Index of Citations (09/01/2024)
Citations apply to controlled substances only
Statutes are in Chapter 195 and Chapter 579, RSMo.
Regulations are in 19 CSR 30 Chapter 1
DEA Federal Regulations are in Title 21 CFR Section 1300
Registration Issues
| Violation | Authority/Citation |
|---|---|
| Registration required before activities take place | 195.030.2 RSMo; 19 CSR 30-1.017(2)(A) |
| Activity must be within authority of license and registration | 195.030.3 RSMo; 19 CSR 30-1.026(2) |
| When registrations are required at multiple locations | 195.030.6 RSMo; 19 CSR 30-1.026(3) |
| Fees for registration & exemptions & fees not refundable | 19 CSR 30-1.015(3) |
| Missouri practice locations required for full registrations | 19 CSR 30-1.019(2) |
| Requirement to notify BNDD of change in address or name | 19 CSR 30-1.023(1)(c) |
| Failure to notify BNDD of change in address within 30 days | 19 CSR 30-1.023(2) |
| DEA Certificate must be on site and retrievable | 21 CFR 1301.35(c) |
| Disposal drug box requires registration modification | 19 CSR 30-1.078(1)(D) |
Grounds for Denying/Revoking Registration
| Reason for Denial/Revocation | Authority/Citation |
|---|---|
| Person abusing drugs cannot have a registration | 195.040.2 RSMo |
| No registration for 7 years if guilty plea to felony drug crime | 195.040.2 RSMo |
| No registration for 2 years if guilty plea to misdemeanor drug crime | 195.040.2 RSMo |
| Applicant did not maintain controls to prevent diversion | 195.040.3(1) RSMo |
| Noncompliance with applicable state and local laws | 195.040.3(2) RSMo |
| Conviction(s) under state or federal laws | 195.040.3(3) RSMo |
| Establishment lacks controls against diversion | 195.040.3(4) RSMo |
| Provided false information on application | 195.040.3(5) RSMo |
| DEA registration has been revoked/suspended | 195.040.3(6) RSMo |
| Other factors consistent with public health | 195.040.3(7) RSMo |
| Professional license not currently active | 19 CSR 30-1.017(5)(H) |
| Application not completed – no response in 60 days | 19 CSR 30-1.017(3)(D) |
DEA Form 222 – Official Order Forms
| Violation | Authority/Citation |
|---|---|
| C2 purchasing/receipt procedures not followed | 195.050.3 RSMo |
| Order form not used to obtain/transfer C2 | 21 CFR 1305.03 |
| Agent/employee executing forms without power of attorney | 21 CFR 1305.04/1305.05 |
| Electronic 3rd copy off computer – no date of receipt | 21 CFR 1305.22(g) |
Agencies with Access to Records
| Access Detail | Authority/Citation |
|---|---|
| BNDD has access to drug record | 195.050.6 RSMo 195.375.5 RSMo 579.084 RSMo 19 CSR 30-1.041(2) |
| Law Enforcement has access to drug records | 195.375.5 RSMo |
| Records must be produced to BNDD within 3 days | 19 CSR 30-1.044(5) |
Record Keeping
| Violation | Authority/Citation |
|---|---|
| Required records must be maintained | 195.050.6 RSMo |
| Pharmacy prescription records not readily available | 195.060.1 RSMo |
| Pharmacy prescription records not maintained for 2 years | 195.060.1 RSMo |
| Failure to keep, maintain or furnish any drug record | 579.084 RSMo |
| Drug records not kept for 2 years | 19 CSR 30-1.041(2) |
| Drug records not maintained at registered location | 19 CSR 30-1.041(2) |
| Drug records stored at central location without permit | 19 CSR 30-1.041(2) |
| Drug records not available for inspection | 19 CSR 30-1.041(2) |
| C2 records not separate from C3-C5 – pharmacy | 19 CSR 30-1.041(4) |
| C2 records not separate from C3-C5 – pract, dist, import, export | 19 CSR 30-1.041(3) |
| Manuf, Distrib, Import and Export records not readily retrievable | 19 CSR 30-1.041(3) |
| Pharmacy records not readily retrievable | 19 CSR 30-1.041(4) |
| Separate inventory lacking for separate location | 19 CSR 30-1.042(1)(B) |
| Initial Inventory lacking (must be within 2 years) | 19 CSR 30-1.042(2)(A) |
