept. 28, 1973, effective Nov. 4, 1973. for administration through implants to cattle 20. Testagen Clint Pharmaceuticals, 55553-257 Amended: Filed Jan. 3, 1974, effective Jan. Nashville, TN or other nonhuman species and which have 13, 1974. Amended: Filed Oct. 9, 1974, 21. TEST-ESTRO Rugby Laboratories, 0536-9470 been approved by the Secretary of Health and Cypionates Rockville Centre, NY effective Oct. 19, 1974. Amended: Filed July 22. Testoderm Alza Corp., 17314-4608 Human Services for such administration and 17, 1975, effective July 27, 1975. Amended: 4 mg/d Palo Alto, CA are excluded from all schedules pursuant to 23. Testoderm Alza Corp., 17314-4609 Filed Oct. 8, 1975, effective Oct. 18, 1975. 6 mg/d Palo Alto, CA section 195.017.5, RSMo. Refiled: March 24, 1976. Amended: Filed 24. Testoderm Alza Corp., 17314-2836 with Adhesive Palo Alto, CA Trade Name Company NDC or DIN No. Oct. 12, 1976, effective Jan. 13, 1977. 6 mg/d (A) Component E-H Vetlife, Inc., 021641-002 Amended: Filed March 15, 1977, effective 25. Testoderm Alza Corp., Norcross, GA March 24, 1977. Amended: Filed Nov. 14, in-process film Palo Alto, CA (B) Component E-H Elanco, 01968327 26. Testoderm Alza Corp., Scarborough, ON 1977, effective Nov. 6, 1977. Amended: Filed with Adhesive Palo Alto, CA (C) Component TE-S Vetlife, Inc., 021641-004 Sept. 28, 1977, effective Jan. 13, 1978. in-process film Norcross, GA Amended: Filed March 9, 1978, effective Feb. 27. Testosterone I.D.E.-Interstate, 0814-7737 (D) Component T-H Vetlife, Inc., 021641-006 Cyp 50 Estradiol Amityville, NY Norcross, GA 24, 1978. Amended: Filed Oct. 2, 1978, Cyp 2 (E) Component T-S Vetlife, Inc., 021641-005 effective Sept. 27, 1978. Amended: Filed 28. Testosterone Best Generics, No. 54274-530 Norcross, GA Nov. 14, 1978, effective June 16, 1978. Cypionate- Miami Beach, FL (F) F-TO Animal Health, 00093351 Estradiol Cypionate Upjohn International, Amended: Filed Nov. 14, 1978, effective Oct. Injection Kalamazoo, MI 25, 1978. Amended: Filed Feb. 13, 1979, 29. Testosterone Schein Pharmaceuticals, 0364-6611 (G) Finaplix-H Hoechst Roussel effective Feb. 9, 1979. Amended: Filed Feb. Cypionate- Port Washington, NY Vet, 12799-807-10 Estradiol Cypionate Somerville, NJ 19, 1980, effective Feb. 11, 1980. Amended: Injection (H) Finaplix-S Hoechst Roussel 30. Testosterone Steris Labs., Inc., 0402-0257 Filed Oct. 14, 1980, effective July 24, 1980. Vet, 12799-807-07 Cypionate-Estra- Phoenix, AZ Amended: Filed Oct. 14, 1980, effective Aug. Somerville, NJ diol Cypionate (I) Heifer-oid Anchor Division, 21, 1980. Amended: Filed Oct. 14, 1981, Injection Boehringer Ingelheim, 31. Testosterone Goldline Labs, 0182-3069 effective Oct. 30, 1980. Amended: Filed Oct. Cypionate-Estra- Ft. Lauderdale, FL St. Joseph, MO 14, 1981, effective May 8, 1981. Amended: (J) Heifer-oid Bio-Ceutic Division, diol Cypionate Filed Oct. 14, 1981, effective Aug. 20, 1981. Injection Boehringer Ingelheim, 32. Testosterone The Upjohn Co., 0009-0253 St. Joseph, MO Amended: Filed Nov. 1, 1982, effective Dec. Cypionate-Estra- Kalamazoo, MI (K) Heifer-oid Ivy Laboratories, Inc., 11, 1982. Amended: Filed Jan. 12, 1983, diol Cypionate Overland Park, KS Injection (L) Implus-H The Upjohn Co., 0009-0434-01 effective Feb. 11, 1983. Amended: Filed 33. Testosterone Goldline Labs., 0182-3073 Kalamazoo, MI March 11, 1983, effective April 1, 1983. Enanthate-Estra- Ft. Lauderdale, FL (M) Implus-H Upjohn Co., Animal 06-0434-01 Amended: Filed Sept. 2, 1983, effective Dec. diol Valerate Health Division, 01968327 Injection Orangeville, ON 11, 1983. Amended: Filed Nov. 7, 1983, 34. Testosterone Schein Pharmaceuticals, 0364-6618 (N) Revalor-G Hoechst Roussel Vet, 12799-811 effective Dec. 11, 1983. Amended: Filed July Enanthate-Estra- Port Washington, NY Somerville, NJ 12, 1984, effective Aug. 11, 1984. Amended: diol Valerate (O) Revalor-H Hoechst Roussel Vet, 12799-810 Injection Somerville, NJ Filed Sept. 20, 1984, effective Nov. 11, 1984. 35. Testosterone Steris Labs., Inc., 0402-0360 (P) Revalor-S Hoechst Roussel Vet, 12799-809 Amended: Filed Jan. 15, 1985, effective Feb. Enanthate-Estra- Phoenix, AZ Somerville, NJ diol Valerate (Q) Synovex H Fort Dodge Labs, 0856-3901 11, 1985. Amended: Filed May 29, 1985, Injection Fort Dodge, IA effective June 27, 1985. Amended: Filed July

14 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

24, 1985, effective Aug. 26, 1985. Amended: which establish the intended meaning of cer- to a patient; Filed Sept. 12, 1985, effective Oct. 11, 1985. tain terms used throughout this chapter. (L) Pre-hospital emergency medical ser- Changed to 19 CSR 10-130.010, effective Oct. vice means an emergency medical services 11, 1985. Amended: Filed Jan. 3, 1986, (1) As used in this chapter, the following system as defined in Chapter 190, RSMo pro- effective Jan. 16, 1986. Changed to 19 CSR terms shall have the meanings specified: viding services to persons prior to admission 30-1.010, effective Aug. 11, 1986. Amended: (A) Commercial container means any bot- to a hospital; Filed April 17, 1987, effective May 14, 1987. tle, jar, tube, ampule or other receptacle in (M) Prescription means an order for med- Amended: Filed July 3, 1987, effective Aug. which a substance is held for distribution or ication which is dispensed to or for an ulti- 27, 1987. Amended: Filed May 3, 1988, dispensing to an ultimate user and, in addi- mate user but does not include an order for effective May 26, 1988. Amended: Filed Sept. tion, any box or package in which the recep- which is dispensed for immediate 25, 1989, effective Oct. 27, 1989. Emergen- tacle is held for distribution or dispensing to administration to the ultimate user. (For cy amendment filed April 3, 1991, effective an ultimate user. The term commercial con- example, an order to dispense a drug to a bed April 13, 1991, expired Aug. 10, 1991. Emer- tainer does not include any package liner, patient for immediate administration in a hos- gency amendment filed May 1, 1991, effective package insert of other material kept with or pital is not a prescription.); May 11, 1991, expired Sept. 7, 1991. Emer- within a commercial container, nor any car- (N) Readily retrievable means that certain gency amendment filed July 23, 1991, effec- ton, crate, drug or other package in which records are kept by automatic data processing tive Aug. 2, 1991, expired Nov. 28, 1991. commercial containers are stored or are used systems or other electronic or mechanized Amended: Filed April 3, 1991, effective Sept. for shipment of controlled substances; record keeping systems in a manner that they 30, 1991. Amended: Filed May 1, 1991, (B) Controlled substances administration can be separated out from all other records; effective Sept. 30, 1991. Amended: Filed record means the form used to record infor- and/or records are kept on which certain March 2, 1992, effective Aug. 6, 1992. mation when administering individual drug items are asterisked, redlined, highlighted or Amended: Filed July 6, 1993, effective Dec. doses to patients; in some other manner visually identifiable 9, 1993. Emergency amendment filed Jan. 5, (C) Dispenser means an individual practi- apart from other items appearing on the 1994, effective Jan. 15, 1994, expired May tioner, institutional practitioner, pharmacy or records; and records are provided within 14, 1994. Amended: Filed Jan. 5, 1994, pharmacist who dispenses a controlled sub- three working days of a request; effective July 30, 1994. Rescinded: Filed stance; (O) Registration means a Missouri con- April 14, 2000, effective Nov. 30, 2000. (D) Hospice means a public agency or pri- trolled substances registration; vate organization or subdivision of either of (P) Reregistration means a registration State v. Miller, 588 SW2d 237 (Mo. App. these that is primarily engaged in providing issued to a person who was previously regis- 1979). Evidence of the presence of care to dying persons and their families and tered and whose application for reregistration amphetamine is sufficient to support a con- meets the standards specified in 19 CSR 30- was received by the Department of Health trolled substances conviction; no quantitative 35; prior to the expiration of the previous regis- analysis is necessary. Those rules refiled (E) Hospital employee means a nurse, tration; between January 1 and March 31, 1976 were physician, pharmacist or other responsible (Q) Temporary location registration means not required to be published under section patient-care employee; a registration issued to an individual practi- 536.021, RSMo. Also, courts must take judi- (F) Individual practitioner means a physi- tioner who: cial notice of the contents of the Code of cian, dentist, veterinarian, optometrist or 1. Has a current Missouri professional State Regulations. other individual licensed, registered or other- license to practice and is registered with the wise permitted by the United States or Mis- Department of Health at the address listed on Selvey v. State, 578 SW2d 64 (Mo. App. souri to dispense a controlled substance in the his/her professional license; 1979). Phenmetrazine, originally established course of professional practice, but does not 2. Has a federal Drug Enforcement statutorily as a Schedule III controlled sub- include a pharmacist, a pharmacy or an insti- stance, was rescheduled by the Division of Administration registration that is valid in tutional practitioner; Missouri; Health to Schedule II. Such a rescheduling is (G) Institutional practitioner means a hos- within the statutory power granted the Divi- 3. Anticipates practicing in Missouri pital or other person (other than an individu- sion of Health and does not usurp the leg- within the next 12 months; al) licensed, registered or otherwise permit- islative power of the general assembly. 4. Does not practice for more than 90 ted by the United States or Missouri to consecutive calendar days at any location; State v. Davis, 450 SW2d 168 (Mo. App. dispense a controlled substance in the course 5. Maintains a record of the date(s) and 1970). Statutes which direct the Division of of professional practice, but does not include location(s) of all practice activity in Missouri Health to prepare a list of drugs classified as a pharmacy; and makes the record available to the Bureau and stimulants, the sale of which (H) Long-term care facility means a nurs- of Narcotics and Dangerous Drugs. This are made unlawful by statute, does not violate ing home, retirement care, mental care, or record shall be retained for two years; the Missouri Constitution prohibition in Arti- other facility or institution which provides 6. Maintains all required controlled sub- cle I, section 31 against delegation of author- extended health care to resident patients; stance records at each location; ity to an agency to make a rule fixing a fine (I) Name means the official name, com- 7. Does not receive or stock controlled or imprisonment as punishment for its viola- mon or usual name, chemical name or brand substances at any location; tion. name of a substance; (J) Nurse means a registered or licensed (2) Any term not defined in this rule shall practical nurse licensed under Chapter 335, have the definition set forth in Chapter 195, 19 CSR 30-1.011 Definitions RSMo; RSMo. (K) Patient care areas means any area of a PURPOSE: This rule contains definitions hospital where medical attention is rendered AUTHORITY: section 195.195, RSMo 2000.*

JOHN R. ASHCROFT (3/31/19) CODE OF STATE REGULATIONS 15 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

Original rule filed April 14, 2000, effective registrant shall pay a fee of thirty dollars or employment at their government practice Nov. 30, 2000. Amended: Filed Jan. 31, ($30); and location. If the person conducts controlled 2003, effective July 30, 2003. (F) Import or export controlled substances substance activities away from his or her gov- listed in any schedule, the registrant shall pay ernment practice location, the person shall *Original authority: 195.195, RSMo 1957, amended a fee of sixty-six dollars ($66). apply and submit the required fee for a non- 1971, 1989, 1993. exempt registration.