| Annual Inventory lacking | 19 CSR 30-1.042(3) |
| New controlled substance not on inventory | 19 CSR 30-1.042(4) |
| Drug records are to be current, complete and accurate | 19 CSR 30-1.044(1) |
| Dispensing log – what information is required | 19 CSR 30-1.048(1) |
| Dispensing log non-existent | 19 CSR 30-1.048(1) |
| Receipt records incomplete- what is required | 19 CSR 30-1.048(1) |
| Receipt records non-existent | 19 CSR 30-1.048(1) |
| Disposal/waste/destruction records incomplete | 19 CSR 30-1.048(1) |
| Disposal/waste/destruction records non-existent | 19 CSR 30-1.048(1) |
| Administration records C2-C5 incomplete-what is required | 19 CSR 30-1.048(2) |
| Prescribing records for C2 incomplete | 19 CSR 30-1.048(2) |
| Drug transfer records incomplete | 19 CSR 30-1.048(4) |
| Drug transfer records non-existent | 19 CSR 30-1.048(4) |
| DEA Order Form 222 not used to transfer C2 | 19 CSR 30-1.048(5) |
| Practitioner not filing faxed scripts in separate chronological file | 19 CSR 30-1.048(7) |
| LTCF not maintaining E-kit transfer records | 19 CSR 30-1.052(1) |
| Expired drug destruction records incomplete/non-existent | 19 CSR 30-1.078(1) |
| Pharmacy computer system unable to retrieve records | 21 CFR 1306.22(b) |
| Records not available for inspection | 19 CSR 30-1.041(2) |
| Daily printout of electronic communicated transmissions Not maintained properly | 19 CSR 30-1.048(9) |
Practitioners Required to Maintain Patient Charts
| Violation | Authority/Citation |
|---|---|
| Requirements for charts and contents by physicians | 334.097 RSMo |
| Requirements for charts and contents by dentists | 332.052 RSMo |
| Requirements for charts and contents by veterinarians | 340.284 RSMo 20 CSR 2270-4.041 20 CSR 2270-6.011(8) |
Controlled Substance Security
| Violation | Authority/Citation |
|---|---|
| Controls and procedures must be adequate to detect and prevent diversion | 19 CSR 30-1.031(1) |
| Physical security not commensurate with types and quantities of drugs | 19 CSR 30-1.031(2) |
| Non-practitioner lacks system to detect suspicious orders | 19 CSR 30-1.032(2) |
| Non-practitioner fails to notify BNDD of loss/theft | 19 CSR 30-1.032(3) |
| Practitioner must lock C2 drugs | 19 CSR 30-1.034(1)(A) |
| Practitioner must lock C3-C5 drugs | 19 CSR 30-1.034(1)(B) |
| Person with guilty pleas for drug crimes must have waivers to access drugs | 19 CSR 30-1.034(2)(A) |
| Practitioner failed to notify BNDD of loss/theft | 19 CSR 30-1.034(2)(B)(1) |
| Records inadequate to conduct audit of drugs | 19 CSR 30-1.031(1) |
| Prescription pads left out unattended in patient area | 19 CSR 30-1.031(1) |
| Pre-signing a blank prescription-still found blank | 19 CSR 30-1.062(3) |
| Pre-signing a blank prescription-drugs were dispensed | 19 CSR 30-1.062(3) |
Packaging and Labeling
| Violation | Authority/Citation |
|---|---|
| Childproof containers required | 19 CSR 30-1.066(1)(B) |
| Labeling requirements for containers | 195.100.5 RSMo 19 CSR 30-1.066(1)(C) |
| Label that warns patient against illegal transfer | 195.100.3 RSMo |
Retail Pharmacy Dispensing
| Violation | Authority/Citation |
|---|---|
| Prescription valid for only 6 months | 195.060.1 RSMo |
| Dispensed fraudulent/invalid or incomplete prescription | 195.060.1 RSMo |
| Dispensed C2 prescription without practitioner’s signature | 195.060.1 RSMo 19 CSR 30-1.062(1) |
| Dispensed Rx must document pharmacy employee and date dispensed | 195.060.1 RSMo |
| Dispensing must occur in good faith | 195.060.1 RSMo |
| Unauthorized refill of C2 prescription | 195.060.1 RSMo |
| C3-C5 prescriptions refilled more than 5 times | 195.060.1 RSMo |
| Dispensing more than allowable supply | 195.080.2 RSMo |
| Fail to notify BNDD when prescriber did not supply original C2 prescription for emergency | 19 CSR 30-1.070(1)(D) |
| Practice pharmacy without license | 338.010.2 RSMo |