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

16 CODE OF STATE REGULATIONS (3/31/19) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(C) Registrations for manufacturers and separate application and registration. of a corporate applicant, or individual distributors may be assigned to a single employed by any applicant having access to group, and the expiration date may be less (4) All applicants shall make full, true, and controlled substances, has ever entered a plea than twelve (12) months from the date the complete answers on the application. The of guilty, no contest, nolo contendere, or oth- registration was issued. Department of Health and Senior Services erwise been convicted of any violation of any (D) Training program registrations may be may require an applicant to submit docu- state or federal law related to the possession, assigned to a single group, and the expiration ments or written statements of fact relevant to manufacture, distribution, dispensing, or pre- date may be less than twelve (12) months the application as considered necessary to scribing of controlled substances. If the from the date the registration was issued. determine whether the application should be answer is yes, the applicant shall provide an (E) A certificate of registration shall be granted. The failure of the applicant to pro- explanation; made available online and printable to the vide these documents or statements within (H) If the applicant is an individual or a registrant which shall include the name and sixty (60) days after being requested to do so registrant that holds a professional license, address of the registrant, the expiration date shall be considered to be a waiver by the whether he or she is currently licensed and of the registration, and a registration number applicant of an opportunity to present these registered to practice his or her profession for the convenience of identifying a registra- documents or facts for consideration in grant- under the laws of this state; tion or a registrant. The same registration ing or denying the application. (I) If the applicant is not an individual or number may be used for a new registration registrant that holds a professional license, for the same person. (5) Applications for Individual Practitioner the applicant shall answer yes or no to Registrations. Applications by physicians, vet- whether the applicant is currently authorized (3) Requirements for All Applicants. erinarians, optometrists, podiatrists, and to conduct business under the laws of this (A) Any person who is required to be reg- researchers for Missouri Controlled Substance state; istered and who is not so registered may Registrations shall include: (J) Previous Discipline. If the applicant cur- apply for registration at any time. No person (A) The applicant’s full legal name (first rently holds or has previously held a state or required to be registered shall engage in any name, middle name, and last name), includ- federal controlled substance registration or activity for which registration is required ing any suffixes such as junior, senior, or III, state professional license or registration, the until the application for registration is pro- gender, race, and ethnicity; applicant shall answer yes or no to whether the cessed and the registration is issued. All (B) A listing of all addresses and practice applicant’s license, registration, or application applications are for new registrations. locations where controlled substance activi- or renewal thereof has ever been surrendered, (B) Applications for registration shall be ties will be taking place. The applicant’s revoked, suspended, denied, restricted, or made on forms designated by the Department street addresses, cities, zip codes, counties, placed on probation and if any such action is of Health and Senior Services. Application and state. The number of hours worked per pending. If the answer is yes, the applicant forms may be requested from the Missouri week for each location shall be provided for shall provide an explanation; Department of Health and Senior Services, performing direct patient care (non-hospital), (K) Whether the applicant is abusing or has PO Box 570, Jefferson City, MO 65102-0570 administration, research, teaching, in-patient abused or been treated for or diagnosed with or may be completed online and submitted hospital care, and other. The applicant shall regarding controlled substances dur- electronically via the Missouri Department of also identify his or her primary, principle ing the past year. For purposes of this subsec- Health and Senior Services’ website at practice location, where he or she spends the tion, “abusing” or “abused” means using or www.health.mo.gov along with the required most time. This will be the principle practice having used a controlled substance in a man- fee. address that appears on the controlled sub- ner not authorized under Chapter 195, (C) A written application in paper form stances registration. A physical street address RSMo; shall contain the signature of the applicant is required and post office box addresses shall (L) Copies and attachments of any guilty and shall be provided to the Department of not be accepted; pleas, convictions, or disciplinary actions Health and Senior Services with any required (C) Whether the application is for a physi- identified in subsections (G) and (J) of this fee. This is a nonrefundable processing fee. cian, veterinarian, optometrist, podiatrist, or section, if the department does not already (D) An application which does not contain researcher; have them on file; or is not accompanied by the required infor- (D) His or her anticipated drug activities (M) The original signature of the individu- mation or fee may be denied sixty (60) days such as administering, prescribing, or dis- al applicant, if the application is submitted on after notifying the applicant of the deficiency. pensing; paper; (E) An application may be withdrawn by (E) The required fee and fee information. (N) His or her Social Security number and making a written request to the Department If claiming an exemption from a fee, the date of birth (MM/DD/YYYY); of Health and Senior Services. applicant shall identify the name of the gov- (O) The date the application is signed; (F) A person who is registered may con- ernment agency that employs him or her; (P) What drug schedules the applicant is duct activities with controlled substances in (F) His or her business telephone number, requesting authority in; and Schedules II, III, IV, and V, as authorized by fax number, email address, federal controlled (Q) A listing of mid-level practitioners by statute, unless a registration is restricted as to substances registration number, if applicable; name and license number with whom appli- schedules or activities because of a settlement professional degree, if applicable; and pro- cant has agreements pursuant to Chapter 334, agreement, probation, or other disciplinary fessional license number, if applicable. If the RSMo. action taken by the Department of Health and applicant has an application pending for a Senior Services, the Drug Enforcement federal controlled substances registration (6) Applications for Pharmacies and Busi- Administration, or a professional licensing number, the applicant shall indicate the appli- nesses. Applications for retail pharmacies board. Authority to conduct activities with cation is pending; and ambulance services, ambulatory surgery controlled substances in Schedule I requires a (G) Whether the applicant, or any officer centers, analytical laboratories, correctional

JOHN R. ASHCROFT (3/31/19) CODE OF STATE REGULATIONS 17 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

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

18 CODE OF STATE REGULATIONS (3/31/19) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(I) A copy of the applicant’s collaborative 2003, effective July 30, 2003. Amended: department. No fee shall be required to be or supervision agreements with physicians, Filed April 29, 2011, effective Nov. 30, 2011. paid for the modification. The application for and a list of controlled substances from each modification shall be handled in the same physician that the mid-level practitioner is *Original authority: 195.195, RSMo 1957, amended manner as an application for registration. 1971, 1989, 1993. authorized to conduct activities with, in that (B) Any registrant may request to modify agreement; his or her name or address as shown on the registration provided that such a modification (J) The applicant’s street address, city, zip 19 CSR 30-1.019 Registration Location code, county, and state of the applicant’s pri- does not constitute a change of ownership or mary, principle practice location. This will be PURPOSE: This rule establishes require- location. The request shall be made in writ- the principle address that appears on the con- ments for the physical location of a registra- ing and no fee shall be required to be paid for trolled substances registration. Post office tion. the modification. The request for changes boxes shall not be accepted. Applicants shall may be submitted electronically using the also provide any secondary practice location (1) A controlled substance registration shall department’s online database system. Requests submitted in paper form shall con- addresses and the number of hours worked be issued at a U.S. Postal Service street tain the registrant’s signature. per week for each location for performing address. (C) When the registrant’s name or address direct patient care (non-hospital), administra- (2) A controlled substance registration shall as shown on the registration changes, the reg- tion, research, teaching, in-patient hospital istrant shall notify the Department of Health care, and other; be issued to an individual practitioner at a Missouri practice location where controlled and Senior Services in writing, including the (K) The applicant’s business phone num- registrant’s signature, prior to or within thir- ber and fax number; substance and other patient care activities occur. ty (30) days subsequent to the effective date (L) The applicant’s criminal history infor- of the change. No fee shall be required to be mation as it pertains to controlled substance AUTHORITY: section 195.195, RSMo 2000.* paid for the modification. laws. The applicant shall answer yes or no as Original rule filed April 14, 2000, effective (D) Collector of Unwanted Controlled to whether the applicant or any employee Nov. 30, 2000. Amended: Filed Jan. 31, Substances. A current registrant with the with access to controlled drugs has ever pled 2003, effective July 30, 2003. Amended: department may request to have their regis- guilty, no contest, nolo contendere, or ever Filed April 29, 2011, effective Nov. 30, 2011. tration modified to authorize the collection of been convicted of any violation of state or unwanted controlled substances. Requests federal law relating to controlled substances; *Original authority: 195.195, RSMo 1957, amended shall be submitted in writing to the Bureau of (M) Information regarding any previous or 1971, 1989, 1993. Narcotics and Dangerous Drugs, PO Box pending disciplinary actions regarding the 570, Jefferson City, MO, 65102-0570. applicant’s professional license or any con- Requests shall provide the requesting regis- trolled substance registration, as to whether 19 CSR 30-1.020 List of Excepted Sub- trant’s name, address, and current Missouri the applicant’s privileges or authority have stances Controlled Substances Registration number. been revoked, surrendered, suspended, (Rescinded November 30, 2000) Requests shall identify the method of collec- restricted, or placed on probation, or if any tion such as either a collection receptacle box application for a state license or any drug AUTHORITY: section 195.195, RSMo Supp. or mail-back return system, or both, and shall registration has ever been denied; 1989. This rule was previously filed as 13 identify the exact physical address of the (N) Whether the applicant has abused or CSR 50-130.020. Original rule filed Sept. 28, receptacle. Collection receptacles located in been treated for or diagnosed with addiction 1977, effective Jan. 13, 1978. Amended: long term care facilities shall be maintained regarding controlled substances during the Filed Nov. 14, 1978, effective Dec. 11, 1978. by a retail pharmacy or a hospital/clinic with past year. For purposes of this subsection, Amended: Filed Oct. 12, 1979, effective Nov. an on-site pharmacy. The bureau will respond “abusing” or “abused” means using or having 11, 1979. Amended: Filed Oct. 14, 1981, to the registrant’s request in writing. Regis- trants authorized by the department to collect used a controlled substance in a manner not effective Nov. 2, 1981. Amended: Filed Nov. unwanted controlled substances shall comply authorized under Chapter 195, RSMo; 1, 1982, effective Dec. 11, 1982. Amended: with all requirements for record keeping and (O) The application shall be submitted Filed Nov. 7, 1983, effective Dec. 11, 1983. Amended: Filed Oct. 2, 1991, effective Feb. security in accordance with federal regula- with the required fee and fee information. If tions. The privilege of being a collector may claiming an exemption from a fee, the appli- 6, 1992. Rescinded: Filed April 14, 2000, effective Nov. 30, 2000. be terminated if the registrant’s authority to cant shall identify the name of the govern- collect is terminated by the United States ment agency that employs the applicant; Drug Enforcement Administration, a judicial (P) The applicant shall provide copies and 19 CSR 30-1.023 Registration Changes order, an act by a state licensing board or attachments of any guilty pleas, convictions, agency, or if the collector’s registration is or disciplinary actions identified in subsec- PURPOSE: This rule establishes procedures restricted as a matter of public discipline by tions (L) and (M) of this section, if the for modifying an existing registration, the department. An authorized collector who department does not already have them on describes the conditions under which a regis- wishes to cease being a collector shall notify file; and tration automatically terminates, and pro- the bureau in writing of the date that collec- (Q) The applicant shall sign and date an hibits the transfer of a registration. tions will cease. application submitted on paper and may use the electronic process if applying online. (1) Modification of Registration. (2) Termination of Registration. (A) Any registrant may apply to modify (A) The registration of any person shall AUTHORITY: section 195.195, RSMo 2000.* his/her registration to authorize the handling terminate— Original rule filed April 14, 2000, effective of controlled substances in additional sched- 1. On the expiration date assigned to the Nov. 30, 2000. Amended: Filed Jan. 31, ules by submitting a request in writing to the registration at the time the registration was

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 19 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

issued; 2019. Amended: Filed Sept. 17, 2018, effec- (2) No activity shall be conducted with any 2. If and when the person dies; tive March 30, 2019. controlled substance in any schedule not 3. If and when the person ceases legal requested for and shown on the current regis- existence; *Original authority: 195.195, RSMo 1957, amended tration. 4. If and when a business changes own- 1971, 1989, 1993, 2014. ership, except— (3) Separate Locations. A separate registra- A. The registration shall not termi- tion is required for each principal place of nate for thirty (30) days from the effective 19 CSR 30-1.025 List of Exempt Anabolic business or professional practice at one (1) date of the change if the new owner applies Steroid Products general physical location where controlled for a registration within the thirty- (30-) day (Rescinded November 30, 2000) substances are manufactured, distributed, or period and the corresponding Drug Enforce- dispensed by a person. ment Administration registration remains AUTHORITY: section 195.015.4, RSMo (A) For purposes of registration only, the effective as provided for by the Drug Supp. 1989. Original rule filed July 6, 1993, following locations shall be deemed not to be Enforcement Administration; effective Dec. 9, 1993. Rescinded: Filed places where controlled substances are man- 5. If and when the person discontinues April 14, 2000, effective Nov. 30, 2000. ufactured, distributed, or dispensed: business or changes business location, 1. A warehouse where controlled sub- except— stances are stored by or on behalf of a regis- A. The registration shall not termi- 19 CSR 30-1.026 Separate Registrations tered person, unless these substances are dis- nate for thirty (30) days from the effective tributed directly from the warehouse to date of the change if the person applies for a PURPOSE: This rule defines the require- registrants other than the registered person or new registration or modification within the ments for controlled substance registrations to persons not required to register; thirty- (30-) day period; or for separate activities and for separate sites, 2. An office used by agents of a regis- 6. Upon the written request of the regis- and defines when a separate registration is trant where sales of controlled substances are trant. not required. (B) A mid-level practitioner’s registration solicited, made, or supervised but which nei- shall be contingent upon the physician with (1) Independent Activities. The following ther contains these substances (other than whom he or she has entered into an agree- eight groups of activities are deemed to be substances for display purposes or lawful dis- ment pursuant to Chapter 334, RSMo, having independent of each other and require sepa- tribution as samples only) nor serves as a dis- a current and valid registration. When such rate registration: tribution point for filling sales orders; 3. An office used by a practitioner (who physician’s registration expires, closes, or is (A) Manufacturing controlled substances; is registered at another location) where con- no longer valid, any mid-level practitioner(s) (B) Distributing controlled substances, with whom he or she has entered into an trolled substances are prescribed but neither except: agreement shall no longer have controlled administered nor otherwise dispensed as a 1. A dispenser distributing less than substance authority. The mid-level practition- regular part of the professional practice of the 5% of the total combined dosage units of con- er(s) shall cease controlled drug activities practitioner at the office and where no sup- trolled substances distributed and dispensed until the physician has obtained a new regis- plies of controlled substances are maintained; in a calendar year shall be exempt from tration or the mid-level practitioner(s) 4. A location on the immediate or con- obtaining a separate registration for distribut- obtain(s) another agreement with another tiguous property of a hospital, provided that ing; physician pursuant to Chapter 334, RSMo. the location is owned and operated by the 2. A dispenser distributing more than Mid-level practitioners and any physician hospital and controlled substances are not 5% of the total combined dosage units of con- with whom he or she has entered into an dispensed for use away from the location; agreement pursuant to Chapter 334, RSMo, trolled substances distributed and dispensed 5. A separate location from a registered shall notify the Department of Health and in a calendar year must obtain a separate reg- pre-hospital emergency medical service loca- Senior Services of the termination of any istration as a distributor but shall be exempt tion where an emergency vehicle is housed such agreement. from maintaining separate inventories under that does not have a permanent location of (C) Any registrant who ceases legal exis- 19 CSR 30-1.042; operation; and tence or discontinues business or profession- (C) Dispensing controlled substances listed al practice shall notify the Department of 6. A pre-hospital emergency medical in Schedules II–V; service located outside the state of Missouri Health and Senior Services of the effective (D) Conducting research and instructional date of this action and promptly return that renders assistance to a pre-hospital emer- activities with controlled substances listed in gency medical service located in the state of his/her registration certificate to the Depart- Schedule I; ment of Health and Senior Services. Missouri under a mutual aid contract in the (E) Conducting research with controlled case of an emergency, major catastrophe, or (3) Transfer of Registration. No registration substances listed in Schedules II–V; other unforeseen event that jeopardizes the or any authority conferred by registration (F) Conducting a narcotic treatment pro- ability of the local Missouri pre-hospital shall be assigned or otherwise transferred. gram with narcotic controlled substances list- emergency medical service to promptly ed in Schedules II–V; respond. AUTHORITY: section 195.195, RSMo Supp. (G) Conducting instructional activities (B) A separate registration is not required 2018.* Original rule filed April 14, 2000, with controlled substances listed in Schedules for each separate practice location for an effective Nov. 30, 2000. Amended: Filed Jan. II–V; individual practitioner who has a temporary 31, 2003, effective July 30, 2003. Amended: (H) Importing controlled substances; location registration. Filed April 29, 2011, effective Nov. 30, 2011. (I) Exporting controlled substances; Emergency amendment filed Sept. 17, 2018, (J) Conducting chemical analysis with con- AUTHORITY: section 195.195, RSMo 2016.* effective Sept. 27, 2018, expired March 25, trolled substances listed in any schedule. Original rule filed April 14, 2000, effective

20 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Nov. 30, 2000. Amended: Filed Oct. 30, forth in 19 CSR 30-1.032–19 CSR 30-1.034 with the Department of Health and Senior 2020, effective April 30, 2021. as standards for the physical security controls Services to determine that the person is reg- and operating procedures necessary to pre- istered to possess the controlled substance. *Original authority: 195.195, RSMo 1957, amended vent diversion. Substantial compliance with 1971, 1989, 1993, 2014. these standards may be deemed sufficient by (2) The registrant shall design and operate a the Department of Health after evaluation of system to disclose to the registrant suspicious 19 CSR 30-1.027 Investigative and Admin- the overall security system and needs of the orders of controlled substances. The regis- istrative Procedures applicant or registrant. trant shall inform the Department of Health and Senior Services of suspicious orders PURPOSE: This rule establishes procedures (2) Physical security controls shall be com- when discovered by the registrant. Suspicious for the handling and disposition of informa- mensurate with the schedules and quantity of orders include orders of unusual size, orders tion indicating violations of Chapter 195, controlled substances in the possession of the deviating substantially from a normal pattern RSMo by the Department of Health, pursuant registrant in normal business operations. If a and orders of unusual frequency. to the mandates of section 195.040. controlled substance is transferred to a dif- ferent schedule, or a noncontrolled substance (3) The registrant shall notify the Department (1) The Department of Health may allow offi- is listed on any schedule, or the quantity of of Health and Senior Services of any theft or cers of state and federal administrative agen- controlled substances in the possession of the significant loss of any controlled substances cies to attend and participate in informal con- registrant in normal business operations sig- upon discovery of this theft or loss. ferences conducted with Missouri controlled nificantly increases, physical security con- (A) The registrant shall complete and sub- substances registrants, Missouri regulated trols shall be expanded and extended accord- mit a Report of Loss, Theft or Diversion of chemical registrants or applicants in order to ingly. Controlled Substances or Regulated Chemi- assist the Department of Health in its delib- cals to the Department of Health and Senior erations. (3) All registrants who receive or transfer Services no later than seven (7) business days substantial quantities of controlled substances after the discovery of such a loss. If the extent AUTHORITY: section 195.195, RSMo 1994.* in normal business operations shall employ of the loss cannot be fully determined in that Original rule filed April 14, 2000, effective security procedures to guard against in-tran- time frame, the registrant shall contact the Nov. 30, 2000. sit losses. Department of Health and Senior Services to request permission to submit an interim *Original authority: 195.195, RSMo 1957, amended AUTHORITY: section 195.195, RSMo 1994.* 1971, 1989, 1993. report and arrange for a complete report to be Original rule filed April 14, 2000, effective completed and submitted. The registrant may Nov. 30, 2000. attach a copy of a completed Drug Enforce- 19 CSR 30-1.030 Requirements for Con- ment Administration Loss Form in lieu of trolled Substances Registration *Original authority: 195.195, RSMo 1957, amended completing the back or second page of a (Rescinded November 30, 2000) 1971, 1989, 1993. Report of Loss, Theft or Diversion of Con- trolled Substances or Regulated Chemicals AUTHORITY: section 195.195, RSMo 1994. form. In the event of theft, diversion or sus- This rule was previously filed as 13 CSR 50- 19 CSR 30-1.032 Security for Nonpracti- tioners pected theft or diversion, the report submit- 131.010. Original rule filed Jan. 31, 1972, ted to the Department of Health and Senior effective April 1, 1972. Amended: Filed April PURPOSE: This rule describes specific Services shall be accompanied by or followed 12, 1983, effective July 11, 1983. Amended: actions required of nonpractitioner regis- by a summary of the internal investigation Filed May 31, 1989, effective Oct. 1, 1989. trants to maintain effective security. performed, the outcome of the investigation, Amended: Filed Nov. 26, 1991, effective April and a copy of any law enforcement agency 9, 1992. Amended: Filed Aug. 26, 1992, PUBLISHER’S NOTE: The secretary of state report completed if applicable. effective April 8, 1993. Amended: Filed Nov. has determined that the publication of the (B) If an insignificant amount of a con- 1, 1994, effective June 30, 1995. Rescinded: entire text of the material which is incorpo- trolled substance is lost during lawful activi- Filed April 14, 2000, effective Nov. 30, 2000. rated by reference as a portion of this rule ties authorized under Chapter 195, RSMo, would be unduly cumbersome or expensive. the reason for the loss or a description of 19 CSR 30-1.031 Physical Security Re- This material as incorporated by reference in what occurred, the name of the drug and the quirements this rule shall be maintained by the agency at amount lost shall be documented in writing, its headquarters and shall be made available signed by the registrant and attached or filed PURPOSE: This rule requires applicants and to the public for inspection and copying at no with the last completed annual inventory. registrants to maintain security controls and more than the actual cost of reproduction. procedures to prevent theft and diversion of This note applies only to the reference mate- (4) The registrant shall not distribute any controlled substances. rial. The entire text of the rule is printed controlled substance as a complimentary here. sample to any potential or current customer (1) All applicants and registrants shall pro- without the prior written request of the cus- vide effective controls and procedures to (1) Before distributing a controlled substance tomer, to be used only for satisfying the legit- guard against theft and diversion of con- to any person who the registrant does not imate medical needs of patients of the cus- trolled substances. In order to determine know to be registered to possess the con- tomer and only in reasonable quantities. The whether a registrant has provided effective trolled substance, the registrant shall make a request must contain the name, address and controls against diversion, the Department of good faith inquiry either with the federal registration number of the customer and the Health shall use the security requirement set Drug Enforcement Administration (DEA) or name of the specific controlled substance

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 21 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

desired. The request shall be preserved by the (A) Controlled substances listed in Sched- seven (7) business days after the discovery of registrant with other records of distribution of ules I and II shall be stored in a securely such a loss. The loss report form shall con- controlled substances. In addition, the locked, substantially constructed cabinet. tain the following information: name and requirements for order forms shall be com- (B) Controlled substances listed in Sched- address of registrant, business phone num- plied with for any distribution of a controlled ules III, IV and V shall be stored in a secure- ber; Missouri Controlled Substance Registra- substance listed in Schedule I or II. ly locked, substantially constructed cabinet. tion Number; federal Drug Enforcement However, pharmacies may disperse these sub- Administration Registration number; date of (5) Entities registered with the Department of stances throughout the stock of noncontrolled theft or loss; date of discovery of theft or Health and Senior Services as distributors substances in such a manner as to obstruct loss; county of location; principal type of shall be deemed to have met security require- the theft or diversion of the controlled sub- registration such as M.D., D.O., D.P.M., ments for storage of Schedule V controlled stances. O.D., D.V.M., D.D.S., D.M.D., A.N.P., substance drug products containing ephedrine (C) This rule also shall apply to nonpracti- emergency medical service, pharmacy, hospi- or pseudoephedrine if those products are tioners authorized to conduct research or tal, manufacturer, nursing home kit, narcotic stored in compliance and consistent with the chemical analysis under another registration. treatment program, teaching institution, dis- regulated chemicals requirements set forth by tributor, importer, exporter, or other speci- the United States Drug Enforcement Admin- (2) Other Security. fied business; whether or not the loss or theft istration and 21 CFR 1309.71 which is here- (A) The registrant shall not employ as an was reported to law enforcement; the name by incorporated by reference in this rule, as agent or employee who has access to con- and phone number of the law enforcement published on April 1, 2005 by the U.S. Gov- trolled substances any person who has been agency reported to; the number of losses or ernment Printing Office, U.S. Superinten- found guilty or entered a plea of guilty or thefts the registrant has experienced in the dent of Documents, Washington, DC 20402- nolo contendere in a criminal prosecution past twenty-four (24) months; the type of loss 001; www.gpoaccess.gov/cfr/retrieve.html. under the laws of any state or of the United or diversion such as, break in/burglary, rob- This rule does not incorporate any subse- States for any offense related to controlled bery, employee theft, forged or falsified quent amendments or additions. Distributors substances or who has had an application for records, lost in transit, or other explained will be required to conduct background a state or federal controlled substance regis- type of loss; if lost in transit, the name of the checks on employees with access to these tration denied or has had his/her registration common carrier and name of consignee; the substances and to report losses of controlled revoked or surrendered for cause at any time. name(s) of the individual diverting controlled substances as required in 19 CSR 30-1.034. For purposes of this subsection, the term for substances who was responsible for the theft cause means a surrender in place of or as a or loss; copy of registrant’s internal inves- AUTHORITY: sections 195.017, RSMo Supp. consequence of any federal or state adminis- tigative report involving the loss or theft; the 2005 and 195.195, RSMo 2000.* Original trative, civil or criminal action resulting from full name, date of birth and Social Security rule filed April 14, 2000, effective Nov. 30, an investigation of the individual’s handling 2000. Emergency amendment filed Aug. 18, of controlled substances. number of the individual(s) responsible for 2005, effective Aug. 28, 2005, expired Feb. 1. A registrant may apply in writing to the theft or diversion, if known; a copy of the 23, 2006. Amended: Filed Sept. 1, 2005, the Department of Health and Senior Ser- police report if law enforcement was notified; effective Feb. 28, 2006. vices for a waiver of subsection (2)(A) of this if the loss or diversion was in transit, identi- rule for a specific employee. fy the origin of the delivery, the name of the *Original authority: 195.017, RSMo 1971, amended 1987, carrier(s) used and the name of the con- 1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195, 2. The Department of Health and Senior RSMo 1957, amended 1971, 1989, 1993. Services may issue a written waiver to any signee; a list of all controlled substances lost, registrant upon determination that a waiver stolen or diverted by their generic name, would be consistent with the public health trade name, the dosage strength, dosage form 19 CSR 30-1.033 Hearing Procedures on and safety. In making this determination, the and quantity; the signature of the person Controlled Substances Registration Department of Health and Senior Services completing the loss report and their title and (Rescinded November 30, 2000) shall consider—the duties of the employee, the date of their signature. If the extent of the the circumstances surrounding the convic- loss cannot be fully determined in that time AUTHORITY: sections 195.040.11 and tion, the length of time since the conviction frame, the registrant shall contact the Depart- 195.195, RSMo Supp. 1989. Original rule was entered, whether a waiver has been ment of Health and Senior Services to request filed Aug. 26, 1992, effective April 8, 1993. granted by the federal Drug Enforcement permission to submit an interim report and Rescinded: Filed April 14, 2000, effective Administration (DEA) pursuant to 21 CFR arrange for a complete report to be complet- Nov. 30, 2000. 1301.76, the security measures taken by the ed and submitted. The registrant may attach a copy of a completed Drug Enforcement employer to prevent the theft and diversion of Administration Loss Form in lieu of complet- 19 CSR 30-1.034 Security for Practitioners controlled substances, and any other factors consistent with public health and safety. ing the back or second page of a loss report PURPOSE: This rule describes specific (B) A registrant shall notify the Depart- form provided by the Department of Health actions required of practitioner registrants to ment of Health and Senior Services of the and Senior Services. In the event of theft, maintain effective security. This rule also cre- theft, diversion or significant loss of any con- diversion or suspected theft or diversion, the ates and defines the form which must be used trolled substances or regulated chemicals report submitted to the Department of Health by a registrant to report any theft or loss of upon discovery. and Senior Services shall be accompanied by controlled substances to the Department of 1. The registrant shall complete and or followed by a summary of the internal Health. submit a report of the loss or diversion of investigation performed, the outcome of the controlled substances to the Department of investigation, and a copy of any law enforce- (1) Physical Security. Health and Senior Services no later than ment agency report completed if applicable.