| Partial dispensing of prescriptions | 19 CSR 30-1.064 |
| Prescriber must fill out prescription/pharmacy cannot fill out | 21 CFR 1306.04 21 CFR 1306.05 |
Practitioner Prescribing
| Violation | Authority/Citation |
|---|---|
| Prescription must bear the date it was issued – no post dating | 195.060.1 RSMo |
| Prescription must be signed by prescriber | 195.060.1 RSMo |
| Prescribed outside of scope of professional practice | 195.070.1 RSMo |
| Prescribed without established practitioner/patient relationship | 195.070.1 RSMo |
| Prescribed outside scope of veterinary practice | 195.070.2 RSMo |
| Practitioner cannot prescribe or dispense to self | 195.070.4 RSMo |
| Cannot prescribe to obtain office stock for administering and dispensing in office | 19 CSR 30-1.048(6) |
| Pre-signing a blank prescription – found blank | 19 CSR 30-1.062(3) |
| Pre-signing a blank prescription – drugs were dispensed | 19 CSR 30-1.062(3) |
| Emergency oral C2 prescription issued in a non-emergency | 19 CSR 30-1.070(1) |
| Prescribed opiates to addict for unauthorized detoxification | 21 CFR 1306.07 |
| Requirements of a prescription – prescriber must complete | 21 CFR 1306.05(a) |
| Use of false DEA number | USC CSA 843(c)(a)(2) |
| Refills overlapping too soon causes diversion | 19 CSR 30-1.031(1) |
| Patient chart not documented to determine if a refill is timely | 19 CSR 30-1.048(2) 19 CSR 30-1.031(1) |
| Written C2 prescription must be written to cover emergency oral prescription within 7 days | 19 CSR 30-1.070(1)(D) |
| Physical examination required by practitioner | DEA case law |
| Faxed prescription must bear fax number, date and time of transmission | 19 CSR 30-1.048(7) |
| Prescriber must fill out prescription/pharmacy can not | 21 CFR 1306.04 21 CFR 1306.05 |
| Mid-Level practitioners limited to only a 5 day supply of opiates | 195.070.2 RSMo |
| Mid-Level’s only C2 drug authority is for hydrocodone only | 195.070.2 RSMo |
| First time or new prescription for opiates is limited to 7 days | 195.080.2 RSMo |
| Patients receiving opiate prescriptions must receive counseling | 195.080.2 RSMo |
| C2 prescriptions must be issued to patient or pharmacy on same date issued | 19 CSR 30-1.062(3) 21 CFR 1306.05 |
| Electronic prescribing required unless practitioner has waiver | 195.550 RSMo |
| Practitioner may take possession of patient prescription for office use, only if authorized by DEA | 195.070 RSMo |
Practitioner Dispensing
| Violation | Authority/Citation |
|---|---|
| Dispense without established practitioner-patient relationship | 195.070.1 RSMo 19 CSR 30-1.066(1)(D) |
| Dispense outside of scope of practice | 195.070.1 RSMo |
| Unsupervised dispensing by staff | 195.070.1 RSMo 19 CSR 30-1.066(1)(A) |
| Dispensing outside of scope of veterinary practice | 195.070.3 RSMo |
| Dispensing drugs to self for personal use | 195.070.5 RSMo |
| For non-controlled drugs, physician must follow State Regulation | 20 CSR 2150-5.020 |
| Dispensing log must have required information | 19 CSR 30-1.048(2) |
| Disposing of partial doses contaminated by patient contact | 19 CSR 30-1.078(2) |
| Disposing of drugs that are expired, not contaminated by patient | 19 CSR 30-1.078(1) |
Criminal Violations
| Violation | Authority/Citation |
|---|---|
| Drug activities without a registration | 579.084 RSMo |
| Fraudulently obtain a drug by fraud/misrepresentation | 579.045 RSMo |
| Fail to make, keep, maintain or provide a drug record | 579.084 RSMo |
| Falsifying a drug record for theft/diversion | 579.045 RSMo |
| Possess or utter a forged prescription | 579.045 RSMo |
| Possess illegal drug paraphernalia | 579.074 RSMo |
| Practicing pharmacy without a license | 338.010.2 RSMo |
| Practicing medicine without a license | 334.010 RSMo |
| Stealing a controlled substance | 570.030.5(m) RSMo |