22 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

2. If an insignificant amount of a con- exempted by 19 CSR 30-1.041–19 CSR 30- by the employees without a warrant of any trolled substance is lost during lawful activi- 1.052. kind; ties authorized under Chapter 195, RSMo, (B) Registered individual practitioners and (C) The failure of the registrant to perform the reason for the loss or a description of institutional practitioners are required to keep his/her agreements under the permit shall what occurred, the name of the drug and the records with respect to controlled substances revoke, without further action, the permit and amount lost shall be documented in writing, which are prescribed, administered or dis- all other such permits held by the registrant signed by the registrant and attached or filed pensed. under other registrations. In the event of a with the last completed annual inventory. (C) A registered person using any con- revocation of other permits under subsection trolled substance in research conducted in (2)(C) of this rule, the registrant, within 30 AUTHORITY: section 195.195, RSMo 2000.* conformity with an exemption granted under days after the revocation, shall comply with Original rule filed April 14, 2000, effective section 505(i) or 512(j) of the federal Food, the requirement that all records be kept at the Nov. 30, 2000. Amended: Filed Jan. 31, Drug and Cosmetic Act (21 U.S.C. 355(i) or registered location. 2003, effective July 30, 2003. 360(j)) at a registered establishment which maintains records in accordance with either (3) Each registered individual practitioner, *Original authority: 195.195, RSMo 1957, amended of those sections is not required to keep institutional practitioner, manufacturer, dis- 1971, 1989, 1993. records if s/he notifies the Department of tributor, importer and exporter shall maintain Health of the name, address and registration inventories and records of controlled sub- stances as follows: 19 CSR 30-1.035 Requirements for Pre- number of the establishment maintaining (A) Inventories and records of controlled scribing, Dispensing and Administering these records. (D) A registered person using any con- substances listed in Schedules I and II shall Controlled Substances trolled substance in preclinical research or in be maintained separately from all of the (Rescinded November 30, 2000) teaching at a registered establishment which records of the registrant; maintains records with respect to these sub- (B) Inventories and records of controlled AUTHORITY: sections 195.040.3(2), stances is not required to keep records if s/he substances listed in Schedules III, IV and V 195.050.6 and 195.195, RSMo 1994. Origi- notifies the Department of Health of the shall be maintained either separately from all nal rule filed Nov. 14, 1988, effective Feb. name, address and registration number of the other records of the registrant or in a form 24, 1989. Amended: Filed Aug. 26, 1992, establishment maintaining the records. that the information required is readily effective April 8, 1993. Amended: Filed Nov. (E) Notice required by subsection (1)(D) of retrievable from the ordinary business 1, 1994, effective June 30, 1995. Rescinded: this rule shall be given at the time the person records of the registrant. Filed April 14, 2000, effective Nov. 30, 2000. applies for registration or re-registration and shall be made in the form of an attachment to (4) Each registered pharmacy shall maintain the application, which shall be filed with the the inventories and records of controlled sub- 19 CSR 30-1.036 Disposing of Unwanted application. stances as follows: Controlled Substances (A) Inventories and records of all con- (Rescinded November 30, 2000) (2) Maintenance of Records and Inventories. trolled substances listed in Schedules I and II Every inventory and other record required to shall be maintained separately from all other AUTHORITY: section 195.050.6, RSMo be kept under 19 CSR 30-1.041–19 CSR 30- records of the pharmacy and prescriptions for 1986. Original rule filed Jan. 18, 1989, 1.052, shall be kept by the registrant and be these substances shall be maintained in a sep- effective April 27, 1989. Rescinded: Filed available, for at least two years from the date arate prescription file; April 14, 2000, effective Nov. 30, 2000. of the inventory or record, for inspecting and (B) Inventories and records of controlled copying by authorized employees of the substances listed in Schedules III, IV and V Department of Health, except that financial shall be maintained either separately from all 19 CSR 30-1.040 Dispensing and Distribu- and shipping records (such as invoices and other records of the pharmacy or in a form tion of Controlled Substances in Certain packing slips, but not executed order forms) that the information required is readily Situations may be kept at a central location rather than retrievable from ordinary business records of (Rescinded July 30, 2003) at the registered location if the registrant the pharmacy and prescriptions for those sub- obtains from the Department of Health stances shall be maintained in a separate pre- AUTHORITY: section 195.195, RSMo 1986. approval of his/her central record keeping scription file. This rule was previously filed as 13 CSR 50- system and a permit to keep central records. 132.010. Original rule filed Jan. 31, 1972, The permit to keep central records shall be AUTHORITY: sections 195.050 and 195.195, RSMo 1994 and 195.030, RSMo Supp. effective April 1, 1972. Rescinded: Filed Jan. subject to the following conditions: 1999.* Original rule filed April 14, 2000, 31, 2003, effective July 30, 2003. (A) The permit shall specify the nature of the records to be kept centrally and the exact effective Nov. 30, 2000. location where the records will be kept; (B) The registrant agrees to deliver all or *Original authority: 195.030, RSMo 1939, amended 1971, 19 CSR 30-1.041 Records Requirements 1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended any part of these records to the registered 1971, 1989; and 195.195, RSMo 1957, amended 1971, PURPOSE: This rule defines the record keep- location within three working days of receipt 1989, 1993. ing and inventory requirements for various of a written request from the Department of classes of registrants. Health for these records and if the Depart- ment of Health chooses to do so in lieu of 19 CSR 30-1.042 Inventory Requirements (1) Persons Required to Keep Records. requiring delivery of records to the registered (A) Each registrant shall maintain the location, to allow authorized employees of PURPOSE: This rule defines requirements records and inventory required by 19 CSR the Department of Health to inspect the for the form and maintenance of controlled 30-1.041–19 CSR 30-1.052, except as records at the central location upon request substance inventories.

JOHN R. ASHCROFT (5/31/20) CODE OF STATE REGULATIONS 23 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

(1) General Requirements. (4) Inventory Date for Newly Controlled est metric unit weight or the total number of (A) Each inventory shall contain a com- Substances. On the effective date of a rule by units of finished form; the reason for the sub- plete and accurate record of all controlled the Department of Health adding a substance stance being maintained by the registrant and substances on hand on the date the inventory to any schedule of controlled substances, whether the substance is capable of use in the was taken. Controlled substances shall be which substance was not listed immediately manufacture of any controlled substance in deemed to be on hand if they are in the pos- prior to that date in any such schedule, every finished form. session of or under the control of the regis- registrant required to keep records who is trant, including substances returned by a cus- manufacturing, distributing or dispensing that (6) Inventories of Distributors. Each regis- tomer, substances ordered by a customer but substance shall take inventory of all stocks of tered distributor shall include in his/her not yet invoiced, substances stored in a ware- the substance on hand. After that, this sub- inventory the same information required of house on behalf of the registrant and sub- stance shall be included in each inventory manufacturers in subsections (5)(C) and (D) stances in the possession of employees of the made by the registrant. of this rule. registrant and intended for distribution as (7) Inventories of Dispensers and complimentary samples. (5) Inventories of Manufacturers. Each regis- Researchers. Each person registered to dis- (B) A separate inventory shall be made by tered manufacturer shall include the follow- pense or conduct research with controlled a registrant for each registered location. In ing information in his/her inventory: (A) For each controlled substance in bulk substances and required to keep records shall the event controlled substances are in the pos- form to be used in (or capable of use in) the include in his/her inventory the same infor- session or under the control of the registrant manufacture of the same or other controlled mation required of manufacturers in subsec- at a location for which s/he is not registered, or noncontrolled substances in finished form, tions (5)(C) and (D) of this rule. In deter- the substances shall be included in the inven- the name of the substance and the total quan- mining the number of units of each finished tory of the registered location to which they tity of the substance to the nearest metric unit form of a controlled substance in a commer- are subject to control or to which the person weight consistent with unit size (except that cial container which has been opened, the possessing the substance is responsible. Each for inventories made in 1971, avoirdupois dispenser shall do as follows: inventory for a registered location shall be weights may be utilized where metric weights (A) If the substance is listed in Schedule I kept at the registered location. are not readily available); or II, s/he shall make an exact count or mea- (C) A separate inventory shall be made by (B) For each controlled substance in the sure of the contents; a registrant for each independent activity for process of manufacture on the inventory date (B) If the substance is listed in Schedule which s/he is registered. the name of the substance, the quantity of the III, IV or V, s/he shall make an estimated (D) A registrant may take an inventory substance in each batch, stage of manufac- count or measure of the contents, unless the either as of the opening of business or as of ture, or both, identified by the batch number container holds more than 1,000 tablets or the close of business on the inventory date. or other appropriate identifying number and capsules in which case s/he must make an The registrant shall indicate on the inventory the physical form which the substance is to exact count of the contents. records whether the inventory is taken as of take upon completion of the manufacturing the opening or as of the close of business and process (for example, granulations, tablets, (8) Inventories of Importers and Exporters. the date the inventory is taken. capsules or solutions), identified by the batch Each registered importer or exporter shall (E) An inventory must be maintained in a number or other appropriate identifying num- include in his/her inventory the same infor- permanent written, typewritten or printed ber and if possible the finished form of the mation required of manufacturers in subsec- form. An inventory taken by use of an oral substance (for example, ten milligram (10 tions (5)(A), (C) and (D) of this rule. Each recording device must be transcribed prompt- mg) tablet or ten milligram (10 mg) concen- registered importer and exporter who also is ly. tration per fluid ounce or milliliter) and the registered as a manufacturer or as a distribu- number or volume; tor shall include in his/her inventory as an (2) Initial Inventory Date. (C) For each controlled substance in fin- importer or exporter only those stocks of (A) Every person required to keep records ished form, the name of the substance; each controlled substances that actually are sepa- who is registered with the Department of finished form of the substance (for example, rated from his/her stocks as a manufacturer Health after May 1, 1971 and who was not ten milligram (10 mg) tablet or ten milligram or as a distributor (for example, in-transit or registered previously shall take an inventory (10 mg) concentration per fluid ounce or in storage for shipment). of all stocks of controlled substances on hand milliliter); the number of units or volume of (9) Inventories for Chemical Analysts. Each on the date s/he first engages in the manufac- each finished form in each commercial con- analytical laboratory registered to conduct ture, distribution or dispensing of controlled tainer (for example, four 100 tablet bottles or chemical analysis with controlled substances substances. three milliliter (3 ml) vials); the number of shall include in its inventory the same infor- (B) Compliance with federal initial inven- commercial containers of each finished form mation required of manufacturers in subsec- tory date requirements is deemed satisfactory. (for example, four 100 tablet bottles or six tions (5)(A), (C) and (D) of this rule as to Duplicate inventories are not required. three milliliter (3 ml) vials); substances which have been manufactured, (D) For each controlled substance not imported or received by the laboratory con- (3) Annual Inventory Date. After the initial included in subsections (5)(A)–(C) of this ducting the inventory. If less than one kilo- inventory is taken, the registrant shall take a rule (for example, damaged, defective or gram (1 kg) of any controlled substance new inventory of all stocks of controlled sub- impure substances awaiting disposal, sub- (other than a hallucinogenic controlled sub- stances on hand at least once a year. The stances held for quality control purposes or stance listed in Schedule I) or less than twen- annual inventory may be taken on any date substances maintained for extemporaneous ty grams (20 g) of a hallucinogenic substance that is within one year of the previous annu- compoundings), the name of the substance; listed in Schedule I (other than lysergic acid al inventory date. the total quantity of the substance to the near- diethylamide) or less than point five gram

24 CODE OF STATE REGULATIONS (5/31/20) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(0.5 g) of lysergic acid diethylamide, is on 2000, effective Nov. 30, 2000. tity of each distribution and the name, hand at the time of inventory, those sub- address and registration number of each per- stances need not be included in the inventory. *Original authority: 195.050, RSMo 1939, amended 1971, son to whom a distribution was made; Laboratories of the division may process up 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993. 8. The quantity exported directly by the to one hundred fifty grams (150 g) of any hal- registrant, including the date, quantity and lucinogenic substance in Schedule I without export permit or declaration number of each regard to a need for an inventory of those 19 CSR 30-1.046 Records for Manufac- exportation; substances. turers, Distributors, Importers and 9. The quantity distributed or disposed Exporters of in any other manner by the registrant (for AUTHORITY: sections 195.030, RSMo Supp. example, distribution of complimentary sam- 1999 and 195.195, RSMo 1994.* Original PURPOSE: This rule sets requirements for ples or by destruction) including the date and rule filed April 14, 2000, effective Nov. 30, record keeping by manufacturers, distribu- manner of distribution or disposal, the name, 2000. ** tors, importers and exporters of controlled address and registration number of the person *Original authority: 195.030, RSMo 1939, amended 1971, substances. to whom distributed and the quantity dis- 1989, 1993, 1995, 1997, 1999 and 195.195, RSMo 1957, tributed or disposed; amended 1971, 1989, 1993. (1) Records for Manufacturers. Each regis- (B) For each controlled substance in fin- **Pursuant to Executive Order 21-07, 19 CSR 30-1.042, section (3) tered manufacturer shall maintain records ished form— was suspended from March 31, 2020 through May 1, 2021. with the following information: 1. The name of the substance; (A) For each controlled substance in bulk 2. Each finished form (for example, ten

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

JOHN R. ASHCROFT (7/31/21) CODE OF STATE REGULATIONS 25 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

8. The number of commercial contain- (B) The quantity (or number of units or ed by reference as a portion of this rule would ers exported directly by the registrant, includ- volume in finished form) imported, including be unduly cumbersome or expensive. This ing the date, number of containers and export the date, quantity (or number of units or vol- material as incorporated by reference in this permit or declaration number for each expor- ume) and import permit or declaration num- rule shall be maintained by the agency at its tation; ber for each importation; headquarters and shall be made available to 9. The number of units of finished forms, (C) The quantity (or number of units or the public for inspection and copying at no commercial containers, or both, distributed or volume in finished form) distributed to other more than the actual cost of reproduction. disposed of in any other manner by the regis- persons, including the date, quantity (or num- This note applies only to the reference materi- ber of units or volume) of each distribution trant (for example, by distribution of compli- al. The entire text of the rule is printed here. and the name, address and registration num- mentary samples or by destruction), including ber of each person to whom a distribution (1) Each individual practitioner, institutional the date and manner of distribution or dispos- was made; practitioner, and pharmacy shall maintain al, the name, address and registration number (D) The quantity disposed of in any other records with the following information for of the person to whom distributed and the manner by the registrant except quantities each controlled substance received, main- quantity in finished form distributed or dis- used in manufacturing by an importer under tained, dispensed, or disposed: posed. a registration as a manufacture, which quan- (A) The name of the substance; tities are to be recorded, including the date (B) Each finished form (for example, ten (2) Records for Distributors. Each registered and manner of disposal and the quantity dis- milligram (10 mg) tablet or ten milligram (10 distributor shall maintain records with the posed. mg) concentration per fluid ounce or following information for each controlled milliliter) and the number of units or volume substance: (4) Records for Exporters. Each registered of finished form in each commercial contain- (A) The name of the substance; exporter shall maintain records with the fol- er (for example, one hundred (100) tablet bot- (B) Each finished form (for example, ten lowing information for each controlled sub- tle or three milliliter (3 ml) vial); milligram (10 mg) tablet or ten milligram (10 stance: (C) The number of commercial containers mg) concentration per fluid ounce or (A) The name of the substance; of each finished form received from other milliliter) and the number of units or volume (B) The quantity (or number of units or persons, including the date of and number of of finished form in each commercial contain- volume in finished form) received from other containers in each receipt and the name, er (for example, 100 tablet bottle or three persons, including the date and quantity (or address and registration number of the person milliliter (3 ml) vial); number of units or volume) of each receipt from whom the containers were received; (C) The number of commercial containers and the name, address and registration num- (D) The number of units or volume of the of each such finished form received from ber of each person from whom the substance finished form dispensed including the name other persons, including the date of and num- was received; and address of the person to whom it was dis- ber of containers in each receipt and the (C) The quantity (or number of units or pensed, the date of dispensing, the number of name, address and registration number of the volume in finished form) exported, including units or volume dispensed, and the written or person from whom the containers were the date, quantity (or number of units or vol- typewritten name or initials of the individual received; ume) and the export permit or declaration who dispensed or administered the substance; (D) The number of commercial containers number for each exportation, but excluding and of each finished form imported directly by all quantities (and numbers of units and vol- (E) The number of units or volume of the the registrant including the date of and the umes) manufactured by an exporter under a finished forms, commercial containers, or number of containers in each importation; registration as a manufacture, which quanti- both, disposed of in any other manner by the (E) The number of commercial containers ties (and numbers of units and volumes) are registrant, including the date and manner of of each finished form distributed to other per- to be recorded; disposal and the quantity of the substance in sons, including the date of and number of (D) The quantity disposed of in any other finished form disposed. containers in each distribution and the name, manner by the registrant including the date address and registration number of the person and manner of disposal and the quantity dis- (2) Each individual practitioner shall main- to whom the containers were distributed; posed. tain a record of the date, full name and (F) The number of commercial containers address of the patient, the drug name, of the finished form exported directly by the AUTHORITY: sections 195.050 and 195.195, strength, dosage form, and quantity for all registrant, including the date of and the num- RSMo 1994.* Original rule filed April 14, controlled substances prescribed or adminis- ber of containers in each exportation; 2000, effective Nov. 30, 2000. tered. This record may be maintained in the (G) The number of units or volume of fin- patient’s medical record. When the controlled ished forms, commercial containers, or both, *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, substance record is maintained in the distributed or disposed of in any other man- 1993. patient’s medical record and the practitioner ner by the registrant (for example, by distri- is not the custodian of the medical record, the bution as complimentary samples) including practitioner shall make the controlled sub- the date and manner of distribution or dis- 19 CSR 30-1.048 Records for Practitioners stance record available as required in 19 CSR posal, the name, address and registration and Researchers 30-1.041 and 19 CSR 30-1.044. number of the person to whom distributed and the quantity of the substance in finished PURPOSE: This rule sets requirements for (3) Individual practitioners shall maintain the form distributed or disposed. record keeping for practitioners and records listed in subsections (1)(A)–(E) of researchers. It also sets requirements for the this rule separately from patient medical (3) Records for Importers. Each registered use of facsimile and electronic prescriptions. records. importer shall maintain records with the fol- lowing information for each controlled sub- PUBLISHER’S NOTE: The secretary of state (4) A registrant who transfers a controlled stance: has determined that the publication of the substance to or receives a controlled sub- (A) The name of the substance; entire text of the material which is incorporat- stance from another registrant shall maintain

26 CODE OF STATE REGULATIONS (7/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

a written record of the transfer which con- Capitol Street NW, Washington, D.C. 20401, (3) Records of controlled substances used in tains the following information: the date of or at www.gpoaccess.gov/cfr/. This rule does chemical analysis or other laboratory work transfer, drug name, strength, dosage form, not incorporate any subsequent amendments are not required. quantity, name, address and registration num- or additions. ber of the transferring registrant, and the (4) Records relating to known or suspected name, address and registration number of the AUTHORITY: section 195.050, RSMo 2000, controlled substances received as samples for receiving registrant. and section 195.195, RSMo Supp. 2014.* analysis are not required under section (1) of Original rule filed April 14, 2000, effective this rule. (5) Drug Enforcement Administration official Nov. 30, 2000. Amended: Filed Jan. 29, order forms shall be used for transfers of 2015, effective July 30, 2015. AUTHORITY: sections 195.050 and 195.195, Schedule II controlled substances. *Original authority: 195.050, RSMo 1939, amended 1971, RSMo 1994.* Original rule filed April 14, (6) A prescription may not be issued for an 1989 and 195.195, RSMo 1957, amended 1971, 1989, 2000, effective Nov. 30, 2000. individual practitioner to obtain controlled 1993. *Original authority: 195.050, RSMo 1939, amended 1971, substances for dispensing or administering to patients. 1989 and 195.195, RSMo 1957, amended 1971, 1989, 19 CSR 30-1.050 Records for Chemical 1993. Analysts (7) Prescriptions which are transmitted by facsimile to a pharmacy for dispensing shall PURPOSE: This rule sets requirements for 19 CSR 30-1.052 Records for Long-Term include the telephone number of the facsimi- Care Facilities (LTCF) le machine or computer from which it is sent record keeping for chemical analyst regis- trants. and the date and time of transmission. Imme- PURPOSE: This rule sets requirements for diately after a Schedule III, IV or V pre- record keeping by long-term care facility reg- scription or a Schedule II prescription for a (1) Each person registered to conduct chemi- istrants. long-term care facility patient or hospice cal analysis with controlled substances shall patient or for a Schedule II narcotic substance maintain records with the following informa- to be compounded for the direct administra- tion (to the extent known and reasonably (1) Long-term care facilities (LTCFs) and tion to a patient by parenteral, intravenous, ascertainable by him/her) for each controlled their suppliers shall maintain written records intramuscular, subcutaneous, or intraspinal substance: of transfers of controlled substances from the supplier to the LTCF emergency kit. infusion is transmitted to a pharmacy by fac- (A) The name of the substance; simile equipment, the practitioner or the (B) The form(s) in which the substance is (2) The records shall include the date of practitioner’s agent shall sign and date the received, imported or manufactured by the transfer; the name of each controlled sub- face of the prescription. The prescriptions registrant (for example, powder, granulation, shall be maintained in chronological order stance, the strength, dosage form and quanti- tablet, capsule or solution) and the concen- separately from patient medical records in a ty; the name, address and controlled sub- tration of the substance in that form (for manner so each prescription is readily stance registration number of the supplier and retrievable for inspection at the transmitting example, Chemically Pure (CP), United the name, address and controlled substance practitioner’s office. In the event the facsimi- States Pharmacopeia (USP), National Formu- registration number of the LTCF. Federal le is transmitted from a long-term care facil- lary (NF), ten milligram (10 mg) tablet or ten Drug Enforcement Administration (DEA) ity or hospital, the prescription shall be main- milligram (10 mg) concentration per official order forms shall not be used to tained at the long-term care facility or milliliter); record transfers of controlled substances to hospital in chronological order separately (C) The total number of the forms LTCF emergency kits. from the patient medical records in a manner received, imported or manufactured (for so each prescription is readily retrievable, or example 100 tablets, 30 one milliliter (1 ml) (3) No physician’s order or prescription shall maintained in the patient medical records. vials or ten grams (10 g) powder), including be used for initial stocking or replacement of the date and quantity of each receipt, impor- (8) Any pharmacy receiving a controlled sub- controlled substances in the emergency kit. stance prescription transmitted by facsimile tation or manufacture and the name, address Controlled substances contained in the kit equipment shall maintain the facsimile copy and registration number, if any, of the person shall be obtained from a pharmacy, hospital of the prescription along with the date and from whom the substance was received; and or practitioner who holds a controlled sub- time of transmission and the telephone num- (D) The quantity distributed, exported or stances registration. ber of the facsimile machine from which it destroyed in any manner by the registrant originated, as a part of its original prescrip- (except quantities used in chemical analysis (4) The administration and medical staff of tion records. or other laboratory work), including the date the LTCF, in conjunction with the primary and manner of distribution, exportation or supplier, shall designate in written protocols (9) The creation, signature, transmission, and destruction and the name, address and regis- and procedures who may have access to the processing of controlled substance prescrip- tration number, if any, of each person to emergency kit, who may administer con- tions electronically and record keeping for whom the substance was distributed or electronic controlled substance prescriptions trolled substances from the emergency kit and shall meet the requirements of 21 CFR Parts exported. under what circumstances and a list of the 1300 to end, which are hereby incorporated controlled substances it intends to maintain in by reference in this rule as published April 1, (2) Order forms, import and export permits, the emergency kit. These protocols and pro- 2014, by the Office of Federal Register, import invoices and export declarations relat- cedures shall be subject to review and National Archives and Records Administra- ing to controlled substances shall be main- approval by the Department of Health. Only tion, and are made available to the public by tained separately from all other records of the those individuals designated in the LTCF’s the U.S. Government Printing Office, 732 N. registrant. written policies and procedures shall have

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 27 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

access to or administer controlled substances PURPOSE: This rule sets requirements gov- made by an individual practitioner whether from the emergency kit. erning the transmission of prescription infor- communicated by the practitioner or his/her mation. authorized agent by the authorizing practition- (5) Each administration of controlled sub- er or the practitioner’s agent to the pharmacy. stances from the emergency kit shall be based PUBLISHER’S NOTE: The secretary of state All oral prescriptions shall be promptly has determined that the publication of the upon a practitioner’s order and shall be reduced to writing by the pharmacist contain- entire text of the material which is incorporat- recorded in an administration record separate ing all information required in section ed by reference as a portion of this rule would 195.060, RSMo, except for the signature of from the patient’s medical record. This be unduly cumbersome or expensive. This the practitioner. administration record shall include: the date, material as incorporated by reference in this patient’s name, drug name, drug strength, rule shall be maintained by the agency at its (3) Written Prescriptions. All written con- dosage, ordering practitioner’s name and headquarters and shall be made available to trolled substance prescriptions shall be signed name of the person administering the con- the public for inspection and copying at no by the prescribing practitioner on the date trolled substance. more than the actual cost of reproduction. prescribed. No controlled substance prescrip- This note applies only to the reference materi- tion shall be signed prior to the actual date it AUTHORITY: sections 195.050 and 195.195, al. The entire text of the rule is printed here. is issued. RSMo 1994.* Original rule filed April 14, (1) Prescriptions in Schedule II. A pharma- (4) Prescriptions Transmitted by Electronic 2000, effective Nov. 30, 2000. cist may dispense a controlled substance in Computer Transmission. A pharmacist may Schedule II only under a written prescription dispense a controlled substance in Schedule II, *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, signed by the practitioner, except as provided III, IV, or V under a prescription transmitted 1993. in section 195.060.3, RSMo. A prescription from the prescribing practitioner to a pharma- for a Schedule II controlled substance may be cy by electronic computer transmission pro- transmitted from the prescribing practitioner vided that the prescription and its transmission 19 CSR 30-1.060 Determining Lawful Pre- to a pharmacy by facsimile equipment, pro- complies with federal law regarding electronic scribing, Dispensing and Administering of vided the original written, signed prescrip- prescriptions as found in the Code of Federal Controlled Substances tion is presented to the pharmacist for review Regulations, Title 21 Part 1300 to end. The prior to the actual dispensing of the con- federal rules regarding electronic prescrip- PURPOSE: This rule defines the statutory trolled substance, except that— tions are hereby incorporated by reference in and regulatory basis for determining what is (A) A prescription written for a Schedule this rule as published April 1, 2014, by the II narcotic substance to be compounded for lawful prescribing, dispensing and adminis- Office of Federal Register, National Archives the direct administration to a patient by par- tering of controlled substances. and Records Administration, and are made enteral, intravenous, intramuscular, subcuta- available to the public by the U.S. Govern- neous, or intraspinal infusion may be trans- When determining if controlled substances ment Printing Office, 732 N. Capitol Street mitted by the practitioner or the practitioner’s NW, Washington, D.C. 20401, or at are being lawfully prescribed, dispensed and agent to the pharmacy by facsimile. The fac- www.gpoaccess.gov/cfr/. This rule does not administered by practitioners, the Depart- simile which has been reduced to writing incorporate any subsequent amendments or ment of Health shall enforce Chapter 195, shall serve as, and shall be maintained in the additions. RSMo, the Department of Health rules in 19 same manner, as an original written prescrip- CSR 30 pertaining to controlled substances, tion. AUTHORITY: section 195.195, RSMo Supp. and the federal Controlled Substances Act 21 (B) A prescription written for a Schedule II 2014.* Original rule filed April 14, 2000, U.S.C. 801–966, and its regulations, 21 CFR substance for a resident of a long-term care effective Nov. 30, 2000. Amended: Filed Jan. 1300–1399. In determining lawful prescrib- facility may be transmitted by the practition- 29, 2015, effective July 30, 2015. ing, dispensing and administering of con- er or the practitioner’s agent to the pharmacy trolled substances, the Department of Health by facsimile. The facsimile which has been *Original authority: 195.195, RSMo 1957, amended reduced to writing shall serve as, and shall be 1971, 1989, 1993. also shall consider the provisions of Chapters maintained in the same manner, as an origi- 330, 332, 334, 335, 336, 338 and 340, nal written prescription. RSMo, the rules in 4 CSR 110, 4 CSR 150, (C) A prescription written for a Schedule 19 CSR 30-1.064 Partial Filling of Con- 4 CSR 200, 4 CSR 210, 4 CSR 220, 4 CSR II substance for a patient of a hospice may be trolled Substance Prescriptions 230 and 4 CSR 270, and protocols relating to transmitted by the practitioner or the practi- the respective practitioners established and on tioner’s agent to the pharmacy by facsimile. PURPOSE: This rule sets requirements for file at the respective licensing boards. The practitioner or the practitioner’s agent the partial filling of Schedule II prescriptions. shall note on the prescription that the patient (1) The partial filling of a prescription for a AUTHORITY: sections 195.030, RSMo Supp. is a hospice patient. The facsimile which has controlled substance listed in Schedule II is 1999 and 195.195, RSMo 1994.* Original been reduced to writing shall serve as, and permissible, if the pharmacist is unable to sup- rule filed April 14, 2000, effective Nov 30, shall be maintained in the same manner, as an original written prescription. ply the full quantity called for in a written or 2000. emergency oral prescription, and s/he makes a *Original authority: 195.030, RSMo 1939, amended 1971, (2) Prescriptions in Schedule III, IV, or V. A notation of the quantity supplied on the face of 1989, 1993, 1995, 1999 and 195.195, RSMo 1957, pharmacist may dispense directly a controlled the written prescription (or written record of amended 1971, 1989, 1993. substance in Schedule III, IV, or V only under the emergency oral prescription), or in the a written prescription signed by a practitioner electronic record. The remaining portion of or a facsimile of a written, signed prescription the prescription may be filled within seventy- 19 CSR 30-1.062 Transmission of Prescrip- transmitted by the practitioner or his/her two (72) hours of the first partial filling; how- tions authorized agent or under an oral prescription ever, if the remaining portion is not or cannot

28 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

be filled within the seventy-two- (72-) hour 19 CSR 30-1.066 Dispensing by Individual (A) The order is for a legitimate medical period, the pharmacist shall so notify the pre- Practitioners purpose and the practitioner who orders the scribing individual practitioner. No further administration of a controlled substance is quantity may be supplied beyond seventy-two PURPOSE: This rule sets requirements for acting in the usual course of his/her medical (72) hours without a new prescription. individual practitioners who dispense con- practice, after sufficient examination and trolled substances. establishment of a practitioner/patient rela- (2) The partial filling of a prescription for tionship; controlled substances listed in Schedules II, (1) An individual practitioner who dispenses (B) The practitioner who orders the admin- III, IV, or V is permissible, provided that— controlled substances shall— istration of a controlled substance is a medi- (A) Provide direct supervision to employ- cal staff member of the hospital; (A) Partial filling may occur at the request ees or agents who assist in the administering (C) The administration of a controlled sub- of a patient or it may be directed by the pre- or dispensing of controlled substances. Con- stance is documented in a formal medical scriber, unless the prescription is written for trolled substances shall not be dispensed from record for the patient; a patient in a long-term care facility (LTCF) an individual practitioner’s inventory unless a (D) The patient is assessed in the hospital or for a patient with a medical diagnosis doc- practitioner is physically in the registered by a practitioner, when available, or a regis- umenting a terminal illness, in which case the location except pursuant to the provisions of tered nurse. If the patient is not assessed by a pharmacist must record on the prescription section (2) of this rule; practitioner in the hospital, a registered nurse whether the patient is “terminally ill” or (B) Package all controlled substances dis- shall assess the patient and confirm and doc- “LTCF patient.”; pensed from an individual practitioner’s ument in the patient’s medical record the (B) Each partial dispensing is recorded in inventory in compliance with the Pre- existence of a preestablished pract- the same manner as a refilling would be; vention Packaging Act of 1970, 15 U.S.C. itioner/patient relationship with the practi- (C) With each partial dispensing, the phar- 1471–1476; tioner who ordered administration of a con- macy must document the date and quantity (C) Permanently affix a label to the exteri- trolled substance; dispensed on the original prescription record or of the drug container which includes: the (E) The order is written in the patient’s or their electronic computer applications, date, the name and address of the dispensing medical record and is authenticated by the provided that the electronic system meets all practitioner, the name of the patient, direc- ordering practitioner within a time frame and manner as defined by the medical staff in of the federal requirements for handling of tions for use, and the exact name and strength cooperation with nursing and administration. electronic prescriptions for controlled sub- of the drug dispensed for all controlled sub- stances dispensed; This policy shall be included in the hospital’s stances, including the ability to retrieve the written policies and procedures. information pertaining to partially filled con- (D) Dispense only to individuals with trolled substances; whom the practitioner has established and AUTHORITY: section 195.195, RSMo 1994.* (D) The total quantity dispensed in all par- documented a practitioner/patient relation- Original rule filed April 14, 2000, effective tial fillings cannot exceed the total quantity ship. An individual practitioner shall not dis- Nov. 30, 2000. prescribed; pense under the order of another practitioner (E) No dispensing occurs— not practicing at that location. *Original authority: 195.195, RSMo 1957, amended 1. For controlled substances listed in 1971, 1989, 1993. (2) Mid-level practitioners shall not indepen- Schedule II, after sixty (60) days after the dently purchase, stock, administer, and dis- date on which the original prescription was pense controlled substances. Controlled sub- 19 CSR 30-1.070 Emergency Dispensing of issued; and stances may be administered or dispensed Schedule II Substances 2. For controlled substances listed in from an individual practitioner’s inventory by Schedules III and IV after six (6) months a mid-level practitioner with whom he or she after the date on which the original prescrip- PURPOSE: This rule provides for the pre- has entered into an agreement pursuant to scribing and dispensing of Schedule II drugs tion was issued; Chapter 334, RSMo, when the practitioner is in an emergency situation. (F) A partial dispensing is not considered not present at the registered location. a “refill” if the patient does not receive the (1) In the case of a bona fide emergency sit- full authorized amount at one time; and AUTHORITY: section 195.195, RSMo 2000.* uation, as defined by the Department of (G) The prescription was written and filled Original rule filed April 14, 2000, effective Health, a pharmacist may dispense a Sched- in accordance with all other applicable laws Nov. 30, 2000. Amended: Filed April 29, ule II controlled substance upon receiving and regulations. 2011, effective Nov. 30, 2011. oral authorization of a prescribing practition- AUTHORITY: section 195.080, RSMo Supp. *Original authority: 195.195, RSMo 1957, amended er; provided, that— 2020, and section 195.195, RSMo 2016.* 1971, 1989, 1993. (A) The quantity prescribed and dispensed is limited to the amount adequate to treat the Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 29, patient during the emergency period. Pre- 19 CSR 30-1.068 Administering In Emer- scribing or dispensing beyond the emergency 2015, effective July 30, 2015. Emergency gency Rooms amendment filed Sept. 17, 2018, effective period must be pursuant to a written pre- Sept. 27, 2018, expired March 25, 2019. PURPOSE: This rule sets requirements for scription; Amended: Filed Sept. 17, 2018, effective administering controlled substances in hospi- (B) The prescription immediately shall be March 30, 2019. Amended: Filed Oct. 30, tal emergency rooms. reduced to writing by the pharmacist and 2020, effective April 30, 2021. shall contain all information, except for the (1) Controlled substances may be adminis- prescribing practitioner’s signature; *Original authority: 195.080, RSMo 1939, 1965, 1971, tered to a hospital emergency room patient (C) If the prescribing practitioner is not 1987, 1989, 1997, 2005, 2010, 2012, 2014, 2018, 2019 and under a verbal order of a registered practi- known to the pharmacist, s/he must make 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014. tioner who is not physically present if— reasonable effort to determine that the oral

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 29 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

authorization came from a practitioner, by may be refilled only as expressly authorized the person, including forms of identification verifying his/her phone number against that by the prescribing individual practitioner. If acceptable under federal regulations 8 CFR listed in the directory and other good faith this authorization is not given, the prescrip- 274a.2(b)(1)(v)(A) and (B). efforts to insure his/her identity; tion may not be refilled. A pharmacist dis- (D) Within seven days after authorizing an pensing those substances pursuant to a pre- (2) Dispensing Without a Prescription. A emergency oral prescription, the prescribing scription shall label the substance and file the controlled substance listed in Schedule V practitioner must cause a written prescription prescription. which is not a prescription drug under the for the emergency quantity prescribed to be federal Food, Drug and Cosmetic Act, and is delivered to the dispensing pharmacist. The (2) An individual practitioner may administer not a methamphetamine precursor product, prescription shall have written on its face or dispense directly a controlled substance may be dispensed by a pharmacist without a authorization for emergency dispensing. The listed in Schedule V in the course of his/her prescription to a purchaser at retail; provid- written prescription may be delivered to the professional practice without a prescription. ed, that— pharmacist in person or by mail, but if deliv- (A) Dispensing is made only by a pharma- ered by mail it must be postmarked within the (3) An institutional practitioner may adminis- cist and not by a non-pharmacist employee seven-day period. Upon receipt, the dispens- ter or dispense directly (but not prescribe) a even if under the supervision of a pharmacist ing pharmacist shall attach this prescription controlled substance listed in Schedule V (although after the pharmacist has fulfilled to the oral emergency prescription which had only pursuant to a written prescription signed his/her professional and legal responsibili- earlier been reduced to writing. The pharma- by the prescribing individual practitioner or ties, the actual cash transaction, credit trans- cist shall notify the Department of Health if pursuant to an oral prescription made by a action, or delivery may be completed by a the prescribing practitioner fails to deliver a prescribing individual practitioner and non-pharmacist); and promptly reduced to writing by the pharma- written prescription to him/her; failure of the (B) Dispensing, sale, distribution, or oth- cist (containing all information required pharmacist to do so shall void the authority erwise providing is limited to not more than except for the signature of the prescribing conferred by this section to dispense without two hundred forty cubic centimeters (240 cc) individual practitioner) or pursuant to an a written prescription of a prescribing practi- or eight ounces (8 oz.) of any controlled sub- order for medication made by an individual tioner. stance containing opium, nor more than one practitioner which is dispensed for immediate hundred twenty cubic centimeters (120 cc) or (2) Definition of Emergency Situation. For administration to the ultimate user. four ounces (4 oz.) of any other controlled the purpose of authorizing an oral prescrip- substance, nor more than forty-eight (48) AUTHORITY: section 195.195, RSMo 1994.* tion of a controlled substance listed in Sched- dosage units of any controlled substance con- Original rule filed April 14, 2000, effective ule II of the controlled substances law (sec- taining opium, nor more than twenty-four Nov. 30, 2000. tions 195.010–195.320, RSMo), the term (24) dosage units of any other controlled sub- emergency situation means those situations in *Original authority: 195.195, RSMo 1957, amended stance may be dispensed at retail to the same which the prescribing practitioner determines 1971, 1989, 1993. purchaser in any given forty-eight (48)-hour that— period. (A) Immediate administration of a con- trolled substance is necessary for proper 19 CSR 30-1.074 Dispensing Without a (3) Methamphetamine precursor products treatment of the intended ultimate user; Prescription may be sold, dispensed, distributed, or oth- (B) No appropriate alternative treatment is erwise provided only as follows: available, including administration of a drug PURPOSE: This rule provides for dispensing (A) Products that are designated Schedule which is not a controlled substance under Schedule V controlled substances without a V controlled substances which contain any Schedule II; prescription in certain situations. detectable amount of pseudoephedrine, (C) It is not reasonably possible for the ephedrine, , their salts prescribing practitioner to provide a written (1) Definitions. For the purposes of this rule, or optical isomers, or salts of their optical prescription to be presented to the person dis- the following terms shall apply: isomers may be sold, distributed, or other- pensing the substance prior to the dispensing. (A) “Dispenser” means a pharmacist, wise provided only by a pharmacist or phar- intern pharmacist, or registered pharmacy AUTHORITY: section 195.195, RSMo 1994.* macy ancillary personnel as authorized by the technician who sells, dispenses, or otherwise Missouri State Board of Pharmacy; Original rule filed April 14, 2000, effective provides methamphetamine precursor prod- Nov. 30, 2000. (B) Dispensers of methamphetamine pre- ucts to purchasers. cursor products shall exercise reasonable care (B)“Methamphetamine precursor prod- *Original authority: 195.195, RSMo 1957, amended in assuring that the purchaser has not exceed- ucts” means both Schedule V pseu- 1971, 1989, 1993. ed the three and six-tenths- (3.6-) gram limit doephedrine products and any other drug per day or the seven and two-tenths- (7.2-) product containing any detectable amount of gram limit per thirty- (30-) day period. With- 19 CSR 30-1.072 Dispensing of Schedule V ephedrine, pseudoephedrine, or phenyl- in any twelve- (12-) month period, no person Substances propanolamine, including the salts or optical isomers or salts of optical isomers or shall sell, dispense, or otherwise provide the PURPOSE: This rule provides for the pre- ephedrine, its salts or optical isomers, or salts same individual, and no person shall pur- scribing, administering and dispensing of of optical isomers of ephedrine, pseu- chase, receive, or otherwise acquire more Schedule V drugs. doephedrine, or phenylpropanolamine. than forty-three and two-tenths- (43.2-) (C) “Valid photo identification” means a grams, without regard to the number of trans- (1) A pharmacist may dispense directly a photo identification that is issued by a state or actions; controlled substance listed in Schedule V the federal government or a document that, (C) Dispensers shall utilize the real-time pursuant to a prescription. A prescription for with respect to identification, is considered electronic pseudoephedrine tracking system a controlled substance listed in Schedule V acceptable and showing the date of birth of established and maintained by the Missouri

30 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

Department of Health and Senior Services such as tablet, capsule, or milliliter, and database to see what changes and alterations (DHSS). No prescription shall be required number of dosages per transaction; or pharmacy employees have entered regarding for the sale or dispensing of these drug prod- (III) Other mechanism identified by sales of methamphetamine precursors. The ucts; however, prescribers and patients may the database provider/vendor; and date and time that the pharmacist-in-charge voluntarily choose to use a prescription by 9. Form of pseudoephedrine in a manner conducts this monthly review shall be docu- voluntary choice when deemed appropriate defined by the database provider/vendor, mented in the bound logbook maintained by by the prescriber in the course of his or her including but not limited to: the pharmacy in addition to the electronic professional practice; A. Tablet; system; (D) Methamphetamine precursor products B. Capsule; (K) Documentation in the bound logbook regulated by Missouri law as controlled sub- C. Liquid-filled gelcap; or shall be maintained in a readily retrievable stances shall only be sold to customers eigh- D. Liquid; manner for two (2) years from the date of the teen (18) years of age or older who present a (F) Purchaser information provided and transaction and available for inspection and valid photo identification; entered into the DHSS electronic database copying by authorized DHSS employees and (E) Any dispenser who sells, dispenses, or shall be the same as that on the presented law enforcement; otherwise provides any methamphetamine identification. Full names shall be used and (L) Denials of Sales and Dispensings. precursor product shall submit the following not merely initials or a nickname; 1. Except as provided in subsection (D) of information to the DHSS electronic database (G) If the DHSS electronic database is not this section, if an individual attempts to pur- at the time of purchase: available at the time of the sale of the chase a methamphetamine precursor product in 1. Date and time of transaction; methamphetamine precursor product, the violation of the three and six-tenths (3.6) gram 2. Pharmacy identification information, information to be provided in subsection per day or seven and two-tenths (7.2) gram per including: (3)(E) above shall be recorded manually and month quantity restrictions or age restriction A. National Council for Prescription entered into the DHSS electronic database as established by sections 195.017 and 195.417, Drug Programs identification number; or soon as practicable after the system is back RSMo, the dispenser shall refuse to make the B. National Association of Boards of online, as specified in subsection (3)(I). Sig- sale. The purchaser must be at least eighteen Pharmacy identification number; or natures shall be captured on paper and then (18) years of age. C. Vendor assigned site and/or phar- may be scanned to the database; 2. Sales of methamphetamine precursor macy identifier; (H) Every dispenser who sells, dispenses products shall be denied to purchasers who 3. Purchaser information, including the or otherwise provides any methamphetamine are not able to produce a valid government following fields: precursor product shall maintain a bound log- issued identification card with the required A. Purchaser’s given or first name; book in addition to the electronic database information displayed on it. B. Purchaser’s middle name (if any); system. The logbook shall be used for docu- 3. In the event that the dispenser per- C. Purchaser’s surname or last name; menting a clear audit trail of any alterations, ceives that refusal of the purchase may place D. The purchaser’s full name shall be changes, or deletions to the original transac- him or her in imminent physical harm, then entered into the database without the use of tion record, and sales that occurred during the dispenser may use the database safety initials or nicknames; system failures, including date and time of override function to proceed with the transac- E. Purchaser’s date of birth; and entry into the database, justification, and tion, provided that— F. Purchaser’s address, including resultant contacts with law enforcement A. When jeopardy is no longer per- number, street, city, state, and zip code; because the override button was used; ceived, the dispenser shall immediately con- 4. Identification of the form of valid (I) In the event that the DHSS electronic tact local law enforcement to report the pur- photo identification presented by the purchas- database is unavailable for five (5) minutes or chase; and er; including issuing agency of the photo more due to a failure on the DHSS network B. The dispenser shall document in identification and identification number or because of a failure attributable to systems their manual log, the circumstance, the indi- appearing on the photo identification; other than the DHSS, the dispenser may con- vidual contacted at the local law enforcement 5. Purchaser’s signature; tinue with the transaction until the system is agency, and the date and time of that contact; 6. Dispenser identification, including: available. All information required to be cap- (M) Pharmacy Employees. Employees in a A. The name of the individual per- tured with each transaction shall be retained pharmacy shall be assigned individual per- forming the transaction; or and documented. The information may be sonal passwords to identify their own trans- B. The initials of the individual per- entered into the database where it may be actions in the database. forming the transaction; held pending until the system comes back on 1. Pharmacy employees shall only use 7. Transaction number, assigned by the line, or all of the required information for their own passwords for their own transac- database provider/vendor; transactions occurring during the time the tions and shall not dispense or make a sale 8. Purchase transaction information, DHSS electronic database is unavailable must under the password of another person. including the following: be recorded manually and entered into the 2. The database computer shall not be A. Product Universal Product Code DHSS electronic database by the registrant as left on and unattended so that another person (UPC); soon as is practicable, but within no more can use the previous user’s password. Users B. Product National Drug Code than forty-eight (48) hours following the shall close out their personal access when (NDC) (optional); resumption of operability. Documentation their activities are completed. C. Unique product description; and shall also identify the reason for the late entry 3. The pharmacist-in-charge shall be D. Purchase quantity, in grams as— into the DHSS electronic database; responsible for insuring pharmacy employees (I) Product grams per box and (J) At least once each month, the pharma- have adequate password privileges. The phar- number of boxes in transaction; cist-in-charge shall review the logbook of macist-in-charge shall insure that new (II) Product grams per dosage form changes and the changes captured by the employees have their own personal passwords

JOHN R. ASHCROFT (3/31/21) CODE OF STATE REGULATIONS 31 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

and also insure that ex-employees have their AUTHORITY: section 195.017, RSMo Supp. *Original authority: 195.195, RSMo 1957, amended passwords removed from the system; 2020, and sections 195.030, 195.050, 1971, 1989, 1993. (N) Access to Database by Law Enforce- 195.195, and 195.417, RSMo 2016.* Origi- ment and Regulatory Agencies. nal rule filed April 14, 2000, effective Nov. 1. Access to the database and controlled 30, 2000. Emergency amendment filed Aug. 19 CSR 30-1.078 Disposing of Unwanted substance records shall be made available to 18, 2005, effective Aug. 28, 2005, expired Controlled Substances those agencies with authority under Chapter Feb. 23, 2006. Amended: Filed Sept. 1, 2005, 195 and Chapter 338, RSMo. effective Feb. 28, 2006. Emergency amend- PURPOSE: This rule establishes procedures 2. Law enforcement agencies and regu- ment filed July 9, 2010, effective Sept. 28, for disposing of unwanted controlled sub- latory agencies shall only have the ability to 2010, expired March 26, 2011. Amended: stances. Filed June 29, 2010, effective Jan. 30, 2011. read and review and shall not be able to enter Amended: Filed Oct. 30, 2020, effective April (1) A registrant in possession of any con- data or change records. 30, 2021. trolled substance(s) and desiring or required 3. It shall be the responsibility of each to dispose of such substance(s) shall: agency’s administrator, chief, sheriff, or *Original authority: 195.017, RSMo 1971, amended 1987, (A) Return the controlled substances to the other chief executive officer to insure— 1989, 1994, 1996, 1997, 1998, 2001, 2005, 2006, 2008, original supplier; A. Only authorized employees have 2010, 2011, 2014, 2018, 2020; 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1997, 1999, 2014; (B) Transfer the controlled substances to a access to the database; 195.050, RSMo 1939, amended 1971, 1989, 2014; distributor authorized to accept controlled B. Employees only use their own 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014; substances for the purpose of disposal; passwords and passwords are not shared; and 195.417, RSMo 2001, amended 2003, 2005, 2008, (C) Retain a DEA Form 41 in compliance C. Each employee adheres to all state 2014, 2020. with federal regulations; and federal laws regarding confidentiality; (D) Become an Authorized Collector of and 19 CSR 30-1.076 Emergency Distribution Controlled Substances. Registrants shall dis- D. As employees change, that new by a Pharmacy pose of all unwanted controlled substances passwords are assigned to new employees and and keep records in accordance with federal passwords of ex-employees or transferred PURPOSE: This rule provides for dispensing regulations. Only manufacturers, distributors, employees are removed. The chief, sheriff, of controlled substances by a pharmacy in reverse distributors, narcotic treatment pro- or chief executive officer of the law enforce- emergency situations. grams, hospitals/clinics with an on-site phar- ment or regulatory agency shall notify the macy, and retail pharmacies that have modi- DHSS in writing when an employee’s access (1) An emergency means a situation where a fied their state and federal controlled quantity of a controlled substance must be is to be added or removed; and substances registrations may possess a collec- dispensed by a pharmacy to a patient who (O) Method for Enforcement Agencies to tion receptacle for medication disposal or does not have an alternative source for that participate in the DEA approved mail-back Gain or Alter Access to the Database. substance reasonably available to him/her and system; 1. Requests submitted to the DHSS to the pharmacy cannot obtain that substance (E) Contact the Bureau of Narcotics and add or remove an employee from access to through its normal distribution channels Dangerous Drugs (BNDD), Department of the database shall— within the time required to meet the immedi- Health and Senior Services for information A. Be submitted in writing on the ate needs of the patient for that substance. In pertaining to subsections (1)(A), (B), (C) or agency’s letterhead; the event of an emergency, a pharmacy may B. State whether this is a request for distribute (without being registered as a dis- (D) of this rule. an employee to be granted access to the tributor) a controlled substance in Schedule (2) Destruction of controlled substances in database or a request to remove an employ- III, IV or V to a second pharmacy in order ee’s access; for that pharmacy to dispense the substance; patient care areas. (A) Controlled substances that have been C. Provide the employee’s full name provided, that— contaminated by patient contact are to be and title; (A) The amount distributed does not destroyed on site. An excess volume of a con- D. Provide the employee’s Missouri exceed the amount required by the second trolled substance which must be discarded POST certification number if the employee is pharmacy for his/her immediate dispensing; from a dosage unit just prior to administra- a sworn law enforcement officer; and (B) The distribution is recorded as being tion shall also be destroyed on site. E. Be signed by the chief, sheriff, or dispensed by the first pharmacy and the sec- ond pharmacy records the substance as being (B) Controlled substances that have not chief executive officer of the requesting agen- been contaminated by patient contact or are cy. received. Each pharmacy will retain a signed receipt of the distribution; not excess volumes of a dosage unit shall not 2. Multiple requests for multiple be destroyed on site unless the registrant employees and actions may be submitted on (C) The second pharmacy is registered to dispense the controlled substance to be dis- maintains a DEA Form 41 in compliance one (1) letter. tributed to him/her; with federal regulation. Unwanted controlled 3. The DHSS shall notify the provider of (D) If the substance is a Schedule II con- substances that have been expired, discontin- the database in writing of persons who are trolled substance, the official order form des- ued, or are otherwise unwanted shall be dis- given access or have access removed. ignated by the federal Drug Enforcement posed of by methods listed previously in sec- 4. The DHSS may restrict access to the Administration must be used to document the tion (1) of this rule. database to a limited number of people in transfer. (C) In a patient care area of a hospital with each agency, depending on the size of the an on-site pharmacy, unwanted controlled agency, their locations, and number of sworn AUTHORITY: section 195.195, RSMo 1994.* substances that have not been contaminated officers engaged in the actual enforcement of Original rule filed April 14, 2000, effective by patient contact shall be returned to the controlled substance laws. Nov. 30, 2000. pharmacy for final disposal.

32 CODE OF STATE REGULATIONS (3/31/21) JOHN R. ASHCROFT Secretary of State Chapter 1—Controlled Substances 19 CSR 30-1

(D) The destruction of controlled sub- 5. The following shall be entered in the (C) Record keeping for collection recepta- stances shall be in such a manner that it ren- controlled substance administration record or cle boxes. Registrants or their employees ders the medication unrecoverable and a separate controlled substance destruction shall not inventory the contents of the collec- beyond reclamation so that it cannot be record when the controlled substance(s) is tion receptacle box. The collection receptacle diverted. destroyed in the patient care area: the date box is to be opened by two (2) people; one (E) The destruction and documentation of and hour of destruction, the drug name and shall be an employee of the pharmacy and the destruction shall be performed and completed strength, the amount destroyed, the reason other may be an employee of the facility by two (2) people. One of the people must be for destruction, and the patient’s name and receiving pharmaceutical services. All regis- a licensed physician, nurse, pharmacist, intern room number. The nurse, pharmacist, or trants with collection receptacle boxes shall pharmacist, or pharmacy technician, assistant physician and the witnessing hospital employ- maintain a perpetual log that documents entry physician, physician assistant, podiatrist, ee shall sign the entry. The drug shall be into the collection receptacle box, changing optometrist, dentist or veterinarian. The sec- destroyed so that it is beyond reclamation. of liners, and transfers of drugs from the reg- ond person, the witness, is not required to be The controlled substance administration or istrant to a reverse distributor. These logs a licensed medical professional, but must be destruction records are to be retained for two shall be maintained on file at the registered an employee of the registrant, unless in an (2) years and available for inspection by location for inspection and shall document EMS setting. Department of Health investigators; the date of entries into the collection recepta- (F) The following shall be entered in the 6. All other controlled substances which cle box, the names of the employees entering controlled substance administration record or are not patient contaminated but which are to the collection receptacle box, the reason for a separate controlled substance destruction be disposed of shall be returned to the phar- entering the receptacle, the serial number of record when the controlled substance is macy for disposal; a liner being removed, and the serial number destroyed in the patient care area: the date (B) When disposal of controlled sub- of a new liner being installed. This log shall and hour of destruction, the drug name and stance(s) is in the pharmacy— also be used to document the transfer of a strength, the amount destroyed, the reason 1. Single units of controlled substance(s) liner from the registrant to a reverse distribu- for destruction, and the patient’s name and which are contaminated other than by patient tor by documenting the date of transfer, seri- room number if applicable, and the names or body fluids and are not an infectious hazard, al number of the liner, names of the persons initials of the two (2) persons performing the have been removed from their original or involved in the transfer, and the DEA number destruction. The controlled substance admin- security packaging, are partially used, or are of the reverse distributor. The log shall also istration and destruction records are to be otherwise rendered unsuitable for patient use document when the pharmacy changes out retained for two (2) years and available for shall be destroyed by a pharmacist in the the interior liner bags and document the seri- inspection by the Department of Health and presence of another hospital employee or held al number of the bag being removed and of Senior Services; for later destruction; the new bag being installed. 2. All other controlled substances which (3) In the event the registrant is a hospital, are not patient contaminated but are to be dis- AUTHORITY: sections 195.050 and 195.195, the following procedures are to be used for posed of shall be placed in a suitable con- RSMo Supp. 2018.* Original rule filed April the destruction of controlled substance(s): tainer for storage and disposed of as 14, 2000, effective Nov. 30, 2000. Emergen- (A) When disposal of controlled sub- described in section (1) of this rule. cy amendment filed Sept. 17, 2018, effective stance(s) is in patient care areas— Sept. 27, 2018, expired March 25, 2019. 1. Controlled substances which are con- (4) Collection Receptacle Boxes and Mail- Amended: Filed Sept. 17, 2018, effective taminated by patient body fluids are to be Back Programs for Patients’ Unwanted Con- March 30, 2019. destroyed by a physician, nurse, or a pharma- trolled Substance Prescriptions. *Original authority: 195.050, RSMo 1939, amended cist in the presence of another hospital (A) Manufacturers, distributors, reverse 1971, 1989, 2014 and 195.195, RSMo 1957, amended employee; distributors, narcotic treatment programs, 1971, 1989, 1993, 2014. 2. An excess volume of a controlled sub- hospitals/clinics with an on-site pharmacy, stance which must be discarded from a and retail pharmacies are authorized to install dosage unit just prior to use shall be collection receptacle boxes or participate in a 19 CSR 30-1.080 Electronic Prescribing destroyed by a nurse, pharmacist, or physi- DEA approved mail-back method to collect Waiver cian in the presence of another hospital unwanted controlled substance prescription employee; from patients. Registrants must PURPOSE: This rule establishes the process 3. The remaining contents of opened comply with federal regulations regarding for practitioners to obtain waivers to the elec- glass ampules of controlled substance(s) shall security and record keeping. Collection tronic prescribing requirements established be destroyed by a nurse, pharmacist, or receptacles shall be used only for patients’ by section 195.550, RSMo. physician in the presence of another hospital unwanted medications and not for the expired employee; or unwanted stock of a practitioner or facili- (1) Practitioners required to utilize electronic 4. Single units of single dose packages ty. prescribing pursuant to section 195.550, of controlled substance(s) which are contam- (B) All facilities and locations with collec- RSMo may request a waiver of this require- inated other than by patient body fluids and tion receptacle boxes and mail-back systems ment from the Department of Health and are not an infectious hazard, have been shall comply with federal regulations. Senior Services. removed from their original or security pack- 1. Patients’ medications from long-term (A) Applications shall only be submitted aging, are partially used, or are otherwise care facilities and narcotic treatment pro- by practitioners with active Missouri Con- rendered unsuitable for patient use shall be grams shall be placed in a receptacle within trolled Substance Registrations. Applications destroyed by a nurse, pharmacist, or physi- three (3) days of the expiration date on the shall not be submitted by a registrant’s cian in the presence of another hospital medication; or upon a discontinuation of use designee or representative. employee or returned to the pharmacy for authorized by a prescriber; or upon the death (B) Applicants requesting a waiver shall destruction; of a patient. submit an application for a waiver by sending

JOHN R. ASHCROFT (5/31/21) CODE OF STATE REGULATIONS 33 Secretary of State 19 CSR 30-1—DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30—Division of Regulation and Licensure

their application to [email protected]. A sample application may be found on the Depart- ment’s website, www.health.mo.gov/safety/bndd. (C) The application shall include: 1. Applicant’s first and last name; 2. Applicant’s licensure type; 3. Applicant’s Missouri Controlled Sub- stance Registration number; 4. Applicant’s email address; 5. The Applicant shall indicate for which of the following reasons they are seek- ing a waiver: A. Economic hardship; B. Technological limitations; or C. Other exceptional circumstances; 6. The Applicant shall provide any addi- tional details they consider necessary to sup- port their waiver request; 7. The Applicant shall certify that the information included in their application is true and accurate; and 8. The Applicant shall sign and date the application. An electronic signature will sat- isfy this requirement. (D) Waivers granted by the department shall be valid for one (1) year after the date on which they are issued. (E) Waivers shall be kept on file at the practitioner’s primary, principle practice location and available for review by the department.

AUTHORITY: section 195.550, RSMo Supp. 2020.* Emergency rule filed Dec. 15, 2020, effective Dec. 31, 2020, expired June 28, 2021. Original rule filed Dec. 15, 2020, effective June 30, 2021.

*Original authority: 195.550, RSMo 2019.

34 CODE OF STATE REGULATIONS (5/31/21) JOHN R. ASHCROFT Secretary of State